"The deficiencies," the agency said, "may compromise the safety and effectiveness of the products, particularly their sterility."
According to the FDA, if not sterile, the use of these devices poses a reasonable probability of serious adverse events or death.
But critics say the real story here involves the FDA's knowledge about the safety hazards at Shelhigh dating back to at least 2000, and the fact that it allowed patients to be implanted with the firm's devices for basically 7 years.
In the press release, the FDA says it inspected the Shelhigh facility last fall, and warned the firm in a meeting that failure to correct the violations could result in an enforcement action. The agency also noted that it had sent two previous warning letters to the firm about manufacturing deficiencies and other violations.
However, on its web site, Shelhigh has posted a response to the public statements made by the FDA and squarely points the finger of blame at the agency for allowing the sale of the potentially contaminated devices to continue."If the FDA truly believes what it claimed," Shelhigh states, "then the FDA is negligent and guilty of professional misconduct for permitting the use of Shelhigh products during the 10 weeks when 2-3 FDA inspectors were present at the Shelhigh facility and for 4 months afterwards."
But the history of the controversy at the center of this blame game goes back a lot further than last fall. According to the complaint filed in US District Court of New Jersey by the US Attorney for the District of New Jersey, to support the seizure of Shelhigh's products, the first FDA warning letter referred to in the agency's press release was sent 7 years ago on April 26, 2000, and the second warning letter was sent December 14, 2005.
In assessing blame, its necessary to understanding that FDA regulations require device makers to have systems in place to accept and analyze all complaints received from doctors and hospitals and to forward all complaints that indicate that a device failure may have contributed to the injury or death of a patient to the FDA.
The first warning letter proves that on April 26, 2000, the FDA was aware that patients who were implanted with Shelhigh devices were developing serious infections that required surgery to remove the devices and that Shelhigh refused to investigate the adverse events to determine whether its products were contaminated.
In the letter, the FDA said, Shelhigh "failed to evaluate" complaints of patients who developed infections which required surgical removal of the implant to determine whether the infection was due to the malfunction of the device.
The agency also pointed out that despite the fact that there were 4 separate event reports filed with Medwatch from one source that involved patients with infections so severe that the device had to be explanted, there "was no written evaluation or investigation of these Medwatch complaints," by Shelhigh.
The letter also stated that there were 43 problems related to infections of implanted devices reported by the firm's distributor, Classic Medical on October 14, 1999, which "were not recorded and evaluated as product complaints."
Jumping ahead to the FDA's latest list of safety violations, they include Shelhigh's failure to (1) adequately monitor critical manufacturing environments for possible microbial contamination; (2) properly test products for sterility and fever-causing contaminants; (3) scientifically support product expiration dates; and (4) manufacturing products in a poorly constructed and maintained clean room where sterilized devices are further processed.
On April 18, 2007, the FDA sent out a Dear Healthcare Provider letter stating, "This is to notify you that all medical devices manufactured by Shelhigh ... were manufactured under conditions that may have contaminated the devices and may result in devices that fail to function for the expected life of the products."
The FDA also said, it was aware of published reports of premature or accelerated failure associated with some devices and the products could potentially be contaminated with bacteria, fungi, and endotoxin. The letter recommended that providers assess the overall health status of each patient, and provide the testing, monitoring and care appropriate to each patient's individual case.
On April 19, 2007, the FDA issued a public advisory for patients stating: "Devices manufactured by Shelhigh, Inc. may have been implanted during various surgical procedures, including open-heart surgery for valve replacement; and repair of soft tissue structures during abdominal, pelvic, heart, lung, brain, shoulder, and spine surgery."
The advisory warns that patients vulnerable to infection and those at high risk for complications include the critically ill, children, the elderly, and pregnant women.
Noting that the devices have been available since 1997, the FDA tells patients, "The number of these devices that may be contaminated or experience problems isn't known at this time," and problems "could occur at anytime, and may become apparent to you and your physician during routine examination."
