Shelhigh: Anatomy of an FDA Medical Device Products Seizure

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Shelhigh: Anatomy of an FDA Medical Device Products Seizure

December 03, 2008 - 08:18 PM

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Category: Medical Devices & ImplantsTags:

FDA, Shelhigh, medical, device, manufacturer, CDRH, safety,

dangerous, MAUDE, AER0 Comments Print Article Feed Usually, our

discussions address how the FDA might have timely recalled defective

and dangerous medical devices and drugs. However, this is a story

about the way that the FDA seems to have overreacted in April 2007,

when it ordered US Marshalls enter Shelhigh, Inc.'s New Jersey

factory premises and seize every medical device that the company had

manufactured and warehoused.

Shelhigh is a boutique medical device manufacturer known for its

proprietary No-React® tissue products that utilize the widely

accepted glutaraldehyde fixation process. Using its its proprietary

know how, Shelhigh has managed to avoid the problems that accompany

glutaraldehyde tissue processing.

These life saving No-React devices include the MitroFast mitral

valve repair device, the BioMitral bicuspid valve, the BioRing

annuloplasty ring, the BioConduit Stentless Valve, and Endura No-

react Dura (photo unavailable).

It is hard to figure whether the joint FDA-US Marshalls strike on

Shelhigh was an attempt by the FDA to show the world that it could

regulate with impunity, or whether that strike was merely an

arbitrary contest between a small manufacturer and a division within

the FDA.

Amidst all of the action that was occurring between the FDA and

Shelhigh in 2007, Dickinson, an investigative reporter for

Medical Device and Diagnostic Industry magazine (MD & DI), found that

the FDA behaved differently toward small device manufacturers. He

noticed that the FDA singled out small manufacturers for total

facility shut down, and that those manufacturers were usually

corporations with a single line of products and no other revenue

stream.

According to Dickinson, the FDA's Center for Devices and

Radiological Health (CDRH) would review a small company's

documentation for evidence of deficiencies. And even when the CDRH

could find no palpable evidence of product defects or risk to public

health, it would demand remedial action that directly affected the

entire line of devices; action that usually resulted in a total

facility shut down.

Here is the general regulatory scenario. When the FDA mandated a

total facility shut down, the typical small device company would

realize that it had no choice and it would challenge the FDA because

it was a matter of corporate life and death. The company would then

attempt to discuss the merits of the FDA's position, but something

about the company's aggressive stance (or desperation) would anger

someone at the FDA. In response, the CDRH set about creating

negative publicity that would damage the company's sales, and bring

the company to the threshold of bankruptcy.

The FDA would then penalize the small company for standing its

ground, and the agency would refuse to discuss matters any further.

Then the FDA would issue more damaging publicity and would become

unresponsive to all substantive questions, whether from the company,

its attorneys or the media. And it would do no good to launch a

stepwise appeal to higher levels in the FDA, because the CDRH would

just continue to stand by its original decisions.

Shelhigh's predicament was not unique. Over the years, the FDA had

challenged several small device companies, including TMJI in 2007,

Utah Medical Products in 2004, Products in 1997, Myo-

Tronics in 1994, Laedral in the same year, and Bioclinical Systems

in 1988.

Of course, each of those device companies prevailed against the FDA

in court, but they all had won what amounted to Pyrrhic victories,

because their experience with the FDA led to bankruptcy, near

bankruptcy or severe business interruption for nearly all of them.

Let's take a closer look at Shelhigh's encounter with the FDA by

starting with a few adverse events reports.

ADVERSE EVENTS ANALYSIS:

A search of the FDA's MAUDE database date range [1/1/2003 - Present]

revealed 17 Adverse Event Reports (AERs) that concerned one of

Shelhigh's devices, the Endura No-react Dura. Endura is a grafting

material used as a substitute for the Dura mater, a tough sinuous

sheet that covers the brain.

There were 58 reports for Shelhigh's vast array of related tissue

based devices. Among the 17 AERs for Endura, two reports fell within

the date range [1/1/08 - Present]. Moreover, most of the 17 MAUDE

reports involved Shelhigh's distributor, Integra Lifesciences. That

company filed several AERs just to report that Integra had received

letters from the FDA regarding Endura No-react Dura. The first

Shelhigh AER involving the Endura No-react Dura is dated March 10,

2003, and here is an excerpt from that report:

" Event Description [as submitted]

In 2003 this pt had brain surgery for malignant brain tumor. The

dura was closed with durashield [sold as Endura] and a ventricular

drainage catheter was placed. (could also be a source of

contamination). One week post-op, the pt had cns symptoms and a

lumbar puncture was performed to analyze their csf; was abnormal but

found to be sterile. Subsequently the pt developed infection of the

lumbar spine, and eventually grew Aspergillus fumigatas. Although

rare, this hospital infection could be related to the lumbar

puncture or to the procedure. The device was obviously sterile.

