BY MICHELLE ROSENBERG
Staff Writer
On March 17, 2003, a parent’s worst nightmare became reality for Darlene and Andrew Kiss of Aberdeen Township, Monmouth County.
On that ill-fated day, the Kiss family was forced to say good-bye to their 3-year-old daughter, Heather Rose, who passed away after complications from two life-threatening diseases.
Heather Rose suffered from Stevens-Johnson syndrome (SJS), which later led to toxic epidermal necrolysis (TEN).
The cause of the two deadly diseases, according to the Kiss family, was severe side effects caused by an over-the-counter drug.
The Kiss family is now suing Wyeth, the makers of Children’s Advil (ibuprofen), claiming that two doses of the product led to the death of their daughter.
The nine-count lawsuit was filed on Jan. 21. The Kiss family is being represented by the law office of James C. Barber, Dallas, Texas, and the Dallas-based law firm of Waters and Krause.
The family is suing Wyeth for defective design, failure to warn, breach of express warranty, breach of implied warranty, negligence and wrongful death. They are seeking unspecified compensatory and punitive damages from the New Brunswick-based health-care company.
Wyeth is standing behind its product’s labeling and safety.
“The labeling and warnings on our Advil products are both appropriate and effective as evident by the outstanding safety profile of the Advil products over more than 20 years on the OTC [over the counter] market,” said Lowell Weiner, Wyeth spokesman.
According to the lawsuit, Heather Rose developed a fever sometime around March 1, 2003, and was given a dose of Children’s Advil.
She received another dose of the same medicine on March 8, when another fever appeared, accompanied by itchy eyelids. A rash developed on her face on March 9 and she was seen by her pediatrician on March 10.
On March 11, she was admitted to the pediatric intensive care unit at Monmouth Medical Center, Long Branch. She was diagnosed with SJS.
SJS is a fatal disease that is typically caused by an adverse reaction to a drug or virus. Symptoms of the disease are blisters, a rash, or red spots on the skin; fever; swelling of the eyelids; and blisters in the mouth, nose, ear or genital area.
According to the lawsuit, SJS had caused TEN, and Heather Rose had to be transferred from Monmouth Medical Center to the burn unit at St. Barnabas Medical Center, Livingston, on March 12, where she was treated for burns over 70 percent of her body.
Five days later, Heather Rose passed away “as a direct and proximate result of ingesting the drug,” and suffering “serious painful and permanently disabling injuries,” according to the lawsuit.
“Be careful with ibuprofen,” Darlene Kiss warned other parents at a charity event held in Matawan last summer. At the event, the Kiss family was honored with the Heather Rose Tribute of Courage plaque, in honor of their daughter.
Reached by phone for comment, Darlene Kiss referred a reporter to Mark Mills, a legal assistant with the Barber firm, who did not return calls by press time.
Wyeth strongly supports its product and claims that both SJS and TEN can be caused in a number of other fashions.
“We stand by the safety of Advil and Children’s Advil when taken as directed,” Weiner said. “It’s important to understand that SJS and TEN are exceedingly rare conditions and can be caused by numerous medications and viral infections, or can be idiopathic [arising from an unknown cause.]”
The second count of the lawsuit, failure to warn, claims that the product did not include an adequate warning that taking the drug could lead to SJS/TEN, or any other type of severe life-threatening skin reaction. In addition, the warnings and instructions that came with the drug did not adequately warn consumers on the risks of either disease, or what to do if a consumer developed an adverse skin reaction to the drug.
The lawsuit alleges that the “defendants did not include a warning that if a rash or mucosal reaction developed, the drug should be stopped immediately and medical care should be sought.”
“Our lawsuit contends that this product is unreasonably dangerous as marketed, and is intended to force this drug maker to put a warning on the box and bottle of Children’s Advil warning about this life-threatening and potentially fatal drug reaction, specifically to include a warning to consumers that if they develop a rash, mucosal lesions or other recognizable symptoms to stop the drug immediately,” James Barber, the Kiss family attorney, said in a press release.
“Heather’s suffering from SJS was horrific and unimaginable,” Ron Eddins, the Kiss family attorney from Waters and Krause, said in the release. “Andrew and Darlene want to prevent this tragedy from happening to any more children. They believe the drug should be removed from store shelves or, at a minimum, that Children’s Advil should include a warning about the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis.”
Weiner said that both Advil and Children’s Advil carry warning labels noting that ibuprofen can cause severe allergic reactions, and in the case that this happens, consumers should immediately stop use of the product and seek medical attention.
The law office of James C. Barber is the first to successfully settle litigation with health-care companies over SJS and TEN and medicines, other than Children’s Advil, that contain ibuprofen, according to the Internet Web site www.Stevensjohnsonsyndrome.com