Category: MDL

Zofran Birth Defect Fraud Claims to Proceed in MDL

By Emily Cox
Zofran Birth Defect Lawsuits
Photo by Nana B Agyei

The judge presiding over all federal Zofran birth defect lawsuits has struck down the drug maker’s attempt to have certain fraud-based claims dismissed, ruling that plaintiff allegations were sufficient to proceed on the basis that pregnancy warnings for the anti-nausea drug were false and misleading.

Judge Dennis Saylor filed the memorandum and order Monday in the District of Massachusetts. The order denied Zofran maker GlaxoSmithKline’s (GSK) motion to dismiss plaintiffs’ fraud claims. Judge Saylor acknowledged that the plaintiffs’ didn’t have grounds to claim fraud based on the drug maker’s marketing and advertising. He also noted that there were no allegations that specific GSK representatives had made false statements to prescribing physicians. Regardless, he found that fraud allegations based on product labeling satisfied federal rules’ mandates.

“Here, the master complaints allege generally that plaintiffs and their physicians relied on the misrepresentation in the label in prescribing and ingesting Zofran and/or ondansetron,” wrote Judge Saylor. “In this context, at least, that is sufficient. Pharmaceutical product labeling is highly regulated, and its very purpose is to advise prescribing physicians, who may reasonably rely on the representations in such labeling. Whether a particular physician did, in fact, rely on the representations in the labeling is of course a question of fact that cannot be resolved on the pleadings.”

Zofran Birth Defect Risk

Zofran is an anti-nausea medication. It works by inhibiting the body’s serotonin signaling. However, serotonin signaling regulates processes that are critical to normal embryonic development. Consequently, it has been linked to reports of children born with cleft palate and lip. It can also cause atrial septal defects, ventricular septal defects, and other birth defects.

According to at least 364 lawsuits, GSK knew and concealed the birth defect risk for decades. These complaints allege that GSK discovered the birth defect risk during pre-clinical studies in the 1980s. These studies showed that Zofran crosses the placental barrier during mammalian pregnancy, exposing the fetus to the drug. This exposure revealed clinical signs of toxicity. This led to intrauterine fetal deaths, stillbirths, congenital heart defects, craniofacial defections, incomplete bone growth, and other birth defects. Subsequent research has confirmed that Zofran also crosses this barrier during human pregnancy.

Allegedly, from 1992 to the present, there have been reports of Zofran birth defect risks that GSK was aware of.

Despite mounting scientific evidence that Zofran could cause harm to unborn children, GSK allegedly launched marketing scheme in 1997 to promote Zofran to obstetrics and gynecology doctors and patients as a safe and effective treatment for pregnancy-related nausea and vomiting. As a result of its aggressive marketing campaign, Zofran became the most frequently prescribed drug for treating pregnancy-related nausea and vomiting in the United States by 2002. However, GSK never warned of the substantial risk the drug posed to unborn children.

Zofran Birth Defect Study Statistics

In November 2011, Birth Defects Research Part A: Clinical and Molecular Teratology published a cleft palate study.  It showed Zofran may increase the risk for cleft palate by 2.37 times.

A 2013 review of 900,000 pregnancies’ data in the Danish Medical Birth Registry concluded that children were two to four times more likely to suffer a septal defect, involving holes in the heart, if their mothers had taken Zofran during pregnancy.

Reproductive Toxicology published a study in October 2014 that found that there was a 62 percent increase in risk for certain heart defects with early pregnancy Zofran use.

 

Eliquis Deaths Linked to High Percentage of FDA Adverse Event Reports

By Emily Cox
Eliquis Deaths
Photo by Michael Vines

According to a new lawsuit, Eliquis deaths constituted a sizable percentage of FDA adverse event reports involving the controversial new-generation anticoagulant, but the drug makers still neglected to warn patients of the uncontrollable bleeding risks regardless.

There were more than 1,000 adverse event reports filed with the FDA involving serious, irreversible bleeding in 2014 alone. At least 100 of these reports involved fatal bleeding. This constitutes at least a 10 percent mortality rate from Eliquis-related uncontrollable bleeding. Despite being aware of these irreversible bleeding events and Eliquis deaths, the drug’s manufacturers, Bristol-Myers Squibb and Pfizer, failed to adequately warn users and the medical community. To the contrary, they aggressively marketed and advertised the drug to convince consumers to use Eliquis without regular blood monitoring and instead of safer alternatives like Coumadin (warfarin).

