Category: Defective Drugs

1st Xarelto Loss Slams J&J and Bayer with $29M Verdict

By Emily Cox

Xarelto Loss

The Philadelphia Xarelto trial was the first of its kind and could prove to be a significant turning point in the litigation. It was not only the first to go before a jury outside of the ongoing federal multidistrict litigation (MDL). It’s now also the first to successfully take Johnson & Johnson and Bayer to task for actively hiding life-threatening bleeding risks associated with their billion-dollar blood thinner. In the first Xarelto loss, the jury awarded $29 million in damages for the manufacturers risking patients’ lives for financial gain.

The verdict substantiates an Indiana woman’s claims that she suffered serious gastrointestinal bleeding due to the medication. However, three previous juries in the ongoing MDL sided with the companies earlier this year over these same types of risks.

Plaintiff Lynn Hartman alleges she had to undergo four blood transfusions to counteract Xarelto’s dangerous bleed-out effects. Furthermore, these bleeding issues completely resolved when she switched to another blood thinner.

Hartman is only one of 1,500 individuals with cases pending in Philadelphia Court of Common Pleas’ mass tort program. These cases allege that J&J and Bayer consciously hid Xarelto’s significant bleeding risks. These subversive marketing tactics skyrocketed the blood thinner to the tops of their mutual pharmaceutical rosters. However, time and again federal juries have failed to make these companies take responsibility for their reprehensible actions. Consequently, the Pennsylvania program has taken matters into its own hands to consolidate Xarelto claims outside of the decidedly defense-favoring MDL.

Xarelto Loss Trial

Hartman’s trial focused on claims that J&J subsidiary Janssen Pharmaceuticals and Bayer intentionally mishandled and misrepresented clinical trial results to promote the blockbuster blood thinner. During opening arguments, attorneys focused on the companies rigging a clinical trial. The clinical trial compared the drug’s efficacy and safety to warfarin. Warfarin (Coumadin) has been anticoagulant go-to for decades. Janssen and Bayer were aggressively seeking to dethrone the traditional blood thinner. So, the companies loaded the trial with Eastern Europe patients where physicians more frequently mishandle warfarin dosing.

“They made sure the warfarin patients did not receive the right amount of medicine, and they did it on purpose,” attorney Ned McWilliams said.

Consequently, warfarin users appeared to suffer similar rates of bleeding incidents and strokes as Xarelto users. But, when North American data was isolated, Xarelto users who experienced serious adverse effects were significantly higher than warfarin patients. The rate among U.S. participants was 8.1 percent annually versus 3.6 percent annually among global participants. Despite knowing that Xarelto was considerably more dangerous than warfarin, the companies continued to conceal this information, sacrificing patients for profits.

“They intentionally rigged a clinical trial, so they could make billions of dollars,” McWilliams said.

The correct data would not appear on Xarelto’s label until September 2015. As a result, doctors were unaware of Xarelto’s comparative risks when prescribing the medication.

Further Condemning Evidence in Xarelto Loss

Hartman’s attorneys indicated that the companies failed to warn about the significantly higher risk of bleeding when using Xarelto with aspirin. They also didn’t inform doctors that some patients end up with significantly higher blood levels of the medication than others. Instead, J&J and Bayer continued to insist that blood testing was unnecessary to make Xarelto appear more convenient than warfarin. Warfarin requires regular blood testing to ensure safe dosages. However, J&J and Bayer forewent these safety measures for the sake of a successful marketing campaign.

Furthermore, attorneys claim Xarelto’s risks are significantly higher than Eliquis and Pradaxa. These are other popular new generation anticoagulants.

“Xarelto is the worst in class of the new blood thinners,” said an attorney for Hartman. “The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks, and if patients were given the choice to switch to Eliquis and Pradaxa, which are safer and far more effective.”

Former FDA chief David Kessler added yet more fuel to the fire during his trial testimony. Kessler told jurors that Xarelto’s warning label lacked critical information about the severity of the drug’s potential bleeding risks.

Xarelto Loss Going Forward

As a result of the overwhelming evidence, the Philadelphia jury ordered J&J and Bayer to pay $1.8 million in actual damages and $26 in punitive damages. The jury levied these punitive damages to punish J&J and Bayer for exploiting patients and physicians to further their own financial interests. Xarelto is now Bayer’s top-selling product. It generated $3.2 billion in sales last year alone. Xarelto is J&J’s third-biggest seller, bringing in $2.3 billion in 2016. This goes a long way to replace J&J’s profits from its Remicade arthritis treatment, which lost patent protection a year ago. These lost profits are a large part of J&J’s devious mechanizations to fraudulently market Xarelto.

