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Motrin - Supreme Court Coverage 1/19/16
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U.S. Supreme Court won't review J&J appeal of $140 million judgment
Jan 19, 2016 | Reuters
By Jessica Dye
The U.S. Supreme Court said on Tuesday it will not hear Johnson & Johnson’s appeal of a $140 million judgment in a lawsuit alleging it failed to warn that Children’s Motrin pain and fever medication could cause a devastating skin condition. -
High Court Rejects Appeal Over $63M Judgment in Motrin Case
Jan 19, 2016 | Associated Press
The Supreme Court has rejected an appeal from the manufacturer of Children's Motrin over a $63 million judgment awarded to a family whose daughter developed a life-threatening disease after taking the medicine. -
Supreme Court rejects appeal over Plymouth family's $63M judgment
Jan 19, 2016 | The Patriot Ledger
By Staff
The Supreme Court has rejected an appeal from the manufacturer of Children's Motrin over a $63 million judgment awarded to the family a Plymouth girl who developed a life-threatening condition after taking the medicine. -
Supreme Court declines to hear J&J appeal of Children's Motrin lawsuit
Jan 19, 2016 | Pharmalot - Stat News
By Ed Silverman
In a setback to the pharmaceutical industry, the US Supreme Court declined on Tuesday to hear an appeal sought by Johnson & Johnson of a $63 million verdict that found the company failed to properly warn consumers about the risks of its Children’s Motrin painkiller. -
High Court Won't Hear J&J Appeal Of $140M Motrin Verdict
Jan 19, 2016 | Law360
By Emily Field
The U.S. Supreme Court on Tuesday declined to review a $140 million jury verdict over inadequate warnings on Johnson & Johnson's Children's Motrin in favor of a teenager who had developed a life-threatening skin condition, which had been upheld by Massachusetts' highest court. -
Supreme Court rebuffs another J&J appeal, leaving $140M failure-to-warn judgment intact
Jan 19, 2016 | FiercePharma
By Tracy Staton
Johnson & Johnson ($JNJ) is oh-for-two at the U.S. Supreme Court this month.
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U.S. Supreme Court won't review J&J appeal of $140 million judgment
Jan 19, 2016 | Reuters
By Jessica Dye
The U.S. Supreme Court said on Tuesday it will not hear Johnson & Johnson’s appeal of a $140 million judgment in a lawsuit alleging it failed to warn that Children’s Motrin pain and fever medication could cause a devastating skin condition.
The decision leaves intact one of the largest verdicts ever awarded by a Massachusetts jury.
Johnson & Johnson and its McNeil-PPC Inc subsidiary had asked the high court to decide whether it should be held liable because they say federal drug regulators would not have approved adding warnings to the drug’s labels about the life-threatening condition suffered by the plaintiff, Samantha Reckis.
J&J’s petition had been closely watched by pharmaceutical industry trade groups.
They had urged the court to hear the case in order to clarify what constitutes “clear evidence” that the U.S. Food and Drug Administration would have rejected a label warning about the diseases at issue in the lawsuit. If regulators did not think a warning was necessary, they argued, companies should not be liable for failing to warn consumers about that risk.
Reckis and her parents sued J&J and McNeil in 2007, claiming they were not warned about the link between the active ingredient in Children’s Motrin, ibuprofen, and Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, two rare, related skin conditions.
Reckis said she developed toxic epidermal necrolysis when she was 7 years old after receiving several doses of Children’s Motrin, leading her to lose 95 percent of the top layer of her skin and suffer other serious injuries including heart failure, stroke and an aneurysm.
A Massachusetts jury found J&J and McNeil liable for failing to warn Reckis about those side effects and awarded her and her parents $63 million. With interest, the judgment totals $140 million.
J&J said the case should have been dismissed because the FDA had declined to grant a petition from several doctors and consumers seeking to add the names of those skin conditions to the warning label because they are unfamiliar to most consumers, and instead referenced potential redness, rash and blisters that are symptoms of those conditions.
The company said this constituted “clear evidence” that such warnings were unnecessary. But the Massachusetts Supreme Court disagreed, saying the FDA's past actions did not indicate how it would rule on proposed changes from J&J, and affirmed the verdict last year.
