Whistleblower case contends surgical device maker misled FDA — and patients paid the price

Jerome Lew is a Hollywood screenwriter, and what happened to him could have come straight out of a horror film.

In 2009, Lew went to UCLA Medical Center for surgery to relieve numbness and pain in his hands. The operation appeared to be a success. But he later began having trouble speaking. His left eye drooped. He developed severe nerve pain and weakness in his neck, arms, and hands.

Lew concluded that the problem had been caused by an implant fused into his neck. It had never been approved to replace a bone in the neck.

“Jeremy’s injuries from this surgery have been devastating,” said his attorney, Robert Vaage. “His life was ripped away by one surgery and the devices that were used.”

In July, Lew, 52, settled with the University of California for $4.2 million; the manufacturer of the device, Medtronic, also settled for a confidential amount. Both parties denied any wrongdoing.

Yet the legal challenge is not over for Medtronic. The company, one of the world’s largest medical device manufacturers, now faces a whistleblower lawsuit that claims it sought Food and Drug Administration approval for its devices under false pretenses — and that the devices have been regularly used for a purpose that was never intended by regulators.

“They were labeled, ‘not for cervical spine use,’ and yet in everything about them, including emails from their marketing folks, it makes clear that they were meant to be and were used in the cervical spine,” said Dr. Vikas Saini, president of the Lown Institute, a Boston health care think tank, who has followed the case.

Medical devices are lightly regulated by the FDA, and once they have been cleared by the agency, physicians may use them however they see fit. But patient advocates and others say the story of the Medtronic implant is a cautionary tale when it comes to medical device safety.

The case, they say, is only the latest in which a manufacturer is alleged to have promoted its devices for unapproved or “off-label” uses, despite regulations prohibiting them from doing so.

In Lew’s case, an email unearthed by attorneys, and shown to STAT, shows a former Medtronic sales supervisor asserting to UCLA that, although the company’s device is generally used in the thoracic and lumbar spine, because of its small size, “many surgeons choose to use it in the cervical spine.”

The sales supervisor, Paul McClintock, declined to respond to multiple requests for comment.

Medtronic declined to address Lew’s case. But it denied its device, a “cage” implant that is known as a VERTE-STACK system, was designed or promoted for use in the neck.

“VERTE-STACK components were specifically designed and cleared by the FDA for use in the thoracic and lumbar spine,” that is, below the cervical spine, spokesman Eric Epperson told STAT.

“Medtronic’s company policies and extensive training expressly provide that we promote our products only for those uses that are consistent with the labeling approved by the FDA,” he said.

According to Medtronic, the implant was designed to treat degenerative disc disease, by restoring the disc space to its original height, relieving pressure on nerves. During surgery, a protein soaks into a sponge, which then serves as a scaffold to form new bone. The cages stabilize the spine, while the protein has a chance to fuse the vertebrae together. The entire system is known as INFUSE Bone Graft.

Medtronic makes a host of devices for use in spinal surgeries. For fiscal 2016, the company reported $2.9 billion in spinal device sales, including the INFUSE system, and its products are used in about 100,000 spinal surgeries each year.

But the company has been beset by personal injury lawsuits. Corporate filings to the Securities and Exchange Commission in June show that at least 6,000 people have sued the company — or plan to — for INFUSE-related personal injuries, among them bone and nerve injury, urinary problems, male sterility, and infection. Some patients have reported excessive and painful bone growth, which Lew also suffered in the neck, court documents show.

In its June annual report, Medtronic noted that it had set aside more than $140 million for INFUSE litigation, and has paid $68 million in fiscal years 2015 and 2016.

Lew’s case is believed to be the first focused on the stackable cages that deliver the bone-growing protein. But his attorney, Vaage, said the case also makes clear that Medtronic knew its devices were being used for a non-approved purpose.

Court records claim a Medtronic sales representative was in the room during Lew’s operation, suggesting the company was aware of how its device was being used. And the records claim that the implant’s co-inventor said in a deposition that he intended the cage for implants in the neck. (The co-inventor, Dr. Zafar Khan, told STAT he did not remember his deposition well and could not comment further.)

The whistleblower lawsuit against Medtronic is what is known as a qui tam, or False Claims Act case, in which a person or persons with inside knowledge of a fraud against the government files suit on the government’s behalf, seeking restitution and penalties.

In an unusual move, the whistleblower in the case is named only as the Dan Abrams Co. LLC, and may represent more than one present or former Medtronic employee.

Attorneys for the whistleblower or whistleblowers contend Medicare, Medicaid, and other federal agencies reimbursed health care providers using the Medtronic device with hundreds of millions of dollars for “false claims” — that is, payments for devices that were illegally marketed, misbranded, and not proven safe.

“The case illustrates the unfortunate imbalance of influence that companies like Medtronic exercise over everything from patient safety to doctors and hospital systems and the government health care system … and then as well as regulatory bodies that are supposed to hold them in check,” said John Parker, an attorney with Cutter Law, who is one of the attorneys for the whistleblower. “Medtronic is the 800-pound gorilla.”

Experts say damages could be significant if the court sides with the whistleblowers.

“It’s a very expensive product and the False Claims Act provides for triple damages plus penalties,” said Ross Brooks, who co-chairs the whistleblower practice at the law firm Sanford Heisler LLP and who has been involved in other litigation against Medtronic.

“As a practical matter, this type of case could result in astronomical penalties,” he said.

Medtronic has not yet responded to the whistleblower suit. Court records in the case were unsealed in April, and the company has until October to respond.

The FDA declined to say whether it believes Medtronic has violated regulations guiding the off-label use of medical devices or other regulations. But a spokeswoman said the device was “cleared explicitly for use in the thoracic and lumbar spine.”

Patient advocates say the case highlights the shortfalls of the regulatory system. Medical devices, unlike prescription drugs, are not subject to clinical trials, as is the case with prescription drugs.

Diana Zuckerman, president of the National Center for Health Research, said more scrutiny in a trial would have made it clear that the Medtronic device was sized to fit in the neck.

“Had it been tested in a clinical trial, the orthopedic surgeon would have said, ‘What the hell, this doesn’t fit in the lumbar spine,’” said Zuckerman.

The FDA “didn’t have any data about safety or effectiveness or even whether it would fit where it was supposed to,” she said. “The truth is, FDA is doing such an inadequate job of reviewing devices that if it weren’t for the lawsuits, even more patients would be harmed.”

Epperson, the Medtronic spokesman, said its system “comes in a variety of sizes to accommodate the unique anatomies of different sized patients.”

Lew is not a party to the whistleblower case, although records show that he was initially, along with one or more unnamed present and former Medtronic employees.

If the case moves forward and a court rules against Medtronic, the whistleblower would get a sizable chunk of whatever money is awarded — generally 25 percent to 30 percent. The US Treasury would reap the rest.