WASHINGTON, D.C. - (Mealey's) Several U.S. Supreme Court justices on March 19 questioned whether New Hampshire law allows a design defect claim against a generic drug manufacturer that escapes preemption under the high court's two drug preemption rulings (Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett, No. 12-142, U.S. Sup.). [lexis.com subscribers may access Supreme Court briefs for this case].
(Transcript available. Document #28-130321-014T.)
Karen L. Bartlett was prescribed sulindac, the generic version of Clinoril, to treat shoulder pain and developed Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), reactions that resulted in burnlike damage to 60 to 65 percent of her body. Bartlett spent 70 days in a hospital, including a burn unit, and suffered permanent tissue damage and near blindness.
In 2010, a jury in the U.S. District Court for the District of New Hampshire awarded Bartlett $21 million against the defendant, generic drug maker Mutual Pharmaceutical Co. Inc. Design defect was the sole surviving claim at trial.
Lower Court Preemption Rulings
Both the District Court and the First Circuit U.S. Court of Appeals ruled that a design defect claim under New Hampshire law is not preempted by the Supreme Court's generic drug preemption ruling. The First Circuit added that if Mutual Pharmaceutical could not legally change it sulindac warning label to add a warning about SJS and TEN, it could have avoided liability by stopping the sale of the drug.
Mutual Pharmaceutical appealed to the Supreme Court.
Justice Elena Kagan told Jay P. Lefkowitz of Kirkland & Ellis in New York, who argued for Mutual Pharmaceutical, that if the case is only about design defect and not about failuretowarn, it makes no difference if the drug is brand name or generic. Lefkowitz said he was not sure there is a way to make a distinction.
Lefkowitz said the case is about impossibility preemption because under the Supreme Court's generic drug preemption ruling in PLIVA, Inc. v. Mensing (131 S. Ct. 2567 ) [enhanced version available to lexis.com subscribers], generic drugs must carry the same warning label as brand-name predecessor drugs. Lefkowitz also agreed with Justice Kagan that there can be tort liability claims involving drugs approved by the Food and Drug Administration.
Did FDA Approve Design?
If Bartlett had taken Clinoril, the brand-name version of sulindac, Lefkowitz said Bartlett would have had a failure-to-warn claim against that manufacturer. "How?" asked Justice Sonia Sotomayor. "The FDA approved the design?"
Lefkowitz said the brand-name manufacturer can change the warning. He said the First Circuit stated that the label was relevant to the design defect claim and that a lack of a clearer warning made the drug dangerous under the risk/benefit tests.
Justice Samuel Alito said Bartlett argued that the thrust of New Hampshire law is that the state has an absolute product liability system. Lefkowitz said the New Hampshire Supreme Court made clear that the state does not have that.
In answer to a question by Justice Ruth Bader Ginsburg, Lefkowitz said FDA drug approval operates as both a floor and a ceiling. But he admitted that there is nothing in the Food, Drug and Cosmetic Act (FDCA) that says the states have no role with respect to the safety and efficacy of drugs.
Don't Have To Sell
Picking up on the First Circuit's finding, Justice Kagan said "[I]t seems as though what we have in the FDCA is a statute . . . that says you can sell this. But it doesn't say you must sell it, and it doesn't give you a right to sell it."
Lefkowitz said "the quintessential example of impossibility has nothing to do with a Federal right at all. It is simply conflicting standards."
Anthony A. Yang, assistant to the solicitor general, argued for the government in favor of finding Bartlett's claim preempted.
Different From Mensing?
Chief Justice John G. Roberts Jr. said Bartlett's case is "a little different" from Mensing. He said New Hampshire's strict liability regime doesn't talk about different duties or additional warnings, just that "if you do this, you're going to have to pay for the damage. It's not a different duty."
In answer to a question by Justice Anthony M. Kennedy, Yang said the government defines New Hampshire's duty on drug manufacturers to be that they cannot market an unreasonably dangerous drug in light of the warnings. He said imposing a state obligation conflicts with the drug maker's federal duty.
Chief Justice Roberts, however, said the state's duty is different from that of the federal law. Justice Kagan added, "But if there's no obligation . . . where do you get the impossibility from?"
"[W]hen the state is imposing an obligation, they do it based on a safety standard - that is in fact second-guessing the FDA - that is preemptive," Yang said.
