When court documents were unsealed in a Yaz MDL Illinois in December 2011, Bayer was said to have hidden important information about how dangerous the drugs are. Side effects linked to Yaz and Yasmin are numerous and potentially life threatening. Some of those side effects […]
As Bayer’s Yaz settlements continue to make headlines in recent weeks, many have wondered exactly how much the drug giant agreed to settle for. It turns out Bayer is going to shell out at least $110 million in settlements to cover 500 Yaz lawsuits which […]
Ninth Circuit Rules Medtronic Pain Pump Claims Expressly or Impliedly Preempted – Stengel v. Medtronic
I’ve written here many times before, as a dangerous medical device attorney, about the flaws of the Supreme Court’s decision in Riegel v. Medtronic. That 2008 case found that federal law preempts most state-law cases alleging that a dangerous medical device hurt or killed a patient. Effectively, this means medical device makers face absolutely no accountability for making and selling products they know or should know will hurt patients who trust them, which presents obvious safety problems. Patients and their families can and do still try, but they must find a way in which the device violates federal law, or another exception. Such a case was recently dismissed by the Ninth U.S. Circuit Court of Appeals. In Stengel v. Medtronic Inc., Richard Stengel of Arizona and his wife, Mary Lou Stengel, brought a lawsuit alleging several causes of action against Medtronic after a pain pump implanted in Richard made him permanently paraplegic.
The pain pump at issue, which is called the SynchroMed EL Pump, is surgically implanted in patients’ abdomens and delivers medication to the spinal area to control chronic pain. Stengel had it implanted in 2000 and began feeling paralysis and numbness in his extremities in 2005. Doctors eventually realized the device was causing inflammation in his spine and removed it and the buildup, but were unable to stop his permanent paralysis. The Stengels sued under Arizona law, alleging breach of express and implied warranties, negligence and strict liability. Medtronic removed the case to federal district court, which dismissed the claims as preempted by federal law. While that motion to dismiss was pending, the Stengels asked to amend their claims to add a new allegation that Medtronic violated FDA regulations by failing to evaluate and report complaints about the device, which would have allowed warnings to doctors. This was denied on the grounds that it was impliedly preempted anyway.
The couple appealed the dismissal of their original claims as well as the denial of leave to amend, but the Ninth Circuit’s majority upheld the district court. It agreed that the original claims made by the Stengels are expressly preempted by the Medical Device Amendments to the Food and Drug Act and under Riegel; indeed, the Stengels did not deny that Medtronic complied with federal requirements. However, it examined the proposed amended complaint to determine whether it could survive preemption. To the extent that their failure to warn claim paralleled federal requirements, the appeals court said, it is not expressly preempted — but it is impliedly preempted. Relying on 2001’s Buckman Co. v. Plaintiffs’ Legal Committee, the Ninth said allowing the claims to go forward would interfere with the FDA’s authority to punish noncompliance with its own rules. The Ninth acknowledged a split in the circuits on preemption of state failure to warn claims for medical devices, but disagreed with the logic of the opposing circuit. Judge Noonan, dissenting, pointed out that the court’s conclusion creates a situation where manufacturers of “sensitive devices” are liable for their actions “only in nonexistent cases.”
As a defective medical device lawyer, I couldn’t agree more. In this ruling, the Ninth sides with our own home circuit, the Eighth, in finding that Buckman disallows suits based on express violations of FDA rules. Under this logic, plaintiffs may not sue over anything that violates state law as long as it complies with FDA rules — but they also may not sue over violations of FDA rules, even when they parallel state requirements. This is no doubt welcomed by medical device manufacturers that wish to cut safety corners in order to maximize their profits, but it’s a terrible way to protect the public. In addition, the dissent in this case suggests that the ruling violates Supreme Court precedent. Along with the circuit split, this suggests that this case may ultimately wind up being reheard by the full Ninth Circuit. As a pharmaceutical liability attorney, I look forward to more precedent on the issue from the Ninth and its sister circuits.