Supreme Court rules against Wyeth in pre-emption case

The U.S. Supreme Court on Wednesday ruled 6-3 that consumers harmed by an FDA-approved pharmaceutical product can sue the drugmaker for liability in state courts, the San Francisco Chronicle reports (Egelko, San Francisco Chronicle, 3/5).

The ruling in Wyeth v. Levine "undercuts years of business efforts to block state suits over the safety of their products," by claiming that federal approval of a product's warning label pre-empts state law from judging the effectiveness of that label, the Wall Street Journal reports (Bravin, Wall Street Journal, 3/5). The Bush administration included language supporting pre-emption in 50 different regulations from various federal agencies, including FDA, according to the Journal (Johnson et al., Wall Street Journal, 3/5).

In its decision, the court upheld a verdict of $6.7 million in favor of Diane Levine, whose arm was amputated after a clinician injected the Wyeth anti-nausea drug Phenergan directly into her vein to treat a migraine. Levine argued that Wyeth had not taken adequate measures to warn of the risk of using Phenergan in this manner (Biskupic/Appleby, USA Today, 3/5). Though the drug's FDA-approved label did not prohibit this method, known as IV-push, it noted that "extreme care" was necessary to avoid hitting an artery because "likely" complications include "gangrene requiring amputation" (Bravin, Wall Street Journal, 3/5).

Justices John Paul Stevens, Anthony Kennedy, David Souter, Ruth Bader Ginsburg and Steven Breyer voted in favor of Levine (Savage, Baltimore Sun, 3/5). Stevens in the majority opinion wrote that Wyeth's case was "meritless," noting a lack of evidence that the firm tried to enhance warnings or that FDA denied stronger language. He noted that FDA's stance in favor of pre-emption in recent years was "inherently suspect" because interested parties were given no opportunity to comment on the rule change (Hill, Philadelphia Inquirer, 3/5). He also cited "powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness." Stevens added that FDA has "limited resources" for overseeing all the pharmaceutical products on the market, and that "state tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly" (Barnes, Washington Post, 3/5). Justice Clarence Thomas voted with the majority but differed in his reasoning. He wrote that he objected in general to "far-reaching implied pre-emption doctrines" that "wander far from the statutory text."

Chief Justice John Roberts and Justices Samuel Alito and Antonin Scalia voted in favor of pre-emption. In the dissenting opinion, Alito wrote that Wyeth had provided sufficient notice of the risk of gangrene associated with the drug in "six separate warnings," some of which were "in boldfaced font and all-capital letters," on its label. He added that juries see only the "tragic accident" in drug liability cases and are "ill-equipped to perform FDA's cost-benefit-balancing function." FDA, however, "has the benefit of the long view" and "conveys its warnings with one voice," according to Alito. He wrote, "This case illustrates that tragic fact makes bad law" (Liptak, New York Times, 3/5). Alito also wrote that with the majority decision, the Supreme Court "holds that a state tort jury, rather than the FDA, is ultimately responsible for regulating warning labels for prescription drugs" (Philadelphia Inquirer, 3/5).

Reaction

Levine's attorney David Frederick said, "The Supreme Court's opinion reaffirms the important role state law plays in promoting consumer safety and providing compensation for injuries" (Edney, CongressDaily, 3/4). Senate Judiciary Committee Chair Patrick Leahy (D-Vt.) said, "The Court's decision soundly rejects the anti-consumer position of the Bush administration, and reaffirms Congress' primacy concerning the extraordinary power to pre-empt state law," adding, "Most of all, the decision reclaims for all American citizens the ability to seek justice in their lower courts of law" (Stern, CQ HealthBeat, 3/4).

Wyeth attorney Bert Rein said the firm was unable to change the drug's warning label, which left to the physician the decision of whether to administer the drug by IV-push or by a slower method, such as IV drip. He said, "The practical impact of this is going to be much greater caution" by physicians in deciding whether to use the most effective method of administering a drug or the least risky method. Rein said he does not expect a greater number of lawsuits to be brought against drugmakers as a result of the decision. However, Rein said he does anticipate future pre-emption defenses that concentrate on issues raised by this ruling, such as whether there is evidence FDA would have rejected an attempt to change warning labels.

WBB Securities analyst Steve Brozak said the ruling will lead drugmakers to "make dollars-and-cents decisions on what (research) programs will go ahead and what drugs will be pulled" from the market. According to Brozak, "They'll defend the blockbusters, but the smaller drugs with meaningful downsides" will be sold off or put on hold. Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said FDA drug experts "are in the best position to evaluate voluminous information" about a drug, but that after this decision health care providers and patients could "second-guess FDA-approved labeling" (Johnson, AP/Washington Times, 3/5).

Editorials

• New York Times: The court "made a wise and surprising decision" when it "demolished the notion that federal regulatory rulings automatically pre-empt the state from enforcing even tougher standards on drugs," a Times editorial states. The editorial continues that the ruling "exposed as a sham the Bush administration's strenuous efforts to protect its allies in industry with phony pre-emption claims." The Times concludes, "The decision ... will give consumers another avenue of redress for injuries and should force the manufacturers to exercise greater care in production and labeling. We hope this decision will put the brakes on efforts to stifle damage suits in other areas as well" (New York Times, 3/5).
• Wall Street Journal: The Wyeth decision is "a huge victory for plaintiffs lawyers, but it's a much bigger defeat for drug innovation and public health," a Journal editorial states. According to the editorial, in cases like Wyeth v. Levine, "[j]uries are presented with tragic plaintiffs who were injured, not the unknown patients who are helped, by a product," so "they tend to focus on risks more than overall benefits." The editorial continues that "federal regulators are tasked to take the long view and factor in the interests of all potential users of a drug." According to the editorial, "Yesterday's ruling will expose drug companies to a kind of double innovation jeopardy." Drugmakers traditionally have "endure[d]" the "burden" of research and development costs, despite an "11% success rate on average," because of "the understanding that FDA approval will give them a period to sell that drug with patent protection and that FDA approval provides some protection from lawsuits," the editorial states. The editorial concludes, "Now they will have to contemplate paying up front -- and paying later, even if the tragic mistake in applying the drug is someone else's. Wyeth is a dream come true for the plaintiffs bar" (Wall Street Journal, 3/5).

NPR's "Morning Edition" on Wednesday reported on the court's decision. The segment includes comments from Levine, as well as drug industry advocate Victor Schwartz and Georgetown University law professor and consumer advocate David Vladick. The segment also was aired as part of NPR's "All Things Considered" on Wednesday (Totenberg, "Morning Edition," NPR, 3/5).

NBC's "Nightly News with Brian Williams" on Wednesday reported on the ruling. The segment includes comments from Rein and Brian Wolfman of Public Citizen's Litigation Group (Williams, "Nightly News with Brian Williams," NBC, 3/4).