Doctors, lawyers and a movie star are expected to criticize government regulations Wednesday that have shielded drug and medical device companies from lawsuits brought by patients.
For decades consumers who felt they had been injured by a drug or device have used state laws to sue companies for damages. But in 2006 the Food and Drug Administration said any product that meets its standards for approval is not subject to state liability laws.
The Supreme Court and others are still grappling with the issue, but consumer advocates fear rulings that favor federal rules could make it more difficult for patients to sue drugmakers _ potentially saving those companies billions of dollars.
More than a half dozen witnesses are expected to testify on the issue at a 10 a.m. hearing before the House Committee on Oversight, chaired by Rep. Henry Waxman, D-Calif.
Film actor Dennis Quaid is expected to join the usual lineup of medical, regulatory and legal experts. Quaid and his wife, Kimberly, are suing Deerfield, Ill.-based Baxter Healthcare Corp. for putting vastly different doses of a blood-thinner into confusingly similar packages.
The Quaids allege that their infant twins were given 2,000 times more blood thinner than prescribed because of Baxter's packaging. The massive overdose caused the twins' blood to thin to dangerous levels, though both made a full recovery.
Lawmakers will hear from former FDA Commissioner David Kessler and New England Journal of Medicine Editor Gregory Curfman. No company representatives are scheduled to testify.
Earlier this year the Supreme Court left in place a ruling favoring patient lawsuits in a case against Pfizer subsidiary Warner Lambert. Patients who used its diabetes drug Rezulin had sued the company for allegedly misleading FDA about its risks. The court was split over whether FDA regulations should overrule state liability laws, upholding a lower court decision that favored the patients.
But in February justices ruled in a case against Medtronic Inc. that federal rules pre-empt lawsuits in state courts against medical device manufacturers.
Waxman and Rep. Frank Pallone, D-N.J., have drafted legislation that would effectively nullify that decision, allowing consumers to seek damages from device makers. A spokesman for Pallone said the bill will be introduced in the coming weeks.
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