DaVita Employee's Whistleblower Suit Ends in $389 Million Settlement

October 24, 2014,

12857222344_037d571444_o.jpgA whistleblower lawsuit filed against DaVita HealthCare Partners recently concluded in a $389 million settlement. The kidney dialysis company agreed to settle investigations into transactions it made with doctors over the last ten years. Whistleblower lawyers at Pintas & Mullins highlight this case as an example of how average citizens can help improve American healthcare.

This suit was brought by a former DaVita employee, David Barbetta, who was a senior financial analyst in the company's mergers and acquisitions department. Barbetta filed the whistleblower lawsuit on behalf of the federal government in 2009, and will receive a substantial percentage of the $389 settlement.

DaVita operates thousands of outpatient dialysis clinics throughout the country, treating approximately 170,000 Americans. The company is accused of carrying out a complex scheme to pay doctors for referring patients to DaVita's clinics, a practice known as "kickbacks," which is illegal. Federal anti-kickback laws ensure that patients receive the best possible care from their doctors, who make their referral decisions based on the best interest of the patient and not on any financial incentives.

According to the investigations, DaVita has been paying doctors for referrals since 2005. The company's kickback scheme involved targeting physicians who treated a lot of dialysis patients and gathering information about those physicians to determine if they could be incentivized. For example, DaVita identified one physicians group to receive kickbacks because the doctors were "young and in debt."

Once physicians were identified, DaVita would offer them lucrative opportunities to refer their patients to DaVita's clinics. The company would pay physicians to perform various tasks and had them sign noncompete agreements. These agreements were contracts that forbade the doctors from sending patients to any of DaVita's competitors. These schemes took place throughout the country, in places like Central Florida and Denver, where the company is based.

Ethics Complaints Ignored


Barbetta, the whistleblower in this case, was a key witness in the government investigations. The former DaVita employee gave prosecutors e-mails, sales spreadsheets, and insider knowledge of DaVita's illegal schemes. Barbetta worked as a senior financial analyst from 2007 to 2009; during that time he frequently complained to upper management about the kickbacks and warned about the ethics of the schemes. His complaints were either ignored or drew scorn from higher-ups.

In one of the internal emails, DaVita executives explained how the "deals" with physicians were manipulated to funnel cash into their pockets in exchange for referrals. In 2009, Barbetta found another job and quit DaVita, fed up with the company's hypocrisy.

DaVita's marketing and sales tactics tout the company as a high-quality, fair, and compassionate resource for dialysis patients. Barbetta was tired of seeing these messages and having to work at the company every day, experiencing what actually happens behind closed doors. He made the decision to file a whistleblower lawsuit because, although everyone knew what was going on, no one else was willing to do anything about it.

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Lawsuit Accuses Hip Implant Maker of Putting Sales Before Safety

October 22, 2014,

91201736_f0cc7f3329_o.jpgPatients implanted with metal-on-metal hip implants are suffering serious health consequences from the devices and accusing manufacturers of putting marketing before patient safety. Thousands of patients have filed lawsuits against these companies, including Johnson & Johnson subsidiary DePuy Orthopaedics, which recently recalled many of its all-metal devices. Hip implant lawyers at Pintas & Mullins detail one of the most recent cases against DePuy currently in trial.

This latest trial against DePuy is considered a bellwether trial, which are used in large-scale litigation (there are about 6,500 hip cases pending against DePuy). In a bellwether trial, a judge selects a few cases to represent the majority of plaintiffs. These cases are then fully prepared on both sides and tried before a jury. They are meant to be representative of issues that arise in most injured peoples' cases, to give everyone an indication of what is likely to happen in future trials.

For the DePuy cases, one of the plaintiffs selected as a bellwether is coming to a close in Dallas. Over the past eight weeks, the client has accused DePuy of prioritizing marketing and sales over patient safety in its Pinnacle line of all-metal hip implants. She is also accusing the company of negligence, designing a defective product, failing to warn, and violating laws related to marketing.

DePuy stopped selling the Pinnacle implant in 2013 once it became clear the devices were failing in extremely high rates. DePuy sold two other metal-on-metal hip systems, the ASR Hip Resurfacing System and ASR XL Acetabular System, which were both recalled in 2010.

This is the first case to go to trial over the Pinnacle device, and the jury is currently in deliberation. We will update this blog once they make a decision. The plaintiff is asking the jury to recognize that DePuy hid the safety risks of all-metal devices, failed to warn doctors and patients that the implants could shed metal ions into the bloodstream, infecting the surrounding tissue and causing metal toxicity in some patients.

More Metal More Problems


Regarding its marketing, DePuy is accused of pushing the metal-on-metal devices specifically to younger, more active patients, claiming the all-metal devices would provide better mobility and would last longer. The opposite turned out to be true, with several studies pointing to early failure rates much higher than traditional hip implants.

Medical experts estimate that at least 10% of Pinnacle hips will fail within two to three years of implantation. When hip implants fail, doctors must go in for a revision surgery, which are often expensive and painful. Since such a high number of all-metal hips failed, there is much evidence that the implants were causing even more destruction in the body than they realized.

Patients implanted with defective metal-on-metal were showing signs of severe tissue death, ruptured tendons, fluid pockets, and other serious health effects. Additionally, as mentioned above, the metal implants release chromium and cobalt particles into the body, causing inflammation, pain, and difficulty moving. Long term effects of metal poisoning include brain and heart problems.

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Medical Device Makers No Longer Required to Report Product Changes

October 15, 2014,

laproscopic-surgery-robot.jpgCompanies that manufacture medical devices used to have to report any changes they made to the devices to the FDA. On Tuesday, the FDA announced that it would no longer make companies report this information, except when they apply to recalls or safety concerns. Defective medical device lawyers at Pintas & Mullins highlight the importance of this news and how it will affect patients.

