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gavelAs lawsuits against manufacturers of transvaginal mesh (TVM) products go to trial, our team of TVM lawyers are happy to announce victories on behalf of severely injured women. In one of the latest verdicts, a woman in Delaware was awarded $100 million by a jury, though the judge later reduced the award to $10 million.

The original award to Deborah Barba was the largest ever in a trial involving TVM products. She filed a claim against Boston Scientific, one of seven TVM manufacturers collectively facing more than 100,000 injury lawsuits.

Barba received the mesh in 2009 to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh caused extensive health problems for Barba, including recurring bladder infections, severe pain, and two additional forced surgeries. She filed suit against Boston Scientific in 2011.

Over the course of her 14-day trial, Barba argued that Boston Scientific was negligent in designing and making its TVM devices, and failed to warn both doctors and patients about the possible risks.

The jury agreed with this, finding Boston Scientific negligent and liable for Barba’s injuries. They awarded her $25 million in compensatory damages and $75 million in punitive damages, which are meant to punish defendants for especially fraudulent behavior. The judge reduced the award, believing it too high in comparison to other TVM verdicts, which range from $1 to $7 million.

Seven Companies, Over 100,000 Lawsuits

Another TVM plaintiff in Missouri, Eve Sherrer, recently made her final plea to the jury on Monday, February 1, 2016. She filed her TVM lawsuit against Boston Scientific and C.R. Bard, claiming the devices rendered her incontinent. The devices were covered in scar tissue when removed from her body. Scarring on a TVM device causes it to shrink, harden and adhere to internal tissue, creating dangerous and painful health issues.

Both Bard and Boston Scientific agreed that this scarring is not normal and should not have happened, but blamed the woman’s condition on doctor error and past medical problems. The case centers on Boston Scientific’s Solyx mesh and Bard’s Align mesh.

Sherrer argues that the particular materials used in these devices was not medical grade, were prone to failure, and were neither designed nor intended for permanent implantation. When the company who provided the mesh material to Boston Scientific learned what it was being used for, it terminated its contract with Boston Scientific. Boston Scientific cut a deal with the company, promising to buy 10 years’ worth of the dangerous mesh and release the manufacturer from liability.

In other words, companies like Boston Scientific and C.R. Bard used mesh they knew to be unfit for women’s reproductive organs, without testing, and fully knowing the complications could be devastating, in a race to profit. Because these meshes were not intended for medical use – again, which the companies knew but did not warn of – they destabilized and degraded inside women’s bodies.

Despite all of this clear, irrefutable evidence, many TVM devices remain on market today. The reason for this is complicated and beyond the scope of this post. Our TVM lawyers urge women implanted with these devices or considering implantation to research the devices thoroughly.

Aside from C.R. Bard and Boston Scientific, other companies facing massive TVM injury litigation include:

  • American Medical Systems, which recently set aside $1.6 billion to settle injury claims.
  • Endo International, which set aside more than $400 million
  • Ethicon, a subsidiary of Johnson & Johnson, which is facing more than 23,000 cases
  • Coloplast, which agreed to pay $16 million to settle hundreds of claims
  • Cook Medical Systems, which is facing its TVM claims in West Virginia

There have been nearly 20 TVM verdicts so far. Contact our TVM attorneys on more information on these claims and how you can take part in the litigation.

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public waterResidents of Michigan’s second-largest city recently filed three class action lawsuits against the city, state and federal government. The lawsuits center on Flint’s contaminated water supply. Our team of lead poisoning attorneys detail this water crisis and similar water contamination lawsuits we have handled.

Flint has struggled immensely in recent years, accruing millions of dollars in debt. From 2011 to 2015, Michigan Governor Rick Snyder appointed a series of four Emergency Managers to aid in the city’s financial crisis. Emergency Managers are given unusually broad powers, and as part of the restructuring, in 2014 managers approved switching the public’s water source from Lake Huron to the Flint River, in an effort to save costs.

Residents and Doctors Ignored

For the last 50 years, Flint has relied solely on Detroit to route treated water from Lake Huron for its public water supply. When a new pipeline, from Lake Huron to the Flint area, began construction, Flint officials decided to save money by sourcing its water exclusively from the Flint River until the pipeline’s completion in 2016.

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IVCAccording to C.R. Bard’s internal documents, the company was well aware that its G2, G2 Express and Recovery IVC filters were associated with dozens of deaths and hundreds of injuries. Despite this knowledge, Bard kept its IVC filters on market, selling hundreds of thousands. The IVC filter lawyers are now accepting claims of serious injury from C.R. Bard’s filters.

Interior vena cava (IVC) filters are surgically implanted to stop blood clots from entering the lungs and heart. These filters are typically recommended for patients who cannot tolerate or do not respond to pharmaceutical blood thinners. There are two types of IVC filters: permanent and temporary. Temporary filters are designed to be retrievable, and must be removed as soon as the risk of blood clotting subsides.

