Chicago Injury Law Blog

Recently, the FDA notified consumers and healthcare professionals about reports of serious medical errors where patients had mistakenly used Maalox Total Relief, when they intended to use a Maalox liquid antacid.  Both products are available without a prescription, but are not interchangeable. Consumers were confusing traditional Maalox with Maalox Total Relief, an anti-diarrhea medication that contains strong drug ingredients which may cause internal bleeding. Traditional Maalox uses a gentler formula which helps neutralize stomach acid. Due to the confusion, Novartis, the manufacturer of Maalox, has agreed to change the name and packaging of the potent medication Maalox Total Relief.

The FDA has announced that children and teenagers recovering from illness should not take the higher-strength Maalox. The higher-strength Maalox can also negatively interact with certain medications, such as oral antidiabetic drugs, anti-inflammatory drugs like aspirin, and the blood thinners warfarin and Plavix.

Avandia, a popular drug used to treat Type 2 diabetes, has been linked to a higher risk of heart attack and heart failure than any other diabetes drug. The drug has recently made headlines due to the uncovering of confidential government reports, in which doctors from the Food and Drug Administration concluded that “Rosiglitazone [Avandia] should be removed from the market.”

The uncovered reports are part of an intense debate over whether the federal agency should withdraw Avandia from the market. The debate has also been fueled by disagreements over a new clinical trial on the risks of Avandia and a Senate investigation which concluded that Avandia’s manufacturer, GlaxoSmithKline, should have warned patients about its risks years earlier. As Senator Baucus, a Montana Democrat who oversaw the Senate advisory committee on Avandia stated, “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.”

At one time, Avandia was one of the biggest-selling drugs in the world, until the risks associated with taking it emerged in 2007. Hundreds of thousands of diabetics still use Avandia, although top endocrinologists have stopped prescribing it. Avandia was ranked first among all prescribed drugs for the number of resulting serious or fatal problems, including 304 deaths in just the third quarter of 2009.

Contact an Experienced Pharmaceutical Litigation Attorney

If you or a loved one has suffered a heart attack or been diagnosed with congestive heart failure after taking Avandia, please contact the Pintas firm immediately. Our law firm will provide you with a free no-obligation consultation and explain your legal rights. However, do not discontinue taking your medication unless you have checked with your physician first.

Recently, the FDA warned consumers that a counterfeit version of the over-the-counter weight loss product Alli could be harmful. The counterfeit Alli has been sold in 60mg capsules as part of a 120 count refill kit on online auction websites like Ebay. The manufacturer of Alli, GlaxoSmithKline, has stated that tests on the counterfeit version of the drug showed that it contained sibutramine. Sibutramine may interact adversely with other medications, and should not be ingested by patients with certain medical conditions.

Consumers can identify counterfeit versions of the drug through the following differences:

(1)    There is no “LOT code” on the top of the outer cardboard packaging of the counterfeit version.

(2)    The genuine version has an expiration date that only includes the month and the year.

(3)    The counterfeit version does not have the statement “SEALED FOR YOUR PROTECTION” on the seal of the bottle.

(4)    The counterfeit version has a slightly larger capsule size.

(5)    The content of the capsules in the counterfeit version is powdery, which is not true in the genuine version.

Consumers who believe they have purchased the counterfeit version of the drug should contact the FDA at http://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm.

Recently, the United States Food and Drug Administration (FDA) added new warnings to the weight loss pill Meridia.  On the same day, the European Medicines Agency (the European equivalent of the FDA) advised doctors and pharmacists to stop using the drug as the “risks…are greater than their benefits”. The FDA’s new warnings indicate the increased risk of heart attacks and strokes in patients who have a history of heart problems, such as heart failure, hypertension and irregular heartbeats.  Public Citizen, a consumer advocacy group, criticized the FDA for not being tougher with warnings for the drug.  Last year, the group petitioned the FDA to take Meridia off the market due to new data regarding risks of heart problems resulting in death. The group has estimated that Meridia was prescribed to a quarter million patients last year.

Contact an Experienced Personal Injury Attorney

Our attorneys have extensive experience in drug litigation cases. If you or someone you know has suffered from a heart attack or stroke as a result of taking Meridia, contact the Pintas firm immediately. Our Chicago law firm will provide you with a free consultation and an explanation of your legal rights.  

On November 7, 2008 Ethex Corporation, a subsidiary of KV Pharmaceuticals, issued a nationwide recall of five of its generic drugs.   The recall was due to the risk that the pills contained a higher dosage of medication than indicated.  These drugs were carried by pharmacies and wholesalers all over the country.

Some patients received up to twice the intended dosage, and were hospitalized due to the overdoses.   One of the serious complications from overdose of these drugs is arrhythmia, or abnormal heart rhythm.  Symptoms associated with arrhythmia include dizziness, discomfort in one’s chest, shortness of breath, and lightheadedness.  In some cases, heart surgery will be necessary to treat this condition.

Since the November 2008 recall, Ethex has recalled all of their drugs.  In January 2009, the FDA expanded the earlier recall to include 60 generic drug products manufactured by Ethex Corp, as the company may not have complied with federal manufacturing regulations.  The recalled products include narcotics, cardiac medications, prenatal vitamins, and iron supplements.  The FDA also ordered KV Pharmaceuticals and its subsidiaries to stop production and shipment of their drugs for over a year. In February 2009, additional recalls were issued by Ethex and another subsidiary of KV pharmaceuticals, the Ther-Rx Corporation.

Anyone who has purchased drugs affected by this recall should return the medication to their pharmacy for a replacement or refund.  If you believe you have suffered complications as a result of taking the recalled pills, you should seek medical help immediately.  Please visit the following links to see lists of recalled drugs on different recall dates:

November 2008 Recall

January 2009 Recall

February 2009 Recall by Ethex

February 2009 Recall by Ther-RX

Contact an Experienced Attorney

Our attorneys have extensive experience in drug litigation cases. If you or someone you know has suffered complications such as arrhythmia as a result of taking generic drugs manufactured by Ethex or Ther-Rx Corp, contact the Pintas firm immediately. Our Chicago law firm will provide you with a free consultation and an explanation of your legal rights.  

McNeil Consumer Healthcare, a division of Johnson & Johnson, recently recalled several hundred batches of popular over-the-counter medicines: Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin, and Tylenol.  The batches were recalled after McNeil received complaints about moldy-smelling bottles of Tylenol Arthritis Relief Caplets.  As a result, some consumers have reported temporary digestive problems like nausea, vomiting, and stomach pain.  The company has reported that the moldy smell is the result of breakdown of a chemical (2,4,6-tribromoanisole) used to treat wood pallets that transport and store product packaging.

The FDA issued an inspection report asserting McNeil failed to respond quickly to the problems consumers experienced.  The report states that the recall came 20 months after the company first received consumer complaints about Tylenol.  The FDA report also noted that McNeil did not conduct a thorough investigation, failed to quickly identify the source of the problem, and did not notify authorities in a timely fashion.

Gabby Swank, a teenager in high school, decided to get the Gardasil vaccine after seeing the popular commercials. After she got each dose of the vaccine she became more and more ill, eventually suffering from seizures, strokes and heart problems.  Eventually, her neurologist determined that Gardasil was to blame for her condition. Gardasil is a vaccine given to prevent certain types of the human papillomavirus which lead to cervical cancer and genital warts.

In 2008, the US government and Gardasil’s manufacturer concluded that there was no link between Gardasil and severe health effects like the ones Gabby Swank suffered.  However, the National Vaccine Information Center, a private vaccine-safety group, later reported that Gardasil had three times the number of Emergency Room visits compared to another vaccine given to young people for meningitis.  Currently, there have been over 30 deaths reported in two years with regard to Gardasil.

Some severe side effects that have been associated with Gardasil include:

1.      Seizures

2.      Blood clots

3.      Paralysis

4.      Bell’s palsy: This is a condition where problems arise with one’s facial nerve, and the sufferer is unable to control facial muscles in the affected area.

5.      Guillain-barré syndrome: This is an autoimmune disorder that affects one’s nervous system. It is usually severe, and is characterized by continued paralysis that begins with weakness in one’s legs and spreads to the upper limbs and face.

6.      Miscarriage or spontaneous abortion

Contact an Experienced Attorney

Personal injury attorneys at Pintas Law Firm are currently representing clients who suffered injuries as a result of taking Gardasil. If you have suffered of the above side effects following the Gardasil vaccine, contact us for a free consultation.

The FDA recently announced that it would review the safety of widely used anemia drugs sold by Amgen and Johnson & Johnson: Aranesp, Epogen, and Procrit.  This announcement comes in the wake of a finding that high doses of the anemia drug Aranesp might lead to an increased risk of heart attacks, blood clots and strokes in its users.  A recently published commentary in The New England Journal of Medicine stated that the new findings raise “major concerns” about drugs used to treat anemia caused by chronic kidney disease.

The FDA also plans to consider new ways to control the doses of these drugs. Since 2007, the FDA has held three advisory panel meetings regarding these drugs, and has changed the labels accordingly to warn of risks associated with them.

Some experts have called for additional caution due to the new commentary from the New England Journal Medicine. Dr Ajay Singh of Brigham Women’s Hospital and Harvard Medical School has stated that avoiding the use of drugs in kidney patients not undergoing dialysis “is now the soundest approach.”

Contact an Experienced Personal Injury Attorney

Personal injury attorneys at Pintas Law Firm are currently representing clients who suffered injuries as a result of taking anemia drugs such as Aranesp, Epogen, and Procrit. If you have suffered a heart attack, a stroke, or other complication involving blood clots following a course of treatment with these drugs, contact us for a free consultation. 

The FDA and the Texas Department of State Health Services recently notified healthcare professionals and consumers about the dangers of the product Nzu, which is a traditional remedy sold in African specialty stores for morning sickness.  This medical alert applies especially to pregnant or breastfeeding women, and came in the wake of the discovery of high levels of lead and arsenic found in the product.

Exposure to lead may expose a developing child to risks of brain and nervous system defects.  Long-term exposure to arsenic has been linked to many adverse health effects, including bladder cancer, lung cancer and skin cancer.

Nzu is also referred to by the names:

(1)    Calabash Clay

(2)    Calabar Stone

(3)    Mabele

(4)    Argile

(5)    La Craie

The Pintas Law Firm has extensive experience in drug litigation. If you or your child has experienced any of the complications listed above while taking Nzu, contact our firm immediately. We will provide you with a free no-obligation consultation and explain your legal rights.

Recently, it was reported that radiation overexposure from CT scans may be more severe than health care professionals previously thought.  Research from two new studies published in the Archives of Internal Medicine has found that patients may be exposed to four times more radiation than estimated by prior studies.  The studies caution against the overuse of CT scans, as well as other medical technologies using radiation, including mammograms.  

The studies also found that there is a large variation in the amount of radiation patients receive from the most common types of CT scans, those of the abdomen, pelvis and chest.  A survey of four hospitals revealed that some patients received 13 times more radiation than others for the same type of scan. Researchers stated that the large differences between scans may be attributed to the lack of standardized settings in CT technology, as well as differences in how the doctors use the technology for each patient.  CT scans are able to produce images of the body that offer more detail than x-rays, and their use has more than tripled to 70 million since the 1990s.

Ultimately, the studies determined that the 72 million CT scans currently performed yearly in the U.S. could lead to 29,000 more cases of cancer and 15,000 more deaths a year.  The most common type of predicted radiation-associated cancer is lung cancer, followed by colon cancer and leukemia.  On December 7, 2009 the FDA issued interim regulations requiring closer monitoring of CT scans.  These regulations came after more than 250 cases of exposure to excess regulation were reported over the past two years.  

The consumer advocacy group Public Citizen is petitioning the government to ban the popular weight loss pill Meridia. A recent 10,000 patient study, also known as the SCOUT study, showed that a higher risk of heart attack, stroke, and death are associated with the drug. Meridia is used by about 250,000 people, and it is prescribed to treat obesity by acting as an appetite suppressant.

