Endotec’s Ankle Implant Stands Up to Court Scrutiny

It’s not often the little guy takes on the federal government and wins.

Endotec, a small South Orange, NJ-based maker of orthopedic devices, did just that this summer after years of fighting with the FDA for permission to legally market its unique ankle joint replacement implant.

The victory came after the FDA sought a court injunction barring the company from making and distributing the Buechel-Pappas Ankle, accusing it of trying to evade the law after it “failed miserably” during a clinical trial to test the safety and effectiveness of its product.

A federal judge in Florida not only rejected the FDA’s claims, he chastised the agency for impeding medical progress.

“While the court agrees that Endotec has faulty record keeping, the government has neither alleged that the B-P Ankle is unsafe or dangerous nor that the defendants have caused harm to any patient,” Judge Kendall Sharp wrote.

“FDA’s stringent regulations and strict interpretation of procedural requirements are resulting in technological innovation being stymied, rather than advanced,” he wrote. “Indeed, the evidence presented at trial showed the B-P Ankle provided greater benefits to patients than the alternative available in the United States.”

The FDA is appealing Sharp’s ruling and declined to comment on the case.

The decision was a vindication for the founders of the company, Frederick Buechel, an orthopedic surgeon in South Orange, NJ, and Michael Pappas, a professor of mechanical engineering at the New Jersey Institute of Technology in Newark, NJ.

“No one wants to be in the position of having your own government come after you when you are doing what you consider the right thing. It was most unpleasant,” Buechel said. “Despite our best attempts to satisfy the FDA and educate them about the artificial ankle joints and current technology, they would just turn a deaf ear to our scientific recommendations and our pleas.”

Pappas was more blunt.

“The FDA is not about protecting the public — they are just about protecting their bureaucracy,” he said. “The issue was not about the quality of our product, but about maintaining their power.”

The Endotec case revolved around the FDA’s procedures for approving medical devices.

The most heavily regulated are Class III devices, which can include heart valves, pacemakers and some joint replacements, and frequently require clinical studies and detailed documentation to prove their safety and effectiveness before marketing.

Some Class III devices can avoid the lengthy and costly clinical trial process if they are deemed “substantially equivalent” to a product that was on the market before 1976, when the medical device amendments to the FDA law were enacted by Congress.

There is also an exception to the pre-market review requirements for “custom devices” that are not generally available and are intended for a specific patient, or made to the specifications of a specific surgeon.

The Endotec ankle replacement was deemed a Class III device, requiring a pre-market review including a clinical trial, because it was considered different from other products on the market prior to 1976.

Buechel and Pappas developed a unique three-piece design with a mobile bearing that allowed for rotation and absorbed stress and pressure. Other devices on the market did not allow for as much mobility or flexibility, Pappas said.

An early version of the product was licensed by Pappas and Buechel around 1978 to a major device manufacturer, which began a clinical trial and then abandoned it in the mid-1980s.

Endotec continued to make the device available for custom use to Buechel and other doctors and for customers overseas, and in 2000 undertook its own clinical trial.

But the Endotec trial was fraught with problems, a point even Pappas and Buechel acknowledge.

“They failed miserably, running a clinical study that employed inexperienced and untrained clinical investigators with inadequate supervision, failing to maintain accurate data,” the government said in legal papers.

With the FDA refusing to accept the data, Endotec urged the agency to lower the classification to eliminate the need for more clinical studies while it continued to make the device available using the custom exemption. It cited peer-reviewed papers showing success of the device in Europe and the United States.

One satisfied customer was Christine Klipphahn of Clinton, NJ, who had her ankle crushed in a car accident in 1991. The 47-year old woman said she was badly disabled, but since getting the implant almost 17 years ago has been able to lead a normal life.

“It was miracle. I owe my life to Dr. Buechel,” she said.

The company’s efforts for reclassification were never accepted and in 2002, Endotec received a warning from the FDA about its practices. Finally, in 2006, the FDA filed a lawsuit seeking to block further distribution of the ankle replacements and asking for disgorgement of profits.

The FDA said the company, which has only about $2 million a year in sales for all of its products, was breaking the law under the ruse of the custom exemption. Over the years, Endotec has sold more than 4,000 of its ankle replacements in the United States and overseas, according to court documents.

“Simply put, defendants have not created any ‘custom ankles’; rather, they have created a fiction to distribute the B-P Ankle without pre-marketing approval from the FDA,” the government said in court papers.

The judge saw it differently.

“The court finds the ankle devices were not generally available or generally used by other physicians and each was manufactured to meet the needs of a specific patient,” the judge said.

Pappas said the ruling means patients can continue to benefit from the ankle replacement, but he noted he and Buechel will not likely profit from the victory. The patent on the ankle implant, he said, has expired and now DePuy, a division of Johnson & Johnson, is conducting a clinical trial on a similar design that could be approved in several years.

SOURCE: The Star-Ledger