Family Blames Girl's Blindness on Motrin
Lawsuit Claims Child's Stevens-Johnson Syndrome Due to Children's Motrin
By
Daniel J. DeNoon
WebMD Health News
Reviewed By
Louise Chang, MD
June 13, 2008 — Children's Motrin caused the severe Stevens-Johnson syndrome that
blinded a California girl, a lawsuit claims.
The lawsuit — and at least nine others scheduled this year and next in
cities across the U.S. — seeks stronger label warnings and punitive damages
against drugmakers.
The
girl, Sabrina Johnson, was 6 years old in September 2003 when she was sent home
from school with a fever. Her parents gave her Children's Motrin drops
that afternoon and again that night.
The next morning, the lawsuit says, Sabrina woke with a high fever. Her eyes
were pink and her mouth was swollen and covered with sores. Her pediatrician
had her hospitalized at Cedars Sinai Pediatric Intensive Care Unit. By the next
day, she was blind in both eyes. Doctors diagnosed Stevens-Johnson
syndrome.
"This is a very important consumer case involving the really potent
tragedy of a little girl blinded by Children's Motrin, an over-the-counter,
seemingly benign medication," Browne Greene,
the attorney representing the Johnson family, tells WebMD.
Greene claims that McNeil PPC, a subsidiary of Johnson & Johnson, has
long known of a link between ibuprofen, the active ingredient in Motrin, and
Stevens-Johnson syndrome. While the prescription version of the drug has
stronger warnings, Greene says, the over-the-counter version mentions nothing
about this risk.
"The parents gave the Motrin to a very healthy little girl, 6 at the
time, and soon thereafter she started getting worse, and there was nothing on
the package insert or label that said anything significant or life-threatening
might happen," Greene says. "The label carries only the most benign and
general kind of stuff."
In a statement provided to WebMD by a McNeil spokesman, the company says it
is aware of reports alleging an association between Children's Motrin and
Stevens-Johnson syndrome. The statement notes that Stevens-Johnson syndrome has
been linked with a wide variety of medications and even viral infections.
"We are deeply concerned about all matters related to our products and
have reviewed case reports, reviewed the scientific literature, reviewed the
latest studies and consulted with the top experts in the field," the
statement says. "Based upon our investigation we firmly believe that it is
unlikely ibuprofen can cause SJS and that Children's Motrin is safe and
effective when used as directed, and is labeled appropriately."
Greene says one of the major goals of the lawsuit is to demand that
ibuprofen products carry warning labels. The suit also asks compensation for
medical and legal expenses, pain and suffering, and punitive damages.
Stevens-Johnson syndrome is a rare, often fatal adverse reaction triggered
by many different kinds of drugs, particularly certain antibiotics and some
painkillers. A recent New York study linked ibuprofen to nearly half of the 32
children referred to a local burn unit over an eight-year period.
Burn units generally treat patients because Stevens-Johnson syndrome attacks
the skin and mucous membranes. It can cause the top layer of the skin to
separate from the lower layer of the skin in affected areas. When large areas
of skin are involved, the disease is known as toxic
epidermal necrolysis, although there is overlap between the two
diagnoses.
Often the eyes are involved, leading to blindness. Sabrina was not only
blinded, but also left highly sensitive to light. When she goes out, she wears
a large hat pulled down over her face.
Stevens-Johnson syndrome is fatal in about 5% of cases; toxic epidermal
necrolysis kills about 30% of patients.
While ibuprofen has been linked to Stevens-Johnson syndrome, so have many
other drugs. There is no definitive proof that ibuprofen causes Stevens-Johnson
syndrome. Ibuprofen is in dozens of products and is used by millions of adults
and children who do not suffer serious side effects.
Greene says he will file two more lawsuits against McNeil, each linking
Children's Motrin to the death of a child.
Greene says that before Sabrina fell ill, there were 15 known cases of
Stevens-Johnson syndrome in children who took ibuprofen. Since then, he says,
there have been 12 more cases in which children were "blinded, burned, or
killed."
"They have settled a bunch of cases. This isn't the first case they've
had," Greene says. "They settle these all confidentially in which they
get the victims to agree not to tell the settlement amount and to give back any
information that they have. That's basically how they keep the other victims
and the public from hearing about it."
One of those cases involved Kaitlyn Langstaff, a California girl who in
April 2002 developed toxic epidermal necrolysis at the age of 9. After a heroic
struggle chronicled by local media, she died in December 2003.
Jury selection began this week for the Johnson case, which is being heard in
Los Angeles Superior Court. Arguments are expected to begin next week.
SOURCES: Sabrina Brierton Johnson v. Johnson & Johnson et al., Case TC018540,
Superior Court of the State of California for the County of Los Angeles. Statement, McNeil Consumer Health Care, personal communication. Browne Greene, Broillet & Wheeler, LLP, Santa Monica, Calif. Dore, J. and Salisbury, R.E. Journal of Burn Care Research,
November/December 2007; vol 28: pp 865-870. Roujeau, J.-C. The New England Journal of Medicine, Dec. 14, 1995;
vol 333: pp 1600-1607. Roujeau, J.C. and Stern, R.S. The New England Journal of Medicine,
Nov. 10, 1994; vol 331: pp 11272-1285. Kaitlynlangstaff.org web site. eMedicine: "Stevens-Johnson Syndrome," Jan. 23, 2008.
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