The Case
In November 2003, seven-year-old Samantha Reckis took Children’s Motrin after showing signs of a fever. The popular pain reliever did not improve her condition. Instead, Samantha developed toxic epidermal necrolysis (“TEN”), a life-threatening skin condition that caused her to lose 80 percent of her lung capacity, 90 percent of her skin, and her vision. Since 2003, Samantha has undergone almost 100 surgeries, which have kept her alive.
Samantha and her parents sued Johnson & Johnson, the manufacturer of Children’s Motrin, for allegedly failing to provide adequate warnings about the risks associated with the drug. Specifically, the Reckis family claimed that Children’s Motrin should have included a warning that its use could result in a life-threatening condition. In February 2013, a Plymouth County jury returned a $63 million verdict in favor of the Reckis family.
The Appeal
Johnson & Johnson appealed the verdict, primarily arguing that the United States Supreme Court’s 2009 decision Wyeth v. 
Levine preempted the plaintiffs’ claims because the Food and Drug Administration (“FDA”) would have rejected the warning that the Reckis family argued should have been on Children’s Motion. In Wyeth v. Levine, the Supreme Court found that a drug manufacturer could still be liable for failure to warn even after the FDA had approved a drug’s warning label. However, the Court also indicated that if there was “clear evidence” that the FDA would have rejected a manufacturer’s proposed warning change, then the manufacturer would not be liable for failing to include such a warning.
In 2003, when Samantha Reckis took Children’s Motrin for her fever, the warning on the drug advised users to stop using it if an allergic reaction occurred, but did not mention TEN or that its symptoms could be a sign of a life-threatening condition. Thereafter, a group of citizens petitioned the FDA to revise the warning on pain relievers with ibuprofen, such as Children’s Motrin, to reflect that use of the product could lead to potentially life-threatening conditions such as TEN. The FDA rejected this petition and specifically noted that including disease names such as TEN would not be useful to consumers because most consumers would be unfamiliar with such terms. Johnson & Johnson argued that this rejection constituted clear evidence that the FDA would have rejected a revised label for Children’s Motrin that included any mention of it potentially causing “life-threatening” diseases.
The SJC rejected this argument, explaining:
the FDA’s decision not to request that manufacturers add a warning about life-threatening diseases could well have been merely a byproduct of its rejection of these requested warnings on the basis that they mentioned [certain life-threatening diseases] by name. Whether the FDA also would consider including a mention of life-threatening diseases, by itself, to be inappropriate and off limits on the OTC label is anybody’s guess; certainly the reason specified by the FDA for rejecting use of the disease names – consumer unfamiliarity – does not apply to use of such a phrase.
The SJC also rejected Johnson & Johnson’s argument that the $63 million verdict was excessive.
The Lesson
The SJC’s upholding of the verdict, one of the highest personal injury awards in Massachusetts history, highlights that manufacturers must be proactive with their warnings and ensure that warnings provide a thorough list of any potential adverse effects. Manufacturers must also remember that they, not the FDA or any other governmental agency, bear the ultimate responsibility for labeling their products appropriately. Furthermore, at least in Massachusetts, manufacturers should be very wary of relying on any argument that there was “clear evidence” that the FDA would have rejected a recommended warning change. As Johnson & Johnson just learned, the SJC’s standard for clarity is extraordinarily high.