State Claim Not Preempted By Federal Drug Labeling Law

The decisive March 4 U.S. Supreme Court ruling against Wyeth in a landmark pharmaceutical product liability case may also close off a major front in a hard-fought battle by businesses and the Bush administration to insulate national corporations from state tort litigation. By a 6-3 margin in Wyeth v. Levine, the Court ruled that the federal drug labeling law did not preempt the state court claim of Vermont musician Diana Levine, who sued when she lost her forearm in 2000 to gangrene because of improper administration of Phenergan. The labeling on the Wyeth-produced anti-nausea drug, she claimed, had failed to adequately warn medical personnel that the method used to give her the drug, an “IV-push,” was dangerous and could lead to gangrene.

“Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling,” Justice John Paul Stevens wrote for the majority. He also noted that until recent years, the Food and Drug Administration viewed state litigation as complementary to its regulations.

The Plaintiff Wins, and So Do Countless Others

The decision means Ms. Levine will finally benefit from a roughly $7 million jury award she won in 2004, plus interest, that Wyeth had challenged on federal preemption grounds. (Earlier, she also reached a settlement with the Vermont clinic that administered the drug.)

“Diana was overcome with emotion and felt joy, a redemption, a feeling of justice, when I spoke with her,” said David Frederick, the partner at Washington, DC's Kellogg, Huber, Hansen, Todd, Evans & Figel who argued for Ms. Levine before the Court. “I'm very pleased personally for Diana, and this is a huge win for consumers.”

In a telephone news conference from her home in Vermont, Ms. Levine was exultant about the ruling. “Next to getting my hand back, it's the best thing that could happen,” she said, adding that, “I feel like I've done something worthwhile” for consumers in similar situations.

More broadly, according to Georgetown University Law Center professor David Vladeck, the ruling represents “a real body blow to the Bush administration's efforts to change tort law through implied preemption.” That campaign is “as dead as a dead yak,” said Mr. Vladeck, who filed a brief supporting Ms. Levine on behalf of former FDA commissioners Donald Kennedy and David Kessler. Mr. Vladeck and other consumer advocates say that Bush administration regulators seeded a range of regulations and legal briefs with “implied preemption” arguments when it became clear Congress would not enact explicit preemption provisions benefiting business.

But other litigators said preemption arguments are still available to pharmaceutical and other industry defendants who seek a uniform rule instead of the vagaries of 50 state
legal systems. “The decision is disappointing from an industry perspective, but it is limited to this category of implied preemption in failure-to-warn claims,” said Steven Weisburd, a partner at Dechert in Austin, TX. “There are a lot of issues this ruling does not decide.”

The decision was applauded by liberal and consumer groups as a rare win coming from a Court that is usually viewed as consistently pro-business. “The six justices who stood up for accountability sent a clear message that FDA approval does not necessarily grant a corporation a license to hit and run,” said Nan Aron of the liberal Alliance for Justice, who had launched a Facebook campaign to support Ms. Levine.

“Legal immunity for drug manufacturers ' as called for by the drug companies and the Bush administration ' would have been a huge mistake,” said Brian Wolfman of Public Citizen. “We believe the Supreme Court appreciated that.”

Unlikely Alliance

The Court's lineup in the Wyeth case highlighted how preemption cases, which raise issues of states' rights and federalism as well business uniformity, are not always decided along liberal-conservative lines. Conservative Justice Clarence Thomas offered a powerful concurrence to the liberal Justice Stevens' majority, suggesting he would go even further than Justice Stevens in questioning federal preemption doctrine. Justice Thomas said “congressional and agency musings” about possible intent to preempt state suits are not adequate substitutes for explicit preemption provisions enacted into law.

Justice Stevens also won over Justice Anthony Kennedy, leaving the three remaining conservatives to form the minority: Chief Justice John Roberts Jr. and Justices Samuel Alito Jr. and Antonin Scalia. The chief justice remained in the case even though his last financial disclosure form indicated he owns stock in Pfizer, which has announced plans to acquire Wyeth. His participation suggests either that he has sold the stock or did not believe recusal was required.

