Ethicon, Inc. and Johnson & Johnson filed a motion to exclude the general-causation testimony of Brian Raybon, M.D. in federal transvaginal mesh products liability litigation, arguing that he is not qualified under the Daubert standard.
Ethicon is a defendant in Transvaginal Mesh Litigation consolidated in MDL 2327 before Judge US District Court Judge Joseph R. Goodwin the Southern District of West Virginia. In pretrial order #235, Judge Goodwin scheduled a status conference and meetings in the MDL on September 13-14, 2016 at the Robert C. Byrd United States Courthouse.
Separately, the U.S. Attorney’s Office in Boston announced on July 22, 2016, that medical device manufacturer Acclarent Inc., has agreed to pay $18 million to resolve allegations that it caused health care providers to submit false claims to Medicare and other federal healthcare programs. Acclarent — a subsidiary of Ethicon, a Johnson & Johnson company — marketed and distributed the sinus surgery device, the Relieva Stratus, for use as a drug delivery device without U.S. Food and Drug Administration (FDA) approval of that use.
Incidentally, Dr. Rabon served as an expert witness for the defendant despite the fact that it appears he was also the implanting surgeon for some of the plaintiff cases that could be affected by his expert testimony on behalf of the defendant.
Working as an urogynecologist and pelvic floor surgeon, he implanted more than 300 of the Avaulta POP mesh kits, which are similar in design and implantation method to Gynecare’s Prolift devices. He also implanted more than 25 Prolift products, but stopped using the Prolift products in 2008 due to an unacceptably high erosion rate and personal knowledge of the fact that Gynecare did not exercise due diligence in ensuring that implanting physicians were adequately trained. In the years since, he has removed more than 75 of the Prolift products.
In his opinion, Dr. Rayborn says:
- The Prolift +M was defectively designed and its risks outweighed any benefits.
- Ethicon had at its disposal a number of safer feasible alternative designs that count have been utilized.
- Ethicon failed to adequately warn physicians and patients about known problems with the Prolift +M.
- Clinical trials demonstrated to Ethicon that functional outcomes are not superior with transvaginally placed armed mesh (TVM).
He says that he has personally observed and treated patients who have been implanted with Ethicon Prolift+M products that experienced 17 difference device-related complications.
“Based upon my education, training, experience and knowledge, and my familiarity with the literature relating to this subject, it is my professional opinion to a reasonable degree of medical certainty that the injuries and complications that I have personally observed, diagnosed, and treated relating to the Prolift+M are directly attributable to the defective design of this product as described previously. It is also my opinion that many if not all of these complications could have been prevented had Ethicon used safer feasible alternatives to the implant”s design or had completely and adequately instructed surgeons and warned surgeons and patients of significant known risks associated the implant,” he says.