Carol Woody filed the complaint Monday. In November 2014, Woody suffered a severe gastrointestinal bleeding event, requiring hospitalization. While Woody survived her uncontrollable Eliquis bleeding incident, it required extensive blood transfusions and an extended hospitalization.

Eliquis Deaths and Injuries Could Have Been Avoided

The lawsuit alleges that Woody could have avoided her injuries if the manufacturers had been forthcoming about the bleeding risks. It further asserts that the companies did not just hide this information but falsified it, providing false information about the safety of Eliquis. The claim maintains that the manufacturers knew or should have known that the drug could cause bleeding events that could become uncontrollable due to the lack of an antidote to reverse its blood thinning effects.

“These representations were made by Defendants with the intent of defrauding and deceiving the Plaintiff, the public in general, and the medical and healthcare community including Plaintiff’s prescribing doctor, and were made with the intent of inducing the public in general, and the medical community in particular, to recommend, dispense and purchase Eliquis, all of which evinced a callous, reckless, willful, depraved indifference to health, safety and welfare of the Plaintiff herein,” the lawsuit states. “The Plaintiff and the prescribing physicians were not aware of the falsity of these representations.”

This means that Woody could not make an informed decision on her care and medication. Bristol-Myers Squibb and Pfizer took that away from her and countless other patients.

Eliquis Deaths and Injuries History

Eliquis is part of a new generation of oral anticoagulants introduced recently, which includes Xarelto and Pradaxa. Their respective manufacturers aggressively marketed them as a replacement for Coumadin. Coumadin was the standard anticoagulation treatment since the 1960s. However, vitamin K will reverse Coumadin’s blood thinning effects in emergency bleeding situations. Unfortunately, there was no reversal agent for Eliquis, Pradaxa or Xarelto when they hit the market.

Since Eliquis’ 2012 approval, there has been a growing concern regarding the absence of guidance for dealing with Eliquis’ bleeds. According to the lawsuit, a 2014 noted that ‘[a] concern among clinicians is a virtual absence of guidance from clinical trials for reversing the anticoagulant effects of these drugs in clinical settings such as life-threatening bleeding or a need for emergent procedures that carry bleeding risk.”

Eliquis had a ballooning market share and a 400% increase in prescriptions in 2015. However, its makers still couldn’t be bothered to provide any specific information how to stop a potentially life threatening bleeding event in their clinical information.

Eliquis Deaths and Injuries Lawsuits

Woody joins a growing number individuals filing similar lawsuits nationwide. Many of these cases involve wrongful Eliquis deaths. These cases allege that the drug makers knew or should have known about the serious risks. However, they withheld information about the lack of an effective reversal agent to protect their own financial interests.

Xarelto Failure to Warn Claims to Proceed Despite Summary Judgement Motions

By Emily CoxXarelto Failure to Warn

The judge presiding over all federal Xarelto lawsuits denied two partial summary judgement motions filed by the manufacturers of the oral anticoagulant to dismiss Xarelto failure to warn claims about the uncontrollable bleeding risks associated with the controversial blood thinner.

District Judge Eldon Fallon issued the order April 17.  The order denied partial summary judgement in two of the upcoming bellwether cases that would have dismissed claims filed by Joseph Boudreaux, Jr. and Joseph Orr, Jr.

Boudreaux’s trial begins today, followed by Orr’s on May 30. They will both take place before juries in the Eastern District of Louisiana. Additional bellwether trials will take place in Mississippi and Texas.

All these cases involve dangerous, irreversible bleeding, resulting in severe injuries, hospitalizations, and death, as a consequence of Xarelto not having an antidote to reverse its anticoagulant effects. Whereas, vitamin K will reverse the traditional blood thinner warfarin’s (Coumadin) effects in an emergency. These lawsuits all allege that Xarelto manufacturers knew about the risks but sought to conceal them in order to maximize profits at the cost of consumer health.

Xarelto Failure to Warn Motions

In a last ditch effort, Bayer Healthcare and Johnson & Johnson subsidiary Janssen Pharmaceuticals contended that Xarelto failure to warn claims should be excluded from litigation. The pharmaceutical giants indicated that plaintiffs could not prove that their doctors would have prescribed different medication even if Xarelto’s warning label was stronger. However, Judge Fallon ruled that applicable Louisiana law does not mandate proof that the doctors would have prescribed a different drug. The applicable law presumes that doctors will follow warning labels accordingly.

