Chicago Injury Law Blog

Recently, the FDA overwhelmingly refused to take Avandia, the diabetes drug, off the market, despite studies that showed increased heart attack as a very realistic side effect. Weaknesses in those studies were one of the reasons cited by the FDA for their decision. However, one of the solid conclusions reached was that Avandia does increase heart attack risk.

The FDA did suggest a "black box" warning, the most severe, to warn consumers about the risk. Further suggestions included discouraging joint use of Avandia and insulin, as this also increases heart attack risk. FDA experts also recommended that the drug be investigated further.

In early 2007, Avandia was the second highest grossing diabetes drug in the United States. An analysis of 42 studies showed that there is a 43 percent higher chance of heart attack risk with diabetic patients taking Avandia than those taking any other or no diabetes medication. Avandia is used to control the body's blood sugar by increasing sensitivity to insulin. Before the studies, this treatment was commonly perceived to decrease heart risks already associated with diabetes. Diabetes affects more than 18 million Americans today.

Congress is in the process of overhauling the FDA's decision, and points to the Avandia situation as evidence of the FDA's inability to handle the safety risks of drugs that have been approved for the market.

In the case of Avandia, it appears that the FDA is too lax in dealing with hazards associated with certain drugs. Conversely, many poor countries around the world are not even close to lax with their policies surrounding drugs that should be deemed necessities. Morphine is one prime example, as a pain reliever. Countless poor countries find it extremely difficult to secure this drug even in the cases of uncontrollable cancerous tumors that cause excruciating pain. However, even in these cases, morphine is not allowed due to an intense fear of patient addiction.

Is the FDA too lax in their drug safety control policies? Are foreign countries not lax enough?

See the following articles for more information:
Avandia:
www.msnbc.msn.com/id/20036086/from/ET/
Morphine:
www.nytimes.com/2007/09/11/health/11pain.html
www.nytimes.com/2007/09/10/health/10pain.html

"How do pharmaceutical companies know which doctors prescribe the latest and most expensive brand name drugs?

They have inside information on the prescribing habits of virtually every doctor in the United States. Pharmaceutical and device manufacturers buy this information from the American Medical Association and from companies that match the AMA's data with pharmacy records.

While such practices have gone on for years, the issue is expected to be a hot topic at this week's annual meeting of the AMA in Chicago, with some groups planning to protest during the gathering at the Hilton Chicago.

"Doctors are not aware that companies are out there that know every prescription a doctor prescribes," said Dr. John Santa, an internist at the Portland Veterans Affairs Medical Center and consultant to the Prescription Project, which is part of a coalition trying to curb drug companies' access to doctor prescribing information."

Read the full article in the Chicago Tribune.

No great surprise to the readers of this blog, but a recent study published in the Journal of the American Medical Association reveals that litigation serves an important role in protection American from dangerous drugs.  An excerpt is found below:

"In the past decade, several widely used prescription medications have been observed to cause life-threatening adverse effects, and some have been removed from the market. When an approved medication is found to be unsafe, the courts are sometimes called on to determine fault and allocate remedies for injured parties. But in modern prescription drug cases, litigation has taken on additional significance. There are often important gaps in the ascertainment and reporting of adverse effects associated with prescription drugs, and the balance of information presented to physicians about the risks and benefits of medications may understate the former and inflate the latter.¹ However, once it approves a drug, the US Food and Drug Administration (FDA) has limited authority to mandate further collection of data to better define adverse effects or to ensure compliance with suggested alterations in marketing practices."

You may buy the full article here.

A recent article in the New England Journal of Medicine reported a study  indicating a 48% increased risk of heart attack with the diabetes drug Avandia.  Avandia is taken by more than over 1 million people and generated sales of over $3 billion for GlaxoSmithKline last year.
Could this be another Vioxx?  Well, not to the same scale, but the author of the recent study, Dr. Steven Nissin, was one of the main critics of Vioxx.  We will have to wait to see just how much Glaxo new before this study came out.