Unfortunately, we now know that temporary IVC filters consistently fracture, migrate away from the implant site, and cause serious, life-threatening complications. Thousands of patients have been told their temporary IVC filters cannot be removed due to device defects, leaving them no choice but to live knowing they are implanted with a ticking time bomb.

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hospitalHealthcare fraud costs the U.S. tens of billions of dollars every year. It is a type of white-collar crime that involves filing dishonest or false billings to the government (through Medicare, for example). This can take many forms, which is why it is so difficult to detect, and so important for anyone with knowledge of fraud to come forward. The whistleblower lawyers at Pintas & Mullins detail recent multi-million dollar lawsuits and the private citizens who exposed the crimes.

Whistleblowers – individuals who report the fraud – are protected from retaliation and job loss through federal statute. They are also rewarded, receiving between 15 to 25 percent of the recovery. This can add up to millions of dollars for the whistleblower, particularly if defendants are deep-pocketed companies like hospital chains or pharmaceutical companies.

What is a Whistleblower Lawsuit?

First, some basics: whistleblower lawsuits (also called qui tam lawsuits) are filed under the False Claims Act. This law allows private citizens with evidence of fraud to sue the individual or company on behalf of the government. The lawsuit is not made public until the Department of Justice investigates the evidence and chooses whether or not it will join the case. Even the person or company being accused of fraud is not told of the lawsuit until after the government’s decision.

It is critical, however, that the whistleblower hires an attorney and files their claim as soon as possible. Only the first person to file the claim is entitled to a percentage of the settlement or verdict. How much the whistleblower receives depends on how involved or critical the whistleblower was in the case.

Most qui tam lawsuits are settled through negotiation rather than court trials. For example, a group of 32 hospitals recently settled with the government over allegations that they submitted fraudulent claims to Medicare. The hospitals allegedly billed Medicare for inpatient stays for a type of spinal fracture treatment (kyphoplasty), which can often be done as an outpatient procedure.

This is part of a larger crack down on these types of procedures. The Justice Department has recovered more than $100 million in settlements with more than 130 hospitals over false billings for this spinal procedure.

Individual doctors can also be targeted for whistleblower claims. A cardiologist in Ohio was recently sentenced to 20 years in prison for falsely billing Medicare for unnecessary heart surgeries, stent insertions, and other treatments. The doctor, Harold Persaud, was charged with overbilling totaling $29 million.

Pharmaceutical Companies

Fraud charges aimed at Big Pharma typically center on advertising and kickback schemes, where they indirectly pay doctors to prescribe or sell their products. Big Pharma companies like Pfizer are publically-traded, meaning they have to appease Wall Street and shareholders with large profits. Because they are expected to make so much money, they intentionally market drugs and devices to patients who do not really need them.

It goes without saying that medical decision-making should never be controlled by Wall Street, but it is. Not only are we receiving drugs and devices unnecessarily, making ourselves vulnerable to devastating side effects, but we are also wasting billions of healthcare dollars.

A perfect example of this type of fraud is the recent lawsuit over Risperdal, an antipsychotic drug sold by Johnson & Johnson. In November 2013, J&J agreed to pay $2.2 billion for illegally marketing Risperdal and several other drugs, in the largest health care fraud settlement in U.S. history.

In that lawsuit, which was filed by a whistleblower with knowledge of the violations, evidence showed that J&J hired a ghostwriter to collaborate on articles for medical journals with doctors. The company would then have their salespeople distribute the articles, making it seem like third-party studies were confirming Risperdal’s safety and efficacy, when in fact they were written by a J&J employee. Doctors would then prescribe Risperdal for off-label uses based on these “studies,” such as to young men with behavioral problems.

Unfortunately, Risperdal turned out to promote the growth of female hormones. So these same young men (between the ages of 7 and 17) were prescribed a powerful antipsychotic drug that was never proven to be safe or effective for their conditions. As a result of the drug’s hormonal side effects, thousands of boys developed female breasts, a condition called gynecomastia.

Marketing Ripserdal to children was illegal, and just one of the reasons J&J agreed to the largest health care fraud settlement in history. Thousands of boys have filed gynecomastia lawsuits against the company, and the numbers are expected to rise.

Our team of Risperdal lawyers is currently accepting gynecomastia cases. We offer free case reviews to potential clients nationwide, and will travel to you to help guide you through the process of filing an injury claim.

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sad womanA new study found that women implanted with the permanent contraceptive Essure were 10 times more likely to have additional surgeries within one year than women who chose to have their tubes tied. Our team of Essure attorneys is now accepting claims on behalf of women injured by this device.

This new study examined data from more than 50,000 women who underwent sterilization procedures in New York between 2005 and 2013. About 8,000 of these women opted for the Essure implant, which involves inserting flexible coils into the fallopian tubes. Over a period of three months, tissue grows around the coils, creating a barrier so sperm cannot reach and fertilize the eggs.

