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From Products Liability Law Daily, July 18, 2013

Failure to provide expert medical testimony to establish causation prevents birth control patch claims from proceeding to jury

By Susan Lasser, J.D.

A patient’s evidence in support of her products liability claims against the manufacturer of a birth control patch failed to create a genuine issue of material fact as to whether the patch caused her injuries (Vargas v. Ortho-McNeil Pharmaceutical, Inc., July 17, 2013, Katz, D.).

Background. The patient, Natalie Vargas, proceeding pro se, alleged that she developed ovarian cysts, a benign ovarian tumor, and ovarian torsion as a result of her use of an ORTHA EVRA® birth control patch. Following her going to the emergency room complaining of acute abdominal pain and nausea, doctors performed exploratory surgery, determined that she had ovarian cysts and ovarian torsion, and removed the cysts, her ovary, and part of the fallopian tube. One of the cysts removed was a rare, but benign, tumor called a Struma Ovarii.

In March 2006, the Judicial Panel on Multidistrict Litigation centralized all civil litigation relating to the patch in the Northern District of Ohio, noting the following common allegations: i) the Ortho Evra contraceptive patch was defectively designed, and ii) plaintiffs received inadequate warnings regarding Ortho Evra’s side effects and safety profile. All actions sought damages for personal injury and/or economic damages on behalf of users of the patch, asserting various state law claims, including negligence, products liability, breach of warranties, and negligent and/or fraudulent misrepresentation regarding the risks of using Ortho Evra.

Vargas filed her complaint on August 23, 2007, in a New York trial court. The case subsequently was removed to a federal district court in New York and then was transferred to the current court as part of the Ortho Evra contraceptive patch multidistrict litigation (MDL). The court indicated that it has given Vargas, as a pro se litigant, “much latitude and time to comply” with the court’s orders. The court also indicated that pro se complaints are held to “less stringent standards than formal pleadings drafted by lawyers,” but that such litigants must still comply with relevant rules of procedural and substantive law, and should not expect special treatment.

Causation and the requirement of expert medical testimony. Although expert testimony is not always required when determining causation in products liability cases, the court, citing precedent, stated that when the central issue in a products liability case is a medical question, expert testimony is required to establish causation. In the current case, the injuries alleged were complex medical issues and were not within the common knowledge of jurors. An ordinary juror was not likely to know whether ovarian cysts, ovarian torsion, and Struma Ovarii were commonly caused by use of the Ortha Evra birth control patch, according to the court. The court even questioned the likelihood that an ordinary juror would have any knowledge of the patient’s medical conditions, let alone familiarity with their causes. The court concluded that the determination of causation in the case required the testimony of medical experts, and the patient had repeatedly failed to provide such testimony.

The patient cited a number of cases supportive of the assertion that expert medical testimony was not necessary. The court, however, found them distinguishable because most were workers’ compensation cases or they involved products liability cases in which admissible evidence of causation was presented. The court observed that the facts in the current litigation were not as straightforward as the cases cited by the patient. Also, facts in two of the cases cited by the patient (one involving the Ortha Evra patch) presented evidence of scientific studies or a physician’s affidavit to establish causation. In the current case, instead of providing expert medical testimony, Vargas submitted multiple articles from a variety of websites regarding the possible side effects associated with the use of the Ortha Evra patch, including those from attorney websites. The court maintained, however, that because her case involved complex medical issues that were beyond the knowledge of the average juror, it was necessary for the patient to produce admissible evidence in the form of expert testimony or a report to show causation. Therefore, the court held that because Vargas failed to meet the threshold requirement of providing sufficient admissible evidence that her injuries were caused by the use of the patch, she did not present a genuine issue of material fact for submission to a jury. As a result, the court granted judgment as a matter of law to the manufacturer.

The case number is 1:08 oe 40113.

Attorneys: Natalie T. Vargas, Pro Se. Julie A. Callsen (Tucker Ellis LLP) and Patrick Gallagher Broderick (Dechert LLP) for Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Companies: Ortho-McNeil Pharmaceutical, Inc. and Janssen Pharmaceuticals, Inc.

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