Read more at WSJ.com.

"Purdue Pharma has agreed to pay $19.5 million to 26 states and Washington, D.C., to settle claims that the company promoted its painkiller OxyContin for off-label uses, the company announced on Tuesday, the Wall Street Journal reports (Wall Street Journal, 5/9). According to Connecticut Attorney General Richard Blumenthal and state Consumer Protection Commissioner Jerry Farrell, Purdue also allegedly violated FDA rules by promoting OxyContin for use every eight hours, rather than the approved dosage of every 12 hours (Hathaway, Hartford Courant, 5/9).

The states allege that Purdue violated FDA rules by promoting the drug as the painkiller "to start with and the one to stay with" for a variety of pain, including from surgery and broken bones, even though the drug was approved by FDA for limited use in people who need long-term pain management. In addition, the states allege that Purdue tied the pay of its sales representatives to how much OxyContin doctors prescribed, while playing down the addictive properties of the drug (Jadhav, St. Louis Post-Dispatch, 5/9). The cumulative effect of such practices has led to "misuse, diversion and abuse" of OxyContin by increasing the amount of the drug in circulation, according to Blumenthal."

Read the full article at MedicalNewsToday.com

"The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).

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.

A recent ruling by Texas state court Judge Randy Wilson may be the end of nearly 1000 Texas Vioxx cases. The ruling was based on a recent FDA Administrative Rule which effectively preempts all state law failure to warn claims.

Read more at WSJ.com.

A federal judge in Pennsylvania recently ruled on a Thimerosal case that may have disastrous effects on those harmed by the vaccine preservative. The ruling essentially states that the FDA is the law of the land on drugs, preempting all state consumer protection laws.  Considering the track record of the FDA in protecting Americans over the last 5 years, that is a frightening thought.

"The defendants raised two preemption arguments, one of express preemption under the Vaccine Act and a second of conflict preemption under the Food and Drug Administration’s position expressed Jan. 24, 2006, as the Preamble to the Final Rule. Judge Stengel disagreed with the express preemption argument, but said the legislative history of the Vaccine Act as set forth in Blackmon v. Am. Home Prods. Corp (328 F. Supp. 2d 659, 663-66 [S.D. Tex. 2004]) shows that Congress intended to preempt claims asserting strict liability and design defect based on negligence, but not failure to warn.

However, the judge ruled that failure to warn on all products is conflict preempted by the FDA’s Preamble/Final Rule, which says state laws requiring stronger or different labels conflict with the FDA’s authority over the contents of drug labels."

Read the full article at LexisOne.

A recent article in Forbes magazine brings light just how embeded the pharmaceutical industry is in the medical profession.

"The ties between doctors and drug manufacturers are close indeed, with virtually all doctors reporting some kind of relationship with industry, even if it's as seemingly innocuous as accepting free food and beverage, a new study has found.

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."

"The high-profile trial over Vioxx late last month in Madison County was just an early skirmish in what could be years of litigation here and elsewhere over Merck & Co.'s once highly touted painkiller.

The jury, after a month-long trial, rejected pleas to slap Merck with tens of millions of dollars in damages for the 2003 death of a Granite City woman who spent 20 months on Vioxx.

Though the drugmaker's lawyers celebrated their win in a county with a reputation for being unfriendly to corporate defendants, they'll be back soon for the next Vioxx trial in Madison County, scheduled for September.

Two Vioxx trials are also set for December in the county, according to Merck's trial calendar, but those would probably be pushed off. A fourth was slated to face a jury in October but was transferred to Chicago."

Read the full article in the St. Louis Dispatch.

"The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States.

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."

