Injured by recalled DePuy ASR and Pinnacle Hips? Metallosis, pain and suffering, hip replacement? Read More Here >>
Injured by recalled Stryker Rejuvenate and ABG II Hips? Metallosis, pain and suffering, hip replacement?Read More Here >>
Injured by Metal on Metal Hips, Biomet M2A Magnum, Smith and Nephew, Wright Conserve? Metallosis, pain and suffering, hip replacement? Read More Here >>
Injured by Trans Vaginal Mesh complications following Pelvic Organ Prolapse and Urinary Incontinence surgery? Pain and suffering, redo surgery, urinary incontinence? Read More Here >>
Injured by Mirena IUD complications? Mirena uterus perforation and uterus imbedment requiring surgery? We can help, Read More Here >>
Injured by Actos Bladder Cancer? We can help, Read More Here >>
Injured by Pradaxa Hemorrhage or Stroke?We can help, Read More Here >>
Injured by NuvaRing Deep Vein Thrombosis, Pulmonary Embolism, Stroke? We can help, Read More Here >>
Injured by Januvia/Byetta/Victoza Pancreatic Cancer?We can help, Read More Here >>
Birth Defects by Zoloft/
SSRI Antidepressants?
We can help, Read More Here >>

Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

Published on:

Johnson & Johnson, (J&J) the world’s largest pharmaceutical and medical device maker recently received a one, two punch over its antipsychotic blockbuster drug, Risperdal.

Dallas Defective Medical Device attorneyThe drug manufacturer lost the first trial in state court in Philadelphia over allegations that Risperdal causes gynecomastia or abnormal breast growth in boys and young men exposed to the popular antipsychotic drug.

The jury slapped Johnson & Johnson to pony up $2.5 million in compensatory damages to a young Alabama man blamed the company for promoting the “off label” use of Risperdal, which in turn resulted in gynecomastia.

South Carolina Wins its Lawsuit Against J&J Risperdal

On the heels of that verdict,  J&J was slammed again when South Carolina’s Supreme Court ordered J&J  to pay a penalty of $136 million, upholding a jury’s finding that the drugmaker’s Janssen unit had improperly marketed its anti-psychotic drug Risperdal and concealed its risks.

A trial court had earlier ordered J&J to pay $327 million, but the Supreme Court more than halved that penalty, citing a provision in South Carolina law that no action can be taken in such cases after three years of the discovery of unlawful conduct. South Carolina filed its complaint in April 2007.

According the Supreme Court Chief Justice, “Janssen’s desire for market share and increased sales knew no bounds, leading to its egregious violation of South Carolina law.”

While the verdicts may have sent J&J reeling, unfortunately they are not knockout punches and J&J has not raised the white flag in the Risperdal litigation. The injured plaintiffs continue to battle on. Justice delayed is justice denied.

“Red Flag” Study

In the Philadelphia trial, expert testimony presented by an ex-FDA chief, found that J&J’s Janssen unit funded a medical study in 2001 that demonstrated 3.8 percent of boys given Risperdal during the clinical trial developed breasts that were either “probably or very likely” caused by the drug.

The former FDA chief, Kessler told jurors in the trial that the study “certainly was a red flag to me.” The lawsuit brought by Austin Pledger, a 20-year-old Alabama man, claims that the drug caused his 100-pound weight gain and the development of female breasts, which will require surgical removal because of their size.

Over 1,250 Risperdal Male Breast Lawsuits

J&J, is exposed more than 1,250 lawsuits over the Risperdal breast growth side effect in state court in Philadelphia, centralized in the Philadelphia Court of Common Pleas as a mass tort. There are several thousand Risperdal Gynecomastia lawsuits pending in California state court.

In 2012, J&J settled the first case to go to trial over the allegations that the drug caused gynecomastia, or abnormal breast development, in boys.

J&J Paid $2.2 Billion in Criminal Fines

In 2013, J&J agreed to pay $2.2 billion to settle criminal and civil investigations that the company illegally marketed the drug to children and the elderly. That settlement, which also includes marketing claims about two other J&J drugs, was one of the largest U.S. health-fraud penalties in history.

Risperdal Gynecomastia Side Effects

Gynecomastia is defined as the growth of breast tissue among males. In the Risperdal cases, the plaintiffs blame the breast development caused by Risperdal for the surgical treatment to remove the breasts, which causes scarring, physical injury, and severe psychological damage from Risperdal breast growth.

