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.

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Rumors are swirling about potential Actos Bladder Cancer settlements. According to Bloomberg News, Takeda Pharmaceutical Co. has indicated that it will pay more than $2.2 billion to settle Actos lawsuits over bladder cancer claims. Asia’s largest drugmaker tentatively agrees to settle more than 8,000  Actos bladder cancer lawsuits in federal and state courts in the U.S.

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This  potential settlement deal, begs the question; does Actos Increase the Risk of Bladder Cancer? Why would Takeda settle for any amount, if there was no link between Actos and the increased risk of bladder cancer?

Any settlement deal would average about $275,000 for each case, and would be the first in the four year old litigation over the diabetes drug. The 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 currently scheduled in 2016. The first settlement meeting is scheduled next week.

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 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.

FDA Warnings

In June 2011 The U.S. Food and Drug Administration (FDA) warned the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk was added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines was revised to include information on the risk of bladder cancer.

8,000 Actos Bladder Cancer Lawsuits Cannot Be Wrong

More than 4,000 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.

Takeda is blamed for not disclosing that that Actos use can lead to bladder cancer. All of the lawsuits allege that Takeda knew or should have know about the increased risk of bladder cancer and yet failed to alert patients, doctors and the FDA. The Japan-based drugmaker suggested the settlement thinking that it could avoid more huge verdicts and to put this litigation behind them. They will be getting off cheap if accepted.

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.

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.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).

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Zofran, is an anti-nausea medication that is commonly prescribed for post surgical, chemotherapy and morning sickness patients over the past 20 years. According to experts, recent medical studies have found pregnancy side effects that may increase the risk of severe and debilitating birth defects in children.

fort_worth_personal_injury_attorney (2)-thumbGlaxoSmithKline Allegations

Patients have blamed GlaxoSmithKline’s failure to adequately research their medication or warn about the risk of congenital malformations. Parents and injured children are filing Zofran birth defect lawsuits throughout the United States who have developed, Cleft Lip, Cleft Palate and severe Heart Defects, especially Atrial Septal Defect and Ventricular Septal Defect.

What is Zofran?

Zofran (generic 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, and 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.

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As a Dallas Xarelto Bleeding Death attorney and Texas medical doctor, I would like to update my readers about the ongoing status of the Xarelto litigation. Most recently, a wrongful death lawsuit was filed against the makers of Xarelto; Bayer Healthcare and Johnson and Johnson’s subsidiary, Janssen.

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Cook Medical is exposed to a personal injury and product liability claim by a Michigan man, who blames the Celect Inferior Vena Cava filter for causing severe injury when it broke apart and punctured his heart.

Dallas Defective Medical Device attorneyLarry and Brenda Johnson recently filed a lawsuit in the U.S. District Court for the Eastern District of Michigan, claiming that the filter used to prevent blood clots traveling from the legs to the lungs damaged his heart.

Johnson was implanted with the retrievable IVC filter to prevent blood clots from traveling to his lungs and causing a pulmonary embolism.

According to Johnson, he had to undergo four emergency heart surgeries before doctors discovered a thin wire had punctured his heart.

There are two major manufacturers of the Inferior Vena Cava (IVC) filters that have recently come under fire over their allegedly defective medical devices. The two big players in the device manufacturers include CR Bard and Cook Medical.

Federal Cook Celect Multidistrict Litigation

There are about 60 Cook IVC filter lawsuits filed throughout the federal court system, alleging problems with the Celect and Gunther Tulip filters.

In the fall of 2014, all Cook Celect and Cook Gunther Tulip lawsuits have been consolidated in the federal court system as part of an MDL, or multidistrict litigation, which is centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana.

Bard Recovery and G2 Lawsuits

This Cook Celect litigation is similar to the design defects claimed in Bard Recovery IVC filter and Bard G2 IVC filter lawsuits. These IVC filters are made of fragile metal, which leads to premature fracture, migration or perforation of vital internal organs and blood vessels.

In recent trial in February, C.R. Bard reached a settlement agreement to resolve a personal injury and product liability lawsuit that claimed the plaintiff suffered severe heart injuries because of a Bard Recovery Inferior Vena Cava filter.

The trial took place in the U.S. District Court for the District of Nevada, in a lawsuit brought by Kevin Phillips, in which he blamed the IVC filter for breaking apart and puncturing his heart.

Details of the settlement agreement were not released and remains confidential. Bard has been quietly settling several Bard IVC Recovery and G2 lawsuits as they have been on the verge of trial. There are about 200 lawsuits filed over the Bard devices and many more are on the way as these devices continue to fail with alarming frequency.

Currently there is no federal MDL consolidation and centralization for the Bard IVC litigation, but according to sources an application for MDL status for pretrial discovery maybe forthcoming in the next few weeks, because of a lack of progress in a global settlement.

What’s the Problem with IVC Filters?

IVC filters, are inserted into the vena cava and act as an umbrella to prevent leg blood clots from travelling to the lungs when anticoagulant therapy is contraindicated because of bleeding or when the therapy has failed.

Medical Studies: 100% Perforation

A 2012 study, in the medical journal Cardiovascular Interventional Radiology, reported that 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal cava wall in less than 3 months of implantation. The study also reported that 40% of the filters became tilted and out of position.

