Devices Used in Knee Surgery Had No Safety Proof

OtisMed Corporation didn’t have approval from the FDA for its OtisKnee guides before it started selling them. The FDA ultimately rejected the company’s application, saying that OtisMed failed to show that the product was safe and effective.

So why was the device used in the knee replacement surgery on Carla Muss-Jacobs, who suffered a terrible outcome?

A story reported by ProPublica.org and the New York Times explained that the tool was supposed to speed both the surgery and the patient’s recovery, but Muss-Jacobs suffered terrible pain, and had to undergo a second knee replacement.

According to the story, about 700,000 knee replacements are performed every year. It’s the most common elective surgery in the U.S., and the demand will only increase as the population ages, leaving an attractive market for companies that serve the surgical community.

OtisMed’s device was a system of guides directing the angle of the surgeon’s cuts to enhance the alignment of the artificial knee. It was supposed to help surgeons tailor bone cuts to a patient’s anatomy.

The FDA allows manufacturers to classify their devices, which basically lets them determine whether safety studies are required before they are sold. “That can allow some products that should receive closer scrutiny to slip by,” the reporters said.

The FDA has three classes of medical devices:

  • Class III devices, like pacemakers, require extensive testing because they are implanted or sustain or support life and could put patients at serious risk.
  • Class II devices, like powered wheelchairs or pregnancy tests, are approved if companies assure that they are similar to other devices on the market.
  • Class I devices – bandages, dental floss, forceps, etc. – must be registered but don’t require premarket review because they present a low risk. They may be sold without any other FDA involvement.

For OtisKnee, OtisMed told providers that its cutting guides were a Class I device and didn’t need FDA approval or clearance.

In 2008, despite an earlier surgery, Muss-Jacobs had a terribly painful left knee. Orthopedic surgeon Ronald Teed told her many doctors were using the OtisKnee device, and their patients recovered faster with less pain, she told ProPublica/Times.

She woke up from her procedure with so much pain that she couldn’t stop crying. She hobbled around with a walker and couldn’t work. After six months later, she consulted another surgeon, Dr. Ira Weintraub, who said the new knee had failed and was misaligned. He performed a complex revision surgery. Muss-Jacobs walked the next day, but still had a long, painful recovery.

But the damage was done. Without an income, in 2009 she declared bankruptcy and sued Teed. The case was dismissed. (Teed told the reporters that Muss-Jacobs had refused to comply with her rehabilitation plan. “She didn’t do what she was told,” Teed said, “and she ends up with a bad outcome.”)

Despite her legal loss, Muss-Jacobs learned of other complaints about the OtisKnee, that some surgeons questioned whether the device was safe and that it had not been approved by the FDA.

OtisMed marketed OtisKnee to providers at fancy events of the American Academy of Orthopedic Surgeons promising that it would simplify surgery and boost fees due to additional MRI scans, according to Justice Department case filings. It promised that more of a patient’s bone and ligaments would be preserved, improving fit and longevity. But according to the Justice Department, none of the promotional claims had been evaluated by the FDA.

Still, number of surgeons adopting the OtisKnee doubled each month in 2007.

Teed endorsed the OtisKnee, calling the surgery in an informational video a “piece of cake,” that it would reduce the risk of infections and other complications. “Eventually, though,” wrote ProPublica/Times, Teed found problems. “He said he had taken part in an OtisMed study and was one of the first surgeons to discover that the procedures were not always working as hoped. ‘Some did. Some didn’t …They weren’t perfect.'”

He brought the problems to the company’s attention, but said “they seemed like they couldn’t figure it out.” Later, he heard that OtisMed had revised the materials in the cutting guides, which might have led to them warping when they were sterilized before surgery.

“The FDA should have been sterilizing ‘the crud’ out of those things to test them,” Teed said. But he denied that faulty cutting guides were the problem in Muss-Jacobs’ case. Still, he said OtisKnee had taught him a lesson: “Don’t jump on the bandwagon too early.”

In December, OtisMed and its former chief executive pleaded guilty in federal court to criminal charges of distributing adulterated medical devices. The Justice Department said the company sold and distributed 18,000 OtisKnee devices from 2006 to 2009 without FDA approval.

In September 2009, the FDA notified OtisMed that it had not demonstrated that the guides were safe, and called the device a Class III device and told the company not to distribute it.

The OtisMed board voted to halt shipments, according to the Justice Department, but the company’s chief executive directed employees to ship some that had been held up since the FDA denial, and 218 were sent to surgeons, the Justice Department filings state.

Did OtisKnee cause Muss-Jacobs’ problems? That’s unknown, but U.S. Attorney Paul J. Fishman announced an $80 million settlement of criminal and civil charges against OtisMed, and said patients “should be entitled to trust that the devices their doctors are using are safe, effective, tested and approved.”

It’s not known how many people were harmed by OtisKnee. Finding a number wasn’t part of the Justice Department’s case.

An FDA spokeswoman told ProPublica/Times that there are so many Class I medical devices that the agency usually doesn’t check to see if they are properly classified. “It’s based on voluntary compliance,” she said. “We presume companies know the rules and regulations.”

The Muss-Jacobs case illustrates why all surgical patients must carefully investigate the tools their doctors intend to use. They must find out how long the surgeon has been using the procedure or technology, and what was the extent of his or her training. They must confirm that any device has been approved by the FDA. See our backgrounder on surgical errors and our blogs about knee replacement

As ProPublica/Times said, “An examination of the OtisKnee case shows how easily that trust can be violated in the rapidly evolving world of medical devices, a thriving $110 billion-a-year industry. If not for a whistle-blower, the public might never have learned about the widespread use of a potentially dangerous device that sidestepped regulation.”

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