U.S. Supreme Court Quietly Limits Rights of Victims

 Posted on July 12,2013 in Uncategorized

By: Daniel M. Kotin

In the same week that the United States Supreme Court made big headlines by issuing opinions on high profile cases involving same sex marriage, affirmative action, and voting rights, the court quietly reached a 5-4 decision substantially limiting the rights of citizens who are injured by generic drugs.

In 2004, Karen Bartlett was prescribed Clinoril, a brand name non-steroidal anti-inflammatory (NSAID) for shoulder pain.  Her pharmacist dispensed a generic form of the drug, Sulindac, manufactured by Mutual Pharmaceutical.  Bartlett soon developed an acute case of toxic epidermal necrolysis resulting in catastrophic injuries.  A federal court jury in New Hampshire applying New Hampshire strict liability law found in favor of Bartlett on her design defect claim and awarded her over $21 million.  The First District Court of Appeals affirmed the verdict.  Nevertheless, on June 24, 2013, Justice Samuel Alito, writing on behalf of a 5-4 majority, concluded that since the Federal Food, Drug, and Cosmetic Act (FDCA) requires that generic drug manufacturers must make exact copies of brand name drugs, the manufacturer of the generic version of Clinoril could not be held responsible for claims that the drug was unsafe.  Mutual Pharmaceutical Company, Inc. v. Bartlett,2013 WL 3155230.  Accordingly, the plaintiff’s verdict was overturned based upon federal preemption.

In a lengthy dissenting opinion, Justice Sonia Sotomayor said that this decision was a disturbing expansion of the concept of “impossibility preemption”.  Traditionally, impossibility preemption exists when one government system requires something that another system prohibits.  Here, the Court is expanding it to allow federal premarket review procedures to preempt state common law remedies.

In addition to the absurdity of generic drug manufacturers having immunity from liability when their brand name counterparts may not, this decision is particularly alarming since generic drugs now account for more than 80% of all prescriptions.

What’s the larger lesson from this decision?  Well, despite the fact that rulings from this Supreme Court related to the Affordable Care Act and DOMA might lead some to conclude that the Court’s current balance is rather moderate, rulings such as this one which further infringe on victim’s rights,  simply confirms that this Court is increasing pro-business and anti-consumer.