“This Court finds that Plaintiffs do not contend that prescribing physicians never should have prescribed Xarelto. Instead, they argue their claim survives merely by showing the doctor would have acted differently had they been adequately instructed, and that Plaintiffs’ injuries could have then been avoided,” Judge Fallon said in his ruling. “Louisiana law contains a presumption that if adequate warning is provided, that warning would have been followed, or ‘heeded.’”

Expert Exclusion Struck Down Along with Xarelto Failure to Warn

In addition from trying to dismiss Xarelto failure to warn cases, Xarelto makers also fought to exclude or limit testimony from key plaintiff experts. However, Judge Fallon ruled that four major experts were acceptable.

Dr. Suzanne Parisian is a former food and drug administration (FDA) Chief Medical Officer. She is also physician, author of FDA Inside and Out, and a Board Certified Pathologist. She is also the President of the clinical and regulatory consulting firm Medical Device Assistance, Inc. Dr. Parisian’s testimony will help the jury understand regulatory requirements applicable to the manufacturers and FDA drug labeling.

Former FDA Commissioner Dr. David Kessler has testified to Congress on multiple occasions. He has published many articles on the federal regulation of drugs and medical devices. His articles also cover federal regulation and state law. His testimony will be on the conduct of pharmaceutical companies.

Dr. Nathaniel Winstead is a gastroenterologist and hepatologist. He will testify that Xarelto probably caused the plaintiff’s gastrointestinal bleed.

Toxicologist and pharmacologist Dr. Laura Plunkett is a Diplomate of the American Board Toxicology and registered patient agent. She has extensive experience consulting and advising on regulatory matters including label content. She will provide testimony regarding drug pharmacology, general causation, regulatory measures, and the adequacy of labels for FDA-approved drugs.

 

First Xarelto Trial Begins April 24

By Emily Cox
First Xarelto Trial
Bleeding Hearts Flower Photo by Salem Eames

The first Xarelto trial out of about 17,000 pending lawsuits over severe bleeding while on the anti-coagulation medication will begin April 24 unless lawyers negotiate a settlement.

A similar litigation involving the blood thinner Pradaxa reached a settlement just before trials began. Boehringer Ingelheim, the drug’s manufacturer, was facing about 4,000 lawsuits from people who were injured or died from bleeding while on Pradaxa.  Just before the first trials were about to begin, the manufacturer and plaintiffs reached a $650 million settlement agreement. The average payout was $162,500.

Currently, there are 15,611 federal Xarelto lawsuits in Louisiana with another 1,343 cases at the state level in Philadelphia. All of these lawsuits involve people who experienced dangerous bleeding while taking Xarelto.

The Judicial Panel on Multidistrict Litigation (JPML) centralized all the federal lawsuits under Judge Eldon Fallon in the District of Louisiana. Multidistrict litigations (MDLs) use early “bellwether” trials to gauge how juries are likely to respond to evidence that is central to the litigation.

Xarelto Trial Lawsuits

The first Xarelto trial will take place in Louisiana. The plaintiff, Joseph Boudreaux, Jr., used Xarelto for around a month before developing internal bleeding. His severe bleeding required hospitalization and several blood transfusions.

The second Xarelto trial will also be in Louisiana. The plaintiff, Joseph Orr, alleges that his wife died of uncontrollable bleeding in her brain after taking Xarelto for one month.

The third trial will take place in Mississippi. It involves Dora Mingo. Mingo suffered gastrointestinal bleeding after taking Xarelto to prevent blood clots. The fourth Xarelto trial will occur in Texas and involves William Henry who died of gastrointestinal bleeding while taking the drug for atrial fibrillation. The court will determine these last two Xarelto trial dates in June.

All these lawsuits accuse Johnson & Johnson and Janssen Pharmaceuticals of aggressively marketing Xarelto to replace Coumadin (warfarin) despite not having an antidote to reverse bleeding while on the drug. Plaintiffs assert that these companies downplayed the bleeding risks for financial gain.

Warfarin has been the standard of anticoagulant care since the 1950s. Unlike Xarelto, a dose of vitamin K will deactivate its blood thinning properties.

