FDA may eliminate liability exemption for generic pharmaceutical makers Blog added by Grace La Guerta on August 9, 2013
Grace La Guerta

Grace La Guerta

Joined: August 09, 2013

The U.S. Supreme Court was trending on social media for several days in late June for its decisions about gay marriage, American Express small business credit cards and the Voting Rights Act of 1965. Lost in the hysteria surrounding those cases was the decision rendered in Mutual Pharmaceutical Company vs. Karen Bartlett, which was decided that same week. The highest court in the land effectively granted immunity to generic drug makers that fail to warn consumers about potential adverse side effects, even if someone is nearly killed in the process.

Ms. Karen Bartlett

It was 2004 when Bartlett, of Plaistow, N.H. was having shoulder pain and was prescribed the anti-inflammatory drug Sulindac, a generic name for Clinoril. Three weeks later, Bartlett began experiencing a painful reaction to the drug known as Stevens-Johnson Syndrome, which causes the skin to peel off and expose raw flesh. She remembers very little from her three months in a Massachusetts hospital, but said she looked like a mummy and can describe the experience only as hell on earth. The 53-year-old woman was left legally blind and permanently disfigured. She also suffers a lung condition and has difficulty swallowing anything.

Judicial process

Bartlett sued Mutual Pharmaceutical Co. in New Hampshire Superior Court and was ultimately awarded $21 million in damages by a jury. A state appellate court upheld the verdict. The award was reversed by the U.S. Supreme Court on June 24 in a 5-4 decision. The court ruled that generic drug makers cannot be held liable for damages due to incomplete labeling because they are required by law to copy, verbatim, the brand name drug’s label.

The Consumer Reports National Research Center estimates that 75 percent of all prescribed drugs in the U.S. are generic. IMS Research, a marketing and consulting firm, says that number will reach 86 percent in the near future. Ralph Neas, the CEO of the Generic Pharmaceutical Association, said in a press release that the decision affirms the U.S. Food and Drug Administration’s ultimate power to regulate prescription drugs.

FDA intervention

Bartlett’s case has caught the attention of the FDA, and changes may be on the way. The federal agency plans to “create parity” between brand name and generic drug manufacturers, according to the U.S. Office of Information and Regulatory Affairs (OIRA). The FDA is required by law to notify the OIRA as the first step in the process of publishing a new rule, so the move is largely bureaucratic at this point. But if the rule is enacted, generic drug manufacturers would be given the authority to change labels as they see fit, thus making them liable for any adverse reactions. Sandy Walsh, an FDA spokeswoman, told the New York Times that discussions regarding the new rule were ongoing, but would not confirm if the new rule will in fact be enacted.

Meanwhile, Bartlett now lives off disability checks and says she has no independence.
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