North Carolina seems to be on its way to approving a bill that would immunize manufacturers of drugs in most cases if the drugs were approved by the FDA

Pharmalot is reporting that North Carolina lawmakers have passed a bill that would protect drugmakers from liability in lawsuits in most cases if the drug has been approved by the FDA. The only other state that has a similar law is Michigan.  Go here for the full story.

As originally presented, the bill only allowed possible liability if the plaintiff proved the FDA approval had been obtained by fraud or bribery.  However, to respond to criticism, the approved bill also recognizes the possibility of liability if the plaintiff proves that the drug is unsafe or ineffective. 

This seems to leave the state of the law in the same place it was before, since it seems to recognize a cause of action for damages caused by a defective product.  Yet, there is a "catch" and it is that the new law changes the burden of proof.  In order to recover, the plaintiff now has to prove his or her case by "clear and convincing" evidence.

In other words, given that the defense of preemption already exists, the bill is a roundabout way to simply change the burden of proof in product liability cases against drug manufacturers for injuries caused by drugs previously approved by the FDA.  I would not have a problem with this if we could trust the FDA as a capable overseer of product safety but the reality is that it has proven to be quite the opposite. 

Given this reality, it makes more sense to me to allow state law to operate as a compliment to federal regulation in an attempt to promote consumer safety.  What the bill does, unfortunately, is eliminate - or at least weaken - the possible safety net for consumers.  And that, I think, is not good public policy.

You can read the bill here and the amendment here.