Attorney Daily - Your source for the most important legal news

On November 18, 2008, Medtronic Inc. said that it received a subpoena from the United States Department of Justice regarding use of its popular bone graft product in ways not approved by federal regulators, a practice that could lead to serious injuries in patients with back problems.

CEO William Hawkins said in a conference call with Wall Street analysts the company is complying with the Justice Department’s request. He attributed the harsh spotlight on the company’s product, called Infuse Bone Graft, to several factors, including a public health notice issued by the FDA in July which warned doctors not to use the product “off-label.”

Hawkins also said “negative stories in the press,” plus a recently filed whistleblower lawsuit, might have piqued the Justice Department’s interest. A lawsuit filed last spring against some of the nation’s top spine surgeons alleged that they used Infuse in off-label ways in return for kickbacks from Medtronic.

Infuse is a genetically engineered product used in spine fusion surgery, which permanently links damaged vertebrae. Before regulators approved the product in 2002, spine fusion required two surgeries, one a painful harvest of bone from the hip, and a second to implant the bone inside thimble-like cages inserted into the spine.

Infuse is approved for a single-level fusion in the lower back and other limited uses. Doctors are free to use medical devices and products beyond the scope of what the FDA approved, but companies may not market the devices for uses beyond those approved.

People with diabetes who use ReliOn insulin syringes should check their syringe package because of an important recall. On November 6, 2008, Tyco Healthcare Group (Covidien) issued a recall of 4,710 boxes of syringes with 100 syringes in each box that were sold at Wal-Mart and Sam’s Club from Aug. 1, 2008 through Oct. 8, 2008.

The recall was initiated to overdose risks and potential mislabeling.”The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death,” states an FDA news release.

The recall only applies to the following products:

• ReliOn Insulin Syringes 31 gauge 1 cc (with 100 syringes per box)
• Lot number: 813900 (on the back panel of the carton, or on the white paper backing of each syringe’s “peel pack”)
• Product identification number: 38396-0403-02 (on the top panel upper right-hand corner of the syringe box)

The FDA says some syringes labeled for use with U-40 insulin got packaged with syringes for U-100 insulin. The FDA notes that Tyco Healthcare recalled this lot of syringes in October, and Wal-Mart and Sam’s Club stores have posted information about the recall and notified more than 16,500 customers about the recall.

For more information, call 866-780-05436 or visit the ReliOn recall web site for more information. Customers will be provided with a replacement package.

On April 25, 2008, there was a meeting of the FDA Ophthalmic Devices Advisory Panel involving representatives of the panel, the Joint LASIK Study Task Force, and members of the public. Members of the public spoke out about their negative experiences with LASIK and PRK and the depression and anxiety they have suffered since their operations.

For several years and all ads promising that laser vision surgery lets you toss your glasses is a stark reality. Not everyone’s a good candidate and an unlucky few do suffer life-changing side effects that include lost vision, dry eye, night-vision problems.

How big are those risks? The FDA thinks about 5 percent of patients are dissatisfied, but can’t provide more specifics and is pairing with eye surgeons for a major study expected to enroll hundreds of Lasik patients to try to better understand who has bad outcomes and exactly what their complaints are.

“Clearly there is a group who are not satisfied and do not get the kind of results they expect,” FDA medical device chief Dr. Daniel Schultz said. The study should “help us predict who those patients might be before they have the procedure.”

About 7.6 million Americans have undergone some form of laser vision correction, including Lasik. Other side effects, however, are harder to pin down. Dry eye, for instance, can range from an annoyance to so severe that people suffer intense pain and need surgery to retain what little moisture their eyes form. That’s the kind of question the FDA’s new study aims to answer.

Dry-eye specialist Dr. Craig Fowler of the University of North Carolina says other research suggests 48 percent of patients experience some degree of dry eye at least temporarily after Lasik. Cutting the corneal flap severs nerves responsible for stimulating tear production, and how well those nerves heal in turn determines how much dry eye lingers long-term, he said.

Even if the risks are low, that’s little consolation to suffering patients.

The FDA has long known of those side effects, and thus for years has a Web site with warnings for Lasik patients and required that doctors give every potential patient a brochure outlining risks.

The agency will ask its outside advisers if its warning efforts go far enough.