– Patricia Caplinger says Medtronic’s Infuse product caused bones in her spine to grow out of control. The excess bone growth began after a 2010 back operation in which doctors implanted Infuse in a way that the U.S. Food and Drug Administration never approved.

Caplinger says Medtronic encouraged this off-label use of Infuse, which produced ongoing unnatural bone growth that pinched her spinal nerves. She has undergone two additional surgeries and faces future operations, along with a life of pain.

Caplinger is hoping for a day in court to argue that Medtronic should be held accountable for her injuries. But she will need a decision by the United States Supreme Court to get it.

Caplinger has asked the nation’s highest court to hear her case because a federal appeals court said she has no right to sue Medtronic. The appeals court ruled that FDA approval of Infuse for a single, limited use protects its maker from injury claims resulting for any use, even non-FDA-approved uses that Medtronic promoted through studies, seminars and sales.

The justices are expected to decide in early January if they will take Caplinger’s case.

In filings, her lawyers have asked the justices to correct a “pervasive misunderstanding” of medical device approval and oversight that is “recurring and important.” The appeals court decision, Caplinger’s lawyers wrote, makes Medtronic “immune from liability” for marketing products for potentially harmful uses “never approved by the FDA.”

“That result gives safe haven to bad actors at the expense of innocent patients,” Consumers Union and AARP warned in a friend of the court brief urging the justices to hear Caplinger’s arguments.

Medtronic, which currently faces thousands of injury claims alleging improper off-label promotion of Infuse, is fighting to keep Caplinger’s case off the Supreme Court docket.

CEO Omar Ishrak declined to answer a Star Tribune question about the possible Supreme Court case after a quarterly earnings call last week. But in a filing with the justices, the company said that once the FDA approves a device for a single, limited use, every other kind of use is protected from patient injury suits — even those the FDA never tested for safety and effectiveness.

FDA approval “applies to devices, not specific uses” of those devices, Medtronic maintained, adding that the current Infuse label adequately explains the risks of off-label use.

The company further asserted that federal law does not prohibit device makers from promoting non-FDA-approved uses of products. Medtronic denied misbranding Infuse, which it said could be illegal. But misbranding is still not a viable claim by injured patients, the company argued, because the fraud would be against the FDA, not the person who was hurt.

“The FDA has never withdrawn its premarket approval for Infuse and has never alleged that Medtronic misbranded or adulterated the device,” the company concluded.

Off-label use common

The law allows doctors to implant Infuse in non-FDA-approved ways if they think it will help patients.

But the law places some limits on how device makers can market their products.

Despite those limits, Medtronic has spent hundreds of millions of dollars funding studies for off-label uses of rhBMP-2, the bone growth agent in Infuse, and paying royalties to doctors who developed products into which the biologic can be inserted in non-FDA-approved ways. A 2010 study at a New York hospital showed doctors implanted Infuse off-label 96 percent of the time.

Still, legal experts say the Caplinger case and other Infuse injury suits working their way through the court system offer a legal challenge to judges. They must balance free speech and technical innovation with patient safety and corporate accountability. And they must apply the constitutional concept of pre-emption, which generally does not allow state injury claims to take precedence over federal laws.

The Supreme Court itself ruled against a claim similar to Caplinger’s in a 2008 case that also involved Medtronic, said product liability expert David Prince of William Mitchell College of Law.

Prince said he would be “surprised” if the justices took Caplinger’s case because the 2008 case, Riegel v. Medtronic, involved a patient denied the right to sue after being injured by off-label use of a Medtronic heart device.

Asserting that the Riegel case is wrong will work against Caplinger, as will the fact that lower courts have relied on the Riegel decision in recent years, Prince said.

The question that might gain traction is how manufacturer promotion of non-FDA-approved uses changes the equation.

“Manufacturers are not allowed to market off-label for anything they want,” said Dr. Aaron Kesselheim, who directs Harvard Medical School’s Program on Regulation, Therapeutics, and Law.

Allowing device makers to seek FDA approval for “extremely narrow indications” then allowing them to promote for uses that regulators have not judged safe or effective works “to the potential detriment of patients,” Kesselheim said. Letting manufacturers avoid lawsuits from those injured by that practice is “unfair.”

Nevertheless, Medtronic has used pre-emption to avoid thousands of Infuse lawsuits by arguing that federal approval of the product for relatively rare kinds of surgeries disqualifies the claims of those injured by any use of it. The company’s success with pre-emption has led some lawyers to urge badly injured clients to accept small settlements in cases where Medtronic offers them.

Given these restrictions, issues raised in the Caplinger case call into question the ability of the FDA to protect Americans, Kesselheim and Prince said. The agency does not test off-label device uses. Its monitoring of injuries caused by off-label device uses depends largely on industry-initiated reporting. Its enforcement efforts for companies not reporting injuries are rare, as are sanctions for misbranded devices.

“I don’t get why the FDA has not looked harder at Infuse,” Prince said. “The frequency with which these injuries arise is significant.”

An FDA study of its database of device malfunctions showed that 99.5 percent of complaints from Infuse patients came after off-label uses. Hundreds of Infuse complaints roll into the database each month.

If those people can’t sue Medtronic, AARP and Consumers Union wrote to the Supreme Court, there is a real question about “whether … patients injured as a result of manufacturers’ promotion of off-label uses … have any remedy at all.”