Products Liability Law Daily Dismissal of lawsuit against generic acne drug maker affirmed on claim preclusion and untimeliness grounds
Thursday, December 19, 2019

Dismissal of lawsuit against generic acne drug maker affirmed on claim preclusion and untimeliness grounds

By Leah S. Poniatowski, J.D.

New complaint’s failure-to-update theory was based on the same operative allegations as the plaintiff’s previous complaint: inadequate warnings.

An individual purportedly injured from a generic acne treatment drug manufactured by Mylan Pharmaceuticals failed to bolster her claims on appeal and, thus, a federal trial court in Kansas did not err in determining that her claim alleging that the manufacturer failed to update the generic drug’s label was essentially the same cause of action as had been previously dismissed by the lower court. Additionally, her alleged uncovering of the cause of action during discovery in the prior case had no impact on tolling the statute of limitations. Therefore, the federal district court’s ruling was affirmed by the U.S. Court of Appeals for the Tenth Circuit (Watson v. Mylan Pharmaceuticals, December 18, 2019, per curiam).

An individual used Mylan Pharmaceuticals’ Amnesteem® product, a Food and Drug Administration (FDA)-approved generic version of the anti-acne drug Accutane®. She alleged injuries caused by her use of the product in 2014 and filed a products liability lawsuit in 2016. The lawsuit was dismissed, and the dismissal was affirmed on appeal. There after, the individual filed a pro se lawsuit in New Jersey that also was dismissed. She then re-filed the complaint in the Kansas federal district court in 2018, asserting that the manufacturer had failed to update the warnings for the drug’s use, in addition to adding parties she had not named in the prior lawsuit.

Trial court. The lower court ruled that her lawsuit was barred by claim preclusion and Kansas’ statute of limitations [see Products Liability Law Daily’s July 25, 2019 analysis]. The lower court explained that the cause of action concerned the same transactional theory as the case filed in the previously dismissed case, satisfying the first element of claim preclusion. There was privity between Mylan N.V., the parent company of Mylan Pharmaceuticals, and two executives of Mylan N.V. Catalent Pharma Solutions, the alleged distributor and contract manufacturer of the drug, also was in privity with Mylan N.V. despite not falling into one of the specific categories recognized by the Tenth Circuit because the relationship and similar litigation interests were sufficiently close, the court reasoned. Therefore, the individual’s claims against those entities were barred.

Further, the trial court determined that Kansas’ two-year statute of limitations applied to bar the individual’s claims because the actionable injury occurred more than two years before she had filed the present lawsuit, evidenced by her filing the prior claim. Consequently, her claims were time-barred. Moreover, she could not toll the statute of limitations because she failed to meet the pleading requirements to support the theories of fraudulent concealment or equitable estoppel.

Inadequate warnings. The appellate court also was not persuaded that the individual’s failure-to-update claim was valid. The appellate court stated that the "allegations remain the same: inadequate warnings resulted in injuries from taking Amnesteem in 2014." Because this was identical to the prior claim and could have been added by seeking to amend her complaint, the lower court did not err in its claim preclusion finding.

Statute of limitations. The individual also was not successful in challenging the trial court’s determination that her state-law claims were time-barred under Kansas’s two-year statute of limitations. The appellate court clarified that under Kansas law, the statute of limitations allows plaintiffs time to determine that an injury may be caused by some act of the defendant, but that the time after discovery of the cause of injury is not "infinite." The appellate court surmised that the individual had been aware that she had a claim when she filed her first complaint in 2016. Her assertion that she did not know the manufacturers had a duty to update the label until 2016, during discovery, was of no consequence. Moreover, because she was fully aware of the basis of her cause of action when she filed her first complaint, and she failed to plead fraudulent concealment with the required particularity, the lower court’s ruling that the claims were time-barred also was correct. Therefore, the lower court’s ruling in favor of the manufacturers was affirmed.

The case is No. 19-3162.

Attorneys: Carmen Naomi Watson, pro se. Bryan Timothy Pratt (Shook, Hardy & Bacon) for Mylan Pharmaceuticals and Mylan N.V.

Companies: Mylan Pharmaceuticals; Mylan N.V.; Mylan Labs; Mylan Inc,; Genpharm; Mylan Inc.

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