As a defective medical device attorney, I was pleased to read a decision keeping a defective medical device claim alive despite dismissal by the trial court. In Bass v. Stryker Corp. et al., Alton Bass sued several related Stryker entities, alleging that he was injured by a malfunctioning Stryker hip implant. He made both state-law and federal claims, but the district court dismissed his state claims, saying they were barred by the Supreme Court’s 2008 Riegel v. Medtronic, which found that many state-law tort claims in defective medical device lawsuits are preempted by federal law. The Fifth U.S. Circuit Court of Appeals ultimately affirmed the dismissal of his breach of warranty claims; remanded certain other claims for determination of whether they were based on FDA-related laws and rules; and remanded a Texas state Deceptive Trade Practices Act claim for determination of whether it relies on breach of implied warranty.
Bass underwent hip replacement surgery in August of 2007 and received a replacement hip made of four Stryker-manufactured parts. He continued to feel pain in his hip for the next two years despite following his doctor’s instructions. When he underwent a revision of the hip replacement, the surgeon found that the hip replacement was too loose. In his lawsuit, Bass alleges that the looseness was caused by manufacturing residuals that caused his body not to grow over the replacement properly. He sued in the Northern District of Texas, alleging strict liability, negligence, design defects, breach of express warranty, breach of implied warranty and violations of the Deceptive Trade Practices Act. Stryker moved to dismiss, arguing this was preempted by the Medical Device Amendments to the Food, Drugs and Cosmetics Act under Riegel, and the motion was granted. Bass appealed.
Under Riegel, the Fifth Circuit said, a state tort claim is preempted if the federal government has established requirements for the device and the state claims set safety or effectiveness standards different from, or in addition to, federal standards. Bass’s hip replacement satisfied the federal requirements prong of this test, the Fifth said, because of the kind of approval it received. However, it drew fine distinctions among Bass’s tort claims when it came time to decide whether those claims were preempted or merely parallel to FDA requirements, and thus acceptable. Under recent Fifth Circuit decisions — including one in a lawsuit over the same brand of hip replacement — a medical device cause of action may continue if the plaintiff can show that the device manufacturer violated the FDA’s Medical Device Reporting regulations. To the extent that Bass’s claims are based on violations of those regulations — including a safety recall of the product — the court found that they are parallel and can survive a preemption defense. Thus, it remanded many of the claims for determination of their basis.
As a pharmaceutical liability lawyer, I’m pleased to see so much thought put into tort claims for defective medical devices after Riegel. This federal preemption finding was bad news for injured people like Bass, who were initially thought to be without any recompense at all. As the Fifth Circuit noted in its opinion, at least some courts have instead allowed claims that parallel federal requirements, permitting plaintiffs to collect when there has been a violation of an undisputed FDA regulation or federal law. This is fewer rights than plaintiffs had before Riegel, but it’s better than allowing medical device manufacturers to avoid any responsibility for their actions at all. As a dangerous medical device attorney, I frequently see patients who, like Bass, have suffered needlessly because of a device defect they had no way to anticipate or fix.
Carey, Danis & Lowe represents clients across the United States who suffered a serious injury or illness or death of a loved one because of a defective pharmaceutical product. To tell us your story or learn more about your legal rights, send us an email or call today at 1-877-678-3400.
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