In a case involving a Philadelphia company, a divided U.S. Supreme Court ruled Monday that federal pharmaceutical laws preempt a person’s ability to sue in state court alleging that a generic drug is designed badly and therefore is dangerous.
The court’s 5-4 decision in Mutual Pharmaceutical Co. v. Bartlett is a victory for the drug industry and, indirectly, the U.S. Food and Drug Administration.
A New Hampshire woman, Karen Bartlett, suffered severe skin reactions and is nearly blind after using a generic drug made by Mutual. The drug, sulindac, is an anti-inflammatory Bartlett took for a sore shoulder in 2004. After her suit was moved from state court, a federal jury awarded Bartlett $21 million in damages.
The FDA joined the Generic Pharmaceutical Association (GPhA) and other pro- business groups in backing Mutual, with the FDA not wanting a jury to “second- guess” the agency’s safety decisions.
“Decisions with this much at stake belong in the hands of the scientific, public health, and regulatory experts at the FDA,” GPhA president Ralph G. Neas said in a statement Monday after the decision, noting that the drug had been on the market for 30 years.
Bartlett could not be reached for comment.
Mutual’s parent company, URL Pharma, was founded in Philadelphia in 1946, and both still operate here, though they are now part of India-based Sun Pharmaceutical Industries.
Calls and e-mails to URL Pharma and Sun were not returned.
Mutual had argued that FDA rules prevented a generic manufacturer from changing the composition of, or official label for, a drug once it was approved by the agency because the medicine was based on the brand-name drug.
The U.S. Court of Appeals for the First Circuit agreed with the jury and the trial- court judge, suggesting that Mutual could simply not sell the product if it thought a drug’s design made it dangerous.
That was “no solution,” Supreme Court Justice Samuel A. Alito Jr. wrote for the majority Monday, overturning the appeals court. His opinion, he said, meshed with a 2011 court decision preempting state suits alleging insufficient warnings on drug labels of potential adverse effects. Alito was joined by Chief Justice John G. Roberts Jr. and Justices Antonin Scalia, Clarence Thomas, and Anthony M. Kennedy.
“Should we move to Iran?” Philadelphia plaintiffs attorney Stephen Sheller said half- jokingly, suggesting that nation has stronger laws to protect consumers.
Justices Stephen G. Breyer and Elena Kagan combined on one dissent, Sonia Sotomayor and Ruth Bader Ginsburg on a second. They noted that the decision could apply to other industries, such as food additives and pesticides; that the FDA is not all-knowing; and that Congress had specifically not exempted drug companies from state lawsuits.
Lamenting the “de facto immunity” of such preapproved products, Sotomayor wrote, “Consumers injured by those products will have no recourse.”
Link and related information
U.S. Supreme Court Protects Generic Drugmakers in 5-4 Ruling, by Eric Palmer, Fierce Pharma, June 24, 2013
High Court Further Limits Generic-Drug Suits, by Brent Kendall, The Wall Street Journal, June 24, 2013