The widely talked about medical malpractice bill thought to be introduced into Congress during President Bush’s second term has many media outlets buzzing about a possible cap for pharmaceutical companies liability due to negative side effects of their drugs. The speculation is that drug companies would be safe from punitive damage lawsuits for drugs that have been approved for sale by the FDA.

Some of loudest opponents to this possible bill are of course the Association of Trial Lawyers of America. The lawyers’ group claims that by taking away the ability to sue pharmaceutical companies for large punitive damages, it would take away the companies incentive to ensure the drugs are safe. The purpose the FDA was formed in the first place was to ensure that the drugs being produced and sold to Americans were safe and effective. Why is the government shielded from any sort of litigation or fault if it approves for sale a new drug, which later turns out to have some negative side effects? Even the largest scale clinical trials involve a few thousand people at most, these trials are definitely not representative of the entire population. Every person’s body reacts differently to medications, so how can companies truly show that no one will have negative side effects without performing clinical trials that include millions of people for a more accurate cross section of America. If that is the case, imagine the costs of such trials and what it would do to the cost of developing new drugs. If the general public believes medications are expensive now, wait to see those costs passed on to the consumer.

Now, this is not to say pharmaceutical companies should not be held accountable for their products. There is no other industry in America that is as tightly regulated as the pharmaceutical industry and the companies are constantly in contact with the FDA to ensure their products and processes are in compliance with what the government agency wants and expects of them. Capping the damages that companies are made to pay out in cases where negative side effects are experienced would go a long way to lowering the costs of new drugs. Many times the direct link to the drug is often not straight forward, for example, can someone whose family has a history of heart disease truly prove the reason he or she suffered a heart attack was because they were taking Vioxx. There is a chance that he or she would have suffered a heart attack regardless whether or not they were taking Vioxx, could it have been their poor diet and lack of exercise that contributed to the problem? There should of course be exceptions to the bill when companies purposely withhold negative results of clinical trials in order to get their drug approved by the FDA, or when companies are criminally negligent, an example of which would be when a company continues to manufacture a drug after being audited by the FDA and there processes found to be detrimental to the safety of the drugs. In those cases, companies should be fully liable for any and all punitive damages brought against them.