In a ruling on January 14, 2016, the U.S. Court of Appeals for the Fourth Circuit affirmed the first jury verdict in multidistrict litigation involving more than 70,000 cases against the makers of transvaginal mesh medical devices.
The court upheld the jury award of $250,000 in compensatory damages and $1,750,000 in punitive damages to a woman and her husband in a case against device manufacturer C.R. Bard Inc., the Legal Examiner reports.
The case involved a transvaginal mesh device, used to treat pelvic organ prolapse (POP) in women. Such devices are designed to be implanted to treat POP and stress urinary incontinence (SUI), but many women experience serious complications and are left in chronic pain, facing worse problems than those the surgery was intended to remedy.
The Food and Drug Administration (FDA) says 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 remove the mesh and repair organ damage. These surgeries are not always successful.
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 submitted the device under 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. They argued 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 appeals court rejected these arguments.
The Legal Examiner explains that the argument was wrong because the 510(k) process does not actually establish that a product is safe or effective. Clearance merely establishes that the device is “substantially equivalent” to another device on the market. 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 transvaginal mesh devices from Class II to Class III. This would mean that pelvic mesh devices used for POP repair would no longer be able to receive clearance through the 510(k) approval process. Manufacturers would be required to conduct clinical trials to prove that the devices are safe and effective.