A Medical Device Daily

Tenet Healthcare (Dallas) reported that it has reached what it termed “a broad agreement“ with Florida Attorney General Charlie Crist, paying $7 million to resolve all matters involving Tenet currently being litigated or investigated by Crist's office.

The funds include $4 million to establish a fund to pay for care of indigent, uninsured patients at the 13 county hospital districts and systems in Florida that were plaintiffs in the lawsuit. The remaining $3 million will be allocated to the Florida Medicaid Fraud Control Unit and public hospitals in Florida.

Tenet will record a $7 million charge in its fourth quarter ended Dec. 31. The settlement ends the suit titled, State of Florida, Office of the Attorney General, Department of Legal Issues, et al. v. Tenet Healthcare Corporation, with the resolution including a civil lawsuit regarding Medicare outlier payments filed by the attorney general's office in March 2005 on behalf of 13 county hospital districts, healthcare systems and non-profit corporations in the state.

Tenet said that none of its South Florida hospitals were named as individual defendants in the lawsuit.

The settlement ends an investigation begun in mid-2003 by the Florida Medicaid Fraud Control Unit of certain Medicaid payments and a separate investigation begun in early 2005 by that unit of certain Medicaid psychiatric billings at a Tenet hospital in South Florida. In the settlement agreement, the company did not admit, and specifically denied all of the allegations made in the suit.

Peter Urbanowicz, general counsel for Tenet, said, “We appreciate the attorney general's recognition of the important role that Tenet's hospitals play in the delivery of healthcare to the people of South Florida . . .“

Under the Compact With Uninsured Patients, signed by Tenet in January 2003, its hospitals provide managed-care style discounts to all uninsured patients and charity care. “[O]ur $4 million contribution provides another means for dealing with the uninsured crisis in Florida,“ Urbanowicz said.

Tenet said that the settlement does not resolve a separate purported class-action civil lawsuit filed in March 2005 on behalf of Boca Raton Community Hospital and most other private acute-care hospitals in the U.S. In that suit, Boca Raton Community Hospital Inc. v. Tenet Healthcare Corporation, Tenet has filed for partial summary judgment, asserting that the case cannot proceed as a class action.

Tenet, through its subsidiaries, owns and operates acute-care hospitals and related health care services.

In other legalities, a lawsuit has been filed against Ortho-McNeil Pharmaceutical, a division of Johnson & Johnson (New Brunswick, New Jersey), on behalf of a 33-year-old Georgia woman who suffered a venous thrombosis and stroke after using the Ortho Evra contraceptive patch for six months.

The suit says that in early 2004, the plaintiff began suffering headaches, nausea and vomiting. After tests revealed venous thromobis and stroke, she was airlifted to Emory University Hospital (Atlanta) and received anticoagulant therapy.

The suit, filed by Parker & Waichman in the U.S. District Court for the District of New Jersey, says that the woman is likely to need prolonged anticoagulation treatment, possibly for the rest of her life.

Ortho Evra is an adhesive, transdermal birth control patch that is worn on the torso. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn on the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and more than 4 million women have used Ortho Evra since its approval.

The suit alleges that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks.

The FDA reportedly has logged more than 9,000 reports of adverse reactions to the patch over a 17-month period,

Ortho Evra continues to be marketed to consumers and physicians.

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