Risperdal has been also linked to excessive weight gain and diabetes. The drug, once J&J’s biggest seller, generated worldwide sales of $24.2 billion from 2003 to 2010, reaching $4.5 billion in 2007.

J&J Quietly Settling Risperdal Gynecomastia Claims

Johnson & Johnson has been quietly been settling the breast growth litigation over Risperdal for the past several years, but the number of claims has continued to increase as more families and young adults learn that there may be a link between gynecomastia and Risperdal use as a child.

The case is PP v. Ortho-McNeil Janssen Pharmaceuticals, 120401997, Court of Common Pleas Philadelphia County (Philadelphia)

Published on:

Published on:

DePuy ASR metal on metal hip replacements continue to fail prematurely and require painful and risky revision surgery. Johnson and Johnson, the world’s largest pharmaceutical and medical device maker and its subsidiary DePuy, recently agreed to extend the settlement of its notorious line of failed metal on metal hips, to include cases where the faulty hip was replaced as of January 2015.

DePuy ASR Metallosis Injury AttorneyThis extension, provides further relieve to injured plaintiffs who were locked out of the original settlement, which cut off claims as of August 2013.

Total Number of Settlements Exceeds 9,400 Cases

Johnson and Johnson (J&J) and its subsidiary DePuy Orthopaedics, has agreed to add another 1,400 hip injury claims to a settlement agreement reached in 2013. This new agreement extends the deal to include recalled ASR implants that were revised as of January 31, 2015.

J&J had initially agreed to settle about 8,000 ASR lawsuit cases, that folks brought when their hip replacement failed and had to be removed prior to August 31, 2013. The initial agreement left several thousand DePuy ASR hip lawsuits in limbo.

Settlement Extended to Cover J&J ASR Revisions as of January 31, 2015

On February 20, the U.S. District Judge presiding over the federal litigation was notified that an agreement has been reached that extended the settlement program to include U.S. citizens or residents who received an ASR hip and had revision surgery on or before January 31, 2015.

J&J ASR Settlement Details

Under terms of the original agreement, plaintiffs will receive an average payment of $250,000 for pain and suffering, with the age of the plaintiff, the length of time the implant was in place, the weight of the plaintiff, whether they were a smoker, will be considered prior to a final award.

Patients who developed “extraordinary injuries”, and complications associated with the revision surgery, can also obtain additional compensation and all medical expenses will be covered by the manufacturer.

Thousands of Defective J&J ASR Hips in Americans

Despite the settlements, there are thousands of people throughout the U.S. who still have a defective implanted DePuy ASR hip.

August 2010 J&J ASR Recall

The metal-on-metal implant was recalled in August 2010, because of a high rate of failures associated with the flawed design. This defective hip released cobalt and chromium metallic debris into the body and the hip joint as the components grind against each other during normal use. This accumulation of heavy metals is known as metallosis.

DePuy Hip Failure Rate

The metal-on-metal hip replacement system was recalled from the market after medical data found that about one out of every eight would fail within five years.

More recent data has suggested that the DePuy hip failure rate may be substantially higher, ending up in the 35% to 45% range.

Latest $2.5M Oklahoma Jury Verdict

Andrea Smith, from Oklahoma has been awarded $2.5 million after suffering metal blood poisoning from DePuy ASR hip replacements. The state court jury found the DePuy ASR hip to be defective and unreasonably dangerous.

Smith, received ASR hip implants on each side in October 2006 and February 2007. According to Smith, she had to undergo revision surgery to have the implants removed in 2011 and 2012, after high levels of Cobalt and Chromium metal ions were found in her blood.

6,500 J&J DePuy Pinnacle Hip Lawsuits

J&J is continues to deny, delay and defend thousands of cases involving similar metallosis and premature failure problems from the DePuy Pinnacle hip. The DePuy Pinnacle is an older model that features a substantially similar metal-on-metal design.

There are currently more than 6,500 DePuy Pinnacle hip lawsuits pending throughout the U.S. In the federal court system, all complaints involving problems with DePuy Pinnacle implants are centralized in the U.S. District Court for the Northern District of Texas under U.S. District Judge Ed Kinkeade as part of a multidistrict lawsuit (MDL).