Last month the FDA directed all manufacturers of drugs approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides alerting patients to the potential risks of the drugs.  In addtion to past risks, the Medication Guides are intended to warn of possible cardiovascular events and adverse psychiatric events. 
It seems that we are routinely hearing about new concerns and warnings regarding ADHD drugs. Considering the millions of people that take these drugs, the FDA should take a hard look at the benefits vs. risks of each drug in the class.

The full FDA news release may be found here.

"A New Jersey jury found Friday that Merck failed to warn about the cardiovascular risks of the painkiller Vioxx in the case of a man who had a heart attack in 2001.

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.

"A jury on Tuesday awarded $3 million to an Ohio woman who claimed a hormone replacement drug made by Wyeth caused her breast cancer.

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.

"The Food and Drug Administration (FDA) is notifying health care providers and consumers about 28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (trade name RotaTeq), manufactured by Merck and Co., Inc. Intussusception is a serious and potentially life-threatening condition that occurs when the intestine gets blocked or twisted. One portion of the intestine telescopes into a nearby portion, causing the intestinal obstruction. The most common site is where the small intestine joins the large intestine."

Read the FDA's full news release here.

"Taking such popular heartburn drugs as Nexium, Prevacid or Prilosec for a year or more can raise the risk of a broken hip markedly in people over 50, a large study in Britain found.

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 drug maker Eli Lilly instigated legal action against a number of doctors, lawyers, journalists, and activists over hundreds of internal corporate documents and emails said to have been obtained by them regarding the antipsychotic drug olanzapine (Zyprexa). Eli Lilly obtained a court injunction on 29 December ordering 16 individuals and organisations to stop publishing the documents and to remove any copies posted on the internet. The documents created a furore after they were leaked to the New York Times, which reported that they showed that Eli Lilly 'engaged in a decade-long effort to play down the health risks of Zyprexa'"

Read the full article at the British Medical Journal.

"Drug companies are spending exorbitant sums of money on television advertising, and their efforts are not in vain. Nowadays, consumers go to their physicians requesting prescriptions for drugs they've seen advertised on TV. But is drug advertising misleading consumers, asks a new study in the Annals of Family Medicine .

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 FDA MedWatch program recently reported its concerns with child infant mortality and children's over-the-counter cough and cold remedies.
"The Centers for Disease Control and Prevention (CDC) issued a Morbidity and Mortality Weekly Report (MMWR) article describing three deaths in US infants aged less than 12 months associated with cough and cold medications. These medications were determined by medical examiners or coroners to be the underlying cause of death. "

Read the full release here.

"The drug maker Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers.

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.

"FDA and Bayer Pharmaceuticals notified healthcare professionals of revisions to the prescribing information for Trasylol.  The new labeling has a more focused indication, a new Warning that Trasylol
administration increases the risk of renal dysfunction and may increase the need for dialysis in the perioperative period, and stronger warnings about anaphylactic reactions. In addition, due to the higher risk for anaphylactic reactions, re-administration of Trasylol to patients with a known or suspected exposure during the past 12 months is contraindicated."

Read the FDA release here.

""In a long-awaited analysis, health officials reported yesterday that antidepressant medications appeared to increase significantly the risk of suicide attempts and related behaviors in adults under 25, while reducing such risks in older people. The analysis, the most comprehensive and rigorous to date, found that suicidal behavior of any kind was rare, and that people taking the medications were no more likely to kill themselves than those taking placebo pills. But adults under 25 taking the drugs were more than twice as likely as those on placebos to report a suicide attempt, or to prepare for one by, say, writing a suicide note. The report, which included more than a dozen medications, was compiled by the Food and Drug Administration and posted on its Web site."

Read more at NY Times online.

"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.

"A medical study to be released today suggests that high doses of a best-selling drug used to treat anemia in dialysis and cancer patients may increase the risk of heart problems and deaths.

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.

"GlaxoSmithKline PLC has agreed to pay $63.8 million (€50 million) to settle a lawsuit's claims that it promoted its antidepressant drug Paxil for use by children and adolescents while withholding negative information about the medication's safety and effectiveness.

