- Court – United States District Court for the Southern District of West Virginia, Charleston Division
- Jurisdiction – Federal
- Case Name – In re Ethicon Inc. Pelvic Repair Sys. Prod. Liab. Litig.
- Citation – 2016 U.S. Dist. LEXIS 117911
Ethicon, a subsidiary of Johnson & Johnson and a manufacturer of medical devices, was sued in a multidistrict product liability case concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
The plaintiffs retained Dr. Jerry Blaivas, M.D., a urologist with extensive experience treating patients with mesh sling surgery complications, to testify on various aspects of the case. Ethicon and Johnson & Johnson moved to exclude Dr. Blavais’ opinions on several different issues under Daubert.
Dr. Blaivas offered his opinion that there are safer alternatives to Ethicon’s mesh products. Ethicon argued that such an opinion was neither scientifically reliable nor relevant to the case. However, the court reserved its ruling on both grounds noting that while relevance was to be determined on a case-by-case basis, an expert’s experience – on its own or accompanied by little else – was a reliable basis for expert testimony.
Dr. Blaivas also opined regarding the safety of alternate mesh designs and offered an article he had co-authored, entitled Safety Considerations for Synthetic Sling Surgery, in defense of his opinion. Ethicon argued that Dr. Blaivas wasn’t qualified to opine on this issue. Ethicon called attention to notations made by the authors of one of the sources that Dr. Blaivas’ article cited. The authors noted that the sources concerning hernia repair mesh were insufficient to allow for “any meaningful conclusions.” Dr. Blaivas never explained how the statement of uncertainty, which contradicted the opinion of his expert testimony, had been dispelled. This portion of his testimony was therefore excluded under Daubert.
Dr. Blaivas next opined on mechanical-cut and laser-cut mesh citing internal Ethicon documents to support his opinion. The court noted that it did not have enough information to assess the reliability of this opinion, which was primarily based on his experience, and reserved its ruling. However, the court granted Ethicon’s motion to exclude Dr. Blavias’ testimony regarding mesh length, the size of the surgical trocars, the implantation technique, and that an alternative implantation approach would have been safer.
The second set of objections from Ethicon targeted Dr. Blavais’ testimony regarding 1) the adequacy of the product’s warnings and usage instructions, 2) the product’s safety, efficacy, and complication rates, and 3) general information about biomaterials, including mesh degradation, shrinkage, and other deformations. The court excluded Dr. Blavais’ opinions on all three of these topics asserting that he was not qualified to opine on product warnings or biomaterials. Furthermore, it was noted that his unreliable methodology regarding complication rates had already been excluded by the court in the past. The court also excluded his opinion after finding him unqualified to offer opinions about additional product testing Ethicon should have conducted and what such testing would have revealed about the product’s safety.
While the court denied the exclusion of his testimony that criticized the medical literature about mesh products, claiming some studies were biased, it did exclude testimony that Ethicon colluded with other manufacturers to influence reimbursement.
The motion to exclude certain general opinions of Jerry Blaivas, M.D. was granted in part, denied in part, and reserved in part.
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