ReGen Biologics’ long battle against the FDA entered a new phase this year, with the medical device company’s appeal in a lawsuit it filed against the watchdog agency, its top regulator and the secretary of the U.S. Health & Human Services Dept. over the FDA’s decision to rescind the clearance granted to ReGen’s Menaflex knee implant.
Oral arguments were held in the U.S. District Court of Appeals for the D.C. Circuit yesterday in ReGen’s appeal of the 2011 lawsuit it filed against the FDA, its Center for Devices & Radiological Health chief Dr. Jeffrey Shuren and HHS head Kathleen Sebelius. In April 2013 a lower court granted the FDA’s motion to dismiss, agreeing that the federal watchdog agency was within its rights to turn its green light for Menaflex to red.
The Hackensack, N.J.-based company declared bankruptcy in 2011, a year after the FDA’s Center for Devices & Radiological Health pulled the 510(k) clearance it granted the Menaflex device in 2008. ReGen filed the lawsuit later that year, calling the decision to pull the FDA clearance "arbitrary and capricious, an abuse of discretion, not in accordance with law, and in excess of statutory jurisdiction, authority and limitations" and asking the U.S. District Court for the District of Columbia to nullify the rescission.
Now the company argues that the appeals court’s own precedent in another case, American Methyl and New Jersey, when it held that "when Congress has provided a mechanism capable of rectifying mistaken actions … it is not reasonable to infer authority to reconsider agency action," according to court documents.
"Because Congress provided a mechanism in [the FDA statutes] capable of rectifying mistaken classification determinations, American Methyl and New Jersey dictate that FDA has no inherent authority to reconsider such decisions," according to the documents.
"But even if FDA did have inherent reconsideration authority, its action would still be unlawful because Dr. Shuren did not evaluate the [Menaflex collagen scaffold] based on the intended use set forth in its labeling. FDA does not dispute that under § 513(i)(1)(E), 21 U.S.C. § 360c(i)(1)(E), labeling is controlling of a device’s intended use in the context of substantial equivalence determinations. Here, the labeling unambiguously states that the CS is "intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus" and that it "is not a prosthetic device and is not intended to replace normal body structure." [emphasis theirs]. Dr. Shuren did not give these statements controlling weight, and relied on factors external to labeling to conclude that the CS is "intended to replace, rather than reinforce or repair, meniscal tissue." JA1327. FDA does not offer any plausible explanation of how to square Dr. Shuren’s intended use finding with the text of the labeling."
The appeal adds yet another layer to the ReGen story and its protracted and public battle with the FDA. The rescission of the Menaflex device, a bio-absorbable mesh implant designed to encourage the re-growth of damaged knee cartilage, forced ReGen to pull the device from the U.S. market until clinical trials proved its safety and efficacy. ReGen wasn’t shy about voicing its displeasure over the rescission, with then-CEO Gerald Bisbee calling it "totally unbelievable."
The FDA said it wants ReGen to "discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness," 5 years after the company began the 510(k) application process.
ReGen sank $30 million into its successful 510(k) bid, "only to have the agency reverse decisions made by previous CDRH officials by stating that they were in error with no substantial evidence that is true."
The Menaflex 510(k) clearance in December 2008 came over the objections of FDA scientists. In September 2009 the agency admitted that undue influence from 4 New Jersey congressmen and former commissioner Andrew von Eschenbach affected the decision to green-light the device and announced a probe into the foofaraw.
In March 2011, the FDA’s Orthopedic & Rehabilitation Devices Panel decided that, while the implant is reasonably safe, its effectiveness needed to be further analyzed. That decision came the same week that the FDA released a report saying ReGen failed to produce adequate evidence that device was safe before it was cleared to hit the market.
"It’s unbelievable that after more than five years of 510(k) review of this product — and after being told by the ODE Director and the CDRH Director to file two separate 510(k) submissions for this device as a surgical mesh — [CDRH head Dr. Jeffrey] Shuren now says that they were wrong,"Bisbee said in prepared remarks on March 22. "This arbitrary and unsubstantiated intention is an example of why the investment community is increasingly wary of investing in companies with products requiring FDA approval."
That wasn’t the only shot Bisbee fired across the FDA’s bow.
"We and they both know the agency has no legal authority to rescind its clearance of Menaflex. There is ample evidence the FDA completely botched its review of our Collagen Scaffold at every stage," he said. "After six years of unthinkable bias, mistakes and blunders, we are opting out of the FDA’s administrative process and pursuing other legal options for continuing to market Menaflex to U.S. orthopedic surgeons and their patients."