A Medical Device Daily

Endotec (South Orange, New Jersey), a maker of orthopedic devices, scored a victory over FDA after years of fighting with the agency for permission to legally market its ankle joint replacement implant.

The victory came after 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 (Medical Device Daily, Oct. 11, 2006).

A federal judge in Florida, where the company has a manufacturing facility in Orlando, not only rejected FDA's claims, but also chastised the agency for impeding medical progress.

"While the court agrees that Endotec has faulty recordkeeping, 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.

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

"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 told the Newark Star-Ledger. "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 told the Star-Ledger. "The issue was not about the quality of our product, but about maintaining their power."

The Endotec case revolved around 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 also is an exception to the premarket 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 newspaper noted that the Endotec ankle replacement was deemed a Class III device, requiring a premarket review, including a clinical trial, because it was considered different from other products on the market prior to 1976.

Buechel and Pappas developed a 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 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 U.S.

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 U.S. 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 premarketing 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.

In other legal news, a couple in Mt. Vernon, Washington, who used an unproven medical device to treat people with hepatitis and cancer have been sentenced in federal court.

Donald Brandt was ordered to spend 30 days in prison and sentenced to four months of home detention. His wife, Sharon Brandt, received five months of home confinement. They were ordered to pay a collective fine of $10,000 by U.S. District Judge Richard Jones.

The couple operated a clinic for several years and offered treatments using a so-called "Vibe Machine," which purportedly uses radio frequencies to cure disease. Donald Brandt sometimes posed as a doctor, according to court documents.

Sharon Brandt was in charge of scheduling appointments, and allegedly told patients, their family members and undercover state investigators to "keep quiet" about their treatments or the clinic would be in trouble for their "unapproved and clandestine" work, according to state and federal records.

The federal charges stemmed from an investigation by FDA and the Washington State Department of Health. The state investigation showed Brandt earned $807,950 in treatment fees since 1995.

At least one person — a 32-year-old Bellingham, Washington, man — died while being treated by the Brandts with an unproven machine, according to a search warrant.

Donald Brandt treated the man, who was diagnosed with testicular cancer, for more than a year although the man's physician had recommended immediate surgery to save his life. After refusing surgery and spending several thousand dollars on the device treatments, the man died on Dec. 14, 2004, of cancer, leaving a wife and three young children.

"You were a charlatan and fraud, preying on vulnerable victims," Jones told the couple.

Prosecutors said the Brandts "took advantage of many very sick people who desperately sought some hope as they were dying, taking thousands of dollars from them in their last days."