The companies announced Tuesday that they plan to appeal the Xarelto loss. However, many are speculating that this could be a turning point in the litigation. And, the companies still face more than 20,000 cases pending in the federal proceedings and 1,500 in Pennsylvania state court.

 

 

Consumer Advocacy Group Calls for Benicar Ban

By Emily Cox

Benicar ban

On the heels of a $300 million Benicar (olmesartan) settlement, a consumer advocacy group has petitioned the FDA to institute a formal Benicar ban.

The organization Public Citizen that Ralph Nader originally founded formally petitioned the FDA on November 15. The group is calling for the Benicar ban due to the controversial blood pressure medication’s “life-threatening” side effects.

“Keeping the medication on the market would continue to put hypertension patients’ lives at risk for the sake of corporate profits,” the organization warned in a press release after it sent the 20-page petition to the FDA. The FDA has acknowledged receiving the Benicar ban petition. However, it is still not known what the agency will do with the petition. Historically, the FDA has taken years to consider similar requests. Meanwhile, Benicar patients will continue to suffer serious side effects and weight loss. These stem from a severe gastrointestinal condition that often requires hospitalization.

Benicar causes sprue-like enteropathy. The condition “leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss,” Public Citizen states.

“The condition is called sprue-like enteropathy because of its similarity to sprue or celiac disease – a gastrointestinal illness triggered by gluten ingestion. However, unlike with celiac disease, sprue-like enteropathy does not improve with a gluten-free diet.”

The debilitating condition can be misdiagnosed as celiac disorder, leading to ineffective treatment protocols.

Benicar Ban Background

Benicar is a hypertension drug that the FDA indicates for the treatment and management of high blood pressure. Olmesartan is effective in this role. However, patients and Public Citizen indicate that Benicar side effects and risks far outweigh the benefits. Furthermore, other hypertension medications are equally effective at lowering blood pressure. And, they do it without dire side effects like sprue-like enteropathy, illness, and weight loss. Benicar, Azor, Benicar HCT, and Tribenzor are unique in their link to sprue-like enteropathy. Consequently, manufacturers are facing product liability lawsuits and Public Citizen wants the drugs off the market.

“There is overwhelming evidence that olmesartan causes severe sprue-like enteropathy and that the risk of this life-threatening complication is far greater with olmesartan than with the other seven FDA-approved ARBs,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “There is no justification, other than corporate profits, to subject any patient to this danger when there are so many effective but much safer alternatives for treating hypertension.”

Benicar Ban Petition

In its Benicar ban petition, the advocate cited a 2012 Mayo Clinic study. The study documented the connection between olmesartan and sprue-like enteropathy. In 2013, the FDA concluded that olmesartan “can cause” the condition as well. However, the agency only issued a safety warning about the drugs.

“However, rather than pulling olmesartan from the market, the agency required only the addition of a weak warning about this risk to the product’s labeling,” Public Citizen said in a press release.

“Since 2012, numerous studies together have documented more than 150 cases of this disorder in patients worldwide who took this medication,” Public Citizen continued. “The studies found that most of the patients experienced serious complications – including profound malnutrition and kidney injury – and required hospitalization.”

The group pled the FDA to  “immediately require the removal from the market of all medications containing olmesartan medoxomil, including medications branded as Azor, Benicar, Benicar HCT, and Tribenzor, as well as all generic versions of these drugs.”

In the past, Public Citizen has sued the FDA when the group felt the agency was dragging its heels on an issue, while patients were suffering. But, it is still too early to tell if the advocacy group will push the FDA into court once more.

 

Testosterone Drug Trials Will Continue to Target AbbVie in Early 2018

By Emily Cox
testosterone drug
Man applying testosterone gel

While the federal testosterone drug litigation involves several manufacturers, the multidistrict litigation (MDL) has focused primarily on AbbVie’s AndroGel with two of the first three bellwether trials addressing heart attacks caused by the testosterone gel. Now, it appears that this trend will continue into 2018. The judge overseeing the MDL has set two cases for trial in January. Kicking off the new year will be a trial against AbbVie within the first ten days. To cap off 2018’s inaugural month, the court will also investigate claims against another member of Big Pharma royalty, Eli Lilly.