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hospitalOver the last month the FDA has issued several warnings and recalls for heart devices, ranging from IVC filters to rotablator systems to intravascular devices. These recalls are not new: in the past five years, manufacturers have announced dozens of recalls for serious safety issues due to patient injuries and deaths. Our team of dangerous medical device lawyers highlights the most recent recalls below.

IVC Filters

Although there has only been one recall to date, IVC filters are now linked to extremely serious risks, including filter fracture, perforation and migration. IVC filters are implanted in patients who cannot tolerate blood thinners to help stop blood clots from reaching the heart and lungs. There are two types of IVC filters: permanent and temporary. The most severe injuries are occurring in patients who received temporary filters that remain implanted for far too long.

Temporary filters are not designed to stay in patients for longer than a few weeks, or a few months, at most. If left in for longer periods of time, filters can break, not only failing to prevent dangerous blood clots, but also sending pieces of the filter to other parts of the body. Pieces of the IVC filter can puncture through major veins, arteries and organs, causing infections, embolism, or even death.

Hundreds of injury lawsuits have been filed against manufacturers of temporary IVC filters and we are currently accepting these claims. If you or someone you love had an IVC filter implanted contact our firm as soon as possible for a free case review. You may be entitled to compensation for current or future injuries.

Intravascular Devices

The FDA recently released a Safety Communication to health care providers who treat patients for intravascular procedures. The devices at issue include catheters, guidewires, balloon angioplasty catheters, and implant delivery systems. These types of devices have special lubricious coatings to reduce the friction between blood vessels and the devices, giving doctors better grip and reducing injuries to patients.

Unfortunately, these coatings can separate from the devices and cause serious injury to patients. Separation can be caused by a wide range of factors, such as the patient’s individual anatomy or the doctors’ technique.

In the last year alone, there have been at least 500 reports made to the FDA regarding coating separation.This type of malfunctions can cause injuries such as: tissue death, pulmonary embolism or infarction, myocardial embolism or infarction, and wrongful death. Device coating defects often result in surgical interventions, heart attacks, and brain bleeds.

Since 2010 there have been 11 recalls from manufacturers due to coatings separating from devices. Most of these recalls were for guidewires. One of these guidewires, as part of a rotablator system, was recalled on November 27th of this year.

Rotablator Systems

Boston Scientific recently announced its recall of RotaWire Elite core wires due to cracking and separation from the rest of the system. This type of defect can cause injuries such as blood in the sac around the heart, causing decreased heart function, heart attack, and fire fragment migration throughout the body. At least one patient death has been linked to this defect so far.

The recalled system is used to open narrowed arteries and cut plaque from the artery wall to improve blood flow to the heart. Patients may have to undergo emergency heart surgery if one of these guidewires separates from the rest of the system during surgery.

Our dangerous medical device lawyers are currently investigating cases of serious injury or death from recalled or defective devices like the IVC filter. We work exclusively on a contingency fee basis, meaning we do not charge anything unless we win you a settlement.

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SCOTUSThe U.S. Supreme Court recently ruled in favor of a police officer who shot and killed a fugitive in a high-speed chase. In the dissent, Justice Sonia Sotomayor condemns our culture of police brutality, which not only allowed the officer to be reckless in his actions but ultimately granted him immunity. Our police brutality lawyers highlight Justice Sotomayor’s dissent and discuss the merits of this case.

The incident that led to this lawsuit occurred in March 2010 in Texas when an allegedly armed and intoxicated fugitive, Israel Leija Jr., was fleeing from local police. As the chase ensued, a trooper for the Texas Department of Safety, Chadrin Mullenix, stood on an overpass considering how to handle the situation.

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Army tankThe qui tam lawyers at Pintas & Mullins often write about whistleblower lawsuits in the healthcare industry, specifically concerning Medicare and Medicaid fraud. Although this is an important issue, we would also like to highlight a recent whistleblower case concerning the Womack Army Medical Center. The whistleblower in that case, Teresa Gilbert, recently settled with the U.S. Army over claims involving retaliation.

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unsafe waterPintas & Mullins is happy to announce that the village of Crestwood recently agreed to a $15 million settlement with current and former residents harmed by contaminated public water. We represented many of these residents and are glad that Crestwood officials agreed to finally resolve this case.

Crestwood, a southern suburb of Chicago, will pay for the settlement with $9 million from a bond issue, $3 million in current funds, and the remaining $4 million from insurance.

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file000480371600Thousands of injuries have been reported to the Food and Drug Administration (FDA) from the sterilization device Essure since its approval in 2002. Recently, the FDA’s panel on Obstetrics and Gynecology met to discuss the safety of Essure and how doctors and patients can best avoid serious complications. Our team of dangerous medical device lawyers details this meeting below.

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