On May 1, 2014, the U.S. Food and Drug Administration (FDA) published two proposed administrative orders which seek to reclassify and heighten the approval standard for transvaginal mesh (TVM) products.
The first proposed administrative order seeks to reclassify TVM from a class II (“moderate-risk”) to a class III (“high-risk”) device, over concerns that current precautions in place are not sufficient to guarantee these products’ safety and effectiveness.
The second proposed order, built upon the first, would require a TVM manufacturer to file a premarket approval application (“PMA”) before its product could be placed on the market.
The PMA process requires the manufacturer to provide the FDA with “reasonable assurance” that the device is safe and effective, which usually entails the conducting of clinical safety trials and testing. Currently, surgical mesh manufacturers are only required to file a 510(k) substantial equivalence application, which – when approved – allows them to bypass clinical safety trials altogether.
IMPACT ON FUTURE TVM PATIENTS
The potential enactment of these proposed FDA orders would be significant to future patients who might be implanted with TVM products.
If the proposed orders are finalized, any new TVM used in surgery for feminine stress urinary incontinence (SUI) or pelvic organ prolapse (POP) repair will have undergone additional testing and scrutiny before reaching the marketplace. This testing, in theory, should mean that the products will be safer, more effective, and have better warnings than the current TVMs that are the subject of multiple litigations and over 60,000 lawsuits. The PMA process is not, however, entirely good news for the thousands of patients who might use these new TVMs in the future.
MEDICAL DEVICE RECALLS
The unfortunate reality is that there are still numerous recalls of PMA medical devices every year, and the men and women who are injured by those products end up having almost no recourse against the sometimes grossly negligent manufactures.
Under the Federal Food, Drug, and Cosmetics Act (FDCA), which governs all medical devices sold in the United States, any potential plaintiffs are “preempted” from bringing claims for defective devices approved through the PMA process. Specifically, if a device has been subjected to the PMA process, the U.S. Supreme Court has ruled any claims that the device is defective are preempted under the Medical Device Amendments to the FDCA at 21 U.S.C. § 360(k). This issue came to a head with the Supreme Court’s 2008 ruling in Riegel v. Medtronic, 552 U.S. 312, 128 S. Ct. 999 (2008).
In Riegel, the Supreme Court found that plaintiffs’ state-law claims for strict products liability, breach of implied warranty, and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of a medical device which had been approved through the FDA’s PMA process were not allowed to go forward under the FDCA (See Riegel, 128 S. Ct. at 1007-10).
EFFECTS OF THE RIEGEL RULING
The tragic cooling effects of the Riegel ruling were made clear through the words of Hon. Richard Kyle of the U.S. District Court in the District of Minnesota. In a January 5, 2009 order, Judge Kyle dismissed with prejudice the personal injury cases of approximately 15,000 claimants who had brought claims (including claims for wrongful death, unnecessary replacement surgeries, and for instances of being needlessly shocked up to 100 times) against Medtronic for its Sprint Fidelis lead wire products. In his Order, Judge Kyle stated:
“[T]he Court recognizes that at least some Plaintiffs have suffered injuries from using Sprint Fidelis leads, and the Court is not unsympathetic to their plight. But Plaintiffs assert claims for which the Court simply cannot provide a remedy. Congress has decided to limit medical-device manufacturers’ liability in order to spur innovation, even though individuals are sometimes injured when using medical devices. Plaintiffs’ remedy, therefore, lies with Congress, and not with this Court (or any other court).”
In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 0:08-md-01905-RHK-JSM (Document 233) at 36 (emphasis added).
WHAT THIS MEANS FOR YOU
Ultimately, while the FDA’s proposed orders could provide potential additional safeguards against putting defective TVMs on the market, it appears upon deeper examination that these proposals might actually create more harm than good.
Until Congress corrects and amends the current statutory language so that victims’ rights to a trial are not stolen from them, the FDA proposed changes will inadvertently serve to shield future TVM manufacturers of almost all consequences when one of them negligently designs and pushes through the FDA another product that injures thousands of women.