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Wednesday, March 19, 2014

Jury in Actos Cancer Trial Told of Drug Company Misconduct

Jury in Actos Cancer Trial Told of Drug Company Misconduct

MARCH 11, 2014 By: Susan Green

The opening witness in the first “bellwether” Actos cancer trial told the jury about drug manufacturer Takeda’s pretrial misconduct.  The case is the first of several scheduled in the ongoing Actos Multidistrict Litigation (MDL) in federal court in Louisiana.

Terrence Allen and his wife’s lawsuit charges that Allen developed bladder cancer as a result of using Actos to treat diabetes between 2004 and 2011.  Plaintiffs argue that Actos manufacturer Takeda failed to disclose the link between Actos and bladder cancer.  Takeda claims that Allen’s cancer was not caused by the drug, and that the company provided proper notification of Actos’s risks.

Takeda’s pretrial misconduct 

Just before the Allens’ Actos cancer trial began on January 27, the judge ruled that Takeda had acted in bad faith by hiding or destroying evidence that the company should have given plaintiffs during the pretrial process.  The judge held that plaintiffs could reveal Takeda’s improper actions to the jury.  Thus plaintiffs’ first witness was an Actos employee, who testified about the company’s evidentiary misconduct.

The next witness was Dr. David Kessler, a physician who served as Commissioner of the FDA from 1990-1997.  Dr. Kessler told the jury that the FDA is required to determine that a drug is safe and effective before the agency can authorize that drug’s use in the United States.  Dr. Kessler described the types of data Takeda was required to obtain to demonstrate Actos’s safety and effectiveness, and explained what the manufacturer was obligated to show the FDA in order to obtain authorization for the drug.

Several medical experts then testified about the studies linking Actos use to a high risk of bladder cancer.  Takeda employees also took the witness stand to describe what the company knew about the connection between bladder cancer and Actos use.

Actos cancer trial details 

Millions of Americans have used Actos to treat their Type 2 diabetes since the FDA approved the drug in 1999.  In 2011, however, the FDA advised that use of Actos for longer than one year increased patients’ risk of bladder cancer by as much as 40% compared to patients who had never used the drug.  The FDA’s advice was based on results after five years of a planned ten-year study of over 193,000 diabetes patients.

Nearly 3,000 Actos cancer lawsuits were centralized in the Louisiana federal court as a way to streamline pretrial proceedings.  The MDL procedure allows the court to resolve pretrial issues common to all the lawsuits at one time.  Then the parties select a few representative or “bellwether” cases to go to trial.  The procedure often facilitates settlement, as defendants understand the likely outcome of the remaining cases, and try to minimize the time and expense of multiple separate trials.

On top of the thousands of cases pending in the MDL, many other patients have filed lawsuits in state courts around the country charging that Actos caused bladder cancer.  To date at least three cases have been concluded.  Two 2013 trials resulted in jury verdicts of $1.7 million and $6.5 million, although the verdicts ultimately were vacated.  A third trial led to a decision in favor of Takeda.

The Actos cancer trial in Louisiana will continue to draw attention as witnesses testify for both sides.  Based on the parties’ original estimates, the jury should begin its deliberations sometime in late March.

 


Wednesday, March 19, 2014

NEW JERSEY JURY ORDERS DRUG MAKER ROCHE TO PAY $1.5 MILLION IN ACCUTANE TRIAL

NJ jury orders drugmaker Roche to pay $1.5M at Accutane trial

By Bloomberg News
on March 11, 2014 at 2:42 PM, updated March 11, 2014 at 2:44 PM

A New Jersey jury today found drug maker Roche failed to properly warn Kamie Kendall's doctors that acne medicine Accutane could cause ulcerative colitis and were liable for her injuries.

Drug maker Roche must pay more than $1.5 million in damages to a woman who developed bowel disease after using the company’s Accutane acne medicine, a jury ruled in her retrial.

Officials of Basel, Switzerland-based Roche failed to properly warn Kamie Kendall’s doctors that Accutane could cause ulcerative colitis and were liable for her injuries, jurors in state court in New Jersey concluded today.

It was the second trial of Kendall’s Accutane claims. A New Jersey appeals court overturned a $10.5 million verdict in 2010, ruling that a judge improperly barred Roche from using evidence about the medication’s use. Roche has lost 10 of 13 suits brought by former Accutane users that have gone to trial since April 2007, according to data compiled by Bloomberg.