The FDA had previously rejected a petition by Public Citizen in 2002 to ban the drug, stating that it wanted to wait until the 10,000 patient study was completed. Public Citizen stated that 84 deaths have been associated with Meridia as of June 2009. Speaking on behalf of the group, Dr. Sidney Wolfe stated in a letter to the FDA, “We would hope the science behind the results seen in this study would mandate the only appropriate FDA action to protect the public health: immediate removal of ‘Meridia’ from the market.”

Although the FDA has not issued a warning yet, a decision on whether or not to regulate the drug is likely to come soon.

The FDA recently reminded healthcare professionals and patients about the increased risk of severe birth defects, including spinal defects, severe facial defects, and heart defects, associated with the drug Depakote. Depakote is commonly used to treat bipolar disorder, and has also been used to treat epilepsy, major depressive disorder, and migraine headaches.

The FDA letter to healthcare professionals, dated December 3, 2009, was not the first warning regarding Depakote and birth defects. In October 2006, the FDA issued a black box warning regarding these exact dangers of Depakote. The recent letter serves as a reminder to healthcare professionals that Depakote, and other drugs containing valproic acid and divalproex sodium, should only be used for pregnant women if it is essential to their health.

Depakote has especially been noted for leading to an increased risk of the birth defect spinal bifida. In the general population, spinal bifida occurs in fewer than one in one thousand births. Pregnant women on Depakote have a significantly higher risk of having a child with this defect. Spinal bifida occurs when some verterbrae of the baby’s spine do not completely fuse and the baby’s spinal column does not completely fuse. The defect usually results in disability.

Contact an Experienced Attorney

If you or a loved one had a baby with birth defects, and was taking Depakote while pregnant, contact our law firm immediately. Our experienced drug litigation lawyers have over 35 years of experience. We will provide you with a free, no-obligation consultation and explain your legal rights.

BusinessWeek recently reported that some drugs used for MRI imaging may be riskier for patients with pre-existing kidney issues than previously believed. These drugs are all gadolinium-based, and include Omniscan, Magnevist, and Optimark. Some major hospitals had already ceased use of Omniscan when reports came out in 2006 that its use may lead to an increased risk of developing a condition called nephrogenic systemic fibrosis.

Nephrogenic systemic fibrosis (NSF) is a rare, but potentially fatal disease. In May 2006, Danish medical regulators issued a warning that patients in Denmark and Austria with pre-existing kidney issues had suffered NSF after undergoing an MRI. The warning stated that the dye used to make MRI images clearer contributed to the development of NSF in these patients. Researchers in the U.S. and Europe subsequently found that gadolinium-based drugs have a higher risk of NSF than other drugs used for MRIs.

The newest development over this controversy is that the FDA is considering further regulation of Omniscan, Magnevist and Optimark. An advisory panel was scheduled to assess on December 8 whether or not new restrictions are necessary for these gadolinium-based drugs. To date, over 400 lawsuits have been filed over the drugs and their increased risk for development of NSF in patients with kidney problems.

Contact an Experienced Attorney

If you or a loved one has developed nephrogenic systemic fibrosis, and you believe that a gadolinium-based MRI drug may have been a contributing factor, contact the experienced drug litigation attorneys at the Pintas Law Firm today. We will provide you with a free no-obligation consultation and explain your legal rights.

The Washington Times reported recently that Bayer, the maker of the popular birth control Yaz, is currently facing thousands of lawsuits regarding the safety of the drug. The lawsuits were filed due to Yaz’sincreased risk of blood clots to users. This increased risk has led to serious injuries such as heart attacks, strokes and gallbladder disease for many women. In August, a study published in the British Medical Journal found evidence that Yaz, and its predecessor Yasmin, led to a higher risk of blood clots than other forms of birth control. A generic form of the birth control, Ocella, may lead to this increased risk of blood clots as well. The three drugs, Yaz, Yasmin, and Ocella, contain drospirenone, which is blamed for the increased risk of blood clots.

Many clients pursuing cases against Bayer have no history of problems with blood clotting. The FDA issued a letter to Bayer last year, telling it to cease misleading advertising for Yaz. At the time, Bayer was running television advertisements that overstated the benefits of the drug and downplayed the severity of its side effects.

Contact our Personal Injury Attorneys

If you or a loved one has taken Yaz, Yasmin, or Ocella, and has suffered from blood clots, heart attack, strokes, or gallbladder disease, contact our experienced personal injury attorneys today. The Pintas Law Firm can provide you with a free, no-obligation consultation and explain your legal rights.

A recent report from the Wall Street Journal stated that the FDA is seeking to change labels on pain pumps that deliver pain medication to patients after surgery. Pain pumps are small plastic tubes that deliver and regulate pain medication, usually for a couple of days. The proposed label changes come in the wake of many reports of irreversible cartilage damage from patients who had the medication delivered to their joints, primarily after shoulder surgery. Doctors say that after a procedure like shoulder surgery, the pain pumps can provide too much medication to the tissue, resulting in severe and permanent damage.

From 2006 to 2008, the FDA states that it has received 35 reports of severe cartilage damage from these pumps. Manufacturers of the pumps include I-Flow Corp., Stryker Corp, and Moog Inc., and the FDA has given them 30 days to update the warning labels to account for potential cartilage damage. The pain pumps in question have been approved by the FDA for use after abdominal and certain other surgeries, but not after joint procedures like shoulder surgery.

Hundreds of cases have already been filed against these companies due to the severe cartilage damage many patients have experienced. If you or a loved one has used a pain pump and sustained cartilage damage, contact the personal injury attorneys at the Pintas Law firm immediately. We can provide you with a free no-obligation consultation and explain your legal rights to you.

Millions of Americans take the blood thinner Plavix to reduce their risk of blood clots, which may lead to heart attack or stroke. Since Plavix can lead to an upset stomach, doctors often prescribe Prilosec and Nexium to treat this symptom. However, the FDA recently issued warnings that these medications may decrease the anti-clotting benefits by Plavix by almost half. This can be very dangerous, as patients may not be effectively treated for their risk of heart attack or stroke as a result.

In January 2009, the prescription information of Plavix was first updated by the FDA to warn against simultaneous use of Prilosec. The latest warning by the FDA from November 18, 2009 regarding Plavix describes the extent of the effect Prilosec has on Plavix. It also includes additional drugs that may lead to a decreased effectiveness of Plavix. These drugs inhibit production of an enzyme that allows Plavix to work. Other drugs that may lead to the decreased effectiveness of Plavix include:

Diflucan, Felbatol, Intelence, Luvox, Nizoral, Prozac, Serafem, Symbvax, Tagamet, Ticlid, VFEND

If you are currently taking any of these drugs with Plavix, do not discontinue taking them until you have checked with your doctor. If you have suffered a heart attack or stroke, or any other blood clot-related adverse event while on Plavix and Prilosec or Nexium, contact the personal injury attorneys at the Pintas Law Firm today. Our Chicago law firm has over two decades of experience, and we have extensive knowledge about drug litigation. Contact us today for a free no-obligation consultation and to learn about your legal rights.

In June of this year, Roche Holding quietly pulled the drug Accutane from the market. Accutane is prescribed to treat moderate to severe cases of acne. The drug has had an extensive history of leading to adverse effects since its approval in 1982, such as suicidal behavior and birth defects. The removal of the drug from the market came in the face of increasing proof that Accutane leads to another serious health problem: Inflammatory Bowel Disease. Last week, a study quantified the increased risk that Accutane presents with regard to developing this disease. Users of the medication were found to incur almost twice the risk of developing inflammatory bowel disease over people not on Accutane.

Accutane and Inflammatory Bowel Disease

Inflammatory Bowel Disease encompasses a group of diseases that cause the intestines to become swollen and red. The disease usually recurs and lasts a long time. Two types of inflammatory bowel disease associated with Accutane are:

Ulcerative Colitis: Ulcerative Colitis typically causes ulcers along the lower section of the large intestines. Those with the disease often suffer symptoms of abdominal pain, weight loss and bloody diarrhea. The disease may also be associated with symptoms that affect other parts of the body. For example, painful, arthritic knees in a young person who uses Accutane may be a manifestation of ulcerative colitis. This disease is also associated with an increase in the risk of colorectal cancer.

Crohn’s Disease: Crohn’s Disease typically causes ulcers along the small and large intestines. Like those who suffer from ulcerative colitis, people with Crohn’s Disease suffer from abdominal pain, weight loss, and bloody diarrhea. Other symptoms may include vomiting, skin rashes, arthritis, and eye inflammation. Crohn’s disease is associated with an increase in certain types of cancer, primarily of the area that is inflamed as a result of the disease.

Contact an Experienced Attorney

If you or a loved one has suffered an inflammatory bowel disease or other harmful side effects, such as birth defects and suicidal behavior, as a result of taking Accutane, contact an experienced attorney at the Pintas Law Firm immediately. We can provide you with a free no-obligation consultation and explain your legal rights.

The Chicago Tribune recently reported that Abbott Laboratories is under investigation for their sale and marketing practices of Depakote. Depakote is prescribed primarily to treat bipolar disorder. In certain cases, it is also used to treat major depressive disorder, epilepsy, chronic pain associated with neuropathy, and migraine headaches. The federal probe was initiated to find out if Abbott violated civil or criminal laws in marketing Depakote. Among the laws the federal government is investigating is a violation of the Federal Food, Drug, and Cosmetic Act, a set of laws passed to allow the FDA to oversee the safety of food, drugs and cosmetics.

Depakote and FDA Warnings

Depakote has a history of being a problematic drug, and the FDA has issued numerous safety alerts modifying its warning label. In September 2000, the FDA required Depakote’s first black-box warning due to reports of life-threatening pancreatitis from users of the drug. In January 2007, the FDA issued another warning revising Depakote’s label due to its risk of causing severe birth defects in pregnant women. This warning came on the heels of a study released in August 2006 asserting that birth defects and fetal death were more common in women who took Depakote while pregnant than women on other epileptic drugs. Birth defects that may result from Depakote use include:

Spina Bifida: A birth defect in which some verterbrae of an infant’s spine do not completely fuse and the spinal column fails to completely develop. This condition commonly leads to disability.

Cleft Palate: This defect occurs when the two plates of the skull that form the roof of the mouth are not completely joined. 

In May 2009, the FDA issued another safety alert due to the use of Depakote being potentially associated with an increase in suicidal behavior or thoughts about suicide. Depakote’s label was again changed to accommodate this new risk.

Contact an Experienced Attorney

If you or a loved one has had a baby with birth defects, and you suspect Depakote may have been the cause, contact an experienced personal injury attorney at the Pintas Law Firm today. Our attorneys have over twenty years of experience in drug litigation. Call for a free no-obligation consultation to learn about your legal rights today.

The New Jersey Judiciary is currently considering a request for mass tort status for an increasing number of lawsuits against the popular birth control drugs Yaz, Yasmin and Ocella. The lawsuits allege that use of these contraceptives results in serious health effects, such as stroke and heart attacks. The New Jersey Law Journal reports that this consideration for mass tort status is due to a number of factors, including the projected increase in these lawsuits, different geographic locations of the parties involved, and increased efficiency of having one judge oversee the issues in the case. Currently, there are 39 lawsuits pending against the drug manufacturers in New Jersey counties. However, the current plaintiffs’ lawyers have informed the judiciary that the number of lawsuits could increase into the thousands. The increasing number of lawsuits reflects the growing concern about the safety of Yaz, Yasmin, and Ocella.

Yaz Safety Concerns

In August 2009, two British Medical Journal studies were published that found Yaz, Yasmin, and Ocella lead to a higher risk of venous blood clots, or venous thrombosis, than other oral contraceptives available on the market. These blood clots may lead to such adverse health effects as heart attack, stroke, and development of pulmonary embolism. Use of these contraceptives may also lead to gallbladder disease and pancreatitis.

In October 2008, the FDA issued a warning letter to Bayer to pull misleading ads from the public overstating the efficacy of the drug and minimizing the risks associated with the drug. The current lawsuits against the manufacturers of Yaz, Yasmin, and Ocella claim that its users have suffered from illnesses such as deep vein thrombosis, pulmonary embolism, stroke and heart attack as a result of the drugs. The suits state that the Bayer and Teva should have known that these contraceptives lead to a higher risk of such illnesses than other contraceptives on the market.

