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Tylenol Trial Coverage
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J&J defeats first lawsuit on Tylenol’s link to liver damage
Oct 16, 2015 | Boston Globe
By Jef Feeley
Johnson & Johnson defeated a lawsuit claiming it had improperly designed its Tylenol pain reliever, in the first case to go to trial over the link between the widely used over-the-counter drug and liver damage. -
Trial Records: Doctors Recommended Tylenol — But Only at Lower Doses
Oct 16, 2015 | HuffPost Business
By Jeff Gerth and T. Christian Miller
For more than 30 years, the Johnson & Johnson unit that makes Tylenol has delivered a consistent message: it’s the pain reliever that doctors recommend most. McNeil Consumer Healthcare marketing experts have spent hundreds of millions of dollars promoting it through television and magazine advertisements. It is a refrain that many American consumers know by heart. -
Johnson & Johnson Prevails In First Tylenol Liver Damage Trial
Oct 16, 2015 | CVN
By David Siegel
A New Jersey state court jury cleared Johnson & Johnson subsidiary McNeil Consumer Healthcare of all liability on Friday in the first of hundreds of lawsuits to go to trial alleging the company failed to adequately disclose the risks of liver damage from taking Extra Strength Tylenol. -
J&J Wins First Tylenol Liver Damage Trial
Oct 16, 2015 | Law360
By Sindhu Sundar
Johnson & Johnson and its subsidiary McNeil Consumer Healthcare on Friday won the first trial over the alleged liver damage risks of McNeil's Extra Strength Tylenol when a New Jersey state jury found that it was not clear whether the woman claiming the painkiller was defectively designed had taken the Extra Strength version. -
J&J Defeats First Lawsuit on Tylenol's Link to Liver Damage
Oct 16, 2015 | Bloomberg
By Jef Feeley
Johnson & Johnson defeated a lawsuit claiming it had improperly designed its Tylenol pain reliever, in the first case to go to trial over the link between the widely used over-the-counter drug and liver damage. -
J&J Win in First Trial Against Tylenol Skirts Defective Design Claim
Apr 19, 2016 | Insurance Journal
By Jef Feeley
Johnson & Johnson defeated a lawsuit claiming it had improperly designed its Tylenol pain reliever in the first case to go to trial over the link between the widely used over-the-counter drug and liver damage, according to a J&J spokesman. -
J&J chalks up a win in first Tylenol liver-damage case to go to trial
Oct 19, 2015 | FiercePharma
By Emily Wasserman
Johnson & Johnson ($JNJ) scored a victory in the first case to go to trial over claims that its blockbuster painkiller Tylenol causes liver damage and its dosing doesn't adequately account for the risk. A New Jersey jury ruled that the plaintiff did not prove that she took the painkiller. -
Johnson & Johnson Emerges Victorious in Lawsuit on Tylenol’s Risks
Oct 20, 2015 | ProPublica
By Jeff Ferth and T. Christian Miller
A jury in Atlantic City has handed Johnson & Johnson a victory in a lawsuit alleging that Tylenol, the popular pain reliever, was defectively designed. On Friday, the jury decided the plaintiff, Regina Jackson, hadn’t proven she took Extra Strength Tylenol. She had claimed that an overdose of the drug landed her in the hospital.
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Trail Coverage
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J&J defeats first lawsuit on Tylenol’s link to liver damage
Oct 16, 2015 | Boston Globe
By Jef Feeley
Johnson & Johnson defeated a lawsuit claiming it had improperly designed its Tylenol pain reliever, in the first case to go to trial over the link between the widely used over-the-counter drug and liver damage.
Jurors in New Jersey concluded that Regina Jackson, 55, who said she spent a week in the hospital after overdosing on the pain medication, failed to prove her case. The jury ruled she couldn’t prove she had actually taken Extra Strength Tylenol and didn’t rule on the merits of her claim the pain medication was defectively designed.
The alleged defect is that the recommended dosage doesn’t provide enough of a safety margin to protect users from overdose.
