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Shelhigh and FDA play Blame Game Over Sale of Contaminated Devices

Evelyn Pringle May 15, 2007

On April 17, 2007, the FDA issued a press release to announce that US Marshals had seized all implantable medical devices from Shelhigh, Inc, in Union, NJ, after finding “significant deficiencies in the company’s manufacturing processes.”

“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.

On May 3, 2007, Mr Gabbay issued his own press release and callously refused to recall the devices to prevent the possibility of more implant victims. “This is the first formal request by the FDA for Shelhigh to recall its products,” he said, “and since the FDA allegations are unfounded, Shelhigh has no intention to initiate a product recall.”

“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.

Filed under: 2007, FDA, medical devices, Shelhigh

Shelhigh and FDA Play Blame Game Over Sale of Contaminated Devices

Evelyn Pringle May 2007

On April 17, 2007, the FDA issued a press release to announce that US Marshals had seized all implantable medical devices from Shelhigh, Inc, in Union, NJ, after finding “significant deficiencies in the company’s manufacturing processes.”

“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.

On May 3, 2007, Mr Gabbay issued his own press release and callously refused to recall the devices to prevent the possibility of more implant victims. “This is the first formal request by the FDA for Shelhigh to recall its products,” he said, “and since the FDA allegations are unfounded, Shelhigh has no intention to initiate a product recall.”

“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.

Filed under: 2007, Braslow, FDA, medical devices, Shelhigh

Battle of Device Maker Shelhigh and FDA Rages On Part I

Evelyn Pringle May 2007

In a court hearing on May 15, 2007, US District Court Judge William Martini in New Jersey informed medical device maker Shelhigh that it was unlikely that he will allow the release of any inventory seized by US Marshals at its Union City plant, after the FDA found “significant deficiencies in the company’s manufacturing processes.”

A seizure is an enforcement action taken as a last resort to remove a dangerous product from commerce. The FDA initiates the action by filing a complaint with the District Court where the product is located and a US marshal is then directed by the court to take possession of the goods until the matter is resolved. The complaint against Shelhigh was filed on April 16, 2007

The US Marshal did not physically remove the devices from the plant but rather “seized them in place,” meaning Shelhigh cannot remove, attempt to remove or in any way interfere with the products without the prior written permission from the US Marshal. The firm’s products have also been embargoed by the state of New Jersey.

Shelhigh sought an emergency hearing on a request for some of the quarantined materials to be released for export to Spain and Italy. Shelhigh says the majority of its business results from exports and claims the company will go under and have to lay off its 50 employees if it is not permitted to export devices to other countries.

In its request, Shelhigh argued that the firm’s tissue-based products imported to other countries are exempt from the FDA’s rulings but Judge Martini disagreed and said, “I’m inclined to agree with the government interpretation,” during the hearing.

Its difficult to understand how Shelhigh believes it has a legal leg to stand in light of the FDA’s last 7 years of warnings, threats, and promises. Investigators documented deficiencies in the firm’s Union City facility in 2000 and 2005, and those inspections resulted in warning letters to Shelhigh in April 2000 and December 2005.

A December 14, 2005 warning letter spelled out what Shelhigh was facing. Your failure to comply with any post-approval-requirement, the FDA explained, constitutes a ground for withdrawal of the Human Device Exemption and commercial distribution of a device that is not in compliance with these conditions is a violation of the Federal Food, Drug, and Cosmetic Act.

“Federal agencies are advised of the issuance of all Warning Letters,” the FDA wrote, “about devices so that they may take this information into account when considering the award of contracts.”

“Additionally,” it said, “no premarket approval applications for Class III devices to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected.”

Also, in language highly relevant to this case, the letter warned that, “no requests for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected.”

The FDA instructed Shelhigh to take “prompt action” to correct the problems. “Failure to promptly correct these deviations,” it warned, “may result in regulatory action being initiated by the Food and Drug Administration without further notice.”

“These actions include, but are not limited to, seizure, injunction, and/or civil money penalties,” the FDA stated.

