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Jay Trucks and Associates Legal Blog
Saturday, January 10, 2009
Drug Lawsuits Protect Public
I was surprised by a Jan. 29 opinion piece by Sally Pipes proposing federal preemption of state laws protecting citizens from negligent pharmaceutical companies ("Don't let trial lawyers overdose on drug suits"). Pipes' proposal gives irresponsible companies a competitive edge over responsible companies at the expense of patient safety.
Federal preemption, as Pipes explains, would leave patients without the protection of state laws when FDA regulations are followed. The FDA has an imperfect record on ensuring consumer safety, and the tort system protects consumers when the FDA errs. Vioxx, which caused approximately 100,000 heart attacks, followed FDA regulations. The manufacturer voluntarily withdrew the drug for fear of increased legal liability. Under Pipes' proposal, the manufacturer would have no financial incentive to withdraw unsafe drugs. More people would have died. Those who had heart attacks would have no recourse.
Cut medical costs, but not by compromising safety. Pharmaceutical companies are in the best position to decrease their liability by promptly removing unsafe drugs from the market, ensuring that marketing claims are factual and taking greater measures to ensure product safety. FDA regulations are meant to increase drug safety by ensuring minimum safety standards. To treat them as unquestionably sufficient in all cases would, perversely, decrease drug safety.
Written by: Daniel Bahls
Ann Arbor
Federal preemption, as Pipes explains, would leave patients without the protection of state laws when FDA regulations are followed. The FDA has an imperfect record on ensuring consumer safety, and the tort system protects consumers when the FDA errs. Vioxx, which caused approximately 100,000 heart attacks, followed FDA regulations. The manufacturer voluntarily withdrew the drug for fear of increased legal liability. Under Pipes' proposal, the manufacturer would have no financial incentive to withdraw unsafe drugs. More people would have died. Those who had heart attacks would have no recourse.
Cut medical costs, but not by compromising safety. Pharmaceutical companies are in the best position to decrease their liability by promptly removing unsafe drugs from the market, ensuring that marketing claims are factual and taking greater measures to ensure product safety. FDA regulations are meant to increase drug safety by ensuring minimum safety standards. To treat them as unquestionably sufficient in all cases would, perversely, decrease drug safety.
Written by: Daniel Bahls
Ann Arbor
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