Articles Posted in Dangerous Drugs and Medical Devices

On April 30th, Endo International Plc (“Endo”) agreed to pay $830 million to resolve legal claims filed by women who have been injured by various transvaginal mesh devices.  In its annual report filed with the U.S. Securities and Exchange Commission, Endo reported that as of February 2014, the company and its American Medical Systems (“AMS”) subsidiary faced approximately 22,000 lawsuits over the devices, and that in 2013, Endo agreed to pay $54.5 million to settle an undisclosed number of the cases.

This most recent settlement is aimed at resolving all of Endo’s pending legal claims across the country related to these devices; however, several other manufactures, including C.R. Bard, Inc. and Johnson & Johnson’s Ethicon unit manufacturer, remain pending and are not part of the announced settlement.  At last count, nearly 44,000 cases filed by injured women were pending in the U.S. District Court for the Southern District of West Virginia, alleging varying injuries, including pain during intercourse, bleeding, and additional complications, many of which have required additional surgeries to remove the devices.

Transvaginal mesh devices are net-like implants used to treat various conditions, including pelvic organ prolapse and stress urinary incontinence – common conditions for women after a hysterectomy, menopause, or childbirth.  However, over time and beginning in 2008, the U.S. Food and Drug Administration (“FDA”) began notifying manufacturers of reports of complications linked to the devices.  This ultimately led to post-marketing safety studies mandated by the FDA to be conducted by AMS and other manufacturers to monitor the rate at which adverse events were being reported.  The effect of these reports has been that at the beginning of May, the FDA announced that it is considering proposals which would tighten safety standards for mesh devices used to treat pelvic organ prolapse.  These proposals, if adopted, would require manufacturers to submit data which proves the devices’ safety and efficacy before allowing the manufacturer to take the device to market.

On April 7th, a jury in the first federal court Actos bladder cancer trial returned a verdict for almost $9.15 billion dollars against co-defendants, Takeda Pharmaceuticals USA Inc. and Eli Lilly & Co. Inc. (In Re: Actos [Pioglitazone] Products Liability Litigation, MDL Docket No. 2299, No. 6:11-md-2299, Allen v. Takeda Pharmaceuticals North America Inc., et al., No. 12-62, E.D. La.), the seventh largest verdict in U.S. history.

The plaintiffs in the case, Terrence and Susan Allen, were awarded $1,475,000 in compensatory damages (i.e., damages for medical bills, lost wages, pain and suffering, emotional distress, and/or mental anguish), and $9 billion in punitive damages.  The jury found that Takeda was 75% liable and Eli Lilly was 25% liable, and split the punitive award accordingly – $6 billion against Takeda and $3 billion against Lilly.  The plaintiffs’ case was premised on the theory that the drug manufacturers had marketed Actos knowing it could cause cancer, but failed to disclose this information to doctors and failed to warn consumers about the risks associated with taking the drug.  The plaintiffs alleged that the pharmaceutical companies failed to disclose this information in order to reap the substantial profits Actos supplied.  For example, in 2011, Actos sales revenue was $4.5 billion and accounted for nearly 27% of Takeda’s total revenue for that fiscal year.  Since its release in 1999, Actos has generated more than $16 billion in sales for Lilly and Takeda, who partnered together to produce and market the drug in the United States.

Actos was originally approved by the FDA in 1999 as an oral medication for type 2 diabetes blood sugar control.  According to the original drug applications and approval literature, it was recommended for patients who have been unsuccessful at regulating blood sugar levels through diet and exercise alone.  However, at the heart of this litigation was an FDA mandated 10-year safety study which was required at the time of approval, to assess whether Actos had any link to bladder cancer.  That study was concluded in 2011, and found that the use of the drug for more than one year continuously might be associated with an increased risk of bladder cancer.