“The important health issue that the Food & Drug Administration and the medical community has put on the table about Tylenol was not answered by this jury verdict,” said Clay Milling, a lawyer for Jackson. He said he intends to make the argument again in one of several similar suits pending against J&J.
The verdict comes as J&J fights about 220 lawsuits against it and its McNeil Consumer Healthcare unit in state and federal court in New Jersey and Pennsylvania. The first federal trial is slated for early next year in Philadelphia, where approximately 200 cases have been consolidated. Not all of the cases involve overdoses, as some plaintiffs claim they got liver damage from taking the recommended dose.
“We are committed to providing consumers with safe, effective, and high-quality products and recommend consumers always read and follow the product label,” McNeil spokeswoman Jodie Wertheim said. She said the jury’s verdict “reflects the facts” of the case.
The lawsuits aren’t expected to have a significant financial effect on J&J, said Damien Conover, an analyst at Morningstar Inc. While the pain medication is one of the company’s signature brands, “in the totality of the overall business, Tylenol is relatively small because J&J is such a large diversified company,” he said.
Lawyers for Jackson argued during the trial that J&J touted Tylenol’s safety even though it knew for decades that the painkiller could harm users who inadvertently exceeded the daily recommended dose.
J&J countered that the medicine was safe at the recommended dose at the time of two pills every four hours, up to a maximum dose of eight pills a day. The recommended dosage has since changed. Warnings about liver damage are already on the label, and Jackson’s problems were caused by an overdose, the drug maker’s lawyers said during the trial.
Jackson’s lawyers argued that the recommended dosage should be two pills three times a day, which would make people less likely to overdose.
The lawsuits come amid longstanding concerns about links between acetaminophen, the main ingredient in Tylenol, and liver damage. The American Liver Foundation warned in 2006 that at the maximum recommended dose for two weeks, healthy adults could have increased liver enzymes that could lead to liver damage, according to a past press release from the organization, which aims to cure liver disease.
“I do think if liver toxicity issues were more significant, that could hurt the drug’s sales, but Tylenol has been around for so long and it’s been proven to be pretty safe,” Conover said.
https://www.bostonglobe.com/business/2015/10/16/defeats-first-lawsuit-tylenol-link-liver-damage/Tj2gpvNRHSq4OyOPFmrQCM/story.html
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Trial Records: Doctors Recommended Tylenol — But Only at Lower Doses
Oct 16, 2015 | HuffPost Business
By Jeff Gerth and T. Christian Miller
For more than 30 years, the Johnson & Johnson unit that makes Tylenol has delivered a consistent message: it’s the pain reliever that doctors recommend most.
McNeil Consumer Healthcare marketing experts have spent hundreds of millions of dollars promoting it through television and magazine advertisements. It is a refrain that many American consumers know by heart.
But it’s also not the whole story, according to internal company records that have emerged in a trial pitting McNeil against a New Jersey woman who claims that Tylenol sent her to the hospital. The trial is set to go to the jury today.
The regular surveys conducted by McNeil show that while most doctors recommended the drug, they also told patients to take the medication at doses far less than the daily maximum allowed by the federal government, according to the previously undisclosed documents.
The reason? Doctors worried that what the government and company described as the maximum safe dose of the active ingredient in Tylenol, a compound called acetaminophen, was too close to the level that can damage the liver and even lead to death.
In 2002, for instance, McNeil noted the “pervasive problem” of health care professionals, or HCPs, recommending doses lower than maximum daily dose of 4 grams of acetaminophen per day, or about 8 extra-strength pills.
“Less than half of HCPs recommend the maximum daily dose,” one internal company memo said. The memo – labeled “Restricted Document. Distribute and Disclose on a Need to Know Basis” – also said patients had stopped taking the drug or reduced their intake, many due to safety concerns. The “lost dollars” or “financial impact” on Extra Strength Tylenol, the memo estimated, would be $3 million from the drug’s $430 million in projected annual revenue.