The testosterone drug lawsuits are part of the ongoing federal MDL, consisting of more than 7,500 lawsuits against Androgel, Testim, Axiron, and other testosterone therapy medications. Plaintiffs allege that the manufacturers colluded to create “Low-T” in order to expand market share for testosterone drugs. “Low-T” essentially just describes the normal male aging process. However, testosterone drug makers made it into a treatable medical condition. The drug makers specifically targeted and exploited aging men to increase sales despite serious cardiovascular risks, putting their greed before patients’ very lives.

Given the scope of the litigation, the Judicial Panel on Multidistrict Litigation (JMPL) consolidated the litigation before U.S. District Judge Matthew Kennelly in the Northern District of Illinois to avoid duplicate discovery and conflicting pretrial rulings that could further hold up the complex litigation. To evaluate the relative strength and weaknesses on both sides of the v. in the overall arc of the litigation, Judge Kennelly has established bellwether proceedings. These are a series of early trials that help parties gauge how juries are likely to respond to evidence that appears throughout the litigation.

Testosterone Drug Bellwether Defense Challenges

If the first two trials are any indication of general juror reactions, then testosterone drug companies are in big trouble going forward. Ironicially, juries in both trials cleared AbbVie of product liability in the product liability litigation. The first trial did not even award compensatory damages. However, the Illinois jury slammed the drug conglomerate with $150 million in punitive damages for its insidious marketing practices and flagrant misrepresentations of Androgel’s safety. The second jury awarded the plaintiff $140,000 in compensatory damages. But, this was merely a footnote to the $140 million in punitive damages the court levied for AbbVie’s reprehensible behavior.

These decisions to punish the company for the morality of its actions rather than its drug’s safety could be an insurmountable obstacle for testosterone drug companies as the litigation continues.

“I’d be really concerned about how my behavior was going to be judged by the juries,” a plaintiff attorney said.  “It definitely shows them they’re at huge risk.”

In the long run, fixing plaintiff problems is far easier than fixing juries’ outrage over the drug makers’ actions. While plaintiffs change case-to-case, the Low-T marketing strategy will remain the same throughout the litigation.

“Correcting the anger, that’s the bigger mountain to climb,” a plaintiff attorney said.

Consequently, these types of incendiary response over AbbVie’s behavior could weigh heavily into any jury decision regardless of the actual strength of the case at hand.

The first bellwether against Auxilium over its Testim gel allegedly causing a heart attack began November 6. The trial should continue for at least another week. The verdict should indicate if juror anger is isolated to AbbVie’s immoral business practices or a substantial theme in the litigation.

Testosterone Drug Litigation Going Forward

Judge Kennelly issued the trial scheduling case management order on November 9. The order indicates that the next trial will begin on January 8. The bellwether will address a complaint by Robert Nolte, and his wife, Genieene, against AbbVie over Androgel’s side effects.

Nolte alleges that the testosterone drug caused a pulmonary embolism, necessitating several days in the hospital in November 2012. He had been using Androgel since June 2012. Nolte argues that the testosterone therapy gel is defective and unreasonably dangerous.

Judge Kennelly also set another trial for January 29 over Eli Lilly’s Axiron. This will be Eli Lilly’s first time up to bat in the litigation. The trial will involve either a lawsuit filed by Tracy Garner or a lawsuit filed by John DeBroka, Jr.

Garner claims Axiron caused a heart attack. Meanwhile, DeBroka blames his deep vein thrombosis on his use of the testosterone drug.

The outcomes of these trials are not binding on other lawsuits. However, they may prove influential on eventual testosterone drug settlements. A settlement would circumvent the need for thousands of additional trials in the future.

 

 

 

 

 

 

Xarelto Clinical Trial Rigged by Drug Companies

By Emily Cox

Xarelto Clinical Trials

During the opening of the latest trial over the controversial blood thinner causing life-threatening bleeding, a Philadelphia jury heard arguments that Johnson & Johnson and Bayer rigged a Xarelto clinical trial to make the blockbuster anticoagulant appear safer than its main competitor.

Attorneys focused on a Xarelto clinical trial comparing the drug’s safety and efficacy to warfarin. They claim the drug companies stacked the trial with patients from Eastern Europe, because warfarin is more frequently mishandled there.

“They made sure the warfarin patients did not receive the right amount of medicine, and they did it on purpose,” attorney Ned McWilliams said.

As a result, warfarin users appeared to suffer bleeding incidents and strokes at similar rates as Xarelto users. However, when this data was isolated to North America, where warfarin is given to patients at proper doses more frequently, the number of Xarelto users who experienced bleeding incidents and strokes were significantly higher than warfarin, according to McWilliams. But, this data was not isolated on the label until September 2015. Consequently, doctors were unaware of the comparative risks when prescribing the medication.

