A lawsuit filed Tuesday against Johnson & Johnson alleges that Children’s Motrin causes Stevens-Johnson Syndrome, a harmful reaction resulting in severe burning, blistering, blindness or death in some cases. The Plaintiff, Sabrina Brierton Johnson, age 7, claims that an allergic reaction to taking Children’s Motrin (Stevens-Johnson Syndrome) caused her to become blind and photosensitive.
The lawsuit, Sabrina Brierton Johnson vs. Johnson & Johnson, was filed in Los Angeles Superior Court Compton Division by Greene, Broillet, Panish & Wheeler, LLP.
“This lawsuit is the only warning label that the public is going to get until Johnson & Johnson re-labels Children’s Motrin, so that it carries a warning about the dangers of Stevens-Johnson Syndrome,” Plaintiff’s attorney Browne Greene said.
The complaint charges the defendants with negligence, breach of express and implied warranties, and deceit by concealment.
Defendants named in the lawsuit include McNeil Consumer & Specialty Pharmaceuticals (a division of McNeil-PPC, Inc.); McKesson Corporation; SAV-ON Drug Stores, Inc. (a wholly owned subsidiary of Albertsons, Inc.; Cardinal Health, Inc.; and Ralphs Grocery Company (a wholly owned subsidiary of The Kroger Company.
“Johnson & Johnson and the other Defendants’ failure to warn the public about the possible risk of Stevens-Johnson Syndrome, or any other serious skin reactions associated with using Children’s Motrin makes it an unsafe product and dangerous to sell to consumers,” the Plaintiff contends.
The Plaintiff contends that the Defendants knew about the connection between Children’s Motrin and these severe, potentially fatal reactions since the late 1980s.
Miss Johnson alleges that Defendants were put on notice of the high risk to consumers and users of Children’s Motrin after the completion of a major clinical trial known as the Boston Fever Study, which was the basis of the FDA’s approval of the OTC sale of the drug. She contends that the Defendants knew that there were cases of Stevens-Johnson Syndrome and TENS in the clinical trials, but did not report them and misrepresented the true incidence of serious mucocutaneous reactions associated with the drug during the Boston Fever Study.
“In the name of children everywhere, our family wants Children’s Motrin taken off the market until it carries a warning label about the risk of Stevens-Johnson Syndrome and describes its symptoms,” Sabrina’s mother Joan Brierton Johnson said. “Had there been appropriate warnings on the Children’s Motrin that we gave Sabrina, we would have known what to look for and would have known to stop giving her the drug and call a doctor.”
On September 8, 2003, Topanga, CA resident Sabrina Brierton Johnson, then age 6, came home from school complaining of a fever. Her parents gave her Children’s Motrin that afternoon and again that evening. On the morning of September 9, 2003, Sabrina still did not feel well and was taken to see her doctor. After being examined by her pediatrician, she was hospitalized and isolated in the Pediatric Intensive Care Unit at Cedars-Sinai Medical Center in Los Angeles, CA with a high fever, a redness of the sclera (commonly known as the white of the eye), a sore throat and a rash covering her back, trunk and other parts of her body. On September 10, 2003, Sabrina’s eyes could only be forcibly opened by an ophthalmologist, causing her unbearable, excruciating pain.
By November 2003, Sabrina Brierton Johnson was completely blind. It was later discovered that she suffered a severe, adverse skin reaction known as Stevens-Johnson Syndrome as a result of ingesting Children’s Motrin. Sabrina continues to have ongoing medical problems as a consequence, including photosensitivity. She is unable to independently open her eyes and has had nearly 20 eye surgeries in a continued effort to restore her vision.
(via Business Wire)
9 responses so far ↓
Julia Fung // Dec 30, 2004 at 11:04 pm
There may be far more reactions to ibuprophin than the drug companies want us to know. My 18 year old daughter began having reactions to the drug this year. Every time she takes it her face swells up, and her eyes nearly swell shut. I think there are many people who think they have an “allergy to Motrin”. Could these allergies be less severe reactions, but similar to the one which blinded this young girl?
Nick // Jan 1, 2005 at 10:43 am
No, Julia, you are describing a typical allergic reaction to an NSAID (which is pretty common and may happen if she takes other NSAIDS.)
However, people fail to remember: A DRUG WITHOUT SIDE EFFECTS IS A DRUG WITHOUT EFFECTS. Whenever you take any drug you risk serious injury or even death.
Fortunately, that risk with most medicines is miniscule. Of course even if there is a tiny risk, if enough people use the medicine, someone (in this case Johnson) is going to have a bad reaction.
What they don’t comment on is the children with febrile seizures who would be injured without the drug. Or the kids with juvenile rheumatoid arthritis who are helped by NSAIDS. If more people are helped than harmed, the drug does good. Unfortunately in our society, the single individual who has a vanishingly rare adverse reaction can sue everyone involved and threaten the availability of the medicine to people who need it.