The requirement was called an "806 report," which device makers considered a burden because of the extra paperwork and tasks companies had to perform. It was also a legal burden, as all the documentation would provide ammunition for anyone injured by the medical devices that chose to file a product liability claim against the device maker.

The reports could be used in trial to suggest or even prove that certain versions of a product were dangerous or unsafe. Companies would also have to submit copies of all written correspondence discussing changes made to medical devices.

The FDA proposed the 806 report to make sure device makers kept the FDA informed on any device tweaks that were intended to reduce health risks. It would have included any changes made to previously sold products and those that are not yet being sold. On Tuesday, however, the agency deleted the 806 reporting requirement, likely to appease controversy with device manufacturers. The FDA also nixed many other proposals that would affect recall reporting requirements.

Medical Robots More Costly and More Dangerous


A perfect example of how more reported data from medical device makers could be problematic for them in court is the da Vinci Surgical System. Many hospitals now have surgical robots, which cost millions and are marketed as being safe, more efficient alternatives for minimally-invasive surgeries.

Surgical robots are most often used in gynecologic procedures, such as to remove bladder cancer and ovarian cysts. The company that makes these da Vinci robots, Intuitive Surgical, have long-claimed that they lead to fewer complications and shorter hospital stays, despite a glaring lack of evidence to prove this.

Researchers have started taking the matter into their own labs. One of the more recent studies, conducted by Columbia University, found that surgical robots actually caused higher rates of complications, particularly in surgeries to remove ovaries and ovarian cysts. The study was recently published in the journal Obstetrics & Gynecology. In 2013, Columbia researchers also noted that robotic surgery for hysterectomies did not provide better patient outcomes yet resulted in exorbitant costs.

We recently reported on another similar study done by Johns Hopkins, which found dozens of examples of horrible-gone-wrong surgeries that were never reported to the FDA. Based on the information they were able to gather, Johns Hopkins researchers determined that serious incidents from da Vinci robots were vastly underreported.

Researchers analyzing data from da Vinci robots encourage patients to stop and seriously consider whether using this expensive technology will actually benefit them. The types of surgeries robots are meant to replace (called laparoscopic surgeries) are already minimally invasive, using tiny incisions and are not especially painful. On average, the complication rate for ovarian cyst removal is about 2.7% for laparoscopic surgeries; for robotic surgeries 3.7% of patients suffer complications, despite costing $3,000 more to perform. So, at least for ovarian procedures, using robots turn out to be more expensive and result in more complications that traditional surgery.

Da Vinci robots cost millions of dollars and many experts believe that hospitals are only buying them to stay ahead of the curve in the ultra-competitive healthcare field. Researchers believe that much more research needs to be done before surgical robots are accepted as the standard of care in U.S. hospitals.

Complications resulting from robotic surgeries can also be much more dangerous than those suffered in traditional procedures. The FDA database points to problems in software, battery function, and issues with the robotic lens clarity. There are also reports of "freak accidents," when robots would not let go of tissue or severely burned patients.

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Boeing Whistleblowers Cause $23 Million Settlement

October 13, 2014,

5480437205_8f5c4d3f81_b.jpgChicago-based aerospace company Boeing recently settled a labor law violations lawsuit in the amount of $23 million. The lawsuit was filed after four present and former Boeing employees acted as whistleblowers, exposing false labor submissions regarding contract maintenance workers. Whistleblower lawyers at Pintas & Mullins detail this lawsuit and how other employees who suffer labor violations can file similar claims.

In accordance to federal whistleblower laws (also called qui tam laws), each Boeing employee that came forward about the false labor charges will receive about $4 million. This will settle all allegations against Boeing that it submitted false labor charges on maintenance performed by contract workers on its C-17 Globemaster transport aircrafts.

The C-17 Globemaster is a large military airplane developed for the U.S. Air Force. In a statement, Boeing did not admit to committing any wrongdoing but merely a matter of "inadequate charging discipline." Aside from the $4 million that will be divided up among the whistleblowers, the rest of the settlement will go back to the federal government.

What is a Whistleblower?


Whistleblowers can be any private citizen who has knowledge of fraudulent practices toward the federal government to sue on behalf of the government. The lawsuits are filed under the False Claims Act, which allows the whistleblower to receive a significantly percentage of the ultimate award or settlement, typically between 15-25%.

Claims submitted under the False Claims Act most commonly involve health care, military, or other government spending program. The pharmaceutical industry drive the largest settlements year in and year out, with whistleblowers expose fraudulent claims made to Medicare and Medicaid. These types of pharmaceutical whistleblower cases typically involve marketing drugs for off-label uses not approved by the FDA.

Perhaps the most famous whistleblower lawsuit of this type involved antidepressant drugs manufactured by GlaxoSmithKline. Whistleblowers in that case accused GSK of promoting Paxil, Wellbutrin, Avandia and similar drug for off-label purposes. The company was also charged with failing to disclose critical safety data on these antidepressants, paying physicians to prescribe the drugs, and making false statements about Avandia. GSK was ultimately fined $3 billion for its fraudulent schemes.

It is important to note that doctors are allowed to prescribe drugs for any purpose, including those not approved by the FDA. This only becomes illegal if the doctor is receiving payments directly from the drug companies for prescribing off-label, or if the companies market drugs for non-approved uses. There are federal laws against this type of marketing, which drug companies routinely ignore.

Other types of Medicare fraud are quite prevalent in nursing homes and other elderly healthcare sectors. These can include billing for services not provided (such as if a nursing home resident on Medicaid is supposed to receive physical therapy sessions and the government is billed, but the resident never actually receives them), billing for higher reimbursement rates, and other similar false claims.

One example of this recently occurred in Illinois, when two former nursing home employees filed a whistleblower lawsuit against the facility. The employees allege that, although many residents were receiving grossly inadequate care, the facility was billing Medicare and Medicaid for above-average services. Employees were also directed to forge patient and medication records to reflect false care. Staffing records were falsified as well, to show minimum staffing levels were met but in fact were not.

