Case details
Drug manufacturer failed to warn of cancer risks: plaintiffs
SUMMARY
$6500000
Amount
Verdict-Plaintiff
Result type
Not present
Ruling
KEYWORDS
loss of consortium cancer
FACTS
In 2006, plaintiff Jack Cooper, a retired telephone lineman and construction supervisor who was around 72 years old, was prescribed pioglitazone, under the trade name Actos, a Type-II diabetes drug. Pioglitazone is a prescription drug sold as Actos in the United States. Actos is used for the treatment of diabetes mellitus Type-II and can also be used for diet or exercise programs. It is not used to treat Type-I diabetes. Actos is in a class of medications called thiazolidinediones and works by increasing the body’s sensitivity to insulin, a natural substance that helps control blood sugar levels. Cooper continued to take the prescribed Actos for about five years. Subsequently, in November 2011, Cooper was diagnosed with bladder cancer. Cooper sued Takeda Pharmaceuticals America Inc.; Takeda Pharmaceuticals North America Inc.; Takeda Pharmaceuticals Company Limited; Takeda San Diego Inc.; Takeda California Inc., formally known as Takeda San Diego Inc.; Takeda Pharmaceuticals U.S.A. Inc., formally known as Takeda Pharmaceuticals North America Inc.; and McKesson Corp. He alleged that the defendants failed to properly warn of the drug’s side effects, negligently misrepresented their product, and intentionally concealed any negative side effects of the drug. McKesson Corp. was voluntarily dismissed from the case, and the matter subsequently proceeded to trial against all of Takeda entities. Cooper’s counsel argued that despite the Food and Drug Administration, as well as other sources, publishing recent studies showing severe negative side effects from taking Actos, the drug’s manufacturers have concealed, and continued to conceal, the drug’s unreasonably dangerous medical risks. Counsel contended that in 2007, the FDA requested that Actos boxes be given a black box label, the strongest FDA-requested label change that can be added to a drug, due to the risk of serious cardiovascular events caused by the medication. On June 16, 2011, the FDA required a label change for Actos because it determined that using the drug for more than one year causes a 40-percent increase in the risk for bladder cancer. Plaintiff’s counsel contended that the risk was even greater than the FDA determined and that Takeda failed adequately warn about the drug’s dangers. Notably, the plaintiff’s endocrinology expert, a former key opinion leader for Takeda who was paid by them to give talks to other physicians touting the benefits of Actos, testified that, given what he knows now, he does not believe Takeda marketed the drug in a fair and balanced manner. Takeda claimed that the label for Actos had always contained adequate information about the risk of bladder cancer and that Cooper’s development of bladder cancer while on Actos was mere coincidence., Cooper was diagnosed with urothelial bladder cancer in November 2011. His bladder was subsequently removed the following month. Unfortunately, the cancer returned later in 2012, and metastasized. Plaintiffs’ counsel contended that Cooper, now 79, has to wear an external urostomy bag, and will suffer significant physical limitations and a severely shortened lifespan. Thus, Cooper sought recovery of damages for his medical expenses and pain and suffering. His wife, Nancy Cooper, presented a derivative claim seeking recovery for her loss of consortium. Takeda’s counsel did not dispute the presence of Mr. Cooper’s bladder cancer, but argued that it was not caused by taking Actos and was a mere coincidence.
COURT
Superior Court of San Francisco County, San Francisco, CA
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