The FDA started approving new-generation blood-thinning drugs in 2010, starting with Pradaxa (dabigatran). Xarelto (rivaroxaban) followed shortly after in 2011. At the time, neither drug had a reversal agent to deactivate anticoagulation in emergencies.

 

 

Bard Hernia Plug and Ethicon Hernia Mesh Permanently Disables a Man

By Emily Cox
Hernia Plug and Mesh Permanently Disabled a Man
Photo by Joshua Zader

A new product liability lawsuit claims that a hernia plug and mesh caused extensive medical damage that required multiple surgeries and continues to debilitate a Texas man.

Matthew Ochoa filed the complaint in the Southern District of Texas in March. He named C.R. Bard, Bard Davol, Inc, Johnson & Johnson, and its Ethicon subsidiary as the companies responsible for damage incurred by their hernia mesh products.

Ochoa Hernia Plug and Mesh Difficulties

Ochoa indicates that he first received a Bard Perfix plug in March 2015. His medical complications began mere days after the surgery. He immediately developed groin pain and a spreading rash. Tests revealed that the hernia mesh had folded on itself. Ultimately, the hernia ruptured, requiring repair surgery.

In June 2015, Ochoa underwent hernia repair. Dr. Christopher Shin repaired the hernia with an Ethicon prolene mesh, stapling it all the way around. He didn’t remove the hernia plug, placing the new mesh under the defective device instead. After the surgery, Ochoa felt a sharp, excruciating pain in his lower right abdomen. He continues to feel this debilitating pain to this day.

Ochoa underwent yet another hernia surgery to remove the original, defective hernia plug in August 2015 despite significant risks. Dr. Shin had warned Ohoa that nerve damage and the possibility of losing his right testicle. However, Ochoa accepted the risks. Unfortunately, due to extensive complications, Dr. Shin was unable to remove all the mesh.

“During the operation, Dr. Shin found that the original mesh had been tangled with the nerves and 2% of the mesh concreted onto Matthew’s spermatic cord, which he was unable to remove,” the lawsuit notes. “The operation took 25% longer than anticipated due to the complications that arose from the entanglement.”

Ochoa’s condition continued to deteriorate dramatically. Dr. Shin determined that the defective mesh was causing severe adverse reactions in Matthew’s body. However, not surgical action was taken at this time.

Ongoing Hernia Plug and Mesh Complications

By December 2015, the pain in his testicle was unbearable. In January 2016, the mesh shifted, which only heightened his already substantial pain. When he became light headed, Ochoa pled Houston Methodist West Hospital to help. However, he was released when doctors could not determine a cause for his fever and physical state. Two days later, Ochoa lost his equilibrium and was unable to stand. He was admitted to St. Joseph’s Hospital in downtown Houston where he lost his ability to walk. Then, Ochoa started slurring his words and passed out. Surgeons determined that mesh removal was the best course of action. However, the hospital released him with the mesh still intact and paralyzed from the waist down.

Surgeons finally attempted to remove the mesh in February 2016. They found that 40 percent of the original mesh was tangled around the spermatic cord. The severity of Ochoa’s injuries shocked doctors.

“Dr. Bertini did his best to remove the mesh tangled around the cord, as Dr. Cramer found that the Prolene mesh Dr. Shin put in place, because of its defectiveness, tangled around a lot of nerves and tissue near the groin and lower right belly area,” the lawsuit states. “Once the surgery was over, Dr. Bertini and Dr. Cramer came into the room to explain out of all their collective years of practice, they had never seen a case as bad as Matthew’s.”

Ochoa’s hernia injuries eventually resulted in the loss of his tentacle and liver problems from his hernia mesh infection. Doctors believe some of the mesh is still in his body, causing ongoing severe pain and health problems.

 

Stryker LFit V40 Hip Replacement Lawsuits Centralized for Pretrial Proceedings

By Emily CoxHip Replacement Lawsuits

A judicial panel has ordered that all U.S. Stryker LFit V40 hip replacement lawsuits be brought before
one judge for coordinated pretrial proceedings.

The Stryker LFit V40 is a metal femoral head implant. Surgeons used it in combination with several different types of Stryker hip replacement systems. However, Stryker issued a recall last year for certain sizes and lots of the femoral head due to the growing number of individuals reporting taper lock failure with the metal head, requiring additional painful surgery.

