"Past warning letters," it notes, "do not apply to the recent seizure action, and the content of the 7 year old, 2000 warning letter was addressed."
"The complaint," the firm says, "filed by the FDA that lead to product seizure included different claims which Shelhigh believes are unsupportable and not related to any realistic possibility of unacceptable risks to patients."
If given the opportunity to review the FDA warning letters issued in April 2000 and December 2005, Shelhigh patients might not agree since they mirror the allegations in the complaint filed in April 2007.According to an April 17, 2007, FDA press release the products manufactured by Shelhigh are used in open-heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery.
The April 2000 letter shows that the FDA knew then that patients were developing serious infections that required surgical removal of the devices and that Shelhigh refused to investigate the adverse events to determine whether the products were contaminated.
Because the sales of Shelhigh devices date back to 1997, the FDA now says the number of defective products is not known but warns that problems "could occur at any time, and may become apparent to you and your physician during routine examination."
Another violation listed in the latest complaint alleges that Shelhigh only provided documentation to the FDA to support a 3-year shelf-life for its products, but, "the firm's labeling claims a 4-year shelf-life for all devices."
FDA regulations require device makers to establish and maintain adequate procedures for the health, cleanliness, personal practices and clothing of employees who work in areas where their contact could adversely affect the product. The complaint alleges that adequate requirements "were not established and maintained."
By law, companies must have systems in place to receive and analyze all complaints received from health care providers and must notify the FDA of complaints that indicate that the failure of a device may have contributed to a death or injury.
However, in the April 2000 letter, the FDA reported that the company had "failed to evaluate" complaints of patients who developed infections which required surgical removal of the implant to determine whether the infection was due to malfunction of the device.
The letter noted that there were 4 separate Medwatch reports by one source that involved infections so severe that the device had to be explanted, but there "was no written evaluation or investigation of these Medwatch complaints."
The letter also reported that forty-three problems related to infections were reported by the firm's distributor on October 14, 1999 and "were not recorded and evaluated as product complaints."
The FDA said there was insufficient documentation to support Shelhigh's decision that the product malfunctions were not reportable. "Your position that the infections were due to user technique," the letter said, "does not abrogate your responsibility to report these events."
In each of the complaints, the FDA said, "documentation was lacking to indicate that these incidents were fully reviewed, evaluated and investigated, in order to conclude that the reported failures were due to user error, rather than device nonconformance."
Two complaints, the letter said, reported infection of implanted devices, which required surgical intervention to explant, and documentation was lacking or insufficient to support the conclusion that these events were procedure-related and not product-related.
Even with all that stated in the April 2000 letter, 5 years later in the December 2005 letter, the FDA once again cited Shelhigh's failure to maintain complaint files. "Specifically," the agency said, "no complaint files were maintained for the years 2000, 2002, 2003, 2004, and 2005."
"For example," the letter states, "your firm received oral communication of problems by phone or from physicians during conferences where these complaints are not reported in your complaint log."
This time, the FDA pointed out that Shelhigh had still failed to review and evaluate complaints dating back to 1999 to determine whether an investigation was necessary. "Specifically," the FDA wrote, "your firm has failed to adequately investigate and follow-up on all complaints that were received from physicians by phone or during conferences from 1999 to the present."
"You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice."
As noted above, the December 2005 letter ended with the idle threat that the company needed to take "prompt action" to correct the violations or the company could be subject to sanctions including "seizure, injunction, and/or civil money penalties."
Well, so much for that warning. Following the seizure of the company's products on April 24, 2007, the fearless Shelhigh founder, Dr Shlomo Gabbay, issued a press release stating there is "absolutely no FDA recall" of our devices which the FDA claims may cause injury.
On May 2, 2007, the FDA took the bait by sending Shelhigh a letter requesting a recall of all the firm's medical devices which remained in inventories on the market and warned doctors, hospitals and consumers of the potential risks associated with Shelhigh devices.
The next day, Dr Gabbay issued another press release announcing Shelhigh was refusing to conduct a recall. The company's web site said it had "no intention to initiate a recall," and posed the question: "If the alleged problems were as severe as the FDA claims, why did it wait 6 months to act?"
At least in part, attorney Derek Braslow of the Pennsylvania law firm of Pogust & Braslow agrees that the FDA's inaction is glaringly clear. "All of this could have been avoided," he states, "if the FDA had only followed up on its own warnings."
But ultimately, he says, Shelhigh must be held accountable. "The company was aware of serious problems at its facility," he points out, "and failed to address them, failed to warn physicians, and continued to sell its product to unsuspecting doctors, all the while knowing its products were unsafe."
Business analysts say Shelhigh is playing with fire by engaging in a public battle with the FDA, and its competitors are jumping for joy on the side lines. Datamonitor, a business information firm, lists the top competitors as Medtronic, Baxter International and Bio Vascular.
READ MORE LEGAL NEWS
Mr Reid notes that the FDA has the power to put the firm out of business as well as work with the European Medicines Agency to block overseas sales. "Shelhigh can fight the FDA, but they do so at their own financial peril," he said.
"The regulators are much more in tune with each other than ever before," he told the Times. And if Europe or the United States takes action, "the other will react," he added.
Also see: Battle of Device Maker Shelhigh and FDA Rages On Part I