The overwhelming majority of courts (including all seven federal circuits that considered the issue) have rejected the so-called “innovator liability” doctrine.[1]  In 2017, however, the California Supreme Court in T.H. v. Novartis Pharm. Corp.[2] unanimously recognized the doctrine holding that brand-name prescription drug manufacturers owe a duty to warn to consumers who use generic drugs.[3]  In March of 2018, the Massachusetts Supreme Judicial Court (SJC) considered the issue, and took a middle ground.  Specifically, in Rafferty v. Merck & Co., Inc.,[4] the SJC held that plaintiffs who ingest the generic form of a drug may bring failure to warn claims against the brand-name manufacturer of the drug if the brand-name defendant acted recklessly by “intentionally fail[ing] to update the label on its drug while knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use.”[5]  In so doing, the SJC reasoned that a plaintiff is, in fact, injured by a brand-name product’s label despite never having used said product because statutes require identical labeling of the generically manufactured version.[6]

The Facts

In 2010, a physician prescribed Finasteride, the generic version of the brand name drug Proscar, to treat Rafferty’s enlarged prostate.[7]  Rafferty experienced anticipated temporary side effects from the drug, causing him to stop taking the medication.[8]  Rafferty, however, continued to experience these side effects and his physician informed him that they could actually continue “indefinitely.”[9]  The potential lifelong side effects of this drug were not disclosed within the brand-name manufacturer’s nor the mirrored generic manufacturer’s warning label.[10]  Rafferty presented evidence that the brand-name manufacturer became aware of these potential long-term side effects by 2008, when it updated Proscar’s warning label in select European markets to include this risk.[11]

Rafferty filed suit against the brand-name manufacturer in 2013, asserting a claim of negligence for, inter alia, failure to warn and for violation of the Commonwealth’s Consumer Protection Statute, G.L. c. 93A.[12]  The Superior Court dismissed Rafferty’s claims, “ruling that [the brand-name defendant] owed no duty of care to [him].”[13]  The SJC took over the case by its own motion from the Appeals Court.[14]

The SJC Weighs In

Traditionally, Massachusetts has not recognized liability for products manufactured by others.[15]  However, the SJC noted that The Restatement (Third) of Torts allows a modification to this general rule in exceptional cases.[16] The SJC considered innovator liability to require such a modification given the certainty that a user of a generic drug will rely on the label fashioned by the brand-name manufacturer and as state law shields failure to warn claims from generic manufacturers, leaving plaintiffs without recourse for their injuries.[17] However, the SJC also recognized that imposing innovator liability could impact the public policy of encouraging innovation in the drug market and a potential increase in drug pricing.[18]

Balancing these competing interests, the court held that, “a brand-name manufacturer
Continue Reading Massachusetts Stakes Out a Middle Ground and Allows Brand Drug Liability for Generic Drug Labeling Claims Upon a Showing of Recklessness and Serious Harm

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.

Continue Reading Massachusetts Court Extends Mensing to Bar Failure To Warn Claims Against Generic Drug Distributors