Accutane, Generic Accutane (Isotretinoin)
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This page is updated as of 7/2/2012.
Dear Accutane Client:
Welcome to the confidential page for our Accutane clients. This page is intended to update you on current information, as well as be a repository for past updates and important documents. This page contains the most updated information. We greatly appreciate that you rely on this information. Inquiries to our office are always welcome about unique questions regarding your claim but asking us to repeat the general information below only slows down our work on the files.
A New Jersey jury came back with a Plaintiff verdict for two plaintiffs in the latest Accutane trial. $9 million was awarded to each plaintiff after the jury found they had developed inflammatory bowel diseases after using Accutane. Roche Holdings AG has now lost nine out of thirteen Accutane lawsuits that went to trial.
With the recent decision in Mensing v. PLIVA the status of the Accutane litigation where plaintiff's have taken the generic form of Accutane is currently under review by Judge Higbee and the Plaintiffs. We are still assessing whether or there are viable ways of moving forward in light of that decision and we wil be updating the clients that are affected as soon as we have more information. You can read a copy of the decision here, and you can read an article on our blog about it here.
The next name brand Accutane trial will take place in December/January of 2011/2012. We will update this page as it develops.
In February of 2010 in the case of Andrew McCarrell v. Roche a jury awarded the plaintiff $25,000,000 in damages in addition to $159,530.19 in medical expenses. The jury decided that the makers of Accutane had not adequately warned Andrew of the increased risk on Inflammatory Bowel Disease and that their failure to warn was the proximate cause of Andrew's IBD. Click here to see the Jury Verdict.
The last plaintiff trial in New Jersey was decided in April 2011. One plaintiff was awarded $2 million dollars in damages. The jury did not find in favor of the other two plaintiffs.
The Discovery process is moving along quite well. Roche has produced an extensive hard drive which includes millions of documents useful to Accutane cases.
A recent decision from Judge Higbee in the Reglan Consolidated litigation which she presides over in New Jersey is not a good sign for the generic cases in accutane. Judge Higbee found that all failure to warn claims against a generic manufacturer, as well as all relating claims, are barred by the Supreme Court's decision in Pliva v. Mensing.
For general information about Accutane, the generic Isotretinoin and related injuries you can view our general page.
Links to Latest News on our Blog
Below is are articles reprinted in their entirety regarding an accutane cases in New Jersey.
Bills Seek to Change Rule on Generic Drug Labels
By KATIE THOMAS
Published: April 18, 2012 in the New York Times
Democrats in the Senate and House introduced companion bills Wednesday that would permit generic drug companies to update warning information about the drugs they manufacture, a change that could allow patients to sue the companies for failing to warn about the risks of taking their drugs.
A Supreme Court decision last year, Pliva v. Mensing, barred patients from suing generic drug companies because the court ruled that the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the drugs' risks.
An earlier Supreme Court decision, by contrast, gave permission to patients who took brand-name drugs to sue the drug manufacturers. Since the decision last year, dozens of judges have thrown out cases filed by patients who claim they were harmed by generic drugs even though in many cases they suffered the same injuries as those who took the brand-name versions.
"The Mensing decision creates a troubling inconsistency in the law governing prescription drugs," Senator Patrick J. Leahy of Vermont, who sponsored the bill along with six other Democrats, said in a statement Wednesday.
"If a consumer takes the brand-name version of drug, she can sue the manufacturer for inadequate warnings. If the pharmacy happens to give her the generic version, she will not be able to seek compensation for her injuries," he said.
Two Democrats in the House, Chris Van Hollen of Maryland and Bruce Braley of Iowa, introduced an identical bill Wednesday. Chances are slim that it will pass the House, which is controlled by Republicans.
The consumer advocacy group Public Citizen has asked the Food and Drug Administration to take a similar action, but the agency said last month that it needed more time to decide on the issue.
Generic drug companies have opposed such a move because they say it could create a chaotic situation in which several different drug companies could publish conflicting warning information about the same drugs. Under current law, only brand-name drug companies can update the labels - the lengthy list of a drug's uses, dosages and risks - and generic manufacturers are then required to follow suit.
