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The Biomaterials Access Assurance Act of 1998

By James M. Beck and Mark Herrmann

The Biomaterials Access Assurance Act of 1998?

Why the heck are we writing about that now?

Well, first, it's our blog; if we entertain no one else, at least we can entertain ourselves.

And, second, one of us recently received a call from a sophisticated in-house lawyer at a sophisticated drug or device company for whom this act may do a great deal of good -- but the lawyer was unaware that the act existed. We figure it's time to spread the word.

If you provide the raw material or a component part that is used in manufacturing an implantable medical device, then the BAAA could be a friend indeed. (The full cite is The Biomaterials Access Assurance Act of 1998, 21 U.S.C. Secs. 1601-1606.)

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.

The following description is very general and omits what may, in certain cases, be important elements of the act. But the description at least alerts you to the existence of the act and gives a general description of its operation.

The BAAA creates a procedural device to let the biomaterial provider escape at reasonable cost from litigation aimed primarily at the implant manufacturer. The supplier may file a "motion to dismiss," which can be supported by "affidavits" (21 U.S.C. Sec. 1604(b)), showing that the supplier is not a "manufacturer" of the final implant, is not a "seller" of the final implant, and did not fail "to meet applicable contractual requirements" relating to the raw material. Id. at Sec. 1605(a)(1)-(3). Discovery is then limited to the issues raised by the supplier's motion, and the court must rule based on the resulting record. Id. at Sec. 1605(c)(1)(A). "Thus, the BAAA allows trial courts to dismiss biomaterials suppliers from lawsuits prior to discovery." Whaley v. Morgan Advanced Ceramics, Ltd., No. 07-cv-00912-REB-CBS, 2008 U.S. Dist. LEXIS 29918 (D. Colo. Mar. 31, 2008).

There's not much extant authority interpreting the BAAA. The FDA issued a draft guidance to implement the BAAA in 2001, but a couple of minutes of research didn't reveal whatever became of that. A decade ago, a federal trial court denied a motion to amend a complaint to add four raw material or component part suppliers to a hip implant case, reasoning that amendment would have been futile in light of the BAAA. See Marshall v. Zimmer, Inc., No. 99-0973, slip op. (S.D. Cal. 1999). And, earlier this year, another federal trial court granted a motion to dismiss brought under the BAAA by the supplier of a femoral hip component to a Total Hip System. Whaley, 2008 U.S. Dist. LEXIS 29918.

We're not trying to describe this law in detail here; we're just reminding you that it exists. If you represent the supplier of a raw material or component part, the BAAA may be a quick and relatively inexpensive way to have your client dismissed from litigation.

Don't overlook it.

Full post as published by Drug and Device Law on December 02, 2008 (boomark / email).