Also, if this was device related, the infection would be central and

not distally to the place of implantation.

Manufacturer Narrative

This fungal infection in the spine after brain surgery is very rare

and unfortunate. The treating doctor wrote that they had no problem

with the device. The patch was obviously sterile and infection could

occur in any surgical procedure. The suspicion is that a

contamination could occur via the lumbar puncture test, or via the

drainage catheter. Enclosed are the sterility results. This is a

procedure related complication and not device related. "

The next entry is dated November 18, 2004:

" Event Description

A 6x10 endura patch was implanted in a pt with chiary syndrome.

Postoperatively, they developed a fever, steroid therapy was

administered, and they responded well. After a week, the steroid

therapy was discontinued, and the symptoms returned. The surgeon

decided to remove the patch. Since the fever was of unk origin, the

pt is now doing well. The neurosurgeon was not able to determine if

there was a correlation between the patch and the fever.

Manufacturer Narrative

The neurosurgeon observed that the explanted patch was still soft

and compliant with no inflammatory response. The explanted patch was

sent for biological testing by the surgeon. The culture was

negative. The neurosurgeon was not able to determine if there was a

correlation between the patch and the fever. The patch was not

returned to shelhigh, but rather discarded by the physician or

hospital, therefore there can be no further studies on this patch.

All shelhigh patches are sterilized using a validated method. Prior

to release, the sterility results are reviewed for each production

lot. There have been no patch failures related to product

performance or sterility. Since shelhigh did not receive the lot or

serial number of this patch, a review of the specific lot cannot be

done. All lots of endura patches were reviewed for sterility

documentation. All lots were found to be sterile. "

Most of the remaining AERs consisted of notifications, such as the

following, that were not primary medical complaints:

" Event Description (February 6, 2008)

It has been reported by the patient's attorney, that the female

patient underwent brain surgery in 2005 in which the reported device

was used. It is alleged that due to imperfections in the product,

the patient has suffered a severe brain infection that required

additional hospitalization, medical bills and lost wages as well as

much discomfort and pain. "

" Event Description (there were five similar reports listed for

November 14, 2007)

" On 10/24/07, integra lifesciences received a letter from the fda

indicating that a voluntary medwatch had been filed on the endura

dural graft. The following info was reported, " incident date: 2005

craniotomy for intractable pain… "

" Event description (May 1, 2006), indicating that the graft was

never removed:

… [T]he patient developed a post op wound infection twice since the

operation to treat for syringomyelia. Infections were cultured on

the same day and staphylococcus aureus was identified. Unknown if

infection related to graft. Endura was never removed… "

After subtracting the number of reports from Integra Lifesciences

and others like it (e.g., the AER from the attorney, and the graft

that was never removed), there were relatively few actual injury

cases, and none of those ruled out other sources, such as hospital

infection. Yet on May 2, 2007, the FDA requested a Class I recall of

all of Shelhigh's products, including hospital inventories, because

of sterility concerns.

Let's take a closer look at the interplay between the FDA, Shelhigh

and its distributor, Integra Lifesciences.

TIMELINE:

April 18, 2007:

Shelhigh issued a press release reporting that the FDA and US

Marshalls had seized all implantable medical devices from Shelhigh,

and that the company denied the FDA's allegations that its

manufacturing process compromised the safety and effectiveness of

the devices.

April 19, 2007:

The FDA issued an alert entitled, Preliminary Advice for Patients:

Possible Contamination and Malfunction of Heart Valves and Valve

Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and other

Medical Devices Manufactured by Shelhigh, Inc. The alert made it

clear that US Marshalls had seized Shelhigh's medical devices

because they were manufactured under conditions that may have

contaminated the devices.

April 24, 2007:

Shelhigh issued a press release alleging that the FDA had " yelled

FIRE in a crowded hospital, " and that hospitals were clearly

confused by the recent FDA recall; Shelhigh was fielding a host of

calls from hospitals about the recall. Shelhigh indicated that the

company had assisted FDA inspectors and that the FDA had observed

every aspect of Shelhigh's operations over a 10 week period. In

addition, Shelhigh had provided tens of thousands of documents to

the FDA, including those related to raw materials, finished devises

and distributed devices.