The latest revelations come in a trial over the issue of whether McNeil should have done more to mitigate the risks of Tylenol. There are about 200 other similar cases pending against McNeil, most in federal court in Philadelphia. The company is contesting all the suits, arguing that its product is safe when taken as directed.
The parties in the New Jersey case were set to present their closing arguments today but the jury has already seen previously confidential documents offering a rare view into how corporate managers weighed the safety risks and the financial rewards of one of America’s most iconic brands.
The documents show that for decades McNeil knew that doses near the recommended level could cause liver injury, that some patients used too much of the drug, and that many doctors were telling patients to take less than the recommended dose.
Meanwhile, the company marketed Tylenol as the most recommended pain reliever and calculated how increasing the amount of the drug that arthritis patients take each day could boost the company’s revenues by $25 million, according to one McNeil document.
Last week, New Jersey Superior Court Judge Nelson C. Johnson denied a motion by McNeil to grant a verdict in its favor. But the jury will face a higher hurdle to hold the company liable. It must find that the drug was not only defective but that the defect caused injury to the plaintiff, Regina Jackson.
Last week, the judge, out of ear shot of the jury, noted that Jackson’s “conduct violated just about every recommendation and warning.” But Johnson, ruling before McNeil presented its defense, also said he had a “problem” because of some of the evidence he had seen during the trial, especially involving drug misuse.
“This product is marketed very heavily. It’s marketed as the number one pain reliever, number one recommended, and I don’t doubt that it’s safe if it’s used properly,” Johnson said, explaining why the trial should continue. “But there also seems to be a fair amount of evidence that it’s predictable that some people won’t use it safely. And again, I don’t think we exist to protect people from themselves, but I do think when it’s foreseeable, I need to know that the manufacturer’s done everything they can to deal with that situation. And I’m not satisfied that they did.”
A McNeil spokeswoman, Jodie Wertheim, declined to comment, but in a statement last month she emphasized the safety record of the company and the drug.
“Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division is committed to providing consumers with safe and effective over-the-counter medicines and recommends consumers always read and follow the product label,” she said. “The company has acted appropriately, responsibly and in the best interests of patients regarding Tylenol, which has one of the most favorable safety profiles among OTC pain relievers.”
Jackson, a New Jersey state employee, claims she inadvertently exceeded the recommended daily dose for Extra Strength Tylenol for a couple of days in 2011 and wound up hospitalized with elevated liver enzymes. At the time, the daily limit was no more than 4 grams, or 8 pills of 500 milligrams each.
Under New Jersey law, a manufacturer can be held liable even if their product was misused “if the misuse was objectively foreseeable,” the judge said last week.
A 2013 investigation by ProPublica and This American Life examined McNeil’s efforts to protect its best-selling brand, including opposition to warning labels, dosing restrictions and even some public awareness campaigns. But the Jackson case has shed new light on what company officials knew about their product, including plans to lobby the Food and Drug Administration to block new recommended safety restrictions.
As far back as 1973, McNeil documents show, company officials were told that the more powerful Extra Strength Tylenol should be handled by doctors and not recommended to the general public since “the vast majority of patients, probably 98% are effectively treated” with Regular Strength Tylenol, which contains 325 milligrams in each dose.
In light of a scientific report showing hepatic, or liver, damage at 6 grams per day, a company executive recommended McNeil look at “modifying the acetaminophen molecule to avoid hepatic damage.” McNeil did subsequently research making a safer version of acetaminophen, but that effort failed.
Decades later, after Extra Strength Tylenol became the best-selling version of the brand and reports emerged of patients suffering liver injury near the recommended dose level, health care professionals repeatedly voiced concerns to McNeil about the drug’s risks.
A 1995 survey found “a significant increase in the percentage of physicians citing safety issues as disadvantages” of acetaminophen, often involving liver toxicity.
Moreover, the same survey found that doctors were twice as likely – 66 percent to 33 percent – to recommend a daily dose of 2.6 grams per day – 8 regular strength Tylenol pills – versus 4 grams, 8 doses of Extra Strength Tylenol.