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TVM Company Agrees to $400 Million Settlement

October 9, 2014,

Thumbnail image for 1409594_gavel_4.jpgEndo International, one of the major manufacturers of tranvaginal mesh products, recently agreed to pay more than $400 million to women who were harmed by the devices. More than 10,000 lawsuits will be resolved in this settlement, with an average payout of about $48,000 per plaintiff. Transvaginal mesh lawyers at Pintas & Mullins are happy to report on this settlement and who may be affected by it.

October seems to be a month of good news for those suffering from TVM complications; another major manufacturer, C.R. Bard, reported on a similar settlement agreement. This is a significantly smaller settlement, affecting about 500 plaintiffs who filed injury lawsuits against Bard. The company agreed to resolve these suits for about $21 million, averaging about $42,000 per plaintiff. The specific TVM product affected by this $21 million settlement is C.R. Bard's Avaulta Transvaginal Mesh product, which has been removed from U.S. markets.

Generally, mass settlements like these have to be agreed to by 90-95% of those affected by it. Every woman who has filed a lawsuit against a TVM manufacturer - or is at all considering it - should carefully consider their options when a settlement is announced. Each case is different, with unique injuries and circumstances, and some cases may be better off going to a jury trial. This is something that should be discussed with your TVM attorney.

In one jury case against C.R. Bard, the plaintiff, Christine Scott, was awarded $5.5 million for her injuries. Only two other cases have been heard in jury trials over C.R. Bard TVM products. The company also makes the Composix Kugel hernia mesh, which is now named in hundreds of lawsuits.

Endo International to Pay Billions


The $400 million settlement mentioned above is just the latest in a series of settlements offered by Endo International. Endo manufactured the following TVM products:

• Apogee Vault Suspension System
• Elevate Prolapse Repair System
• Monarc Sling System
• Perigee System
• Sparc Sling System

Despite billions of dollars in settlements, about 5,000 Endo TVM lawsuits remain pending in federal court.

Johnson & Johnson Facing TVM Suits


Ethicon Inc., a subsidiary of Johnson & Johnson, is also facing hundreds of TVM cases, currently consolidated in federal court in Pennsylvania. The location is actually quite important in this litigation group, because of the extensive business J&J conducts in Pennsylvania, including with a polypropylene manufacturer that provided TVM parts to the company. That manufacturer, Secant Medical, has also been named as a defendant in the TVM cases.

J&J has tried several times to have the mesh cases dismissed completely, without success. There are nine other companies currently fighting TVM lawsuits in court. These products were officially deemed unsafe around 2008, after the FDA issued a safety alert about the serious complications associated with mesh products.

Another safety alert was issued in 2009, and by 2010 thousands of voluntary reports were submitted to the FDA. Two years later the agency ordered all nine TVM manufacturers to conduct official studies on the products to determine their actual risks. It is important to note that TVM products inserted through the abdomen were not subject to this FDA request.

Continue reading "TVM Company Agrees to $400 Million Settlement" »

Criticism Over Da Vinci Robotic Systems Continues

October 6, 2014,

fort-belvoir-community-hospital-astounds-with-groundbreaking-technology-and-devotion-to-patient-care.jpgOver the last decades, technology surrounding surgeries have focused on improving how operations are conducted, with emphasis on making surgeries as minimally-invasive as possible. These are often referred to as laparoscopic surgeries, and have been topics of heated medical debates and injury lawsuits throughout the country. Our team of da Vinci surgical robot lawyers can answer any questions patients may have about these legal issues.

The New York Times recently published a piece on a series of reports that criticize the da Vinci surgical robots. The piece begins with the story of a woman, Erin Izumi, who underwent a surgery using robotics in 2009. During the 11-hour surgery, which was to treat endometriosis, the robotic arms tore her rectum and colon. She was rushed to the ER more than a week after the initial surgery, and was hospitalized for five weeks.

In a situation like this, both the hospital and the robotic system company are required to report the injury to the FDA. Despite this requirement no report was made about Izumi's injury in 2009, and a spokesperson for da Vinci told the paper that it became aware of the incident only after Izumi filed a lawsuit.

The da Vinci robots are manufactured by a California-based company called Intuitive Surgical. More than one million surgeries have been conducted using a da Vinci robotic system, with varying consequences. Thousands of incidents have been reported to the FDA, however, as the above situation illustrates, it is certainly possible this is only a miniscule reflection of that actual numbers.

At least one new study attempted to analyze the lapse in reporting, which was recently published in the Journal for Healthcare Quality. Researchers involved in that study are affiliated with Johns Hopkins, and were able to locate examples of horribly-gone-wrong surgeries using da Vinci robots. Based on these findings, they concluded that serious incidents in da Vinci operations were vastly underreported.

This is incredibly important because Intuitive markets this robotic device as an incredibly safe and less intrusive alternative to traditional surgery, although it is increasingly obvious how misleading this is. In reality, very little is known about the disadvantages of the system and the true rates of injury and death.

The Johns Hopkins study followed reports that involved robotic surgeries throughout the country, locating documents specifically mentioning lawsuits filed by injured patients. In many of these legal papers, plaintiffs alleged that Intuitive was aggressively marketing the robots despite lackluster training for physicians. There were also numerous mentions of the immense pressure placed on hospitals and doctors to "keep up," with new and emerging technologies

Doctors Speak Out


Due to this combination of aggressive marketing and pressure to stay ahead of the innovation curve, robotic surgery is growing dramatically in the U.S. Many medical experts argue that this growth is occurring without proper oversight and monitoring. The lead author of the Johns Hopkins study take this one step further, stating that this trend is indicative of a larger problem in American healthcare: lack of adequate evaluation.