DePuy Pinnacle Bellwether Trials

The Dallas court has identified ten different cases that have been selected to be prepared for early trial dates. These early trials are known as “bellwether” cases. The trials help the parties gauge how juries may respond to similar evidence and testimony that is repeated throughout the litigation.

The consolidated federal case is In re DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, U.S. District Court, Northern District of Ohio (Toledo).

Published on:

There is a big push underway to try and resolve all of the Actos bladder cancer lawsuits. Actos_Bladder_Cancer_AttorneyThe U.S. District Judge presiding over all federal Actos bladder cancer lawsuits will require the parties to discuss settlements in advance of a bellwether trial scheduled in 2016.

In that trial at least five different cases may be consolidated for trial before one jury.

Actos Bladder Cancer Lawsuits Continue to Increase

There are more than 4,000 federal personal injury, product liability lawsuits pending against Takeda Pharmaceuticals and Eli Lilly. The claims blame the companies for providing inadequate warnings about the risk of bladder cancer from Actos, a blockbuster type 2 diabetes drug.

Louisiana Federal Multidistrict Litigation

Since December 2011, federal lawsuits have been centralized before U.S. District Judge Rebecca F. Doherty in the Western District of Louisiana, as part of an MDL, or Multi-District Litigation.

It is common in mass tort pharmaceutical and medical device cases, that small groups of cases are prepared for early trial dates, known as “bellwether” cases.

The first federal Actos trial ended in a record breaking $9 billion jury verdict last year. The jury found evidence that the drug makers deliberately destroyed documents about Actos and bladder cancer link. Takeda officials intentionally destroyed documents about the development, marketing and sales of Actos. Takeda also deleted the files of 46 former and current employees, including those of top executives in Japan and U.S. sales representatives.

Judge Doherty post verdict, reduced the punitive damage award in the case to $37 million. The case is on appeal.

8,000 Actos Bladder Cancer Lawsuits Cannot Be Wrong

More than 3,500 Actos suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges.

According to court documents, Takeda is exposed to another 4,500 claims in state courts in Illinois, West Virginia and Pennsylvania,

Actos Blockbuster Diabetic Drug

Actos has generated more than $16 billion in sales since its 1999 release, according to Bloomberg News. Sales peaked in the year ended in March 2011 at $4.5 billion.

Actos Verdicts

The most recent trial in Philadelphia, is the ninth Actos patient to take bladder-cancer claims before a jury, and the fifth case to score a victory against the Asian pharmaceutical giant. The company folks in Osaka, Japan will have to give serious thought to stop the hemorrhaging of money in the defense of these indefensible bladder cancer cases and go for a global settlement.

Second Bellwether Trials Scheduled

As a second group of cases are being prepared for trial to begin in May 2016.
The judge has also scheduled several formal negotiation periods, where the parties will meet with a Special Master to discuss and explore potential Actos settlements.

The next consolidated trial will involve five cases originally filed in the Western District of Louisiana and will go before one jury beginning on May 2, 2016.

Several Actos bladder cancer cases have have been tried in state court, with multi-million damage awards awarded in many of the cases. Most recently, Takeda was hammered with a $3.6 million damage award in a Pennsylvania case, including $1.3 million in punitive damages designed to punish the drug makers.

Published on:

Recently earlier this month, seventeen plaintiffs filed an Actos bladder cancer lawsuit against manufacturer Takeda Pharmaceuticals, blaming that the use of the type 2 diabetes treatment led to the diagnosis of bladder cancer.

Actos_Bladder_Cancer_AttorneyFour of the plaintiffs had died from advanced bladder cancer. The other plaintiffs have experienced recurrences of their cancer, leading to complications and ongoing painful cancer treatments.

Plaintiffs Serious and Catastrophic Injuries From Actos

Recently in a trial that took place earlier in February, the jury found for the plaintiff who developed bladder cancer as a result of Actos use. Kristufek, 74, of Slippery Rock, Pennsylvania, was forced to have his bladder removed as a result of the cancer diagnosis.

Plaintiffs blame Takeda researchers for ignoring concerns about Actos drug’s cancer-causing risk before it went on sale in the U.S. and misled the FDA about the medicine’s safety.

8,000 Actos Bladder Cancer Lawsuits Cannot Be Wrong

More than 3,500 Actos suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges, in a multidistrict litigation or MDL. According to court documents, Takeda is exposed to another 4,500 claims in state courts in Illinois, West Virginia and Pennsylvania.

