Michael Ponterio from Lipsitz, Ponterio and Comerford LLC says they have been representing people that have been injured permanently by prescription drugs. He says they suffered blindness in some cases, paralysis, organ failure, other severe neurological impairments like a stroke and the pharmaceutical companies they have to go through rigorous testing of their drugs for safety. He says the pharmaceutical company has an obligation to report to the FDA any significant side effects from the drug. The FDA issues what they call a black box warning and Michael says they found that some of the pharmaceutical companies did not list all of the significant side effects and that’s where, in part, some of these claims have arisen.
How does that fall through the cracks? Michael Ponterio says it comes from the gathering of their statistics and they may not think that the side effect is not what they call statistically significant, but they have to balance the severity of the side effect versus what it can do to that person who takes that drug. He says it’s a balancing but once the drug is approved, and the FDA says it’s okay to market it, the pharmaceutical company has a continuing duty to test their product and if they gather data afterwards that shows a side effect that they didn’t appreciate the first time, they either have to go back to the FDA and let them know of this new side effect or they have to warn the consumers, the people who are taking that drug of this potential side effect. Michael says the duty of the pharmaceutical company is not to warn the patient who is taking the drug; under the law their duty is to warn the treating prescribing physician and the physician communicates that warning to the patient. He says unlike other product liability cases, where the duty to warn is from the manufacturer to the injured person, in pharmacy cases it is the duty to the prescribing physician to warn.
Michael says it is a little different from traditional cases and the reason is because these are complex drugs with complex warnings so it’s really two bases of litigation, before the drug is manufactured, they have to disclose all significant side effects even after the drug has been made and sold anything that comes to their attention.
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