"Federal law requiring that generic medicines have the identical label as the corresponding brand products has provided American consumers the confidence to trust in generics for 80 percent of their prescription needs," Ralph G. Neas, president and chief executive of the Generic Pharmaceutical Association, the industry trade group, said in a statement. "This misguided legislation, introduced by Senator Leahy, would disrupt this confidence and unduly burden physicians who would have to be aware of multiple labels for the same product."
Accutane Trial Ends With $2 Million Verdict for One Plaintiff
Date Published: Tuesday, April 26th, 2011
Another Accutane trial has ended with a win for a plaintiff. The Street said that the six-week trial resulted in a $2 million award for one of three plaintiffs after their attorneys argued that Roche, the maker of Accutane, knew that Accutane could lead to a serious risk for inflammatory bowel disease and did not properly warn patients of these risks.
Kelley Andrews said she took Accutane, developed Crohn's disease, was hospitalized 25 times, underwent seven "major" gastrointestinal surgeries, and, ultimately, was forced to undergo removal of her colon, said The Street. Closing arguments included a statement that said, essentially, that Roche knew that the drug "induces, triggers, or causes IBD," a type of Crohn's disease, said The Street.
Plaintiff James Marshall also said he took Accutane, which he claims resulted in ulcerative colitis in 1993, suffering also from rectal bleeding, a symptom of ulcerative colitis. Plaintiff Gillian Gaghan said she, too, took Accutane and developed ulcerative colitis, underwent a number of hospital stays, developed lupus-like symptoms, and suffers nighttime bowel control loss, among other symptoms. The jury did not find in favor of these two plaintiffs, and awarded them nothing.
Meanwhile, there are some 2,441 Accutane inflammatory bowel disease (IBD) lawsuits pending in a New Jersey mass tort litigation that began five years ago. Over the fall, more than 800 lawsuits were filed in the Accutane litigation, and it is expected that more cases will be filed in the future.
Approved by the Food & Drug Administration (FDA) in 1982, Accutane has been the subject of controversy for years. It first garnered attention in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to hundreds of cases of suicide in the United States. Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal, and autoimmune systems.
The rare and dangerous skin disorder, Stevens-Johnson syndrome, which can be fatal if untreated, has also been tied to Accutane.
In 2009, Roche decided to stop marketing Accutane for economic reasons. In announcing the decision, Roche cited the high cost of product liability suits involving the drug as one of the factors in the decision.
Bloomberg News reported in August that Roche has lost all seven Accutane cases that had been considered by juries since 2007, including the last three in a row. Following one 2007 trial in New Jersey state court, Roche was able to successfully overturn a jury's award of $2.62 million in compensation awarded to a man who developed inflammatory bowel problems. That case was retried and another New Jersey jury awarded the same man more than $25 million.
In August, the New Jersey Superior Court Appellate Division threw out an award of $10.5 million stemming from a 2008 Accutane trial, and ordered a new case for that trial.
A new Accutane study out of Sweden linked the controversial acne drug to an increased risk of suicide. The study's findings support increased mental health monitoring of patients for up to a year after taking Accutane.
Leahy, Franken, Bingaman, Whitehouse, Brown, Coons, Blumenthal Introduce Bill To Protect Consumers Using Generic Drugs
Bill Addresses Supreme Court Decision In Pliva v. Mensing
April 18, 2012
WASHINGTON (Wednesday, April 18, 2012) - Senator Patrick Leahy (D-Vt.) introduced legislation Wednesday to address a recent Supreme Court decision that threatens to undermine the safety of consumers taking generic drugs. The legislation is cosponsored by Senators Al Franken (D-Minn.), Jeff Bingaman (D-N.M.), Sheldon Whitehouse (D-R.I.), Sherrod Brown (D-Ohio), Christopher Coons (D-Del.) and Richard Blumenthal (D-Conn.).
