Category: Defective Drugs

Manufacturers Manage to Avoid Taking Responsibility for Xarelto Bleeding Risk in 1st Trial

By Emily Cox
Xarelto Bleeding Risk
Photo by N-4

A Louisiana jury sided with Bayer and Janssen on Wednesday in the first trial over the companies’ failure to warn about the allegedly uncontrollable Xarelto bleeding risk.

The federal jury found in favor of Johnson & Johnson’s Janssen Pharmaceuticals unit and Bayer HealthCare Pharmaceuticals in the first of four early trials in the multidistrict litigation (MDL). The trial started April 24. The trial’s plaintiff, along with other patients or their representatives, claim that the drug companies knew about the unstoppable bleeding risk but never warned doctors.

Boudreaux claimed that he started taking Xarelto in January 2014 to reduce his stroke risk from atrial fibrillation. However, less than a month later, he suffered life-threatening gastrointestinal bleeding. Consequently, he spent a week in the intensive-care unit. Boudreaux required several blood transfusions and multiple heart procedures to save his life. Allegedly, doctors could not stop the bleeding. This is because drug makers released the blood thinner without any reversal agent to stop bleeding in an emergency. Whereas, the anticoagulant effects of the traditional treatment, Coumadin (warfarin), since the 1960s are easily thwarted by vitamin K so that bleeding can be stopped.

“I don’t want anybody else to suffer like I have from that drug,” Boudreaux said.

More than 18,000 other plaintiffs in similar cases echo this sentiment. They claim that Janssen and Bayer misrepresented the safety of Xarelto, gambling on their health for profit. Furthermore, they allege issues surrounding certain clinical trial results.

Xarelto Bleeding Risk Trial Loss

“We never expected the struggle to be an easy one,” a lawyer for Boudreaux said after the verdict. “We realize that Bayer and Janssen have a lot of resources and a lot of motivation to protect Xarelto.”

Xarelto generated $3.24 billion in sales in 2016 and $2.5 billion in 2015 for Bayer. Consequently, it is the company’s best-selling product. The drug also ranks three on Johnson & Johnson’s money making roster. It brought in $2.29 billion in 2016.

Unfortunately, Boudreaux’s case hinged on a blood clot safety test that the FDA or other health regulators have not deemed useful to determine if patients should use or continue with Xarelto therapy.

Testimony Begins This Week in First Xarelto Bleeding Risk Trial

By Emily Cox
Xarelto Bleeding Risk Trial
Photo by hickory hardscrabble

New Orleans’ jurors will start hearing testimony this week in the first Xarelto bleeding risk trial, involving the manufacturers’ failure to warn about the blockbuster blood thinner’s potentially life-threatening risks.

With jury selection complete and more than 18,000 additional cases stacked up behind it, Joseph Boudreaux’s trial kicks into high gear this week. This early bellwether trial will be the first indicator of whether juries are likely to side with the drug makers or patients, who claim Johnson & Johnson and Bayer hid the Xarelto bleeding risk for financial gain.

According to Boudreaux, taking Xarelto was one of the biggest mistakes of his life. His doctor prescribed the blood thinner to help reduce Boudreaux’s stroke risk. However, it almost cost him his life. The anticoagulant caused extreme internal bleeding. Boudreaux was in the intensive-care unit for a week. He required several blood transfusions and multiple heart procedures to save his life.

“I don’t want anybody else to suffer like I have from that drug,” Boudreaux said.

Boudreaux finally has his chance to have jurors hold Johnson & Johnson and Bayer responsible for Xarelto’s potentially fatal side effects. His case is the first of four slated for trial over the next three months.

More than 18,000 injured individuals nationwide have filed lawsuits, alleging the blood thinner caused dangerous bleeding. The drug is also responsible for at least 370 deaths, according to FDA reports.

Xarelto is Bayer’s top-selling product, bringing in $3.24 billion in sales last year and $2.5 billion in 2015. It is Johnson & Johnson’s third best seller, generating $2.29 billion in 2016 for the company.

Xarelto Bleeding Risk

Xarelto first hit the market in 2011 to prevent deep vein thrombosis in patients undergoing hip or knee replacement surgery. The FDA has expanded its approved indications several times since to include stroke, blood clots, and stent thrombosis.

Johnson & Johnson and Bayer aggressively marketed Xarelto as a replacement for Coumadin (warfarin), which has been the standard anticoagulant treatment since the 1960s. Coumadin requires regular blood monitoring to ensure proper dosage, while Xarelto reportedly does not. Consequently, manufacturers marketed it as an easier, one-size-fits-all alternative. However, these lawsuits call foul on these claims, alleging fraudulent marketing. Furthermore, Vitamin K reverses the blood thinning effects of Coumadin if bleeding occurs. Bayer and Johnson & Johnson released Xarelto without a reversal agent, opening the door for potentially fatal consequences. Plaintiffs allege that the companies concealed their knowledge of Xarelto’s defects from the FDA, public, and medical community.

“This trial is an important first step in gaining broader awareness of one of the most high-risk drug treatments in medicine today,” one of Boudreaux’s lawyer said.

 

 

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.

