Generic Drugs

Written by Jonathan F. Tabasky and Kate B. Puccio

Massachusetts Superior Court Judge Bruce R. Henry recently dismissed a series of claims against several manufacturers of the generic drug Metoclopramide (“MCP”), against whom failure to warn claims was alleged.  See White v. Elsevier, Inc., Middlesex Superior Court Civil Action No. 11-04441.  In so doing, Judge Henry held that Plaintiffs’ state law claims were preempted by federal law which prohibited different labeling than that associated with corresponding brand-name drugs.

Physicians commonly prescribe MCP and its Brand equivalent Reglan to treat digestive tract problems. In support of their claim for liability, the Plaintiffs proffered evidence that long term use of the drug can cause tardive dyskinesia, a severe neurological disorder.  Documented side-effects have included involuntary muscle movements, tongue protrusions and the like. The Plaintiffs claimed that the warnings in place were too weak, and underreported the incidence of such side-effects.  In support of their claims the Plaintiffs argued that in 2009, the FDA ordered a black box warning, its strongest, which states: “Treatment with [Reglan/MCP] can cause tardive dyskinesia, a serious movement disorder that is often irreversible . . . Treatment with [Reglan/MCP] for longer than 12 weeks should be avoided in all but rare cases.” The Plaintiffs further alleged that these hazards were well known by the defendants before they started taking the drug, and had the black box warning been in place at the time they ingested same, they would have taken another drug, or limited the period during which they took the drug.

The Generic Defendants moved to dismiss the Plaintiffs’ claims pursuant to Mass. R. Civ. P. 12(b)(6), contending that the Plaintiffs failed to state a claim upon which relief may be granted because federal law preempts their claims.  In making this argument, the Generic Defendants relied upon Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011), a United States Supreme Court decision which addressed similar preemption issues concerning the same drug and many of the same generic manufacturers as in this case.

Judge Henry’s opinion contains a useful summary of the regulations governing the production and sale of generic drugs.  He noted that under federal law, “[a] brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label.” Conversely, ‘generic drugs’ can gain FDA approval simply by showing bio-equivalence to the brand-name drug that has already been approved by the FDA, and that the safety and efficacy labeling proposed is the same as the labeling approved for the [brand-name] drug (citations and ellipsis omitted). After this initial FDA approval, generic drug manufacturers have an ongoing federal duty of ‘sameness.’ A generic drug manufacturer that makes unilateral changes to strengthen a generic drug’s warning label would therefore violate the statutes and regulations requiring a generic drug’s label to match its brand-name counterpart’s.

Because the Plaintiffs alleged that the Generic Defendants’ duty to warn could have been satisfied by “Dear Doctor” letters or other modes of communication, Judge Henry noted that the Code of Federal Regulations definition of labeling to include almost every conceivable communication, including but not limited to: brochures, booklets, literature, references published (for example, the Physicians’ Desk Reference, drug information supplied by the manufacturer, packer, or distributor).  He also noted that the Mensing decision held that “Dear Doctor” letters fell within the definition.

Judge Henry concluded that the Plaintiffs’ negligence, breach of warranty, fraud and consumer protection claims arose out of the claim that Reglan/MCP labeling was inadequate. Judge Henry found, however, that the Generic Defendants could not change the labeling of MCP as to do so would have deviated from the labeling of their brand-name Reglan counterparts in violation of federal law.  For the same reasons, the Generic Defendants could not disclose additional safety information to the medical community by “Dear Doctor Letters” or other means. Therefore, just as in Mensing, federal law preempts the plaintiffs’ claims because it is impossible for the Generic Defendants to comply with both their duties to warn under Massachusetts law and under federal law.

The White case is continuing against brand defendant, pharmacy defendants, and patient education monographs (PEM) defendants.  Updates regarding this important case will follow in the near future.

Photo of Jonathan F. Tabasky Jonathan F. Tabasky

Jonathan Tabasky represents architects, attorneys, engineers, real estate brokers and appraisers, and independent insurance adjusters, among others, in negligence/professional malpractice cases. He also represents a broad range of companies in product liability and toxic tort cases including manufacturers of prescription drugs, protective clothing…

Jonathan Tabasky represents architects, attorneys, engineers, real estate brokers and appraisers, and independent insurance adjusters, among others, in negligence/professional malpractice cases. He also represents a broad range of companies in product liability and toxic tort cases including manufacturers of prescription drugs, protective clothing, fittings, heating devices, wire and cable, trucks, aircraft and turbines.