April 9, 2012 ~ On Friday, April 6, American Medical Systems Inc. (AMS) of Minnetonka, Minnesota filed its Position Statement with federal court in the Southern District of West Virginia laying out its strategy in its defense of its synthetic surgical mesh used to treat female conditions of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
There have been 318 lawsuits filed against AMS which makes six synthetic meshes to treat SUI and five which treat POP, all of which remain on the market today.
AMS admits it’s been designing and manufacturing medical devices for men and women’s pelvic health since 1972 but denies the injured are seeking compensation because of a defective product or a failure to warn, the basis of a product liability lawsuit.
It says: “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.”
However, the Plaintiffs are alleging the mesh was defective and that AMS failed to adequately warn both doctors and consumers of the horrible complications the products can cause.
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.
It's interesting that the strategy by the Philadelphia law firm Reed Smith LLP is to hide behind the shield of the U.S. Food and Drug Administration (FDA). 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. Under the 510(K) process, a manufacturer need not prove to the FDA that a proposed new device is either safe or effective. Because there was no FDA approval, which like drugs, requires clinical trials for safety and efficacy, AMS cannot shield itself from liability claiming the Plaintiffs’ suits are preempted by federal law.
Failure to Warn
AMS claims it is not liable for a Failure to Warn – one of the claims of a product liability case, because AMS said it did warn the surgeons in the product inserts. AMS claims its end user is the doctor and not the patient, therefore it did all it is required to do.
“Further, the learned intermediary doctrine (which will apply in almost all of these cases) precludes liability for failure to warn where, as here, the manufacturer warned the plaintiffs’ physicians about the risk of the harm alleged. Under the learned intermediary doctrine, the manufacturer’s duty to warn runs only to the physician prescribing the product at issue, and not directly to the end-user of its product, i.e., the patient. The learned intermediary doctrine recognizes that medical devices, such as the AMS products at issue, require a prescription from a medical professional and thus cannot be obtained without the independent judgment and decision-making of the patient’s treating physician, a “learned intermediary,” who then decides whether to prescribe the product based on his medical knowledge of the treatment options and the individual patient. The learned intermediary doctrine recognizes that physicians will exercise their own medical judgment and will appropriately discuss the risks and benefits of the surgical procedure with their patients. Accordingly, the manufacturer’s duty to warn is satisfied by providing reasonable warnings to the physician and not the patient.”
AMS claims that the Plaintiffs’ negligence claims will fail because there is no evidence that AMS negligently designed or manufactured any of these products.
“Rather, AMS lawfully marketed its pelvic mesh products in accordance with the applicable FDA regulations for Class II medical devices and at all times acted consistently with, or exceeded, industry customs and practices with regard to the safety of its products.”
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. #
MDL Transfer Order Feb 7, 2012
MDL No. 2325 Calendar of Events