Products Liability Law Reporter

The Seventh Circuit Court of Appeals held that a trial court’s summary judgment for Janssen Pharmaceuticals was proper where a plaintiff failed to make proper expert witness disclosures under Federal Rule of Civil Procedure 26(a)(2).

Here, Wisconsin inmate Reginald Cole Jr. took Risperdal for three periods of time between 2007 and 2008 before taking its generic equivalent risperidone for a year. He complained of gynecomastia to a prison health official; however, a nurse found no evidence of the condition. His prolactin levels, which had increased, returned to normal after he stopped taking the risperidone.

Cole sued Janssen Pharmaceuticals, Inc., alleging that Risperdal was defective and caused him to suffer adverse symptoms. He filed three sets of expert witness disclosures, listing several names including two nurses, but was told that his reports were inadequate. The court subsequently struck the disclosures and entered summary judgment for Janssen. The court concluded that Cole had failed to proffer evidence allowing a reasonable fact finder to conclude that Risperdal was defective or had caused him to suffer injury.

The Seventh Circuit affirmed. The court found that Rule 26(a)(2) requires expert disclosures to be accompanied by a written report prepared and signed by the witness who describes the opinion he or she intends to offer during testimony. Had the trial court ruled otherwise, the court said, Janssen would have been forced to prepare its defense on the issue of causation without knowing what Cole’s experts were planning to say.

Citing case law, the court said that in Wisconsin, a plaintiff alleging products liability must prove causation, and expert testimony is required when the issue is outside the realm of ordinary experience. Finding that whether a medication led to a specific symptom falls within this category, the court concluded that summary judgment had been proper.

Citation: Cole v. Janssen Pharms., Inc., 759 Fed. App’x 518 (7th Cir. Apr. 3, 2019).

Comment: See also Merck Sharp & Dohme Corp. v. Albrecht, 2019 WL 2166393 (U.S. May 20, 2019). In this Fosamax failure-to-warn case brought by over 500 patients who had suffered atypical femoral fractures after taking the drug between 1999 and 2010, the U.S. Supreme Court held that whether the FDA would have approved a proposed change to a drug’s label is a question of law for a judge, not a jury, to decide. The Court affirmed its ruling in Wyeth v. Levine, 555 U.S. 555 (2009), which held that state law failure-to-warn claims are preempted where there is “clear evidence” that the FDA would not have approved a change to a drug label. The Court here held that in making such a decision, a judge should ask whether relevant federal and state laws irreconcilably conflict. Accordingly, the Court reversed the Third Circuit’s reversal of a trial court’s summary judgment for Fosamax’s manufacturer.