Actos Verdicts

Kristufek, is the ninth Actos patient to take bladder-cancer claims before a jury, and the fifth case to score a victory against the Asian pharmaceutical giant. The company folks in Osaka, Japan will have to give serious thought to stop the hemorrhaging of money in the defense of these indefensible bladder cancer cases and go for a global settlement.

In 2013, California and Maryland juries ordered Takeda to pay a combined $8.2 million in damages over the handling of the drug.

Those verdicts were thrown out by judges and are on appeal. The company also won defense verdicts in two cases in state court in Nevada.

In October 2014, a Philadelphia jury awarded more than $2 million in damages to a retired accountant who blamed her bladder cancer on Actos.

A federal jury in Lafayette, Louisiana, last year awarded a massive $9 billion in damages against Takeda and Eli Lilly & Co. That record breaking verdict was reduced to $36.8 million. The case is on appeal.

The Pennsylvania case is Kristufek v. Takeda Pharmaceuticals America Inc., Philadelphia Court of Common Pleas. The consolidated Actos case in Louisiana is In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299, U.S. District Court, Western District of Louisiana (Lafayette).

What is Actos?

Actos was approved by the FDA in 1999 for the treatment of type 2 diabetes, and millions of patients have used this drug. In 2011, the FDA issued an Actos safety communication, stating use of the drug for one year or longer could increase a person’s risk for bladder cancer. This announcement was linked to the European Medicines Agency warning that Actos sales had been prohibited in both France and Germany due to concerns about bladder cancer risk.

Despite these warnings, Actos manufacturer Takeda has not recalled the drug or issued a stronger  warning of the bladder cancer risk to patients and medical doctors.

Bladder Cancer Information

Bladder cancer is the sixth most common type of cancer in the U.S., according to the American Urological Association. The cancer is very treatable in the early stages, but the prognosis worsens in the metastatic stage, after the cancer has advanced and spreads to distant organs and lymph nodes.

This type of cancer has a high recurrence rate, and when it does recur, it is often more serious than the original diagnosis. Treatment for bladder cancer typically involves surgery, chemotherapy, radiation or a combination of these methods.

Published on:

Zofran, is an anti-nausea medication that is commonly prescribed for morning sickness. However, recent medical studies have found pregnancy side effects that may increase the risk of severe and debilitating birth defects in children.

GlaxoSmithKline Allegations

Patients have blamed GlaxoSmithKline’s failure to adequately research their medication or warn about the risk of congenital malformations. Injured children are filing Zofran birth defect lawsuits throughout the United States who have developed:

  • Cleft Lip
  • Cleft Palate
  • Heart Defects, especially Atrial Septal Defect and Ventricular Septal Defect

What is Zofran?

Zofran (ondansetron) is a prescription medication approved in 1991 for treatment of nausea and vomiting associated with chemotherapy or following surgery.

Over the past decade, it has been widely prescribed off-label for morning sickness in pregnant women, and there is a lack of evidence to prove that it is safe for the unborn child.

Zofran is available as a pill, oral solution or as an injection. Zofran is a member of a class of drugs known as 5-HT3 receptor antagonists, and works by blocking the actions of serotonin.

Zofran Medical Studies

Several medical studies have highlighted the risk of Zofran side effects, including cleft palate, cleft lip and congenital heart problems, especially atrial septal defects or ventricular septal defects.

Zofran Birth Defect Risks

Zofran has never been approved for use by pregnant women, it is widely promoted as a morning sickness drug off label.

In 2006, a Hong Kong study found that Zofran crosses the placenta when taken by pregnant women. The researchers called for more studies to be conducted on the fetal effects of Zofran on unborn children.

In 2011, as part of the National birth Defects Prevention Study, researchers from Boston found an association between the use of Zofran and an increased risk of birth defects.

The researchers found that women who took Zofran had more than double the risk of giving birth to a child with cleft palate malformations.

In February 2013, a historical cohort study involving more than 600,000 pregnancies in Denmark was reported to find that there was no link between Zofran and birth defects.

Experts found flaws in the study, that the average gestational age of exposure to Zofran was 10 weeks, so more than half of the women involved took Zofran after the baby was no longer at risk of congenital malformations during the first trimester.

This same data was examined by another group of researchers in August 2013, which involved 900,000 pregnancies over a longer period of time. That study found that Zofran doubled the risk of heart defects and may be associated with a 30% increased risk of birth defects overall.

