Utah House Passes Emergency Tort Reform Bill

The Utah House of Representatives passed the Emergency Tort Reform Bill on February 20, 2007.  The House version of the Bill would create a clear and convincing burden of proof for medical malpractice claims against Emergency Medicine physicians.  A clear and convincing burden of proof would not be required, among other reasons, for claims against Emergency Medicine physicians if the physicians had access to the patient's relevant medical care records while the physician is making decisions and providing the emergency care. 

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Foreign Device Manufacturers Must Comply with U.S. Law to Import Devices

The FDA requires that all foreign manufacturers of medical devices and/or products that emit radiation comply with applicable U.S. regulations. A summary of these regulations are provided by the FDA. An initial importer of a medical device must register its establishment with the FDA. Initial importers are also subject to the Medical Device Reporting and other applicable regulations.

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Victory for Brand Name Manufacturers

Manufacturers of brand name pharmaceuticals won another victory in defeating claims arising from a generic's manufacture of a bioequivalent drug. In Goldych v. Eli Lilly, 2006 U.S. Dist. LEXIS 49616 (N.D.N.Y.) (2006), the Court addressed whether the innovator of the drug Prozac could be held liable for the death of a man who took the generic equivalent of Prozac. Decedent never actually took the brand name Prozac but took the generic manufactured by another drug company. Decedent's surviving spouse filed suit against the original manufacturer. In dismissing plaintiff's complaint, the court held that "a brand name manufacturer cannot be held liable to a plaintiff allegedly injured by another company's bioequivalent." The court's opinion contains an excellent discussion of similar cases decided in other jurisdictions.

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Treating Physician as Expert Witness

The Utah Court of Appeals addressed the issue of whether a treating physician must be designated as an expert witness prior to offering opinion testimony at trial. (See Court's Opinion) The Court concluded that a treating physician must be designated as an expert if the physician is going to offer more than a "factual description of his or her personal observations during treatment,...." However, the physician is not required to provide an expert report under Utah Rules of Civil Procedure 26(a)(3)(B) unless the physician is specially retained as an expert.

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Mixed Reaction to AMA's Call for Moratorium on DTC Ads

The AMA recently called for a temporary moratorium on direct-to-consumer (DTC) advertising of newly approved drugs and medical devices. See AMA Wants Halt on Drug Ads Aimed at Consumers (By Steven Reinberg, HealthDay Reporter). The reaction to the AMA's statement was mixed. The Pharmaceutical Research Manufacturers of American (PhRMA) expressed overall support for the AMA's position, but added its own program sufficiently addresses the content of DTC ads. Consumer advocacy groups, such as Commercial Alert, argue the moratorium does not go far enough and claim that DTC ads should be illegal.

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