Fourth Circuit Upholds Verdict in Transvaginal Mesh CaseJan 19, 2016
The U.S. Court of Appeals for the Fourth Circuit affirmed the first jury verdict arising from multidistrict litigation involving more than 70,000 cases against the makers of transvaginal mesh medical devices.
The jury had awarded a woman and her husband $250,000 in compensatory damages and $1,750,000 in punitive damages against device manufacturer C.R. Bard Inc., the Legal Examiner reports.
The case involves transvaginal mesh devices, used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. The devices are supposed to treat the conditions but many women have experienced serious complications that leave them in chronic pain.
The Food and Drug Administration (FDA) reports that the most common side effects associated with transvaginal mesh devices include:
- mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- pain during sexual intercourse
- organ perforation
- urinary problems
Some women have needed additional surgery to attempt to remove the mesh and repair damage to organs.
In addition to cases against C.R. Bard, women have also filed lawsuits against transvaginal mesh device makers including American Medical Systems, Boston Scientific, and Johnson & Johnson’s Ethicon division.
The Fourth Circuit’s January 14, 2016 decision is important to the women who have brought suits because the Court rejected one of C.R. Bard’s key arguments, the Legal Examiner explains. Bard said that because it had complied with the FDA’s 510(k) medical device clearance process, the transvaginal mesh device was necessarily “safe.” Bard argued that it should have been allowed to say that to the jury.
The U.S. Chamber of Commerce and other groups filed briefs in support of Bard, arguing that “evidence of § 510(k) clearance is relevant under Georgia law and easily passes muster under Federal Rule of Evidence 401, as it bears on the safety, efficacy, and reasonableness of the product’s design.” They further argued that “the District Court erred in concluding that the § 510(k) process is not concerned with the device’s safety or effectiveness.”
The Legal Examiner explains that the argument was wrong because the 510(k) process does not actually establish that a product is safe. Clearance merely establishes that the device is “substantially equivalent” to another device that has obtained clearance. The process does not evaluate a product’s safety.
The Fourth Circuit noted that “[w]hile some courts have found evidence of compliance with the 510(k) equivalence procedure admissible in product liability cases, the clear weight of persuasive and controlling authority favors a finding that the 510(k) procedure is of little or no evidentiary value.”
The FDA has proposed a reclassification of mesh devices from Class II to Class III. This would mean that mesh devices used for POP repair would no longer be able to receive clearance through the 510(k) approval process. Manufacturers would have to conduct clinical trials to prove that their transvaginal mesh devices are safe and effective.