Federal Pre-emption of States’ Rights and State Law Presents Dangers

Greg Webb

Attorney
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The Bush administration, along with the pharmaceutical industry, is attempting to prevent consumers from being able to file damage suits for injuries caused by federally approved drugs. The Supreme Court has already barred lawsuits from being made against federally approved medical devices, even if the device injured a patient. This legal doctrine, known as federal pre-emption, will cause the American public to lose a vital tool for regulating the products of companies, which could potentially be very harmful to consumers.

Johnson & Johnson, for example, failed to tell American consumers its Ortho Evra patch was releasing too much estrogen and could potentially cause blood clots and strokes. More than three thousand women have sued the company. The company, however, is arguing the women cannot sue since the patch and its labeling were approved by the FDA. It seems Johnson & Johnson even misled the FDA about the patch, as shown in company documents made public due to the lawsuits. Since the lawsuits, the FDA has made Johnson & Johnson change the label on the patch, citing there is more of a chance a woman will develop blood clots while on the patch, as opposed to using birth control pills. Even so, the FDA stands by its claim that the patch is a safe and effective method of contraception. Without the public being able to sue, many drug manufacturers’ errors will go unnoticed. Since the Food and Drug Administration (FDA) is so severely understaffed, many companies’ errors will go undetected leading many more consumers to face harm, while leaving drug companies unaccountable.  http://www.nytimes.com/2008/04/14/opinion/14mon2.html?_r=2&oref=slogin&oref=slogin