This article is reprinted from "The Gray Sheet" – March 17, 2008
Plaintiffs lawyers are trying to leverage the ambiguous status of combination products as an exception to a Feb. 20 U.S. Supreme Court decision that affirms significant protections for the device industry from personal injury lawsuits.
Steven Angstreich, a trial lawyer with Levy, Angstreich, Finney, Baldante, Rubenstein & Coren in Philadelphia, argues that drug-device products should not be entitled to federal pre-emption under the Food Drug and Cosmetic Act (FDCA).
Stuart Gerson, an attorney with Epstein, Becker & Green who represents pharmaceutical and device companies, agrees that combination products are not a settled matter when it comes to liability protections. "There is plenty of room yet to wiggle and combination products provide that wiggle room," he said.
Angstreich is a lead plaintiffs' counsel in ongoing multidistrict litigation against St. Jude Medical arising from a 2000 recall of the company's Silzone-coated mechanical heart valves. He also represents plaintiffs suing Medtronic following the October 2007 recall of its Sprint Fidelis ICD leads.
St. Jude's coated valve was approved in 1998 as a PMA supplement to St. Jude's conventional uncoated valve. The coated version was pulled off the market in 2000 after an independent clinical trial identified a small increase in paravalvular leaks. St. Jude would not comment on the case or the product.
In the Riegel v. Medtronic decision, the Supreme Court ruled that patient lawsuits cannot go forward against devices approved via a PMA as long as the product is marketed within FDA rules and in a form that was, in fact, approved. The justices cited the express federal pre-emption provision in the Medical Device Amendments of FDCA precluding states from establishing a requirement "which is different, or in addition to" an FDA requirement (1"The Gray Sheet" Feb. 25, 2008, p. 3).
The St. Jude valve, no longer on the market, employed a silver-based coating designed to reduce incidence of an infection that can result from heart valve replacement. Angstreich claims the silver acted as a drug.
There is no analogous FDCA provision relating to pharmaceuticals, so Angstreich's legal team will try to make the case that a PMA product containing what they claim is a drug is not necessarily protected by Riegel.
Riegel only applies to devices approved via PMA, so plaintiffs may be able to show that some product elements were not approved via the PMA statute, Gerson said. "It leaves open a whole bunch of factual questions that could be argued and will be."
Issues relating to combination products may be clarified by two ongoing cases - Warner-Lambert v. Kent, argued before the Supreme Court Feb. 25, and Wyeth v. Levine, which will go before the court next term. Both cases deal with the question of whether federal pre-emption can be applied to drugs.
These cases will not settle all matters, however, Gerson said. Lawyers in Angstreich's position "should be worried" after the Riegel decision, but they are "far from out of the game," he noted.
If St. Jude raises the Riegel decision to drop the case, Angstreich will also argue that the coated valves are not pre-empted because they were approved under a PMA supplement, as opposed to a more demanding original PMA.
Industry lawyers, however, argue that courts should treat a PMA supplement as a PMA for the purposes of pre-emption. They point out that the Evergreen balloon catheter involved in the 1996 adverse event to Charles Riegel (who went on to sue Medtronic) was approved via a 2PMA supplement as well.
A Minnesota federal court judge already ruled in 2004 not to drop the St. Jude case on pre-emption grounds because the plaintiffs assert that the firm violated FDA rules by concealing device problems from the agency (3"The Gray Sheet" Jan. 12, 2004, p. 6).
The Supreme Court's majority opinion in Riegel explicitly supports this reasoning, noting that the Medical Device Amendments do not "prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations."
- Ingrid Mezo
