Amidst Fosamax Lawsuits and Actos Lawsuits, Pharmaceutical Company Appeals Case on Generic Drug Liability
In the Fosamax lawsuits and Actos lawsuits that continue to be filed, hundreds of patients allege the name-brand drug makers failed to warn consumers of the dangerous side effects associated with the medications.
Now, they are trying to do the same with generic drugs, but may soon hit a road block, according to a recent report by the Wall Street Journal.
On Dec. 2,the U.S Supreme Court agreed to hear an appeal issued by Takeda Pharmaceutical Co., the same company defending itself in Actos lawsuits, in a case that could shield generic drug companies from having to defend themselves from product-liability lawsuits brought by consumers.
At stake is a lawsuit by a New Hampshire woman who claims to have suffered permanent injuries after taking sulindac, a painkiller to treat shoulder pain, manufactured by the pharmaceutical giant’s Mutual Pharmaceutical Co. unit.
The plaintiff, Karen Bartlett, won $21 million in the judgment last May in the First U.S. Circuit Court of Appeals in Boston, Mass, when the jury decided there there was “overwhelming evidence” that the painkiller caused Bartlett to develop Stevens-Johnson syndrome, which left her nearly blind and with severe burns.
However, Mutual is attesting that the ‘failure to warn’ claim should be considered void since federal law requires that generic drugs bear the same warning labels as their name-branded equivalents.
In addition to the painkiller at the center of this lawsuit, Takeda Pharmaceutical Co. is also the maker of the controversial diabetes drug Actos, which has been linked to bladder cancer and other side effects that have prompted patients to file Actos lawsuits. Last August, the U.S. Food and Drug Administration issued a Boxed Warning label on Actos and its generic equivalent, pioglitazone, to alert consumers of the medication’s potential to cause or worsen bladder cancer, heart failure, liver disease and bone fractures. If Takeda prevails at the Supreme Court in the generic drug case, users of generic Actos who suffered bladder cancer and other side effects may denied an avenue for legal recourse.
Those who have filed Fosamax lawsuits have also issued ‘failure to warn’ claims against the osteoporosis-drug manufacturer, Merck & Co. These patients allege the medication’s warning label failed to include the risk for femur fractures as well as osteonecrosis of the jaw (bone death). A Supreme Court decision in favor of Takeda and its Mutual Pharmaceutical unit could also endanger any claims plaintiffs have filed against the makers of generic versions of Fosamax.