Recently, a California appellate court issued the first substantive appellate decision in a case involving transvaginal mesh. The California Court of Appeal for the Fifth District affirmed the Superior Court of Kern County’s entry of a $3.6M judgment on a jury verdict in favor of the plaintiffs.
Urogynecologic surgical mesh implants have been all over the news recently. This mesh has been used for pelvic organ prolapse (POP), which occurs when a woman has weak vaginal walls that allow adjoining organs, the uterus, the bladder, and/or the rectum, to drop into the vaginal canal. If noninvasive treatments are not effective, there are various surgical options for pelvic organ prolapse. One option is to use polypropylene mesh to support the vagina. One way to implant this mesh is through an abdominal incision. Beginning around 2003, surgeons began using kits to implant the mesh transvaginally, i.e., through the vagina.
In October 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical transvaginal mesh to treat POP. In July 2011, based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern. The FDA updated its warning to say that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. In January 2012, the FDA ordered postmarket surveillance studies by manufacturers of urogynecologic surgical mesh devices to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP.
The most interesting aspect of the California Court of Appeal’s decision for others litigating similar claims was the holding that the trial court did not err in admitting the FDA’s postsurgery regulatory actions. The appellate court reasoned that the postsurgery regulatory actions were relevant, their admission did not violate the rule excluding evidence of subsequent remedial measures, and their probative value outweighed any risk of undue prejudice. The question of relevance was particularly noteworthy.
When the Superior Court of Kern County heard the in limine motions two months before trial, it barred evidence of postsurgery regulatory actions, including the FDA’s 2008 and 2011 public health notices and 2012 letter requesting clinical trials. The appellate court supported this decision finding that, “initially, this evidence was marginally relevant at best.” The appellate court reasoned that the manufacturer’s liability for negligence or failure to warn was tied to its conduct and knowledge before the surgery.
However, the court found the manufacturer’s opening statement made the FDA’s postsurgery regulatory actions relevant. The FDA regulates transvaginal mesh as a medical device. Before placing its transvaginal mesh product on the market, the manufacturer obtained a pre-market clearance from the FDA. A pre-market clearance means the FDA has determined that the device is substantially similar to a device that is already on the market. In contrast, FDA approval means the FDA has determined that the product is safe and effective. During its opening statement, while the in limine ruling excluding the FDA regulatory actions was in place, the manufacturer explained to the jury that the manufacturer’s transvaginal mesh was cleared by the FDA and then stated:
Now, once the FDA does that and says you may sell, is that the end of it? The answer is a very definitive no. And that is that the FDA is monitoring and regulating these products throughout and they always do that. And so one of the things that is required by regulation [is] complaint handling so if anyone has a complaint or has an outcome if the company finds out it has to be reported to the FDA and there are certain rules and regulations about that, the complaints and the trending and tracking of those complaints would go to the departmental heads, the management review to keep an eye on to see is there anything out of the usual here or is this the incident rate about what we see for other product.
Subsequently, the trial court reversed its pretrial ruling and allowed the plaintiffs to present evidence of the FDA’s public health notices and 2012 letter.
The appellate court explained that the manufacturer caused the FDA’s postsurgery regulatory actions to become relevant when it intimated that the FDA had continued to monitor and regulate transvaginal mesh and had taken no action. Thus, the regulatory evidence became relevant to disabuse the jury of the notion introduced by the manufacturer that the FDA was closely monitoring transvaginal mesh kits and had found no cause for concern about their safety.
Most recently, in April 2014, the FDA issued two proposed orders for surgical mesh for transvaginal POP repair that set forth changes to address the risks associated with these devices. Once final, manufacturers will be required to provide clinical data in a premarket approval application to support the safety and effectiveness of surgical mesh for transvaginal POP.
See: Scott v. C.R. Bard, Inc., 2014 WL 6475366 (Cal.App. 5 Dist., November 19, 2014) (not designated for publication).
By Sarah Kelman, JD, and the experts and editors at Medical Law Perspectives.
For more details, see the Scalpel Weekly News, December 1, 2014.
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