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Health Policy Experts Mull Impact of Wyeth Ruling

March 04, 2009 4:41 PM

By AUDREY GRAYSON, ABC News Medical Unit

The U.S. Supreme Court ruled today against the drugmaker Wyeth, holding that pharmaceutical companies can be held liable for harm from medicines that carry warnings approved by federal regulators.

In a 6-3 vote, the high court affirmed a Vermont supreme court ruling that upheld a $7 million damages award to a guitarist, Diana Levine, who had to have her arm amputated after she was improperly injected with Wyeth's anti-nausea drug Phenergan as part of treatment for a migraine.

Health policy experts overwhelmingly agreed that the ruling represents an enormous victory for consumers.

“This is an enormously important ruling to protect the American people from the excesses of the drug industry,” said Dr. John Abramson, clinical instructor at Harvard University Medical School and a consultant to plaintiffs’ attorneys in litigation involving the drug industry.

The current system for drug labeling depends most heavily on research funded by the drug makers themselves. Many experts argue that this current system is deeply flawed.

“As we have seen in far too many cases, companies hide or explain away data about dangerous drugs, sometimes even from the FDA itself,” said Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest in Washington, D.C.

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said another obstacle to properly identifying drug risks is that “the FDA does not have the resources to fully monitor the uses and outcomes of all approved drugs.”

But the Supreme Court decision appears to suggest that drug companies should identify the risks of the drugs they manufacture.

“The Supreme Court ruling places the responsibility for drug safety directly where it should be -- on the drug makers themselves,” Abramson said. “And now, properly, they will be held responsible for failure to fulfill the obligation to adequately study the safety of their drugs and to adequately communicate the risks of which they are -- or should be -- aware.”

In instances when the FDA fails to properly monitor drug risks, the ruling guarantees that patients harmed by a drug may still obtain a hearing for their case in a state court.

“With this decision, when the FDA fails to take action on a drug risk and a patient is harmed by a drug, patients will still be able to get a hearing in state court,” said Dr. Bruce Lambert, director of the Center for Education and Research on Therapeutics at the University of Illinois at Chicago. “And if the evidence is in their favor, they will be able to get compensation and hold companies accountable.”

While all experts agreed that this ruling is a victory for consumers who are harmed by drugs that carry insufficient warning labels, Gregory Conko, a senior fellow at the Competitive Enterprise Institute in Washington, D.C., said that he doesn’t believe Wyeth or the FDA did anything wrong in this particular case.

“It would have been one thing if new evidence of risk had arisen since FDA approved the label, or if Wyeth were accused of hiding information from the FDA or misrepresenting the data it did provide,” Conko said. “But that is decidedly not the case here.”

Conko added that because Phenergan’s label explicitly warns in six different locations of the high probability of tissue damage if injected into artery, this specific case was not one of negligence on part of the Wyeth, but on the part of the physician’s assistant who injected the drug into Levine’s artery despite the clear warnings on the drug’s labeling.

“Thus, the Supreme Court could have and should have held in Wyeth's favor with a narrowly tailored opinion confined to the facts of this case,” Conko said.

“Here, instead, the court is essentially saying that it doesn't matter that [the] FDA thought [intravenous] administration of this drug was sufficiently safe,” he added. “As long as a sympathetic plaintiff can convince a jury of laymen that her injury could have been prevented if the physician's assistant never tried to administer the drug in such a way that actually would have been safe, then FDA's expert judgment is irrelevant.”

March 4, 2009 | Permalink | User Comments (2)

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Posted by: Sarah | Mar 16, 2009 5:39:47 AM

Posted by: Ed | May 18, 2009 10:35:45 PM

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