Court backs confidentiality of HIV status.

A suit alleging that a heart valve's excessive noise caused pain and suffering in the patient was dismissed for the second time in January. (Bravman v. Baxter, No. 89 Civ. 3444,1994 WL 21131 (S.D.N.Y. Jan. 24, 1994).)

Judge Robert Sweet dismissed for the second time a complaint filed by the patient, Aaron Bravman, and his wife, Muriel of Kingston, Pennsylvania, against Baxter Healthcare Corp. of Deerfield, Illinois. Sweet noted that although heartvalve warning labels are not expressly covered by federal medical device regulations, Bravman's suit is preempted because the valve Bravman received was approved in 1986 after lengthy federal review. (Deborah Pines, Federal Labeling Rules Pre-empt Suit Over Valve, N.Y. L.J., Jan. 28, 1994, at 1.)

In 1988, Bravman--who is in his mid-60s --underwent surgery to replace his deteriorating mitral heart valve with an artificial Edward-Duromedics valve made by Baxter. Bravman's surgery was successful, but Bravman and his wife later filed suit against Baxter alleging that the valve makes an unacceptable amount of noise. Bravman claimed that because of the noise, he cannot sleep, is despondent, and had to retire from his job early.

In May 1992, Sweet dismissed the complaint, holding that Bravman's fear that the valve might fail was insufficient to support an injury claim. The Second Circuit last year reinstated the claim in part, ruling that a jury should determine whether the noises emitted by the valve caused injury and whether Baxter violated a duty to warn Bravman's doctor of the potential noise.

On remand, Baxter argued that once a medical device has been approved by the U.S. Food and Drug Administration, a manufacturer is immunized from state law causes of action. Judge Sweet agreed, saying that state law tort claims based on a failure to warn about noise would in effect constitute an additional labeling requirement beyond the FDA's approval process.