The decision leaves intact one of the largest verdicts ever awarded by a Massachusetts jury.
Johnson & Johnson had urged the US Supreme Court to weigh in on its challenge to a $140 million verdict that the pharmaceutical company must pay because of its Children’s Motrin product.
The kids’ anti-inflammatory drug has allegedly caused a potentially deadly skin condition, and Johnson & Johnson is arguing courts should look to a third party for liability: the U.S. Food and Drug Administration, for rejecting the warning labels proposed by the pharma giant.
Deadly Skin Condition
Plaintiffs Samantha Reckis and her parents brought suit against Johnson & Johnson after the Children’s Motrin product caused Samantha to develop toxic epidermal necrolysis, a terrible skin condition that damages the body’s mucous membranes. Reckis lost 80% lung capacity and 90% of her skin. She is also now blind. Reckis experienced these unbelievable side effects in 2003 at the young age of seven.
Reckis’s parents argued the medication should have come with warnings that specifically mentioned toxic epidermal necrolysis, the related skin condition Stevens Johnson Syndrome, and a general warning that rashes or blisters that develop after taking the drug could lead to a “life-threatening” condition. However, the FDA had rejected warnings similar to those urged by Reckis’s parents.
Stevens-Johnson syndrome, a form of toxic epidermal necrolysis, is a life-threatening skin condition in which cell death causes the epidermis to separate from the dermis. The syndrome is thought to be a hypersensitivity complex that affects the skin and the mucous membranes. The most well-known causes are certain medications, but it can also be due to infections, or more rarely, cancers. Toxic epidermal necrolysis and Stevens-Johnson syndrome essentially cause one’s skin to melt off the body.
Petitioning for Certiorari
Johnson & Johnson had sought in a brief filed December 30, 2015 for the U.S. high court to review the Massachusetts Supreme Judicial Court’s decision affirming the multi-million dollar February 2013 verdict. Johnson and Johnson said in its filing,
“It is beyond dispute that the specific warning language the [Massachusetts Supreme Judicial Court] said Massachusetts law required was proposed to the FDA, rejected by the FDA, and then proposed again at trial by respondents . . . The FDA acts intentionally and purposely when it includes particular language in one label (for patients under a physician’s care) but rejects its inclusion on another label (for over-the-counter consumers) - especially given that this same language was proposed for both products.”
The warnings rejected by the FDA were proposed by a citizens’ petition and not Johnson & Johnson. The Massachusetts high court used these facts to reason that the FDA may not necessarily have rejected such warnings if Johnson & Johnson itself had proposed them.
Johnson & Johnson believes this holding to be based on speculation and has also argued that the FDA specifically requires similar warnings for prescription ibuprofen products, not over-the-counter products (including Children’s Motrin). Johnson & Johnson believes this shows the FDA’s intent not to apply such warning labels to over-the-counter medication, regardless of the entity proposing the warnings.
The case is Johnson & Johnson et al. v. Lisa Reckis et al., case number 15-449, in the Supreme Court of the United States.
Their Duty Alone
Meanwhile, a Philadelphia jury returned a $10 million verdict against Johnson & Johnson in 2010, after siding with a family who said their 3-year-old daughter was struck with Stevens-Johnson syndrome after taking Children’s Motrin in 2000. The Pennsylvania Supreme Court declined to hear an appeal of the case in March after the state’s Superior Court upheld the verdict in July 2014.
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Brown’s attorney told the eight-member Pennsylvania jury in September, “The law is that the drug manufacturer, the one who is making the profit by selling the drug, has a duty. Our country, our government, has decided that the duty is going to fall on the drug manufacturer to make their product safe. It is not a delegable duty. They can’t push it off on the FDA. They can’t push it off on a doctor. They can’t push it off on mom. It is their duty and their duty alone.”