Double Whammy: Fifth Circuit Affirms Dismissal of Suit Against Generic and Brand-Name Drug Manufacturers


Some product liability suits are dead on arrival. At least, that is the position the Fifth Circuit took late last week in affirming the dismissal of a pro se plaintiff’s suit against a collection of generic and brand-name drug manufacturers.

The case in question is Johnson v. Novartis Pharmaceuticals Corporation, et al., and concerns Mr. Johnson’s purported struggles with Peyronie’s Disease (PD), a connective tissue disorder that causes painful, bent erections, after he had ingested generic forms of the prescription drugs Minocin (an antibiotic) and Tegretol (an anticonvulsant).

By way of background, in April 2013, Mr. Johnson began taking generic Minocin (Minocycline) on the advice of his dermatologist. Roughly a year later, Mr. Johnson began developing symptoms of PD. His PD symptoms improved some eighteen months later, following his decision to discontinue Minocycline. A few years later, in June 2017, Mr. Johnson began taking generic Tegretol (Carbamazepine) at the behest of his pain-management physician. After taking this medication for three months, Mr. Johnson’s PD symptoms worsened. Several of his physicians advised him that his PD condition was not caused by these medications, but, following some independent research, he determined that both Minocycline and Carbamazepine could cause drug-induced lupus, a connective tissue disorder (like PD), and that a correlation existed between high TGF-beta blood levels and PD. After receiving an elevated TGF-beta blood test and researching the issue further, Mr. Johnson filed suit in the United States District Court for the Western District of Texas against the manufacturers of Minocycline and Carbamazepine (together, Generic Defendants) and the manufacturers of the name-brand drugs Minocin and Tegretol (together, Brand Defendants). The suit alleged Texas-based theories of strict liability, products liability, breach of warranty, and loss of consortium. The Generic Defendants and Brand Defendants moved to dismiss under Rule 12(b)(6) on grounds of federal preemption and Fifth Circuit precedent. The District Court granted the motions and dismissed the case in its entirety, and Mr. Johnson appealed.

The Fifth Circuit addressed two key issues on appeal: (1) whether Mr. Johnson’s claims against the Generic Defendants were preempted by federal law; and (2) whether Mr. Johnson’s claims against the Brand Defendants failed under Texas law given that Mr. Johnson never ingested the brand-name version of either drug (e.g., Minocin and Tegretol). The appellate court answered both questions in the affirmative.

With regard to the claims against the Generic Defendants, Mr. Johnson alleged that the generic drug labels for both Minocycline and Carbamazepine failed to properly warn users of the risk of developing PD. But the Fifth Circuit, drawing upon its own precedent as well as that of the United States Supreme Court, held that Mr. Johnson’s state-law claims against the Generic Defendants were preempted by federal law because the substance of such claims turned on the adequacy (or alleged inadequacy) of the labeling of the generic drugs. Under federal law, a generic drug manufacturer must use the same warning label as that of the brand-name drug and cannot unilaterally change that label. See Mutual Pharmaceutical Co., Inc. v. Bartlett, 570 U.S. 472, 484-87 (2013); PLIVA v. Mensing, 564 U.S. 604, 618 (2011); Lashley v. Pfizer, Inc., 750 F.3d 470, 474 (5th Cir. 2014); Eckhardt v. Qualitest Pharm., Inc., 751 F.3d 674, 678 (5th Cir. 2014). Because the Generic Defendants were obligated to adhere to the FDA-approved labels for Minocin and Tegretol, the claims against them under Texas law, which were all characterized as products liability claims for failure to warn, were preempted.

As to the claims against the Brand Defendants, the issue was straightforward. Although the generic drug labels contained the same information as the labels of the brand-name drugs, Texas product liability law is grounded on the principle that a claim can only be asserted against a manufacturer for an injury allegedly caused by a defect in its own product. In this case, Mr. Johnson ingested only the generic versions of Minocycline and Carbamazepine. He never used a product manufactured by either of the Brand Defendants, namely Minocin or Tegretol. As a result, he failed to state a products liability claim against the Brand Defendants and was precluded under Texas law from bringing claims against them.

The Fifth Circuit’s decision adds to a growing body of case law concerning the scope of liability for generic manufacturers and for brand-name drug manufacturers that are sued for injuries allegedly caused by generic versions of their drugs.

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About the Author: Elie Biel

Elie Biel helps clients defend, resolve, prevent and manage medical device and pharmaceutical product liability litigation throughout North America. Drawing upon his on-the-ground litigation experience and intimate understanding of the medical field, Elie works with clients in the medical device, pharmaceutical and health care industries to evaluate the strengths and weaknesses of their cases and helps them manage risk and pursue favorable solutions through arbitration, mediation, settlement or trial.

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