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Drug Safety: Who Decides?
What do subprime mortgages, credit default swaps and drug safety lawsuits have in common? All three are speculative investments that offer a handful of insiders the chance for riches while passing the social and economic costs off to the public.

The FDA is responsible for ensuring the safety of pharmaceuticals and for determining what, if any, product warnings should be provided to medical professionals. The agency has extensive, detailed public processes for reaching science-based decisions on potential drug therapies and any associated warning labels.

While the agency is not always right, they have processes for correcting mistakes and to account for new information. If the agency’s science-based decision processes are inadequate, then the solution is to improve them, not for vested interests to seek "relief" through the non-scientific, non-objective and closed process of civil litigation.

The Supreme Court will hear a case involving an FDA regulation "that effectively limits when people can sue in state court over injury claims involving medications." Although there were differences of opinion within the agency, they decided "that state suits could encourage drug makers to propose unnecessary labeling" which "could result in scientifically unsubstantiated warnings...." The FDA also noted that they are "uniquely qualified to make such important and complex judgments."

Public Citizen disagrees. They prefer that jurors with no scientific training make case-specific retrospective safety judgements. As a PC official explained, "This effort to prevent injured citizens from using the courts and holding negligent companies' accountable must be stopped."

Every pharmaceutical product carries the risk of adverse side effects. Which means that every product is potentially subject to litigation. When trial lawyers file enough suits, they are sure to hit at least some big payoffs. Unfortunately, the costs of those lawsuits are passed along to the public through higher insurance premiums, increased drug prices and reduced innovation. Senior officers of Fannie Mae, Freddie Mac and other organizations were able to enjoy significant private gains from their actions while the associated risks and losses were socialized. So far, litigators are allowed a similar personally beneficial and publicly harmful same set-up.

What’s the real difference between subprime mortgage brokers and trial lawyers? The trial lawyers haven’t yet been stopped.

See AP news story

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