Good News About Biomaterials, But...
Makers and users of implants breathed a sigh of relief recently when the House and Senate responded to a potential biomaterials shortage by signing supplier indemnification legislation in a format palatable to both sides of the political leadership.
Just before its August recess, the Senate passed the Biomaterials Access Assurance Act to protect raw materials suppliers from being included in "unwarranted" medical product liability lawsuits. Under the act, suppliers of raw materials used in medical devices can be dismissed from product liability lawsuits if the materials meet the requirements or specifications contracted with the device manufacturer. However, if the court finds evidence of negligence on the part of the material supplier, manufacturers or claimants can file post-trial motions to bring the supplier back into the liability case.
While some industry advocates attempted to expand the bill's scope beyond materials for implants to include materials for containers that collect body fluids or tissues, the final legislation appears to be well received, and offers a significant degree of protection. With the threat of product liability lawsuits removed, many of the material suppliers that withdrew from the medical market are expected to return. It's likely that small device companies without deep pockets will now be more desirable customers for material suppliers, and that their increased access to materials could result in more-sophisticated implants reaching the market.
Despite all this good news, the issue of product liability in the medical industry still looms large. While device manufacturers should be held responsible for negligent activity, the current legal system allows for extensive punitive damage rewards that can have a chilling effect on a company's business. Too many device companies have had to make business decisions to not sell a product in the United States or to discontinue development because of the liability risks.
One solution advocated by industry trade groups is to create uniform product liability standards that cap punitive damages and "pain and suffering" awards, limit attorney contingency fees, and encourage alternative dispute resolution. Such a system could protect plaintiffs with legitimate cases and also shield device companies from frivolous lawsuits or from having to pay unreasonable rewards.
Until Congress decides to face the broader product liability issuewhich it clearly didn't this sessionthe medical device industry will continue to operate in an environment of calculated risks.
Amy Allen[email protected]