A Medical Device Daily
Utah Medical Products (UTMD; Salt Lake City), a defendant in a lawsuit filed more than five months ago by the FDA in the U.S. District Court in Salt Lake City in which the FDA alleges violations of the Quality System Regulation (QSR), reported more from its side of the ongoing story.
On Nov. 16, UTMD reported the admissions made under oath by the FDA designated enforcement official that the FDA is not claiming that UTMD's devices are unsafe, ineffective, defective or causing any harm to patients (Medical Device Daily, Nov. 17, 2004).
“UTMD was pleased with this FDA confirmation of UTMD's history of quality service to the healthcare community, but remains saddened and puzzled by FDA's motivation,“ the company said.
Two more months have passed in the discovery process since that announcement. UTMD said it was providing an update to shareholders, clinicians and other interested constituents with respect to the litigation progress. During this time, as part of the discovery process, a number of FDA and Center for Devices and Radiological Health (CDRH) documents, including expert reports have been obtained, and additional depositions of FDA officials have been taken by UTMD's lawyers. Also, UTMD's independent experts have filed their reports.
According to an expert report filed on Jan. 10 on behalf of UTMD by a 28-year FDA compliance veteran and former FDA district director, “It is my opinion that UTMD is in substantial compliance with all requirements of the QSR.“
That position “directly contradicts“ the FDA's, UTMD said.
Another expert report filed by a 30-year professor in plastics materials engineering at a major university, who previously taught FDA inspectors, expressed that, “The FDA fundamentally misconstrues and misunderstands the nature and principles of plastics parts manufacturing, such as injection molding and extrusion . . . Utah Medical's procedures and guidelines related to extrusion and injection molding operations and process control are superior.“
Utah Medical CEO Kevin Cornwell said, “Our belief that some personnel within the FDA have abused their authority and the concept of due process is strengthened by disclosure of documents that are being discovered only because of the benefit of the judicial process. Expert reports filed on behalf of the FDA rely on information provided by the FDA rather than the on-site manufacturing facility audit that was performed by UTMD's independent experts. Regrettably, FDA documents contain a very subjective and negative characterization of UTMD, its employees and representatives.“
UTMD continues to manufacture and distribute all of its products worldwide without any regulatory restriction, the company said, because the FDA ultimately must prove its allegations. UTMD said it affirms its belief in previous press release statements about its conscientious compliance with the QSR, as well as significant deficiencies in the FDA's performance, which it said appear to be “increasingly supported“ by the evidence in discovery to date.
UTMD, with particular interest in healthcare for women and their babies, manufactures a range of disposable and reusable specialty medical devices.