Contact an Experienced Attorney

If you or a loved one has suffered as a result of using Yaz, contact the lawyers at the Pintas Law Firm immediately. We will provide you with a free legal consultation and explain your legal rights.

On Thursday of last week, a federal appeals court unanimously voted to reinstate a shareholder lawsuit against Matrixx Initiatives, the makers of the popular cold remedy Zicam. The lawsuit claims that the shareholders of the company did not disclose information that the drug was potentially harmful to the public and instead issued incorrect and misleading statements. Judge Tashima, a part of the three-judge panel that decided to reinstate the case, commented that the case was erroneously thrown out in 2004, and questions of if Matrixx Initiatives had withheld information should be decided by a jury.

The lawsuit primarily concerns a 2003 University of Colorado study, which focused on the development of loss of smell of ten patients using Zicam. The researchers planned to present their findings at a science conference in September 2003 but were informed by Matrixx that they could not use the Zicam name in their presentation. Consequently, the public was not informed about the dangers of Zicam until February 2004 on the TV show Good Morning America. However, Zicam continued to issue positive statements about the drug. In addition, Matrixx did not disclose in their SEC reports that a Zicam user had filed a lawsuit because of loss of smell and that more lawsuits may have been forthcoming.

Four months ago, Matrixx withdrew two forms of Zicam cold remedy, the nasal gel and nasal swabs, from the market. The company announced in January that it would be paying out $12 million to the 340 plaintiffs who had filed a lawsuit over inadequate warnings that loss of smell might result from usage of the drug.

Contact the Injury Attorneys at the Pintas Law Firm

If you or someone you know has suffered loss of smell from taking Zicam nasal gel or Zicam nasal swabs, contact the Pintas firm today. Our experienced injury attorneys will provide you with a free no-obligation consultation and explain your legal rights.

A new study published last week pointed to an increased risk of stroke for patients taking the medication Aranesp. Aranesp is part of a class of drugs known as erythropoiesis-stimulating agents (ESAs), which stimulate the body to produce more red blood cells. ESAs are primarily used to treat anemia in patients with chronic kidney failure, cancer patients who became anemic through chemotherapy, and HIV positive patients who became anemic through the drug AZT. ESAs are also commonly used to decrease the need for transfusions in anemic patients. Other popular ESAs that treat these conditions include Epogen and Procrit.  

Aranesp and Increased Stroke Risk

A new study on Aranesp focused on whether or not the drug could prevent heart attacks, heart failure, strokes, or the need for dialysis, as these uses had never been proven. Surprisingly, the results pointed to an increased risk of stroke, more than double that of patients who did not take Aranesp. The study tested 4,038 people with Type 2 diabetes, kidney problems and moderate anemia, and concluded that for many patients, “the risk will outweigh its potential benefits”.

The FDA has repeatedly strengthened the warning label for Aranesp, Epogen and Procrit. In March 2008, the three drugs were required to carry a new black box warning since they may shorten survival time in patients with certain types of cancer. Certain types of cancer tumors would spread faster for patients taking these drugs. In March 2007, the FDA issued a black box warning regarding cardiovascular problems and that the drugs should be administered at the lowest dose possible to avoid transfusions.

Contact an Injury Attorney at the Pintas Law Firm

If you or someone you know has been taking Aranesp, Epogen or Procrit, and has suffered a stroke, contact the Pintas firm immediately. Our experienced personal injury attorneys will provide you with a free no-obligation consultation and explain your legal rights.

Shirlean Meade was given the drug Reglan or metoclopramide to ease her suffering from gastric reflux and heartburn.  Reglan is typically used to treat gastric reflux, heartburn, nausea and vomiting. After Ms. Meade began taking this drug, she began to develop involuntary repetitive movements. These movements included impromptu grimacing, lip smacking and pursing, tongue protrusion, and rapid eye blinking. Eventually, Ms. Meade discovered that she had developed tardive dyskinesia, a movement disorder. Consequently, Ms. Meade filed a lawsuit alleging the makers of Reglan had concealed the risk of dangerous side effects such as tardive dyskinesia.

Reglan and Tardive Dyskinesia

On February 26, 2009, the FDA required Reglan to place a black box warning asserting that use of Reglan had been linked to the movement disorder tardive dyskinesia, even after the drug was no longer taken.  Developing this disorder is directly related to the amount of time a patient has taken the drug as well as the dosage level. Tardive dyskinesia is characterized by involuntary repetitive movements, such as grimacing, lip smacking and pursing, tongue protrusion, rapid eye blinking, and impaired finger movements.  Sufferers typically lose control over these areas of their body which may be permanent. To prevent cases like Ms Meade’s from recurring, the FDA advised that chronic use of Reglan should be contemplated only in rare cases where the benefits outweighed the risks.

Contact the Injury Attorneys at the Pintas Law Firm

If you or someone you know has developed tardive dyskinesia after taking Reglan, contact the Pintas firm immediately.Our experienced personal injury law firm can provide you with a free no-obligation consultation and explain your legal rights.

Diana Levine was given the medications Demerol and Phenergan via IV push to treat her migraine headache.  However, the nurse administering the treatment missed the vein in her arm. As a result, Diana Levine’s arm turned purple then black and was amputated within a couple of weeks. Subsequently, Ms. Levine filed a lawsuit claiming that the FDA should have contained stronger warnings with regard to the risk of promethazine injections. Phenergan, or promethazine, is an antihistamine that is used to treat motion sickness, nausea, allergic reactions, migraines, and as a sedative.

Phenergan and Amputation

In September 2009, the FDA issued a black box warning for promethazine injections. As in Ms. Levine’s case, when promethazine injection is administered incorrectly there is a risk of severe tissue injury. The injection should not be administered into an artery or under the skin due to this risk of tissue damage, which could be as severe as gangrene or death of tissue. Once a patient contracts gangrene, amputation of the affected area is highly likely. Another risk associated with promethazine injection is that the drug can leak out from the vein during IV administration and cause severe damage to surrounding tissue.

Contact the Injury Attorneys at Pintas Law Firm

If you or someone you know has had an amputation that may be related to a faulty injection of promethazine, contact the Pintas firm immediately. Our Chicago law firm will provide you with a free consultation and an explanation of your legal rights.  

Tysabri Leads to Rare and Deadly Disease

Tysabri is a drug that is used to treat relapsing forms of multiple sclerosis, a disease of the nervous system in which the body’s immune response attacks one’s central nervous system. Tysabri is also marketed to treat severely active Crohn’s disease, a disease in which the body’s immune system attacks the gastrointestinal tract. Thousands of users each year take Tysabri to combat these two serious illnesses. Since the drug has been on the market, the FDA has received numerous reports of users of Tysabri developing progressive multifocal leukoencephalopathy (PML), which is a rare and usually fatal viral disease that has no known cure.

Tysabri and Progressive Multifocal Leukoencephalopathy

Progressive multifocal leukoencephalopathy is characterized by progressive damage or inflammation of certain areas of the brain. Tysabri was pulled from the market due to safety concerns in 2005, a year after it was introduced. Before it was pulled from the market in 2005, it had led to three confirmed cases of PML, and two resulting deaths.

However, it was re-introduced to the market in 2006 with more stringent regulations. Despite these precautions, there have been 13 FDA-confirmed cases of deadly Tysabri-related PML in patients who were being treated for multiple sclerosis since the drug was re-introduced. The risk of developing PML increases with the number of Tysabri infusions received.

Contact the Injury Attorneys at the Pintas Firm

If you or a loved one has suffered from progressive multifocal leukoencephalopathy as a result of using Tysabri, please contact an injury attorney at the Pintas Firm immediately. However, do not discontinue your medication unless you have checked with your physician first.

The respiratory drug Ketek has been linked to at least 55 cases of liver failure and five deaths. Additional side effects include loss of consciousness, vision problems and irregular heartbeats.

On February 12, 2007, Sanofi-Aventis added a black box warning to the antibiotic Ketek and the FDA severely restricted its use. A black box warning is the strictest warning the FDA can place on a prescription drug and illustrates the health hazards associated with use of the drug.

Amid further concerns regarding the safety of the drug, the FDA also required new labeling to indicate the drug should only be used to treat pneumonia of mild to moderate severity. The agency removed previously approved uses for bronchitis and sinusitis, saying “the balance of benefits and risks no longer support approval of the drug for these indications.”

Personal injury attorneys at Pintas Law Firm firmly believe it was the responsibility of drug manufacture Sanofi-Aventis to warn users of all safety risks associated with Ketek use. In failing to do so, thousands have been unknowingly exposed to these risks. . Experienced attorneys at our Chicago law firm will  provide you with a free consultation and explanation of your legal rights.

On May 21, 2007 the FDA issued an alert warning people with underlying heart disease are at an increased risk of heart attack or stroke while taking Avandia. On July 30, 2007, the FDA’s advisory committee concluded that the use of Avandia for treatment of Type 2 diabetes was associated with a greater risk of cardiovascular problems compared to a placebo. The FDA is now requiring GlaxoSmithKline, the maker of Avandia, to conduct a cardiovascular outcome trial on Avandia to provide a definitive answer to whether Avandia poses an unacceptable risk of cardiovascular disease.

Avandia has also been associated with other health risks including a greater risk of fractures in women as well as a higher risk for macular edema (swelling in the retina). In addition, Public Citizen, a consumer advocacy organization, has identified 14 cases of liver failure induced by Avandia, including 12 deaths.  

The FDA has not recalled Avandia, but has required the drug to include a black box warning as of November 14, 2007. The warning states that people with underlying heart disease should be monitored closely while taking Avandia. If you believe you or a family member have  suffered heart problems or a stroke while taking  Avandia, please contact the Pintas Firm immediately. Consult your physician before discontinuing your medications.

Hydroxycut, one of the most popular and heavily advertised weight loss-brands in the country, has been linked as the cause of death and dozens of serious health problems. 

The Hydroxycut brand includes pills, drinks and powders marketed to burn fat, increase energy and control appetite. Makers Iovate Health Sciences Inc. of Oakville, Ontario, sold more than nine million items last year. But the risks associated with these well-known dietary supplements far outweigh the benefits.  The FDA received 23 reports of death and other serious health problems resulting from their use, including liver failure, kidney failure and seizures. The agency said the consumers were healthy before using Hydroxycut and only took the recommended dose.

On May 1, 2009, the FDA warned consumers to stop using the products immediately. Subsequently, the makers removed 14 Hydroxycut products from store shelves. The products contain a variety of ingredients and herbal extracts and the agency does not yet know which ingredients are associated with the risks.

A list of the recalled products can be found at the FDA website. If you have any of these products, retain them for any possible legal claim you may have. Also be wary of any symptoms that could indicate liver damage and other health problems. These symptoms include yellowing of the skin or whites of the eyes, brown urine and loose stools. If you’ve experienced any adverse side effects during or after using  Hydroxycut, immediately contact one of the attorneys at the Pintas Law Firm. All consulations are free unless we obtain a settlement for your claim.

Chicago personal injury lawyers at William G. Pintas and Associates are responding to recent recommendations by an FDA advisory panel to ban two of the most popular prescription pain killers in the country, Vicodin and Percocet, because of the liver damage and death they may cause.

The two drugs combine a narcotic with acetaminophen, an ingredient proven to be the leading cause of liver failure in the United States. FDA research shows acetaminophen overdoses are responsible for 400 deaths and 42,000 hospital visits a year.

On June 30, 2009, the advisory panel also suggested requiring a prescription for extra-strength Tylenol medication and lowering the maximum daily dose from 4,000 milligrams to 2,600 milligrams. Tylenol also contains acetaminophen and can produce dangerous results when taken even slightly over the advised level or in combination with alcohol.

The Pintas law firm is currently investigating the dangerous effects of acetaminophen. If you or a loved one has suffered as a result of this drug, please contact our personal injury law firm for a thorough evaluation and explanation of your legal rights. The Pintas law firm routinely represents persons outside the Chicago area.

Chicago personal injury lawyers at Pintas Law Firm recently learned of plans by pharmaceutical maker Hoffmann-LaRoche, Inc. to withdraw Accutane from the U.S. market. 

