Supreme Court Rules Federal Drug Rules Preempt State Laws

(A. Kotok)

The U.S. Supreme Court yesterday ruled 5-4 that in cases involving generic drugs, federal laws take precedence over an individual’s right to sue in state courts. The case, Mutual Pharmaceutical Co., v. Bartlett, overturned lower-court rulings in favor of the plaintiff, who sued the generic drug manufacturer Mutual Pharmaceutical — now part of Sun Pharmaceutical Industries Ltd. — for damages as a result of taking the drug Sulindac, a generic form of Merck’s non-steroidal anti-inflammatory drug Clinoril.

The plaintiff, Karen Bartlett suffered a severe reaction to Sulindac that she took for shoulder pain, causing an acute case of toxic epidermal necrolysis, a potentially life-threatening disorder that is most commonly induced by drugs. The reaction to Sulindac left Bartlett with physical disabilities, severely disfigured, and nearly blind. A jury in a New Hampshire state court decided the drug had a dangerous design flaw and under state product-liability law awarded Bartlett $21 million in damages.

Mutual Pharmaceutical appealed the decision in federal court claiming, according to an analysis in ScotusBlog, the company could not both meet state product liability requirements and federal design and labeling rules issued by the FDA. Federal courts, including the Court of Appeals for the First Circuit, disagreed with Mutual, saying it could, among other things, abstain from selling the drug in New Hampshire, while still marketing it nationwide under FDA guidelines.

The majority decision, written by Justice Samuel Alito and joined by the court’s four other conservative justices, agreed with Mutual that the company would have to either change the composition of the drug or revise its label, both of which are prohibited by the FDA. The majority opinion referenced a 2011 Supreme Court decision that made pharmaceutical companies responsible for safety warnings on its own brand-name drug labels, but not those of generic versions, and in that decision cited the priority of federal over state regulations.

The four more liberal justices disagreed, issuing two dissenting opinions. Justice Steven Breyer noted that FDA pre-eminence should not apply, since the agency held no hearings nor solicited arguments about the case. Justice Sonia Sotomayor argued that the decision assumes that federal law gives drug companies a right to market an FDA-approved drug free of common-law liability, removing key protections for consumers in the process.

Reuters reports that the Obama administration supported Mutual’s arguments that FDA’s rules took priority over state laws.

Read more:

• Generic HIV Drugs Save Money, But Could Impair Effectiveness
• Trial to Test Branded vs. Generic Anti-Rejection Drugs
• Study: FDA Approves Drugs Faster Than in Europe, Canada
• Generic Drugs Can Generate Sharp Health Care Cost Reductions
• $4 Generics Could Save the U.S. $6 Billion

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