Our Out-Of-Control Healthcare Litigation System Is A Threat To Innovation And Jeopardizes Patient Health
While the tort system's ability to fairly and equitably determine those harmed by prescription drugs and compensate them appropriately is questionable at best, it exacts a significant price on public health. One price we pay is the loss of valuable therapeutic options.
Each year over 7.5 million lives in America are either saved by or improved through implantable medical devices or products like pacemakers and stents. The fear of frivolous litigation and outrageous jury verdicts causes manufacturers to limit distribution or stop production altogether. 75% of suppliers of biomaterials used to make medical implants banned sales to U.S. manufacturers as a result of these fears. Although the Biomaterials Assurance Assistance Act of 2000 aimed to remedy this by providing important legal protections to suppliers in liability lawsuits, numerous medical device producers choose to remain overseas. (Study by New York-based Aronoff Associates for HIMA entitled "Biomaterials Availability: a Vital Health Care Industry Hangs in the Balance ; "How FDA Regulation and Injury Litigation Cripple the Medical Device Industry" Policy Analysis 412, August 28, 2001)
Products to enhance women's reproductive health have been particularly targeted.
Silicone breast implants were the subject of lurid media stories and massive litigation in the early 1990's. Yet, the lawyer-manufactured "science" underlying the vague claims of autoimmune disease stemming from the implants was never proven. In 1995, the doctor who chaired the FDA's advisory panel that implemented the moratorium testified before Congress that there was a medical consensus that no scientific evidence linked silicon implants to such maladies. This was further supported by a study conducted by the Institute of Medicine in 2000. Nevertheless, no manufacturer has yet been able to bring a silicone implant back to the U.S. market. ("House Committee on Government Reform and Oversight," Federal News Service, Aug 1, 1995; Institute of Medicine, Information for Women About the Safety of Silicone Breast Implants, 2000)
Introduced in 1990, Norplant, implanted just below the skin of the patient's arm, provided long-term, mistake-proof, reversible contraception for women. It became a liability target in 1994. Norplant's implanted capsules were made from silastic, a hardened silicone elastomer, leading tort lawyers to target the product as causing the same alleged "autoimmune" disorders that formed the basis for the silicone breast implant litigation. When the FDA reiterated its view that the product was safe and effective, plaintiffs' lawyers shifted their strategy to an attack on the product's routine side effects. As a result, the manufacturer voluntarily removed the product from the market in 2002. ("Will the Lawyers Kill Off Norplant?" New York Times, May 28, 1995; Leslie Lawrence, "Your Perfect Birth Control… Blocked?" Glamour, September, 1999)
Copper-7 and other IUD's largely left the marketplace due to litigation involving the Dalkon Shield, an IUD that never went through the FDA's approval process. The FDA-approved Copper-7 still found itself named in over 2,000 lawsuits, which forced its manufacturers, as well as other IUD manufacturers, to withdraw from the market. Clinicians wary of malpractice claims stopped recommending the one IUD that remained on the market, and medical schools have stopped training students in their proper use. ("Senate Committee on the Judiciary" Federal News Service July 26, 1995)
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