RESPONDENT: Karen L. Bartlett
LOCATION: Massachusetts General Hospital
DOCKET NO.: 12-142
DECIDED BY: Roberts Court (2010-2016)
LOWER COURT: United States Court of Appeals for the First Circuit
CITATION: 570 US 2468 (2013)
GRANTED: Nov 30, 2012
ARGUED: Mar 19, 2013
DECIDED: Jun 24, 2013
Anthony A. Yang - Assistant to the Solicitor General, Department of Justice, for the United States as amicus curiae supporting the petitioner
David C. Frederick - for the respondent
Jay P. Lefkowitz - for the petitioner
Facts of the case
In December 2004, Karen Bartlett's doctor prescribed Sulindac, a generic anti-inflammatory medication, to help treat her shoulder pain. Within months she began suffering from a severe reaction called Stevens-Johnson syndrome, which caused the skin condition toxic epidermal necrolysis. This condition deteriorated over 60 percent of her skin to the point of causing open wounds. As a result, she has suffered permanent and serious injuries, including near-blindness.
Bartlett filed a lawsuit against the Sulindac medication manufacturer, Mutual Pharmaceutical Company. Bartlett initially presented several negligence and product liability claims, but only her design defect product liability claim made it to trial. Beginning in August 2009, a jury at the Federal District Court for the District of New Hampshire heard evidence that Sulindac was unreasonably dangerous to consumers and therefore was defectively designed. Mutual countered, among several other defenses, that federal law governs generic drug manufacturers' conduct; therefore Karen could not pursue a state design defect claim.
After 14 days of trial, the jury deliberated and sided with Bartlett, awarding over $20 million in compensatory damages. Mutual appealed the decision for several reasons, including the following: the district court misunderstood New Hampshire product liability law; and, the court improperly admitted several pieces of evidence and the jury award of damages was excessive. Mutual also reasserted its claim that federal law should prevail over a state defective design claim. Despite Mutual's arguments, the United States Court of Appeals for the First Circuit affirmed the lower court's decision. Mutual appealed further to the Supreme Court of the United States, which granted certiorari.
Does federal law preempt a state design defect claim against a generic drug manufacturer?
Media for Mutual Pharmaceutical Co. v. BartlettAudio Transcription for Oral Argument - March 19, 2013 in Mutual Pharmaceutical Co. v. Bartlett
Audio Transcription for Opinion Announcement - June 24, 2013 in Mutual Pharmaceutical Co. v. Bartlett
John G. Roberts, Jr.:
Justice Alito also has our opinion this morning in case 12-142, Mutual Pharmaceutical Company versus Bartlett.
Samuel A. Alito, Jr.:
In this case, we must determine whether New Hampshire's design-defect tort law cause of action was preempted by federal law.
Responding Karen Bartlett was prescribed Clinoril, the brand name version of the pain reliever sulindac for shoulder pain.
Her pharmacist dispensed a generic form of sulindac manufactured by petitioner Mutual Pharmaceutical.
The results were disastrous.
Respondent experienced a rare hypersensitivity reaction to sulindac and suffered severe and permanent injuries.
She sued Mutual Pharmaceutical and a federal jury ultimately retuned a large verdict against Mutual Pharmaceutical based on a New Hampshire design-defect tort law cause of action.
The First Circuit affirmed.
The Supremacy Clause of the Constitution provides that the laws and treaties of the United States are the supreme Law of the Land and we have long held that state laws that conflict with federal law are preempted.
That is without a fact.
One way that state laws can conflict with federal law is by requiring a private party to take an action that federal law prohibits.
In such cases, there is what has been termed impossibility pre-emption.
Here, state law imposes just such a duty. New Hampshire's design-defect cause of action requires a manufacturer to ensure that its products are not unreasonably dangerous to consumers.
It may fulfill that duty in any or all of three ways by increasing the products' usefulness, by decreasing its risk of danger, or by strengthening the products' warnings.
Here, the first two avenues were close to Mutual by both federal law and basic chemistry.
Changing sulindac's usefulness or risk of danger would have required Mutual to change sulindac's chemical composition, but federal law prohibits manufacturers from making such changes.
The Federal Food and Drug Act fast tracks generic drugs to market on the assurance that their chemical composition is identical to that of their brand-name counterparts and federal law prohibits manufacturers from deviating from that approved design.
Moreover, because sulindac is a one-molecule drug redesign, it was chemically impossible.
Thus, New Hampshire law ultimately required Mutual to strengthen its label.
Unsurprisingly, allegations that sulindac's labeling was inadequate featured prominently at trial.
But as we recognized two terms ago in PLIVA, Inc. versus Mensing, federal law prohibits generic drug manufacturers from changing the labels that the FDA has approved for their drugs.
Accordingly, because it required Mutual to take actions that federal law prohibited New Hampshire's warning-based design-defect cause of action is pre-empted.
The First Circuit solution that Mutual could have complied with both state and federal law by simply pulling sulindac from the market is no real solution.
Our impossibility pre-emption cases have presumed that an actor seeking to satisfy conflicting state and federal law obligations is not required to cease acting altogether in order to avoid liability, at least where neither state law nor federal law imposes such an obligation.
Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless in every case including PLIVA in which we have found impossibility pre-emption would have been wrongly decided.
This case arises out of tragic circumstances and we reach our conclusion only reluctantly, but the application of long standing pre-emption principles compels our result.
The judgment of the First Circuit is reversed.
Justice Breyer has filed a dissenting opinion in which Justice Kagan has joined.
Justice Sotomayor has also filed a dissenting opinion in which Justice Ginsburg has joined.