A group of LFit V40 hip replacement plaintiffs filed a request for centralized litigation in January. The motion asked the Judicial Panel on Multidistrict Litigation (JPML) to transfer all LFit V40 cases to one judge for pretrial proceedings. These coordinated proceedings help prevent duplicate discovery and conflicting pretrial orders. According the JPML, this serves judicial efficiency, saving all parties time and money.

LFit V40 Hip Replacement Lawsuits Multi-District Litigation (MDL)

The JPML issued the transfer order April 5, following oral arguments March 30. While all parties supported centralization, they differed on the location of the consolidation. The order calls for all LFit V40 hip replacement cases to go before a judge in the District of Massachusetts.

“After considering the argument of counsel, we find that the actions in this litigation involve common questions of fact, and that centralization in the District of Massachusetts will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation,” the JPML ruled. “While any number of the parties’ proposed transferee districts would be suitable, we are persuaded that the District of Massachusetts is the appropriate transferee district for this litigation. Five LFIT V40 cases in the District of Massachusetts are pending before Judge Indira Talwani, who has not yet had an opportunity to preside over an MDL docket.”

There are currently six LFit V40 lawsuits pending in three different districts. However, the panel noted 27 additional possible cases.

The JPML established similar centralized proceedings after the 2012 Stryker Rejuvenate and ABG II voluntary recall. These centralized proceeding resulted in thousands of lawsuits.

Following coordinated discovery in that MDL, Stryker agreed to pay more than $1 billion to settle the hip replacement lawsuits. This settlement was to resolve cases where individuals required revision surgery when the recalled implant failed.

Aventis Jumps to Prevent Expanded Discovery Scope into Taxotere Marketing Fraud

By Emily Cox
Aventis Attempts to Keep Court Out in Taxotere Marketing Fraud
Photo by theilr

Following an order that expanded the Taxotere marketing fraud lawsuit’s discovery to include two additional drugs, the breast cancer drug manufacturer was quick to file a response to prevent the court from compelling the company to produce this evidence.

Judge Lawrence F. Stengel issued the order late last week to expand the discovery scope in investigating alleged Taxotere marketing fraud to include Aventis drugs Nasacort and Lovenox. The order was in response to plaintiff Yoash Gohil’s motion to compel the discovery and prevent Aventis from withholding evidence. The motion suggested that evidence related to these other drugs showed a corporate policy of illegal and fraudulent marketing activities like the ones the company is accused of in relation to Taxotere.

“[This evidence is] relevant to the defendants’ state of mind, motive, corporate intent, and/or reckless disregard for the truth or falsity of claims,” the motion states.

Gohil also asserted that this evidence proves that Aventis violated the Federal Food, Drug, and Cosmetic Act. Furthermore, the illegal and fraudulent Nasacort, Lovenox, and Taxotere marketing directives may have come from the same management. Gohil strongly indicated that this evidence shows a corporate culture of deceit, fraud, and corruption.

“[There is] extensive evidence of corporate goals to promote Taxotere and other drugs off-label; the use of corporate-wide kickbacks; systematic destruction of corporate records directed by the legal department to conceal off-label promotion and kickbacks, as well as obstruction of FDA inquiries,” the motion states.

Now, Aventis is desperate to keep the Taxotere marketing fraud investigation focused solely on Taxotere. In its response filed Tuesday, the company called the expanded discovery disproportionate to the needs of the case. Aventis pled the court to withhold this evidence.

Taxotere Marketing Fraud Lawsuit

Gohil is joined by the U.S. in his qui tam lawsuit, also known as a whistle blower lawsuit. They claim that Aventis engaged in fraudulent marketing practices. They further allege that the company provided illegal kickback and other illicit incentives. This was to encourage doctors to use Taxotere as first line treatment for less aggressive cancers. The FDA has only approved Taxotere for the treatment of certain aggressive, late stage cancers when other treatments have failed. The lawsuit indicates that the company has engaged in this behavior since 1996.

Allegedly, Aventis trained and directed employees to misrepresent the safety and effectiveness of off-label Taxotere use. The company also paid healthcare providers illegal kickbacks to get doctors to prescribe Taxotere for off-label use. These kickbacks included entertainment, sports, concert tickets, sham grants, speaking fees, travel, preceptorship fees, and fee reimbursement.