The drug maker has been faced with high exposure from personal injury lawsuits that the company continues to defend vigorously despite widely recognized side effects, which include mental health problems, birth defects and miscarriage. Additionally, hundreds of suicide cases have been linked to Accutane in the U.S.

Less serious side effects also include drowsiness and dizziness, which can be extremely dangerous if combined with alcohol use.

The personal injury attorneys at Chicago law firm William G. Pintas and Associates are committed to protecting clients’ rights in Illinois and throughout the country. The firm has successfully handled thousands of personal injury lawsuits and is currently analyzing persons right to a claim after they call the firm. Consultations are free. Contact the Pintas firm  if you or a loved one has suffered any of the above non-problems while taking Acutane. 

Generic versions of the acne drug, known as isotretinoin, will still be available from several manufacturers. The FDA has more information on isotretinoin products. 

In the News:

Roche Discontinues and Plans to Delist Accutane in the U.S.

Medtronic pacemakers are recalled on 05/18/2009 by the FDA. 

This is a Class 1 recall, the most serious type of recall action. The major concern of the recall was its failure, “due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.” The malfunctioning pacemakers can cause abnormal heart rates, fainting or lightheadedness. More serious concerns are serious injury or death.

The affected pacemakers are Kappa Series 600/700/900 and Sigma Series 100/200/300 manufactured primarily between November 2000 and November 2002. Most were implanted at least 5 years ago. 

The Pintas Law Firm is currently investigating these claims. If your pacemaker is affected by this recall contact our firm now for additional free information. See the following websites for more information on the recalled pacemakers and the adverse health effects they may cause:

 wwwp.medtronic.com/ProductLookup/lookup.html

wcms.fda.gov/ucm/groups/fdagov-public/documents/image/ucm162880.gif

On April 8, 2009 notice was sent to physicians that Genentech, Inc. voluntarily withdrew the psoriasis medication Raptiva.  This was prompted because of increased risk of progressive multifocal leukoencephalopathy (PML)

Our law firm is accepting clients who have suffered injuries from Raptiva

The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide."

Read the FDA's full press release here.

But the relationships vary depending on the kind of medical practice and specialty, the patient mix and the professional activities of the physician, according to the study, published in the April 26 issue of the New England Journal of Medicine.

Over the past two decades, physician-industry relationships have attracted increasing scrutiny. One review found that, on average, physicians meet with industry representatives four times a month, and medical residents accept six gifts annually from industry representatives."

Zelnorm is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65. Zelnorm is marketed in 55 countries."

But the same jury found that Merck did properly warn of Vioxx's heart risks in the case of a second man, who had a fatal heart attack in 2002.

The jury also found Merck violated a New Jersey consumer-protection law, but hasn't yet assessed damages.

The trial in Atlantic City, N.J., now moves onto a second phase to determine whether Vioxx was a primary cause of Frederick Humeston's heart attack in September 2001. If the jury finds in Humeston's favor, it can award compensatory and punitive damages. In Friday's verdict in favor of Humeston, who survived his heart attack, the jury concluded that Merck failed to warn his prescribing physician of Vioxx's risks."

Read the full article at WSJ.com.

Jennie Nelson, 67, of Dayton, was diagnosed with breast cancer in 2001 after taking Prempro for five years to treat symptoms of menopause. Her lawyers said Wyeth knew for decades the drug could cause breast cancer, but failed to warn patients.

More than 5,000 women have sued New Jersey-based Wyeth over its hormone drugs Premarin and Prempro. Wyeth has won two cases and lost two cases, which have been heard in Arkansas and Philadelphia.

Eli Lilly agreed yesterday to pay up to $500 million to settle 18,000 lawsuits from people who claimed they had developed diabetes or other diseases after taking Zyprexa, Lilly's drug for schizophrenia and bipolar disorder.

Including earlier settlements over Zyprexa, Lilly has now agreed to pay at least $1.2 billion to 28,500 people who said they were injured by the drug. At least 1,200 suits are still pending, the company said. About 20 million people worldwide have taken Zyprexa since its introduction in 1996.

The study raises questions about the safety of some of the most widely used and heavily promoted prescription drugs on the market, taken by millions of people.

The researchers speculated that when the drugs reduce acid in the stomach, they also make it more difficult for the body to absorb bone-building calcium. That can lead to weaker bones and fractures.

Hip fractures in the elderly often lead to life-threatening complications. As a result, doctors should make sure patients have good reason to stay on heartburn drugs long term, said study co-author Dr. Yu-Xiao Yang of the University of Pennsylvania School of Medicine.

'The general perception is they are relatively harmless,' Yang said. 'They often are used without a clear or justified indication for the treatment.'"

Read the full article at SignOnSanDiego.com.

The pharmaceutical industry says TV ads provide consumers with important information about certain drugs. However, research showed that while the ads were technically accurate, the tone of the messages were often misleading."

Read the full story at adrugrecall.com.

The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes.

"A disputed government study of common painkillers found that naproxen increased the risk of heart attack and other cardiovascular events compared with a fake pill, according to data published yesterday, nearly two years after the study was halted.

The study's results relate to whether naproxen, which is sold over the counter as Aleve by Bayer AG of Germany, is as safe as is commonly believed. The results didn't point to a clear conclusion. The class of drugs to which naproxen belongs is generally considered to carry some heightened cardiovascular risks. This study's results "provide some support" for that theory, the study's authors wrote, but added that "the measure of this risk remains a matter of speculation."

Read the full article at the Wall Street Journal online.

Almost a million Americans a year receive prescriptions for the drug, known as epoetin, or darbepoetin, a closely related drug also used in anemia treatment. Worldwide, sales of the two drugs — sold under the brand names Epogen, Procrit and Aranesp — topped $9 billion last year for Amgen and Johnson & Johnson, their makers.

Researchers for the study, to be published in The New England Journal of Medicine, divided anemic patients with kidney disease into two groups. One group received epoetin with a goal of almost fully correcting their anemia, a lack of red blood cells associated with fatigue and shortness of breath."

Read the full article in the New York Times.

Members of the class, including all U.S. residents who bought Paxil and Paxil CR, a controlled-release version of the drug, for their children each could get full refunds if they have records of their purchases. Anyone without such documentation can get $15 (€11.75) returned to them.

As part of the settlement, London-based GlaxoSmithKline denies the lawsuit's claims, including that consumers paid too much for the drugs, but the world's second-largest pharmaceutical company wants to resolve the matter to avoid further litigation costs."

Read the full article in the International Herald Tribune.

Bayer scientists even appeared at a public meeting called by the F.D.A. on Sept. 21 to discuss the possibility that the drug, Trasylol, might have serious risks. But they did not mention the study or its worrisome results.

In a highly unusual move, the food and drug agency released a public health advisory saying it had learned of the study’s existence only on Wednesday. Preliminary results of the study demonstrate “that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes,” the advisory said."

Read the full article in the NY Times.

"CHICAGO - Accutane, the powerful acne drug already known to cause birth defects, seems to raise the risk for potential heart and liver problems more than doctors had expected, according to a new study.

The findings came from lab tests on 13,772 patients taking the popular acne drug and underscore the need to closely monitor people taking isotretinoin, which is sold as Accutane and in three generic versions. Abnormal results for cholesterol and liver function were more common than expected."

Read more at Yahoo! news.

All six authors of the study have done consulting work or received research financing from makers of treatments for migraines or heart-related problems. Their research appears in Wednesday’s journal.

The authors said they did not report their financial ties because they did not believe they were relevant to the study. The editor, Dr. Catherine D. DeAngelis, said she would have published the authors’ associations with drug makers had she known about them."

Read the full article in the NY Times here.

A recent report on National Public Radio uncovered another disturbing fact in the Vioxx saga. As we know, Merck halted a study in 2004, and withdrew the drug from the market, after researchers discovered an increase in heart attack deaths. However, the cardiovascular risk showed up as early as 1999 in a study that Merck researches decided to continue. Started before the 2001 VIGOR study, results from the earlier study indicated a two fold risk of heart attack.
Not only did Merck continue the study, but they made a concerted effort to downplay the results.

See the NPR transcript here.

"Pharmaceutical companies try to sway doctors with gifts as little as coffee mugs and as lavish as $25,000 speaking engagements, according to a report released Thursday.

Doctors are pushed to prescribe expensive prescription drugs through a variety of means, according to the study by consumer groups.
However, the report could not find a direct link between the gifts and physicians doing the bidding of drug companies.

Still, 'the report really bolsters the case for drug company oversight,' said Blair Horner, of the New York Public Interest Research Group, who co-wrote the study. 'Drug companies spend billions of dollars to convince doctors to prescribe their drugs.'"

Read the full article in The Ithaca Journal here.

In light of a recent study indicating a higher rate of suicide and suicide attempt with Paxil over a placebo for treatment of psychiatric disorder including Major Depressive Disorder, the FDA and Paxil maker GlaxoSmithKline updated their warning label to include suicide.
This warning is long in coming, especially in light of the similar warning directed towards adolescents and children put on Paxil last year.
This new warning, coupled with the teratogenic effects recently uncovered, raises serious questions about the benefit/risk ratio of this drug.

Read the FDA's statement here.

A recent study reveales that thousands of people are treated in emergency rooms across the U.S. due to accidental and intentional overdoses from attention-deficit hyperactivity disorder (ADHD) drugs. The US Center for Disease Control released the study, estimating that over 3,000 people each year are sent to the ER. Based on this information many doctors are calling for the FDA to place a black box warning for overdose and cardiac side-effects on ADHD drugs.

Read more in USA Today here.

A second look at the APPROVe study, which indicated an increased risk of heart attacks and strokes after 18 months of Vioxx use, shows an actual risk increase after only 4 months of use. Researchers reviewing the APPROVe data show an increase in the amount of reported heart attacks after only 4 months of Vioxx use.
Of course this strikes at the very core of Merck's key defense: that the increased risk of cardiovascular events only arises after 18 months of Vioxx use.
The papers lead author, Dr. Bresalier, stood by the articles main results, but said that researchers did not find the 18-month threshold critical. Only Merck thought this to be especially significant. "Of course they (Merck) want to minimize their liability," was Dr. Bresalier comment in reponse to Merck's playing up the 18-month data.

"Vaccine industry officials helped shape legislation behind the scenes that Senate Majority Leader Bill Frist secretly amended into a bill to shield them from lawsuits, according to e-mails obtained by a public advocacy group. E-mails and documents written by a trade group for the vaccine-makers show the organization met privately with Frist's staff and the White House about measures that would give the industry protection from lawsuits filed by people hurt by the vaccines. The communications were made public in a report released this week by the group Public Citizen. Its study follows a February story in The Tennessean that Frist, along with House Speaker Dennis Hastert, R-Ill., ordered the vaccine liability language inserted in a defense spending bill in December without debate and in violation of usual Senate practice."

Read the complete article in The Tennessean here.

Just when we thought mercury would be phased out of all childrens' vaccinations, the poison makes a return. The following is excerpted from a recent LA Times article:
"The push for legislation comes long after the uproar over continued use of thimerosal, a mercury-based antibacterial agent, appeared to subside in 1999, when manufacturers began phasing it out of routine pediatric vaccines.

But the controversy flared anew when flu shots containing thimerosal were added to the childhood immunization schedule in 2004 and the CDC refused to recommend thimerosal-free shots for infants and pregnant women.

Angered by the CDC's refusal — and fearing a backslide into more thimerosal use — state lawmakers and anti-mercury advocates began pushing for outright thimerosal bans."

Read the full article here.

This week, David Longmire, M.D., an Alabama neurologist and specialist in neuropathic pain evaluation and management, filed a lawsuit against Warner-Lambert, Inc. and its parent company, Pfizer for fraudulent misrepresentation, concealment and deceit.

This lawsuit arises out of a May 13, 2004 prosecution in which Warner-Lambert and its Parke-Davis division, acquired by Pfizer in 2000, pled guilty to charges that it criminally violated the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 331 et seq. associated with its marketing and sales practices for their epilepsy drug known Neurontin.

Related to the 2004 case, Dr. Longmire's lawsuit charges that Warner-Lambert defrauded him by exploiting his medical expertise and reputation and luring him to unwittingly participate in a deceptive scheme to market Neurontin for certain unapproved uses, commonly known as "off-label" uses.