The plaintiff also introduced records from a 2004 national sales meeting in which executives were told that “physicians state 4 g/day is ‘close’ to an unsafe dose. Currently recommend 2.5/day on avg.”
The document’s “conclusion”: “MUST reassure TYLENOL is safe AND effective at 4 g/day.”
In 2011, McNeil dropped the maximum recommended daily dose of Tylenol to 3 grams after an FDA panel recommended doing so.
http://www.huffingtonpost.com/entry/tylenol-lower-doses_us_56214ee7e4b08589ef475f9c
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Johnson & Johnson Prevails In First Tylenol Liver Damage Trial
Oct 16, 2015 | CVN
By David Siegel
A New Jersey state court jury cleared Johnson & Johnson subsidiary McNeil Consumer Healthcare of all liability on Friday in the first of hundreds of lawsuits to go to trial alleging the company failed to adequately disclose the risks of liver damage from taking Extra Strength Tylenol.
The unanimous 10-member jury returned the verdict following a trial that began on Sept. 22. The panel rejected 55-year-old plaintiff Regina Jackson’s claims that McNeil is responsible for her liver damage after she accidentally took Extra Strength Tylenol for longer than the recommended dosage period, finding that Jackson had failed to prove she took Extra Strength Tylenol prior to falling ill.
The trial was recorded gavel-to-gavel from the start of witness testimony forward by Courtroom View Network. (Click here to see video from the trial).
Friday’s defense verdict could influence the outcome in over 200 similar suits pending in state and federal court, with most of the cases centralized in multidistrict litigation being overseen by U.S. District Judge Lawrence F. Stengel in Pennsylvania. A bellwether trial in the MDL, in which plaintiffs plan to pursue unlimited punitive damages, is scheduled for October 26, according to court records.
The current recommended dose of Extra Strength Tylenol is eight pills per day, but Jackson’s attorneys argued that studies have shown as few as two pills per day for extended periods can cause liver damage, and that McNeil knew about the risks for years. They said more stringent warnings would prevent consumers like Jackson from taking too much of the popular over-the-counter medication
McNeil argued that Extra Strength Tylenol is safe, and that Jackson failed to prove she actually took the drug, suggesting that she also took cold medicine and Aleve, another over the counter painkiller, prior to being hospitalized with elevated liver enzymes in 2011.
"Tylenol has more than 50 years of use and over 150 studies to support its safety and efficacy, and, when used as directed, it has one of the most favorable safety profiles among over-the-counter pain relievers," J&J spokeswoman Jodie Wertheim told CVN in an e-mailed statement.
The trial revealed efforts by McNeil and J&J to fight increased regulation of acetaminophen, the main ingredient in Tylenol, by the U.S. Food & Drug Administration. Despite studies showing the drug to be the leading cause of acute liver failure in the United States, the FDA has not issued regulations for the safe use of the drug since beginning hearings on the issue 38 years ago.
In 2009 the FDA began considering reducing the daily recommended dose of acetaminophen and requiring a prescription for extra strength versions of the drug, an effort Jackson's attorneys claim McNeil resisted, because it would significantly reduce the company's profits from the over-the-counter medication. Tylenol sales generate over $400 million each year for McNeil, Jackson’s attorneys argued in court.
Jackson's attorney Chris Sisi of Ashcraft & Gerel LLP told CVN that because the jury determined Jackson didn't prove she took Extra Strength Tylenol, the verdict doesn't address the underlying issue of what McNeil knew about the drug's alleged risks. He said his team is considering an appeal.
"For over a decade the FDA and the medical community have been urging McNeil to take action to reduce the deaths, transplants and hospitalizations every year from this drug,” Sisi said.
The case is Regina Jackson v. McNeil Consumer Healthcare, et al., case number ATL-L-880-13, in the Superior Court of New Jersey in Atlantic County.
Jackson is represented by Christopher Tisi of Ashcraft & Gerel LLP, R. Clay Milling of Henry Spiegel Milling LLP and by Moshe Horne of Seeger Weiss LLP.
