Wyeth case could affect provider liability
The health care industry is awaiting a ruling from the U.S. Supreme Court in the case of Wyeth v. Levine, a case that could determine the future of drug labeling and potential liability for providers who don't follow those instructions to the letter.
The ruling is expected to determine whether manufacturers can rely on "pre-emption," meaning the Food and Drug Administration's approval of their label protects them from state court lawsuits alleging that the label was insufficient. If not, manufacturers could be subjected to endless lawsuits in each state. A ruling in favor of the plaintiff, some legal analysts say, also could lead to more precise instructions for drug use, and that would in turn create a tricky problem for providers: Either follow the instructions exactly, and rob your caregivers of the ability to practice medicine as they see best, or deviate from them and run the risk of huge liability.
Peter Reichertz, JD, a partner in the Washington, DC, office of the law firm Sheppard Mullin, says the verdict could lead to more risk for the provider, if the end result is that plaintiffs have a harder time suing the manufacturer.
"It appears the court may find some limited degree of pre-emption, shielding manufacturers from liability if, for example, the manufacturer and FDA were aware of the risk, the manufacturer did not conceal it from FDA, and it is dealt with in labeling," he says. "That said, if the court finds any degree of pre-emption, I think it is all but certain that the new Democratic-controlled Congress will either pass legislation in advance of any decision to negate such a ruling or do so after the court rules."
They also could possibly deal with prior decisions relating to pre-emption found regarding use of medical devices, Reichertz says. There is an express pre-emption provision for devices, stemming from the Riegel v. Medtronic case. In Riegel, the Supreme Court determined that the federal authority of the FDA trumped state laws, blocking liability suits concerning allegedly defective medical device labels in state courts. If the FDA said the labeling of the device was correct, the court ruled, then it wasn't fair to have plaintiffs sue in state court and claim the labeling should have been bette. .Many in Congress feel that the Riegel decision went too far, so they may be eager to counter that ruling also.
But if the manufacturers find some protection from the courts and Congress doesn't find a way around that, the providers could be the ones left vulnerable.
"As to any finding of pre-emption and its effect on health care providers and institutions - if pre-emption is found and in the unlikely event that Congress doesn't change the law to negate any such decision - it could mean that plaintiffs would need to focus on the health care provider who administered or prescribed the product and/or the institution or setting it was administered or prescribed," Reichertz says. "In general, plaintiffs always sue both now as it is. In the Wyeth v. Levine case, the plaintiff had already obtained a judgment from the provider."
Karen Gibbs, JD, an attorney in the law firm of Crowell & Moring in Irvine, CA, also sees potential bad news for providers in the outcome of Wyeth. She notes that these types of cases often are brought as combination medical malpractice and product liability suits. Many defense attorneys consider Wyeth to be primarily a medical malpractice case, given the mistakes made in administration of Phenergan to the plaintiff, she says.
"A ruling against Wyeth thus is not likely to result in deflection of liability from hospitals or other providers," Gibbs says. "Hospitals are not likely to see any fewer allegations of malpractice based on the use of FDA-approved prescribed medications. On the other hand, if Wyeth prevails, a likely consequence may be an increase in malpractice lawsuits against and also an increase in the amount of damages demanded from hospitals, physicians, and other providers."
The former head counsel for the FDA tells Healthcare Risk Management that he is worried providers may take on more liability risk as a result of the Wyeth ruling. One question in Wyeth involves who was really responsible for Levine's injury and who should be responsible for compensating her, says Sheldon Bradshaw, JD, currently a partner in the food and drug practice at the law firm of Hunton & Williams in Washington, DC. Many observers say the case is simple malpractice and that the clinic and caregivers were the only ones who should have compensated her. Bradshaw believes Levine received $100,000 from the clinic, which was the cap on its insurance.
"Obviously that wasn't enough to compensate a professional musician who lost her arm, and the next step was Wyeth, which had much deeper pockets," he says. "A lot of people are worried that if the ruling determines that Wyeth wasn't responsible for putting more clear warnings on the product, that will completely transfer the liability and risk solely to the provider."
Bradshaw may not go that far himself. While he does see some potential for increased risk, he says some analysts may be overstating the threat.
"I don't think they will be held liable in cases where the drug maker would be held liable, just because of pre-emption, absent any evidence of malpractice," Bradshaw says. "But I do think there is good reason to review your insurance limits to make sure you are adequately protected. And you may want to make sure you have good protocols in place for the use of drugs that come with known risks, as was the case here."
Bradshaw speculates that the FDA did not insist on a label specifically warning against injecting Phenergan into an artery because that obviously was bad clinical practice.