The study author, Dr. Martin Makery, said that doctors and hospitals blindly adopt new expensive technologies without knowing what they're actually getting out of it, whether it will be beneficial to patients in the long run. A large part of the problem is that the federal "requirement" for hospitals and companies to report adverse events is not at all enforced. Makery states that the reports have "no oversight, no enforcement, and no consequences."

Continue reading "Criticism Over Da Vinci Robotic Systems Continues" »

Power Morcellators Pulled From Global Markets

October 2, 2014,

6025359063_81a0b67b4c_b.jpgThree companies recently recalled their power morcellator devices due to recent national outcry over their safety. These devices, used in hysterectomies and other gynecological procedures, are now connected to a serious risk of uterine and abdominal cancer. The team of uterine cancer attorneys at Pintas & Mullins urges all women recently diagnosed with abdominal cancer to seek legal advice as soon as possible.

Power morcellators are used in thousands of minimally-invasive procedures every year, most often to remove growths known as uterine fibroids. According to the Mayo Clinic, uterine fibroids are noncancerous growths inside the uterus that most women will develop at some point in their lives. The growth patterns of these fibroids vary from person to person - in some women they grow rapidly and spread throughout the uterus, causing severe complications. In others, the fibroids grow and shrink on their own without causing any symptoms at all.

In more severe cases, uterine fibroids can cause infertility, major blood loss, pelvic pain, and even miscarriages. For these patients, doctors often recommend removing fibroids before trying to conceive. Although there are many ways to remove or treat fibroids - no single best treatment is identified as 'best' - many doctors suggest using power morcellators to shave down fibroids into small pieces, so they may be removed through a tiny incision.

This is among the most minimally-invasive modes of removal, which is why so many women have chosen this form of treatment. In the past, the procedure was recommended because patients would benefit from shorter hospital stays, fewer complications, and smaller scars than other alternatives.

Studies published in 2012 revealed that these power morcellation procedures were causing devastating illness in women throughout the country. We recently wrote a post on the two doctors, a husband and wife, who brought this issue to national attention. Dr. Amy Reed was diagnosed with advanced-stage cancer after undergoing a hysterectomy using a power morcellator.

Senators Urge FDA to Recall All Morcellators


In August 2014, two U.S. senators asked the FDA to remove all power morcellator devices from the market. The two senators wrote a joint letter to the federal agency, citing recent studies from Bringham and Women's Hospital in Boston, which found that the actual risk of cancer spread is nine times greater than patients are currently told. This is unacceptable.

This is the same study that caused Johnson & Johnson to recall three models of power morcellators from hospitals worldwide. For its part, the FDA has urged all doctors to stop using power morcellators in gynecologic procedures, however, it has stopped short of issuing a total ban.

Power morcellators are also used in spleen and renal surgeries, although they have not been associated in cancers in these organs. A spokesperson for J&J recently told reporters that the risks and benefits of these devices remain unknown, and the decision to remove them from global markets was prompted by an FDA meeting in July 2014.

In this meeting, the FDA detailed the risks associated with the device and problems within the medical community. The most pressing problem is that, although women who undergo procedures to remove uterine fibroids are screened for several forms of cancer, the most aggressive forms are undetectable. Among the most serious cancer types that can spread from power morcellator use is metastatic leiomysarcoma, which occurs primarily in women aged 40 to 60.

The FDA issued a safety report on this type of cancer specifically in April 2014, alerting doctors to the possibility of cancer spread an discouraging the use of power morcellators. The good news is that there are many ways to remove uterine fibroids without using a device like a power morcellator. Surgeons can go in manually with a scalpel or scissors, which is more invasive but considerably safer.

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Soccer Player Sues University for Brain Injuries Caused by Hazing

September 18, 2014,

7308313216_544db242b7_h.jpgA former soccer player for Clemson University is suing her fellow players, coaches, and several members of the administration after suffering severe brain injuries from hazing. The woman sustained permanent trauma as a freshman, during the hazing ritual planned by the players, supported by the coaches, and ignored by the Clemson athletic department. Traumatic brain injury lawyers at Pintas & Mullins examine this case and advise students and parents on how to stay healthy.

The United States, for better or worse, is in love with sports - we go nuts over the Super Bowl, Olympics, even the World Cup had its moment. Sports and sportsmanship provide valuable lessons to young athletes: discipline, respect for authority, and the ability to work with others to accomplish a goal are lifelong virtues. Unfortunately, in the midst of our romance with professional sports and players, we have lost sight of what truly matters in the long-run, which is health and safety.

NFL Admits to Long-Term Brain Damage


The NFL recently stated in federal court that one in three players will develop long-term cognitive problems, and that these conditions will manifest at young ages. This is significant in many ways, not least of which because the NFL has denied these facts for several decades, disputing evidence that its players suffered significantly higher rates of brain damage than the general population. The League is only admitting this, however, out of necessity. There are now troves of irrefutable evidence on this topic that specifically centers of the NFL and its players.

Much of this evidence came to light in court, where more than 5,000 former players sued the NFL for hiding the risks of repeated concussions. The case infamously settled for $675 million, which will cover treatment for the injuries and diseases associated the NFL players suffered from their careers. Although this seems like a significant pool of money, the settlement has been widely criticized as inadequate to cover the true costs of medical care.

Among the conditions linked to repeated head trauma include chronic traumatic encephalopathy (CTE), which, like dementia, is both chronic and degenerative. The vast majority of players receiving compensation from this settlement will suffer from Alzheimer's or advanced dementia. Other conditions include Parkinson's disease, CTE, and amyotrophic lateral sclerosis.

Clemson Sued for Negligence


The lawsuit against Clemson, filed by Haley Ellen Hunt, details the circumstances leading up to and after the brain trauma. Hunt's injury occurred in August 2011 during a ritual freshman hazing near Riggs Field. The freshmen were blindfolded, demeaned, and ordered to perform various tasks. Hunt was spun around in circles in order to be disoriented, then ordered to sprint down the field while blindfolded. She was told to run as fast as she could and ran head first into a brick wall. No one attempted to stop her.

