The medical device company, Smith & Nephew, are the manufacturers of the Birmingham Hip Resurfacing Device (“BHR”). The BHR is an artificial hip, that is advertised as an alternative to total hip replacements.
Human hips involve a ball and socket structure. The end of the femur bone, the big thigh bone in your leg, closest to the hip, is called the femoral head. It is shaped like a ball and sits inside a socket in the hip called the acetabular cup. These bones can break, fracture, or otherwise fail as we get older or due to accidents.
The BHR system replaces the hip joint with metal components. The femoral head is capped with a metal covering and inserts into a metal cup within the acetabular cup. The problem is that unlike the way this works in our bodies, there is friction between the metal components of the BHR system due to movement within the joint. That, in turn, causes metal debris to accumulate within the joint. That metal makes its way into the blood and can cause metallosis, when metal builds up in the body, and other problems.
It can cause significant medical problems such as swelling and pain, immune system reactions, pseudotumors, and premature loosening of the BHR device, which can then require a surgery to remove the device and replace it with a new one or take other corrective action. Many people have experienced this and have therefore sued Smith & Nephew.
A major legal issue Plaintiffs injured by the BHR medical device face is whether the lawsuits are preempted by federal law, a topic we discussed previously. It arises from the way the medical device got to the market, through the FDA PMA process as discussed on our medical device litigation practice area page. This is an issue in several medical devices litigations, including Essure
The basis for Smith & Nephew’s efforts to avoid compensating injured patients is the fact that FDA approved the device in 2006.
In the BHR litigation, Over 200 Plaintiffs have sued Smith & Nephew under various common law theories of liability—strict products liability; negligence; strict liability for failure to warn; negligent failure to warn; negligent misrepresentation; negligence per se; breach of express warranty; and manufacturing defect—for, among other things, misrepresenting the safety of BHR device and failing to report adverse incidents to the FDA, including that the BHR system was “wearing down more quickly” than expected.
Smith & Nephew recently filed a motion to dismiss in the MDL litigation pending before a federal court in Maryland. It argues in part that Plaintiffs’ claims are either preempted under 21 U.S.C. § 360k. That law states:
[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
21 U.S.C. § 360k(a). State law requirements, like the bases for suing medical device companies discussed on our medical device practice area page, are “different from, or in addition to,” requirements under the statute if: (1) “the Federal Government has established requirements applicable to” the challenged medical device and (2) the state law requirements are “different from, or in addition to” those requirements and “relate to safety and effectiveness.” Riegel v. Medtronic, Inc., 552 U.S. 312, 321-24 (2008).
States can impose duties that “parallel, rather than add to, federal requirements” such as by “providing a damages remedy for claims premised on a violation of FDA regulations.” Id. at 330. In such cases, people injured by a medical device that FDA approved through the PMA process are still able to bring a lawsuit to recover damages.
The Court in the BHR MDL found that the federal government has regulated the BHR system and that Plaintiffs’ common law claims constitute requirements under the Riegel case. The determinative issue then was whether the claims Plaintiffs were bringing were different from or in addition to the FDA’s requirements.
The Court held Plaintiffs’ strict liability claims were preempted because Plaintiffs were arguing that it had the power to declare these medical devices unreasonably dangerous, but the FDA had already granted the device approval. It would interfere with the FDA’s decision making power that conflicts with Congress’s intent when it passed the Medical Device Amendments in 1976. Thus, “[s]uch products liability laws add to, or are different from, federal regulations and are therefore expressly preempted” and the Court granted Smith & Nephew’s motion to dismiss Plaintiffs strict product liability claims.
Plaintiffs other claims survived preemption because they parallel, rather than differ from or add to, federal requirements. Those claims were negligence, failure to warn, representation, warranty, and manufacturing. Each theory is grounded “in a violation of one of several federal requirements: Smith & Nephew’s obligation to report adverse incidents, disseminate only truthful information about the device, implement a surgeon training program, and to manufacture the device exactly as approved.” Because these claims could be satisfied by Smith & Nephew’s alleged failure to comply with duties already required by the FDA, the Court denied the motion to dismiss and the litigation continues.
Thus, Plaintiffs in the BHR litigation, just as the women in the Essure litigation, were able to continue pursuing monetary damages for the injuries they suffered. While we believe there should not be preemption and there should not be an issue in the first place, this is at least a good outcome for Plaintiffs. Therefore, we are continuing to work with people who have swelling and pain, immune system reactions, pseudotumors, and premature loosening of the BHR device.
If you or a loved one has suffered from a BHR Hip Device, contact us at KBA Attorneys.