Read the full article here.

A recent flurry of gross scientific misconduct has brought light on a disturbing new trend-scientists engaging in everything from twisting test results to achieve a certain result to flat out fabrication and falsification. The world saw the worst when the breakthroughs in stem cell cloning by a South Korean researcher were found to be completely faked.
More close to home, in December we learned that Merck employees withheld critical data from the VIGOR study which first linked Vioxx with heart attacks. Another study released last October indicating that NSAIDs reduced the risk of oral cancer turned out to be completely fabricated.
Not to shift accountability away from the scientists who perform these studies, but the current environment for scientific research is fertile ground for fraud and malfeasance. Using drug companies as an example, millions of dollars go in to research for new and existing drugs. If the researchers do not already work for the drug company, they are handsomely rewarded to perform the study. The lure of big money has a way to create or mold a study that caters to goals of the financiers. To produce unbiased studies of significance, this financial carrot needs to be removed from the scientific process.

Read more about the trend in Forbes online here.

The Wall Street Journal recently reported that Senator Grassley of the Senate Finance Committee demanded a probe into the FDA's handling of safety concerns with the popular antibiotic Ketek. Produced by Sanofi-Aventis, the drug is being linked to liver failure and deaths.
Most disturbing is the fact that a researcher who worked on a major study of Ketek pleaded guilty to charges that she fraudulently reported false and inaccurate data to the study. The FDA required Sanofi-Aventis to perform the study after earlier studies raised concerns about the liver toxicity of the drug. The full extent of the problems relating to the study in question have not been fully revealed to the public.

Read more in the Wall Street Journal online here.

"A new UC Davis study links a mercury-containing preservative once prevalent in many children's vaccines to immune system dysfunction in mice.

The findings are sure to heighten the debate over whether vaccines play a role in causing autism, especially since there is growing evidence that many autistic children have irregular immune systems.

The researchers released their results with an abundance of caution, stressing that numerous questions remain about thimerosal's effect on humans and its relationship, if any, to the recent rapid rise in the numbers of autistic children.

The study is a road map for future investigations of the effect mercury from a variety of sources has on developing immune systems, said senior author Isaac Pessah, a UC Davis toxicologist."

Read the full article in the Kansas City Star here.

"Pharmaceutical giant Eli Lilly and Co. recently funded five studies that compared its antipsychotic drug Zyprexa with Risperdal, a competing drug made by Janssen. All five showed Zyprexa was superior in treating schizophrenia.

But when Janssen sponsored its own studies comparing the two drugs, Risperdal came out ahead in three out of four.

In fact, when psychiatrist John Davis analyzed every publicly available trial funded by the pharmaceutical industry pitting five new antipsychotic drugs against one another, nine in 10 showed that the best drug was the one made by the company funding the study.

"On the basis of these contrasting findings in head-to-head trials, it appears that whichever company sponsors the trial produces the better antipsychotic drug," Davis and others wrote in the American Journal of Psychiatry."

Read the full article in the Washington Post here.

"Painkillers called COX-2 inhibitors may increase the risk of heart attacks by raising blood pressure and making the blood more likely to clot, researchers said on Thursday.

They do so by the same mechanisms that they use to reduce pain and inflammation, said University of Pennsylvania School of Medicine researcher Dr. Garret FitzGerald, who led the study.

But the finding shows that a new generation of anti-inflammatory drugs could avoid the problem, FitzGerald reported in the Journal of Clinical Investigation."

Read the full article from Reuter's here.

Fosamax is a widely prescribed drug to treat osteoperosis. The drug is included in a class of drugs called bisphosphonates, which work by inhibiting the bone function which removes old bone so that new bone may be laid.
The drug, as reported in the Journal of Oral and Maxillofacial Surgeons, is linked to a rare and serious jaw bone disorder called Osteonecrosis of the Jaw or "ONJ". Individuals who have dental work while on the drug are especially at risk.
Fosamax, manufactured by Merck, had sales of over $1 billion dollars last year alone.

Read more here.

A Texas state jury awarded $7 million in compensatory damages and an additional $25 million in punitive damages to the family of a 71 year old man who died of a heart attack after one month of Vioxx use. The jury found that Vioxx caused the man's heart attack, and that Merck willfully withheld important information regarding the drug's cardiovascular risks from the FDA, doctors, and the American public.
This brings the scorecard to 3 wins and 3 losses for Merck, with many more trials to come.
The important thing to note is that with all plaintiffs' victories, the jury awarded punitive damages against Merck.

Read more here.

A recent article in the New England Journal of Medicine discusses the widely prescribed class of drugs to treat ADHD and their association with cardiovascular events. On February 9, 2006, the Drug Safety and Risk Management Advisory Committee of the FDA voted by a narrow margin to place a black box warning on all ADHD drugs for cardiovascular risks such as heart attack and stroke. In spite of the Committe recommendation, the FDA recently refused to add the warnings.

The NEJM release discussing the article may be found here.

The same jury that found Merck failed to properly warn and committed consumer fraud in two Vioxx cases last week, awarded $9 million in punitive damages as punishment for Merck's malfeasance.

In the 'two trials in one' last week, the jury held Merck accountable for failing to timely warn of Vioxx's cardiovascular risks, finding that Vioxx was a substantial cause in one plaintiff's heart attack and awarding him $4.5 million in compensatory damages. The jury did not find that Vioxx caused the second plaintiff's heart attack, and awarded him only $45 for the cost of Vioxx prescriptions.

Under new tort reform laws in New Jersey, punitives are decided during a separate trial. Punitives may be awarded only if the jury finds that Merck intentionally withheld information from the FDA. No drug company has ever had punitives awarded against them since the new tort reform law was enacted.

As the jury found, even under the most stringent standard for proving punitives, Merck willfully withheld crucial information from the FDA, doctors and consumers that may have prevented tens of thousands of heart attacks.

The verdict forms are reprinted below:

Question: Has the plaintiff proved by clear and convincing evidence that Merck knowingly withheld or misrepresented information required to be submitted to the FDA under the FDA regulations which information was material and relevant to the harm in question?

Answer: Yes.

Question: Has the plaintiff proven by clear and convincing evidence that Merck's actions show a wanton and willful disregard of another's rights so as to justify an award of punitive damages?

Answer: Yes.

Question: What amount, if any, of punitive damages should be awarded?

Answer: $9 million.

Read more here.

The second New Jersey state trial, involving two plaintiff's cases in the same trial, ended yesterday with the jury finding that Merck failed to properly warn of Vioxx's risks of heart attack and stroke. The jury awarded the 77 year old plaintiff $4.5 million in compensatory damages, finding that Vioxx substantially caused his heart attack. The jury only awarded the 60 year old plaintiff in the trial $45, compensating him for money spent on Vioxx prescriptions. The nominal amount was awarded as the jury found that Vioxx was not the cause of the 60 year old's heart attack.

This is a big victory for those injured by Vioxx across the country. Not only did the jury find that Merck failed to properly warn of the cardiovascular risks of Vioxx, but they found the drug to be a substantial cause of a 77 year old's heart attack; a man who suffered from diabetes and had many other complicating risk factors in his medical history. This finding could not have been more correct. People with risk factors for heart attack and stroke are exactly the group that should not have been on Vioxx, and if Merck would have acted responsibly and timely warned people of the dangers, many lives would have been saved.

Under New Jersey law, a separate trial immediately begins to determine if Merck's actions should be punished, and if so, the amount of punitive damages to award.

A recent article in the Washington Post details a rather bizarre, and potentially catestrophic, side effect of drugs used to treat Parkinson's Disease. The drugs, including Permax and Mirapex, work as dopamine agonists, which increase the levels of dopamine in the brain. Dopamine is associated with many addictive behaviors such as gambling and sex manias. Particular cases described in the article involves people losing their jobs and families due to compulsive behaviors starting after taking the Parkinson's drugs.
Clinical studies have yet to be performed on the relation between these drugs and compulsive behaviors.

Read the full article here.

In an effort to speed up the drug approval process, the FDA allows companies to perform safety studies after the drug has been approved and is on the market. However, many promised studies are never performed. A recent NY Times articles uncovered that hundreds of these studies have been pending for years, with no follow up by the drug companies.
The problem is that there is little incentive to follow through on the post-marketing studies. The studies are very expensive, and there is little threat of reprisal from the FDA if the studies go unfinished. The FDA's only recourse is to withdrawal the drug, which is considered so drastic that the notion is never considered in these circumstances.

Read the NY Times article here.

"The government-approved system for preventing pregnant women from taking Accutane, the acne drug linked to miscarriages and severe birth defects, is a 'disaster,' the nation's leading dermatology association told a federal advisory panel on Friday. 'Pharmacies, prescribers and patients are confused and frustrated,' said Dr. Diane M. Thiboutot of the American Academy of Dermatology, who held a stack of what she said were samples of 200 complaints from dermatologists. She asked the panel to delay the system's mandatory starting date of March 1 by at least two months. But advocates of regulating Accutane said complaints about the new system were exaggerated."

Read the full article in the NY Times here.

"The U.S. Food and Drug Administration, though it has improved a drug labeling regulation through revisions announced today, continues to ignore the fact that its rule will not guarantee patients the most accurate, up-to-date information about their medications, Public Citizen said today.
Further, in an end-run around Congress, the FDA has added to the rule a preamble designed to preempt lawsuits filed by patients under state law, potentially leaving victims of FDA-approved drugs with no remedy for any harm caused by the approved drug.
Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said revisions in the final version of the rule released today will simplify and prioritize the labeling information that doctors receive. But the vast majority of patients will not get that information unless they specifically request it. Instead, they commonly receive patient information leaflets (PILs) that are commercially produced but whose content is not scrutinized by the FDA."

Read more from Public Citizen here.

Reports of deaths, strokes, heart attacks and hypertension in children and adults taking drugs to treat attention deficit hyperactivity disorder are spurring new government studies into the medications' safety.

Sales of drugs to treat ADHD have increased sharply in recent years, with use growing at a faster rate among adults than children, according to a recent study by Medco Health Solutions, a prescription benefit manager. Spending on ADHD drugs soared from $759 million in 2000 to $3.1 billion in 2004.

The Food and Drug Administration said it had received reports of what it called "serious adverse events" — including deaths — in association with the therapeutic use of the drugs. The agency considers the reports "rare though serious," FDA spokeswoman Susan Bro said Wednesday.

Read the article from the Kansas City Star here.

Pharmaceutical giant AstraZeneca today removed their anti-coagulant drug
Exanta from the marketplace. Used in a small amount of patients for short-term prevention of blood clots after surgery, AstraZeneca removed the drug due to adverse event reports of serious liver damage.

Read AstraZeneca's press release here.

This week a new study was published in the New England Journal of Medicine which raised quite some eyebrows. The drug Trasylol which is normally used after surgery to control bleeding has been found to increase the risk of kidney failure and increase the risk of an heart attack.

Trasylol of which the working ingredient is atropinin, is one of the leading drugs produced by Bayer AG, the German pharmacy company. The drug is used in over 60 percent of all surgeries, an astonishing fact considering that this drug might be lethal to some of these patients. The risk on heart failure or heart attacks increased by a baffling 55 percent and the risk on a stroke or the breakdown of brain tissue even doubled.

The FDA's Public Health release is found here.

The FDA released a public health advisory last month for women taking Paxil while pregnant. The advisory came in the wake of multiple studies indicating a 2 fold increase in the risk for heart malformations in the fetus. The heart malformations include holes in the walls of the heart that range in severity from requiring surgery to life-long monitoring.
This warning is added to the long list of dangerous side effects for this over-prescribed drug. As recently as this week, researchers in Europe advised against high doses of Paxil. Britian's Committee on Safety of Medicines stated that the efficacy of the drug did not increase with high doses, while side effects greatly worsened.