An FDA warning letter is supposed to signal that a company had better clean up its act or the ax is going to fall. In the case of Shelhigh, the FDA refuses to explain how the firm managed to keep selling defective devices for 7 years..

And to this day the company is openly defying the FDA and showing no remorse for its part in this fiasco. In fact, orders are still coming in for Shelhigh products, according to Mike Furgal, vice president of sales, in a report by Thomas Gaudio for NJBiz.com on May 15, 2007.

“We have a number of distributors,” he states, “throughout the United States and the rest of the world that are shipping products to accounts that are asking for it.”

“The products are continuing to be implanted around the entire country and outside the United States,” Furgal told Mr Gaudio.

And for its part, according to Mr Gaudio, the FDA would not comment on why it waited 5 years between warning letters and then nearly a year-and-a-half between the December 2005 letter and the seizure, or why it then waited 2 more weeks after the seizure to send Shelhigh a formal request for a product recall.

The tissue-based products manufactured by Shelhigh are used in surgical settings including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery, according to an FDA press release on April 17, 2007.

In a letter to health care providers on April 18, 2007, the FDA noted published reports of premature or accelerated failure associated with some Shelhigh devices and said they could potentially be contaminated with “bacteria, fungi, and endotoxin.”

A public health advisory was issued the next day telling patients: “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.”

In addition to the warning letters, the FDA’s press release noted that Shelhigh had been warned to correct the problems at its facility at a meeting but did not mention that the meeting took place last June 16, 2006. That date was revealed in the complaint filed in court and alleges, “the firm was again warned by FDA that continuation of the violative conduct could result in seizure, injunction, and/or civil money penalties.”

According to the legal filing, the fall 2006 inspections revealed ongoing problems that included manufacturing devices in a poorly constructed and maintained clean room, failure to adequately monitor for possible microbial contamination, failure to properly test products for sterility, failing to scientifically support product expiration dates and failing to properly train employees.

As an example of employee misconduct, the complaint alleges that a Shelhigh employee fabricated “test results on retained samples and presented the data to an FDA investigator because she could find no record of the original test results.”

The complaint also explains that employee training “must include the consequences of improper performance so that the personnel will be aware of the effects that their actions can have on the safety and effectiveness of the device and know what process and product defects can occur as a result of deficient practices, procedures, or conditions.”

But then the December 2005 letter cited the firms failure to ensure that all employees were trained to adequately perform their assigned responsibilities, and to document the training. “Specifically,” the letter said, “your employees training records do not specify what procedures each employee was trained on, and how their training relates to the procedures that apply to their areas of responsibility.”

The FDA’s complaint also says, Shelhigh illegally made design changes to a device that is implanted in infants and children without notifying the FDA. Reporting changes is required to create a history of evolution of the design and such records “are integral to failure investigations and preventing the repetition of errors and the development of unsafe or ineffective designs,” according to the complaint.

But this allegation is nothing new either. The April 2000 warning letter noted that Shelhigh devices were not in conformance with the Quality System/Good Manufacturing Practice Regulations, and noted that there was no “Master Device Record” for one device.

The FDA letter specifically stated: “Design controls for the Uropatch are lacking with regard to the following: Design history file; Design plan; Design inputs; Design outputs; Design review, Design verification and Design validation.”

In addition, the second warning letter in 2005, following inspections on April 28 through May 16, 2005, and July 21 through August 10, 2005, cited the company’s failure to follow its “own written procedures for design control” in order to confirm that the changes made to certain devices were controlled to include validation or where appropriate, verification prior to their implementation, and a failure to demonstrate that the device history records for certain devices were manufactured in accordance with the device master records.

According to Vince Boehm, who monitors FDA enforcement activities, “It is surreal that the first FDA warning letter in this case was sent 7 years ago on April 26, 2000, and the second warning letter was sent December 14, 2005.”

“This horror story,” he says, “documents the crass outcomes of the Prescription Drug User Fee Act.”

“The PDUFA,” he notes, “puts all the cards in the manufacturers hands, and leaves the FDA impotent to act on it’s own to remove a dangerous product.”

