Dangerous Product Alert: Transvaginal Mesh Manufacturer Agrees to Pay Injured Women

Endo International has agreed to pay $830 million to resolve legal claims in transvaginal mesh litigation against its subsidiary American Medical Systems without admitting liability or fault. Approximately 22,000 lawsuits have been filed by women who allege they have suffered injuries from the mesh devices such as painful sex, bleeding, and other complications. Reuters reports that the agreement is still subject to several conditions, including confirmation of medical records from plaintiffs.

According to an FDA News Release, on April 29, 2014, the US Food and Drug Administration issued two proposed orders to address the health risk associated with surgical mesh used for transvaginal repair of pelvic organ prolapse. If finalized, surgical mesh would be reclassified from a moderate-risk device to a high-risk device and require manufacturers to submit a premarket approval application for the agency to evaluate safety and effectiveness.

Dangerous Product Alert: Medical Devices for Children Tested in Adults

According to a recent study, almost all medical devices that have been approved for use in children were not actually tested on children first. The study “Postmarketing Trials and Pediatric Device Approvals” was published in the Pediatrics journal, and discusses how devices can be approved for pediatric use after being tested on subjects between 18–21 years old. The study was meant to see how the 2007 Pediatric Medical Device Safety and Improvement Act is working.  According to an article in Reuters, the lead author Thomas J. Hwang remarked that “children are not simply ‘small adults,’ and a device found to be safe and effective in adults may have a very different safety and effectiveness profile when used in a pediatric population.” 

Dangerous Product Update: Toyota Auto Recall

Yet another enormous auto recall was announced yesterday, this time by Toyota. The recall will cover nearly 1.8 million vehicles for numerous defects including air bags that may not inflate. Included in the recall are: the 2009-2010 Corolla; 2009-2010 Matrix; 2008-2010 Highlander; 2009-2010 Tacoma; 2006-2008 RAV4; 2006-2010 Yaris; 2009-2010 Pontiac Vibe (from when GM and Toyota shared a plant); 2006-2010 Yaris hatchback; 2007-2010 Yaris sedan; and the 2008-2010 Scion XD. According to the AP, automakers have recalled about 9 million vehicles in the U.S. already this year.

It is important to recognize that two-pronged safety net of government oversight and civil tort liability are driving these companies to recall these vehicles.  The best case scenario is a recall like this Toyota recall where it appears, through reports from the manufacturer, that the defects have not injured anybody yet. According to the AP, the recent spate of bad publicity and government investigation has resulted in the recalls. Clarence Ditlow, executive director of the nonprofit Center for Auto Safety, said that when faced with this pressure, auto makers “look through their inventory of defective vehicles and recall some of the ones that they had passed over before.”

Even  The Wall Street Journal, which is typically adverse to regulation, recognizes that aggressive regulators and potential for court action have pressured the industry to act, pointing out that the new recalls come weeks after Toyota agreed to settle the criminal investigation conducted by the US Attorney’s Office. There,  Toyota admitted that it mislead consumers by making deceptive statements concerning the two issues that caused  sudden acceleration in conduct that Attorney General characterized as “shameful.”   Under the settlement, Toyota also agreed to pay $1.2 Billion.  This marks the largest penalty ever imposed by the government on a car manufacturer.  I have a feeling that GM is a candidate to surpass that amount.  

Actos Bellwether Trial: $9 Billion Verdict for Plaintiffs

A jury in Lafayette, Louisiana, handed down the seventh-largest award in US history against Takeda Pharmaceutical, Asia’s largest drugmaker, and Eli Lilly & Co according to Bloomberg. The federal court jury found the companies hid the cancer risks of their Actos diabetes medicine and ordered them to pay a combined $9 billion in punitive damages. The verdict will most likely be reduced because the US Supreme Court has said punitive verdicts, imposed for bad conduct, must be proportional to the actual damages that underlie them. Takeda and Lilly have announced they will appeal. Plaintiff Terrence Allen blamed the drug for his bladder cancer. His lawyer, Mark Lanier, said that he hoped the Takeda executives in Japan heard what the jury had to say loudly and clearly.

It was learned during the trial that Takeda officials intentionally destroyed documents about the development, marketing and sales of Actos. Because Takeda failed to properly protect the documents, US District Judge Rebecca Doherty penalized the company by instructing jurors they could infer that the files may have reinforced Allen’s claims that the company wrongfully hid the medication’s health risk.

Though a long court battle is still ahead, today the verdict sends a message to global corporations that they must put health and safety ahead of profits or American juries will hold them accountable. 

Dangerous Product Update: GM Ignition Switch Case - Victim’s Compensation Fund?

Lawmakers and victims have joined together calling for General Motors to set up a victim’s compensation fund for those impacted by the defective ignition switches that have caused serious and fatal auto accidents. According to U.S. Senator Claire McCaskill, chair of the Senate subcommittee on consumer protection and product safety, “it is now time for them to come clean, be transparent and most of all make all victims whole no matter when this deadly ignition caused heartbreak in their families…”  The Senator was quoted in this Chicago News Tribune story which detailed the need for restitution with the families and, possibly, criminal charges for those responsible.

Why the tough talk?  Because it appears from the recently revealed evidence that GM intentionally misled government regulators and its customers.  Remarkably, GM decided not to replace the switch in 2005 when it could have at cost of about $1 per car. In 2006, GM changed the faulty ignition switch in some cars, but did not change its identifying part number, which McCaskill said showed an intent to deceive.  At least 13 people were killed in accidents caused by switches that shut down cars.  McCaskill said on ABC’s This Week “You don’t need an investigation to understand that they had a defective switch and someone at GM in the engineering department changed that switch and didn’t change the part number. There is no reason to keep the same part number unless you’re trying to hide the fact that you’ve got a defective switch out there that in fact ended up killing a number of people on our highways.”

According to TIME, GM chief executive Mary Barra last week testified before Congress that “the company is considering compensating families” of the 13 people who died in accidents caused by faulty ignition switches in its Cobalt and other small-engine vehicles. Perhaps she is thinking this is generous of GM.  Hardly.