A J&J spokeswoman said the company sympathized with the plaintiff but was disappointed with the high court's decision not to hear the appeal.
Link to article: http://www.reuters.com/article/us-usa-court-johnson-johnson-idUSKCN0UX1VW
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High Court Rejects Appeal Over $63M Judgment in Motrin Case
Jan 19, 2016 | Associated Press
The Supreme Court has rejected an appeal from the manufacturer of Children's Motrin over a $63 million judgment awarded to a family whose daughter developed a life-threatening disease after taking the medicine.
The justices on Tuesday let stand a lower court ruling that said Johnson & Johnson should pay the judgment awarded to the family of Samantha Reckis.
Reckis was 7 in 2003 when she was given the ibuprofen product for a fever. She developed a rare skin disease and was blinded.
A jury ruled in 2013 that the company failed to provide sufficient warnings about potential side effects.
The Supreme Judicial Court of Massachusetts rejected the company's arguments that the family failed to prove the medicine caused the disease and damages were excessive.
Link to article: http://abcnews.go.com/Health/wireStory/high-court-rejects-appeal-63m-judgment-motrin-case-36375156
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Supreme Court rejects appeal over Plymouth family's $63M judgment
Jan 19, 2016 | The Patriot Ledger
By Staff
The Supreme Court has rejected an appeal from the manufacturer of Children's Motrin over a $63 million judgment awarded to the family a Plymouth girl who developed a life-threatening condition after taking the medicine.
The justices on Tuesday let stand a lower court ruling that said Johnson & Johnson should pay the judgment awarded to the family of Samantha Reckis, who was 7 in 2003 when she was given the ibuprofen product for a fever and developed a rare skin disease that left her nearly blind.
A jury ruled in 2013 that the company failed to provide sufficient warnings about potential side effects. The state's Supreme Judicial Court upheld the ruling last year, rejecting the company's argument that the award was excessive and that the family had failed to prove the medicine caused the disease.
Reckis, now a teenager, became suddenly ill around Thanksgiving 2003 after her parents gave her several doses of Children’s Motrin brand ibuprofen to treat a mild fever. As her condition rapidly worsened, doctors diagnosed her with toxic epidermal necrolysis – a rare condition that causes flesh to blister and burn from the inside out – and placed her in a medically induced coma for several weeks to shield her from the pain.
Reckis survived, but she was left frail, badly burned and nearly blind, with 95 percent of her skin burned off and her lung capacity reduced by 80 percent. Her family says she faces a lifetime of medical treatments and increased risk of disease and will never be able to drive or have children, according to the decision.
The family sued McNeil, a subsidiary of Johnson & Johnson, in 2007, claiming that the company failed to warn consumers of symptoms that could indicate a life-threatening allergic reaction to ibuprofen. Reckis’ parents, Lisa and Richard Reckis, say they would have stopped giving her Motrin after she developed a rash if such a warning had been printed on the bottle.
Link to article: http://www.milforddailynews.com/news/20160119/supreme-court-rejects-appeal-over-plymouth-familys-63m-judgment
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Supreme Court declines to hear J&J appeal of Children's Motrin lawsuit
Jan 19, 2016 | Pharmalot - Stat News
By Ed Silverman
In a setback to the pharmaceutical industry, the US Supreme Court declined on Tuesday to hear an appeal sought by Johnson & Johnson of a $63 million verdict that found the company failed to properly warn consumers about the risks of its Children’s Motrin painkiller.
At issue was whether Johnson & Johnson should have upgraded its product labeling to reflect the risk that a patient may develop toxic epidermal necrolysis, which can lead to a rare disease called Stevens-Johnson syndrome. The condition can cause skin blistering, as well as lung, liver, and vision damage.
A Massachusetts family successfully pressed a lawsuit claiming the company could have upgraded the warnings. In 2003, they gave their seven-year-old daughter the over-the-counter medicine and she subsequently developed Stevens-Johnson syndrome. She eventually lost 95 percent of the top layer of her skin and suffered heart failure, stroke, and an aneurysm. She is also legally blind, according to court documents. The verdict withstood appeal.
