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From Products Liability Law Daily, November 29, 2017

Juveniles’ claims against Risperdal makers barred due to prior FDA approval for use in adults

By John W. Scanlan, J.D.

Product liability claims brought by a number of juvenile male users of Risperdal in Michigan who subsequently developed gynecomastia were barred by the Michigan Products Liability Act (MPLA) because the prescription drug had been approved for use in adults, even though it had not yet been approved for use in juveniles, a Pennsylvania superior court held in affirming a trial court’s grant of summary judgment favoring the manufacturers. The MPLA barred such claims as long as the drug received FDA approval, regardless of the population for which it had been approved, and its label was compliant with FDA regulations, the court held (In re Risperdal Litigation, November 28, 2017, Panella, J.).

In 1993, the FDA approved the use of risperidone to treat schizophrenia in adult patients. Sold under the trade name Risperdal, risperidone was first brought to the market in 1994. In 2003, the FDA approved its use to treat manic episodes in adults with bipolar disorder I, to treat irritability associated with autistic disorder in children aged five to 16 in 2006, to treat schizophrenia in adolescents in 2007, and to treat manic episodes associated with bipolar I disorder in children aged ten to 17 in 2007. After the manufacturers discovered a potential use between Risperdal use by juveniles and gynecomastia, the label was updated to include a warning of this risk in October 2006, when it was first approved for use by juveniles.

With one exception, the young men involved in the case at bar were prescribed Risperdal prior to FDA approval of their individual conditions, and subsequently experienced weight gain and developed gynecomastia. They filed their complaints in the Pennsylvania court of common pleas as part of the Risperdal mass tort program, alleging claims for negligence, negligent and strict liability design defect, strict liability failure to warn, fraud, and other claims against Janssen Pharmaceuticals, Inc., Johnson & Johnson Company, and Janssen Research and Development, LLC, asserting that the companies had concealed and failed to warn of the risk and prevalence of developing gynecomastia.

The manufacturers moved for summary judgment, arguing that Michigan law governed because the consumers were all Michigan residents when they were prescribed and used Risperdal and, thus, the manufacturers had statutory immunity under the MPLA because they had complied with the statute’s conditions for protection. The consumers countered that Pennsylvania law applied, but even if Michigan law applied, the manufacturers were not entitled to the MPLA’s affirmative defense because they had withheld or misrepresented evidence to the FDA. Furthermore, the MPLA did not protect the manufacturers because Risperdal had been prescribed to the affected consumers as an off-label use and, therefore, had not been "approved" by the FDA regarding these specific consumers. The trial court granted summary judgment favoring the drug companies, finding that the MPLA barred the claims and that the consumers’ statutory consumer protection act claims failed as a matter of law. The consumers appealed, arguing that the MPLA did not apply to indemnify the manufacturers because Risperdal had not been approved for use by juveniles at the time they used it and that they had presented substantial evidence that the MPLA’s fraud exception prevented the manufacturers from being immune to suit.

FDA approval. The consumers’ argument that the MPLA did not apply because Risperdal was not approved for juveniles failed, the court said. Unlike Pennsylvania law, Michigan law limits the liability of drug manufacturers and sellers when a drug has been approved by the FDA and labeled in compliance with FDA standards. Observing that no Michigan court has addressed whether the MPLA protects manufacturers when the FDA approval was for a different population that those who had been adversely affected, the court found that the clear language of the statute shows that the legislature chose to offer a blanket immunity to drug manufacturers once they had received any type of FDA approval.

There have been federal court decisions concluding that the FDA "approval" triggering the application of MPLA immunity does not need to be specific to the affected population, and all Michigan case law referring to FDA "approval" refers to approval of a drug rather than approval of the drug for a specific population. It was undisputed that the drug had been approved by the FDA in 1993, and that even though the consumers alleged that the label was inaccurate, they conceded that at all times the drug was labeled in compliance with FDA regulations. As a result, the MPLA’s immunity provision applied to the consumers’ claims.

Fraud. Furthermore, the MPLA’s "fraud on the FDA" exception did not bar application of the immunity provision. According to the court, it was not necessary to address the manufacturers’ argument that this exception was preempted by federal law, or the circuit split on this question, because the consumers provided no facts or arguments that the manufacturers had fraudulently obtained the initial FDA approval in 1993. Although the consumers provided data to support their assertions that the manufacturers had fraudulently obtained FDA approval in 2006 and 2007 for use of Risperdal by juveniles, the MPLA indemnifies a drug manufacturer once the FDA has approved use of a drug for any use; therefore, to succeed on their fraud claims, the consumers were required to present proof of fraud relating to the original approval. Finally, the consumers could not prove that the FDA would have withdrawn Risperdal from the market due to the medication’s link with gynecomastia because the trial record showed that the FDA explicitly had declined to withdraw the drug for this reason.

The cases are Nos. 577 EDA 2015, 578 EDA 2015, 579 EDA 2015, 580 EDA 2015, 581 EDA 2015, 582 EDA 2015, 583 EDA 2015, 584 EDA 2015, 585 EDA 2015, 586 EDA 2015, 587 EDA 2015, 588 EDA 2015, and 589 EDA 2015.

Attorneys: Becker, Charles Lyman (Kline & Specter, PC) for MA.J.L. and M.L., A.H., Jr and A.H. and Daniel Brewer. Murphy, Kenneth Alonzo (Drinker Biddle & Reath, LLP) for Janssen Pharmaceuticals, Inc., Johnson & Johnson Co., and Janssen Research and Development, LLC.

Companies: Janssen Pharmaceuticals, Inc.; Johnson & Johnson Co.; Janssen Research and Development, LLC

MainStory: TopStory DefensesLiabilityNews WarningsNews DrugsNews PennsylvaniaNews MichiganNews

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