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"The Biomaterials Access Assurance Act of 1998"



There's surprisingly little good discussion online about this noteworthy if narrow piece of federal liability-reform legislation, as I found when trying to research it a while back. Now Beck and Herrmann help fill the gap. An excerpt:

In 1998, Congress was concerned that suppliers of raw materials were being unfairly targeted in litigation. DuPont, for example, supplied less than $100 worth of a resin, Teflon, to a jaw implant manufacturer, and ended up being named in 651 lawsuits against the implant manufacturer and paying millions to defend itself. Although the law in most jurisdictions recognizes a "raw material supplier" or "bulk supplier" defense, the supplier must nonetheless endure expensive discovery before being able to extricate itself from the litigation. Suppliers of surgical stainless steel, resins, and nickel and titanium memory metals withdrew from the medical device supply market because of the threat of litigation.

Congress responded. The BAAA creates immunity for companies that provide biomaterials that are used to manufacture implantable medical devices. The manufacturer of the device itself may be liable, of course, but the company that provided raw materials or component parts generally is not.

Although the litigation lobby bitterly assailed the legislation, it seems to have worked as intended and the crisis in biomaterials availability subsided.

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Isaac Gorodetski
Project Manager,
Center for Legal Policy at the
Manhattan Institute
igorodetski@manhattan-institute.org

Katherine Lazarski
Press Officer,
Manhattan Institute
klazarski@manhattan-institute.org

 

Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.