Background: Wyeth case centers on labeling
The U.S. Supreme Court recently heard arguments in Wyeth v. Levine, and the ruling is expected to determine whether federal Food and Drug Administration approval of a drug warning label pre-empts product safety suits brought in state courts. The plaintiff is musician Diana Levine, who sued Wyeth after an injection of the nausea medication Phenergan, made by Wyeth, caused gangrene, which led to the amputation of one arm. The injury came when the drug was administered with a push IV injection rather than intramuscular, the method cited on the label as the preferred delivery method. Push IV was not listed as a preferred delivery method, but the label did not specifically prohibit that method either. During the push IV, the drug was accidentally injected into an artery, which led to the gangrene and the amputation.
Levine sued the physician, the physician assistant, the clinic, and Wyeth. All of the parties settled except Wyeth. In state court in Vermont, Levine argued that the Phenergan label was insufficient and should have warned about the known risk of gangrene from the push IV. A jury agreed with her and awarded $6 million.
Wyeth appealed, and the Vermont Supreme Court upheld the decision, so Wyeth appealed to the U.S. Supreme Court. The company argued that FDA approval of medication labels should preclude lawsuits in state courts related to the labels.
Wyeth says the risk of gangrene from push IV was known during the FDA approval process and that the FDA made no effort to have that method explicitly prohibited on the label. Since the FDA approval process is so intricate and demanding, Wyeth says, it isn't fair to hold the company liable for supposed deficiencies in a label that was approved by the FDA.
A ruling in favor of the plaintiff, Wyeth told the court, would leave manufacturers in a no-win situation, forced to comply with the extensive FDA labeling process but still subject to state court verdicts when a plaintiff claims the label wasn't good enough.
"You shouldn't have to put on the label 'don't inject directly into the spine, don't inject directly into the eye.' You could have a long laundry list of things that really amount to telling the provider not to practice bad medicine," he says.
Bradshaw expects the Supreme Court to rule in favor of Wyeth, but with a narrow pre-emption, providing protection to manufacturers only when there was no information about risks that the company could have provided to the FDA. There could be some shift in liability risks, he says, but the provider still is safe as long as there is no malpractice. There is no need to panic as long as you are taking adequate steps to ensure the proper administration of dangerous drugs and as long as you have adequate insurance.
"I think there are a lot of providers who haven't thought about the risk management principles in this area and aren't doing a good enough job of making sure they are followed," he says. "There could be a need to do some more training and updating of your protocols. You need to make sure your people are very carefully trained and monitored on these drug procedures."
Regardless of the outcome, Wyeth probably will prompt hospitals to increase training and review protocols for drugs with potentially serious side effects, says Timothy Ray, JD, a partner in the litigation practice group at the law firm of Neal Gerber in Chicago.
Ray cautions against risk managers taking too much comfort in a ruling that favors Wyeth. A Supreme Court ruling may tell manufacturers that they have some protection once the FDA approves the label, but that protection will not be unlimited for the provider.
"If you used the drug exactly as described on the label, followed all the instructions exactly and didn't do anything wrong, then I think the label provides an affirmative defense for any unforeseen injuries," he says. "But if you make any mistake in administering the drug, any errors in the actual providing of the drug to the patient, or if you use the drug in a way that is not prescribed on the label, then that defense is of no help to you."
A ruling against Wyeth could prompt manufacturers to revise drug labels to be much more explicit, says Jill M. Wheaton, JD, an attorney with the law firm of Dykema in Ann Arbor, MI. Levine was arguing in her case that the Phenergan label should have specifically prohibited push IV, so if that view is upheld, drug makers may protect themselves by making labels even longer than they already are and far more specific.
"This would really create a burden for the provider. It would tie the hands of doctors, who would either have to comply with these instructions or take on the risk of using the drug in the way they see fit," she says. "The labels currently give some deference to the treating physician, but drug manufacturers may be forced to change that."
For more information on the Wyeth case, contact:
Sheldon Bradshaw, JD, Partner, Hunton & Williams, Washington, DC. Telephone: (202) 955-1575. E-mail: firstname.lastname@example.org.
Karen Gibbs, JD, Attorney, Crowell & Moring, Irvine, CA. Telephone: (949) 798-1329. E-mail: email@example.com.
Maureen Martin, JD, Senior Fellow, Legal Affairs, The Heartland Institute, Chicago. Telephone: (920) 295-6032. E-mail: firstname.lastname@example.org.
Timothy Ray, JD, Partner, Neal, Gerber & Eisenberg, Chicago. Telephone: (312) 269- 8456. E-mail: email@example.com.
Peter Reichertz, JD, Partner, Sheppard Mullin, Washington, DC. Telephone: (202) 772-5333. E-mail: firstname.lastname@example.org.
Jill M. Wheaton, JD, Attorney, Dykema, Ann Arbor, MI. Telephone: (734) 214-7629. E-mail: email@example.com.