In a 2011 case, Pliva v. Mensing, a 5-4 majority of the U.S. Supreme Court held that manufacturers of generic drugs cannot be held liable under state tort law for "failure to warn," even if the manufacturer knows that its label is inadequate. The Court based its decision on a federal law that requires generic manufacturers to use the same label as their brand-name counterparts. However, the Supreme Court held in 2008 that brand-name manufacturers can be held liable under state tort law for failure to warn, because federal law permits brand-name drugs to improve their warning labels. The Patient Safety and Generic Labeling Improvement Act introduced Wednesday will address this discrepancy and reverse the effects of the Mensing case.
"The Mensing decision creates a troubling inconsistency in the law governing prescription drugs," said Leahy. "If a consumer takes the brand-name version of drug, she can sue the manufacturer for inadequate warnings. If the pharmacy happens to give her the generic version, she will not be able to seek compensation for her injuries. The Patient Safety and Generic Labeling Improvement Act will promote consumer safety by ensuring that generic drug companies can improve the warning information for their products in the same way that brand manufacturers can under existing law."
Leahy chairs the Senate Judiciary Committee. Under his leadership, the Committee has held a series of hearings in recent years spotlighting the importance of the Supreme Court's decisions on the lives of hardworking Americans, including a number of recent Supreme Court decisions decided by a narrow 5-4 majority that affect the pocketbook issues facing all Americans, from equal pay for equal work, to consumer protections, to the 2010 campaign-finance decision in Citizens United.
"Right now generic drug manufacturers are prohibited from updating their labels to accurately reflect all of the side effects or risks associated with their drugs," said Franken. "This means that a senior in Minnesota may have no idea that a prescription drug she's taking could cause a neurological disorder. That's just not right. This bill will help right this wrong to make sure that Minnesotans know exactly what risks are associated with the medications they're taking."
"While essential to the treatment of many illnesses, prescription drugs can pose risks and have health-threatening side effects. For this reason, prescription drug warning labeling is an important part of ensuring consumer safety," Bingaman said. "By giving generic drug manufactures the ability to update their labeling, this bill will help individuals make an informed decision about the medications they take."
"Consumers of generic prescription drugs should have the same rights as those who are prescribed brand-name drugs," said Whitehouse. "I thank Chairman Leahy for drafting legislation to address this truly wrong-headed decision by the Supreme Court, and I hope we can take action soon to protect Rhode Island consumers."
"Regardless of whether they use generic or brand-name drugs, Ohioans should have full access to information regarding the safety of their prescriptions," Brown said. "This legislation would ensure that generics and brand-names are held to the same labeling standards, which is critical given that approximately 75 percent of prescriptions filled in the U.S. are generics."
"It's common sense that any drug manufacturer - whether generic or brand name - ought to have the responsibility of warning its users of the risks of side effects for the drugs that they sell," Coons said. "According to the Supreme Court's decision last year in Mensing, however, federal law actually prevents generics from warning customers when they discover a new risk. I applaud Chairman Leahy for his work in drafting legislation that will fix this, keeping generic medicines safe, effective, and a key component of affordable health care."
"Generic drug manufacturers must clearly warn patients of known possible life threatening drug side effects - and be held accountable when they fail. Victims in Connecticut have been harmed and left without recourse. I will continue to fight to ensure this loophole no longer jeopardizes patient safety," said Blumenthal.
The plaintiff in Mensing, Minnesota resident Gladys Mensing, developed a severe neurological disorder as a result of the long-term use of a generic drug manufactured by Pliva. She filed suit against Pliva under state tort law, arguing that the drug's label failed to adequately warn of the risks associated with long-term use. In the 10 months since the Supreme Court issued its decision, more than 40 judges have dismissed cases alleging inadequate labeling by generic manufacturers. Over 75 percent of all prescriptions are filled by generic drugs.
In 2008, the Supreme Court held that a patient can sue a brand-name drug manufacturer for failure to warn, in a case involving Vermont musician Diana Levine. Leahy filed an amicus brief in the Supreme Court on behalf of Ms. Levine with 17 Congressmen, including Vermont Senator Bernie Sanders and Vermont Congressman Peter Welch.