The defendants are represented by Michael Hewes, Taylor Mayes and G. Brian Jackson of Butler Snow LLP and by David Kott of McCarter & English LLP.
http://blog.cvn.com/breaking-johnson-johnson-prevails-in-first-tylenol-liver-damage-trial
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J&J Wins First Tylenol Liver Damage Trial
Oct 16, 2015 | Law360
By Sindhu Sundar
Johnson & Johnson and its subsidiary McNeil Consumer Healthcare on Friday won the first trial over the alleged liver damage risks of McNeil's Extra Strength Tylenol when a New Jersey state jury found that it was not clear whether the woman claiming the painkiller was defectively designed had taken the Extra Strength version.
After a roughly four-week trial, the jury returned its verdict after about an hour of deliberations, finding only that there was not enough evidence that plaintiff Regina Jackson had taken Extra Strength Tylenol or just the regular version. The jury did not reach the other questions on the safety of the drug's acetaminophen content.
The case is among a dozen similar liver damage suits over Tylenol in New Jersey state court. More than 200 such suits are presently consolidated in multidistrict litigation in Pennsylvania federal court, where the first bellwether trial is scheduled for early 2016, according to Clay Milling of Henry Spiegel Milling LLP, an attorney for Jackson.
"The jury did not address the dominant questions in the case; namely the public health issue of acetaminophen induced liver injury," Milling said Friday. "Rather, the jury simply concluded that there was ambiguity in what medication this plaintiff took, which allowed the jury to not address the key issues in the trial."
In the trial, Milling had pointed to purported evidence of the potential harm of over the counter medication that contains acetaminophen, including notes by the U.S. Food and Drug Administration in a 2009 Federal Register notice on an advisory panel hearing on the subject.
The agency had said in the notice that "taking just a small amount of acetaminophen over the recommended total daily dose (4 grams per day) may lead to liver injury," according to a copy of the notice.
McNeil issued a brief statement Friday saying that the verdict "reflects the facts of this case."
"Tylenol (acetaminophen) has more than 50 years of use and over 150 studies to support its safety and efficacy, and, when used as directed, it has one of the most favorable safety profiles among over-the-counter pain relievers," McNeil Consumer Healthcare Division's spokeswoman Jodie Wertheim said in the statement. "We are committed to providing consumers with safe, effective and high-quality products and recommend consumers always read and follow the product label."
The upcoming federal bellwether trial involves the case of Denice Hayes, who allegedly died of acute liver failure after taking Extra Strength Tylenol. The suit was filed by Hayes' sister, Rana Terry, according to court documents.
Earlier this year, U.S. District Judge Lawrence F. Stengel, who is presiding over the MDL, ruled that Alabama law applies in her case, because Hayes lived in Alabama, bought the medicine in Alabama and died in Alabama.
The decision was a blow to Johnson & Johnson, as plaintiffs can seek unlimited damages under Alabama law. Johnson & Johnson and McNeil, which are New Jersey corporations, had sought to apply New Jersey laws that would have minimized the wrongful death and punitive damages claims in the case, according to court documents.
Jackson is represented by Clay Milling of Henry Spiegel Milling LLP and others.
J&J is represented by Butler Snow LLP.
The current case is Jackson v. McNeil Consumer Healthcare, case number ATL-L-880-13, in the Superior Court of New Jersey, Atlantic County.
http://www.law360.com/articles/715349/j-j-wins-first-tylenol-liver-damage-trial
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J&J Defeats First Lawsuit on Tylenol's Link to Liver Damage
Oct 16, 2015 | Bloomberg
By Jef Feeley
Johnson & Johnson defeated a lawsuit claiming it had improperly designed its Tylenol pain reliever, in the first case to go to trial over the link between the widely used over-the-counter drug and liver damage.
Jurors in New Jersey concluded that Regina Jackson, 55, who said she spent a week in the hospital after inadvertently overdosing on the pain medication, failed to prove her case. The jury ruled she couldn’t prove she had actually taken Extra Strength Tylenol, and didn’t rule on the merits of her claim the pain medication was defectively designed.
