Health

FDA's handling of probe of alleged counterfeit spinal implants angers patients, critics

L.A. County Sheriff's Deputy Abraham Pena was injured during an altercation with an inmate at a County men's jail where he works. After several surgeries he has filed a lawsuit alleging his surgeon used counterfeit hardware that has caused debilitating pain and required additional corrective surgeries.
L.A. County Sheriff's Deputy Abraham Pena was injured during an altercation with an inmate at a County men's jail where he works. After several surgeries he has filed a lawsuit alleging his surgeon used counterfeit hardware that has caused debilitating pain and required additional corrective surgeries.
Maya Sugarman/KPCC
L.A. County Sheriff's Deputy Abraham Pena was injured during an altercation with an inmate at a County men's jail where he works. After several surgeries he has filed a lawsuit alleging his surgeon used counterfeit hardware that has caused debilitating pain and required additional corrective surgeries.
Abraham Pena's photos of his x-Rays show the metal plate and spacer in the front of his neck. He worries the hardware is counterfeit and part of a massive workers compensation fraud scheme.
Maya Sugarman/KPCC
L.A. County Sheriff's Deputy Abraham Pena was injured during an altercation with an inmate at a County men's jail where he works. After several surgeries he has filed a lawsuit alleging his surgeon used counterfeit hardware that has caused debilitating pain and required additional corrective surgeries.
After being injured in a car accident, Jo Dixon underwent several back surgeries and a spinal fusion. She suspects that some of the hardware put in her body was counterfeit.
Maya Sugarman/KPCC
L.A. County Sheriff's Deputy Abraham Pena was injured during an altercation with an inmate at a County men's jail where he works. After several surgeries he has filed a lawsuit alleging his surgeon used counterfeit hardware that has caused debilitating pain and required additional corrective surgeries.
Surgeons removed this hardware from Jo Dixon in September 2014.
Maya Sugarman/KPCC


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Jo Dixon emptied a small orange prescription bottle of screws, rods and bolts onto her dining room table in Big Bear. They were the relics of five spinal surgeries that left her weak, sometimes barely able to walk and in so much pain she often couldn't get down the stairs to her living room without her husband's help.

"I thought I was going to be all better and I was actually going to make a wind chime out of it and have it on the porch so I could say, oh look, I’m free," said Dixon, 44.  "Well it hasn’t been a freeing experience, so they’re in the jar still."

Surgeons removed this hardware from Jo Elizabeth Dixon in September. Dixon keeps the screws in this container. (Maya Sugarman/KPCC)

Dixon is one of dozens of spinal surgery patients who have filed lawsuits against hospitals, doctors, executives and medical device makers alleging they were implanted with hardware that is not approved by the FDA and made from unknown metals.

These patients are at the center of the largest workers' compensation fraud in California history. It was a complex scheme that involved political bribes, payoffs to doctors and allegedly counterfeit hardware that was implanted into patients. 

The Food and Drug Administration - which oversees medical-device makers - had been tipped off to the alleged manufacture of counterfeit hardware, but a KPCC examination of the FDA's investigation reveals that the agency did not try to determine whether the hardware was genuine, and focused instead on the targeted company's quality control procedures. 

The company went out of business before the FDA could take more aggressive measures, and the agency dropped its investigation at that point. The episode has prompted patients and critics to ask why the FDA didn’t do more to protect the public from the alleged spinal surgery scam.

Counterfeit screws, rods and cages?

Former State legislator Ron Calderon (D-Montebello) was indicted last year for taking millions of dollars in bribes from former Long Beach hospital executive Michael Drobot to maintain a law that allowed Drobot to overbill the state workers' compensation system for thousands of spinal fusion surgeries, according to court documents.

Federal authorities also indicted Drobot over his spinal surgery network, which charged upwards of $160,000 per operation. He pleaded guilty and is cooperating with federal officials, according to his plea agreement.

Out of that financial scheme spooled an even uglier tale – it involved kickbacks to doctors who used Drobot’s Pacific Hospital for surgeries, and a network of companies - including Spinal Solutions, International Implants and Orthopedic Alliance - that made and distributed the hardware used in those spinal operations. 

Whistleblowers and attorneys representing patients across the state allege in multiple lawsuits that the Drobot-connected companies were producing counterfeit screws, rods and cages that were knowingly implanted into patients. The hardware was allegedly made by a now-shuttered auto machine shop in Temecula.

Last year Drobot sued the attorneys who are suing him, challenging their claim that he knew about the counterfeit hardware and that it was part of his scheme. A judge sided with Drobot this past April, removing the claims of a counterfeit hardware conspiracy from the suit on the grounds that the plaintiffs did not present evidence to support them.

A whistleblower's tip

According to FDA documents, in 2011 the agency received a tip from an anonymous informant that Spinal Solutions, based in Riverside, had hired the Temecula machine shop to make its screws and other hardware, even though they were not FDA-approved.

The agency conducted an inspection that found the company's paperwork in chaos. The FDA began sending warning letters to the company outlining quality and documentation deficiencies in such areas as verifying the quality of incoming products from suppliers, training of personnel and procedures for handling complaints.

For two years the FDA corresponded with Spinal Solutions about deficiencies in its distribution operation.

In January of 2012 the FDA sent a warning letter to Spinal Solutions outlining serious violations, including the charge that the firm's products were "not in conformity with the current good manufacturing practice requirements of the Quality System regulation." The FDA also said the company failed to establish quality audits, and failed to keep device history records.

