The family of a Plymouth-area girl who nearly died and was left legally blind after taking one of the country's most common household medicines, Children's Motrin, was awarded $63 million Wednesday by a Massachusetts jury that found health care giant Johnson & Johnson failed to warn patients adequately about the painkiller's potential side effects.
The family of Samantha Reckis, who was 7 at the time she suffered the severe reaction, said the verdict by a Plymouth County jury was a "historic day for consumer safety." The unusually large award still needs the approval of the trial judge in the case.
The child was given the popular pain reliever after showing signs of fever around Thanksgiving in 2003. But as she continued to take the drug, her condition only worsened, to the point where her family didn't know whether she would survive.
Within days, doctors determined she suffered from Toxic Epidermal Necrolysis, an extremely rare and painful skin disorder caused by adverse reaction to some medications, including ibuprofen, the popular painkiller sold under many brand names including Motrin. Known as TEN, it is the most severe form of a more common skin disorder, called Stevens-Johnson syndrome.
"It's like having your skin burned off of you," said one of the family's attorneys, Bradley M. Henry, of the Boston law firm Meehan, Boyle, Black & Bogdanow. "Imagine your worst sunburn times 1,000. It's an absolutely devastating condition."
Reckis was in and out of the hospital for months, had multiple surgeries, lost nearly all her skin, suffered permanent lung and liver damage, and could not walk more than 150 yards without exhaustion, according to the family's lawsuit. Now 16, she is legally blind.
On Wednesday, a jury in Plymouth Superior Court determined that Johnson & Johnson failed to provide sufficient warnings about the potential side effects of Motrin — which could have alerted the family or her doctors to immediately stop using the drug as her condition worsened. The jury awarded the girl $50 million and each parent $6.5 million.
"Drug companies like Johnson & Johnson can no longer hide behind an approval by the overworked FDA as an excuse not to warn consumers about known, devastating drug reactions" such as those Samantha experienced, the Reckis family said in a brief statement after the verdict. "Parents like us have a right to know."
Johnson & Johnson issued a statement saying it sympathized deeply with the family, but disagreed with the verdict and said it is considering its legal options.
"Children's MOTRIN® (ibuprofen), when used as directed, is a safe and effective treatment option for minor aches and pains and fever," the company said, "and we believe the medicine is labeled appropriately."
Henry, the family's attorney, pointed out that in 2003 the prescription version of Motrin contained a brief reference to Stevens-Johnson syndrome, but that the over-the-counter medication for children contained no warning at all.
"We are not saying they should take it off the market," Henry said. "They just need to warn people."
In 2005, the US Food and Drug Administration instructed makers of ibuprofen and several other common painkillers to amend the warning labels on their products to include an "allergy alert" and "descriptions of early symptoms associated with Stevens-Johnson syndrome."
The current label for ibuprofen products including Children's Motrin carries the FDA recommended warning that the medicine may cause "a severe allergic reaction," with symptoms that can include hives, facial swelling, rash, and blisters.
Stevens-Johnson syndrome is a skin disorder typically caused by an allergic reaction to medicine. In its mildest form, Stevens-Johnson syndrome can produce rashes and inflammation of the mucus membrane, but more severe reactions include lesions, blisters, and other severe burn-like injuries, peeling of the skin and blindness.
Dr. Robert Sundel, director of rheumatology at Boston Children's Hospital, said that Samantha Reckis's reaction is incredibly rare and that parents should not be scared to give their children ibuprofen or similar medications.
"Drugs like ibuprofen are a rare cause of Stevens-Johnson syndrome," said Sundel, who did not treat Reckis and was not involved in the lawsuit. "Parents should definitely not stay up at night worrying about this possibility."
He said the condition is so rare that there are only about 300 cases per year in the United States, with medications such as ibuprofen believed to cause Stevens-Johnson syndrome in fewer than 1 in 1 million cases. Risk of death is rarer still, with an estimated 1 in 10 million people dying each year from the disease, he said.
Sundel said that much is still unknown about the disease and what triggers such severe reactions in some patients. While specialists believe the syndrome can be caused by viral infections, malignancies, or severe allergic reactions to medication, the leading cause appears to be the use of antibiotics and sulfa drugs, he said.
But a patient advocate noted that because of such adverse reactions, people need to read drug labels carefully, even for common medications that are generally considered safe.
"All drugs have risks and people need to be aware of them," said Dr. Sidney Wolfe of Public Citizen, a consumer group based in Washington, D.C.
Other drug makers have also been sued by consumers who said they suffered similar severe reactions to their medications. Johnson & Johnson has battled several lawsuits over Children's Motrin, and was found liable in at least two other cases. A California court awarded a $48 million judgment in Los Angeles in September 2011 and a Philadelphia court awarded a $10 million judgment in July 2011. But another California court found in 2008 that Johnson & Johnson was not responsible for injuries in another case where an 11-year-old was left blind.
About two dozen witnesses testified during the five-week civil trial in Plymouth, which included 20 minutes of testimony by Samantha Reckis and a total of four hours by her parents, according to Henry, the family's attorney. The 12-member jury deliberated for about 14 hours over four days before returning its verdict Wednesday.
If the award is upheld by the trial judge, Henry estimated that the total award against Johnson & Johnson and its subsidiary, McNeil Consumer & Specialty Pharmaceuticals, would total $109 million after the court adds in interest.
Eric J. Parker, a personal injury lawyer who is not involved in the suit, said it's extremely rare for a jury in Massachusetts to award such a large amount of money for a case involving a single patient or family.
"By Massachusetts standards, this is an exceptionally high verdict in a personal injury case," said Parker, a lawyer with Parker Scheer in Boston. "It's a spectacular victory for the plaintiffs."