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In USA Today, April 23, 2008, the editors opine on the right of citizens to sue the FDA for defective drugs, “Our view on pharmaceutical safety: If a drug has FDA‘s OK, should you be able to sue?”
USA Today acknowledges the important role of attorneys in holding drugs companies accountable but would limit the right of citizens to collect for damages unless they can demonstrate that a company deliberately deceived the FDA or knowingly failed to warn about the risks of its medicines, they shouldn’t be able to collect a dime.

USA Today does not discuss the major problem of off-label uses promoted by drug companies and the current obligation of manufacturers under current law to constantly update their disclosures as soon as evidence is available of side effects of pharmaceutical products.

Off-label use occurs when a drug approved for one application is later used by physicians for other uses. Fen-phen, the diet drug combination, is a classic example of a medicine exploited by the manufacturer for a use quite different from that approved by the FDA, in this case weight loss with resulting heart valve damage from this off-label use.

Botox is another drug for which the overwhelming majority of uses are far greater than the limited approval granted for treatment of forehead wrinkles.

Federal law mandates accurate warning labels on prescription drugs and requires pharmaceutical companies to supplement warning labels when new information is available. Current law supports the right of an injured person to sue a drug manufacturer for personal injuries caused by a manufacturer’s negligent failure to disclose adverse reports or personal injuries caused by the “off label” use of a product with serious side effects.

The devil is in the details and the legal concept is known as preemption.

Today drug companies are asking U.S. Supreme Court to hold them immune from being held liable for personal injuries on the theory that all regulation of drugs has been preempted by the FDA and that citizens are not allowed to sue manufacturers for their personal injuries.

If preemption is granted by the Supreme Court, that would leave consumers outside the law when they have suffered severe personal injuries caused by defective drugs, the failure to disclose adverse reports, drug company frauds, cover-ups and willful misconduct. In short, the drug companies would benefit financially and all the burdens of their negligence and willful misconduct would be imposed on the consumer.

USA Today suggests that drug companies should only be sued when their misconduct is willful. That position ignores a long-standing public policy that drug companies owe the public full and complete disclosure and when information is not revealed which causes injuries, lawsuits are allowed, whether by negligent failure to update disclosures or willful cover-ups of adverse reports. For all the details why that is the law today see my article: Holding Drug Manufacturers Responsible for Personal Injuries: Why Pharmaceutical Makers Are Not Immune from Liability.

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Richard Alexander