How did this Medical Device Ever get Sold and Used?

How did a medical device hailed as a great time-saver for a popular operation turn into millions of dollars in corporate fines and possible jail time for the maker’s CEO? It turns out there is plenty of blame to go around.

Knee replacement surgery is one of the most performed procedures in the United States, about 700,000 each year. OtisMed developed a cutting guide for knee replacement surgeries, called OtisKnee. The company claimed the customized cutting guide would lead to more successful outcomes for patients and quicker surgeries for doctors, which meant doctors could do more of these lucrative procedures.

The medical device maker marketed the product directly to surgeons and sold about $27 million of the OtisKnee cutting guides. With this success, the company drew the attention of a much larger medical device maker, which made a bid to buy OtisMed.

However, there was a problem. OtisMed never had the U.S. Food and Drug Administration (FDA) approve OtisKnee. The larger company therefore had OtisMed submit OtisKnee for FDA review. The FDA subsequently refuted the patient safety claims and ordered the product not be sold. However, the CEO of OtisMed still ordered the shipment of 218 of the potentially unsafe medical devices, according to federal government allegations.

Prior to the FDA’s review and rejection of OtisKnee, there were numerous patient complaints following knee replacement surgeries that used the cutting guide.

So how was the questionable medical device allowed to be sold in the first place?

Medical devices are placed in three FDA categories: Category I, Category II and Category III. Category I devices are the most basic – such as forceps – and don’t require FDA review. The FDA allows medical device makers to determine which category their products belong in. In this instance, OtisMed self-labeled the OtisKnee a Category I product. Only during the FDA’s post-market review did the agency determine it really was a Category III medical device and required government approval before being used on patients.

The U.S. Justice Department took action against the company, which recently agreed to pay $80 million in fines. Its CEO pleaded guilty to federal crime and faces up to three years in jail.

While the federal government received a measure of justice, just how many patients were harmed by the medical device is still unknown.

When products are knowingly misrepresented, manufacturers should be held responsible to their victims for the harm they cause. If you believe you or a loved one was injured by a faulty product, you may want to consult an attorney experienced in defective product litigation.

The choice of a lawyer is an important decision that should not be based solely on advertising.