Seventh Circuit Clarifies Expert Evidence Requirements for Medical Device Cases in Indiana

On June 4, 2018, the Seventh Circuit affirmed an Indiana federal judge’s determination that a woman’s product liability suit for a broken intrauterine contraceptive device (IUD) required expert evidence under the Indiana Products Liability Act (IPLA) in Dalton v. Teva N. Am., No. 17-1990.

Indiana courts have already found that plaintiffs in pharmaceutical cases must present expert evidence to prove causation, Tucker v. SmithKline Beecham Corp., 701 F. Supp. 2d 1040, 1047 (S.D. Ind. 2010), and Dalton adds further support that this requirement generally applies to medical devices as well. Absent “uncomplicated facts that lead to only one logical conclusion,” plaintiffs must provide expert evidence in medical device cases.

In 2013, Cheryl Dalton’s doctor attempted to remove her IUD but recovered only a portion of it because the device splintered. After the doctor advised Dalton that the remaining piece could only be extracted through a hysterectomy, she filed product liability claims against Teva Pharmaceuticals, the device’s manufacturer, in federal court alleging manufacturing defect and failure to warn claims. However, Dalton failed to provide expert evidence to support these claims, and the Indiana district court granted Teva’s motion for summary judgment. It found the issue of causation outside the scope of a lay juror’s understanding without this expert evidence.

Dalton appealed to the Seventh Circuit, arguing the claim did not require expert evidence because the broken IUD represented an “obvious” error, but the Seventh Circuit disagreed. The court reasoned that, without expert evidence, a lay juror could only speculate on whether the device was defective and, even if a defect could be established, on whether the defect contributed to Dalton’s injury. Accordingly, the court affirmed the grant of summary judgment in favor of the manufacturer.