Writing for the dissenters, Justice Alito acknowledged the force, at a human level, of Ms. Levine's case against Wyeth: “This case illustrates that tragic facts make bad law.” Justice Alito said that under federal law, it is the job of the FDA, not state juries, to make the safety determinations that go into deciding the appropriate labeling and warnings for a drug.

But Justice Stevens' majority opinion, while reciting the facts of Ms. Levine's case for six pages, did not dwell on them, instead filling the rest of the 25-page argument with the pros and cons and history of preemption and refuting Wyeth's arguments.

Labeling Arguments

Wyeth, represented by Seth Waxman of Wilmer Cutler Pickering Hale and Dorr, asserted that it could not meet any state duty to improve the warnings on Phenergan without violating the federal drug labeling law, which calls for FDA approval of labels. But Justice Stevens said that FDA regulations in fact allow manufacturers to add or strengthen labeling in advance of receiving FDA approval.

Justice Stevens also rejected Wyeth's argument that adhering to state labeling requirements would thwart the purposes of Congress in enacting federal drug labeling regulations. “The most glaring problem with this argument is that all evidence of Congress' purposes is to the contrary,” he wrote.

In a statement, Bert Rein of Washington's Wiley Rein, a part of Wyeth's legal team, said in reaction to the ruling, “The medical and scientific experts at FDA are in the best position to weigh the benefits and risks of a medicine and to assess how those benefits and risks should be described in the product's label.”

The Pharmaceutical Research and Manufacturers of America also issued a statement criticizing the decision.”Health care providers and patients rely on FDA-approved drug labeling every day in making critical decisions about whether a medicine is the best treatment for an individual,” the association's Ken Johnson said. “Unfortunately, patients could ultimately suffer if the Supreme Court's decision forces health care providers and patients to second-guess FDA-approved labeling.”

Tony Mauro is the Supreme Court Correspondent for The Legal Times, an Incisive Media sister publication of this newsletter.

The decisive March 4 U.S. Supreme Court ruling against Wyeth in a landmark pharmaceutical product liability case may also close off a major front in a hard-fought battle by businesses and the Bush administration to insulate national corporations from state tort litigation. By a 6-3 margin in Wyeth v. Levine, the Court ruled that the federal drug labeling law did not preempt the state court claim of Vermont musician Diana Levine, who sued when she lost her forearm in 2000 to gangrene because of improper administration of Phenergan. The labeling on the Wyeth-produced anti-nausea drug, she claimed, had failed to adequately warn medical personnel that the method used to give her the drug, an “IV-push,” was dangerous and could lead to gangrene.

“Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling,” Justice John Paul Stevens wrote for the majority. He also noted that until recent years, the Food and Drug Administration viewed state litigation as complementary to its regulations.

The Plaintiff Wins, and So Do Countless Others

The decision means Ms. Levine will finally benefit from a roughly $7 million jury award she won in 2004, plus interest, that Wyeth had challenged on federal preemption grounds. (Earlier, she also reached a settlement with the Vermont clinic that administered the drug.)

“Diana was overcome with emotion and felt joy, a redemption, a feeling of justice, when I spoke with her,” said David Frederick, the partner at Washington, DC's Kellogg, Huber, Hansen, Todd, Evans & Figel who argued for Ms. Levine before the Court. “I'm very pleased personally for Diana, and this is a huge win for consumers.”

In a telephone news conference from her home in Vermont, Ms. Levine was exultant about the ruling. “Next to getting my hand back, it's the best thing that could happen,” she said, adding that, “I feel like I've done something worthwhile” for consumers in similar situations.

More broadly, according to Georgetown University Law Center professor David Vladeck, the ruling represents “a real body blow to the Bush administration's efforts to change tort law through implied preemption.” That campaign is “as dead as a dead yak,” said Mr. Vladeck, who filed a brief supporting Ms. Levine on behalf of former FDA commissioners Donald Kennedy and David Kessler. Mr. Vladeck and other consumer advocates say that Bush administration regulators seeded a range of regulations and legal briefs with “implied preemption” arguments when it became clear Congress would not enact explicit preemption provisions benefiting business.