Zofran Lawsuits

More recently, several Zofran lawsuits have been filed on behalf of children, alleging that the manufacturer failed to adequately warn about the risks associated with use of the drug during pregnancy.

In 2012, a study found that women prescribed Zofran during the first trimester may be 2.37 times more likely to give birth to a child with a cleft palate.

In August 2013, a study was presented that found first-trimester of pregnancy Zofran use may double the risk of having a child with heart problems.

Published on:

After a hard fought, protracted and bitter fight that has consumed the last 5 years, the Bard Avaulta transvaginal mesh litigation is finally heading for a global settlement. U.S. District Judge, John Goodwin, who presiding over all federal vaginal mesh lawsuits has appointed a Special Master to forge settlement talks between C.R. Bard and women who allege the mesh and bladder sling company’s products left them with painful and serious injuries.

75,000 Women Cannot Be Wrong

There are currently more than 75,000 product liability, and personal injury lawsuits filed in the federal court system involving transvaginal mesh or bladder sling products made by Bard, American Medical Systems (AMS), Ethicon, Boston Scientific, Coloplast Corp., Cook Medical and Neomedic.

Seven different MDLs (multidistrict litigations) have been organized against the various manufacturers, and are all centralized before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia for discovery and pretrial proceedings.

The Bard Avaulta MDL was the first to be centralized in the Southern District of West Virginia in October 2010. Several “bellwether” trials have resulted in multi-million dollar damage awards for plaintiffs. But their has been slow progress to resolve large numbers of vaginal mesh claims by most of the manufacturers.

Only AMS has settled the majority of claims involving their products, agreeing to pay about $1.6 billion to resolve more than 20,000 claims.

Special Master Appointed to Push Bard Settlements

In a February 12 , court order, Judge Goodwin appointed Ellen Reisman to serve as a Special Master in the Bard litigation, to work with the manufacturer and plaintiffs’ lawyers to help jump start serious settlement talks.

Reisman served as the national settlement counsel for AMS, and according to Judge Goodwin, Reisman is the most qualified person to  promote settlement between Bard and injured women.

Trans Vaginal Mesh Claims Continues to Grow

According to the latest data released by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on February 17, there are over 10,348 Bard Avaulta mesh lawsuits, 23,523 Ethicon vaginal mesh lawsuits, 19,159 American Medical Systems (AMS) mesh lawsuits, 15,278 Boston Scientific mesh lawsuits, 1,830 Coloplast vaginal mesh lawsuits, 289 Cook Medical vaginal mesh lawsuits and 83 Neomedic vaginal mesh lawsuits.

Plaintiffs Allegations

According to the complaints, injured women suffered pain and severe complications from vaginal mesh implanted for treatment of pelvic organ prolapse (POP) and stress urinary incontinence.

The mesh and bladder slings caused infections, erosion of the mesh through the vagina and other severe injuries.

What is TransVaginal Mesh?

Vaginal mesh, or pelvic mesh, is a plastic surgical device that is implanted into the vaginal area to prevent pelvic organ prolapse (POP), which can occur in women after childbirth or abdominal surgery.

Pelvic organ prolapse causes the womb or uterus to slide into the vagina, and can lead to the bladder and bowels shifting onto the vagina, causing pain, discomfort, and urinary incontinence.

FDA Warning No Benefit

According to a FDA warning in July 2011, there is no evidence that vaginal mesh bladder sling surgery provides any greater clinical benefit than non-mesh surgeries.

The FDA stated that the agency has received thousands of reports of complications after the bladder sling mesh has been implanted, and also warn of an increased risk of organs being punctured during the surgery to implant the devices.

Published on:

In the most recent DePuy ASR defective metal hip trial, an Oklahoma woman has been awarded $2.5 million after suffering metal blood poisoning or metallosis from DePuy ASR hip replacements.

Andrea Smith, received ASR hip implants on each side in October 2006 and February 2007. Smith’s blamed DePuy in her lawsuit, claiming that she had to undergo revision surgery to have the implants removed in 2011 and 2012, after being diagnosed with high levels of Cobalt and Chromium metal ions in her blood.

12,000 DePuy ASR Lawsuits and Counting

More than 12,000 personal injury and product liability DePuy ASR hip lawsuits have been filed in the United States. DePuy a subsidiary of the pharmaceutical giant, Johnson and Johnson, issued a worldwide recall in 2010 after they acknowledged the high risk of premature failure of the metal on metal hip implant.

