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I 4 Wall St. Journal New York, NY J" 21 1993 1FDA Approval Shields Firms In Injury Suits By Eowman FrsiexrH,u. I And L ae Beamrr StofJ Reybf("t oJ TNF: W ALL STRF.F.T JOURNAL A U.S. appeals court ruled that regttia- i tory approval of some medical devices largely shields the products' makers from { lawsuits seeking damages for injuries to users. The First U.S. Circuit Court of Appeals i in Boston said approval of the devices by the Food and rug A ministration bars more aggres- sive state regttla- tion or lawsuits based on state law for claims such as negligence, breach of warranty and fraud. "This case is probably the single most important case to the medical-device industry in American history," said Peter Hutt, a Washington lawyer and fortner general counsel of the FDA. Mr. Hutt's law firm, Covington & Bttrtitta, represents the Health Industry Manufacturers Associ- at on. which filed a friend-of-the-court brief in the case. Mr. Hutt said the decision gives manufacturers "a single national control system for our most important life-saving pharmaceuhcal•type prod- ucts." Although the case specifically applies to only one device and becomes law only in the four-state region covered by the Boston court. lawyers said other courts may choose to adopt the court's reasoning in cases involving an array of products, like heart valves for example. If so, the deci- sion would sharply curtail suits by plain- tiffs who allege that devices they used were negligently designed or that the manufacturer failed to adequately warn about side-effects and other health risk.s, the lawyers said. The decision doesn't apply to drugs, which are regulated by a different set of federal laws. In the First Circuit case, the plaintiff. Jane King. sued Coliagen Corp., of Palo / Please 1Lrn to Page B7. Cblumn I FDA Approval Is a Shield From Lawsuits) GbntiRued From Page $l Alto, Calif., alleging she developed an autoimmune disease after ustngZyderm. a Collagen cosmetic device that is injected under the skin to correct wrinkles and skin deformities. In her lawsuit. Ms. King made a variety of allegations, includ- ing claims that Zydet'm, which is still on the market, was negligently designed and manufactured, that it is "unreasonably dangerous to users," and that its package wasn't adequately labeled to warn users of the device's risks. But the appeals court threw out those claims, saying they were precluded by the ~FDks initial approval of the product in -M and by the agency's "extensive regu- lation" of Zyderm. The approval process, the court said, "is designed to provide a 'reasonable assurance of . . . safety and effectiveness' for medical devices which are too dangerous or unknown to permit less regulation." Ms. King will appeal the decision to the ~ U.S. Supreme Cottrt, said Susan Allinger. an attorney in Houston who represents Ms. King. Other lower courts have precluded state-law claims against manufacturers of medicat devices. But the First Clrcuit's decision is apparently the first by a federal appeals court to specifically bar such clairns against the group of medical de- vices that the FDA classifies as requlriag greater scrutiny to ensure safe use. Ia addition to Zyderm, other examples of thh type of device include heart valves and len,s, implants for cataract treatments. In recent years, the FDA's approval process has been criticized as tax, partictr latiy following allegations that the agency didn't sufficiently scrutinize several com- panies' breast-implant products. Now some legal specialists worry that, by pro- tecting manufacturers frota liability, the First Circuit decision may mate the conr patties less vigilant about tnaking sure their devices are safe. Lawyers said it is unclear whether breast implants would fall under the scope of the decision because they were put on the ntarket before the regulatory law for medical devices took effect. The implants have since beetl placed under the same classification of devices such as Zyderm. "It's frightening to think that tomorrow if you were hurt by a medical device. you can't do anything about it because 12 or 15 years ago the FDA looked at it and said it's fine," Ms. Allinger said. In a concurring opinion, one of the three judges who heard the appeal wrote that in establishing the FDA approval process. Congress intended to encourage development of medical devices and to permit them to be marketed without delay. "Perfection is impossible." the judge wrote, "and a few individuals may be denied full protection at the cost of benefit- ing the rest." Lawyers said the case's broad scope leaves open only a narrow window for suits against manufacturers of such devices, possibly allowing claims that involve cer tain types of fraud or violations of express warranties. Ms. Aliinger, however, said she believes the case rules out claims that the manufacturer fraudulently withheld information from the FDA. Federal law i prevents plainttffs from suing the FDA itself. JaneKtnq vs. Cbilagen Lbrp., Fl"rst C'.S CYrctut Court of APpeats, No. 9f•tt78! I