FYI and ACTION
The US Supreme Court is asked to rule on whether drug manufacturers–who are in possession of the most comprehensive data about their products’ safety–can be held liable if the company fails to disclose a drug’s hazardous effects–whether or not the FDA, with its limited access to safety information–required the company to issue such warnings.
The issue before the court is whether FDA’s approval of a drug and its label at the time of approval preempts the manufacturer’s duty to warn about drug hazards.
If drug safety disclosure requirements were to be limited by FDA’s imperfect drug safety determinations, physicians’ access to drug safety information will be severely limited–thereby affecting physicians’ ability to determine the risks and benefits of drugs they prescribe. Hence, the ruling could affect the practice of medicine.
The ruling will also determine whether consumers’ legal right to seek just compensation from a pharmaceutical company that fails to warn physicians and the public about serious risk of harm caused by its marketed FDA-approved prescription drug. The case, Levine v. Wyeth, focuses on manufacturers’ legal responsibility under state consumer safety laws, to warn physicians and the public about emergent serious adverse drug effects.
See links to Amici Curiae briefs by prominent healthcare experts and jurists:
You have a chance to register your opinion–Sign the Anti-Preemption Petition.
The initiative comes from a non-political, grass roots, free-standing group of health-care professionals, patient advocates, academics, and the like, who have initiated this entirely independently. Among them, are very committed conservative Republicans, liberal Democrats, and everything in between.
I’m told that industry supporters “behind the scenes” are very much with us.
Underscoring their independence and non-anti-pharma stance, is the disclosure by (at least) one of the group:
“I am not anti-pharma; not even close. I have significant investments in device and drug companies. Being against FDA preemption is, from my perspective, one way to try to protect those investments – and to protect legal rights and public health as well.”
Contact: Vera Hassner Sharav
We, the undersigned, petition Congress to guarantee the right to a day in court if a person is harmed or killed by an FDA-approved product. Specifically, we stand against the policy of FDA preemption.
What is FDA preemption? The Food and Drug Administration, whose responsibility it is to safeguard the public, is attempting to take away the right of American citizens to hold a manufacturer accountable for damages caused by an FDA-approved medication or medical device.
Such preemption reduces industry accountability, even while it endangers our civil rights and public health.
>From The New England Journal of Medicine,July 3, 2008:
“Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA’s regulatory actions and enhance patient safety. …
In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people.”
Sign the petition: