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Labeling Action Against Generic Drug Manufacturers Dismissed


The doctors of certain consumers prescribed Reglan. The doctors relied upon information published in the package inserts for Reglan, the Physicians' Desk Reference, or other information disseminated by the brand name manufacturers of Reglan. The consumers’ pharmacists filled the prescription for Reglan with its generic equivalent, metoclopramide. The consumers ingested the metoclopramide in excess of twelve weeks. At no point did the consumers ingest Reglan. The consumers subsequently developed various movement disorders, allegedly as a result of long-term use of metoclopramide.

 

The consumers sued the manufacturers of the prescription drug Reglan and its generic equivalent, metoclopramide, under the Tennessee Products Liability Act (TPLA).The generic manufacturers moved to dismiss the claims against them, arguing that all of the claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), and under the Supreme Court decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011). The brand-name manufacturers moved for summary judgment, contending that they were not liable because none of the plaintiffs ingested Reglan. The United States District Court for the Western District of Tennessee granted both motions.

 

The Sixth Circuit United States Court of Appeals affirmed. The court held that the fact that the consumers only ever used the generic prescription drug precluded the consumers’ claims under Tennessee product liability law against the brand name manufacturers. Regarding the consumers’ claims against the generic manufacturers, the court held that most of the claims were conflict preempted by the FDCA including the claim that the generic drug should have been modified to conform to the properties described in the label, the warranty claims based on advertising and promotional materials, and the implied-warranty claims that were premised entirely on a failure-to-warn theory. The court also held that the express warranty claims were not viable because the labels never explicitly warranted that metoclopramide was safe for long-term use and claims for failure to update labels to match brand-name labels failed because the complaint did not specifically allege when metoclopramide was ingested and by whom it was used with regard to a specific generic manufacturer.

 

The court noted that when a generic manufacturer could not obey federal law without being held liable under a state-law warranty action, the state action is preempted by the FDCA.

 

The consumers’ warranty claims based on advertising and promotional materials were preempted by the FDCA, since the materials were considered labeling, and labeling was limited by federal law to the information contained in the labeling of the brand name drug. The consumers argued that the generic manufacturers, on their own initiative, could have distributed “Dear Health Care Professional” or “Dear Doctor” letters to medical professionals to warn them of the dangers of metoclopramide that were not adequately communicated on the drug's label. Under the FDCA, “labeling” embraces all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. The Supreme Court has held that the first clause includes advertising or descriptive matter that goes with the package in which the articles are transported. The second clause includes any supplement or explanation, with no physical attachment necessary. FDA regulations include brochures, booklets, mailings, catalogues, films, sound recordings, and literature, among other things, in the definition of “labeling.” The court concluded that “Dear Doctor” letters qualified as “labeling” under FDA regulations, and thus, any such letters from generic drug manufacturers had to be consistent with and not contrary to the brand name drug's approved labeling.

 

The court held that the consumers’ implied warranty claims that were premised entirely on a failure-to-warn theory were also conflict preempted by the FDCA, since generic manufacturers would have had to give a stronger warning than they were permitted to give under federal law.

 

The court held that the consumers’ express warranty claims were not viable because the labels never explicitly warranted that metoclopramide was safe for long-term use. In order to establish a prima facie claim for breach of express warranty in Tennessee, a plaintiff must prove that: (1) the seller made an affirmation of fact intending to induce the buyer to purchase the goods, (2) the buyer was in fact induced by the seller's acts, and (3) the affirmation of fact was false regardless of the seller's knowledge of the falsity or intention to create a warranty. The patients' allegations did not identify any affirmation of fact made on the product labeling that they alleged to be false.

 

The court also held that the consumers’ “failure-to-conform” or “failure-to-update” claims were not viable. The consumers failed to allege when the metoclopramide was ingested and by whom it was used with regard to specific generic manufacturers, facts essential to show that a particular generic manufacturer's label was not updated during the time that a particular plaintiff was using its product.

 

Therefore, the Sixth Circuit held the implied-warranty claims that were premised entirely on a failure-to-warn theory were preempted by the FDCA; the warranty claims that were based on advertising and promotional materials were preempted by the FDCA; the express-warranty claims were not viable; the design-defect claims that rested on inadequate warnings were preempted; “Dear Doctor” letters qualified as “labeling” under FDA regulations, and thus, any such letters from the generic drug manufacturers had to be consistent with and not contrary to the drug's approved labeling; the implied-warranty claims that were based on a failure-to-withdraw or stop-selling theory were preempted; the “failure-to-conform” or “failure-to-update” claims were not viable; and the punitive-damages claims were not viable. The court affirmed the grant of summary judgment to the brand-name manufacturers, and affirmed the dismissal against the generic manufacturers.

 

See: Strayhorn v. Wyeth Pharmaceuticals, Inc., 2013 WL 6224337 (C.A.6 (Tenn.), December 2, 2013) (not designated for publication).

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

 

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