Taxotere’s illegal promotion increased the drug’s revenue from $424 million in 2000 to $1.4 billion in 2004. Consequently, it unnecessarily exposed thousands of women to the increased toxicity of Taxotere. This increased toxicity also comes with more severe side effects, including permanent hair loss.

In fact, the number of Taxotere lawsuits continues to skyrocket as more women discover Aventis knew about this permanent hair loss risk for more than a decade. However, the company hid it from American breast cancer victims. While the company started including permanent hair loss warnings on Taxotere in other countries, starting in 2005, it kept Americans in the dark until late 2015.

 

 

Bair Hugger Infection Bellwether Cases Chosen

By Emily Cox
Bair Hugger Infection Justice
Photo by Dan4th Nicholas

Patients and 3M identified about 30 Bair Hugger infection bellwether trial cases Friday in the multidistrict litigation (MDL) against 3M’s patient-warming device’s alleged tendency to cause infection after orthopedic surgery.

The patients and 3M each identified 16 cases from the 150 that the court randomly selected in January. The sides identified one common case. Consequently, this brings the total number of federal case nominations to 31. The parties selected these nominations from cases involving either a hip or knee implant procedure.

These early trials will help gauge how juries are likely to react to evidence that will be present throughout the litigation.

Bair Hugger Infection Background

Hypothermia is a common side effect of anesthesia during the first hour. 3M designed the Bair Hugger Forced-Air Warming system to prevent and treat unintended hypothermia during surgery. However, patients claim the warming device caused them to develop post-surgical infections. The device blows hot air into a specially designed blanket covering the patient. Consequently, this allegedly spreads bacteria from the hospital floor or from inside the device itself. In at least one instance, the Bair Hugger infection was drug-resistant and resulted in amputation.

The Judicial Panel on Multidistrict Litigation (JPML) first consolidated the cases in 2015 in the District of Minnesota. At that time, 3M claimed the lawsuits were nothing more than a smear campaign by Bair Hugger inventor Scott Augustine. Augustine also founded Augustine Medical, which eventually became 3M’s Arizant Healthcare. Arizant also manufacturers Bair Hugger.

According to 3M, Augustine left the company in 2003 when his company was being investigated for Medicare fraud. Augustine ended up pleading guilty to one misdemeanor count of Medicare fraud and agreeing to pay the government $2 million in 2004. His company also pled guilty to criminal charges. The government dropped charges against Arizant. 3M bought Arizant from private equity company Court Square Capital in 2010.

3M continues to assert that it will vigorously defend the Bair Hugger device’s safety. However, with almost 1,600 patients claiming Bair Hugger infections, the company has an uphill battle ahead.

Aventis Fraud May Extend Beyond Controversial Breast Cancer Drug Taxotere

By Emily Cox
Aventis Fraud Whistleblower Lawsuit
Photo by Steven Depolo

A new order in the Aventis fraud lawsuit, alleging that the drug company engaged in illegal marketing tactics to increase Taxotere’s market share, indicates that these fraudulent and illicit practices extended to at least two of the company’s other drugs.

District Judge Lawrence F. Stengel issued the order late last week. He issued the order in response to plaintiff Yoash Gohil’s Motion to Compel Discovery. Gohil’s motion strongly indicates that evidence related to the drugs Nasacort and Lovenox shows that the sort of illicit and fraudulent activities surrounding Taxotere’s marketing is a matter of corporate policy.

Judge Stengel’s order mandates that Aventis produce this evidence by May 22. This expanded evidentiary scope applies to all future discovery as well.

“For purposes of all future discovery conducted in this matter, Aventis shall not withhold any documents or testimony from Plaintiff on the basis that the documents or testimony pertain to drugs other than Taxotere in connection with these requests,” Judge Stengel wrote.

Aventis Fraud Does Not Appear Limited to Taxotere

This order comes after Aventis refused to produce certain evidence in February. This evidence pertained to Aventis management’s knowledge of off-label marketing of Nasacourt and Lovenox. The company had agreed to produce certain responsive documents. However, they refused to procure compliance documents related to drugs other than Taxotere. Regardless, the court has decreed that these documents are discoverable.

“[This evidence is] relevant to the defendants’ state of mind, motive, corporate intent, and/or reckless disregard for the truth or falsity of claims,” the motion states.

