Should AMS Be Granted Protection Simply for Getting Their Device Approved Through the FDA Drive-through Lane?
We now have a better idea of how one synthetic mesh medical device maker, American Medical Systems, Inc., plans to defend itself against the 318 lawsuits that have been consolidated in the Southern District of West Virginia before The Honorable Joseph R. Goodwin.
In a Position Statement, issued and filed Friday, April 6, American Medical Systems, Inc. (AMS) of Minnetonka, Minnesota admits it’s been designing and manufacturing medical devices for men and women’s pelvic health since 1972 including six synthetic meshes to treat stress urinary incontinence (SUI), and five which treat pelvic organ prolapse (POP), all of which remain on the market today.
The statement denies the injured are seeking compensation because of a defective product or a failure to warn, the basis of a product liability lawsuit.
“Rather, Plaintiffs are using the courts to second-guess FDA’s regulatory regime for clearing these treatment options in the first place, as well as to second-guess the surgeons who chose to prescribe them for a particular patient, even when those surgeons were aware of the risks.”
A quick review of the papers filed by Plaintiffs reveals those statements to be way off base. Plaintiffs are alleging that the products are defective and that AMS failed to adequately warn both doctors and consumers of the horrible complications the products can cause.
In addition, Plaintiffs are in fact, embracing the “regulatory regime” under which these defective products came to market. Most of the devices at issue in this case were simply rubber stamped by the FDA under the less rigorous, fast track 510(K) process. That being the case, AMS cannot hide behind the federal government’s skirt and claim Plaintiffs’ suits are preempted by federal law. Under the 510(K) process, a manufacturer need not prove to the FDA that a proposed new device is either safe or effective. It must simply point to a previous device that was commercially marketed and claim the new product to be substantially equivalent to that device. In regulatory lingo, the previous device is referred to as the predicate device. What most people don’t know is that the family tree of predicate devices for many pelvic mesh products includes devices that were abject failures, subjected their makers to lawsuits and were either recalled or removed from the market.
Surprising? Sure it is to most folks. A new device can obtain FDA clearance even if predicate devices in the family tree were defective and recalled!
AMS markets the following products for incontinence: SPARC, Monarc, BioArc, In-Fast, MiniArc, and MiniArc Precise. AMS markets the following monofilament polypropylene mesh to treat POP: Apogee, Perigee, Elevate, Straight-In/Y mesh.
An expert panel meeting last September agreed that POP repair mesh should be upgraded from a Class II to a Class III medical device which would no longer allow these products to be cleared through the 510(K) process. Instead, they would be forced to file detailed applications for approval including a sufficient showing of safety and efficacy. Class III mesh would have to be evaluated for safety and efficacy as a drug is evaluated. The panel did not change any regulation of the SUI repair mesh, but may reclassify a mini-sling mesh.
So far there are 318 pending lawsuits filed against AMS from federal courts in 35 states that have been consolidated before Judge Joseph R. Goodwin in the Southern District of West Virginia in Multidistrict Litigation No. 2325.