“This is another in a long line of juries that have found Roche knew this drug caused bowel disease and wrongfully withheld that information from patients and their doctors,” Mike Hook, Kendall’s lawyer, said in a phone interview.

About 16 million people have taken Accutane, once Roche’s second-biggest selling drug, since it went on the market in 1982. Roche, which recently exited its shuttered its sprawling campus on the border of Nutley and Clifton, lost patent protection in 2002 and continued to sell the drug along with generic competitors. In addition to bowel disease, Accutane has been linked to birth defects and depression.

Roche, the world’s biggest maker of cancer drugs, pulled its brand-name Accutane off the market in 2009 after juries awarded millions of dollars in damages to former users over the bowel-disease claims.

In 2012, a New Jersey jury ordered Roche to pay a total of $18 million to two former Accutane users. The same jury rejected claims by two other patients who blamed their bowel ailments on the drug.

 


Thursday, February 20, 2014

Accepting Testosterone Therapy Drug Injury Cases

New Research Suggests that Testosterone Drugs Linked to Increased Risk of Heart Attack and Stroke

The FDA recently announced the launch of an investigation of the cardiovascular risks associated with testosterone therapy. The medical safety alert is to warn men of potential risks and/or side effects associated with testosterone therapy.

  Studies have shown that, as early as one month and up to the first 90 days after starting testosterone therapy, dangerous blood clots can occur. Further the risk for men over the age of 65 doubles for a heart attack. There is a nearly triple the risk of suffering a serious or fatal complication for men under 65 years of age that have pre-existing heart disease. The risk to men, with unknown inherited clotting disorders, is higher for developing clots. These cardiovascular risks are generally not set forth in the product labels.

 Testosterone therapy was approved by the FDA to treat abnormally low testosterone levels. However, some of the manufactures of these products are promoting their use for conditions not necessarily related to low testosterone levels, such as energy loss, mood changes, reduced sex drive, among others. These conditions may not be related to low testosterone but simply the aging process, not properly dieting and exercising or other reasons. Because of these aggressive marketing strategies, the estimated sales of testosterone drugs are projected to reach $5 billion by 2017.  

                                                             These products include:

Androgel®, Androderm®, Fortestra®,

Axiron®, Testim®, Bio-T-Gel®, Delatestryl®,

 Depo-Testosterone®, Striant®, and Testopel®. 

 Hutton & Hutton is investigating injuries related to the use of these products for potential lawsuits against the manufacturers. If you are interested in consulting our firm on this litigation or on referring potential cases, please contact Steven Foulston at 888-882-1166.

 At Foulston Law Office we are committed to protecting the rights of persons injured by pharmaceutical companies that put profits before patients.  We are an experienced leader nationally in pharmaceutical litigation and have successfully taken on the largest drug companies on behalf of our clients

 For more information regarding additional cases we are investigating,

please call Steven L. Foulston at 888-882-1166. We look forward to working with you.

 

 

 

 

 

 

 


Monday, February 3, 2014

Transvaginal Mesh Lawsuits Heating Up—Litigation Update

 


New York, NY:
 Over 40,000 transvaginal mesh lawsuits have been filed in federal court involving vaginal mesh pelvic repair systems manufactured by multiple medical device companies. While some claims have been settled, a staggering 3,000 TVM lawsuits a month are still being filed.

Thousands upon thousands of women claiming injuries due to transvaginal mesh products have filed in multidistrict litigation in federal court in Charleston, West Virginia. As of January 2014, the following manufacturers have either settled some claims, begun bellwether trial proceedings or are scheduled for trial:

(Bellwether trials take place to help both plaintiffs and defendants by determining how juries are likely to respond to evidence and testimony presented. These trials are the norm in complex medical device litigation, particularly in the case of transvaginal mesh products involving multiple medical device companies. Representative cases for bellwether selection include women aged 40 and 60 years old at the time when they had the pelvic mesh surgeries, with three or less revision surgeries. A successful outcome typically indicates a global settlement.)

American Medical Systems (AMS)

AMS transvaginal mesh cases were scheduled to begin last December. AMS has already agreed to settle a number of cases for $54.5 million, and the company is expected to attempt a global settlement in many more of the 6,000 cases pending in federal court in West Virginia before Judge Joseph R. Goodwin (In re: C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation; MDL-2187, U.S. District Court for the Southern District of West Virginia).