A 2002 statute extended user fee policies to cover medical devices. This month the Senate passed FDA reform legislation but the bill did not give the FDA the much needed control over medical devices.

“The new version of the law, Mr Boehm says, lacks the crucial authority to permit the FDA to act on it’s own to remove dangerous or harmful products.

“Under the PDUFA,” he notes, “the FDA has only one option, to haggle, haggle and haggle some more with maker of a dangerous product.”

“In the case of Shelhigh,” he points out, “it took seven years of haggling.”

“This puts the FDA in a perfect “out” position,” he says, “because the FDA can always tell an injured patient protesting an injury or death of a loved one that their hands were tied.”

Filed under: 2007, Braslow, FDA, medical devices, Shelhigh

Battle of Device Maker Shelhigh and FDA Rages On Part II

Evelyn Pringle May 2007

In response to references about warning letters dating back 7 years in the FDA’s complaint filed in New Jersey US District Court to initiate the seizure of all products made by device maker Shelhigh, on its web site, the company claims the old letters don’t count.

“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 being that they mirror the allegations in the complaint filed in April 2007.

The April 2000 letter shows 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 anytime, 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 four 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 and 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.

With all that said 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.”

And 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 because 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.

Kenneth Reid, publisher of Washington Information Source, which monitors FDA enforcement actions, told Newhouse News Service in The Times, on May 13, 2007, that Shelhigh’s aggressive stance is fraught with risks.

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.

Filed under: 2007, Braslow, FDA, medical devices, Shelhigh

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Matthew Schultz killed by Effexor. Two hours old.

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Big Pharma Victim

  • I haven't been on in awhile thanks to all those who followed 4 years ago
  • @LindsayRush yay IOWA! 4 years ago
  • Another rainy day here in IOWA. Well at least i had a good time swimmin yesterday. 4 years ago
  • Hey everyone hope you have a great day! THanks to all the new followers :) and for those that continue to follow 4 years ago
  • srry if I dont get on here much I mostly just look at my facebook acct. thanks to all the new followers! 4 years ago

The Indiana Star

Christiane Schultz

  • Is not coping well at all. Loss sucks! 5 years ago
  • is scared to bond with this baby, just in case. 5 years ago
  • Happy 6 months today baby. I love you Matthew. 5 years ago
  • Living with loss, sucks. 5 years ago
  • Thinking I need to discuss plans for this baby soon or I will be having it in my doctors office. Where do I deliver? 5 years ago

Amery Schultz

Seeking Parents in Missouri for Celexa / Lexapro Class Action – Call 800-827-0087

TWEET FOR LIFE

BREATH – The Official Blog of MADNAP – momsandmeds.com

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  • Untitled
    Originally posted on The Bitter Pill:Kickstarter is a website for artists to use to raise money and complete awesome projects. The best thing to come to the informed consent movement since Thomas Szasz could just be the new, upcoming film by Dan Jenski, “ADDicted” which basically gives Ritalin, Adderall, Concerta and the like a…
  • Untitled
    Originally posted on The Bitter Pill:In the studies submitted to the FDA for approving Zoloft (a drug that has killed numerous families, babies, mothers, children), the drug maker covered up the fact that Zoloft failed to outperform placebo, according to a new consumer fraud lawsuit filed by the firms Baum, Hedlund Aristei & Goldman…
  • Antidepressants Again Linked to Preterm Birth & Seizures
    In what was more than likely originally an attempt to prove that depression causes birth complications, researchers from Yale, Tufts, et al found in two new studies that antidepressants increase the risk of preterm birth and seizures. Read more at this link on the newly redesigned UNITE website.
  • Who Could Do This On Purpose
    Read this blog to find out
  • Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed
    Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed (Cross-Posted on The Bitter Pill blog) Amery and Christiane Schultz have been asked to provide input on proposed recommendations regarding psychotropic drugs in pregnancy in Canada. Amery & Christiane are hard-working activists affiliated with UNITE and MADNAP. Please send […]

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