Huge DePuy Failure Rate

The hip replacement system was recalled after data suggested that about one out of every eight would fail within five years.

According to some experts, the DePuy hip failure rate may be substantially higher, more likely ending up in the 35% to 45% early failure range.

In other words, between one third to a half of the implanted DePuy ASR hips, may fail with five years, when they were touted to last 20 years. An outrageous and unacceptable failure rate.

What is the Problem with the DePuy ASR Design?

The plaintiffs claim that DePuy designed and sold a defective and unreasonably dangerous hip implant. The metal-on-metal design causes the release of metallic trash into the hip joint as the metal parts grind against each other during normal daily activity.

DePuy ASR Hip Settlement Agreement

This trial took place after DePuy agreed to settle thousands of ASR cases for more than $3 billion. Some plaintiffs have decided not to accept the settlement and are continuing to try their claims individually.

The global settlement was announced in November 2013, with a cut off date for claimants to have a revision surgery before August 31, 2013, in order to qualify for the settlement.

This agreement still leaves several thousand cases in limbo, involving individuals who filed a lawsuit after August 2013 revision date and folks who have not had a revision but are symptomatic or too sick to undergo painful and risky revision surgery.

There was 36,000 DePuy ASR implants implanted in the U.S. before the recall and since there are many implants still in place, it is expected that DePuy ASR hips will continue to fail over the foreseeable future, and lead to new claims and hip settlements.

Tolling Agreement For Non Revised Claimants

DePuy has announced a tolling agreement with non-revision plaintiffs, which will “pause” running of any deadlines on filing new lawsuits in return for a dismissal of the current claim and agreement not to refile the case until hip revision surgery is required or they are told that they are unable to undergo the risks of revision surgery due to their underlying medical condition.

Under this tolling agreement, plaintiffs who elect to dismiss their case may refile within one year after they receive ASR hip revision surgery in the future or within six months of being told that revision surgery is necessary, but too risky.

Published on:

A Philadelphia state court jury earlier this week, concluded that Actos caused bladder cancer. Takeda Pharmaceutical Co. the manufacturer of Actos, received another setback in the conclusion of yesterday’s trial, when the jury also determined that the company acted recklessly and found that punitive damages should be awarded.

Takeda Pharmaceutical Co. was ordered to pay more than $2.3 million in damages to a Pennsylvanian man who blamed the company’s Actos diabetes drug for causing his bladder cancer.

The jury panel awarded John Kristufek more than $300,000 for his medical expenses and $2 million for pain and suffering from the cancer diagnosis.

The panel will re-convene Friday to determine punitive damages, which are designed to punish the company.

Hopefully, the jurors will be sufficiently outraged by the corporate malfeasance of the company directors and award a large enough punitive damage that will shock and wake up the folks in Japan. Takeda should have no choice but to settle, otherwise face bankruptcy from the tsunami deluge of claims.

Takeda Knew of Cancer Link in 2004

According to court testimony, executives at Takeda knew by 2004 that medical studies tied Actos to cancer but waited seven years to issue a warning to protect billions of dollars in sales, they simply put profits before people.

Plaintiff Serious Injuries From Actos

Kristufek, 74, of Slippery Rock, Pennsylvania, was forced to have his bladder removed as a result of the cancer diagnosis.

Plaintiffs blame Takeda researchers for ignoring concerns about Actos drug’s cancer-causing risk before it went on sale in the U.S. and misled the FDA about the medicine’s safety.

8,000 Actos Bladder Cancer Lawsuits Cannot Be Wrong

More than 3,500 Actos suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges.

According to court documents, Takeda is exposed to another 4,500 claims in state courts in Illinois, West Virginia and Pennsylvania,

Actos Blockbuster Diabetic Drug

Actos has generated more than $16 billion in sales since its 1999 release, according to Bloomberg News. Sales peaked in the year ended in March 2011 at $4.5 billion.

Takeda Destroyed Key Documents

According to Mike Miller, Kristufek’s attorney, Takeda officials intentionally destroyed documents about the development, marketing and sales of Actos.

Takeda also deleted the files of 46 former and current employees, including those of top executives in Japan and U.S. sales representatives.

“It wasn’t an accident. The dog did not eat the homework,” Miller told the panel. “They deleted those documents so you couldn’t see what was in them.”

