Knee Replacement Cutting Guides Not Approved But Used In Surgery

As a Medical Malpractice lawyer that is close to needing a knee replacement a recent article in the New York Times caught my attention.  We recently finished a trial involving a failed knee replacement surgery, so I was familiar with the medical malpractice issues involving replacement surgery.  That being said, I was unaware that a company by the name of the OtisMed Corporation, the maker of the OtisKnee, was selling cutting guides (the guides work like carpentry jigs, and are placed over the thigh and shin bones to line up the bone saw precisely) without seeking clearance from the Food and Drug Administration.  When Otis did apply for F.D.A. review, its application was rejected because, the agency said, the company failed to show that the product was safe and effective.

Joint replacement surgery is a big money maker for doctors, hospitals, and product manufacturers.  In the case we just tried the doctor performed 6 surgeries that day.  He completed our clients surgery in 24 minutes.   Not sure about you, but I want my doctor taking a little more time.  In the NY Times article the doctor that performed the surgery using the Otis device was doing 12 surgeries a day, and began using the Otis device when OtisMed approached him and said that with the OtisKnee, he could work even faster.

Otis had the perfect sales pitch, The OtisKnee would simplify surgery and bring in extra revenue from additional M.R.I. scans, and faster surgical times.

The focus of the Times article is Carla Muss-Jacobs, whose clinical presentation was typical of so many baby boomers looking for relief from an arthritic knee.  In 2008, Ms. Muss-Jacobs, had a terrible pain in her left knee. Years earlier, she had a knee operation, but things were getting worse, so she went to see Dr. Ronald Teed, an orthopedic surgeon.

Dr. Teed performed the arthroplasty in May 2008 and when Ms. Muss-Jacobs awoke she was in so much pain, she couldn’t stop crying. She knew immediately that something was wrong.  After 6 months of being unable to walk she went to a different doctor, who said the new knee had failed, was misaligned, and that she needed a  complex revision surgery.  Dr. Teed blamed Ms. Muss-Jacobs for failure to comply with physical therapy-That is the common defense in joint replacement medical malpractice cases.

In order to prevail in her medical malpractice case, Ms Muss-Jacobs would need to prove that Dr. Teed fell below the standard of care by misaligning her knee, which can happen by making improper cuts.  The article says that she was unable to get a lawyer to take her case, and I would suspect the reason was that she made a good recovery after the revision surgery.  Thus the damages are limited to that 6 month period of pain and suffering-while substantial, that may not warrant the substantial costs of a medical malpractice lawsuit.

So how did Otis sell the product without FDA approval?

The F.D.A. regulates medical devices by classes, and each is treated differently.

• 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 and the like — must be registered but don’t require premarket review because they present a low risk. They can be sold without any other F.D.A. involvement.

The F.D.A. gives companies some freedom in classifying their devices. And in the case of the OtisKnee, OtisMed officials told doctors and hospitals that its cutting guides were a Class I device and didn’t need F.D.A. approval or clearance, the Justice Department said.

In September 2009,  the F.D.A. notified OtisMed that it had not demonstrated that the guides were safe. The F.D.A. notice said that the OtisKnee was a Class III device and that OtisMed’s submission was missing data about how patients had fared, raising concerns about failure rates.   Otis continued to sell the device, and ultimately paid $80 million in criminal and civil fines.

In you are considering knee replacement surgery (arthroplasty) or any surgery for that matter-do not be afraid to ask questions, and do your own research.  Ask the doctor which implant he/she intends to use? Why that brand?  What cutting guides?  Why? How long have you been using that product?  Why do you think that product is best? How many surgeries are you performing the day of my surgery?

 

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