Can't Be Argued
"You're basically saying the minute that the FDA gives you permission to sell, it's a right to sell, and it can't be altered by any state police power," Justice Sotomayorsaid.
"No, we're actually not saying that," Yang replied. "Well, I don't see how you're not saying that," Justice Sotomayor said.
Yang said that a under a "pure design-defect claim," no physician could prescribe a drug regardless of how inclusive its warnings. "And so what we are trying to do is preserve the FDA's role here, not have juries second-guess on a case-by-case basis and state-by-state basis imposing different safety obligations on manufacturers - when Congress has established the regime for FDA to control this," Yang said.
'12 Men Tried And Few'
When David C. Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel in Washington, arguing for Bartlett, said the New Hampshire law imposes liability for an unreasonably dangerous product, Justice Antonin Scalia asked "The jury decided all of this, right?"
"That's correct," Frederick answered. "That's wonderful," Justice Scalia answered.
"Twelve tried men and few, and true, decided for the whole state what the cost/benefit analysis is for a very novel drug that unquestionably has some deleterious effects, but also can save some lives," he continued. "So the jury's going to decide that?
FDCA Doesn't Preclude Juries
"Yes it is," Frederick said, "and notably, the FDCA doesn't preclude that. Wyeth v. Levine [555 U.S. 555 (2009) [enhanced version] affirms that principle. And what's important here is that under state law, there's not a duty to change the design or change the label."
Chief Justice Roberts disagreed with Frederick's argument that if a drug is unreasonably dangerous and people are harmed egregiously, they have the opportunity to be compensated. The chief justice said the jury's verdict that the risks outweigh the benefits "does seem inconsistent with the federal regime."
He added that one jury can say risks don't outweigh benefits and another can say they do. Frederick said there is no preclusion effect to a jury verdict, not collateral estoppel.
Defendant Waived Comment K
Frederick said Mutual Pharmaceutical can adopt different legal strategies, as it did in Bartlett's case when, on the eve of trial, it waived its defense under comment k of the Second Restatement of Torts.
Justice Kagan noted that the case was litigated "such that the adequacy of the warning is really all over this case . . . which does suggest that this is sort of within the four corners of Mensing." Frederick maintained that warning was not an element of Bartlett's claim.
Justices Stephen G. Breyer and Kagan questioned how well the Bartlett case was able to exclude the warning issue. Justice Kagan said the plaintiffs "really spent a large portion of their case trying to show this, that the warning was inadequate."
Warning's Role At Trial
Frederick said the jury was instructed that "the only role that the warning actually played was whether it could lessen the risk to patients who took the drug, i.e., in the risk/benefit analysis, it's somewhat less risky in weighing it against the benefits." He quoted the judge's jury instructions: "The adequacy of the warning is not an issue for you to decide."
He added that the judge told the jury to consider adequacy of warning only to assess the risk/benefit analysis.
Justice Breyer used an analogy between sulindac and chemotherapy drugs. Frederick said a chemotherapy drug has a "huge benefit," while there were 16 other nonsteroidal anti-inflammatory drugs (NSAIDs) that could have been prescribed to Bartlett.
FDA Evidence Never Presented
Justice Alito asked if Frederick was arguing that sulindac should never have been approved. Frederick said he was not, but that post-approval adverse events should have led to it being taken off the market.
He said the FDA never made a ruling about sulindac when it reviewed all nonsteroidal anti-inflammatory drugs and said Mutual Pharmaceutical never called its expert to testify about what the FDA said or didn't say.
Mutual Pharmaceutical is represented by Michael W. McConnell, Michael D. Shumsky and John K. Crisham of Kirkland & Ellis in Washington and Lefkowitz. Bartlett is represented by Brendan J. Crimmins, Joshua D. Branson and Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel in Washington; Steven M. Gordon and Christine M. Craig of Shaheen & Gordon in Concord, N.H.; and Keith M. Jensen of Jensen & Associates in Fort Worth, Texas.
The United States is represented by Solicitor General Donald B. Verrilli Jr., Stuart F. Delery, Edwin S. Kneedler, Scott R. McIntosh, Jonathan H. Levy and Yang of the U.S. Justice Department and William B. Schultz, David Horowitz, Elizabeth H. Dickinson and Julie Dohm of the U.S. Department of Health and Human Services, all in Washington.
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