 

$3M Verdict Awarded Against Paxil Manufacturer for Lawyer’s Suicide

By Emily Cox
Justice for Generic  Paxil Suicide
Photo by Captain Roger Fenton

An Illinois jury found GlaxoSmithKline (GSK) liable Thursday for Stewart Dolin’s suicide and ordered the company to pay $3 million to the lawyer’s widow, claiming that a generic version of GSK’s Paxil caused Dolin to take his own life.

Following five weeks of testimony, the nine-person jury agreed with Wendy Dolin that generic paroxetine, an antidepressant sold as brand-name Paxil, contributed to her husband’s 2010 suicide.

Dolin alleges that her husband would still be alive today if he hadn’t started taking paroxetine mere days before jumping in front of a downtown Chicago L-train. Dolin claims her husband was restless and agitated during his final days. These are symptoms of a Paxil side effect known as akathisia. GSK denies that akathisia can lead to suicide. However, Dolin contends that the side effect sometimes causes people to act impulsively and violently.

GSK Knew About Increased Paxil Suicide Risk

Furthermore, the lawsuit claims that GSK knew about the increased suicide risk in adults taking paroxetine. This is even more pronounced in the early days of treatment. However, the company allegedly hid this data from the FDA for decades. During the trial, the widow testified that her husband was sometimes anxious. But, he had developed coping mechanisms and was seeing a therapist at the time of his suicide.

The jury awarded Dolin $3 million. They allocated $2 million for the wrongful death of her husband. The jury awarded another $1 million for the pain he suffered in the days leading up to his untimely death. While this was far less than the $39 million Dolin had sought, she said it was about spreading awareness of the drug’s dangerous side effects instead of the money.

“I started a foundation, MISSD. I go to Washington, D.C., and I sit on consumer groups so this, for me, has not just been about the money,” she said. “This has always been about awareness to a health issue, and the public has to be aware of this.”

Paxil Manufacturer Continues to Assert Suicide Was Due to Work Anxiety

GSK tried to pin her husband’s suicide on his chronic anxiety, particularly as it related to his work. However, the managing partner at Reed Smith’s Chicago office testified that it wasn’t work that drove Dolin to suicide.

“He had challenging work, but we sorted it through,” Mike LoVallo, a close friend to Dolin for decades, testified.

After his death, LoVallo searched Dolin’s office. But he found no indication that his work was a contributing factor in his suicide.

Regardless, GSK continues to contend that since they did not manufacture the generic version of the drug that the court should not hold them liable. Dolin originally brought the suit against Mylan NV, the manufacturer of the generic version of Paxil. But District Judge James Zagel ruled that GSK, as the maker of the brand-name drug Paxil, was responsible for ensuring the label was accurate. The ruling still remains controversial.

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.

 

 

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.

 

 

MiraLax May Cause “Horrifying” Changes in Children

By Emily Cox
MiraLax Adversely Effecting Children
Photo by Hartwig HKD

A recent report presents disturbing claims that children have developed neuro-psychiatric problems after taking MiraLax.

The FDA doesn’t recommend MiraLax for children under 17 and limits use to seven days. However, according to a recent investigative report,  families are claiming that pediatricians prescribe it like water and for extended periods of time to treat constipation in children.

While many parents view MiraLax as a godsend for their children’s constipation, several families are coming forward and reporting scary MiraLax side effects in their children. These side effects include behavioral issues, speech problems, anxiety, aggression, and depression.

6 ABC Action News reported that a doctor advised Jeanie Ward to give her three-year-old daughter, Nicole, the laxative. However, within 10 days, Nicole’s personality had drastically changed.

“Near psychiatric events with paranoia, mood swings, aggression, rage, the OCD repetitive chewing” Ward said. “It was horrifying to see my daughter change like that and to not completely go back to normal.”

Ward is not alone. Numerous other families shared similar stories with Action News.

“We saw a lot of the anger, a lot of the rage, a lot of the aggression,” parent Mike Kohler said. “I trusted the medical community, and they absolutely robbed me of part of my fatherhood.”

These sentiments are echoed by Jessica Aman and Sarah Locatelli.

“I feel like my son was absolutely robbed of most of his childhood,” she said.

“After six days on MiraLax, we noticed overnight he acted out of character,“ Locatelli said. “He had the rage, fears, phobias, anxieties.”

While Natalie Saenz had doubts due to MiraLax’s label indications, she trusted her pediatrician. He recommended MiraLax for off-label use on her daughter for eight months.

“All of a sudden, she started having these weird ticks,” Saenz said.

MiraLax Families Fight Back

These families and others complained to the FDA and formed a Facebook group with more than 3,000 members where other families have voiced similar concerns.

Ward also helped write a petition to the FDA to include a warning label and a MiraLax investigation. Consequently, the petition won a $325,000 study of a MiraLax ingredient –  Polyethylene Glycol (PEG).

“I think they are poisoning our chidren,” Ward said.

After the FDA reported 167 adverse side effects in kids, the agency awarded the study to CHOP. The FDA also found small amounts of the antifreeze ingredients in the laxative.

For now, the study is ongoing. Meanwhile, these families are urging pediatricians to avoid MiraLax recommendations. Instead, adding fiber rich foods and prune juice to a child’s diet can help move things along without the cost to mental health.

 

 

 

 

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.

 

 

 

 

 

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