Many public interest groups have called on Congress and the Food and Drug Administration to address the Court's decision in Mensing. Companion legislation is expected to be introduced in the House of Representatives by Congressmen Chris Van Hollen (D-Md.) and Bruce Braley (D-Iowa).
ACCUTANE TRIALS SET IN NEW JERSEY FOR 2011 (Jan. 12, 2011)
A number of Accutane lawsuits will be going to trial this year in New Jersey state court, following an appeals court decision in August that reversed a $10.5 million verdict in one case and resulted in the delay of an Accutane trial involving threeother cases.
There are currently more than 2,500 individuals who have filed an Accutanelawsuit over bowel problems in New Jersey state court. The cases have beencentralized as part of a mass tort before Judge Carol E. Higbee in AtlanticCounty.
All of the claims involve allegations that Roche, the makers of the popular acnemedication, failed to adequately warn about the risk of Accutane side effects,such as inflammatory bowel disease, ulcerative colitis and Crohn's disease.So far, the drug maker has lost all seven cases that have reached a jury in thelitigation, with many resulting in multi-million dollar awards for Accutane damages.
In August, the New Jersey Superior Court Appellate Division reversed a $10.5 million jury verdict in an Accutane lawsuit brought by Kamie Kendall, finding thatRoche was wrongly prohibited from introducing evidence to the jury about thenumber of individuals who have used the acne medication over the years.As a result of that decision, Judge Higbee delayed the start of an Accutane trialinvolving actor James Marshall, which was scheduled to begin the week theappellate court decision was released. Two other cases, Andrews v. Hoffman-LaRoche, Inc. and Gaghan v. Hoffman-La Roche, Inc., were to be tried togetherwith the Marshall case.
According to an Order issued December 22, Judge Higbee has rescheduled theMarshall, Gaghan and Andrews trial to begin with jury selection on February 14, 2011. A number of well-known Hollywood stars, such as Martin Sheen, Brian Dennehy and Rob Reiner, are expected to testify on behalf of Marshall, whoportrayed a marine on trial for murder in "A Few Good Men." Marshall claims thathe suffered severe bowel problems from Accutane that resulted in the removal of his colon, ruining his acting career.
In the same order, Judge Higbee indicated that the retrial of the Kendall case,which was overturned on appeal, will begin with jury selection on May 10, 2011.At a case management conference this week, the Court is expected to select oneor two additional Accutane suits that are compatible with the Kendall case to goto trial before the same jury.
Kendall was originally awarded $10.5 million at trial in 2008. However, a new jurywill rehear the case and could award more, or less, compensation if they ruleagainst the drug maker.
This is the second New Jersey jury verdict Roche was able to successfullyoverturn on appeal. The first involved a case filed by Andrew McCarrell, who was originally awarded $2.62 million at trial in 2007. After that verdict was overturned,another New Jersey jury awarded McCarrell more than $25 million in damagesfor inflammatory bowel disease from Accutane during the retrial in February 2010.
There is currently a pending petition for certification to the Supreme Court filed byRoche in the Kendall case. Judge Higbee has indicated that a group of four othercompatible cases will be prepared for trial to begin on May 10, 2010 in the eventthe Supreme Court agrees to hear the further Kendall appeal. Otherwise, thosecases are expected to be set for trial later in the year.
Accutane (isotretinoin) has been used by more than 16 million people worldwidesince it was first introduced in the early 1980s as a treatment for severe acne.Roche discontinued Accutane in June 2009 due to the increasing costs of the litigation, but a number of generic versions remain available under names such as Claravis, Sotret, Amnesteem and generic isotretinoin.
Roche Ignored Accutane Risks, Actor's Lawyer Tells Jurors (2)
By Jef Feeley - February 22, 2011 16:49 EST
Feb. 22 (Bloomberg) -- Roche Holding AG executives ignored research showing that the company's Accutane acne drug causes inflammatory bowel disease, a lawyer told a New Jersey jury hearing a Hollywood actor's claims over the medicine.
