Massachusetts Recognizes New Cause of Action Against Drug Manufacturers

In a dramatic turnaround, the highest court in Massachusetts has recognized a cause of action against a drug manufacturer whose product was not even being used by the allegedly injured plaintiff. In Rafferty v. Merck & Co., 479 Mass. 141 (2018), Chief Justice Ralph Gants, speaking for the Supreme Judicial Court, overturned a lower court decision dismissing the plaintiff’s claim. In so doing, the Court departed from a long line of Massachusetts products liability decisions and greatly expanded the legal exposure of brand-name drug manufacturers in Massachusetts.

The case involved unhappy facts. Brian Rafferty suffered from an enlarged prostate, and his physician prescribed a generic version of a drug called finasteride. Unfortunately for Mr. Rafferty, the drug caused serious adverse side effects that persisted even after he stopped taking the drug.

The brand-name version of finasteride is marketed as Proscar, and the primary manufacturer of Proscar was, and is, the pharmaceutical giant Merck & Co., Inc. It was not disputed that Mr. Rafferty never took Proscar; rather, he took a generic version of the drug that was not manufactured by Merck.

Undeterred, Mr. Rafferty sued Merck anyway, alleging that Merck had negligently failed to include on the Proscar label a warning of the persistent dangers of the drug and had violated the Massachusetts consumer protection statute, G.L. c. 93A. Rafferty further alleged that Merck had changed the label on versions of Proscar sold overseas to warn of the persistent complication, but had not done so in the version sold in the United States.

Mr. Rafferty did not sue the generic manufacturer, because of a federal law and a decision of the United States Supreme Court effectively immunizing the generic manufacturer for claims as long as its label was identical to Merck’s. See 21 U.S.C. § 355(j)(2)(A)(v), (j)(4)(G); PLIVA, Inc. v. Mensing, 564 U.S. 604, 608-09 (2011). Mr. Rafferty’s claim was, in essence, that if Merck had placed the same warnings on the American version of Proscar that it had on the overseas version, the generic manufacturer would have followed suit, and Mr. Rafferty would not have chosen to take the drug.

Merck moved to dismiss Mr. Rafferty’s complaint, citing the fact that Mr. Rafferty had not ingested any of its products. The lower court accepted this argument and dismissed Mr. Rafferty’s complaint, citing a line of Massachusetts products liability decisions requiring that an allegedly injured plaintiff actually consume the product of the manufacturer he or she is suing. See, e.g., Mathers v. Midland-Ross Corp., 403 Mass. 688, 691 (1989); Mitchell v. Sky Climber, Inc., 396 Mass. 629, 631 (1986).

The Supreme Judicial Court reversed the lower court and reinstated Mr. Rafferty’s claims against Merck. Chief Justice Gants’ 39-page opinion went to some lengths – occasionally painful ones – to explain why the Court believed it was appropriate to change Massachusetts products liability law in such a dramatic way. In the first instance, Chief Justice Gants held that henceforth liability would attach to a brand-name manufacturer such as Merck only when the manufacturer “recklessly” failed to change its warning label. As mentioned above, manufacturers of generic versions of drugs are immune from claims as long as their labels are “identical” to the original manufacturers’. Second, Chief Justice Gants reasoned that the expansion of product liability exposure would not measurably add to the costs of drug development or production, nor would it deter manufacturers from developing new drugs. Chief Justice Gants seemed unconcerned that the case put Massachusetts in a small minority of states which recognize any cause of action against the drug companies by consumers of generic products. Likewise, the “recklessness” standard puts Massachusetts in a class of its own.

As most practitioners know, Massachusetts already imposes what is the functional equivalent of strict liability on product manufacturers. See Mitchell v. Stop & Shop Cos., 41 Mass. App. Ct. 521, 523 (1996). On top of this, Massachusetts now imposes a “recklessness” standard in the circumstances described above – which is relatively uncommon in tort litigation and difficult to apply. The Rafferty opinion appears to be content to let the lower courts struggle with this on a case-by-case basis and leave clarification for another day. In the meantime, developers and manufacturers of drugs have yet another potential liability with which to contend.

KATHERINE A. KELTER

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2018-04-18T14:11:58+00:00 March 29th, 2018|Categories: Katherine Kelter, Manufacturing Processes, Pathology|0 Comments

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