According to the agency, the seizure last month involves many products and includes pediatric heart valves and conduits, described as "tube-like devices for blood flow," surgical patches, arterial grafts, dural patches, which aid in tissue recovery after neurosurgery, and annuloplasty rings, used to help repair heart valves.
The FDA may not know how many devices have been sold but in the May 3, 2007, Star-Ledger, Shelhigh's marketing director, Douglas Goldman reported that, "thousands and thousands of the company's implants have been used since Shelhigh began distributing products 10 years ago."
The FDA's warning to patients amounts to a life-sentence of worry and medical care because the devices are permanently implanted into infants, children and adults and the agency advises doctors to monitor patients for infections and proper device functioning throughout "the expected lifetime of the device."
The meeting referred to in the FDA press release took place almost a year ago on June 16, 2006, and according the complaint filed with the court, "the firm was again warned by FDA that continuation of the violative conduct could result in seizure, injunction, and/or civil money penalties."
The inspections referred to in the press release took place between October 11 - December 20, 2006, and "revealed that the methods used in, and the facilities and controls used for, the manufacture, design, packing, storage, and installation of the devices do not comply" with safety regulations, according to the complaint.
"Because the firm's devices are implanted into patients," it states, "ensuring continued sterility is critical."
However, ensuring sterility was apparently not a priority to the FDA being it permitted the hazardous devices to be implanted for 7 years. The complaint was not filed until April 16, 2007, and in it, the FDA now claims, "the firm allowed at least four lots of devices that failed sterility testing to be released for distribution in the last two years."
This is certainly a bizarre allegation considering that the FDA allowed the sale of the devices in the same two years. On April 24, 2007, the arrogant founder of the Shilhigh, Shlomo Gabbay, MD, blasted the FDA on this point in a press release stating:
"There is absolutely no FDA recall of our devices which the FDA claims may cause patient injury. If our products were truly questionable as the FDA is leading the Public to believe, the FDA could have requested a remedy at any time - why haven't they?"Legal experts are not amused by the public spectacle of the firm and the FDA arguing over who's to blame for knowingly implanting patients with potentially contaminated devices.
Attorney, Derek Braslow, of the Pennsylvania Law Firm, Pogust & Braslow, has plenty of experience fighting for the "little guy" against the giant drug companies in large part because of the fact that the industry friendly FDA, under the Bush Administration, refuses to protect the public from dangerous products placed on the market by an industry comprised of the most generous Bush campaign contributors.
In this instance, Attorney Braslow says the conduct of both Shelhigh and the FDA is "outrageous."
"This is another example of a pharmaceutical company placing profits over people and further," he says, "why we cannot continue to rely on the FDA to protect Americans from dangerous drugs and devices."
"Instead of feigning worry about Americans importing contaminated drugs from Canada," he notes, "our government should be more concerned about the contaminated products in its own backyard."
"I doubt that even the Senate's proposed new drug safety legislation will end up being strong enough to prevent this kind of outrageous conduct," he warns.
"As far as I'm concerned," he says, "the FDA's action is too little, too late."
But Mr Braslow also says, "the failure of the FDA does not give this company a free pass."
"Shelhigh must be held responsible for its criminal conduct," he points out, "not only by the government but by those patients it injured."
According to the FDA, at the time of the seizure, Shelhigh was asked several times to voluntarily recall all of the products that remained on the market but declined to do so. On May 2, 2007, the FDA sent a letter to Shelhigh formally requesting the recall of all devices including those in hospital inventories.
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"The FDA," he said, "should understand that it must prove its allegations before it can make a request and their newest statements do not provide any further factual support for their claims."
Mr Gabbay and the FDA can argue over blame until the cows come home but the cold hard truth is that nobody will ever know how many serious injuries and deaths have occurred over the past 7 years that were not rightly attributed to the company's contaminated devices and the FDA's failure once again to protect the public.