The alleged defect is that the recommended dosage doesn’t provide enough of a safety margin to protect users from overdose.
The verdict gives hopes to plaintiffs pursuing about 220 lawsuits against J&J and its McNeil Consumer Healthcare unit in state and federal court in New Jersey and Pennsylvania.
“The important health issue that the Food & Drug Administration and the medical community has put on the table about Tylenol was not answered by this jury verdict,” said Clay Milling, a lawyer for Jackson. He said he intends to make the argument again in other suits pending against J&J.220 Lawsuits
The first federal trial is slated for early next year in Philadelphia, where about 200 of the cases have been consolidated. Not all of the cases involve overdoses, as some plaintiffs claim they got liver damage from taking the recommended dose.
“We are committed to providing consumers with safe, effective and high-quality products and recommend consumers always read and follow the product label,” said McNeil spokeswoman Jodie Wertheim. She said the jury’s verdict “reflects the facts” of the case.
The lawsuits aren’t expected to have a significant financial impact on J&J, said Damien Conover, an analyst at Morningstar Inc. While the pain medication is one of the company’s signature brands, “in the totality of the overall business, Tylenol is relatively small because J&J is such a large diversified company," he said.
Extra Strength Tylenol generates about $400 million in revenue a year for New Brunswick, New Jersey-based J&J, with the regular strength version adding another $14 million, according to the plaintiff’s court papers. J&J declined to confirm the number.
Lawyers for Jackson argued during the trial that J&J touted Tylenol’s safety even though it knew for decades that the painkiller could harm users who inadvertently exceeded the daily recommended dose.
J&J countered that the medicine was safe at the recommended dose at the time of two pills every four hours, up to a maximum dose of eight pills a day. The recommended dosage has since changed. Warnings about liver damage are already on the label, and Jackson’s problems were caused by an overdose, the drug maker’s lawyers said during the trial.
Jackson’s lawyers argued that the recommended dosage should be two pills three times a day, which would make people less likely to overdose.
The lawsuits come amid longstanding concerns about links between acetaminophen, the main ingredient in Tylenol, and liver damage. The American Liver Foundation warned in 2006 that at the maximum recommended dose for two weeks, healthy adults could have increased liver enzymes which could lead to liver damage, according to a past press release from the organization, which aims to cure liver disease.Liver Toxicity
"I do think if liver toxicity issues were more significant, that could hurt the drug’s sales but Tylenol has been around for so long and it’s been proven to be pretty safe,” Conover said.
Tylenol has more than 50 years of use and over 150 studies to support its safety and efficacy, Wertheim said.
The FDA is still evaluating a 2009 recommendation by one of its advisory committees that drugmakers lower the maximum recommended daily dose of acetaminophen because of the potential for liver damage.
In early 2014, J&J launched getreliefresponsibly.com, saying it wanted to make sure people don’t take more than the maximum daily dose of acetaminophen by combining drugs.
"Acetaminophen is safe when used as directed, but taking too much of it can harm your liver," Edwin Kuffner, vice president of medical affairs at McNeil at the time, said in a 2014 press release.
The case is Jackson v. McNeil Consumer Healthcare, ATL-L-880-13, Superior Court of New Jersey (Atlantic County). The multi-district case in Pennsylvania is In re Tylenol (Acetaminophen) Marketing, Sales Practices and Product Liability Litigation; 13-md-02436, U.S. District Court, Eastern District of Pennsylvania (Philadelphia).
http://www.bloomberg.com/news/articles/2015-10-16/j-j-jury-finds-no-tylenol-design-defect-spokesman-says
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J&J Win in First Trial Against Tylenol Skirts Defective Design Claim
Apr 19, 2016 | Insurance Journal
By Jef Feeley
Johnson & Johnson defeated a lawsuit claiming it had improperly designed its Tylenol pain reliever in the first case to go to trial over the link between the widely used over-the-counter drug and liver damage, according to a J&J spokesman.