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.

Merck pulled off another victory in federal court recently, with the New Orleans jury finding that Vioxx did not cause a 64 year-old's heart attack after taking VIoxx for ten months. The case took a bad turn for the plaintiff when he testified that he had stopped taking Vioxx about four days before his heart attack.  He had maintained that he was on Vioxx continuously for 10 months before the event up until his testimony. A handful of trials in federal and New Jersey state court are slated for the new year.

Recent studies indicate that Trasylol, a drug used during heart surgery to minimize bleeding, is linked to kidney failure.  The drug has attracted further criticism by is high costs-nearly ten times the cost of other, equally effective drugs.  Since the drug is used during the actual surgery, patients rarely know if the drug has been administered.  Patients with kidney failure after heart surgery should be aware of this side effect, and inquire about Trasylol's use during their heart surgery. 

A recent article in the NY Times highlighted the problems surrounding Eli Lilly's sepsis drug Xigris.  The drug, which costs $8000 for a four day treatment, is considered to be no more effective than other, much less expensive drug.  Further, Lilly halted two clinical trials when results indicated a higher risk of severe, life-threatening bleeding. 
Approved in 2001, Lilly heavily marketed Xigris to hospitals and doctors, using questionable science to back up the claims made in the marketing. 

The FDA recenlty warned of and increased risk of overdose death with the antidepressant Effexor.  The FDA's release indicates that there is a increased risk of overdose with Effexor, especially when used with other drugs and alcohol.  Further, the Effexor overdoses may be more likely to be fatal than overdoses with other similar drugs called SSRI's. 

Former FDA Chief Lester M. Crawford will plead guilty to charges that he failed to properly disclose stocks that he owned which conflicted with his duties at the FDA. In plain terms, as Chief of the FDA he could make decisions that would effect the stock price of stock he owned. Federal law prohibits this type of ownership when the company is considered to be "significantly regulated" by the FDA.

Last week a Pennsylvania state jury awarded $1.5 million in compensatory damages to a women diagnosed with breast cancer after taking the osteoporosis drug Prempro for 5 years. However, this is only the first of two parts of the trial. In the second phase of the trial, plaintiff's attorney Ken Suggs will have to convince the jury that Wyeth Pharmaceuticals, the maker of Prempro, failed to adequately warn of the breast cancer risk. If the jury finds that Wyeth did fail to warn, then they may add punitive damages. If however they do not find that Wyeth failed to warn, the initial compensatory award will be nullified. 

The FDA recently released a warning regarding the life threatening side effects of Bayer's Trasylol, and it looks like another case of a drug company intentionally withholding a products dangerous side effect.

"Bayer A.G., the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke, the Food and Drug Administration announced Friday.

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.

"The government's drug safety system is seriously out of balance, devoting too much attention to approving new medications and not enough follow-up to uncovering risky side effects, a blue-ribbon scientific panel concluded in a major report released Friday.
Convened at the request of the Food and Drug Administration after a popular painkiller was linked to heart attacks, the experts in medicine, pharmacology, law and other fields issued a sweeping call for reform. Its 25 recommendations include establishing a fixed term for the FDA commissioner, restricting ubiquitous drug commercials and placing a special cautionary symbol on the packaging of newly approved medications.
The panel found "an imbalance in the regulatory attention and the resources available before and after approval" of new drugs, said Chairwoman Sheila Burke, a former Republican Senate staffer who now is chief operating officer of the Smithsonian. "Staff and resources devoted to pre-approval are substantially greater than those available post-approval."

Read the full article in the LA Times.

