Nov 8, 2008

Texans Bring Liability Resolution to AMA

Courts, Congress, and state legislatures shouldn’t grant pharmaceutical and medical device manufacturers immunity from liability simply because their products were used according to Federal Drug Administration (FDA) guidelines, and TMA says the American Medical Association (AMA) needs to get involved. “Physicians may become not simply the ‘deep pocket,’ but quite likely the ‘only pocket’ against whom patients who are injured by said drugs or devices may seek redress,” says a resolution the Texas Delegation is bringing to the AMA House of Delegates meeting in Orlando. The resolution also calls on AMA to support liability protections for “physicians who use FDA-approved devices and pharmaceuticals in a reasonable and prudent manner.” The resolution stems from a lawsuit, Wyeth vs. Levine, which the U.S. Supreme Court heard on Monday, Nov. 3. TMA joined with several organizations, not including the AMA, in filing a brief in the case. Below is the full text of Resolution 201:

Equality of Civil Liability Preemption for Physicians
Whereas, The physicians of America rely on the US Food and Drug Administration (FDA) to perform the vital role of ensuring the reasonable safety of pharmaceuticals and devices used in the diagnosis and treatment of their patients; and Whereas, The FDA Pre-Market Approval (PMA), 510k (substantial equivalence), and New Drug Application (NDA) processes are designed to ensure that physicians can prescribe, implant, and apply the devices and pharmaceuticals that are FDA-approved with reasonable assurance of their safety for patients; and Whereas, Despite the methods and standards that the FDA employs, manufacturers from time to time withdraw drugs and devices, reveal significant new safety information concerning such products, or make labeling changes such as the addition of a black box warning; and Whereas, Patients do, from time to time, have adverse events from appropriately prescribed FDA-approved pharmaceuticals and medical devices; and Whereas, The current FDA administrator has opined in court proceedings that FDA approval preempts the drug or device manufacturer from civil liability in state courts, but these proceedings do not address preemption for physicians who prescribe or utilize these same FDA-approved drugs and devices; and Whereas, The Supreme Court of the United States (SCOTUS) ruling in February 2008 in Riegel v. Medtronic upheld preemption of the defendant medical device manufacturer from civil liability, yet did not address the protection for physicians who use or implant said devices; and Whereas, The Wyeth v. Levine case now before SCOTUS involves similar issues of preemption for the manufacturer of an FDA-approved pharmaceutical, without addressing the preemption status of the prescribing physician; and Whereas, If manufacturers of FDA-approved products are unilaterally granted preemption protection in all contexts (including reasonable but non-FDA-approved uses of drugs and devices), physicians may become not simply the “deep pocket,” but quite likely the “only pocket” against whom patients who are injured by said drugs or devices may seek redress; therefore be it RESOLVED, The our American Medical Association oppose efforts to grant greater levels of liability protection for manufacturers than for physicians, whether by court decision or statute (New HOD Policy); and be it further RESOLVED, That our AMA support state and federal legislation that addresses the civil liability of physicians who use FDA-approved devices and pharmaceuticals in a reasonable and prudent manner, so that physicians have no less than the level of protection offered the manufacturer for adverse events resulting from the use of said products (New HOD Policy); and be it further RESOLVED, That our AMA report on AMA activities in support of this policy to the House of Delegates at the 2009 Annual Meeting. (Directive to Take Action)

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