Medtronic Ducks Suit on Off-Label Promotion

(CN) - Rejecting claims against Medtronic over its off-label promotion of a medical device, the 10th Circuit found that the company complied with federal regulations.

Patricia Caplinger, of Oklahoma, brought the case in 2012 based on complications she developed from a Medtronic bone-growth-stimulation device called Infuse, which her doctor implanted in her spine using a posterior approach.

Though the U.S. Food and Drug Administration had only approved an anterior surgical approach for such implants, Caplinger said a Medtronic representative personally recommended using the device the off-label way to her and her doctor.

Caplinger claimed that the company's conduct exposed it to liability under various state tort laws, but the trial court found those claims either insufficiently pleaded or pre-empted under federal law.

The Denver-based 10th Circuit affirmed 2-1 on Tuesday, noting that the Medical Device Amendments to the federal Food, Drug and Cosmetics Act bans states from imposing additional requirements on a device's safety or effectiveness.

"Allowing more regulation of medical devices could yield benefits for patient safety," Judge Neil Gorsuch wrote for the majority. "But it could also mean forcing manufacturers to abide not one but fifty-one sets of requirements, a prospect that could deter or delay access to innovative devices and wind up hurting more patients than it helps."

Noting the difficulty of drafting a complaint that adequately follows the "competing instructions" by the U.S. Supreme Court in its rulings regarding the MDA, Gorsuch likened the task to "navigating between Scylla and Charybdis" in Greek mythology.

"One can't help but wonder if perhaps some of those rules warrant revisiting and reconciliation," the 26-page opinion states. "But if we understand our directions, it seems we aren't supposed to ask whether Ms. Caplinger wishes to use state tort law to impose on Medtronic a safety requirement that is 'different from, or in addition to' a federal requirement so much as whether she seeks to vindicate a state duty that is 'narrower' or 'broader' than a federal duty."

Gorsuch notes that state-law duties that are narrower than or equal to the federal duty survive "through what seems a sort of Venn diagram approach to preemption."

In this case, Caplinger has not tried to identify "a single parallel federal statute or regulation" for her design-defect and breach-of-warranty claims, according to the ruling.

The parallels Caplinger offered for her remaining claims do not apply, the court found, noting that these regulations "govern only a device's labeling and her state law claims go well beyond that, attacking not just Infuse's label but also Medtronic's advertising and oral and written representations to her, her doctor, and others."

"So as a matter of law Ms. Caplinger's state law claims substantially exceed the potential scope of any federal regulation she's identified," the decision continues.

Gorsuch said another problem emerges if the court finds that the labeling attack "falls within the arguable (Venn diagram) scope of the regulations she's cited."

"Infuse is a prescription device," he wrote. "As federal regulations explain, that usually means it isn't possible to prepare adequate directions for its safe use by laymen."

This is why FDA regulations generally absolve medical-device manufacturers as long as they label prescription devices with the approval of the FDA, the panel found.

Caplinger failed to sway the court that "attacking off-label uses should be another entirely separate way around the problem."

"In not a single one of its many and involved encounters with the MDA has the Supreme Court so much as hinted at this alternative path around preemption," Gorsuch wrote.

Though Caplinger failed to identify parallel provisions to save her claims, the court noted that another plaintiff may yet do so successfully.

"After all, the FDA's medical device regulations alone cover 592 pages of eight-point type and the Supreme Court has suggested that in searching for a parallel federal duty a plaintiff may scour them all as well as the statute itself," Gorsuch wrote. "And lurking in there somewhere might be some answer to the apparent conundrum of how a plaintiff might use state law to require more label warnings that federal law seems to prohibit."

A partial dissent by Judge Carlos Lucero notes that some of Caplinger's claims are "at least plausibly parallel and should survive a motion to dismiss" this early in litigation.

Lucero said doctors are not violating federal law when they use a medical device off-label, but they still could face state claims of malpractice and negligence.

"Allowing medical device companies to escape state tort liability in such a situation would improperly shift the risk of liability from device companies that intentionally mislead physicians to the physicians who rely upon that misleading advice when deciding to utilize a device off-label," the 19-page dissent states. "Congress sensibly refused to establish such a dystopic regime."

Medtronic did not immediately respond to a request for comment.

Caplinger's appellate attorney, Allison Zieve with the Public Citizen Litigation Group in Washington, D.C., said it is true that physicians can use medical devices off-label, but manufacturers are still not allowed to market the devices for unapproved uses.

"The issue in this case is whether a medical device manufacturer is immune from liability for harm caused to a patient when its product is FDA-approved for one use, but the manufacturer markets the product for a different use that has not been FDA-approved (that is, a use that the FDA has not found to be safe and effective)," Zieve said in an email. "The notion that a device manufacturer is immune from liability for harm caused by its device when the manufacturer has pushed the device for a use that the FDA never approved is neither logical nor consistent with the Supreme Court's prior rulings about the scope of preemption of claims arising from harm caused by medical devices."

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