To protect profits, Roche researchers turned a blind eye to animal studies that found Accutane could cause bleeding and bowel blockages in users, said Michael Hook, an attorney for James Marshall, who played U.S. Marine Louden Downey in the 1992 hit movie "A Few Good Men." Jurors in state court in Atlantic City, New Jersey, are hearing claims by Marshall and two other ex-Accutane users that the drug destroyed their intestinal systems.
"These people have been seriously hurt," Hook told the seven-woman, one-man jury today in opening statements.
About 16 million people have taken Accutane, once Roche's second biggest selling drug, since it went on the market in 1982, according to plaintiffs' lawyers. Basel, Switzerland-based Roche, the world's biggest maker of cancer drugs, pulled its brand-name version of Accutane off the market in 2009 after juries awarded millions of dollars in damages to former users over bowel-disease claims. Roche has lost all seven cases that have gone to trial.
Marshall, 44, a New Jersey native, is seeking at least $11 million in damages. His portion of the case will feature testimony from Hollywood celebrities such as Martin Sheen, Brian Denehhy and Rob Reiner.
They will testify that Marshall was headed for stardom before bowel ailments allegedly caused by Accutane forced doctors to remove his colon, Hook said before the start of the trial. The surgery left Marshall in severe pain and unable to work, Hook said in his opening statement.
Roche contends that Accutane doesn't cause inflammatory bowel disease, according to court filings. Roche's lawyers will make their opening statements tomorrow, Judge Carol Higbee said late today.
Roche researchers ignored studies, done before Accutane's approval for the U.S. market, showing that dogs given the drug bled in their gastrointestinal tracts, Hook told jurors today. The company never fully disclosed Accutane's risk of causing inflammatory bowel disease in its warning label, he said.
Accutane is made by Roche unit Hoffmann-LaRoche Inc. of Nutley, New Jersey, allowing Marshall, Gillian Gaghan and Kelley Andrews to bring their claims in the state. All three are California residents. Andrews, 29, is an account manager while Gaghan, 34, is a nursing assistant. Marshall was born James Greenblatt, according to court filings.
All three contend the drug left them struggling to deal with their bodily wastes, Hook said before the trial, which is slated to last six weeks. Both Andrews and Marshall battle incontinence while Gaghan has "developed Lupus-like symptoms" as a result of taking drugs to deal with her Accutane-linked bowel disease, he said.
Marshall took Accutane over a two-year period, in 1992 and 1993, according to court papers. Andrews, who took Accutane for two years starting in 1997, has endured dozens of hospitalizations and surgeries, including the removal of part of her colon and small intestine, Hook said. Gaghan, who took the drug for five months in 1998, has daily pain from the resulting inflammatory bowel disease, he said.
The case combining the three ex-Accutane users' claims is the eighth to go to trial since juries began weighing allegations against the drug. Juries in New Jersey and Florida have ordered Roche to pay at least $45 million in damages.
Appeals courts have thrown out some of the verdicts, including a 2007 award of $7 million to a Florida man who blamed the drug for his inflammatory bowel disease. Last year, an Atlantic City jury ordered Roche to pay $25.1 million to a man who attributed his inflammatory bowel disease to Accutane. That case was a retrial of an earlier verdict overturned by appellate judges.
In August, a New Jersey appellate court also overturned a $10.5 million Accutane verdict against the company on an evidentiary issue.
Roche has won dismissals of Accutane cases filed in federal court and has challenged the state court verdicts by asking judges to throw them out or filing appeals, officials said last year.
The case is Greenblatt v. Hoffmann-La Roche Inc., ATL-l- 1246-06, New Jersey Superior Court, Atlantic County (Atlantic City).
To contact the reporter on this story: Jef Feely in Wilmington, Delaware at firstname.lastname@example.org.
To contact the editor responsible for this story: John Pickering at email@example.com.
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