Jurors in New Jersey concluded that Regina Jackson, a state employee who said she spent a week in the hospital after overdosing on Extra Strength Tylenol, failed to prove her case, according to J&J spokesman Jake Sargent. The jury ruled she couldn’t prove she had actually taken Extra Strength Tylenol, and didn’t rule on the merits of her claim the pain medication was defectively designed.
The verdict, which couldn’t immediately be confirmed in court records, comes as J&J fights about 220 similar lawsuits against it and its McNeil Consumer Healthcare unit in state and federal court in New Jersey and Philadelphia. The first federal trial is slated for early next year in Philadelphia, where roughly 200 cases have been consolidated. Not all of the cases involve overdoses, with some plaintiffs saying they had liver damage from taking the recommended dose.
The lawsuits aren’t expected to have a significant financial impact on J&J, said Damien Conover, an analyst at Morningstar Inc.. While the pain medication is one of the company’s signature brands, “in the totality of the overall business, Tylenol is relatively small because J&J is such a large diversified company,” he said.
Lawyers for Jackson argued during the trial that J&J touted Tylenol’s safety even though it knew for decades that the painkiller could harm users who inadvertently exceeded the daily recommended dose.
J&J countered that the medicine is safe at the recommended dose of two pills every four hours, up to a maximum dose of eight pills a day. Warnings about liver damage are already on the label, and Jackson’s liver damage was caused by an overdose, the drug maker’s lawyers said during the trial.
Jackson’s lawyers argued that the recommended dosage should be two pills three times a day, which would make people less likely to overdose.
The lawsuits come amid longstanding concerns about links between acetaminophen, the main ingredient in Tylenol, and liver damage. The American Liver Foundation warned in 2006 that at the maximum recommended dose for two weeks, healthy adults could have increased liver enzymes which could lead to liver damage, according to a past press release from the organization, which aims to cure liver disease.Liver Toxicity
“I do think if liver toxicity issues were more significant, that could hurt the drug’s sales but Tylenol has been around for so long and it’s been proven to be pretty safe,” Conover said.
The FDA is still evaluating a 2009 recommendation by one of its advisory committees that drugmakers lower the maximum recommended daily dose of acetaminophen because of the potential for liver damage.
In early 2014, J&J launched getreliefresponsibly.com, saying it wanted to make sure people don’t take more than the maximum daily dose of acetaminophen by combining drugs.
“Acetaminophen is safe when used as directed, but taking too much of it can harm your liver,” Edwin Kuffner, vice president of medical affairs at McNeil at the time, said in a 2014 press release.
http://www.insurancejournal.com/news/national/2015/10/19/385433.htm
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J&J chalks up a win in first Tylenol liver-damage case to go to trial
Oct 19, 2015 | FiercePharma
By Emily Wasserman
Johnson & Johnson ($JNJ) scored a victory in the first case to go to trial over claims that its blockbuster painkiller Tylenol causes liver damage and its dosing doesn't adequately account for the risk. A New Jersey jury ruled that the plaintiff did not prove that she took the painkiller.
Jurors dismissed plaintiff Regina Jackson's claims that she spent a week in the hospital for liver damage after accidentally overdosing on Extra Strength Tylenol, concluding that she couldn't prove that she used the J&J product.
But the jury did not rule on Jackson's allegations that the med was defectively designed and could make patients more likely to overdose,Bloomberg reports. Jackson's lawyers argued that J&J and its McNeil Consumer Healthcare unit talked up Tylenol's safety even though it knew the pain reliever could harm people who exceeded the daily dose. The lawsuit contended that the drug's recommended dosage should be two pills three times a day to deter overdosing.
J&J struck back, saying that Tylenol's label warns about liver damage and that the med is safe at the recommended dose--at the time Jackson allegedly used it--of two pills every four hours with a maximum dose of 8 pills a day. The jury's verdict "reflects the facts" of the case, McNeil spokeswoman Jodie Wertheim told the news outlet. "We are committed to providing consumers with safe, effective and high-quality products and recommend consumers always read and follow the product label," she said.
