In 2008 a New Hampshire federal jury awarded Karen Bartlett $21 million for injuries she sustained after using a medication called sulindac. She was prescribed Clinoril for shoulder pain and received the generic version — sulindac. The drug was directly responsible for Bartlett developing Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), conditions that led to severe skin deterioration. Bartlett eventually suffered additional permanent injuries, including near-blindness, lung damage and burns in her esophagus.
The jury award relied on a New Hampshire products liability law allowing for damages based on defective design. The defendant in the case, Mutual Pharmaceutical Company, appealed to the U.S. Court of Appeals for the 1st Circuit arguing that the federal law regulating generic drugs preempts state design-defect laws. The 1st Circuit upheld the lower court decision and Mutual Pharmaceutical then appealed to the U.S. Supreme Court. The Supreme Court agreed to hear the case and oral arguments were held on March 19, 2013.
Mutual Pharmaceutical claims no liability since they are required, pursuant to the Food & Drug Cosmetic Act (FDCA) to use the same ingredients and warning labels as those used by the original manufacturer. In other words, they claim they are legally required to keep a generic drug identical to the brand name drug. Brand name manufactures maintain that they are not responsible for injuries caused by drugs that were not purchased from them.
Ultimately, this case well help clarify how federal law applies to generic pharmaceutical companies as well as determine the extent to which state product liability laws pertain to the generic drug industry.
For a thorough analysis of the legal issues involved in this case see Cornell’s Legal Information Institute.
In a May 1, 2013 press release Takeda Pharmaceuticals announced that the trial court judge granted the defendant’s motion for non-suit. The ruling nullifies the April 26th jury verdict.
A Los Angeles Superior Court jury awarded $6.5 million to the plaintiff Jack Cooper in the first trial involving the diabetes drug Actos (Cooper v. Takeda Pharmaceuticals America, Inc., CGC-12-518535). The jury found Takeda Pharmaceuticals liable for the failure to warn patients that Actos could cause bladder cancer. The verdict awarded $5 million in compensatory damages to Jack Cooper and $1.5 million to his wife. As many as 3000 similar lawsuits are pending in the United States.
According to the attorney representing Cooper, the Japanese drug company was aware of possible links between Actos and bladder cancer as early as 2004. However, the company waited 7 years before reporting these findings to U.S. regulators. In 2011 Actos was removed from the market in both France and Germany after studies revealed that some patients using Actos have increased risk of developing heart problems and bladder cancer.
In 2012 the British Medical Journal reported that patients who use Actos for 2 years are twice as likely to develop bladder cancer. In the same year the Canadian Medical Association Journal published the results of a study showing that users of Actos have a 20 percent increased risk of developing bladder cancer. Canada has since removed Actos from the list of approved medications.
A “black box” warning, the strongest of the FDA warnings, informing users that Actos is linked to congestive heart failure was added to the label in 2007. In 2011 an FDA Safety Announcement informed the public that the use of Actos for more than one year might result in “increased risk of bladder cancer”. The announcement required the drug manufacturer to add this warning to the drug label.
In response to FDA demands, Takeda launched a ten year study addressing the long term risk of bladder cancer associated with Actos. Data from the first five years of the study showed that patients taking the drug for over a year have a 40 percent higher risk of developing bladder cancer. The study was completed in 2012 and the full results should be available sometime in 2013.
Despite assertions that large medical malpractice payouts are largely responsible for the rising cost of health care, a new study by doctors from Johns Hopkins suggests that these claims are mistaken. The research revealed that malpractice payouts account for less than 1 percent of medical expenditures in the United States. The study, directed by Dr. Marty Makary, associate professor of surgery and health policy at Johns Hopkins University School of Medicine, reviewed nationwide medical malpractice settlements and judgments from 2004 to 2010. According to Makary, the data shows that legal reform efforts should focus on curtailing defensive medicine rather than establishing caps on malpractice awards and settlements. “The real problem is that far too many tests and procedures are being performed in the name of defensive medicine, as physicians fear they could be sued if they don’t order them. That costs upwards of $60 billion a year. It is not the payouts that are bankrupting the system — it’s the fear of them.” Makary maintains that the findings support the need for more research to determine procedures to prevent catastrophic errors and improve patient safety. He also asserts the need to reduce unnecessary diagnostic tests and procedures as a means to lowering health care cost.
Click here for more details about the study.