But the FDA never tested the company’s hardware.

"It's hard to believe the FDA was specifically warned about counterfeit screws and then did not actually adequately investigate for that," said Sarah Sorscher, who researches drug and device safety for the Public Citizen Health Research Group and also reviewed the agency's Spinal Solutions investigation. "[Agency officials] went in and inspected this company as if they were not aware of serious issues."

Fused cages and strange blood tests

In the same year that the FDA got its tip about Spinal Solutions, x-rays showed that some of the fusion screws inserted in Jo Dixon's spine were moving around in her body.  A surgeon removed what could be taken out but left two metal cages because they had fused to her neck and her pelvic bone.

Dixon's suspicions about the hardware in her body were fueled by unusual blood test results.

"I don’t know if the cage is good because I don’t know what it’s made of," she said. "My metal was off the charts, copper and titanium, they can’t explain why.

The surgeries  - intended to relieve severe pain from a car accident - changed her life, said Dixon. Once an active runner, camper and frequent traveler, now she can barely move. She had to leave her job as a mortgage underwriter so the family sold its Long Beach home and moved to Big Bear for its lower cost of living. 

The family eventually moved to Michigan in search of an even less expensive place to live.

"I cry just about every day and feel like such a burden to [my husband] Travis and our son," she wrote in an email. "I feel guilty for not being able to help out or even unpack from our move."

A voluntary recall

In 2013 the FDA asked Spinal Solutions to voluntarily recall some hardware because the company wasn’t in compliance with quality control rules.

That was pretty standard procedure for a medical device case, said Larry Stevens, a former FDA official and now a consultant with the private firm, The FDA Group.

"The voluntary recall is the best way to do it because it’s very quick," he said. "A company can make that decision and fix the problem. FDA prefers that ... because if the FDA has to take a legal action, that can take months."

The FDA only provided written responses to KPCC's questions, and would not discuss the specifics of the Spinal Solutions case.

Agency spokesman Chris Kelly wrote that in general if a voluntary recall fails the FDA will work with the Department of Justice to take tougher action - which can include seizure or fines. 

The FDA classified the Spinal Solutions recalls as Class II – indicating a product that may cause temporary or medically reversible adverse health consequences. A Class II recall asks that 100 percent of buyers be contacted and that returned material be destroyed.

Spinal Solutions did agree to the voluntary recall and issued notices for hardware distributed in several states, including California and Texas. But when the FDA followed up a few months later, it discovered the company had shut down. And that was the end of the investigation.

That is not unusual, according to former FDA official Stevens.

"Once the product is no longer on the market and [the] company is not operating the FDA is usually done," he said.

"They clearly dropped the ball"

The Spinal Solutions case angered Public Citizen's Sorscher, who called the FDA's conduct "outrageous."

"You would expect the FDA to have acted more quickly," she said. "They clearly dropped the ball. I think there should be an investigation."

KPCC reached out to six members of the the House Agriculture Committee, which oversees the FDA, but none of the congressmen was available to comment.

Under FDA rules, the agency could have taken quicker, tougher action - such as ordering a mandatory recall - if it had determined that the hardware in question posed an "imminent" public health threat.

The agency "failed" by not recognizing the imminent public health risk, said Sorscher, who noted that the FDA has never used its authority to order a mandatory recall since it was given the power to do so in 1990.

Other critics agree.

“Once they got wind of it they had an obligation to jump on it because this could kill these people," said Bruce Brusavich, an attorney representing another injured spinal patient, Abraham Pena.

Twisted "like a piece of licorice"

At his home in Castaic, Pena spreads out nearly a dozen photos on the coffee table in his living room. One image of his neck shows a metal screw leaning precariously in the wrong direction and dangerously near an artery.

Abraham Pena works at the Men's Central Jail. After being injured during an altercation in January 2013, Pena had surgery at Pacific Hospital in Long Beach and has experienced extensive fall out from it. (Maya Sugarman/KPCC)

Pena, a Los Angeles County sheriff's deputy, injured his back in an altercation with an inmate at the men’s jail where he works.

While the FDA was corresponding with Spinal Solutions about quality control issues, Pena underwent several operations. His surgeon put a cage in his back and spacers between his discs, and inserted a few artificial discs.

The 35-year-old is now suing his Drobot-connected doctor, claiming the surgeon put counterfeit hardware into his body.

Last year Pena underwent his first corrective surgery – with the same surgeon. Pena said the doctor told him the cage was twisted "like a piece of licorice." During that surgery the original plate in his neck shattered and had to be replaced.

Pena worries the replacement hardware is counterfeit because it is also failing. He is waiting to have another cervical surgery this year with a different surgeon.

"They should have shut these people down"

The multiple neck surgeries have left Pena’s voice raspy. He’s on modified duty at work, and he had to give up his hobbies of fixing cars and going to the gym. He said he has trouble sleeping, and when he does he feels like he’s choking. 

The constant pain, financial worries and limited physical movement is a reminder of his fight with the Drobot network, said Pena.

"It's disturbing to me that not only that they did it but that they did it for so long, that it wasn’t exposed," he said. "They should have shut these people down."

Even though the FDA's investigation is over, critics say the agency still has a responsibility to track down the leftover Spinal Solutions inventory, and to alert people who have the company’s hardware in their bodies that there are questions about its authenticity.

For now the only ones trying to find those people are the lawyers who are suing on behalf of patients like Abraham Pena and Jo Dixon.