She was knocked unconscious and carried to the locker room, where the Clemson coaches were called. Some of the players wanted to call an ambulance but the Clemson coaches decided not to take her to the hospital, and told the other players not to tell anyone about the incident. Hunt was sent back to her dorm with a butterfly bandage and without supervision.

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DePuy Recalls Jawbone Medical Device due to Death Risks

September 16, 2014,

6642198091_b415bd587b_m.jpgA Johnson & Johnson company, DePuy, recently recalled its Synthes Craniomaxillofacial (CMF) Distraction System because of risks most severely affected children and infants. These devices are used during operations to the trachea and other respiratory organs, so infants are most at risk for injury and death if the device fails. Medical device lawyers at Pintas & Mullins highlight this and several other important recalls patients must be aware of.

The DePuy CMF system is an implant used in the lower jawbone, to either stabilize or lengthen the bone. It is most often used to correct birth defects in infants or traumatic jawbone events in adults, by gradually lengthening the bone. This device is being recalled because it can reverse direction, causing the lengthening process to cease.

The lengthening process occurs after surgery, and if it stops suddenly it can cause obstruction of the trachea, or windpipe. The trachea is critically important to allowing air to pass through the throat and into the lungs, so any obstruction is a medical emergency. As mentioned, infants utilizing DePuy's CMF device are most at risk of death, as sudden obstruction of the trachea could go unnoticed and lead to respiratory arrest and death.

Children and adults with the CMF device who have the ability to maintain an open airway are considerably less likely to suffer a serious injury if the device fails because the trachea would not be obstructed. In all patients, however, any device failure would require immediate medical intervention.

So far there have been 15 reports of injury associated with this specific device, and DePuy has sent an urgent notice to hospitals and consumers. This recall was initiated on April 16, 2014. Any patient who received this implant and suffered serious complications should contact our firm immediately for a free case review. We are currently investigating cases related to many medical devices, particularly those manufactured by DePuy.

Patients Offered Free Hip & Knee Replacements after Recalls


If the name DePuy sounds familiar, it is likely because of the massive litigation against it for its defective all-metal hip implants. These metal-on-metal devices were once touted as 'revolutionary' new implants that will last for decades and allow better mobility for patients. In reality, the devices were approved without any long-term or adequate testing, and the all-metal components can damage surrounding bone and tissue immensely.

In addition to the bone, muscle and tissue damage, the metal parts grind together through continuous use, release metal ions into the bloodstream. Of course, having high levels of metal debris release into the body is far from healthy, and can lead to metallosis, or metal toxicity. Symptoms of metal toxicity include effects on the kidneys, blood, or nervous, cardiovascular, and gastrointestinal systems.

These metal-on-metal hip and knee devices were implanted in hundreds of thousands of vulnerable patients, despite manufacturer's knowledge that they would likely fail prematurely. In response to this dire need, two hospitals in New York City are offering free hip and knee replacements for eligible patients.

The hospitals, Lenox Hill in Manhattan and Franklin Hospital in Valley Stream are offering operations for patients in need who are either uninsured or underinsured. We recently reported on the recent adoption of offering to help pay medical premiums for needy patients, and this seems to be in the same vein of assistance. Franklin Hospital has been offering this type of free service since 2011, as an opportunity to give back to the community and help patients who are so often ignored.

To qualify for such a procedure patients must undergo a physical evaluation, live within an hour's drive of either hospital, and have an income within the federal poverty line (ranging around $11,600 - $23,300 for an individual). These operations are offered through the Operation Walk USA organization, which provides hundreds of free hip and knee replacements per year for patients across the country. More information on this organization can be found here.

This is welcome news after recent reports that more than 115,000 people could lose their health insurance due to unresolved data issues relating to immigration and citizenship. Making matters worse, another 363,000 people may see their coverage costs change because of, again, data problems with income and federal subsidies. This affects people who applied for medical coverage after immigrating to the U.S., and those who have an income that makes them eligible to receive federal subsidies.

Continue reading "DePuy Recalls Jawbone Medical Device due to Death Risks" »

Four Children Dead in Southside Fire

September 8, 2014,

5443359455_7dc7373b9a_b.jpgA fatal fire in Chicago's Roseland neighborhood on the far south side has left four children dead and two adults critically injured. The fire erupted on the second floor of a building housing nearly 20 unites, around 3:30 a.m. The four children were asleep on the third floor unit, where there were no working smoke detectors. Fire injury lawyers at Pintas & Mullins take a closer look to try to glean some lessons from this tragedy.

The 18-unit building (11200 block of South Vernon) is owned by a landlord who was, according to residents, very neglectful of the building and its tenants. The building failed many city inspections over the last decade, including the most recent inspection on June 9 of this year. According to the city building records, which can be found online, city inspectors cited missing smoke and carbon monoxide detectors along with inadequate furnaces, extensive water damage, and broken doors.

The door to the unit where all four children were sleeping was open when the fire started, which fire officials believe is how the fire spread into that apartment. The second-floor unit where the fire erupted is owned by a man who was not home at the time. He told the Chicago Sun-Times that he complained many times to building management, who would ignore his complaints and requests for maintenance. He noted that lately his stove had been smoking and the locks on his front door were broken.

The mother of the four children killed jumped out of a third-story window with her boyfriend; they are in critical condition at a nearby hospital. The rest of the buildings' 50 residents were able to evacuate safely, although they are now without a home. The Red Cross came to the scene early Monday morning to hand out water and offer services.