The fourth Vioxx trial began today in a Starr County Texas state court. The case involves the late Loenel Garza, a 71 year old man who died of a massive heart attack in 2001. Mr. Garza took samples of Vioxx for about a month before the heart attack, and was told after a stress test shortly before his death that he had a 2% chance of dying from a heart attack.
To further bolster the plaintiff's case, emails where recently released by the editor for the New England Journal of Medicine regarding Merck's failure to report 3 heart attacks to the VIGOR study in 2001. Merck blamed the 4-5 fold increase in heart attacks on the prophylactic effect of naproxen, a comparative drug used in the study. An excerpt from one of the emails reads "[y]our explanation lacked scientific objectivity, the relative risks [of Vioxx and heart attacks] were presented so as to favor naproxen and discount the possibilty that [Vioxx] might be harmful."

The Texas trial is expected to last into March.

Judge Eldon Fallon, the presiding judge in the federal Vioxx litigation, set the Vioxx retrial for February 6 in New Orleans. The last trial, held in Houston, ended in mistrial after the jury could not come to an unanimous verdict after 18 hours of deliberation.
Plaintiffs in the February trial will be able to present evidence of the recent New England Journal of Medicine report that Merck withheld reporting 3 heart attacks from the VIGOR study back in 2001.

A recent article in the Wall Street Journal details the disturbing, if not frightening, practice of trusted scientific journals to publish research studies written by ghostwriters working for pharmaceutical companies. Not only are the writers in the employ of drug companies, but also the articles are published under the bylines of prominent academics. In short, we have drug companies writing scholarly articles and putting the name of respected researchers to increase the credibility of the article.
It is a boon for not only corporations, but academics and journal as well. Academics get more published articles, something integral to their professional advancement. Journals get clearly written articles seemingly authored by well-credentialed authors. Corporations get studies proving the efficacy and/or safety of their drug. The diagram below sums up the situation nicely.

New legislation pushed in the wake of the avian flu scare includes a provision that shields vaccine manufactures from liability for injuries caused by the vaccines. No doubt the bird flu is scary, however why the current Administration seeks to punish victims of vaccine side effects is even more frightening.
The bill protects vaccine manufacturers from lawsuits, even where there is gross negligence or misconduct.
The problem does not stop at punishing victims who suffer serious side effects from vaccinations. Many Americans will refuse to get a flu shot knowing that they have no recourse in the event of a serious reaction.
Consider the comments by Rep. David Weldon (R-FL), who is a medical doctor, recently at a Congressional committee:

"If [Americans] know that, should they have a side effect, they have absolutely no recourse, I think it could undermine the ability of CDC to get the public to comply with the vaccine program."

A recent study study performed by a Danish University supports the link between Cox-2 inhibitors and heart attacks. Taking Cox-2's and high doses of NSAID's after suffering a heart attack raised the risk of death as much as 5 times.
The study was presented at the annual meeting of the American Heart Association. The study showed people taking 25mg of Vioxx had a 5.03 ties greater risk of dying. Celebrex users of 200mg or more a day had a 4.24 times greater risk.
The study may be found here.

The first federal Vioxx lawsuit ended today in a mistrial. U.S. District Court Judge Eldon Fallon declared a mistrial after the jury could not reach a required unanimous verdict after 18 hours of deliberations. The nine person jury recessed on Saturday with five votes for the Plaintiff and four for Merck. Judge Fallon that the jury deliberated for a reasonable amount of time and entered the mistrial. The parties meet next week to determine the next trial date.
Although not a victory for the Plaintiff, it is clearly a blow to Merck's momentum after their victory in New Jersey. The plaintiff in this case used Vioxx intermittently for only 28 days before the heart attack, and is considered a weak case for the Plaintiff. Considering the recent news of even more Merck malfeasance, the added evidence could tip the scales in favor of the Plaintiff.

Judge Higbee set a Jan. 30 trial date for the next New Jersey lawsuit against Merck & Co. over its once-popular painkiller Vioxx. After a daylong closed-door hearing with lawyers, Superior Court Judge Carol Higbee narrowed the list of potential cases to go to trial on that date to seven. In each, the plaintiffs are New Jersey residents who suffered heart attacks after taking the drug for 18 months or longer. One of the heart attacks was fatal. More than 3,400 cases blaming Merck for Vioxx-related injuries have been filed in New Jersey and all are consolidated under Higbee.
The first federal trial began in early November in Houston. That trial should finish before the new year.

The liver toxicity of acetaminophen has been known for years, however a recent study shows that liver damage caused by the drug is on the rise. The damage is caused by an overdose of the drug, and the number of unintentional overdoses is increasing. Acetominophen is found in a variety of pain relivers and cold remedies. The active ingredient in Tylenol, the drug is also found in a variety of other products including Excedrin, Midol Teen Formula, Theraflu, Alka-Seltzer Plus Cold Medicine, and NyQuil Cold and Flu. It is easy to see how consumers can unwillingly take too much of the drug when mixing these over-the-counter medications. Unfortunately the effects of the overdose are severe, with many cases involving complete liver failure.
Inadequate warnings on the labels of products containing acetaminophen are to blame. With the amount of OTC pain relivers and cold remedies on the market, it is very important for the amount of acetaminophen to be clearly labeled and for the consumer to carefully consider the amount ingested.

More information is found here.

The FDA recently asked the makers of Serevent Diskus, Advair Diskus, and Foradil Aeolizer to update thier labels to include risk of severe asthmatic attack. The drugs work to keep asthma episodes to a minimum with a medicine called "long-acting beta 2-adrenergic agonists" (LABA). All asthma drugs with this medicine will include this warning.
The problem is the drugs lower the frequency of asthma attacks, but actually greatly increase the severity of an attack when they occur. There is at least one death reported from the use of these drugs.

Read FDA's statement here.

Earlier this month, the FDA added a new warning to the popular Ortho Evra birth control patch. The patch exposes its users to a large amount of hormones which cause blood clots and other serious side effects.
According to records at MedWatch, about a dozen women in their late teens and early twenties died in 2004 from massive blood clots believed to be related to the birth-control patch. Dozens more had similar but non-lethal strokes and other clot related problems.
The warning comes nearly four months after an Associated Press report told of patch users die and suffer blood clots at a rate three times higher than woman taking the pill.

Read the FDA's FAQ page here.

The Florida Attorney General recently subpoenaed Medicaid-related documents from Eli Lilly regarding Zyprexa sales. Eli Lilly is plagued with problems due to problems with the drug. Last June, the company settled about 75% of outstanding product liability lawsuits for $700 million dollars. The suits allege the drug failed to warn of the drug's ability to cause diabetes.

A recent study published in the Journal of the American Medical Association found that high doses of Pfizer's cholesterol lowering drug Lipitor is no better at preventing recurrent heart attacks and heart related death than other drugs. Specifically, the study found that Lipitor at high doses does not prevent heart-related deaths any better than normal doses of Merck's statin drug Zocor.

More information is found here.

After removing the Cox-2 drug Bextra from the marketplace in April, Pfizer recently applied to the European Medicines Agency to return Bextra to the European market. The Agency denied the application, citing the drugs serious cardiovascular risks and adverse skin reactions. Pfizer has expressed its intent to return Bextra to the market, but absent a showing of the drugs benefits outweighing the risks, this is unlikely.

Read the EMEA's statement here.

It is no wonder that Plaintiff Mike Humeston lost in his trial against Merck on Friday. Recent comments by the jurors in the trial indicate that corporate deception is not only common place, but accepted as part of business. The following is an except from the Wall Street Journal:

Juror Marie Kerr, a 51-year-old administrative assistant, said she and other jurors read through the emails while deliberating and felt many of the inflammatory lines were taken out of context.

"We read the emails completely, and not just the part that said 'bastards,' " she said. Ms. Kerr also said she wasn't moved by a Merck document titled "Dodgeball" that Mr. Seeger portrayed as a way to teach sales representatives how to avoid questions about heart attacks. "We've all seen games like dodgeball at our work," she said.

Overall, Merck succeeded in persuading jurors that concerns voiced by Dr. Scolnick and other executives were a normal part of the scientific process of discovery and of safety investigations. Vickie Heintz, a 40-year-old juror, said she felt Mr. Seeger "cherry picked" a few select emails and tried to impugn the company with them.

Ms. Heintz said she wasn't bothered by Merck's aggressive marketing of Vioxx or documents that showed the company calculating the loss in profits if the warning label was changed to reflect increased risk of heart attack. "Medicine is business," she said. "If I had a business I would calculate what the loss of one of my big products would mean...This is about making money. Merck doesn't do this because they are flower people."

Another juror, Patricia Harley, 44, said: "If someone peeked through all my emails, forget about it."

I do not question the result the jury found in this case. However I must comment that their statements afterwards are a terrifying wake up call to all Americans of the moral decline in our country. That a company's malfeasance is quickly justified by comments like "Merck doesn't do this because they are flower people" and "[w]e've all seen games like Dodgeball at our work" is scary to say the least.

In a stunning defeat for those all those injured by Vioxx across the country, a jury in New Jersey state court found against plaintiff Mike Humeston in the second Vioxx trial in the country. The jury voted 8-1 that Merck did not fail to warn of the known cardiovascular risks of Vioxx. The jury voted unanimously that Merck did not commit consumer fraud, and neither concealed nor misrepresentated the known dangers associated with Vioxx.
The verdict is a surprise considering the FDA did everything short of telling Merck that they failed to warn of the cardiovascular risks associated with Vioxx.
After following the trial for most of the last seven weeks, it is safe to say that Merck successfully employed a strategy of attacking the plaintiff's character versus explaining the science. You might remember the last trial that Merck lost. Many people opposing the verdict cited the juries inabililty to understand the science behind the drug. Conservative groups rallied to the tune of discarding the trail-by-jury system for civil trial, stating that juries are incapable of understanding complicated cases and properly dispensing justice. No doubt these same people will be touting the recent verdict as a triumph of the jury system.
Regardless of the result, our Seventh Amendment right to trial-by-jury should be exahlted.

On October 17, 2005, a Biodefense bill was presented in the U.S. Senate that would effectively shield all vaccine manufacturers from liability from injuries caused by defective or dangerous vaccines. Industry lobbyists routinely blame lawsuits and liability for vaccine shortages.
It looks like their wish may come true, but do not be fooled by the reasoning for it. Lawsuits have nothing to do with the high cost and occasional shortages of vaccines. The Journal of the American Medical Association (not exactly an outwardly friendly journal to attorneys) recently stated: "The historical record provides cause for skepticism that liability relief alone will prevent another flu vccine shortage…These shortages likely resulted primarily from factors other than litigation costs, as did the flu vaccine crisis."
The real reason drug companies shy away from making vaccines are due to a number of factors. Consider the following reasons excerpted from an article distributed by the Center for Justice and Democracy:

*The flu virus mutates easily, requiring new annual production. According to the Washington Post, "Generally, at least one strain each year undergoes so much mutation that it needs to be replaced by an 'updated' version in the next year's vaccine. Consequently, a new flu vaccine formula has to be drawn up each year."
*The industry uses old-fashioned, risky technology. The flu vaccine is made "by injecting virus into fertilized chicken eggs. … Each egg must be hand-inspected and hand-injected. One egg grows enough virus for 4 or 5 doses of vaccine. Millions are needed … They have some of the risk, time pressure and uncertainty of political races and military attacks."
*The market for flu vaccines faces uncertain supply and demand and a small profit margin. According to the Washington Post, "In 2001-02, 10 million doses were pitched. The next year (Wyeth's last) the number was 13 million. Last winter, despite a run on vaccine in an earlier-than-usual flu season, 4 million doses, out of 87 million made, were discarded.… The waste is particularly hard for vaccine makers to stomach because their profit margin is small.… Because much of the vaccine is bought in huge orders by government agencies, the price is low."
*The industry is about to radically change its production. As the Washington Post stated, "[N]obody wants to invest hundreds of millions of dollars and five-to-seven years in building an egg-based vaccine plant when the whole industry is on the verge of switching to a radically new way of making the product.… Sometime in the next decade, flu vaccine will start to be grown in cell cultures, not eggs. It is a technology far more clean, predictable and expandable than the egg-based way of old."

The FDA recently required Eli Lilly and Co. to include warnings for risk of suicide and suicide ideation. Strattera is prescribed to children, adolescents and adults suffering from Attention Deficit Hyperactivity Disorder (ADHD). The warning is directed at children and adolescents on the drug, especially within the first few months of going on the drug.

