Shelhigh, a manufacturer of tissue-based implants and devices used primarily in surgeries, has been a thorn in the FDA's side for years over the relatively small company's housekeeping; specifically, sterility issues.
Warnings and citations delivered to Shelhigh in 2000 and 2005 were apparently met with unsatisfactory response. Similarly, an inspection of the company's manufacturing facility in Union, New Jersey by FDA officials last fall allegedly verified the non-compliance.Then on April 17th of this year, in a scene straight out of reality television, U.S. marshals representing the FDA conducted a raid on the facility and seized a large inventory of product and medical devices. The FDA at the same time implored Shelhigh to issue a voluntary recall of its devices already in circulation.
After Shelhigh refused, The FDA on May 2nd ordered a formal recall of Shelhigh medical devices.
Now at issue are millions of dollars worth of medical devices which Shelhigh needs to export, the company claims, to remain viable. A business with about 50 employees, Shelhigh maintains that its devices are safe, and that FDA action is based on insufficient documentation.
The standoff has all the makings of a classic David vs.: Goliath battle.
On one side is Shelhigh, a privately owned and controlled company dwarfed by larger competitors.
On the other, is the FDA, currently under fire for its response and policies in the huge prescription drug market. Last month the Senate passed legislation which strengthens the FDA's powers to track and expose, and ultimately halt the sale of harmful drug products, which wind up on the market. The U.S. House of Representatives is expected to soon pass similar legislation, although there are no plans to strengthen FDA powers in the area of medical device manufacturing.
For its part Shelhigh is attempting to protect its export market and ensure its survival. An aggressive stance by a small company in the shadow of the FDA juggernaut is no doubt fuelled by a victory won by Utah Medical Products of Salt Lake City, an electro-surgical device manufacturer, in a dispute with the FDA in 2005.
The products affected include paediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings, and arterial grafts. The tissue-based devices are employed in many surgical settings, including open-heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery.
Critically ill patients, paediatric patients and immuno-compromised patients may be at greatest risk. The FDA is recommending that doctors use alternative devices, and monitor any patients with a Shelhigh implant for infection. Patients who have received, or suspect they have received, a Shelhigh device during surgery are advised to contact their doctors.
Among Shelhigh's safety violations are the manufacturing of products in a facility with a poorly constructed and maintained 'clean room' where sterilized devices are processed; failure to adequately monitor critical environments for possible microbial contamination, failing to properly test for sterility and fever-causing contaminants; and failure to properly manage product expiration dates.
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Even so, court documents revealed during a federal court hearing in Newark in mid-May point to the recommendation of Spanish regulators for the use by surgeons of alternative products after seven failures of pericardial patches in 1997, and three incidents of heart valve failures -- two of them fatal.
Members of the legal community advise patients with a Shelhigh implant to contact their doctor, and note that compensation is possible, even if a recalled device has yet to prove defective.