Three Important Pharmaceutical & Medical Device Cases in 2015

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Three Important Pharmaceutical & Medical Device Cases in 2015

The last year has seen a number of high profile lawsuits against major pharmaceutical and medical device manufacturers. As in previous years, lawsuits have been brought against manufacturers who rush their products to market without thorough research into their product’s weaknesses.

When laws, regulations, and best practices are ignored by pharmaceutical and medical device companies, doctors provide care based on limited knowledge of new drugs and devices. This can have devastating consequences for a patient. Victims may pursue lawsuits, using the damages they collect to help them recover. This also helps to hold manufacturers accountable for neglecting to inform medical providers and consumers of possible risks.

Transvaginal mesh, hip implants and Type-2 diabetes drug Actos have turned out to be the three largest lawsuits against pharmaceutical and medical device companies in 2015.  

Actos Settlements: One of the Largest Drug Company Payouts Ever

Since 2011, more than 10,000 lawsuits countrywide were filed against Takeda Pharmaceuticals Co. for injuries related to taking their Type 2 diabetes medication Actos. The past two years, the company lost five bellwether trials, although two verdicts were later overturned on appeal. With this momentum against them, 9,000 claims nationwide were settled in April 2015. As the size of the plaintiff class grows, this settlement total could rise up to $2.7 billion.

Despite the settlements, the drug maker still maintains that the benefits of Actos outweigh the negative side effects. The company believes that they did not act improperly in marketing the product.

The amount each claimant may be awarded will be calculated with a “Points Matrix.” Each claim will be awarded points based on meeting certain criteria. The more points awarded, the greater the damages a claimant could receive.Some of the criteria include:

  • Age
  • Extent of injury and treatment
  • Duration of when Actos was taken
  • The amount of Actos taken
  • Risk factors for bladder cancer, including smoking

Not all plaintiffs may agree to the settlement, leading Takeda to set aside additional funds for other settlements.

Transvaginal Mesh Manufacturer Settles for $200 Million

Medical device manufacturer C.R. Bard recently agreed to settle around 3,000 MDL consolidated cases with a $200 million settlement to victims of its transvaginal mesh.  Lawsuits against Bard represents only about 20% of lawsuits against all transvaginal mesh makers. To date, manufacturers have lost verdicts or chosen to settle, resulting in over $1 billion dollars in payouts.

Transvaginal mesh is used to treat women who develop pelvic organ prolapse (POP) or stress urinary incontinence (SUI) after childbirth, menopause or hysterectomy.  The mesh is typically made from polypropylene plastic (though Bard has also been under fire for its mesh composed from porcine tissue), and inserted into a woman’s vagina.

Mesh lawsuits claim that manufacturers failed to ensure product safety and effectiveness, and gave false and misleading information. C.R. Bard maintains their device is safe, and has not admitted fault in court settlements.

In addition to a high surgical complication rate, transvaginal mesh can erode over time. The result is often painful nerve damage, infections, scaring and associated muscle deterioration that requires reconstruction surgery.  

In cases that have gone to trial, the company diligently tried to reverse decision in appellate court, however the courts upheld previous verdicts.  This led Bard to settle cases before they go to trial.  The first settlement the company agreed to pay was in 2014 in the $21 million dollars, which resolved 500 lawsuits.  Presiding Judge Joseph Godwin warned Bard they were likely to lose more suits in trial and convinced the manufacturer to settle pending claims.  To satisfy ongoing lawsuits, Bard increased its settlement amount to $997 million dollars.

Jury Awarded $4.5 Million in First Wright Hip Replacement Lawsuit

In June, Wright Medical Technology lost a $4.5 million verdict in the first trial over alleged defects in its hip implants. This bellwether case is significant since there are more than 1,000 lawsuits against this manufacturer. This case may be setting the benchmark as to what damages are for failed hip implants, and the damages number in this case is high.

Every year, hundreds of thousands of Americans receive hip replacement devices with the promise of improved mobility and quality of life. Some patients claim their hip implant has caused debilitating injuries and considerable pain. Patients allege that Wright’s CONSERVE product line failed early and released metal debris into the body.

The Los Angeles County Superior Court jury found that Wright’s Profemur R was defectively manufactured, however the design was not. Wright Medical plans to appeal this by stating,

“This was a one-off case involving a particular component with a strong track record of clinical success.”

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