Though the fact that your kid is more likely to die riding in the car to the drug store to get the motrin… that escapes most people. Remember, if the risks outweigh the benefits its a good thing.
CINDY // Feb 15, 2005 at 4:35 pm
MY DAUGHTER, 2 1/2 AT THE TIME, HAD A SEVERE REACTION TO CHILDREN’S MOTRIN ALSO. WITHIN IN MINUTES OF ADMINISTERING THE DOSAGE HER LIPS BEGAN TO SWELL, THEN HER RIGHT EYE SWELLED SHUT. BY THE TIME I GOT HER TO THE E/R SHE WAS HAVING DIFFICULTY BREATHING & SWALLOWING. AFTER A DOSE OF EPINEPHRINE & AN OVERNIGHT STAY SHE WAS GOOD AS NEW. SHE’S 8 1/2 NOW AND HAS NOT HAD ANOTHER DOSE OF MOTRIN OR IBUPROPHIN SINCE.
Leslie // Feb 15, 2005 at 6:04 pm
My son also had an allergic reaction to children’s Motrin at around 18 months. He experienced severe hives on his face and torso. Luckily we only gave him one dose and the hives went away after two days. We have not confirmed that Motrin was the cause of the hives and I have been advised by his pediatrician to try Motrin again to test his reaction. At this point I’m concerned he may have a more severe reaction. I’m not sure what I should do. Any advice?
Rhonda // Feb 17, 2005 at 11:48 am
Based on the above stories, my son age 4 recieved Motrin and woke my husband and up stating, “my eyes are puffy”. Upon turning the lights on his eyes were so severly swollen that he had to hold his head back in order to see us. He was taken to his MD and was told that his reaction was most likely from the Motrin since that was the only medicine that he had been given in the past 24 hours.
Joan Z // Feb 17, 2005 at 8:24 pm
My 22 year old son had SJS a year and a half ago. He had a fever and felt ill so he took Motrin every 4 hours. A week later he was sicker and started getting lesions in his mouth. I brought him home from college and took him to 6 doctors over a 4 day period. His symptoms progressively worsened and we got very frustrated. FINALLY, an eye doctor diagnosed him and he was hospitalized for 4 days with IV cortisone. He has fully recovered but I can’t believe how little is known in the medical community about this disease. The nurses in the ospital were looking it up on the internet as they had never heard of it!
Kay Stephan // Feb 20, 2005 at 2:10 pm
I will not use Childrens Motrin ever again and I will warn all my friends with kids to not use it as well. I think it’s horrible that this company is selling this product and making us seem like “bad parents” if we don’t use it and then it can make our wonderful little children blind or dead!
N Lawton // Feb 21, 2005 at 11:04 am
I am the mother of a 5 year old and a 4 year old, I have given both of them Children’s motrin in the past. Does anyone know if one can develop an allergy to this medication or does it happen the first time? Also, my daughter is allergic to peanuts and tree nuts. The reactions described by some people to the ibuprofen sound very much like my daughters allergic reaction to cashews. Her face was immediately filled with hives and her one eye became completely swollen shut. A trip to the hospital and epinephrine cleared things up, but extremely scary.
Mary // Mar 2, 2005 at 12:06 pm
There are many different types of allergies, that are mediated by different types of immune cells or antibodies. The swelling of the face and eyes is NOT the same kind of reaction as Stevens Johnson syndrome. Stevens Johnson is a very rare allergic reaction. The more common milder allergic reaction that you are describing is mediated by a different type of immune cells.
As noted above by Nick, all medications have side effects. Side effects are different than allergies. Allergies are when your body acts as if the medicine is an infection, and attacks your own cells. Depending on which kind of immune reaction occurs, you can have puffiness, hives, redness, difficulty breathing, etc.. In most cases, these respond well to epinephrine and benadryl and prednisone. In very rare cases, the immune system freaks out and makes a person’s skin fall off like a severe burn (this is what happens with Stevens Johnson).
In fact, most medications have the possibility of very rare but potentially fatal reactions such as Stevens Johnson. This can happens more commonly with some medications than others (although still very rare). Anti-seizure medicines are well-known for causing this reaction, but it is still very rare.
The question that is the basis of the lawsuit is not whether or not this can happen (the answer is always yes), but rather whether the drug company misinformed the FDA about the actual incidence in order to get over the counter approval. Was the incidence high enough to actually warrant labeling on the package? What level of risk is necessary to require labeling? Obviously the more serious the side effect, the more we want to know about it even if it is rare. But it is not necessarily a drug company’s responsibility to list every single rare event that can happen when someone takes a medicine; nor should this kind of rare event make people reluctant to take medicine that is needed for an illness when the benefits outweigh the risks and there are not better alternatives. (Is the risk of Stevens Johnson lower for acetaminophen? If so, this may be equally effective with lower risk.) The article does not specify what the actual risk versus what the risk the drug company claimed, or how these numbers were reached, or whether the child was on any other medication that is more likely to have caused her rash, etc.
You must log in to post a comment.