May 3, 2007:

Shelhigh responded to questions that the FDA had posted on its own

website concerning the reasons for the recall, the locations where

the FDA seized the devices, and whether the devices were safe to

use. The FDA's questions also addressed a shipment freeze, the basis

for the seizure; whether Shelhigh even knew that the FDA was

concerned with its manufacturing practices, what products were

involved, and why those products were a serious risk. Shelhigh

alleged that the FDA exhibited little or no expertise about the

manufacture of the company's products, and that the FDA had

implemented an unnecessary abuse of its authority and

responsibility, resulting in a denial of life-saving devices to

patients in need.

Shelhigh also alleged that the FDA was ignoring repeated offers to

meet and discuss any issues that might be surrounding the

manufacture of the allegedly defective medical devices.

Also on May 3, 2007:

Shelhigh issued a press release that it had responded to the FDA's

recall request, indicating that it was the FDA's first request, that

it was unfounded, and that Shelhigh would not be recalling any

products. Shelhigh stated that the FDA had misstated allegations

that company records displayed a number of sterility test failures,

and that the company's testing and retesting procedures were not

properly performed. Shelhigh then went on to mention that an

independent ISO certified facility had performed the testing; the

procedures had been in effect since 2000, and that numerous prior

FDA inspections had not revealed any discrepancies.

May 7, 2007:

Shelhigh received a reply from the FDA concerning the company's

Freedom of Information Act request for reports on the AERs.

May 10, 2007:

Shelhigh received a reply from the FDA concerning the company's

Freedom of Information Act request for the Health Hazard Evaluations

that the FDA allegedly compiled and used to justify the recall.

June 6, 2007:

Shelhigh released a position statement regarding the FDA's actions,

indicating that: 1) no entity or person had received any health

hazard reports from the FDA; 2) the FDA was seeking to financially

strangle the company; 3) the FDA had released a news program on its

website promoting misleading allegations; 4) the FDA had not

produced a Health Hazard Evaluation (HHE) as it must by law before

issuing a recall; 5) the FDA needed actual described defects to

draft an HHE and that it had none; 6) the FDA had posted

misinformation on its website that went far beyond allegations

contained in the complaint; 7) the FDA never discussed its

observations with Shelhigh during the four months between the

inspection and the complaint; 8) the FDA refused to verify

Shelhigh's responses to the inspection; 9) the FDA did not even have

probable cause for the product seizure and that it had to fabricate

justification; the FDA released trade secret information despite

Shelhigh's protests; 11) the FDA was trying to gather evidence after

the fact to support its allegations; 12) Shelhigh was doing its best

to resolve the confusion and misstatements that the FDA was making;

13) any prior warning letters (2000 and 2005) had nothing to do with

the FDA's present allegations; 14) the FDA was unsuccessful in using

the unrelated warning letters to show a continued violation; 15)

Shelhigh had refused to recall its products due to a complete lack

of evidence of any safety hazard; 16) the FDA issued recall language

for Integra to use in a distribution level recall, and it demanded

that Integra recall all Shelhigh devices in distribution, and that

the FDA had already issued its own separate recall days before; 17)

Shelhigh asked what the real reason was for the recall, since it had

a 10-year record of delivering safe devices; 18) the FDA was

probably trying to save face, since it had made mistakes during the

inspection and that supervisors had rubber stamped inspectors

reports, and 19) the FDA should have presented its findings if it

had any, instead of stating that Shelhigh's devices " may " cause a

health hazard.

Also on June 6, 2007:

Shelhigh issued a press release alleging that the FDA was refusing

to disclose facts, and that neither the FDA nor Shelhigh had

recalled any Shelhigh devices [the FDA had been dealing with Integra

only].

June 25, 2007:

Shelhigh issued a press release indicating that the FDA and Shelhigh

had reached an agreement to settle out of court. Both parties agreed

that there had never been a Shelhigh based product recall; and that

manufacturing procedures were in substantial compliance with FDA

requirements. Some minor changes would have to be made to the

manufacturing process, but they would be swiftly and easily

implemented. The court had not ordered the agreement. Instead, the

parties had reached an agreement of their own accord, which the

court implemented in dispensing with the case in 2007.

What might have been a danger to the public, turned out to be a

virtual tug of war between the FDA and Shelhigh. Meanwhile, well

qualified attorneys who were standing by ready to help those who

might have been injured later realized that there was no need to

provide that assistance.

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