“They intentionally rigged a clinical trial, so they could make billions of dollars,” McWilliams said.

The companies’ joint efforts to pack the Xarelto clinical trial with patients who were more likely to experience adverse effects while using the competing medication ultimately resulted in Xarelto’s warning labels understating the drug’s comparative risks. Consequently, the label was “grossly inadequate,” putting patients’ lives at risk.

The Trial Behind the Xarelto Clinical Trial

The Pennsylvania trial centers on allegations that Bayer and J&J subsidiary Janssen Pharmaceuticals hid Xarelto’s dangerous bleeding risks from the FDA, medical community, and patients. Consequently, plaintiff Lynn Hartman suffered serious gastrointestinal bleeding in June 2014 after taking Xarelto for about a year. She was taking the medication to prevent blood clots and strokes from atrial fibrillation.

Attorneys highlighted medical records from Hartman’s four-day hospital stay when she received two blood transfusions to save her life. The records explicitly state that Xarelto had complicated her bleeding. Furthermore, she experienced no additional bleeding after switching to a competing product. Her attorneys say Hartman’s doctor did not have a full understanding of the drug’s comparative risks to warfarin when prescribing Xarelto.

Warfarin has been a standard treatment since the 1950s for Hartman’s condition. It requires regular blood testing to ensure correct dosing. Bayer and Janssen aggressively marketed Xarelto as not requiring this testing. However, many patients allege that this marketing strategy put patients at risk while the drug companies raked in billions of dollars from it.

Beyond a Xarelto Clinical Trial – Bayer and Co. May Have Been Rigging Liability Trials

This is the first Xarelto case to go to trial in state court. The previous three trials were part of the federal multidistrict litigation against the companies. Bayer and Janssen walked away from all three of the federal trials with decisive verdicts in their favor. However, these verdicts have relied heavily on plaintiffs’ doctors’ testimonies. Experts have noted that at least two of these testimonies sounded scripted to provide favorable defense verdicts.

But, the Philadelphia trial may not even allow Hartman’s physician to testify due to possible witness tampering. A Janssen sales representative gave her deposition on Friday regarding visiting Hartman’s doctor mere weeks before he gave his written testimony. The physician’s deposition states that Xarelto did not caused Hartman’s injuries. However, this directly contradicts the doctor’s own medical records. In his records, the physician explicitly indicates that Xarelto complicated Hartman’s gastrointestinal bleeding. The court should release details of the sales representative’s deposition in the next couple of days.

Currently, Bayer and Janssen face about 1,500 Xarelto lawsuits in the Pennsylvania litigation. There are more than 20,000 cases pending in the federal proceedings.

Witness Tampering Accusations Fly in Xarelto Philadelphia Trial

By Emily Cox
Witness tampering
Pennsylvania Courts of Common Pleas (Flickr/Michael Righi)

A mere day into Philadelphia’s first Xarelto trial over serious allegations of life-threatening bleeding caused by the blood thinner, attorneys are battling it out over Xarelto witness tampering. The plaintiff’s legal team are calling to depose a Janssen Pharmaceuticals sales represented for supposedly attempting to influence a doctor’s testimony in the case.

Plaintiff attorneys are calling foul due to the recent discovery of a potentially significant meeting between the sales representative and the plaintiff’s treating physician, Dr. James Aldridge, mere weeks before his deposition. Consequently, they are urging Judge Michael Erdos in the Pennsylvania Courts of Common Pleas to allow the rare midtrial deposition.

“If there’s no fire here and all smoke, why not pull back the curtain and let us see what’s there?” an attorney for plaintiff Lynn Hartman said.

Following revelations that the Janssen sales representative visited Dr. Aldridge a month before his April deposition, plaintiffs requested to bar his testimony in the hours before the trial began Monday, sidelining opening arguments.

Witness Tampering Evidence So Far

According to the plaintiffs, Dr. Aldridge’s testimony following the visit directly contradicted his own medical records from the time of Hartman’s treatment. These medical records indicate that Hartman suffered from a gastrointestinal bleed complicated by Xarelto. However, Dr. Aldridge testified that he did not believe that Xarelto caused Hartman’s condition.

The court requires Janssen to identify any sales staff who has contact with prescribing or treating physicians in any ongoing cases in the mass tort program. However, Janssen failed to include this information in a June filing detailing these meetings. Hartman’s attorneys only learned about the contact between Dr. Aldridge and the sales representative this past month. Furthermore, this was the only time the sales representative has ever had contact with Dr. Aldridge.

