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Failure to Disclose Cases of Serious Motrin Side Effects May Result in Punitive Damages

June 21, 2011

McNeil Consumer Health Care, a subsidiary of Johnson and Johnson, may face punitive damages because McNeil has acknowledged receiving reports of two cases in which patients contracted Stevens-Johnson Syndrome, but in a clinical study report that they later published, these two reports were never mentioned.

The plaintiff's attorney in a pending case alleges that McNeil purposely left the two reports out of the study so that the drug company could win FDA approval and avoid having to warn users of the risk of SJS.

A judge has indicated that this conduct may be considered “implied malice” and form the basis for imposing punitive damages. The term "implied malice" means that someone has intentionally committed a "potentially" fatal act with conscious disregard for the safety of others. A company may be liable for punitive damages when it engages in particularly egregious conduct such that it evidences implied malice or a conscious disregard for human life. A judge has indicated that McNeil Consumer Heath Care, a subsidiary of Johnson and Johnson may be liable for punitive damages because its failure to report the known cases of SJS may constitute implied malice.

The drug company has had their product, Children's Motrin, on the market since the late 80s. Studies were done before the product went to market to make sure that the product was safe to sell as an over-the-counter medication. During those studies two cases were reported in which patients who took Children's Motrin developed what is called Stevens-Johnson Syndrome. Stevens-Johnson Syndrome is a rare and life-threatening condition that causes the epidermis layer of the skin to separate from the dermis layer due to cells dying in the skin. This separation of the skin results in rashes, blisters and even causes the skin to die.

The case at issue involves a 9 year old girl by the name of Kiley Wolfe who was given Children's Motrin back in 1996 by her pediatrician when she complained of stomach pains, headache and fever. She did not get better and developed a rash on her cheeks. Her mother was advised by the pediatrician's office to keep giving her the Motrin. Her rash worsened so her mother took her into Boston Children's Hospital where doctors diagnosed her with Stevens-Johnson Syndrome. She got worse before she got better and sustained such severe liver damage that she required a liver transplant.

Her family is now suing McNeil based on a product liability theory for failure to provide adequate warning on the drug’s label given the drug company’s awareness that patients taking Children’s Motrin had developed SJS. McNeil changed the label from saying "call your doctor" if a rash occurs to "seek medical help right away" if a rash occurs, but not until 2006, ten years after Kiley was injured.

It remains to be seen whether the FDA actually received those reports at all. It does not make sense that if the FDA received the reports that it would not have required the company to place stricter warning labels on their product. The judge decided that all evidence provided on behalf of the plaintiff warranted the issue of punitive damages going to the jury.

This is an interesting case in that the company is being called out for not taking the responsibility for their drug's safety warning. Up until recently, this was something for which the FDA would have taken responsibility, but in 2009, there was a court case called Wyeth v. Levine. In this case, the U. S. Supreme Court ruled that FDA regulations merely sets the minimum safety requirements for drug sellers and that the companies themselves may have to take responsibility to go beyond that if they acquire new information about a drug and its inherent health risks.

The other change that may be coming around the corner for drug warnings is that they may become universal around the globe. It is a known fact that drug companies often apply much milder warnings to their U.S. versions of their drugs than ones they sell in other countries. Foreign labels for Children's Motrin contain more information about SJS than the U.S. labels for the same drug. The information leaflet in a German bottle of Children's Motrin warns: "side effects associated with this OTC product of rare but serious skin reactions, such as reddening and blister formation... which is bullous EM/SJS".

It stands to reason that if a safety warning is worth making in one country, it should be worth making in every country where that product is sold. If you have suffered serious side effects including Stevens-Johnson Syndrome or a loved one has suffered wrongful death, which may have been caused by a dangerous or defective drug, you may have a right to seek compensation for your injuries. You should contact the personal injury lawyers at Montlick and Associates, Attorneys at Law, for a free initial case evaluation. Our Atlanta defective drug attorneys are dedicated to providing exceptional service as part of our goal to be the best Atlanta personal injury law firm, and the best personal injury law firm in all of Georgia.

Our experienced Georgia dangerous drug lawyers are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located our attorneys are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at and use our Free Case Evaluation Form or 24-hour Live Online Chat.

Category: Personal Injury

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All information provided by our blogs is general in nature and should not be relied upon as legal advice. Consult a Montlick attorney for details about your unique situation.