According to court documents, at least two bellwether trials resulted in compensation for the plaintiff. In August 2013, a jury awarded plaintiff Donna Cisson about $2 million in damages and plaintiff Wanda Queen settled out of court for an undisclosed sum.

Court documents also show that more than 14,000 vaginal mesh lawsuits now pending in the Southern District of West Virginia involve AMS. Every complainant alleges that AMS was used to treat pelvic organ prolapse or stress urinary incontinence, but their TVM surgery resulted in mesh erosion, organ damage, chronic pain and other serious vaginal mesh complications.

The first AMS bellwether trial is scheduled to begin on April 7, 2014. The second trial is set for May 5, 2014.

According to a Bloomberg report (September 30, 2013), Bard in September joined Endo Health Solutions (American Medical Systems), Boston Scientific, Cook Medical Systems and Coloplast in talks to settle tens of thousands of federal and state vaginal mesh lawsuits.

C.R. Bard

C. R. Bard, the maker of Avaulta transvaginal mesh, settled the first of four bellwether trials (U.S. District Judge Joseph R. Goodwin presiding) last summer with a $2 million verdict including punitive damages. Bard was accused of failing to warn women about the risk of side effects. The second trial resulted in an agreement to settle during the first trial day. The third trial was voluntarily dismissed by the plaintiff. Another bellwether trial slated for January 10, 2014 has been postponed until May 19, 2014 (Jones v. C.R. Bard, Inc., No. 2:11-cv-00114, U.S. District Court for the Southern District of West Virginia).

More than 6,500 claims have been filed against Bard on behalf of women who suffered severe side effects allegedly due to its Avaulta mesh. Court documents indicate that an additional 940 Avaulta transvaginal mesh lawsuits pending in a multicounty litigation are underway in New Jersey (In re: Pelvic Mesh Litigation/Bard, No. L-6339-10).
Boston Scientific

Thousands of Boston Scientific Corp. (MDL No. 2326) transvaginal mesh lawsuits are pending in the Southern District of West Virginia, and the first Boston Scientific bellwether trial is slated for March 10, 2014. The second is set for trial on July 14, 2014.

A Pretrial Order dated December 19, 2014 has established that the Court schedule two “waves” of 100 cases each in discovery in the proceeding. The parties have each been directed to select 50 cases for each wave, with the selections for the first wave due by January 21, 2014. Second wave case selections are to be submitted by May 21, 2014. (In re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation – MDL No. 2326.)

The cases are limited to women who received only the Boston Scientific Obtryx, Advantage/Fit, Pinnacle or Uphold products, excluding cases where multiple different products were used.

Ethicon Gynecare

Johnson & Johnson’s subsidiary Ethicon Gynecare transvaginal mesh lawsuits are scheduled for trial in August 2014. Ethicon’s Prolift mesh went to trial in New Jersey and ended with the jury awarding the plaintiff $11 million in compensatory and punitive damages (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10; In re: Pelvic Mesh Litigation/Bard, No. L-6339-10).

The Ethicon MDL in West Virginia federal court is preparing for its first bellwether trial in February 2014, which involves about 13,000 cases. The selected case for the trial involves plaintiff Carolyn Lewis ( Lewis, et al. v. Johnson & Johnson, et al., 2:12-cv-04301). The Ethicon MDL is In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation MDL no. 2327 in the U.S. District Court for the Southern District of West Virginia.

As well, Ethicon is being investigated by government agencies for making false claims and engaging in deceptive marketing of its surgical mesh. According to documents filed in In re: Ethicon Inc., Pelvic Repair System Products Liability Litigation; MDL-2327, U.S. District Court for the Southern District of West Virginia, on January 23, 2014, the federal court overseeing the multidistrict litigation involving vaginal mesh products manufactured and sold by Ethicon heard arguments related to a motion accusing Ethicon and its parent company, Johnson & Johnson, of either losing or destroying “at least tens of thousands, maybe hundreds of thousands, of documents that likely contain information relevant to plaintiffs’ claims.”

Attorneys are closely watching bellwether trials - as they believe these cases will have an important impact on state and federal cases.

February 1, 2014, 08:00:00AM. By Jane Mundy


Monday, February 3, 2014

Takeda Jury To Hear Claims Over Actos Destroyed Files

Great news for folks injured by Actos diabetes drug. As most people know the first federal Actos trial is set to start on Monday February 3rd. The jury has been picked and is ready to go into a marathon trial expected to last several weeks.