Negligence and Carelessness in Fire Injury Lawsuits


The cause of the fire is still under investigation. Residential fires can be caused by many factors, such as defective appliances (in this case, a smoking stove), fireplaces, candles, cigarettes, and heaters. Particularly in buildings with several units or decrepit conditions, fires can be inordinately deadly and destructive. According to statistics by the U.S. Fire Administration, more Americans died in fires in 2008 than all natural disasters combined.

When a fire is caused by someone else's negligence or careless behavior, a lawsuit may be filed by those affected. For example, the fire that erupted in Roseland was clearly incited by the building's lack of proper management and oversight. The building failed most of its city inspections, and resident's complaints were routinely ignored. If the landlord has insurance on the building, those affected by the fire would be able to file suit against the company and obtain compensation for the harm done to them.

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Feds Question Chicago Police Shootings

September 3, 2014,

chicago-police-in-toronto-canada.jpgThe Chicago branch of the Fraternal Order of Police, a labor union of law enforcement officers, recently received warning that the federal government was investigating shootings by the Chicago Police Department. Specifically, both the FBI and the U.S. Attorney's Office are investigating shootings involving unarmed victims. The police brutality lawyers at Pintas & Mullins are glad to see that someone is holding CPD accountable for its fatal misconduct.

Officers of the CPD are rarely, if ever disciplined or charged for shooting at residents they deem suspicious or dangerous even if the reasons behind their reasoning are murky at best. Anyone who has been following the news in Ferguson, Missouri knows this is not exclusively to the Chicago community, but a practice followed by police department throughout the country. Just because it is a common practice, however, does not make it right, and the FBI is asking the right questions to shed light on what can be done to remediate the mounting tension between law enforcement and their communities.

Chicago Police were informed of the investigation by a former CPD officer and currently attorney specializing in defending police in court. The man, Daniel Herbert, sent the Chicago Fraternal Order of Police a memo on August 29, 2014 detailing the federal probe, which will focus on "incidents in which an offender's gun was not recovered." Herbert goes on to remind officer that they are not required to cooperate with or speak at any criminal investigations.

CPD officers are encouraged not to speak to any federal agents without legal representation, and contact Herbert immediately if they are approached. The full memo can be found here.

This investigation comes to light just days after a CPD commander was charged with official misconduct and aggravated battery after he put his gun in a suspect's mouth and threatened to kill him. Commander Glenn Evans, who was one of Chicago Police Superintendents Garry McCarthy's most valued officers, oversees the West Side's Harrison patrol district, and is now charged with two felonies.

The incident occurred in January 2013 in the Park Manor neighborhood (at the time Evans was commander of the South Side's Grand Crossing patrol district). Along with two other officers, Evans approached a 24-year-old man standing near 71st and Eberhart allegedly holding a handgun. The man started running the opposite direction, but the officer eventually arrested him in an abandoned house. The charges were later dropped.

During the arrest, Evans reportedly placed the barrel of his gun into the man's mouth - which is confirmed by DNA testing on Evans' gun - tasered his groin, and threatened him with gruesome detail. After these allegations came to light the Independent Police Review Authority investigated the complaint and recommended Evans be relieved of his powers until the case was closed. This never happened, and no discipline was ever taken. More than a dozen complaints were filed against Evans between 2001 and 2006, and he was never disciplined for any of them, although he was also named in several police misconduct lawsuits as well.

The FBI is always able to charge officers with official misconduct in particularly egregious cases, but successful federal prosecution is extremely rare. CPD officers fatally shot 13 residents in 2013, and another 10 people so far this year. One of the most recent victims, Marlon Horton, was fatally shot outside a Chicago Housing Authority building on West Monroe. The shooting was captured by surveillance cameras located in the lobby.

The footage reveals that Horton received no medical assistance in the minutes after he was wounded, despite officers standing just feet away. Police officers are required to secure emergency assistance to any injured persons. Due to this blatant violation of civil rights and official policy, Horton's brother filed a federal lawsuit against the City of Chicago, the officer who shot Horton, the security guard of the building and the company who employed her, and the Chicago Housing Authority.

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Paint Strippers Named as Major Health Risk by EPA

August 29, 2014,

5533610454_e1fbeaa032_b.jpgThe Environmental Protection Agency (EPA) recently released official evaluations of three chemicals found widely in household products. One chemical in particular, which is used in paint stripping products, was especially condemned. The agency estimates that more than 230,000 American are directly exposed to the chemical in their work. Toxic substance attorneys at Pintas & Mullins detail the EPA's report and the health risks of chemical exposure.

Making the problem even more widespread, the EPA notes that the paint stripping chemical is a risk not only to those working directly with it, but also to bystanders in places the product is used. The chemical, dichloromethane (DCM), is also used in pharmaceutical manufacturing, metal cleaning, and degreasing. The Occupational Safety and Health Administration (OSHA) designates DCM as a potential carcinogen.

OSHA has specific standards for DHM exposure in the workplace, which varies between industries. There are unique rules for shipyard employment and the construction industry, for example. Those exposed to DCM are at risk of developing several types of cancer, heart conditions, liver problems, central nervous system problems, or irritation of the skin and eyes. These can occur if DCM is in haled or comes into contact with the skin.

Workers' Rights and Employers' Responsibility


Employers are required by federal and state laws to protect workers from toxic substance exposure of any and all kinds. For DCM, this can be done through engineering controls, like isolating the source of DCM and using ventilators, or by personal protective equipment, such as respiratory equipment or clothing. It is also employers' legal responsibility to make sure all their employees understand the identities and hazards of toxic chemicals. All hazardous substances must be labeled and have corresponding safety data sheets. Employees must also be trained appropriately, including information on the dangers of each chemical and how to protect themselves.

There are over 15,000 chemicals OSHA identifies as toxic or dangerous, some of the most insidious being asbestos, arsenic, benzene, diacetyl and lead. Lawsuits regarding exposure to asbestos - which more often than not occurs in the workplace - are now the largest, longest-running cases in the country. Asbestos is a fibrous material found in construction materials like insulation and heat-resistance materials such as automobile brake pads. If the fibers are inhaled, they can implant permanently in the lungs and, over time, cause a specific type of cancer known as mesothelioma.

