Everyone likes to hear stories about how someone overcame obstacles, right? Magazines and television shows are filled with heartwarming stories of triumph over adversity. Well, Lewkut v. Stryker Corp., No. 09-cv-3695 (S.D. Tex. April 16, 2010), is the story of how a federal court, aided by plucky defense counsel, overcame common obstacles to the early resolution of a preemption defense and granted a motion to dismiss.
Egon Lewkut had problems with his artificial hip replacement, a Howmedica Osteonics Trident System, and sued. The defendant manufacturer moved to dismiss, arguing that all claims were preempted because the FDA had given premarket approval to the Trident System. And here was where Howmedica encountered its first obstacle: courts ruling on motions to dismiss generally can consider only the facts alleged in the complaint, and you can bet that this plaintiff (like most others) made sure to keep the facts concerning the FDA’s approval of the Trident System out of the complaint. Absent essential facts, courts often feel compelled to deny a preemption motion to dismiss and let the case proceed at least with discovery about the device’s FDA approval.
Howmedica overcame this obstacle by establishing the relevant facts surrounding the PMA approval with documents from the FDA’s public records, which were available on the FDA’s website. Id. at 5 n.1. The court found this move was proper based on the established principle that courts can consider documents outside of the complaint when those documents are matters of public record. Id.
As we’ve discussed before, judicial notice is a handy technique to keep in mind in deciding whether to raise a preemption defense in a motion to dismiss or wait until summary judgment. Sometimes lawyers shy away from moving to dismiss because they think that establishing FDA approval requires an affidavit of someone at the company to supply the device’s regulatory history, and most courts won’t consider substantive affidavits at the motion to dismiss stage. Lewkut shows an alternative way to prove those facts to a judge – or at least to judges comfortable with the idea that documents available on the FDA’s website are public records.
The second obstacle may have interest only to preemption geeks like us, but we’ll tell you about it anyway. This device had several component parts. Lewkut targeted the acetabular shell component, which initially received FDA clearance through the section 510(k) – read, no preemption – process. Later on the FDA gave premarket approval to the Trident System. Asserting the non-preemptive nature of §510(k) clearance, Lewkut argued his claims should survive. The court took a careful look at the FDA record from the public documents available on its website and concluded that the FDA had re-approved the acetabular shell component when it gave premarket approval to the entire device. Slip op. at 9. The FDA’s previous approval of this component through the 510(k) process did not matter. Id. The court said that it was not appropriate to separate the component parts of a device for purposes of preemption and that FDA approval of the device included the component that is part of the device. Id. at 10-11.
Having reached this conclusion, the court necessarily found that preemption applied to state law claims concerning the Trident System, including the acetabular shell. Id. at 13-14. But here is where Lewkut threw out the final obstacle to Howmedica’s triumph: his complaint included a claim that his Trident System was “adulterated” under section 351(h) of the Food, Drug, and Cosmetic Act, which allegedly was demonstrated by the recall of acetabular shells manufactured in Ireland in 2008. Id. at 14. Lewkut claimed his “adulteration” claim constituted a parallel violation claim that was immune from preemption under Riegel. The court said he was right about Riegel preemption but found another way over this last hurdle to get to the preemption finish line: our old friend, 21 U.S.C. § 337(a). As we’ve discussed many times, this section provides that only the federal government can enforce the prohibition on adulterated devices. Slip op. at 15. The Lewkut court concluded that “Plaintiff’s allegations, even to the extent that they present parallel state claims and are exempt from Riegel, are nonetheless preempted by the federal statute that explicitly precludes private enforcement of federal laws regarding ‘adulterated’ devices.” Slip op. at 16-17. In reaching this conclusion, the court relied heavily on In re Medtronic, Inc. Sprint Fidelis Leads Product Liability Litigation, 592 F. Supp. 2d 1147 (D. Minn. 2009), one of our top 10 decisions of 2009, and gave the back of the hand to Hofts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830 (S.D. Ind. 2009), one of our least favorite decisions. Slip op. at 13. The court therefore found that all claims were preempted and dismissed the complaint.
For any lawyer defending device companies, this is a heartwarming story with a happy ending.