Furthermore, these documents show that Aventis violated the Federal Food, Drug, and Cosmetic Act. Gohil further contended the Nasacort, Lovenox, and Taxotere marketing directives may have come from the same management. The motion suggests a corporate culture of deceit, fraud, and corruption.

“[There is] extensive evidence of corporate goals to promote Taxotere and other drugs off-label; the use of corporate-wide kickbacks; systematic destruction of corporate records directed by the legal department to conceal off-label promotion and kickbacks, as well as obstruction of FDA inquiries,” the motion states.

Aventis Fraud Lawsuit

Gohil is joined by the U.S. in his Aventis fraud “whistleblower” lawsuit. They allege that Aventis engaged in fraudulent marketing, as well as provided illegal kickback and other illegal incentives to encourage Taxotere as a first line treatment for less aggressive cancers since 1996. Taxotere is only approved for the treatment of certain aggressive cancers when other treatments have failed.

Allegedly, Aventis trained and directed employees to misrepresent the safety and effectiveness of off-label Taxotere use. The company also paid healthcare providers illegal kickbacks such as entertainment, sports, concert tickets, sham grants, speaking fees, travel, preceptorship fees, and free reimbursement to get doctors to prescribe Taxotere for off-label uses.

Taxotere’s illegal promotion increased the drug’s revenue from $424 million in 2000 to $1.4 billion in 2004. Consequently, it exposed thousands of women to the increased toxicity of Taxotere and its more severe side effects, including permanent hair loss.

Taxotere Hair Loss Lawsuits

Taxotere is a high potency breast cancer chemotherapy treatment. The drug has recently come under fire for not disclosing its severe side effects, including permanent hair loss. It has also received scrutiny from the FDA. It received a warning from the agency for claiming superiority over other treatments. However, studies clearly show less toxic treatments to be just as or more effective than Taxotere.

The number of Taxotere lawsuits continues to skyrocket as more women discover that Aventis knew about the permanent hair loss risk for more than a decade. The company updated its warning labels to include this risk in Canada and Europe in 2005 and 2012 respectively. However, it kept U.S. breast cancer victims in the dark until late 2015.

Many of these women assert that they may have chosen a different treatment if they had known about the side effects and that other, less toxic treatments were equally or more effective.

 

 

 

 

 

Talcum Powder Cancer Lawsuits Explode to More Than 4,000 Plaintiffs

By Emily Cox
Talcum Powder Cancer Lawsuits Explode
Photo Steven Lam

More than 4,000 women have filed talcum powder cancer lawsuits against Johnson & Johnson, alleging that long-term use of their Baby Powder and Shower-to-Shower products caused ovarian cancer.

Parties in the consolidated federal multidistrict litigation (MDL) filed the  joint report following the March 28 status conference. The report included an update about the number of cases pending nationwide.

The Judicial Panel on Multidistrict Litigation (JPML) consolidated talcum powder ovarian cancer lawsuits in October 2016. There are just over 200 talcum powder cases included in the centralized litigation. However, many of these cases involve multiple individuals. Consequently, these 200 complaints include more than 2,000 women.

Additionally, there are large dockets of talcum powder cancer lawsuits pending in various state courts. In Missouri, there are currently 1,411 women waiting for justice. In California, there are 472 talcum powder plaintiffs. New Jersey has 201 plaintiffs, while Delaware has 96.

Talcum Powder Cancer Lawsuits

As the number of talcum powder cancer lawsuits continue to mount against Johnson & Johnson, juries have already returned massive verdicts for talcum powder plaintiffs. These juries found that the company knew or should have reasonably known about the cancer risks but concealed them.  Missouri juries returned verdicts of $70 million, $55 million, and $72 million this past year.

All these women allege that despite significant scientific evidence that long-term vaginal exposure to talcum powder can cause ovarian cancer, Johnson & Johnson continued to market its talcum powder products to adult women for “personal freshness” and encouraged whole body use. Even after different organizations classified talc as a carcinogen, and the company’s talc supplier started including warnings on its shipments, Johnson & Johnson still asserts its talcum products are safe.

Despite the large verdicts and mounting lawsuits, Johnson & Johnson still refuses to negotiate Talcum powder cancer settlements. The company indicates that it will continue to defend claims in court.

The latest talcum powder trial will go before a jury next week. Lois Slemp filed the complaint. She alleges that she used Johnson & Johnson talcum powder products for more than 40 years before being diagnosed with ovarian cancer.

 

 

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