Mesothelioma is almost always fatal, and is only caused by exposure to asbestos. It is a particularly devastating form of cancer because so many people are unaware where, when or how they were ever exposed. Mesothelioma patients are often left confused with many questions about asbestos, exposure, and how it developed into cancer.

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Chicago Officials Use Twitter to Tracks Foodborne Illness

August 27, 2014,

twitter-what-are-you-doing.jpgIt seems like every day there is a new recall issued for some type of food contamination - salmonella, E.coli, listeria or other risks of public health. Although the FDA and USDA are trying to ramp up their inspection and enforcement practices, change is simply not coming fast enough to protect those most vulnerable. For their part, health officials here in Chicago are looking to Twitter to help track cases of food poisoning.

Food contamination lawyers at Pintas & Mullins have seen too many cases of serious ailment and even death from dangerous and recalled food. Unfortunately, a major hurdle in overhauling the food safety system is how rarely consumers report illnesses to federal or state health departments, making it difficult to track and locate outbreaks. While people may not generally take the time to officially report their sicknesses, they do quite often take their grievances to Twitter.

Foodborne Chi


This is not lost on Chicago health officials, who are using the social media platform to reach out to those users, asking them where they believe the food poisoning came from. More often than not, their information leads to charges against restaurants selling unsafe food. The handle these officials are working under is @foodbornechi.

To help establish a more efficient method of shifting though Tweets, the Chicago Department of Public Health hired the technological collaborative group Smart Chicago. Together, they developed an app that looks through tweets from Chicagoans or linked to the city that may indicate or reference a foodborne illness. The app is also called Foodborne Chicago, and it responds to Tweeters with a link to an online form for reporting further details. Officials want every state to use this technology, so they have made the app's codes available to the public, found here.

The program, launched in March 2013, has already led to more than 130 unannounced health inspections, resulting in critical violations and, in some cases, restaurant closures. Local consumers are excited that the government is taking initiative, actually listening to their complaints and taking them seriously. Anyone who has been to a DMV in Chicago knows that this is not always the case.

Chicago is not alone in using new technologies to track and detect outbreaks; health officials in New York City have taken to monitoring popular online review websites to see if anyone notes cases of illness, and inspect restaurants with complaints against them. Building on this, many officials are attempting to integrate inspection reports into reviewing websites like Yelp, so potential customers have more access to information.

Far-Reaching Potential


These efforts could potentially help detect cases of massive food problems, such as the recent scandal involving a California slaughterhouse that deceived federal inspectors and sold horribly sick cattle. According to the lawsuit, the Rancho Feeding Corp.'s co-owners knowingly distributed cattle with eye cancer and sold beef that had been condemned by the USDA. It is as horrifying and disgusting as it sounds, and the co-owners have been indicted on federal charges of conspiring to distribute misbranded, adulterated, uninspected meat. They are also charged with mail fraud, and face up to 20 years in prison in addition to hundreds of thousands in fines.

This scandal broke in January 2014, launching a massive recall of Rancho's beef (around ten million pounds) from thousands of major stores and brands, including Kroger, Walmart, and Nestle products. The lawsuit alleges that the Rancho co-owners chose to purchase cattle priced much below average because they exhibited symptoms of eye cancer. They decapitated the animals and led inspectors to cattle heads that did not have signs of cancer to deceive them. Rancho also processed cattle that had been condemned by federal inspectors by carving out the "Condemned" stamps from the animals' skin.

This scandal centered on one slaughterhouse, however, there are systemic problems in the livestock industry as a whole. The USDA recently announced controversial changes to its poultry inspection program and set new requirements with the goal of reducing salmonella and compylabacter outbreaks from poultry. The program is called the New Poultry Inspection System (NPIS), and officials estimate that it will prevent 5,000 foodborne illnesses every year.

NPIS is controversial because many consumer groups actually view it as reduction to the USDA's current level of inspection. Indeed, the plan is to shift inspection duties from federal officials to industry employees. The amount of time taken to inspect chickens (140 birds per minute) will stay the same, however the speed for turkey production lines will speed up, from 51 to 55 turkeys per minute. What's more, processing plants will not be required to implement this new NPIS program - they will have a choice to stick with one of the four current inspection programs. More information on this NPIS system and its details can be found here.

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Millions of Bean Bags Recalled after Child Deaths

August 25, 2014,

555075017_c61c0bdb4c_o.jpgMore than 2.2 million bean bags made by Ace Bayou Corp. are being recalled after two children suffocated to death inside of them. The bean bags, which come in various shapes, colors, fabrics and sizes, were sold at popular stores such as Walmart and Meijer, and online at Amazon. Child product recall lawyers at Pintas & Mullins detail this recall and how consumers should fix the defects.

Ace Bayou is located in New Orleans, and sold the recalled bean bag chairs until July 2013, for anywhere between $30 and $100. The two children that died from these chairs, a three year old from Kentucky and a 13 year old from Texas, were found by their families inside the bean bags, suffocated, with foam beads in their mouths and lungs.

The defective bean bags include zipper than can easily be opened, which is how the children crawled into the bean bags in the first place. As mentioned, the bags were sold at many popular stores, including:

• Meijer
• Walmart
• Amazon.com
• Pamida
• Bon-Ton
• School Specialty
• Wayfair

Anyone who owns an Ace Bayou bean bag should contact the company right away and keep the chairs away from children of any age. Ace Bayou is offering its customers free repair kits that will prevent the zippers from opening, which can be ordered online.

