Trio of Plaintiffs' Verdicts in Risperdal Litigation Present Significant Issues for Johnson & Johnson

Four Risperdal cases were tried in 2015, three of which resulted in verdicts for the plaintiffs. The first case taken to trial was that of Austin Pledger, who took Risperdal in 2002 to manage his mood swings. Pledger developed severe gynecomastia: His evidence at trial demonstrated that his breast size corresponded to bra size 46-DD. During the trial proceedings, a Philadelphia County jury heard testimony from a J&J biochemist, who admitted that the pharmaceutical manufacturer knew about the risk of boys developing abnormally large breast tissue, but concealed it from the government and the health care providers who prescribed Risperdal. Pledger was awarded a verdict of $2.5 Million.

The second case tried to a Philadelphia jury resulted in the only defense verdict for the manufacturer. Plaintiff William Cirba started taking Risperdal when he was six years old, and was also diagnosed with gynecomastia. Here, however, the jury's decision was a mixed result; the jury found the manufacturer negligent in its labeling information, yet returned a finding of “no causation” on the enlarged breast tissue claims.

The third trial was that of plaintiff Nicholas Murray, who was diagnosed with schizophrenia when he was 9 years old. At the time, the FDA had only approved Risperdal for treatment of adults. Murray received a verdict of $1.7 Million from the trial court jury.

Finally, a verdict in the amount of $500,000 was returned in December 2015 in favor of plaintiff Timothy Strange, who took Risperdal for three years to control Tou- rette's Syndrome. (FDA approval of Risperdal for children took place in 2006, the same year Strange began treatment). Approximately one year after he began using Risperdal, then-12-year-old Timothy Strange began to develop enlarged breasts and experienced a 60-pound weight gain. The target of ridicule at his school, Strange eventually underwent breast reduction surgery at age 18. At trial, plaintiffs' counsel conceded that there were no obvious physical scars from the surgery, and instead focused on the humiliation and emotional trauma that his client had endured.

The Role of the FDA: Before and After

The FDA is responsible for enforcing our country's food and drug laws, which, as a fundamental matter, prohibit the distribution via interstate commerce of any drug unless and until it has been shown to be both safe and effective for its intended use. The United States Code requires that “adequate and well-controlled investigations” be employed to demonstrate a drug's safety and effectiveness. More specifically, the “intended conditions” for use of a drug must be listed in the drug's labeling, which must also be reviewed and approved by the FDA. Federal law also prohibits a drug manufacturer from obtaining approval of a drug for one use, then marketing or promoting the drug for unapproved uses.

Risperdal, whose generic chemical name is risperidone, is considered an atypical antipsychotic. A powerful drug, Risperdal has been associated with increased mortality, including an increase in the risk of stroke in elderly patients, neuroleptic malignant syndrome, and tardive dyskinesia. Risperdal has also been associated with weight gain in excess of 7%, as well as metabolic changes. Janssen submitted Risperdal to the FDA in 1992, and one year later received approval to market it for management of certain psychotic disorders in adults.

Risperdal's effectiveness for treatment of schizophrenic inpatients was established in a series of short-term (6-8 weeks) controlled trials. Significantly, the “Adverse Reactions” section of its label included “Endocrine Disorders: Rare: gynecomastia” and further reported that the drug's “safety and effectiveness in children have not been established.” In 2002, Risperdal's label was changed, but continued to note that its “safety and effectiveness in children have not been established.” Another change took place in December 2003, and, once again, the admonition regarding safety/effectiveness in children remained the same.

In the Pledger case, plaintiff counsel introduced the expert opinion testimony of former FDA Commissioner David Kessler. The latter presented evidence of ongoing communications between the manufacturer and the FDA, in which Janssen sought approval for prescription of Risperdal to pediatric patients with different diagnoses, including disruptive behavioral disorder, ADHD, mental retardation, autism and bipolar disorder, among others. According to Kessler, the manufacturer was aware of data revealing the extent to which pediatric patients could develop gynecomastia, but failed to disclose this information to the FDA. Warning labels placed on the drug in October 2006 stated that gynecomastia had been reported in 2.3% of children and adolescents participating in clinical trials. The plaintiffs countered that the actual levels of the disorder were significantly higher, but were not disclosed to the FDA by the manufacturer.

Kessler's testimony followed a settlement of charges brought against Johnson & Johnson and Janssen by the U.S. Department of Justice (DOJ), in which the government alleged that the manufacturer had illegally promoted Risperdal for use in children during the 1990s and early 2000s.

Given a complex regulatory history, the Philadelphia trial juries may well have been influenced by Kessler's testimony, offering an insider's view of the application process and the extent to which government oversight was, or was not, sufficient to address the risks attendant with use of such powerful medication.

2016 and Beyond: Trial and Error?

The verdicts returned in 2015 offer a mixed message for the opposing sides. While the plaintiffs are no doubt encouraged by a 75% success rate, the verdicts were relatively modest, especially given that they were returned in a jurisdiction that is well-known for awarding seven- and eight-figure verdicts on far less compelling evidence. This factor takes on greater weight, given trial court records in which compelling evidence of a manufacturer's attempt to put profits before safety was present.

For the manufacturer, the results are more problematic. Even in the case “won” by the defense, the jury returned a finding of negligence without causation. Two of the three liability verdicts awarded damages in excess of $1 Million, and well over 1,000 cases remain pending for trial over the next several years. The potential exposure here is significant, and may well counsel in favor of a negotiated, global settlement. That being the case, there is a strong likelihood that such discussions are already underway, or will be initiated in the near future.

Michael D. Brophy, a member of this newsletter's Board of Editors, is a partner with Goldberg Segalla LLP, practicing out of the firm's Philadelphia office.