May 2015

Children's MotrinThe Massachusetts Supreme Judicial Court has affirmed a record $63 million jury verdict against healthcare giant Johnson & Johnson for allegedly inadequate warnings about the health risks associated with Children’s Motrin. The facts underlying this remarkable verdict are undeniably tragic, but they also demonstrate just how important clear and comprehensive warnings are for product manufacturers. Further, as explained in more detail below, this case emphasizes that it is extremely difficult in Massachusetts for manufacturers to prove that the FDA would have rejected a plaintiff’s recommended warning change, a showing that the United States Supreme Court has suggested could shield a manufacturer from a failure to warn claim. With interest, Johnson & Johnson is currently liable for over $130 million to the plaintiffs.

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. Johnson & JohnsonLevine 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
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