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."