GlaxoSmithKline and the FDA recently added precautions to Paxil and Paxil CR to reflect the results of a retrospectice epidemiological study indicating an increase in birth defects in those women taking the drug in the first trimester of pregnancy. The letter from GSK to physicians is found here.

The FDA announced today that Cylert, and all similar generics, be removed from the market. Cylert, made by Abbott Laboratories, is a treatment drug for ADHD on the market since the 1970's.
In 1995, Canada and Great Britian removed the drug from their respective markets citing a study that indicated a 45 fold increase in childrens' liver failure. The FDA did not force the withdrawal, and the drug remained on the market for another 10 years.
Abbott Labs stopped marketing and making the drug in May, 2005, citing declining sales.

Read the FDA's statement here.

There is a lot of news recently about child vaccinations and dangerous side effects. The most attention is drawn to Thimerosal, a mercury-based preservative put in nearly all vaccinations up until 2000. Use of the preservative began to phase out for baby vaccines in 1999, when studies surfaced a link between the preservative and not only autism, but other neurological disorders as well.
The supporting science behind this has been diluted by the politics, and politicians, surrounding the issue. However, consider the massive spike in autism beginning in 1989, when Thimerosal was at the height of its use. This spike dropped off around 2000, when Thimerosal was essentially phased out.

An excellent article summing up these issues is found here.

Lawsuits filed recently allege that hormone replacement drugs Premarin, Provera, and Prempro cause breast cancer, blood clots, and other serious health problems. Produced by Wyeth Pharmaceuticals, the lawsuits are based on a July, 2002, study performed by the Womans' Health Initiative stopped short of completion due to a suprising increase in adverse events. Specifically, of the 16,000 participants in the study, there was a 26 percent increased risk of breast cancer, a 41 percent increased risk of strokes, a 29 percent increased risk of heart attacks, a 100 percent increased risk of blood clots, and a 22 percent increased risk of cardiovascular disease.
These drugs remain on the market, however the results of the study were placed on the label and approved in June of this year.

To read the full article click here.

Last month, Merck attorney stated that they would consider settling some Vioxx cases. Falling short of a global settlement, Merck will look at cases where plaintiffs took Vioxx for long periods of time (i.e., 18 months or longer) and indicated little risk for heart disease. To date, no settlements have occurred. However, considering the fact that potentially 100,000 Americans suffered heart attacks as a result of Vioxx, the settlements are inevitable.

Read the full article here.

A small Texas study has shown that Ritalin, when prescribed to children, increases the child's risk of cancer later in life. Experts from the FDA, National Institute of Health, and EPA are currently reviewing the data. The study found chromosomal damage of 12 children who took Ritalin for three months.

The recent punitive damage award in the Vioxx case was $252 million. This amount will be reduced by Texas law to about $1.6 million. Punitive awards are in place as a punishment and deterrant. When federal and state legislation fails, civil trials hit companies for their malfeasance where they really feel it; their pocket books.
So what does $1.6 million mean to Merck? Very little. An excellent breakdown of Merck profits over the years can be found here.

A Texas jury of twelve men and women recently awarded $253 million to the widow of a man whose death was contributed to by Vioxx. The verdict is a victory for all consumers put at risk by drugs that are improperly tested, marketed and absent warnings. However, proponents of tort reform use the verdict as an example of "jackpot justice." This is the idea that huge awards are handed out to unworthy plaintiffs. The truth is verdicts like these are almost always reduced, sometimes to the extent that it is questionable whether justice is served at all.
Consider closely the Vioxx verdict. The jury awarded $450,000 in economic damages for the deceased lost pay. $24 million for mental anguish and loss of companionship awarded to the widow for the loss of her husband. Finally, $229 awarded in punitive damages, designed to punish Merck for acting irresponsibly in testing and promoting Vioxx. It is important to note that the punitive award is the exact amount that Merck saved in delaying updating Vioxx's warning label of cardiovascular risks. Merck contested the FDA's request to update the Vioxx label, delaying the update for seven months in 2002 by inundating the FDA with irrelevant studies and paperwork. The estimated amount that Merck saved by this delay is the exact amount of the punitive award.
Due to tort reform laws in Texas, this punitive award will by reduced to $1.6 million. Considering Merck's revenue is in the billions of dollars, the $1.6 million is the monetary equivalent of a $30 parking ticket.

Accutane (isotretinoin) is prescribed for serious acne in children and adults. It is estimated the 8-12 million people have been prescribed the medication in the United States alone. With that, more than 70,000 adverse events have been reported to the FDA. This number is staggering when considering that it is estimated that only 10% of all adverse events are actually reported.
Studies link up the drug with side effects such as Inflammatory Bowel Disease, cardiovascular injuries, kidney and liver failure, psychiatric injuries and suicidal ideation, and severe birth defects. Roche Laboratories, the maker of Accutane, denies all side effects other than birth defects.
Roche acted improperly in failing to properly warn of Accutane's myriad of side effects. The failure to warn leads to a failure of doctors to monitor for serious conditions caused by the drugs use. Many users are not even aware that Accutane may have caused their condition.

Last week the Judicial Panel on Multidistrict Litigation assigned all federal Celebrex and Bextra cases to the Northern District of California before the Honorable Charles R. Breyer. The MDL will handle all federal claims arising out of the use, marketing and sales of Celebrex and Bextra. Following in the footsteps of Vioxx, these other cox-2 inhibitors will be grouped together for resolution of pretrial issues and discovery.

Read the Transfer Order here.

The jury is selected and opening statements have begun in the second Vioxx trial. The trial is in New Jersey state court, the first of nearly 2,500 cases pending there.
The Plaintiff is Frederick "Mike" Humeston who suffered a heart attack after taking Vioxx for pain stemming from a Vietnam War wound.
Just like the case in Texas, there are some difficulties with the case. Mr. Humeston suffered his heart attack after taking the drug for two months. The largest studies involving Vioxx and cardiovascular risks show an increased risk of heart attack after being on the drug for 18 months.
This trial will be unique in that camaras and audio equipment will be allowed in the courtroom.

One of the biggest flaws with the current state of drug development and safety is the focus on treatments and not on cures. Drug companies spend billions in developing and attaining patent protection on drugs that are designed to treat illnesses, instead of illness prevention and disease cure. The reasoning is simple math. More money is to be made through pumping the public with treatments then to focus on prevention or cures. This is the main topic of a book recently released called Selling Sickness: How the World's Biggest Pharmaceutical Compnaies Are Turning Us All Into Patients.
The book focus on Big Pharma's preying on the culture of fear that has grown in our post-9/11 society. Direct to consumer advertising creates the sense that we may have a certain disorder by using vague illness descriptions and general diagnostic criteria.

In spite of the recent victory for Vioxx plaintiffs in Texas, Merck continues to flirt with the idea of returning Vioxx to the market. The FDA will only allow this if the drug's use is limited and heavy warnings are added to its label.
The problem is the real reason Merck may return the drug to the market is so that plaintiff's attorney may not use the withdrawal of the drug from the market as ammunition for their courtroom arguments. In reality, the overall effect of plaintiff's arguments would be effected little. However, the risk the drug may pose to citizens if it is returned to the marketplace is significant.

Read the full article here.

A recent victory in an anti-trust class action brought against drug maker Smith Kline kept them from inflating the price on their drug, Paxil. Even the Federal Trade Commission was unable to do what a group of trial attorneys accomplished for the benefit of the public.
Smith Kline repeatedly filed patent challenges to delay the introduction of generic forms of the drug. This is a tactic used repeatedly by drug companies, due to the fact that a drug is most profitable when it is protected by a patent (i.e., no generic competitors are allowed). Let's keep in mind the profits from the top 10 drug companies topped $35 billion in 2002, more than the profits from the rest of the 490 Fortune 500 companies combined.
This is another example of how our civil justice system works to protect American consumers across the country.

Justice was served in Texas today. The jury in the first Vioxx case to go to trial awarded $253 million to the wife of the deceased marathon runner, Robert Ernst. This award included $229 million in "exemplary" or punitive damages, sending a clear message to Merck that the public will not stand for the harm caused to potentially tens of thousands of Americans. The $229 million awarded in punitives is the exact amount Merck saved by delaying the warning label update for nearly seven months after the FDA's request. Unfortunately, this punitive award will be reduced under Texas law to twice the amount of economic damages awarded plus $750,000 or about $1.65 million.
Mr. Ernst died of an arrythmia that the jury found was caused by a heart attack. He was in excellent health, and was only married to his wife for four years before his death.
This verdict is excellent news for all Vioxx plaintiffs across the country. It is the first step in forcing Merck to account for the damage caused by their defective drug and deceptive marketing practices.
Merck of course continues to run from responsibility, and vows to appeal the decision.
A clear breakdown of the verdict can be found here.

In 2001 Merck had a dilemma on its hands. A study indicated Vioxx's three-to-five fold increase in the risk of heart attack and other serious cardiovascular events. Doctors were asking questions. Why should they prescribe this drug if there are so many risks associated with the drug? Merck responded by arming their sales force with a pamphlet called "Dodge Ball". The pamphlet included information on how to respond to these doctors' questions while avoiding Vioxx's real risks.

Today there is no way for Merck to dodge the thousands of people that Vioxx has harmed.

A copy of the pamphlet is found here. Be prepared to be infuriated.

A Texas state court of appeals ruled in favor of the plaintiffs last week in the first Vioxx trial in the nation. The interlocutory appeal (an appeal taken before the end of a trial) was filed last week in an attempt to prevent testimony from going to the jury from the coroner who performed the autopsy. The Coroner, Dr. Araneta, did not mention any blood clots in the autopsy report or death certificate. However, she testified on behalf of the plaintiffs that a clot more likely than not caused the arrythmia that ultimately killed the plaintiff.
Merck attorneys appealed the decision to the Texas Supreme Court on Friday.

Read the full article here.

The FDA recently released a warning to patient and caregivers regarding the use of the Duragesic patch for pain control. Deaths and overdoses have occurred with Duragesic and the generic form of the drug. The complete warning may be found here.

The FDA recently asked the makers of the most popular erectile dysfunction drugs to add label warnings for sudden vision loss. The blindess associated with these drugs is caused by non-arteritic ischemic optic neuropathy or NAION. This warning comes in the wake of recent problems with Viagra. The warning is to be placed on Viagra, Cialis, and Levitra.

The jury selection process, called voir dire, began today in the first Vioxx trial. The Texas state trial should last weeks. The fate of many Vioxx cases will be determined by this first case, but there will be many trials to follow over the next year.

Read related article here.

FDA recently released a warning for antidepressants such as Effexor, Paxil and Zoloft. The warning is for suicidality, especially with adults taking these drugs for depression.
These drugs received a similar warning for use in children in March of 2005.

Read the FDA Healthcare and Patient information sheets here.

The first crack at Merck goes to attorney Mark Lanier of Houston, Texas, in the first of many Vioxx trials. Lanier represents Carol Ernst, whose husband died of an arrhythmia at the age of 59 after taking Vioxx for about 6 months. A personal trainer and marathon runner, Mr. Ernst clocked 62 miles per hour on his bicycle just eight days before dying of heart failure in his bed.
This is the bellwether case for the some 3,500 Vioxx cases filed against Merck. A victory for Mr. Ernst is a victory for plaintiffs across the country, as Merck will consider settleing other cases if defeated in the Ernst case.
Read full article here.

Documents recently surfaced in the media that indicate Merck took great efforts to silence those scientist who spoke of the cardiovascular risk of Vioxx. An excerpt of a Merck intercompany email indicates that pressures were put on scientists who were critical of Vioxx. The November 7, 2000, email from Merck's medical director goes as follows:

Tell [Dr. Gurkirpal] Singh that we've told his boss about his Merck-bashing... should it continue further actions will be necessary (don't define it).

Dr. Singh is a doctor from Stanford who initially performed as a spokesperson for Vioxx until the VIGOR study in 2000 indicated a serious cardiovascular risk. Dr. Singh changed his opinion of the drug in light of the study, and made it a point to warn of the cardiovascular risks. This prompted Merck's threats to censure Dr. Singh.

Hear the full report on NPR.