Takeda Pharmaceutical Co., the manufacturer of the type 2 diabetic drug, Actos, must let a jury hear claims that it intentionally destroyed files related its Actos diabetes drug. The federal judge overseeing the trial has made this ruling, to allow this evidence and jury instruction, known as a Spoliation of Evidence. The jury is allowed to infer that the destroyed documents were damaging to the company.

Takeda Allegedly Intentionally Destroyed Key Documents

U.S. District Judge Rebecca Doherty said, Takeda admitted they can’t find files compiled by 46 current and former employees involved with the development, marketing and sale of Actos, including those of two directors. Some files were deleted from company computers after executives warned employees to retain Actos-related material.

“The breadth of Takeda leadership whose files have been lost, deleted or destroyed is, in and of itself, disturbing,” Doherty wrote in a January 27 court filing.

Takeda Under Fire

Takeda, Asia’s largest drug maker, is preparing for the federal-court trial in Lafayette, Louisiana, about a month after it scrapped development of another diabetes drug when research linked it to liver damage.

To punish the company, the judge will let lawyers for an Actos user suing Takeda over his bladder cancer tell jurors about the document destruction at his trial. The judge stopped short of awarding the plaintiff a default judgment over his case, stating that was too severe of a punishment.

Takeda Downplayed Actos Bladder Cancer Concerns

Plaintiffs allege that Takeda researchers ignored or downplayed concerns about the drug’s cancer-causing potential before it went on sale in the U.S. and misled FDA regulators about its risks.

Actos Blockbuster Drug

Sales of Actos peaked in the year ended March 2011 at $4.5 billion and accounted for 27 percent of Takeda’s revenue at the time, according to Bloomberg.
Actos has generated more than $16 billion in sales since its 1999 release, according to court filings.

Federal Court MDL

The consolidated Actos cases in Louisiana are In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299, U.S. District Court, Western District of Louisiana (Lafayette). Allen’s case is Allen v. Takeda Pharmaceuticals North America Inc., 12-cv-00064, U.S. District Court, Western District of Louisiana (Lafayette).

Posted by Shezad Malik MD JD
February 1, 2014 11:31 AM


Tuesday, January 28, 2014

Louisiana Actos Bellwether Trial Started in Federal Court

Today, the jury selection was underway in the first federal bellwether trial to take place involving allegations that the side effects of Actos caused bladder cancer.

Plaintiff Allen Alleges Damages from Actos

This first federal Actos bellwether trial by Terrence Allen and his wife, Susan, will be the first one out of 2,700 pending lawsuits. Allen took Actos from 2004 until 2011, when he was diagnosed with bladder cancer.

The plaintiffs allege that Takeda Pharmaceuticals failed to warn patients and doctors about the elevated risk of bladder cancer with long-term use of the diabetes drug, and withheld this important safety information. Allen maintains that if he and his physicians had known about the risk of bladder cancer, he would have not taken the drug.

Federal MDL Consolidation

U.S. District Judge Rebecca F. Doherty, is presiding over the centralized federal Actos MDL (multidistrict litigation) in the U.S. District Court for the Western District of Louisiana. Trial is expected to last about six weeks.

The Allen case is a “bellwether” trial, designed to help the parties determine how juries are to respond to similar scientific evidence and testimony throughout other Actos bladder cancer lawsuits.

Actos Trial Outcomes

Three Actos cases have gone to trial in various state courts. In May 2013, a California jury found that Takeda liable for increased Actos bladder cancer risk and awarded $6.5 million in damages, but, the trial judge reversed the verdict after excluding the plaintiffs’ expert witness testimony.

In September 2013, a Maryland jury found that Takeda liable for the Actos risks, and awarded the plaintiff $1.77 million in damages. But the jury also found that the plaintiff failed to exercise reasonable care for his own health, which cancelled the negligence of Takeda and so the verdict was reversed.

In December 2013, a Nevada jury, found for the defense, after evidence was presented that the plaintiff also used generic versions of Actos from online pharmacies.

It is expected that if the plaintiffs are successful in this trial, then it may pave the way for a global settlement.

