A Medical Device Daily

A class action on behalf of users of several types of defibrillators made by Medtronic (Minneapolis) has been filed by the law firm of Rheingold, Valet, Rheingold, Shkolnik & McCartney (New York).

The firm said that the defibrillators have batteries "which can fail without warning, due to shorting. They would then not be able to deliver the electrical jolt required if a user developed potentially life-threatening arrhythmias."

The suit has been commenced in the federal court in Brooklyn New York, by Raymond Manners, who had to have his Medtronic defibrillator replaced, and also is on behalf of all persons who have had one of these potentially defective devices implanted.

It seeks the costs of explant and replacement of the devices, which must be done surgically; a fund for medical monitoring of persons who have the device implanted; and other relief, including making a firmer warning to physicians and the public about the risks of the devices.

The devices named by the firm are:

  • ICDs: Marquis VR (7230) and DR (7274), and Maximo VR (7278);
  • and cardiac resynchronization defibrillators: InSync I /II /III Marquis and Insync III Project (7277, 7289)

The defective batteries were in some 87,000 units sold in the period 2001 to 2003, the law firm said.

It said that Medtronic issued a public statement about the devices in February "but did not couch it as a warning and did not inform doctors that the devices should be replaced. Nor did it offer in the statement to pay for replacement."

It went on to say that the company's conduct in the U.S. "is to be compared with its statement in Canada, as guided by that country's health agency, where Medtronic offered to pay for a replacement and gave physicians specific directions about how to detect a failing battery."

Rheingold, Valet, Rheingold, Shkolnik & McCartney says it has handled many cases involving the Sulzer hip implant and Teletronic pacemakers and the pharmaceuticals Vioxx, Bextra, ephedra, PPA and Baycol.

Pediatrix Medical Group (Fort Lauderdale, Florida), a major provider of newborn and maternal-fetal physician services, reported that it will take a pre-tax charge of $6 million, due to an increase in reserves for liabilities for the company's estimated "minimum probable losses" in connection with its pending national Medicaid and TRICARE investigation.

The charge will be shown in its results for the three-month period ended March 31, with the additional reserves based on a settlement offer made to the government last week.

Pediatrix reaffirmed the expectation that '05 earnings will be in the range of previously issued guidance, less the after-tax impact of this charge and any future charge related to this matter.

It said there is no assurance that its offer will result in a settlement.

Pediatrix' neonatal physicians provide services at more than 220 NICUs, and through Obstetrix, its perinatal physicians provide services in many markets where Pediatrix's neonatal physicians practice.

In other legalities:

• Chemed (Cincinnati), which bills itself as the largest U.S. provider of end-of-life care under the Vitas Healthcare (Miami, Florida) brand and plumbing services under the Roto-Rooter brand, last week said that the Office of Inspector General (OIG) for the Department of Health and Human Services served Vitas with civil subpoenas for alleged incorrect billing of Medicare and Medicaid for hospice services.

It said the OIG selected 80 sets of patient records from each of Vitas' three largest programs for review, and another 80 patient records from various programs, from 1997 to the present.

The documents requested, Chemed said, are similar to those provided in a previous industry-wide OIG investigation titled Operation Restore Trust, for the period 1995 to 1998, audited six Vitas hospice programs and over 1,000 patients' records. At the conclusion of the OIG investigation, no adverse actions were taken against Vitas, the company said.

Kevin McNamara, Chemed CEO, said that Vitas consults with many government and non-government groups concerning billing and clinical practice issues and that it meets all Medicare and Medicaid billing standards.

• IntraLase (Irvine, California) reported that the U.S. District Court for the Central District of California has granted its request for a temporary restraining order that prohibits Escalon Medical (Wayne, Pennsylvania) from taking any action to terminate its licensing agreement with IntraLase. It said the court will conduct a hearing on this matter on April 25. It said also that it will file a surety bond as required by the court's order.

IntraLase manufactures a laser, related software and disposable devices used to create a corneal flap, the first step in LASIK surgery. Its lasers also are used for surgeries treating diseased corneas.