Nauseating Cases of Product Liability

Nauseating Cases of Product Liability

Miller Op-ed in The Washington Times
September 06, 2004

Morning sickness –the nausea and vomiting that afflict more than half of pregnant women –can be debilitating.  There once was an excellent prescription medication for it, but the manufacturer stopped selling it in the <?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" />United States. Safety problems?  Unprofitability? Not at all.  Frivolous, debilitating lawsuits killed this drug and left American women to munching crackers, or to quackery like herbal remedies or bracelets that supposedly compress acupuncture points. During the 1970s and 1980s, almost 2,000 lawsuits were filed against Merrell Dow Pharmaceuticals, alleging the company's drug Bendectin had caused birth defects when women took the drug to prevent morning sickness.  Not a single judgment against the company was ever upheld.  But ultimately Merrell Dow discontinued manufacturing the extraordinarily useful drug because of fears an unreasonable and hostile jury might some day award huge damages. Despite a generally high level of rigor and quality control in the pharmaceutical industry and intense regulatory scrutiny by the Food and Drug Administration, drug and medical device companies are tempting targets for product-liability litigation.  Even if no causal relationship between the product and injury or illness in patients can be demonstrated, or if the alleged injury is only a trivial side- effect listed on the product's label, companies are at risk. The most egregious example of damage wrongfully inflicted on a product manufacturer is surely silicone breast implants.  Since the first silicone breast implant case went to trial in the 1980s, hundreds of thousands of women have filed claims in state courts or through a federal class action settlement.  The vast majority of the verdicts have been decided in favor of the defendants, based primarily on medical evidence silicone breast implants are not dangerous. What has befallen Dow Corning and other manufacturers of breast implants is corporate America's worst nightmare: the virtual annihilation of a successful company through civil lawsuits without evidence of either wrongdoing or product defects, or even any association between the product and severe illness.  After more than 20,000 breast implant-related lawsuits, Dow Corning had to file for bankruptcy protection. Experts estimate our tort system costs Americans $180 billion annually in higher costs for everything from Little League baseball bats and football helmets to automobiles.  As much as 20 percent of the price of a stepladder, for example, represents the costs of protection against product liability.  That translates to more than $1,500 per household annually in increased product costs. This is not an efficient societal strategy to prevent sale of dangerous products. The threat of liability suits surely makes businesses wary, but it shifts their primary concern from whether the product actually is safe to how vulnerable the product is to damage claims. Thus, the prospect of baseless litigation is a major disincentive for any company to work on new medical technologies. A corollary is that the lower the profit-margin on a product, the likelier it is to be neglected or abandoned by prospective manufacturers, no matter how useful or badly needed it is. Protecting consumers from shoddy products is important, but for pharmaceuticals (and similar products, such as pesticides), most product liability suits are redundant: (overly) rigorous pre-marketing evaluation and post-marketing surveillance by federal regulators already protect the public from unsafe products. This redundancy argues for introducing a "regulatory compliance defense" against allegations of product liability. In other words, a manufacturer's liability would be mitigated by regulators' extensive control over every phase of pharmaceutical development, including clinical research, marketing approval, post-market surveillance and preparation of labeling and advertising materials. If a pharmaceutical manufacturer meets the stringent and comprehensive regulatory requirements for product approval, and makes the product in the prescribed way, any mishap from would be considered to be nonculpable. Such a defense would apply to damages caused by unforeseen circumstances, but it would not extend to fraud or negligence. The existing system for attributing product liability is a drag on national competitiveness and innovation, a threat to public health, and an unfair (and largely invisible) tax on pharmaceutical products.  This state of affairs is nauseating.  If only I had some Bendectin. <?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />