Co-authored by Brian Gross 

Generic Drugs

In June of 2011, the United States Supreme Court ruled that makers of generic drugs cannot be sued for failing to warn consumers of the possible side effects of their products if they copy the exact warnings used by their brand-name equivalents.  See Pliva, Inc., et al. v. Mensing, 131 S.Ct. 2567 (2011).  In Mensing, the plaintiffs took a generic form of the drug Reglan for several years, and alleged that the manufacturers were liable under state tort law for failing to provide adequate warning labels, despite mounting evidence that long term use carries a risk of tardive dyskinesia far greater than what was indicated on the label.

 The majority of the Court found that, although State law placed a duty directly on all drug manufacturers to adequately and safely label their products, federal drug regulations prevent generic manufacturers from independently changing safety labels which would add or strengthen a contraindication, warning, or precaution.

Where it is impossible to comply with state and federal law, the Supremacy Clause of the United States Constitution controls, and pursuant to the doctrine of preemption, state law must give way.  The majority distinguished the Court’s holding in Wyeth v. Levine, 129 S.Ct. 1187 (2009).  In that case, the federal law in question permitted a brand-name drug manufacturer to unilaterally strengthen its warning without prior FDA approval.

Now, for the first time, a Massachusettsjudge has applied Mensing to bar failure to warn claims arising out of the distribution of generic drugs.  See Stevens v. Community Health Care, Inc., 2011 WL 6379298 (Mass.Super.).  In Stevens, the plaintiff alleged that DAVA Pharmaceuticals, Inc., (“DAVA”) failed to adequately warn, in accordance with Massachusetts law, of the harmful interaction between the generic drug Clarithromycin and Methadone. Relying on the Mensing decision, DAVA moved for summary judgment.  Superior Court Judge Thomas R. Murtagh granted the motion, and held that, although DAVA was a distributor of the generic drug in question and not the manufacturer, it too had no ability to change labeling or warnings.  As a result, like a generic manufacturer, DAVA could not be subject to liability in connection with a state law claim premised on failure to warn theories.  In a related ruling, Judge Murtagh also rejected Stevens’ motion for leave to add Abbott Laboratories, Inc., the brand manufacturer, to the suit due to the earlier plaintiff’s strategic decision to not do so.

We predict that the Mensing decision will continue to have significant ramifications on pharmaceutical litigation in state courts throughout the United States, as only 25% of all prescription drugs dispensed in this country are brand name drugs.  If you would like to discuss these cases and their potential impact upon future litigation, please visit the Product Liability Defense page for contact information.