The Vioxx litigation turned up another damning document against Merck. The documents from 2000 indicate that Merck scientists were formulating another version of Vioxx that did not have cardiovascular risks. Remember that this is the same time the Merck and its 3000 salespeople were aggresively denying any such risk. It begs the question: if there was not a risk, why were they trying to make it safer?

See full article here.

A recent observational study perfomed with data from a UK general practice database found a similiar increase in risk of heart attack between Vioxx, Celebrex, and naproxen. The study is found in the most recent addition of the British Medical Journal. While this came as no suprise, an editorial written by Dr. Peter Juni revealed some disturbing information about attempts to acquire information from the FDA.

[O]nly about 16 out of at least 27 trials of Celecoxib that were performed up to 2002 in patients with musculoskeletal pain were included in the relevant reports. In any event, reporting on study charactieristics nd adverse events was not always transparent, and cmplete data on cardiovascular safety were available for only three trials...

It is hard to believe, but about 70 percent of the financing for clinical drug trials in the US comes from the drug companies themselves. These funds generally go to American Universities for the actual testing to be performed. However, drug companies will select those Universities whose testing standards allow for consistent results showing the drugs safety and efficacy. These companies look for schools that allow them to interfere. This includes inserting their own analyses into the University's test results, suggest revisions before the report is released, or even drafting the report altogether. The report found in the New England Journal of Medicine, was the culmination of surveys sent to 122 American medical schools. ...

It is impossible to watch television nowadays and not see an advertisement for a prescription drug. Most of these commercials indicate relief that is unproven, exaggerate positive results, or fail to warn of serious side effects. The FDA monitors these ads, but with a woefully understaffed department and minimal budget. Dr. Sidney Wolfe of Public Citizen sums the problem up in a recent article from USA Today:

The FDA has encouraged such conduct by handing down weak punishments that sought only to halt offending promotions and others like them. Sometimes the FDA did not act until the promotions had ceased.

That's what happened with GlaxoSmithKline's antidepressant Paxil CR. Last June, the FDA cited its TV ad as misleading and asked that it be pulled — a month after it had stopped airing, Glaxo says.

There's no disincentive to running misleading advertising," says Wolfe. "Drugmakers know they'll be able to run ads for four, five months and get their message out. ... Then FDA says stop, and they stop and go on to something else that may be more misleading.

The FDA announced today that they are requiring a boxed warning be placed on all Non-Steroidal Anti-inflammatory Drugs (NSAIDs) including all Cox-2 inhibitors. The warning notifies patients of cardiovascular and gastrointestinal risks. The FDA warning includes popular over-the-counter NSAIDs, such as Aleve, Advil and Motrin.

This warning comes with little surprise, as indictors of a cardiovascular risk for NSAIDs have been around for years. The concern is that these warnings are too little too late.

Just last March the FDA rebuffed pleas by consumer groups to pull Crestor off the market. However a study published in the American Heart Association's journal Circulation indicates a 2 to 8 fold increase in risk of kidney damage and muscle problems over other cholesterol lowering drugs. The safety of Crestor has been closely watched since its approval in 2003. Early indications that the drug posed a risk of rhabdomyolysis similar to that of Baycol fueled arguments that Crestor should not have been approved at all.
Not suprisingly, the FDA's response to the study is mechanical: "We haven't found any convincing evidence that Crestor poses any more of a risk than the other statins."
Considering the scrutiny under which Crestor is monitored, it is inevitable that the drug will be taken off the market. It is just a matter of how long the FDA will wait before doing their job of protecting U.S. citizens.

Eli Lilly agreed to settle about 8,000 Zyprexa cases claiming the drug caused hyperglycemia and other blood sugar disorders in its users. The drug was improperly labeled prior to September, 2003, and failed to warn of these side effects. Eli Lilly set up a settlement trust of $690 million and will continue to defend those cases not involved in the settlement. Zyprexa is part of a class of drugs called atypical antipsychotics. Other drugs in the same class linked to blood sugar disorders include Geodon, Abilify, Risperdal, and Clozaril.

See related article here.

Dr. Richard Smith, former editor of the British Medical Journal and current chief executive of UnitedHealth Europe, recently expressed his concern over the number of articles printed in scholarly journals funded by the pharmaceutical industry. Dr. Smith states:

Unlike advertisements, trials are seen by readers as the highest form of evidence, he says. Trials funded by drug companies rarely produce unfavourable results and make up between two thirds and three quarters of the trials published in key journals.

See full article here.

An article in the Philadelphia Inquirer reported today that a Harvard Professor lecturing in 2000 on the potential dangers of Vioxx received a call from Merck telling him to stop.
Professor Lee Simon got a call from Louis M. Sherwood, at the time a senior vice president with Merck & Co., regarding the Professor's belief that Vioxx caused more strokes than rival drugs. The article explains

To cultivate experts for their products, drug companies often donate to medical schools, finance research, and sponsor conferences, in addition to paying for clinical trials. Each institution has its own guidelines on whether to accept such financial support.
Companies dangle or withdraw the money at any time, but using it expressly to influence a researcher's opinion is considered by academicians a violation of open scientific debate.
In this environment, Merck and G.D. Searle & Co. - later acquired by Pfizer Inc. - went to battle in 1999 over the multibillion-dollar market in pain relievers called Cox-2 inhibitors. Corporate money quickly tinged the scientific debate by casting researchers as protagonists for one product or another.

See full article here.

Sounds a bit funny at first, but unfortunately it is no joke. Researchers at the University of Minnesota have associated Viagra use with a rare type of blindness called non-arteritic anterior ischemic optic neuropathy or NAION. The study was published in the latest issue of the Journal of Neuro-ophthalmology. A press release by the University states:

The onset of NAION within hours after ingestion of Viagra in 14 patients supports an association between the use of the drug and NAION. Based on the fact that 14 cases of NAION have now been reported soon after the use of Viagra, the researchers believe that ophthalmologists should ask all men with NAION about the use of Viagra, and recommend that patients with a history of NAION in one eye be cautioned that Viagra may increase the risk of NAION in the fellow eye.

A recent article in the USA Today looked into the effectiveness of the FDA's black box warning. This is the most stringent warning the FDA can place on a drug, and most recently placed the warning on antidepressants and the arthritis drug Celebrex...

The federal judge overseeing the consolidated federal court Vioxx cases in New Orleans told plaintiff and defense attorneys that there may be over 100,000 Vioxx lawsuits filed. Judge Eldon Fallon, an experienced mass tort litigation judge, presided over the status hearing where attorneys argued over scheduling and discovery matters. The first Vioxx trials are scheduled to be held in state court. A July trial is set in Texas, followed by an August trial in New Jersey.

Read the full article here.

Pfizer's CEO, Hank McKinnell, stated recently that Bextra will likely return to pharmacy shelves. He failed to mention when this may occur, and in reality it is doubtful whether it happens at all. Drugs returning to the market after being withdrawn are stigmatized and never reach sales equal to those before the withdrawal.
And for good reason. The increased risk of heart attack, stroke, and the potentially deadly skin disorder Steven Johnson's syndrome, are well documented. Even the FDA determined that the serious risks associated with Bextra clearly outweigh the benefits of taking the drug.

See related article at CNNMoney.

The Center for Public Integrity, a consumer protection watchdog in Washington D.C., released some disturbing numbers about drug lobbyists. Since 1998, the pharmaceutical and health products industry lobbied on more than 1,400 congressional bills, spent $759 million in lobbying efforts, and employed almost 3,000 professional lobbyists. This is more money and resources spent lobbying than any other organized interest.
One of the most disturbing results of these payoffs is the recent Medicare Prescription Drug, Improvement and Modernizatin Act of 2003 which goes into effect next year. Buried deep in this Act is...

On April 20, 2005, the FDA declared that manufactures of epilepsy drugs, such as Neurontin and Depakote, need to reexamine their data to see if there is a link between the drugs use and increase in suicide and suicidal behavior.

This is similar to last year's request by the FDA regarding the suicide rate in children and antidepressants known as SSRI's. The FDA placed its sternest warning, the arguably toothless "black box" warning, on the entire class of drugs based on the results of inquiry.

It is true that statistics can be used to reach almost any desired effect depending on the context of their use. Conceding this fact, the following numbers taken from a brief article in the April, 2005, edition of Popular Science is numbing:

100 Percent increase in risk of heart attack and stroke found in a 2004 Merck-sponsored study of 2,586 patients taking the painkiller Vioxx (MD Anderson Cancer Center)

88,000 Estimated cases of serious coronary heart disease in the
140,000U.S. caused by Vioxx since its launch in 1999, according to an FDA study

The more lawsuits that are filed on behalf of those injured by Bextra and Celebrex, the more consolidation seems appropriate. A handful of attorneys in Louisiana are asking the JPML to place Bextra and Celebrex cases in with the Vioxx MDL. Learn about MDL's here. This makes sense considering that the drugs work the same way on the body, cause the same types of cardiovascular events, and present similar questions of fact. The unknown is how this will effect the MDL as a whole. Most likely, the benefits of consolidating these cases will be tempered, if not nulled, by the drag of additional cases in an already large MDL. (See Related Article, Nationwide Bextra and Celebrex Lawsuits Requested to be Consolidated and Transferred to Louisiana Federal Court)

On April 7, 2005, the FDA required Pfizer to put a "black box" warning on Celebrex labels. This is the strongest warning available to the FDA, and requires doctors to prescribe Celebrex as a last resort for patients suffering from pain. The drug is also contraindicated for those post-coronary artery bypass surgery.

This all sounds good, but the fact is that many doctors and patients will never receive this warning. Even with all the news surrounding Celebrex and the entire class of Cox-2 Inhibitors, some doctors and many patients are too busy to read and understand the new warnings. "Dear Healthcare Professional" letters are sent out to doctors for every label change. There is a serious question how many doctors have the time in their busy schedules to actually read all of them.

Check out this article on Vioxx and an attempted settlement:

Vioxx Settlement Negotiations Fail in an Alabama Case

On September 30, 2004, Merck Pharmaceuticals voluntarily withdrew the drug Vioxx from the market. The withdrawal came at the conclusion of a long clinical study to test the effectiveness of the drug on the reduction of colon polyps. During that study, it became clear that people on the drug for more than eighteen months were at twice the risk for heart attacks, strokes, and other serious cardiovascular events.

The withdrawal of Vioxx, and more recently Bextra, has created a hum of corporate irresposibility and deception. Hundreds of Vioxx and an increasing number of Bextra lawsuits are filed. As these cases progress, you will here more and more on the topic of Multi District Litigation, or a "MDL." Below is some helpful information on an MDL and its procedural workings.

An MDL is an attempt to streamline litigation involving many individual lawsuits at the federal level. It is not in itself a class action lawsuit, but may include class actions lawsuits. It essentially brings together federal lawsuits from all over the country with common claims and injuries to determine pretrial matters.

In February, an FDA advisory committee met to discuss the safety of the class of drugs known as Cox-2 inhibitors. Of course, this is the class getting a lot of press lately that includes Vioxx and Celebrex. Pfizer and Merck pharmaceutical companies where there, defending their drugs and making their plea to keep their money-makers on the market.

At the conclusion of the three day seminar, the 32 member panel voted on a variety of issues including whether these drugs increase the risk of heart attack and stroke, and if the drugs should be allowed to stay on the market. The panel voted unanimously that all Cox-2's increase the risk of cardiovascular events (a fact that Pfizer continues to deny to this day). More surprisingly, the panel also voted 17 to 15 in favor of letting Vioxx return to the market. The decision was summed up on the front page of the Chicago Tribune: "Vioxx Returns to the Market." (A bit of irresponsible journalism, but that is another post for another day).

We have been bombarded this holiday season with bad news. Drugs distributed on a mass scale have the ability to actually kill its users. Vioxx, Celebrex, and Bextra, all members of a class of drugs called Cox-2 inhibitors, are the problem.
The first to fall is Vioxx. Merck Pharmaceuticals withdrew Vioxx from the market after a study indicated a two fold risk of heart attack with people who use the drug. About a month later, a similar study is halted when it is discovered that those on Celebrex have a 2.5 increase risk of heart attacks and strokes. Other studies indicate a similar problem with Bextra...