A Medical Device Daily

Massachusetts superior court judge Susan Garsh last week dismissed efforts by DePuy Spine (Raynham, Massachusetts) to throw out four lawsuits filed by patients claiming DePuy's Charité artificial disc is defective.

DePuy had argued that the company should be protected from the legal action since the FDA approved the device (Medical Device Daily, Oct. 28, 2004), a legal defense known as preemption.

The Charité is used in back surgery to replace diseased or damaged invertebrate discs as an alternative to spinal fusion, and it was the first such device approved by the agency for commercialization in the U.S.

"In short, DePuy was claiming that since the FDA gave its approval for the disc's use, it was inoculated against claims of defect or negligence in its design," said Thomas Sobol, a partner with Hagens Berman Sobol Shapiro (HBSS), one of the firms representing the plaintiffs. "We demonstrated to the court that the preemption defense in this case went well beyond the pale."

According to the judge's ruling, DePuy made specific claims in the application process to receive FDA approval, which the plaintiffs said the device failed to achieve.

And in her ruling, Judge Garsh said, "there is evidence to support the device does not perform in the manner which DePuy represented to the FDA that it must perform."

The original complaints also said that DePuy gave patients material stating that the Charité disc "has a clinical history spanning 17 years. Its safety, efficiency and remarkable durability have been proven through thousands of implants worldwide," and went on to make the claim "Natural Motion is Back."

"We argued that just because a medical device manufacturer has FDA approval, that manufacturer still must live up to its obligation to deliver on the promises it makes," said Pete Flowers, attorney with Foote, Meyers, Mielke, & Flowers, the other firm representing plaintiffs. "Certainly that does not mean that every patient must receive complete satisfaction from procedures, but if a company makes performance promises to get FDA approval, they need to live up to those performance promises."

The judge also reviewed evidence that the device manufacturer failed to notify the FDA that it had modified the Charité disc it was using in Europe because of safety and effectiveness concerns, instead telling the FDA the changes were made for physician convenience, court records note.

The cases were originally filed in 2006 after four individuals underwent procedures inserting the Charité disc in the patients' spines. In each instance, the plaintiffs claim the device failed, causing serious and lasting damage.

Last year, the Centers for Medicare & Medicaid Services questioned the device's effectiveness and turned down a request for reimbursement.

In March 2006, DePuy filed the motion to dismiss the charges, citing claims of FDA preemption. The judge's ruling allows Sobol and his team to begin the discovery process.

HBSS filed its first case against DePuy Spine on Jan. 19, 2006, in the Superior Court in Bristol, Massachusetts, and has since filed cases on behalf of more than 100 plaintiffs alleging the Charité is defective.

In other legalities:

The Family Research Council (FRC; Washington), a conservative Christian group and a coalition of other conservative groups, including Concerned Women for America (CWA; Washington), the American Association of Physicians and Surgeons (AAPS; Tucson, Arizona), and Safe Drugs for Women, last week filed suit against the FDA seeking to overturn the recent approval of the Plan B morning-after pill for over-the-counter (OTC) use by women 18 and older.

The drug was approved by the FDA last year after a lengthy political fight that also threatened to delay the appointment of Andrew von Eschenbach, MD, as the head of the FDA (Medical Device Daily, Aug. 25, 2006).

Tony Perkins, president of FRC, said that the agency "sacrificed women's health and committed unprecedented violations of the law by approving the morning-after pill for over-the-counter use." He charged that the agency "bowed to heavy-handed political pressure from Senators [Hillary] Clinton and [Patty] Murray who misused their power by holding up confirmation of the FDA commissioner."

The lawsuit alleges, among other things, that data submitted by Plan B's manufacturer, Barr Pharmaceuticals (Woodcliff, New Jersey), did not establish that it is safe or effective. It also argues that the FDA lacks authority to approve the same drug for both OTC and prescription-only distribution and also lacks authority to approve distribution based on the buyer's age.

The lawsuit also charged that the FDA approved Plan B for non-prescription use without conducting the necessary rulemaking required by the Administrative Procedure Act and the Federal Food, Drug and Cosmetic Act.

The bid to sell the Plan B product without a prescription lingered at the agency for more than three years.

During that time FDA drew criticism from others that it was delaying approval because of political pressure brought by conservative opponents who argued that the drug would promote promiscuity and was tantamount to an abortion.

Taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89% after a single act of unprotected sex. Effectiveness declines as the interval between intercourse and the start of treatment increases. Plan B is more effective when taken in the first 24 hours after intercourse. The decline in efficacy from a delay in treatment is why a broad range of health professionals believe that barriers to more timely access to Plan B should be removed, including making the product broadly available without prescription.