In 2004, major drug companies paid for 53% of the FDA's drug review budget, and the drug firms are looking to give more in an effort to push the industry's agenda. More likely than not, the drug firms will get their wish. The FDA is one of the very few regulatory bodies that actually haggle with the industries they oversee for contributions to their budget. I can't see how this is not a conflict of interest, with the brunt of the conflict falling on U.S. consumers. How can a regulatory body regulate when its budget is supplied by contributions from the very companies they are to oversee? Indeed, there are already examples of the influence drug firms have over the FDA. In 1997 the FDA reduced the amount of review time for a standard application from 12 to 10 weeks, in response for an increase in the amount of fees taken in from drug companies.  Further proof that the FDA is merely a lapdog for the pharmaceutical industry.

A recent study from the highly regarded Institute of Medicine revealed that more than 1.5 million patients are injured by drug error in hospitals, nursing homes, and doctor's offices.  The report found that a hospitalzed patient is subject to at least one medication effor per day, and that a preventable drug error can add nearly $6000 to a hospital bill of a single patient. The Insitute called for all prescriptions to be written electronically by 2010 to reduce the amount of errors.

Read more in the Washington Post.

In the first of thousands of cases involving the hormone replacement drug Prempro and Premarin, a federal jury found for the defendant, Wyeth Pharmaceuticals. The drugs are derived from the urine of a pregnant horse, and have been linked with an increase risk of breast cancer. Not only is the risk of breast cancer increased, but the types of tumors caused by the drug are difficult to detect and treat.
There are many trials set to go in the near future and we will keep an eye on the progress of the litigation.

Read more at law.com

Dr. David Graham of the FDA's drug safety office (who notably first brought the FDA's shortcomings to light late last year while testifying in front of the Senate Finance Committee) is now focusing on the FDA's failure to properly test and warn of the antibiotic Ketek.  The drug has been linked with severe and life threatening liver problems.  Dr. Graham stated in an internal memo:
"It's as if every principle governing the review and approval of new drugs was abandoned or suspended where [Ketek] is concerned.  We don't really know if the drug works; no one is claiming it works better than other, safer drugs; and we're flying blind as far as safety goes, except for our own A.D.R. date that suggests [Ketek] is uniquely more toxic than most other drugs."

The first Prempro trials are set for jury selection in U.S. District Court in Arkansas. The plaintiff alleges that her use of the hormone replacement drug caused her breast cancer. She took Prempro for eight years before being diagnosed with breast cancer. Plaintiff's allege that drugmaker Wyeth withheld important information regarding cancer risks, and were more worried about the bottom line that patient safety. There are over 4,500 Prempro suits filed.

Judge Eldon Fallon threw out the jury's $50 million dollar compensatory verdict in the recent federal Vioxx case.  Finding that no reasonable jury, absent passion or prejudice, could find $50 million in compensatories for the plaintiff.  Compensatory damages include items such as past and future medical bills, past and future lost wages, loss of normal life, loss of society. Considering only compensatories, the $50 million seems excessive.
However, this is a clear indication that the jury found Merck's conduct so reprehensible that they awarded an amount in excess of the plaintiff's actual damages. Judge Fallon refused to overturn the jury's finding that Merck negligently failed to adequately warn of Vioxx's risks and knowingly withheld information regarding the drugs risks from the FDA and consumers.  
Consistent with federal law, Judge Fallon threw out the punitive verdict of $1 million along with the compensatory award. As the damages portion of the case is retried, I would forcast that the compensatory amount will be considerably less, and the punitive award to be considerably more.

Read more here.

"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.

On the same day a jury in federal court awarded Vioxx plaintiff $51 million, New Jersey state court Judge Carol Higbee  threw out the verdict for Merck from the November of last year. Citing new evidence, including the fact that Merck withheld crucial data from the VIGOR study and new deposition evidence, Judge Higbee awarded the plaintiff's request for a new trial. This second victory for those injured by Vioxx brings the win-loss tally to 4 and 4.

