Drug manufacturers have a duty to provide adequate warnings to consumers about the dangers their drugs present. If a drug manufacturer knows or should have known about a risk of injury and fails to adequately disclose it, then under the product liability law theory of “failure-to-warn” the manufacturer may be liable to a consumer who is injured by the drug. However, when the problematic drug is a generic version of a branded drug, the question of the adequacy of labeling becomes a bit more complex. In PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court of the United States was presented with a failure-to-warn case that it had to examine in light of the concept of federal preemption.
In 2001 Gladys Mensing was prescribed Reglan by her physician. Reglan is a brand name for metoclopramide (MCP), a drug that is used to treat diabetic gastroparesis as well as other ailments. MCP received FDA approval in 1980 and soon thereafter A.H. Robins Company began marketing it as Reglan. A few years later it was discovered that long-term Reglan use was associated with a neurological disorder called tardive dyskinesia (TD). There is no cure for TD. As required by the Federal Drug Administration (FDA), in 1985 Reglan modified its label to include a warning about TD, and in 2005 the label was again modified to recommend that Reglan be used for no more than 12 weeks. Pursuant to the guidelines of the Hatch-Waxman Act, a generic version of Reglan was introduced to the marketplace and manufactured by PLIVA. As required by the Hatch-Waxman Act the generic version of Reglan had the same warnings as Reglan.
When Mensing filled her prescription the pharmacist gave her a generic version of MCP manufactured by PLIVA, Inc. After using it for 4 years, in 2005 Mensing was diagnosed with TD. Mensing sued PLIVA in the U.S. District Court asserting the Minnesota law based tort claim that PLIVA failed to adequately warn about the dangers of long-term use of MCP. PLIVA asked the court to dismiss Mensing’s state-based failure-to-warn claim based on federal preemption grounds since the state tort claim conflicted with the labeling requirement of federal law. Mensing v. Wyeth, Inc., 562 F. Supp. 2d 1056, 1065 (D. Minn. 2008). The District Court granted PLIVA’s motion. Mensing appealed to the Eighth Circuit, which sided with Mensing reversing the District Court’s decision. PLIVA appealed to the Supreme Court.
The central issue of the Mensing case is whether federal law that requires labeling of generic drugs to be the same as their branded equivalents preempts state law that suggests different labeling. Article VI, Section 2 of the United States Constitution requires that where there is a conflict between federal and state law, federal law preempts state law. After reviewing the Hatch-Waxman Act and FDA regulations, the Supreme Court concluded that generic drug labeling was meant to be the same as the branded drug labeling. If PLIVA had changed its labeling to provide a stronger warning as required by state law, it would have violated federal law. Thus, any duty imposed by state law that required additional warnings, including heightened warnings would be in conflict with federal law and preempted by it.
Even though the Supreme Court concluded that federal law preempted state law, arguably there were steps that the defendant could have taken to both provide a stronger warning on its MCP and comply with the requirements of the FDA and the Hatch-Waxman Act. For example, it could have sought FDA approval for a change in the labeling. Should federal preemption inhibit drug companies from providing consumers and physicians with enough information to make informed decisions about using a product?
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