Saturday, March 21, 2009

Even FDA approval does not protect a drug company

The Supreme Court botches a drug preemption case. Even when a drug is used in a way contrary to the company's instructions, the company is still liable!

The Supreme Court handed down its decision this month in the case of Wyeth v. Levine, ruling that federal law did not bar plaintiff Diana Levine from suing pharmaceutical maker Wyeth over allegedly insufficient drug safety warnings, even though the warnings had been approved by the Food and Drug Administration (FDA). This decision establishes the troubling precedent that a sympathetic jury can now supersede the expert opinions of the FDA on what qualifies as adequate safety labeling. Ultimately, that means drug firms face higher costs and greater uncertainty. Both are bad for patients.

Levine lost an arm to gangrene after a physician's assistant injected the Wyeth drug Phenergan in such a way that it came into contact with oxygen-rich arterial blood. Although the drug's label explicitly warned that doing so poses a high risk of tissue damage, Levine claimed that the label should have instructed physicians not to use this intravenous "IV-push" method at all. A Vermont jury agreed, and awarded Levine $7.4 million, which the court reduced to $6.7 million.

On appeal, Wyeth could not challenge the jury's fact finding, but argued that the FDA's extensive regulation of drug labeling should preclude claims of negligent failure to warn. The Supreme Court held, by a 6-3 majority, that federal law does not preempt Levine's claim.

According to Justice John Paul Stevens' majority opinion, "The history of the [Food, Drug, and Cosmetics Act] shows that Congress did not intend to preempt state-law failure-to-warn actions." Although true in a general sense, the Court failed to recognize that this is not a typical failure-to-warn case. As Justice Samuel Alito's dissenting opinion notes, Levine conceded that, in 1988, Wyeth proposed a label change that "if followed, would have prevented the inadvertent administration of Phenergan into an artery," but the FDA rejected that language.

Nevertheless, Levine alleged not only that the warning on Phenergan's label wasn't strong enough, but that Phenergan was "not reasonably safe for intravenous administration"—and that the label should have said so. That, however, poses a question regarding FDA's approval of the product for that use, not Wyeth's alleged negligence in drafting the label.

The FDA first approved Phenergan in 1955. And, as the risk of arterial injection became apparent over the years, the agency approved several changes to the drug's label, which now contains six statements (two in all capital letters and bold face type) warning doctors about the exact nature of that risk.

The doctor and physician's assistant who treated Levine nevertheless administered a dose twice as high as indicated, injected it into the inner crook of her arm where the risk of accidental arterial injection is very high, and continued to push in the syringe's plunger despite Levine's protestations of pain, each in direct contravention of explicit label warnings. It was this negligent administration that caused the massive tissue damage that led to the amputation of her arm.

Levine settled a claim against the physician's assistant and the prescribing doctor, then turned her sights on Wyeth. At trial, Levine's attorney argued that, despite the FDA's approval of Phenergan's label, the drug firm acted negligently by failing to add even sterner warnings or changing the label to rule out intravenous injection altogether. But doing the latter would have overruled a FDA decision that permits IV-push injections when that method could provide more benefits than the alternative.

Justice Stevens's majority opinion asserts that the FDA can't keep track of all safety issues that arise after a drug is approved and that the agency never specifically made a determination regarding the safety of IV-push administration. Consequently, Wyeth could have changed its label without the FDA's pre-approval upon receiving information regarding the risk of arterial injection of Phenergan. But that assertion is plainly wrong. The case record shows that the FDA repeatedly and intensively investigated this exact question and determined that IV-push injection provided important medical benefits.

Furthermore, there are no allegations that Wyeth hid any information about the risks of IV injection, nor has any new information regarding the risks arisen that would call the FDA's decision into question. So, the decision in Levine is tantamount to letting a group of laymen overrule the FDA's expert opinion regarding safety. In his closing arguments at trial, Levine's attorney told the jury, "Thank God we don't rely on the FDA to...make the safe[ty] decision...The FDA doesn't make the decision, you do."

A majority of the Supreme Court agreed, concluding that FDA regulation should be seen as a floor, but should not preempt stricter state tort laws. That, however, conflicts with longstanding Court precedent regarding implied pre-emption of state laws that conflict with federal regulatory decisions. As Justice Alito's dissent notes, "the ordinary principles of conflict pre-emption turn solely on whether a State has upset the regulatory balance struck by the federal agency." That is exactly what has happened here.

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. Doing so would not have insulated wrongdoers from punishment, but would have recognized that Congress gave FDA statutory authority over questions of safety and efficacy because it believed a federal expert body could most effectively balance the benefits and risks of new medicines. Empowering lay juries to override those decisions means that fewer patients will benefit from important medicines in the future. Not only is the majority's decision bad law, it's very bad for patients.


Shocked British mother sent 100 miles to have her baby

A PREGNANT woman was sent nearly 100 miles away to have her baby after being told the city's maternity ward was full. Sophie Jacobs, 22, was rushed to the Royal Devon & Exeter Hospital when her waters broke. She was terrified for the health of her baby, which was not due for another six weeks. But to her dismay, Miss Jacobs learned the maternity unit at the hospital was already full and she would have to be sent elsewhere.

Staff at the ward gave her a steroid injection to try to develop the baby's lungs and stop the labour. Others frantically phoned to try to find her a bed elsewhere with facilities for a premature baby. She was devastated when she learned the nearest place was The Royal Gwent, in Newport, South Wales — 96 miles away.

She said: "My pregnancy was all straightforward until the last few weeks, when I started developing signs of pre-eclampsia. "When I got to the RD&E, they gave me an injection to try to stop labour. "They didn't know if it was going to work. They had to find somewhere with a bed. "They tried everywhere from Cornwall up, and said the nearest place they could find was Newport."

She said: "They put me in an ambulance and I was driven up there. Jason, my partner, had to make his own way there. "It took ages in the ambulance because of the traffic. I didn't want to go up there, but I didn't have a choice. "I had the second injection in Newport but it didn't stop the labour and I got more severe signs of pre-eclampsia."

As previously revealed in the Echo, the RD&E has closed its maternity unit twice since 2006 because of overcrowding or staffing issues.

Miss Jacobs ended up having a Caesarean section, and Zachariah was born weighing 4lb 6oz. She added: "I ended up with a very small baby and we had to stay there for 10 days. Because Zachariah was so small and early he needed to be monitored and cared for on the special care baby unit. "He was also a little jaundiced so had to spend a few days under the UV light. The staff were lovely but it was horrible because it was such a long way from home. I wanted to be home and close to my friends and family. They kept ringing to see if there was room for us in Exeter, but there never was. After being let down so many times about being transferred back, we put our efforts into concentrating on getting discharged and eventually managed to get home."

Miss Jacobs, a secretary, said her partner Jason North, 36, had been able to stay locally while she was in Newport. Zachariah, who has a 10-year-old half-sister, Olivia, was born in September and, months on, is healthy and well.

A spokeswoman from the RD&E said: "The incident was the only one of its kind in the last three years and the transfer happened despite our very best efforts to provide more local care. "It was unfortunate that in the four-hour window that the maternity unit was closed, a patient had to be transferred to another hospital but all the decisions were made with patient safety being our priority," she said.


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