“It is very suspect that Dr. Aldridge was called on for the very first – and only – time by the Janssen sales representative at issue … mere weeks prior to his deposition in this case,” plaintiffs argued in Tuesday afternoon’s filing.

Judge Erdos’ decision on deposing the sales representative ultimately hinges on if Janssen violated the case management order requiring the drug company to disclose information on contacts between its sales staff and physicians. However, there are striking similarities between the situation and witness tampering allegations in a DePuy Orthopedics bellwether trial. Furthermore, both DePuy and Janssen are subsidiaries of Johnson & Johnson. In the DePuy litigation, the Texas federal judge hearing the case has called in the FBI and U.S. Attorney’s Office to investigate the witness tampering allegations.

Has Witness Tampering Tainted Federal Litigation?

The Philadelphia mass tort program consisting of about 1,500 cases is only just beginning. However, the federal litigation with 20,000 cases against Janssen and Bayer over Xarelto-related life-threatening bleeding allegations is already three trials in. So far, Big Pharma is batting a thousand in this litigation.

In the first two trials, the drug companies relied heavily on a Louisiana  learned intermediary doctrine to negate any label failings. It provides that if the doctor is aware of the risks, the manufacturer cannot be held liable for them.

In both trials, experts noted that the prescribing physicians testified as though someone had given them a script entitled “How a prescribing physician should testify to support a learned intermediary doctrine defense.”

Wonder who would have given them such a script?

 

Testim Steps Up to Bat in Testosterone Gel Litigation

By Emily Cox
Testim
Flickr/anokarina

Auxilium Pharmaceuticals goes to trial today in Illinois federal court over allegations that the company grossly misrepresented what Testim is safe to treat. This will be the second drug company to face a jury in the ongoing testosterone replacement multidistrict litigation (MDL).

According to plaintiff Steve Holtsclaw, he suffered a heart attack about seven months after his doctor prescribed Testim to treat chronic fatigue. The FDA has only approved Testim to treat classic causes of low testosterone, such as genetic defects and testicular injuries. However, Holtsclaw alleges that the company aggressively marketed the drug to treat a much larger variety of symptoms associated with age-related drops in testosterone. Consequently, Holtsclaw claims that Auxilium deceived the public and medical community about what the drug was safe and effective to treat. Furthermore, he alleges that the drug company failed to warn about significant heart attack risks.

As only AbbVie has faced a jury in the MDL, the trial should provide an exceptionally indicative litmus test as to the relative strengths and weaknesses of one of the country’s largest litigations.

Testim Trial Background

Auxilium, AbbVie, Eli Lilly & Co, and other pharmaceutical companies all face similar allegations in the MDL. Plaintiffs, like Holtsclaw, claim that these companies expended a great deal of resources to create the “Low T” market. Furthermore, they were targeting at risk men in the process. The aggressive “Low T” campaign gave a name to the normal process of male aging, while providing a “quick fix” for men to feel and look younger. In fact, these companies allegedly did more than give it a name. They made it a medical condition and profited massively off the treatment.

Currently, there are more than 7,500 testosterone therapy cases pending in the ongoing Northern District of Illinois MDL. In the first bellwether trial against AbbVie, the jury cleared the big pharma giant of product liability claims. In fact, the jury did not even award any compensatory damages. However, they did levy a $150 million punitive damages verdict for AbbVie’s destructive advertising practices… in a product liability case. AbbVie’s second time before a jury didn’t bode much better for the healthcare conglomerate. The jury awarded compensatory damages of $140,000 for the plaintiff’s heart attack. But, then they hit AbbVie with $140 million in punitive damages. Punitive damages are designed to punish companies for immoral behavior. These verdicts speak volumes about the immorality at work behind the “Low-T” movement.

Consequently, Auxilium may argue that Testim did not directly cause Holtsclaw’s heart attack, but it looks like a product liability defense may not be enough to get them off the hook for their general business practices. Regardless, depending on how jurors react to a new defendant, this trial could potential set the tone for remaining bellwethers.

Xarelto Litigation Hits the City of Brotherly Love

By Emily Cox
xarelto litigation
Flickr/Jordan Staub

The first state court trial in the Xarelto litigation over allegations that the blockbuster blood thinner causes dangerous bleeding begins in Philadelphia today on the heels of three decisive victories by the drug manufacturers in the federal litigation.

