Court: United States District Court for the Middle District of Alabama, Northern Division
Case Name: West v. Janssen Pharms., Inc.
Citation: 2017 U.S. Dist. LEXIS 124276
This case involves two plaintiffs, West and Harper, who alleged that their consumption of the medication Risperdal caused them to develop gynecomastia (irregular breast development in males).
West was first prescribed Risperdal in October 2000 at the age of 17. At the time, his doctor described West as “fully developed.” West’s guardian first observed swelling on his chest in July of 2013. West was diagnosed with gynecomastia in September of 2013 at the age of 30. Harper started taking Risperdal in 1995 at age 5 and stopped taking it in November of 2000. He was diagnosed with “evidence of gynecomastia” in 2001 and formally diagnosed with gynecomastia in August of 2016.
The plaintiffs claim that the defendant manufacturer failed to provide adequate warnings to physicians regarding the medication’s risks and side effects. The plaintiffs further alleged that the defendant knowingly marketed Risperdal for children and adolescents without FDA approval.
The Pediatric Neurology Expert Witness
The defendant offered the testimony of a pediatric neurology expert witness to combat the plaintiffs’ claims. The defendant expert was a board-certified pediatric neurologist who had been in practice for 50 years. He graduated from Emory University School of Medicine and completed his residency at St. Louis Children’s Hospital. The expert also specialized in psychiatry, and he served as a member of several prestigious medical associations. The pediatric neurology expert authored many academic research papers, which were published in various medical science journals. In his testimony, the expert discussed both pediatric neurology and drug labeling issues. He opined that the development of gynecomastia secondary to Risperdal use is rare and that the drug was both safe and effective.
The plaintiffs argued that the expert’s opinions should be excluded. The plaintiffs claimed the pediatric neurology expert relied solely on his firsthand experience and not on any of the peer-reviewed scientific literature. The plaintiffs pointed to peer-reviewed literature that documented evidence that Risperdal causes extremely high levels of prolactin, especially in children and teenagers. The plaintiff challenged the expert witness’s qualifications to testify to the suitability of the Risperdal label and questioned his view that gynecomastia is rare as contradicting both the facts and the product label. The plaintiffs also argued that the expert’s opinion that the drug was safe constituted an argument, not an expert testimony, and should, therefore, be excluded as per the standards set by Fed. R. Evid. 702 and Daubert.
The court noted that the Risperdal label changed in 2006 to include additional language regarding gynecomastia. Harper’s ingestion of Risperdal and development of symptoms occurred prior to the label change, whereas West’s development of symptoms did not occur until 2013, seven years after this label change in 2006. West was physically an adult when he first started taking the medication and was an adult for many years before any symptoms manifested. On the other hand, Harper was a prepubescent male when he was first prescribed Risperdal and began to develop symptoms.
The court noted that doctors and the pharmaceutical industry have produced a number of powerful medicines for the treatment of many terrible conditions, with varying levels of effectiveness, and that all these medicines carry the burden of potential side effects on some or all users. The court was of the view that it is often difficult to determine the source of adverse conditions associated with certain medications. Legal principles of facts and causation are often not readily applicable where scientific knowledge is imperfect or unclear, the court said. Through federal and state legislation, administrative regulations and approvals, and common law, the court noted that we set standards for patients, physicians, and pharmaceutical companies to govern their affairs.
The Daubert motion to exclude testimony of the pediatric neurology expert witness’ testimony regarding pediatric neurology and drug labeling issues was denied as moot. Although there was evidence that Risperdal raised prolactin levels more than any other second-generation antipsychotic medication, the court’s Daubert review was hampered by combined consideration. The court was of the opinion that the jury would likely be confused in trying to sort out the differing courses of treatment, diagnoses, and child versus adult causation theories. It was determined that proceeding separately for pretrial and trial purposes will allow for a clearer presentation of the evidence with the experts’ theories and opinions tailored to each particular plaintiff.