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Regulatory Preemption of Medical Devices ( February 2004 )
The FDA has exercised a rigorous pre-market approval process for medical devices since 1976. Yet not all products liability claims involving medical devices are subject to federal regulatory preemption. This article defines the current boundaries between federal and state laws that affect medical devices. -
Health & Fitness Medical Products--Caveat Emptor & FDA Jurisdiction ( March 2000 )
This article discusses the issue of public safety when using quasi-medical devices without the guidance of a medical professional. This article outlines whether the FDA has jurisdiction over such health and fitness products that are marketed directly to consumers or over the internet. -
Circuits Split Over Federal Preemption of State Claims Against Medical Device Manufacturers ( February 2000 )
Manufacturers of medical devices suffered a major setback recently when a federal appellate court held that "premar. -
Preemptive Defense May Soon Fade in Toxic Shock Syndrome Cases ( February 2000 )
Toxic Shock Syndrome, (hereinafter "TSS"), a serious and often fatal blood disease, has been linked to the use of m. -
Year 2000 Update: Medical Devices (Feb 1999) ( February 1999 )
This article address the life-threatening possibility that medical devices will fail as a result of the year 2000 computer problem. -
Year 2000 Law Bulletin, March 1999 ( March 1999 )
This bulletin provides information about the potential effects of the Y2K problem on medical devices and the health industry. -
Frequently Asked Questions About Preemption and Food and Drug Administration's Final Rule on Tobacco ( May 1997 )
Document prepared by the Food and Drug Administration (FDA) which answers frequently asked questions regarding preemption and the FDA's final rule on tobacco. -
Torts Case Law in Texas ( September 1998 )
A. NEGLIGENCE: 1. DUTY: a.Van Horn v. Chambers, 970 S.W.2d 542 (Tex., July 3, 1998): The Court h. -
Proposed FDA Regulation Should Be Opposed ( January 1998 )
This newsletter covers a new rule issued by the Food and Drug Administration regarding the Medical Device Amendments Act of 1976 which would not only expose manufacturers to more lawsuits, it would deny consumers access to some life-saving or life-enhancing products. -
Users Facilities Requirements Under the Safe Medical Devices Act ( January 1995 )
Manufacturers should be aware of their responsibilities and requirements under the Safe Medical Devices Act. They m.
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