When we take medication prescribed by our doctors, we assume those products are as safe as possible and that any known risks will be disclosed so that we can make informed decisions.
Unfortunately, that isn’t always the case. Pharmaceutical companies routinely market their drugs for off-label purposes, and they don’t always warn of the potential dangers of this.
This was the case in Cooper v. Takeda Pharmaceuticals, where a jury in California granted $6.5 million to plaintiffs in this product liability case against the maker of the diabetes drug Actos. Despite the verdict, the judge in the case granted a judgment notwithstanding verdict in favor of defendants, after deciding to strike the testimony of plaintiffs’ expert witness post-trial.
The original plaintiff in the case subsequently died of causes related to the bladder cancer he had alleged was caused by consuming this drug for his diabetes. His wife, who as part of the original award received $1.5 million for loss of consortium, was named the successor-in-interest and proceeded as the sole plaintiff. She appealed the trial court’s decision.
A California appellate court reversed, finding trial court had abused its discretion, and reinstated the jury’s verdict.
Actos, which goes by the generic drug name pioglitazone, is part of a class of medications classified as thiazolidinediones. Another in that same class is rosiglitazone (Avandia), and both are used to treat type 2 diabetes. The first generic versions of Actos were approved in 2012, though the brand name drug has been on the market since 1999.
Both of these drugs, used on their own and in combination with other drugs, have been found to cause or significantly worsen congestive heart failure. They’ve also been linked to bladder cancer. While they have been shown to have significant benefits for some patients, they also come with serious risk, especially for those with high blood pressure, irregular heartbeats, a history of heart attacks and/or prolonged use of the drugs.
Decedent in this case was prescribed Actos by his doctor in 2006 for treatment of his diabetes. He continued taking it until 2011, when he was diagnosed with bladder cancer.
He and his wife later filed a product liability lawsuit against the pharmaceutical company, alleging it failed to adequately inform his primary care doctor of the risk of bladder cancer. They alleged negligent failure to warn, negligent misrepresentation, fraudulent concealment, strict liability and loss of consortium.
To support their case, they presented the testimony of an epidemiologist and oncologist as well as a urologic oncologist who both testified that this drug caused decedent’s bladder cancer with a reasonable degree of medical certainty. These assertions were primarily rooted in reviews of a number of epidemiological studies.
Defense objected to this testimony prior to and during trial, but the judge allowed it. It was only after the jury returned its verdict that judge decided to strike that testimony as unreliable, and after reaching this conclusion, found there was insufficient proof of causation.
The appeals court reversed, finding the expert testimony should not have been stricken and the original verdict should stand.
Contact our Carolina personal injury lawyers at Lee Law Offices today by calling 800-887-1965.
Cooper v. Takeda Pharmaceuticals, Aug. 13, 2015, California Court of Appeal, Second Appellate District, Division Three
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Report: Blood-Thinning Drug Unmonitored Harms Nursing Home Residents, Aug. 15, 2015, Asheville Product Liability Attorney Blog