1. Explain why the extra labeling could not be placed on the generic version of the drug that Ms. Bartlett purchased.

2. Discuss the relationship between state product liability laws and the duty of manufacturers and federal regulation of generic labels.

3. How does the court address the issue of the tragedy of the case?

In 1978, the FDA approved an anti-inflammatory pain reliever called “sulindac” under the brand name of “Clinoril.” When the patent expired, the FDA approved several generic versions of sulindac for sale, including one developed by Mutual Pharmaceutical (Petitioner). The warnings for Clinoril included the possibility of developing toxic epidermal necrolysis. Karen Bartlett (Respondent) took a generic form of sulindac in December 2004 and developed an acute case of toxic epidermal necrolysis. Sixty to sixty-five percent of Ms. Bartlett’s body deteriorated, was burned off, or turned into an open wound. She spent months in a medically induced coma, underwent 12 eye surgeries, and was tube-fed for a year. She is now severely disfigured, has a number of physical disabilities, and is nearly blind.

At the time Ms. Bartlett got her sulindac prescription, the label did not refer to toxic epidermal necrolysis but warned that the drug could cause “severe skin reactions” and “fatalities.” Toxic epidermal necrolysis was listed as a side effect in the package insert. After Ms. Bartlett was suffering from toxic epidermal necrolysis, the FDA did a comprehensive study and recommended that the product label include more explicit warnings about toxic epidermal necrolysis. 

Ms. Bartlett sued Mutual in New Hampshire state court, and Mutual removed the case to federal court. Ms. Bartlett initially asserted both failure-to-warn and designdefect claims, but the District Court dismissed her failureto- warn claim based on her doctor’s “admi[ssion] that he had not read the box label or insert.”

After a two-week trial on a design-defect claim, a jury found Mutual liable and awarded Ms. Bartlett over $21 million in damages. The Court of Appeals affirmed, and Mutual appealed. The U.S. Supreme Court granted certiorari.

JUDICIAL OPINION

ALITO, Justice … We must decide whether federal law preempts the New Hampshire design-defect claim. The Supremacy Clause provides that the laws and treaties of the United States “shall be the supreme Law of the Land ... any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” “[U]nder the Supremacy Clause, from which our pre-emption doctrine is derived, any state law, however clearly within a State’s acknowledged power, which interferes with or is contrary to federal law, must yield. Federal law prevents generic drug manufacturers from changing their labels. When federal law forbids an action that state law requires, the state law is “without effect.” 

Because it is impossible for Mutual and other similarly situated manufacturers to comply with both state and federal law, New Hampshire’s warning based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce. 

The Court of Appeals reasoned that Mutual could escape the impossibility of complying with both its federaland state-law duties by “choos[ing] not to make [sulindac] at all.” We reject this “stop-selling” rationale as incompatible with our pre-emption jurisprudence. Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be “all but meaningless.” 

The dreadful injuries from which products liabilities cases arise often engender passionate responses. But sympathy for respondent does not relieve us of the responsibility of following the law………………………..