Products Liability Law Daily Vaginal mesh design defect issue to go jury in case against Boston Scientific
Friday, May 29, 2020

Vaginal mesh design defect issue to go jury in case against Boston Scientific

By Leah S. Poniatowski, J.D.

Patient’s failure-to-warn claim rejected on practitioner’s lack of recollection of reading warning despite raising fact issue with respect to the warning.

A multi-count products liability lawsuit against Boston Scientific survived in part as the patient who developed numerous physical ailments after having a vaginal mesh device implanted sufficiently demonstrated that there was a safe feasible alternative design, a federal district court in Texas ruled. However, the patient’s failure to warn claims failed to survive the manufacturer’s summary judgment motion due to the practitioner’s inability to recall reading the directions for use. The court also upheld excluding Boston’s expert’s testimony as to general causation, but allowed the testimony on specific causation (Castillo v. Boston Scientific Corp., May 28, 2020, Pitman, R.).

A Texas resident with gynecological issues had the "Advantage Fit System" medical device manufactured by Boston Scientific Corporation implanted in 2011. A resident of the referring gynecologist managed the pre-operative meetings with the patient to discuss the procedures risks and benefits in order to establish informed consent. Unfortunately, after having the device implanted, the patient experienced numerous physical problems, including chronic pelvic pain and urinary dysfunction. The directions for use provided with the device listed several potential risks and complications, although the resident did not recall reading the directions prior to the consultation with the patient in the present case. The patient filed a multi-count products liability lawsuit against Boston, which became part of a multi-district litigation situated in the federal district court for the Southern District of West Virginia. The patient’s short form complaint complemented the MDL’s master long form complaint and was filed in 2015. The present case was transferred to the Western District of Texas in mid-May 2020, prompting Boston and the patient to file the motions at bar.

Design defect. Boston challenged the patient’s strict liability and negligent design defect claim, asserting that the patient’s expert’s testimony as to the existence of a safer, feasible alternative design was insufficient. The patient’s expert proffered four alternatives to the device, including a different surgical procedure, a fascia sling, an allograft sling, and a sling with less polypropylene than the Boston device. The court agreed that first three alternatives did not meet the "substantially different product" rule because they are not proposed modifications or improvement of the device at issue.

However, the fourth device identified by the expert raised genuine fact issues as to whether it was a safer and functional alternative to the one implanted. The court observed that the patient did not provide extensive evidence as to the details of the alternative device, but case law held that proposed alternatives need only be capable of being developed. Because the matter was one for the jury, Boston’s motion for summary judgment on the design defect issues was not granted.

Failure to warn. Although the patient presented sufficient evidence to raise fact questions as to how adequate the directions for use were, she ultimately failed to clear the causation bar on her failure-to-warn claim. Under Texas law, if a product’s warnings specifically mention the circumstances that an injured party has suffered, the warning is deemed adequate as a matter of law unless the warning was misleading with respect to the risk level associated with the condition occurring. The court provided a chart comparing the language of the warning against the physical ailments the patient experienced, showing the similarities between them, but the warning stated only that these conditions "may occur." The patient also experienced other adverse effects not included in the warning, and noted that Boston admitted that "occurrence rates for adverse events were not disclosed in their brochures or [directions for use]." Thus, the patient raised questions of fact for a jury.

However, the court explained that in the learned intermediary context, causation is determined by a two-part test. The first part requires that the practitioner read or encounter an adequate warning and, second, the adequate warning would have influenced the physician’s decision to treat or disclose risks to the patient. In the present case, the patient could not establish that the resident had read the directions for use. Therefore, Boston was granted summary judgment on the failure-to-warn claims.

Expert testimony. Similarly, the patient’s motion to exclude testimony of Boston’s expert was granted and denied in part. The patient challenged the expert’s general causation opinions, asserting that they were outside the expert’s discovery designation as a case specific expert. The testimony had been prohibited in a prior ruling, prompting the present court to uphold the exclusion on the basis of the law of the case doctrine.

However, the court disagreed with the patient that the specific causation opinion had been insufficiently detailed. The court observed that the expert’s report contained a complete statement of all opinions and the reasons for them, in addition to the facts and data the expert considering when forming her opinion.

The case is No. 1:20-CV-513-RP.

Attorneys: Amy Eskin (Levin Simes Abrams LLP) for Mary Castillo. Alan Ray Vickery (Faegre, Drinker, Biddle & Reath LLP) for Boston Scientific Corp.

Companies: Boston Scientific Corp.

MainStory: TopStory DesignManufacturingNews WarningsNews CausationNews ExpertEvidenceNews MedicalDevicesNews TexasNews

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