In a monumental victory for those injured by Vioxx across the country, a jury awarded Mr. Gerald Barnett $50 million in compensatory damages, and an additional $1 million in punitives damages. Mr. Barnett, a retired FBI agent, suffered a heart attack after 31 months of Vioxx use.
The award is especially significant because of the defense attorney that the plaintiff was up against. Phil Beck, out of Chicago, is considered to be the best in these types of cases. He was an integral figure in the Baycol litigation years ago, saving manufacturer Bayer billions in liability.
However, even the mighty Phil Beck could not overcome the weight of evidence against Merck. The jury found that Merck "knowingly misrepresented or failed to disclose" information about Vioxx to Gerald Barnett's doctors. In awarding punitive damages, the jury found that Merck "acted in wanton, malicious, willful or reckless disregard for the plaintiff's rights."

Possibly one of the first Celebrex cases to go before a jury is Rosie Ware v. Pfizer.  Ms. Ware suffered a stroke at age 53. Ms. Ware took Celebrex for over 4 years before suffering her stroke in 2005. Similar to the Vioxx cases, the lawsuit alleges that the defendant's failed to warn doctors and consumers of the potential risks and serious cadiovascular side effects associated with the drug. 

"FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.

Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea."

Read the FDA's full warning here.

"A 7-year-old boy received $43.1 million in a settlement for a vaccine that rendered him a quadriplegic.The settlement, which will be paid through the National Vaccine Injury Compensation Program, is thought to be one of the largest in its history, according to the plaintiff's attorney, Leland Dempsey. Mario Arturo Rodriguez was 1 on Jan. 25, 2000, when he received a measles, mumps and rubella vaccine at Children's Mercy Hospital in Kansas City.According to Dempsey, Rodriguez sustained a massive cervical spinal cord injury secondary to the development of transverse myelitis, an inflammation of the spinal cord that interrupts communication between the nerves and the rest of the body."

Read more at Lexis.com here

"The pharmaceutical industry is very different from the image it projects in its public relations. Americans spend about $200 billion a year on prescription drugs—the fastest-growing component of our health care bill, which itself is growing at an alarming rate. The soaring expenditures are due to three factors: greater overall use of prescription drugs (that is, volume); higher prices for new drugs; and rapid price escalation of drugs already on the market, particularly top-selling ones. In fact, prices for the 200 top-selling drugs are now rising more than three times faster than the inflation rate."

The full article may be found here.  Also see the book written by former New England Journal of Medicine editor Marcia Angel.

"Days after announcing a crackdown on researchers who do not disclose drug company ties, the editor of The Journal of the American Medical Association said she was misled again, this time by the authors of a study linking severe migraines to heart attacks in women.

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.

"Some products advertised online as natural alternatives to impotence drugs such as Viagra illegally contain the same active ingredients as prescription medicines, the Food and Drug Administration said Wednesday.

The FDA warned consumers not to buy or use seven of the so-called dietary supplements sold online to treat impotence and enhance sexual performance. The list includes Zimaxx, which FDA testing showed contains sildenafil, the same active ingredient in Viagra. Viagra, made by Pfizer Inc., is sold in the United States only by prescription."

Read the full article in the LA Times here.               

A Texas jury awarded $772,500 to the Estate of a woman who died after using a pain relief patch manufactured by Johnson & Johnson. The jury found that the patch 'leaked', releasing a lethal amount of the pain killer into the women's system. 
The patch was first introduced in the 1990's, but J & J sped up production in 2003 when the patent for the drug was about to expire. 
The FDA is looking into about 120 deaths that may be a result of the patch.

Read more in the NY Times.

"Stewart Grossberg soldiers into a Los Angeles courthouse this week as the latest combatant in a drug litigation war that's made the pharmaceutical industry the nation's No. 1 target of product liability lawsuits.

Grossberg, a retired Northridge construction manager, blames Merck & Co.'s pain reliever Vioxx for a heart attack he suffered in 2001. He is the first California plaintiff among more than 23,500 nationwide to have his suit against Merck go to trial."

Read the full article in the LA 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.