 

Posted by Shezad Malik MD JD from "The Legal Examiner"
January 27, 2014 10:06 PM


Thursday, January 16, 2014

Fate of Thousands of Actos Lawsuits at Stake as Cancer Trial Set to Begin

  • With the outcome of thousands of lawsuits potentially at stake, the first bellwether Actos cancer trial is scheduled to begin soon in U.S. District Court for the Western District of Louisiana. This trial is expected to set the tone for future Actos litigation, as plaintiffs, defendants and their attorneys get an early taste of how juries might respond to testimony and evidence. Over 3,000 plaintiffs with complaints currently pending in federal court against Actos manufacturer Takeda will be watching this first bellwether trial with interest to see how their cases might eventually resolve.

Actos is a type 2 diabetes drug that, according to product liability lawsuit complaints, significantly raises the risk of bladder cancer in patients who use the drug for more than 12 months. Plaintiffs who developed cancer after using Actos allege that Takeda never adequately warned them of the risk.

Bellwether case selected out of thousands

The first Actos bellwether trial was selected by representatives for both plaintiffs and defendants out of more than 3,000 Actos bladder cancer lawsuits currently filed in federal court, and thousands more expected to join them. The trial is scheduled to begin on January 27, 2014. The plaintiffs in this complaint, Terrance Allen and his spouse, allege Allen’s use of Actos to treat type 2 diabetes from 2004 to 2011 led to a bladder cancer diagnosis in 2011.

The plaintiffs plan to show in their trial that Actos was a direct cause of his bladder cancer, and thatTakeda failed to warn consumers about the potential risk associated with their drug.

Actos was approved by the FDA to treat type 2 diabetes in 1999. The drug has been used for long-term management of diabetes, as it was in Allen’s case. However, studies have now shown long-term use of Actos can significantly increase a person’s risk for bladder cancer.

History of Actos side effects

In 2011, the FDA reported results from the first half of a 10-year study that showed patients who took higher doses of Actos for one year or longer increased their risk for bladder cancer by as much as 40%. The agency published those results in a safety communication on its website and alerted the medical community and consumers that the warning would also be added to the product’s label. However, many individuals who took the drug and developed bladder cancer prior to the 2011 warning have filed lawsuits against Takeda, claiming the company failed to provide proper warnings about their product.

In December, 2011, eleven cases involving Actos side effects were transferred to the U.S. District Court in Louisiana and coordinated into multidistrict litigation. Also referred to as MDL, multidistrict litigation is assigned when there is a growing number of complaints involving common questions of fact. The coordination is designed to make early trial proceedings more efficient and convenient for plaintiffs, defendants and witnesses.

Growing MDL numbers

Since the MDL was established, the case number has grown to more than 3,000 in coordinated proceedings. In addition, there are hundreds more Actos lawsuits pending in state courts across the country. Three of those cases have already been decided. Two ended in favor of the plaintiffs, including jury awards of $1.7 million and $6.5 million, although one verdict was thrown out by the judge because of a technicality of law, and the other is on appeal. The third was decided in favor of the defendant.

Despite these early rulings, this first bellwether trial will be the one to truly set the stage for future Actos litigation. The judge overseeing these trials, Judge Rebecca Doherty, will preside over all pretrial proceedings, including motions and discovery proceedings. Bellwether trials are also often the catalysts to begin settlement negotiations between plaintiffs and defendants.

As the court, plaintiffs and defendants continue to prepare for this first Actos lawsuit trial on January 27, thousands of eyes will be on the Western District of Louisiana to determine how Actos litigation might proceed in the future.

Reporter Whitney Taylor


Wednesday, December 11, 2013

Johnson & Johnson officials accused of destroying vaginal mesh files

 

12/09/2013 // West Palm Beach, Florida,

West Virginia –Johnson& Johnson officials have been accused of getting rid of files linked to its transvaginal mesh implants that they were ordered by executives to maintain. As reported by Bloomberg, patients’ attorneys have asserted in a court filing that the company should not be allowed to rely on certain defenses in pending trials over the implants due to the loss of the documents, which are stated to potentially be hundreds of thousands.

The attorneys are quoted as writing in the recent court filing, “Ethicon’s document destruction has severely prejudiced the plaintiffs for the upcoming bellwether trials…Defendants should not benefit from the gaps in plaintiffs’ story that defendant created.”

Matthew Johnson, a spokesman for Ethicon, is quoted in the report as stating in an emailed statement in response to the claims, “We have never intentionally destroyed, withheld or failed to produce relevant documents.”