However, Johnson & Johnson sought to convince the Supreme Court that federal law preempted the state court verdict. In response to a citizen’s petition seeking upgraded labeling, the Food and Drug Administration had agreed that an increased warning about skin reactions — such as rashes and blisters — was warranted. But the agency did not agree to add the names of the skin diseases, which are unfamiliar to most consumers.
Consequently, the company maintained it would have violated federal law if the Motrin labeling was updated with the sort of specific language the family believed should have been used, according to its filing with the Supreme Court. In short, Johnson & Johnson complained it was in an untenable bind, which is an argument the pharmaceutical industry has been watching closely.
The debate over preemption came to a head in 2009 when the Supreme Court ruled that a state court lawsuit is not preempted if the FDA would have allowed a drug maker to upgrade its label. That case involved a lawsuit brought by a Vermont woman who claimed she was harmed by a drug sold by Wyeth, which is now owned by Pfizer. She successfully argued that Wyeth should have updated the label for Phenergan, an anti-nausea treatment.
At the same time, the Supreme Court acknowledged that a state court lawsuit could be preempted if there was “clear evidence” showing the FDA would not have approved a change in labeling. Such a situation would otherwise create a conflict between the state and federal labeling requirements. But ever since, the pharmaceutical industry has argued that “clear evidence” was never properly defined.
In this case, Johnson & Johnson argued the hurdle for clear evidence had been met, even though a Massachusetts appeals court disagreed. The company maintained that the less specific labeling for Children’s Motrin, which is intended for consumers, reflected FDA thinking and, therefore, was true to both the letter and intent of the law, according to its filing with the Supreme Court.
The Supreme Court, however, disagreed with the argument. A spokeswoman for Johnson & Johnson, which now faces a $140 million payout when including interest, wrote us that the health care giant is “disappointed the Supreme Court declined to hear this case because we believe it raises important and unsettled preemption issues.”
Link to article: http://www.statnews.com/pharmalot/2016/01/19/johnson-johnson-childrens-motrin-us-supreme-court/
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High Court Won't Hear J&J Appeal Of $140M Motrin Verdict
Jan 19, 2016 | Law360
By Emily Field
The U.S. Supreme Court on Tuesday declined to review a $140 million jury verdict over inadequate warnings on Johnson & Johnson's Children's Motrin in favor of a teenager who had developed a life-threatening skin condition, which had been upheld by Massachusetts' highest court.
The nation's high court, as customary, didn't comment on why it decided to deny Johnson & Johnson's petition for writ of certiorari. The pharmaceutical giant had argued in its Oct. 8 petition that claims by Samantha Reckis and her parents that J&J's Children's Motrin gave Reckis a horrific skin condition, requiring multiple hospital stays and surgeries since she was 7 years old, should have been preempted by the Supreme Court's 2009 decision in Wyeth v. Levine.
That ruling, which held that U.S. Food and Drug Administration approval of a medication does not shield its maker from liability, also held that manufacturers cannot be held liable for not including a label that "clear evidence" indicates the FDA would not have approved.
The Massachusetts Supreme Judicial Court in April upheld the $63 million February 2013 verdict in favor of the Reckis family, which jumps to about $140 million when including interest.
"Samantha Reckis and her parents are enormously grateful and relieved that the careful and just decision of the Massachusetts Supreme Judicial Court has been honored by the U.S Supreme Court," Michael B. Bogdanow of Meehan Boyle Black & Bogdanow PC, counsel for the Reckis family, told Law360 on Tuesday. "The Supreme Court reached a just result in a principled application of settled law to compelling facts. The Reckis case is an example of our justice system at it finest."
In November, industry groups, including the Biotechnology Industry Organization, theConsumer Healthcare Products Association and the Pharmaceutical Research and Manufacturers of America, had backed J&J's contention that Reckis' claims were preempted, contending in a pair of amicus briefs that the upheld verdict presents "a square challenge" to the FDA's regulatory authority.
"The respondents recovered a massive verdict by arguing that [Johnson & Johnson was] required by state law to make a labeling change that FDA specifically considered and rejected after making other warning modifications that FDA deemed appropriate," the industry groups argued. "The verdict thus second-guesses a scientific judgment that FDA made in the exercise of its congressionally delegated authority."