The news provides J&J/McNeil with an early win as it stares down about 220 lawsuits in state and federal court in New Jersey and Pennsylvania. The first federal trial is set for next year in Philadelphia, where about 200 of the cases are consolidated, Bloomberg notes.
Still, J&J is not likely to take a financial beating from the suits, Morningstar analyst Damien Conover told the news outlet. "(I)n the totality of the overall business, Tylenol is relatively small because J&J is such a large diversified company," he said. Extra Strength Tylenol brought in about $400 million last year and a regular strength version added $14 million to that haul, but those are small beans compared with the company's other top-sellers.
But "if liver toxicity issues were more significant" for the drug, sales could take a hit, Conover added. And the New Brunswick, NJ-based company continues to deal with liver damage claims linked to the med, especially in the wake of a 2009 FDA panel recommendation that drugmakers lower the maximum daily dose of acetaminophen, Tylenol's main ingredient, because of its potential for liver damage. The agency subsequently cut the daily recommended dose and put safety warnings on the drug's label.
But J&J is working hard to reassure consumers and protect sales for its top-selling brand. In 2011, the company changed dosing instructions on the label of Extra Strength Tylenol from 8 pills a day to 6 "to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose," the company said at the time. In 2014, J&J launched a campaign, dubbed getreliefresponsibly.com, which cautioned individuals against exceeding the maximum daily dose of acetaminophen by combining drugs, Bloomberg reports.
http://www.fiercepharma.com/regulatory/j-j-chalks-up-a-win-first-tylenol-liver-damage-case-to-go-to-trial
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Johnson & Johnson Emerges Victorious in Lawsuit on Tylenol’s Risks
Oct 20, 2015 | ProPublica
By Jeff Ferth and T. Christian Miller
A jury in Atlantic City has handed Johnson & Johnson a victory in a lawsuit alleging that Tylenol, the popular pain reliever, was defectively designed.
On Friday, the jury decided the plaintiff, Regina Jackson, hadn’t proven she took Extra Strength Tylenol. She had claimed that an overdose of the drug landed her in the hospital.
That meant the jury didn’t address Jackson’s other claims, including whether the margin of safety between a safe dose of Tylenol and a potentially harmful dose is adequate.
Jodie Wertheim, a spokeswoman for McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol, said in a statement that the “jury’s verdict reflects the facts in the case.” She added that Tylenol has a long history of studies backing its “safety and efficacy, and, when used as directed, it has one of the most favorable safety profiles” among over-the-counter pain relievers.
Lawyers for the plaintiff did not immediately respond to a request for comment. But one of them, R. Clay Milling, told Bloomberg that the underlying question about Tylenol’s safety margin, while not addressed by the jury in New Jersey, will be argued again in other pending Tylenol cases.
A federal judge in Philadelphia is overseeing some 200 cases claiming Tylenol is connected to deaths or serious liver injuries. McNeil is contesting all of the cases; the first is scheduled to go to trial next year. Tylenol’s potential toxicity has been an issue in previous trials. McNeil has won the majority of those cases.
In 2011 McNeil lowered the maximum daily recommended dose for Extra Strength Tylenol from 4 grams, or eight pills, to 3 grams, after an FDA panel recommended the change.
As reported in 2013 by ProPublica and This America Life, McNeil has previously opposed warning labels, dosage restrictions and even public awareness campaigns over concerns about profitability.
The investigation also found that the Food and Drug Administration has delayed implementing suggestions to improve the safety of acetaminophen, the active ingredient in Tylenol. The ingredient is found in hundreds of over-the-counter products and is used by tens of millions of American every week.
The 3 1/2 week trial put into the public record new documents showing McNeil was aware that many doctors who told their patients to take Tylenol were recommending that they take less than the maximum dose described on the label.
The jury did not see other documents, including plans by McNeil and Johnson & Johnsonto block potential new safety restrictions on acetaminophen by the FDA.
It is not clear what evidence would be heard by a federal jury in Philadelphia if one of the Tylenol cases goes to trial.
https://www.propublica.org/article/johnson-johnson-emerges-victorious-in-lawsuit-on-tylenols-risks
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