As noted in the report, the U.S. Food and Drug Administration ordered J&J and other mesh manufacturers to study organ damage rates and other health complications linked to vaginal mesh implants last year.

This report is provided by Justice News Flash – 

 

 


Wednesday, December 11, 2013

NATION’S THIRD ACTOS TRIAL INVOLVING BLADDER CANCER ALLEGATIONS NOW UNDERWAY

The nation’s third trial of an Actos lawsuit involving allegations that long-term use of the Type 2 diabetes drug can cause bladder cancer is now underway in the Eighth Judicial District Court of Nevada for Clark County. The lawsuit was brought on behalf a patient who began taking Actos before bladder cancer warnings were added to the drug’s label in 2011.The complaint accuses Takeda Pharmaceuticals of concealing knowledge of an association between Actos and bladder cancer until the company was forced to make the 2011 label change. The jury hearing the Actos lawsuit is expected to begin deliberations by the middle of December.

Actos Lawsuits 
Court records indicate that more than 3,000 Actos lawsuits involving bladder cancer allegations have been filed in courts around the country. More than 2,500 of those claims are pending in a multidistrict litigation now underway in U.S. District Court, Western District of Louisiana. That litigation’s first bellwether trials are scheduled to begin next year

According to court documents, two other Actos lawsuits have gone to trial at the state level, both of which ended with jury decisions favoring plaintiffs. However, a $6.5 million verdict awarded to a Plaintiff in California Superior Court in April was set aside by the judge overseeing the case, and is currently on appeal. (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court)

A second trial involving Actos and bladder cancer concluded in Maryland State Court in September, with $1.7 million being awarded to the family of a man who died of the disease. However, according to court records, the judge presiding over that trial overturned the verdict in accordance with Maryland law because the jury also found that the decedent’s decades-long smoking habit contributed to the development of the disease.

According to court documents, the Actos litigation began to grow after the U.S. Food & Drug Administration (FDA) warned in June 2011 that use of the drug for 12 months or more had been associated with an increased risk of the disease. At that time, the FDA ordered Takeda Pharmaceuticals to add new warnings to the Actos label about its potential to cause bladder cancer.

Long-term users of Actos who have been diagnosed with bladder cancer may be eligible to file an Actos lawsuit against Takeda Pharmaceuticals.

For more information on ACTOS, contact Foulston Law


Wednesday, December 4, 2013

Anti-seizure medication can cause life-threatening skin reactions including Stevens-Johnson syndrome

 

 The Foulston law firm is investigating cases of deaths and serious injuries that may have been caused by, a drug prescribed to treat seizures.

 The Food and Drug Administration issued a public warning on December 3, 2013. "FDA is warning the public that the anti-seizure drug Onfi® (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death. FDA approved changes to the Onfi® drug label and the patient Medication Guide to describe the risk of these serious skin reactions."

  According to the FDA, "[t]hese skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur at any time during the skin reactions, known as Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN), can occur any time during Onfi® treatment. All cases of SJS and TEN in the FDA case series have resulted in hospitalization, one case resulted in blindness, and one case resulted in death."

 Onfi® is classified as a benzodiazepine medication and is used in combination with other drugs to treat seizures associated with Lennox-Gastaut syndrome, a severe type of epilepsy. 

 What is ONFI

Clobazam, also known as ONFI, is a medication classified as a benzodiazepine used for treating seizures, especially those related to the severe form of epilepsy, Lennox-Gastaut Syndrome. Since its approval by the Food and Drug Administration (FDA) in October 2011, ONFI has been linked to a painful skin disease called Stevens-Johnson Syndrome as well as a more severe form of the disease, toxic epidermal necrolysis (TEN). In December 2013, the FDA approved changes to the ONFI label including these conditions as serious side effects of the drug.

IONFI Injuries

Epilepsy patients or others who take ONFI can experience Stevens-Johnson Syndrome or TEN at any time during their course of treatment, but most cases arise within the first eight weeks of treatment or when a patient is taken off ONFI then reintroduced to it. These skin reactions are potentially fatal and cause serious, permanent injury. Patients are warned not to stop taking ONFI abruptly, as the side effects of doing so include unstoppable seizures, hallucinations, nervousness and muscle cramps.

