St. Jude Medical (NYSE:STJ) was slapped with multiple lawsuits in California courts yesterday over its recalled Riata defibrillator lead, alleging that the heart wires were defective and led to injuries or death for more than 30 patients.
The lawsuits generally accuse St. Jude of violating both state and federal requirements for reporting issues with medical devices, also claiming that the company failed to meet FDA manufacturing guidelines.
"From 2005 to 2010 St. Jude Medical applied for over 27 manufacturing or process changes to the Riata leads," according to a complaint filed by plaintiffs Terry and Sherry Byerline. "Upon information and belief, St. Jude Medical failed to manufacture the Riata Leads consistent with these approved changes, thereby creating a defective product."
The Byerline complaint claims that, among other manufacturing issues, the Riata leads were allowed on the market with inconsistent insulation surrounding the electrical conductors, allowing the lead wires to poke through. When St. Jude pulled the devices off of shelves in 2010 it cited issues with "externalized conductors as a result of inside-out abrasion."* The FDA did not issue a recall notice on the device at the time.
The company issued another warning on the devices in November 2011 and the FDA gave the Riata leads Class I recall status later that year after St. Jude said the defibrillator leads failed more frequently than previously reported.
The recall has since been the center of a high-profile public hullabaloo about the true dangers of the Riata and Riata ST silicone-only defibrillator leads and whether the insulation in St. Jude’s next-generation Durata leads are likely to suffer the same problems.
Plaintiffs hoping to win damages from St. Jude Medical may have to overcome substantial hurdles to get their cases heard in court, chief among them a legal precedent that protects medical device makers to a certain degree if the products in question were green-lighted under the FDA’s premarket approval pathway.
In February 2008, the U.S. Supreme Court decided in Riegel v. Medtronic, Inc. (PDF) that a clause in the Medical Device Amendments of 1976 "bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the Food and Drug Administration."
Some complaints aim to snag the company on state laws that might help point to specific violations of FDA rules, but the Supreme Court ruled in Riegel that once a medical device has been approved by the Food & Drug Administration, product liability lawsuits based on state tort laws have no standing – in other words, the federal approval preempts state law.
Lawyers for plaintiffs in the new Riata lawsuits hope to overcome that barrier by arguing that St. Jude violated FDA regulations along with state liability laws, the Wall Street Journal reported.
*Corrected April 5, 2013, to reflect that the original St. Jude warning cited "externalized conductors as a result of inside-out abrasion."