Dozens of different kinds of children's products are recalled throughout the country every month, however, most parents are never informed or aware of how dangerous these products are. One study by Kids in Danger found that just 10% of recalled children's products were successfully corrected, returned, or replaced in 2012. We don't see that dire number going up any time soon without serious intervention from multiple angles.

Furniture is among the most common factors in accidental child injuries and deaths, which is why knowing about recalls and proper assembly is so important. Reporting injuries caused by defective products is also important: on average, it takes about 14 reported incidents and two injuries to initiate a product recall. Incidents, design flaws, and product failures can be submitted to the U.S. Consumer Product Safety Commission (CPSC).

In addition to monitoring current safety recalls, parents should keep in mind that products they find at thrift stores and second-hand shops may also be unknowingly dangerous. One child safety website notes that at least 12% of thrift and second-hand shops sells children's products that were previously recalled or violate federal safety standards. We recently wrote a post on the effectiveness, or lack thereof, of children's product recalls.

How Recalls Work, and Why They Rarely Do


The lack of awareness and enforcement is largely due to the failures in communication between manufacturers, retailers, consumers and the government. As we touched on earlier, in order for a recall to take place, consumers must report incidents to the government, which tracks these in a large database. When enough reports accrue, the government informs the manufactuer that a recall should be made (how seriously they recommend the recall depends on many circumstances). Once the manufacturer decides to issue a recall, it issues a press release and notifies retailers, such as Walmart, to take the product off their shelves and attempt to inform its customers.

Although they should, few people regularly check the CPSC website for recalls, or have updates automatically emailed to their inboxes. We strongly encourage all parents to sign up for a CPSC subscription, so you receive emails every time a recall involves infant or child products. This can be found here.

There have been several large-scale recalls already in 2014. Among them include Car Seats made by Graco (3.8 million) and Evenflo (1.3 million), Pacifier holding clips made by Playtex (1.2 million), and wall mounted lamps (3.5 million) and bed canopies (255,000) from Ikea. Graco also recalled nearly 2 million rear-facing child restraints recently.

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Unnecessary C-Sections Plague American Women

July 25, 2014,

1389252857_45cb4464cc_o.jpgOne in three American mothers deliver their first child through Cesarean section and 90% of those women who then have a second child will deliver through C-section again. It has not always been this way: in the 1970s, only 5% of all births were C-sections. The birth injury attorneys at Pintas & Mullins would like to take a step back and examine this phenomenon, why it came to be, and how it is harming American mothers.

Many people believe that Cesareans reduce the risk of serious complications for both mother and child, however, a report recently issued by the American College of Obstetricians and Gynecologists (ACOG) does not confirm this. Their report actually states that the rapid increase in C-sections has not led to an equivalent decline in complications associated with delivery. In fact, the ACOG expresses deep concern that the procedure is overused in the U.S., and urges doctors to more carefully consider whether a Cesarean is necessary.

Unnecessary C-sections cost more than $5 billion per year, and, more importantly, physically harm patients, sometime fatally. The United States is one of the only places on Earth where maternal mortality (death of the mother during childbirth) is actually rising. The risk of death from C-sections compared to natural delivery is actually three times higher, and is often caused by hemorrhaging, systemic infections, and injury to major organs.

Real Women, Real Harm


Too many mothers, particularly first-time mothers, are unaware of this. They trust their doctors, and rightfully so, but are not making informed decisions for their own care. Among the consequences of C-sections is the likelihood that all children women have in the future will also be delivered by C-section.

Dr. Chileshe Price, a cardiologist at the University of Pennsylvania, is the exception to this. She is the mother of two children; the oldest was born through a C-section, her second through natural birth. This is referred to as a VBAC, or vaginal birth after Cesarean. Delivering her first child was extremely traumatic: she was in recovery for six weeks, and the pain made it difficult to rehabilitate and care for her newborn son.

Dr. Price did not want to undergo major surgery and be forced into post-op for her second child. She found it very difficult, however, to even find a doctor who would facilitate a VBAC. Most doctors are concerned about the possibility of a uterine rupture during VBAC, although the actual statistical risk of rupture is less than 1%. To see an outstanding short film on Dr. Price's journey, click this link, which will take you to the New Yorker's piece titled Unnecessary Cut.

Uterine rupture is an emergency situation that can constitute medical malpractice if the physician does not properly anticipate it. Choosing to deliver a child naturally after having a C-section needs to be the right thing from a medical perspective, and it is important to measure the risks and benefits. Of course, if we reduced the amount of first-birth C-sections, second-time mothers would not have to worry about the VBAC in the first place.

Why Progress Is Not Being Made


Some hospitals in California have an 83% rate of primary C-sections in first-time moms. That is a major problem. It is impossible to believe that more than three-quarters of human beings need major surgery to have a child, when just forty years ago, less than 5% required the procedure. What makes this even more difficult to understand is how much we know about the dangers: the first papers expressing concern about the rising C-section rates were published in 1976, so it is far from a new issue.

The truth of the matter is, C-sections decrease doctors' workloads. Many new moms are in labor for up to 20 hours; C-sections take 30 minutes to complete. As Dr. Neel Shah, an obstetrician at Harvard Medical School put it, medical textbooks teach doctors to treat the patient in front of them; but the labor floor does not work like that. Obstetricians in the real world have to treat the patient in front of them while their pager is going off, while three other patients are in active labor, all at once.

Obstetricians have extremely heavy workloads, and C-sections significantly expedite the labor process. This is not being done out of laziness - many of them are ordering the procedure in good faith. The American College of Obstetricians and Gynecologists used to recommend that a normal birth for first time mothers who receive an epidural would be about three hours of pushing. Beyond three hours, and the delivery becomes abnormal.

Doctors throughout the country interpreted this recommendation by ordering C-sections
for most moms who push longer than three hours. The ACOG recognized that this was unintentionally encouraging C-sections, and recently released new guidelines that allow more time for the delivery process. With hope, the new criteria will help drive down the rates.

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