The FDA says that between October 2011 and September 2013 there have been 31,000 patients received a prescribed dose of clobazam through retail pharmacies nationwide. They noted that clobazam has been marketed outside the United States for treatment of seizures and anxiety for the past 40 years. Benzodiazepines, however, have not previously been linked to skin reactions like Stevens-Johnson Syndrome or TEN.

Signs and Symptoms of SJS and TEN

Stevens-Johnson Syndrome and TEN are life-threatening diseases caused by dying cells that force the dermis and epidermis to separate. It is an extremely painful condition. Patients should be monitored closely to detect signs of Stevens-Johnson Syndrome or TEN.

Some of the most common early warning signs of Stevens-Johnson Syndrome are fever, fatigue and sore throat. As the disease progresses lesions and ulcers begin to form on the mouth, lips, genital and anal regions. Rashes on the torso and limbs will appear next, then on the face and most patients eyes will become infected with conjunctivitis.

Contracting Stevens-Johnson Syndrome and TEN constitutes a medical dermatological emergency. If you have developed a rash, blistering or peeling skin, contact a medical professional immediately. Do not discontinue the use of ONFI without consulting with your doctor. After doing so is approved by your doctor, the FDA recommends discontinuing the use of ONFI and consider an alternative treatment seizure treatment.

Free Consultation

Get the help you need regarding your ONFI lawsuit today by contacting Foulston Law Firm  through the free, no-obligation case evaluation form located at the top of this page.

 


Wednesday, December 4, 2013

Final Bellwether Trial over Bard Avaulta Mesh Begins in Federal Court

DECEMBER 4, 2013By: Katherine Thomas

 

The last of the Bard bellwether transvaginal mesh trials began on December 3 in West Virginia federal court.  The Bard Avaulta mesh lawsuit was originally scheduled to be tried in November, but the judge on the case issued a notice postponing it for a month.  The Avaulta line of vaginal mesh products had been used to treat pelvic organ prolapse (POP) and female stress urinary incontinence before it was taken off the market by Bard in July 2012 rather than comply with FDA-mandated testing.

 

Why women file a Bard Avaulta mesh lawsuit

There are more than 4,800 transvaginal mesh lawsuits in the federal court system against New Jersey-based-C.R. Bard over the Avaulta line of mesh, which many women claim can erode, leading to organ damage and painful sexual intercourse.  The complaints against Bard involve similar allegations that the vaginal mesh was defectively designed and sold without adequate warnings about the risks associated with it. Bard officials pulled the Avaulta mesh off the market in 2012 after the FDA ordered manufacturers of transvaginal mesh to study rates of organ damage, infection, and other complications associated with pelvic mesh devices.

The lawsuits are pending before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia as part of a litigation. They were consolidated into multidistrict litigation with the goal of streamlining the pretrial process by conserving resources and judicial time.

As part of the coordinated pretrial proceedings, four cases were selected for early trial dates.  These cases are known as “bellwethers,” because they are designed to help the parties in the lawsuit gauge how juries are likely to respond to evidence that may be repeated throughout each case.

 

Results of Bard transvaginal mesh trials

The first bellwether trial began in July 2013.  The plaintiff, a nurse from Georgia, won a jury award of $250,000 in compensatory damages and $1.75 million in punitive damages, which are designed to punish the defendant for its actions in the manufacture and sale of the transvaginal mesh.  The nurse had alleged that the mesh damaged her organs and caused other ailments. In the second bellwether hearing the parties reached a settlement agreement during the first day of trial.  Bard agreed to pay an undisclosed amount to a North Carolina woman who said she experienced pain and suffering, permanent injury, and physical deformity because of the transvaginal mesh.  The third bellwether case was cancelled after the plaintiff voluntarily dismissed the case.

 

Pelvic mesh lawsuits coordinated as Multi-District Litigation

Judge Goodwin is also presiding over five other multidistrict litigations involving transvaginal mesh made by other companies, including American Medical System, Ethicon, Boston Scientific, Coloplast, and Cook Medical.  These companies face a combined total of over 30,000 lawsuits in the federal courts over injuries allegedly caused by the transvaginal mesh.

 

The legal proceedings for five of the multidistrict litigations are being handled in the U.S. District Court for the Southern District of West Virginia.  There is also a multidistrict litigation for Mentor Corp., another manufacturer of vaginal mesh, which has been established in the U.S. District Court for the Middle District of Georgia.

 For further information, contact the Foulston Law Firm by using the contact form at the top of the page. 


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