But other litigators said preemption arguments are still available to pharmaceutical and other industry defendants who seek a uniform rule instead of the vagaries of 50 state
legal systems. “The decision is disappointing from an industry perspective, but it is limited to this category of implied preemption in failure-to-warn claims,” said Steven Weisburd, a partner at Dechert in Austin, TX. “There are a lot of issues this ruling does not decide.”

The decision was applauded by liberal and consumer groups as a rare win coming from a Court that is usually viewed as consistently pro-business. “The six justices who stood up for accountability sent a clear message that FDA approval does not necessarily grant a corporation a license to hit and run,” said Nan Aron of the liberal Alliance for Justice, who had launched a Facebook campaign to support Ms. Levine.

“Legal immunity for drug manufacturers ' as called for by the drug companies and the Bush administration ' would have been a huge mistake,” said Brian Wolfman of Public Citizen. “We believe the Supreme Court appreciated that.”

Unlikely Alliance

The Court's lineup in the Wyeth case highlighted how preemption cases, which raise issues of states' rights and federalism as well business uniformity, are not always decided along liberal-conservative lines. Conservative Justice Clarence Thomas offered a powerful concurrence to the liberal Justice Stevens' majority, suggesting he would go even further than Justice Stevens in questioning federal preemption doctrine. Justice Thomas said “congressional and agency musings” about possible intent to preempt state suits are not adequate substitutes for explicit preemption provisions enacted into law.

Justice Stevens also won over Justice Anthony Kennedy, leaving the three remaining conservatives to form the minority: Chief Justice John Roberts Jr. and Justices Samuel Alito Jr. and Antonin Scalia. The chief justice remained in the case even though his last financial disclosure form indicated he owns stock in Pfizer, which has announced plans to acquire Wyeth. His participation suggests either that he has sold the stock or did not believe recusal was required.

Writing for the dissenters, Justice Alito acknowledged the force, at a human level, of Ms. Levine's case against Wyeth: “This case illustrates that tragic facts make bad law.” Justice Alito said that under federal law, it is the job of the FDA, not state juries, to make the safety determinations that go into deciding the appropriate labeling and warnings for a drug.

But Justice Stevens' majority opinion, while reciting the facts of Ms. Levine's case for six pages, did not dwell on them, instead filling the rest of the 25-page argument with the pros and cons and history of preemption and refuting Wyeth's arguments.

Labeling Arguments

Wyeth, represented by Seth Waxman of Wilmer Cutler Pickering Hale and Dorr, asserted that it could not meet any state duty to improve the warnings on Phenergan without violating the federal drug labeling law, which calls for FDA approval of labels. But Justice Stevens said that FDA regulations in fact allow manufacturers to add or strengthen labeling in advance of receiving FDA approval.

Justice Stevens also rejected Wyeth's argument that adhering to state labeling requirements would thwart the purposes of Congress in enacting federal drug labeling regulations. “The most glaring problem with this argument is that all evidence of Congress' purposes is to the contrary,” he wrote.

In a statement, Bert Rein of Washington's Wiley Rein, a part of Wyeth's legal team, said in reaction to the ruling, “The medical and scientific experts at FDA are in the best position to weigh the benefits and risks of a medicine and to assess how those benefits and risks should be described in the product's label.”

The Pharmaceutical Research and Manufacturers of America also issued a statement criticizing the decision.”Health care providers and patients rely on FDA-approved drug labeling every day in making critical decisions about whether a medicine is the best treatment for an individual,” the association's Ken Johnson said. “Unfortunately, patients could ultimately suffer if the Supreme Court's decision forces health care providers and patients to second-guess FDA-approved labeling.”

Tony Mauro is the Supreme Court Correspondent for The Legal Times, an Incisive Media sister publication of this newsletter.