Generic drugs have operated under a different set of rules than brand-name drugs since 1984, when Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984, or Hatch-Waxman Act. Brand-name drug manufacturers must submit extensive evidence from clinical trials to get approval from the Food and Drug Administration (FDA), through its New Drug Application (NDA) process. But generic drug manufacturers, thanks to the Hatch-Waxman Act, need prove only that their products are biologically the same as the brand-name equivalents before physicians and pharmacies can giving them to patients. The law has contributed to the rapid increase in generic drug use over the past couple of decades.
Once FDA approved, generic drugs are considered the same as brand-name drugs. Generics must follow the same marketing rules, and carry the same warnings as their branded counterparts. In 2011, the U.S. Supreme Court issued a landmark decision in PLIVA, Inc. v. Mensing, saying that the federal requirement for sameness protected generic drug makers from liability in claims filed under state tort and consumer protection laws. Since generic drug makers must produce and market their drugs exactly as determined by the FDA and federal law, they cannot be held liable in different states.
State Tort Liability for Generics Back at the Supreme Court
That issue will come back to the Supreme Court this year, in Mutual Pharmaceutical Co. v. Bartlett. The plaintiff alleged she suffered injuries from Sulindac, an anti-inflammatory drug made by Mutual Pharmaceutical, in several types of New Hampshire state tort claims, including that the drug’s design was defective. A jury awarded damages of $21 million.
The First Circuit Court of Appeals upheld the jury’s decision. The court said Mutual was liable for design defects under state law because it could have chosen to stop manufacturing and selling Sulindac altogether if it was unsafe, despite the fact that the FDA had already approved the design and marketing for Sulindac, which Mutual could not change.
If the Supreme Court were to agree with the First Circuit Court in Mutual, it would reverse its own decision in the Mensing case and would open generic drug makers to a potentially large amount of liability under state laws. Since Mensing, federal and state courts across the country have ruled against plaintiffs like the one in Bartlett. The Drug and Device Law Blog has kept a generic drug preemption scorecard, which is a good resource for anyone interested in such cases.
Arguments in Mutual Pharmaceutical Co. v. Bartlett start March 19, 2013. You can read the petition for a writ of certiorari at SCOTUSblog.com. Also check out the amicus brief filed by the U.S. Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America (PhRMA). The Generic Pharmaceutical Association (GPhA) also filed an amicus brief.
Previews for Upcoming Pharma and Biotech SCOTUS Cases
This post is part of a short series of previews about upcoming Supreme Court cases that affect the pharma and biotech industries. Other posts preview cases that deal with patenting human genes, the National Vaccine Injury Compensation Program (VICP), and the legality of pay-for-delay settlements – another case that involves generic drugs.