PHILADELPHIA, PA – On April 30th, Judge Jan E. DuBois of the U.S. District Court for the Eastern District of Pennsylvania ruled that the failure-to-warn claim is not preempted because manufacturers failed to show that the Food and Drug Administration would have rejected a stronger warning.
In this case, Kiley Wolfe alleges that over-the-counter Children’s Motrin caused her to develop Stevens-Johnson Syndrome, a rare and serious skin disorder. SJS starts out mimicking flu-like symptoms, and is usually accompanied by a painful red rash that spreads and blisters. Talk about a headache!
Kiley Wolfe developed a virus in May of 1996 and was prescribed OTC Children’s Motrin by her doctor. Even though she developed a facial rash and her symptoms did not improve, the nurses at her doctor’s office advised her mother, Janet Leland, to keep administering the Motrin to Wolfe. A few days later Wolfe was diagnosed with SJS at the hospital, and eventually required a liver transplant.
In 2006, the FDA recommended that the warnings for the OTC Children’s Motrin – and all ibuprofen products in general – be strengthened to include skin rashes and blisters, as well as urging consumers to consult with a medical professional if an allergic reaction occurs.
During Wolfe’s injury, the FDA-approved label included warnings to “call your doctor if your child does not get relief within the first day of treatment, or pain or fever gets worse…”
Leland testified that the the box and bottle did not have anything on there that mentioned any warnings. Wolfe sued the manufacturers, McNeil-PPC, McNeil Consumer Healthcare, and Johnson & Johnson Inc., alleging negligence, strict liability, breach of express warranty, breach of implied warranty of merchantability, violation of consumer protection law, and punitive damages.
The judge concluded that the FDA stated that drugs like Children’s Motrin “should be improved to warn of the risks of severe skin reactions associated with ibuprofen products.” Therefore the manufacturers did not present clear evidence that the FDA would have rejected a stronger label.
The judge also says that a reasonable jury could conclude that a stronger warning label would have been necessary, and would have prevented the injuries that occurred.
Judge DuBois granted manufacturers summary judgment on the negligence claim, manufacturing defects claim, design defect claim, misrepresentation claim, and breach of warranty claims. However, she denied manufacturers’ motion as to the punitive damages claim because they concealed data from the FDA.
“Plaintiff has presented evidence that defendants concealed from the FDA two cases of SJS found in patients during a massive study it commissioned on the safety of OTC ibuprofen use,” Judge DuBois explained. The manufacturers received these reports, yet a Clinical Study issued by McNeil had no mention of these findings.
There goes our tax dollars hard at work. We fund these pharmaceuticals to conduct studies to ensure our safety, and if they yield findings detrimental to their drug, they mask them? How is that fair??
If you have been diagnosed with Stevens-Johnson Syndrome after taking Children’s Motrin or would like to learn more, stop by our website.