In 2003, Reckis developed a rare and potentially fatal skin condition, toxic epidermal necrolysis, which is marked by severe damage to mucous membranes all over the body, including the mouth and eyes.
The condition cost Reckis 90 percent of her skin, 80 percent of her lung capacity and her eyesight, according to her attorneys. Her parents claimed the condition was caused by the ibuprofen in the Children's Motrin she took.
They argued that the product's label did not sufficiently warn consumers about the risk for the skin condition, a view that a Massachusetts state jury agreed with. After a five-week trial, the jury awarded Reckis $50 million for her injuries and damages and $6.5 million each to her parents for their losses stemming from her health issues.
Massachusetts' high court rejected J&J's argument that the Levine ruling preempted the Reckises' claims because there was "exceptionally clear evidence" that the FDA would have denied the warnings that the Reckises had argued J&J should have had.
But the court found that in this case there was no such clear evidence the agency would not have approved mentioning "life-threatening diseases" on the warning label.
In its petition, J&J argued that the lack of a specific definition for the "clear evidence" standard allowed the court to hold it to an unreasonable, and inconsistent, standard in upholding the verdict.
"The Reckis family has suffered a tragedy, and we sympathize deeply with them," a J&J spokeswoman told Law360 on Tuesday. "We are disappointed the Supreme Court declined to hear this case because we believe it raises important and unsettled preemption issues."
Johnson & Johnson is represented by Walter Dellinger, Charles C. Lifland and Carlos M. Lazatin of O'Melveny & Myers LLP and Jay P. Lefkowitz, Steven J. Menashi and Michael D. Shumsky of Kirkland & Ellis LLP.
Reckis was represented in the state trial and appellate proceedings by Bradley M. Henry, Leo V. Boyle, Michael B. Bogdanow and Victoria Santoro of Meehan Boyle Black & Bogdanow PC.
The Product Liability Advisory Council is represented by staff attorney Hugh F. Young Jr. and by Alan E. Untereiner of Robbins Russell Englert Orseck Untereiner & Sauber LLP.
The industry groups are represented by Robert A. Long Jr., Michael X. Imbroscio, Paul W. Schmidt and Natasha N. Wilson of Covington & Burling LLP.
The case is Johnson & Johnson et al. v. Lisa Reckis et al., case number 15-449, in the Supreme Court of the United States.Link to article: http://www.law360.com/articles/747757/high-court-won-t-hear-j-j-appeal-of-140m-motrin-verdict
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Supreme Court rebuffs another J&J appeal, leaving $140M failure-to-warn judgment intact
Jan 19, 2016 | FiercePharma
By Tracy Staton
Johnson & Johnson ($JNJ) is oh-for-two at the U.S. Supreme Court this month.
Last week, the court refused to weigh its final appeal against a $124 million penalty in a Risperdal marketing case. Now, the high court has said the same about an even bigger judgment.
J&J and its McNeil subsidiary now face a $140 million judgment in a lawsuit over Children's Motrin side effects.
A Massachusetts jury found that the company failed to warn consumers about a rare but potentially fatal set of skin conditions, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. The jury awarded the plaintiff, Samantha Reckis and her parents, $63 million in damages. With interest, the award amounts to $140 million.
J&J had argued that the FDA would not have approved adding warnings about the skin conditions to Children's Motrin labeling. The company cited a citizen petition asking that the label mention Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis; the FDA didn't grant that request, saying that the names weren't familiar to most consumers.
As Reuters notes, J&J argued that the FDA's denial was "clear evidence" that the warnings weren't necessary. But the Massachusetts Supreme Court said the FDA might have acted differently if J&J itself had requested the change.
Trade groups had filed amicus briefs urging the Supreme Court to take up the case to offer greater clarity on just what "clear evidence" means, Reuters reports. The briefs argued that companies shouldn't be held liable for failing to warn about risks if regulators did not think a warning was necessary.
Link to article: http://www.fiercepharma.com/story/supreme-court-rebuffs-another-jj-appeal-leaving-140m-failure-warn-judgment/2016-01-19
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