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From Products Liability Law Daily, August 30, 2018

Patient strikes out on third attempt to prove that defective Risperdal® caused gynecomastia

By Pamela C. Maloney, J.D.

A patient who developed gynecomastia after being treated with the antipsychotic medication Risperdal® produced no reliable expert testimony or other evidence from which a reasonable jury could conclude that the drug had been defectively designed or manufactured or that a reasonable alternative design existed, a federal district court in New York ruled, granting the drug manufacturer’s motion for summary judgment on those claims. Summary judgment was also granted on the patient’s claims for breach of implied warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud, and deceit because there was no evidence that the patient had relied on any misrepresentations made by the manufacturer (Adeghe v. Janssen Pharmaceuticals, Inc., August 29, 2018, Schofield, L.).

The patient, who as a child, teen, and young adult had been prescribed Risperdal to treat various behavioral issues, brought a lawsuit against several companies, including the drug’s manufacturer, Janssen Pharmaceuticals, Inc., alleging that his use of the drug caused him to develop gynecomastia (the development of glandular breast tissue in males). The complaint set forth 11 causes of action, including: negligence, strict products liability design defect, manufacturing defect, and failure to warn. Initially, the court granted summary judgment in favor of the manufacturer with respect to the patient’s failure to warn and express warranty claims [see Products Liability Law Daily’s August 31, 2017analysis]. Following motions for reconsideration by both parties, the court again granted the manufacturer’s motion for summary judgment on the patient’s failure to warn and breach of express warranty claims. However, the court allowed for additional briefing based on the manufacturer’s new evidence that undermined the patient’s design defect, fraud, and misrepresentation claims [see Products Liability Law Daily’s October 26, 2017 analysis].

Design defect. Given the complex chemistry and biology involved in assessing the design of Risperdal and its alternatives, the patient was required to submit expert testimony in support of his design defect claim. However, the only expert proffered by the patient simply opined that the drug caused the patient’s gynecomastia. The expert’s report made no mention of Risperdal’s chemical composition and proffered no better alternative design for the drug. In fact, the word "design" did not even appear in the report, nor did the expert use it in his testimony. Furthermore, the expert did not review materials relevant to Risperdal’s chemical composition in formulating his report. Even accepting the expert’s opinion that Risperdal caused the patient’s gynecomastia, and that the causal mechanisms behind gynecomastia were unknown, the patient still failed to proffer sufficient expert evidence for a reasonable jury to conclude that Risperdal’s chemical composition was unreasonably dangerous in that its risk outweighed its utility, or that there was a better, feasible alternative design for the drug. Thus, summary judgment in favor of the drug manufacturer was warranted on this basis alone.

The patient protested, arguing that even without expert testimony, there was sufficient evidence in the record to forestall summary judgment. The court rejected this argument, explaining that the patient’s reliance on his expert’s reference to an FDA study that used the agency’s Adverse Event Reporting System database, which indicated that the use of Risperdal had been attributed to more cases of drug-induced gynecomastia than six other antipsychotics, as proof of a design defect was misplaced. Similarly, the patient’s reference to testimony proffered by the manufacturer’s own expert, who admitted that Risperdal was associated with higher levels of Prolactin elevation than other antipsychotic agents and that increased levels of Prolactin were associated with gynecomastia did not bolster his case. The fact that Risperdal might be more likely to cause gynecomastia than six other drugs on the market, or that it contained higher levels of Prolactin, did not necessarily suggest that Risperdal’s design was unreasonably dangerous, the court advised. The cited studies and expert testimony failed to shed any light on the relative costs and benefits of Risperdal as compared to similar drugs on the market. In addition, the studies did not suggest that the chemical composition of the drug could be altered to remain an effective antipsychotic, yet decrease the risk of gynecomastia. Concluding that the patient’s evidence relevant to the risk-utility analysis or to the feasibility of alternative designs was insufficient for a reasonable jury to find that the drug was defective, the court granted summary judgment in favor of the manufacturer on the patient’s design defect claims.

Manufacturing defect. Summary judgment also was appropriate on the patient’s manufacturing defect claim because there was no evidence in the record that the Risperdal tablets ingested by the patient deviated from the manufacturer’s intended design and from other Risperdal tablets produced by the manufacturer.

Fraud and misrepresentation claims. The court, finding that there was no evidence that the patient had relied on any misrepresentation made by the drug manufacturer or that he was injured as a result of that reliance, granted summary judgment on the remaining claims for breach of implied warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud, and deceit. Both the patient and his mother acknowledged that they had no recollection of ever reading the warning information that accompanied Risperdal. As a result, even if the Risperdal warning labels were misleading, the patient failed to produce any evidence that he or his physician actually had read the misstatement and had relied upon it.

The case is No. 16 Civ. 2235 (LGS).

Attorneys: Debra Humphrey (Marc J. Bern & Partners LLP) for Jamal Adeghe. Louis Michael Russo (Patterson, Belknap, Webb & Tyler LLP) for Janssen Pharmaceuticals, Inc. a/k/a Ortho-McNeil Janssen Pharmaceuticals, Inc., Johnson & Johnson, and Janssen Pharmaceutical Research & Development, LLC.

Companies: Janssen Pharmaceuticals, Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc.; Johnson & Johnson; Janssen Pharmaceutical Research & Development, LLC

MainStory: TopStory DesignManufacturingNews DrugsNews ExpertEvidenceNews NewYorkNews

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