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From Health Law Daily, November 15, 2017

Voluntary dismissal denied; patient had notice of pending state court action

By Jeffrey H. Brochin, J.D.

A male adolescent patient who used Risperdal® and suffered from breast enlargement was not entitled to voluntarily dismiss his federal court case so as to join a state court case against the drug manufacturer, a federal district court in California has ruled. The patient’s failure to engage an expert who might establish medical causation meant that he would be unable to withstand the manufacturer’s motion for summary judgment on the issue of causation. In addition, his delay in filing the motion until one day before the manufacturer’s filing of their motion for summary judgment indicated that he had insufficient need for dismissal. The manufacturer’s motion for summary judgment was granted because stronger warnings would not have altered the conduct of the prescribing physician (Thompson v. Janssen Pharmaceuticals, Inc., October 23, 2017, Gutierrez, P.).

Background. A California patient was prescribed the medication Risperdal® since 2001 after being diagnosed with tics and other disorders. He testified that the drug effectively controlled his tics and he continued to take the medication despite both the alleged ill side-effects that formed the basis of his instant action against the manufacturer, Janssen Pharmaceuticals, Inc. (Janssen), and the recommendation of his physicians that he stop using the drug. In April 2016, he filed a product liability action claiming that as a result of using the drug, he suffered from gynecomastia (breast enlargement).

On November 28, 2016, the parties filed a Joint Statement of Scheduling Conference and Proposed Discovery Plan which included notice that a proceeding involving Risperdal was already pending in state court. The patient filed his motion for voluntary dismissal on September 1, 2017, claiming that although he had been diligently seeking discovery to prove his case, he was unable to do so effectively in the current forum, and he sought adjudication of the issues in Los Angeles Superior Court where In re Risperdal was pending. Accordingly, he moved for voluntary dismissal without prejudice, which, for the reasons stated below, the court denied. On September 5, 2017, Janssen filed their motion for summary judgment which the court granted.

Failure to disclose an expert. Under Federal Rule of Civil Procedure 41(a)(2), an action may be dismissed at the plaintiff’s request only by court order, on terms that the court considers proper, unless a defendant can show that it will suffer plain legal prejudice as a result. The patient conceded that Janssen expended both effort and expenses in responding to the lawsuit, but contended that the results of those efforts and expenses were directly transferrable to the pending action in state court, In re Risperdal, where the patient intended to re-file his action.

The court was not persuaded by his arguments, and noted that the patient had failed to serve an expert disclosure or expert reports, which are vital in this type of action, and that where a party does not have an expert who can establish medical causation, he cannot withstand the manufacturer’s motion for summary judgment on the issue of causation.

Delay in filing motion. More troubling to the court was the patient’s motion being premised on an intention to join the state litigation, yet offering no explanation as to why he waited until mere days before the deadline for summary judgment motions—when he had notice of In re Risperdal for almost a year. The court interpreted the lack of justification as an insufficient explanation of the need for dismissal. The patient filed his motion just one court day before Janssen filed their motion for summary judgment, which they had given prior notice of before the actual filing. Accordingly, the court found a lack of sufficient justification for voluntary dismissal given the untimeliness of the request and proximity to Janssen’s motion for summary judgment, and they denied the motion.

Motion for summary judgment. All of the patient’s claims were based on an alleged failure to warn about the risk of gynecomastia. However, the court noted the FDA-approved labeling that in fact warned of elevated prolactin as a side effect and that gynecomastia had been reported from the use of prolactin-elevating compounds. The physician who prescribed the drug stated that she generally relied on her past experience and medical studies rather than on medication labels for information about potential side effects, and that at the time she prescribed Risperdal to the patient, it was the standard of care to treat tics in pediatric patients at the clinic where she worked.

The court found that a product defect claim based on insufficient warnings cannot survive summary judgment if stronger warnings would not have altered the conduct of the prescribing physician under the learned intermediary doctrine, and they granted Janssen’s motion for summary judgment.

The case is No. CV-16-2628 (AGRx).

Attorneys: Kenechi Reuben Agu (Law Offices of Kenechi R. Agu) for Vernon A. Thompson, Jr. Steven M. Selna (Drinker Biddle & Reath LLP) for Janssen Pharmaceuticals, Inc., Johnson and Johnson, Inc. and Janssen Pharmaceutical, Inc.

Companies: Janssen Pharmaceuticals, Inc.; Johnson and Johnson, Inc.; Janssen Pharmaceutical, Inc.

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews PrescriptionDrugNews PLDrugNews CaliforniaNews

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