Miller said Kristufek, who racked up more than $318,000 in medical bills, is seeking compensation for his pain and suffering along with punitive damages.

The lawyer urged jurors to find Takeda officials showed “reckless indifference” to Kristufek’s health by hiding Actos’ risks. “They put profits over patient safety every time,” he said.

Actos Verdicts

Kristufek, is the ninth Actos patient to take bladder-cancer claims before a jury, and the fifth case to score a victory against the Asian pharmaceutical giant. The company folks in Osaka, Japan will have to give serious thought to stop the hemorrhaging of money in the defense of these indefensible bladder cancer cases and go for a global settlement.

In 2013, California and Maryland juries ordered Takeda to pay a combined $8.2 million in damages over the handling of the drug.

Those verdicts were thrown out by judges and are on appeal. The company also won defense verdicts in two cases in state court in Nevada.

In October 2014, a Philadelphia jury awarded more than $2 million in damages to a retired accountant who blamed her bladder cancer on Actos.

A federal jury in Lafayette, Louisiana, last year awarded a massive $9 billion in damages against Takeda and Eli Lilly & Co. That record breaking verdict was reduced to $36.8 million. The case is on appeal.

The Pennsylvania case is Kristufek v. Takeda Pharmaceuticals America Inc., Philadelphia Court of Common Pleas. The consolidated Actos case in Louisiana is In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299, U.S. District Court, Western District of Louisiana (Lafayette).

Published on:

Judge Shelly Robins, from Pennsylvania has denied the appeal of a $2 million verdict awarded in October to a plaintiff who blamed Takeda Pharmaceuticals Inc.’s drug Actos was a significant contributor to her developing bladder cancer.

Actos_Bladder_Cancer_AttorneyIn an order docketed on Friday, Philadelphia Court of Common Pleas Judge Shelly Robins New rejected the company’s post-trial motions, in which they had argued that the jury’s verdict overstepped the U.S. Food and Drug Administration’s authority.

The judge also added nearly $100,000 in delay damages, leading to a total judgment of $2.1 M.

Takeda Knew in 2004 of Cancer Link

According to court documents, Takeda knew by 2004 that studies found links between Actos and cancer, and didn’t issue a warning until seven years later to protect billions of dollars in Actos sales.

Takeda Put “Profits Before People”

“Takeda chose to protect profits rather than patients,” Miller, the plaintiff’s attorney, said in closing arguments in Wisniewski’s trial. The company’s main goal was “to protect the product,” Miller added.

4,000 Actos Bladder Cancer Lawsuits in Federal Court

There are more than 4,000 product liability lawsuits filed against Takeda Pharmaceuticals and Eli Lilly, which allege that Actos diabetic medication caused patients to develop bladder cancer. These Actos suits have been consolidated before U.S. District Judge Rebecca Doherty in Lafayette, Louisiana, for pretrial discovery, in what is known as Multidistrict Litigation (MDL).

Actos: Blockbuster Drug Huge Profits

According to Bloomberg, sales of Actos maxed out in March 2011 at $4.5 billion for Takeda and accounted for 27 percent of the company’s revenue. Actos has raked in more than $16 billion in sales since its 1999 release.

Wisniewski and other users allege that Takeda researchers ignored or downplayed concerns about the Actos bladder cancer links before it went on sale in the U.S. and misled U.S. regulators about the diabetic medication risks.

Key Documents Destroyed

The jury found that the Takeda officials intentionally destroyed documents about the development, marketing and sales of Actos. The company ditched files of 46 former and current employees, including those of top executives in Japan and U.S. sales representatives. “We’ll never know what was in those documents,” Miller said.

Actos Verdicts

Of eight lawsuits to go to trial, five have resulted in awards to the plaintiffs. These have included $2 million in damages to Wisniewski, and $6.5 million to a man and his wife (Cooper v. Takeda Pharmaceuticals America Inc., et al, case number CGC-12-518535).

In 2013, juries in California and Maryland ordered Takeda to pay a combined $8.2 million in damages. But those verdicts later were tossed out by judges. The company also won defense verdicts recently in two cases in state court in Las Vegas.

The Pennsylvania case is Wisniewski v. Takeda Pharmaceuticals America Inc., 120702272, Philadelphia County Court of Common Pleas. The consolidated Actos case in Louisiana is In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299, U.S. District Court, Western District of Louisiana (Lafayette).