A 2013 study, in the medical journal JAMA Internal Medicine questioned the effectiveness of IVC filters. JAMA reported that less than 10% of filters in the study were successfully removed and 8% of IVC filter patients suffered a pulmonary embolism while having the device.

FDA Warnings

The FDA issued a warning in 2010, about the risk of IVC filter devices, reporting that it had received hundreds of adverse event reports where filters broke free and migrated and caused perforation injuries.

In a stronger worded warning bulletin in May 2014, the FDA recommended doctors to remove IVC filters after the risk of a pulmonary embolism has passed.

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After 4 years of intense Actos litigation, surrounding the link between the use of Actos and the development of bladder cancer, Takeda Pharmaceuticals is signaling the raising of the white flag, by entering into a series of settlement discussions.

Serious effort are underway to try and resolve all of the Actos bladder cancer lawsuits. Actos_Bladder_Cancer_AttorneyAccording to an order issued on March 17 by U.S. Magistrate Judge Patrick J. Hanna, there are five settlement meetings scheduled between April 16, 2015 and March 18, 2016, before the next “bellwether” trial goes before a federal jury.

The 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 May 2016. In that trial at least five different cases are consolidated for trial before one jury.

Actos Bladder Cancer Lawsuits Continue to Increase

There are more than 4,000 Actos product liability and personal injury lawsuits against Takeda Pharmaceuticals and Eli Lilly, winding their way through the federal court system. The plaintiffs, blame the manufacturers of the popular blockbuster diabetes drug failing to warn about the risk of bladder cancer.

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.

$9 Billion Gangbuster Verdict

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.

9,000 Actos Bladder Cancer Lawsuits Cannot Be Wrong

More than 4,500 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

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. The Court will make a final designation of the cases that will go forward at that time by June 1, 2015.

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 recently 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.

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Johnson and Johnson (J&J) the world’s largest pharmaceutical and medical device maker is hammered in another loss in the on going transvaginal mesh wars.

Trans Vaginal Mesh AttorneyIn the latest of a series of trials held in state and federal court, the jury has awarded $5.7 million verdict against J&J and its Ethicon subsidiary, over Ethicon’s Gynecare TVT Abbrevo device.

Trans Vaginal Wars Continue

There are more than 75,000 personal injury and product liability lawsuits against Ethicon and manufacturers of other similar products, including Boston Scientific, C.R. Bard, American Medical Systems (AMS), Coloplast, Cook Medical, Neomedic and others.

The majority of the lawsuits that have gone before a jury have resulted in major damage awards, and according to experts by the time the transvaginal mesh debacle resolves, the vaginal mesh settlements will likely into tens of billions of dollars.

Can any mesh company CEO face their shareholders and explain why they drove their company into bankruptcy over the proven defective plastic devices? And that they continue to sell them?

Latest California Ethicon Trial

This week, a California state jury sitting in Kern County, ordered Ethicon to pay Coleen Perry $700,000 in compensatory damages for complications with Gynecare TVT Abbrevo mesh.

$5 Million Punitive Damages Awarded

The jury also hammered the mesh manufacturer with $5 million in punitive damages, after they found the company acted with gross negligence.

Punitive damages are designed to punish Ethicon for acting with malice towards Perry and other women, finding that the company knew that the TVT Abbrevo vaginal mesh caused severe and serious complications, but failed to warn the doctors or patients.

Ethicon Federal Trial Currently Underway

There is a federal trial currently in progress involving Ethicon mesh in the U.S. District Court in West Virginia. Here, U.S. District Judge Joseph Goodwin is overseeing seven different multidistrict litigations (MDLs) established for cases against different manufacturers.

Federal Vaginal Mesh MDL Litigation

Judge Goodwin is overseeing coordinated pretrial proceedings for all federal vaginal mesh lawsuits.

The federal complaints blame the products which are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The injured women claim that the products are defectively designed and cause serious complications, including infections, puncturing vital organs and eroding or perforating through the vagina.

Dianne Bellew is the current plaintiff, and this case is the third federal Ethicon lawsuit to go to trial. Bellew alleges she suffered multiple injuries due to the Ethicon Gynecare Prolift vaginal mesh, including mesh erosion, mesh contraction, inflammation, pain during sexual intercourse, urinary incontinence, chronic pain, and recurring prolapse of organs.

According to Bellew, she has undergone at least four operations to have the mesh removed.

Federal Court Frustrations

Judge Goodwin has expressed frustration with the lack of progress by other manufacturers in settling mesh cases. Judge Goodwin has warned vaginal mesh manufacturers that if they do not settle, U.S. juries will award hundreds of millions, or even billions, of dollars in compensatory and punitive damages.

To date, of the major manufacturers only American Medical System, AMS has agreed to settle the claims involving their products, and will pay about $1.6 billion to resolve more than 20,000 claims.

Bard, Boston Scientific and Johnson and Johnson Ethicon are the major hold outs, thinking that they can wear the plaintiffs down in a battle of attrition. To that I say, “Cry Havoc and let slip the dogs of war!”

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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)

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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).