By Robert B. Barnett Jr., J.D.
Lima Corporate qualified as a "biomaterials supplier" because the three parts it supplied to a hip prosthesis could not function independently or be implanted separately.
In a case of first impression, the U.S. Court of Appeals for the Ninth Circuit has ruled that a company that manufactured a three-part hip stem as part of a hip prosthesis was immune from liability in a products liability suit as a "biomaterials" supplier" under the Biomaterials Access Assurance Act (BAAA). The hip stem was not by itself a medical device because it could not function alone and was not intended to be implanted alone. In another matter of first impression, the Ninth Circuit also held that the plaintiffs could not implead the manufacturer, Lima Corporate, back into the action under 21 U.S.C. §1606 because that statute allows impleading only when there are defendants remaining when the biomaterials supplier is dismissed. Because no other defendants remained when Lima was dismissed, §1606 did not apply (Connell v. Lima Corporate, February 17, 2021, Nelson, R.).
The patient underwent left hip revision surgery in 2011. The orthopedic surgeon implanted a dual mobility acetabular shell, a polyethylene liner, and a femoral head connected to a hip stem, which itself consisted of a stem, a neck, and a screw. Three years later, the hip prosthesis fractured, at which point it was removed. Because the prosthesis was discarded, no cause was ever determined for the fracture.
Encore Medical L.P., doing business as DJO Surgical, manufactured and sold the hip prosthesis device. Lima Corporate, an Italian company, manufactured the hip stem. The patient and his wife sued DJO and Lima in Idaho federal court, alleging claims for product liability, negligence, breach of warranties, and negligent infliction of emotional stress. After discovery, the patient settled with DJO, leaving only Lima. Lima then moved for summary judgment on grounds of BAAA immunity.
Immunity. The BAAA immunizes a "biomaterial supplier" from liability in any civil suit. The immunity exists because small quantities of raw materials and component parts used in medical devices exist, and Congress wanted to ensure that suppliers were not discouraged from providing them by the fear of becoming entangled in years-long lawsuits. The BAAA defines "biomaterials supplier" as any entity that: (1) supplies a component part (2) for use in the manufacture of an implant. The court examined both parts of the definition.
Component part. A "component part" is a "manufactured piece of an implant." Under these facts, the hip stem was both manufactured and a piece of an implant. In fact, the pieces were manufactured to DJO’s specifications. The three parts were a "piece" because they could not function on their own. To function, the hip stem had to be combined with a separate compatible femoral head, an acetabular shell, and a liner, none of which Lima supplied.
Implant. The hip stem qualified as an implant because the manufacturer intended that it be placed in a body cavity. The hip stem did not qualify as a separate medical device because it was a component part of the complete hip implant. The court rejected the plaintiffs’ argument that the hip stem was itself an implant because the manufacturer intended that it be placed in the body. The better interpretation was that it was a component part because it was not intended to be implanted by itself. To qualify as "for use in the manufacture of an implant," the court said, Lima needed to have supplied the hip stem to be applied in a new form, quality, or combination to produce a complete hip implant-precisely what Lima did. The hip stem was sterilized and packaged with instructions before being assembled with other component parts.
In finding that Lima was entitled to immunity, the court acknowledged that its ruling may limit recovery for plaintiffs such as the patient. Nevertheless, the court said, it read the statute as Congress’s intention to "broadly preempt liability for those supplying raw materials and component parts." It also cited the "expansive definition of ‘biomaterials supplier.’"
Impleading. Even if immunity exists, 21 U.S.C. §1606 allows a plaintiff to implead the dismissed biomaterials supplier back into the lawsuit if the plaintiff is unlikely to recover the full amount of its damages from the remaining defendants. Apparently, no court had addressed this issue before the Idaho district court ruled on it. The Idaho court had dismissed the impleader effort because settlement with DJO was not a "final judgment." Although the Ninth Circuit affirmed the dismissal of the impleader motion, it did so for a different reason. It took the phrase "from the remaining defendants" to mean that at least one defendant had to be left after the biomaterials supplier was dismissed.
One question was when to determine when no defendants were left: (1) when the biomaterials supplier was dismissed; (2) at the time of final judgment; or (3) when the motion to implead was filed. The court ruled that the most logical interpretation was that it should be determined when the biomaterials supplier was dismissed. Once again acknowledging that its ruling could limit a plaintiff’s recovery in some cases, the court concluded that its interpretation was consistent with Congress’s purpose in enacting the BAAA, which was to broadly limit liability for biomaterials suppliers while keeping avenues open for plaintiffs to recover from the primary manufacturer. Once the patient settled with DJO, and DJO was dismissed from the suit with only Lima remaining, the patient lost his right to implead.
The Ninth Circuit, therefore, affirmed the Idaho district court’s ruling.
The case is No. 19-35797.
Attorneys: Eric S. Rossman (Rossman Law Group PLLC) for Jeffrey D. Connell and Janet Connell. Stephen Raber Thomas (Hawley Troxell Ennis & Hawley LLP) for Lima Corporate and Lima USA, Inc. Andrew H. Winetroub (Nixon Peabody LLP) for DJO Global, Inc.
Companies: Lima Corporate; Lima USA, Inc.; DJO Global, Inc.
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