On June 24, 2011, the Supreme Court, in Pliva v. Mensing, (a 5-4 decision) concluded generic drug manufacturers, under the Hatch-Waxman Amendments, must , under FDA regulations, have the same label as that approved for the brand name drug. Thus, State Court claims for failing to warn directly conflict with FDA regulations and are preempted as it is impossible for manufacturers to comply with both State and Federal requirements. Now, a drug consumer’s right to compensation for inadequate warnings now turns on whether the side effect was caused by brand name drug or generic. This decision affects 75% of all prescription drugs. This decision makes no sense given the legislative history of Hatch-Waxman lowering the price a consumer pays of the equivalent drugs.
The majority opinion invites either Congress or the FDA to change the law and regulations. At Anapol, we see another remedy – placing the duty on the brand name manufacturer for failing to disclose the risks on its label. This remedy, known as Innovator Liability, prior to Pliva, has gotten little traction in State Courts other than in California. Courts should rethink this issue given the newly created anomaly and the ever increasing purchase of generic drugs in the United States. Some of the reasons include:
- Only the brand name manufacturers can add or strengthen warnings;
- Only the brand name manufacturers conduct clinical trials;
- The brand name manufacturers are in the best position to analyze post market safety information;
- Physicians primarily rely on a drug’s safety profile articulated by the brand name in formulating prescribing habits; and
- Only brand name drugs can send out Dear Doctor letters that deviate from the FDA approved label.
We suggest reading Prescription for Fairness: A New Approach to Tort Liability of Brand Name and Generic Drug Manufacturers, 60 Duke L.J. 1123 (February, 2011).
We shall shortly challenge the consequences of this unjust decision in appropriate State Courts to protect our clients rights.