Bayer’s billion dollar baby is used to reduce the risk of stroke and blood clots in patients with atrial fibrillation, a common heart disorder. However, there are currently about 1,500 cases in Philadelphia’s mass tort program alleging Xarelto caused life-threatening bleeding. Lynn Hartman will be the first to go to bat against healthcare behemoths Bayer and Johnson & Johnson’s Janssen Pharmaceutical unit.  Consequently, Hartman’s case could set the pace for this branch of the Xarelto litigation.

The Indiana resident alleges that she suffered gastrointestinal bleeding after using the anticoagulant for about a year. As a result, she spent four days in hospital. Since she’s stopped taking Xarelto, she has not experienced any additional internal bleeding. However, despite the severity of her injuries that doctors attributed to Xarelto, Hartman may have a tough road ahead to win over jurors.

Janssen and Bayer have convinced Louisiana and Missouri federal juries to clear them of all product liability claims thus far. But, Xarelto’s safety has little to do with these victories.

Federal Xarelto Litigation Has Hinged on FDA Interactions

So far in the federal multidistrict litigation (MDL), plaintiffs’ cases have relied on allegations that the Xarelto label should have included information about blood testing to determine if patients had higher bleeding risks. However, Janssen and Bayer have evidence that they went to the FDA to specifically request if this labeling was necessary.  Consequently, jurors ruled that these FDA interactions show that the companies exercised foresight to protect patients even though the companies cashed in heavily on this waiver from the FDA to market Xarelto.

They promised patients that regular blood-testing protocols were a thing of the past to skyrocket Xarelto’s sales. Xarelto made $582 million in sales during its first full year on the market. In 2013, this figure rose to $2 billion for the fiscal year. Xarelto is now Bayer’s top-selling product. It brought in $2.5 billion in sales in 2015 and $3.24 billion in 2016. It is third on Janssen’s product roster, generating $2.29 billion for the company in 2016. Regardless, these factors weren’t enough to sway jurors in favor of previous plaintiffs. There wasn’t even much deliberation before jurors handed over these victories. However, plaintiffs are currently appealing these verdicts based on opinions and speculative testimony from the drug companies’ experts in their trials.

Xarelto Litigation May Take New Direction in Philly

However, Hartman may have an ace in the hole. Most experts expect that jurors will still take FDA interactions into consideration. But, Hartman’s case doesn’t hinge on more complicated disputes over prescription blood testing. Hartman is simply claiming that the companies failed to adequate warn about the bleeding dangers. This includes the fact that Xarelto, unlike other similar blood thinners, doesn’t have a reversal agent to stop emergency bleeding. In a September pretrial hearing, Hartman’s legal team stated that her case was an allegation that “the Xarelto label lacked the requisite intensity to reasonably warn of danger.”

If Hartman’s team can successful win a simple failure-to-warn claim, then this could prove to be a successful strategy going forward in the federal litigation which currently has 20,000 cases pending against the companies.

 

Xarelto Plaintiffs Take Cases to Appeals Court

By Emily Cox
Xarelto plaintiffs appeal
United States Court of Appeals for the Fifth Circuit (Flickr/Jeffrey Schwartz)

There’s no question that Bayer and Johnson & Johnson’s Janssen Pharmaceuticals have absolutely dominated the Xarelto bellwether trials so far. But, Xarelto plaintiffs are not packing it in and heading home to lick their wounds quite yet. Two Xarelto plaintiffs who lost trials earlier this year are calling for round two against the healthcare goliaths for failing to warn about the blood thinner’s uncontrollable bleeding risks. And, now they’re taking their fight to the U.S. Fifth Circuit Court of Appeals

Plaintiffs Joseph Boudreaux and Joseph Orr filed notices of appeal this past Wednesday. The pair outlined a total of nine court decisions dating back to April for the appeals court to consider. This was after the judge overseeing the ongoing multidistrict litigation (MDL) denied them new trials in late September.

Boudreaux lost his trial in May. He is appealing the court’s June 15 judgement on the jury verdict. Meanwhite, Orr lost his trial one month later in June. He is appealing a May 4 order denying him judgement and his jury verdict judgement, as well as the amended verdict judgement. Orr is also questioning another order denying his motion in limine from May 26.

Both Xarelto plaintiffs are appealing September 19 and September 20 orders denying their new trial requests. They’re also both appealing an order denying their request to exclude opinions and speculative testimony from the drug companies’ expert. Finally, they are both appealing an April 18 order sustaining several motions in limine the drug companies had filed.

Having secured their third straight victory, Bayer and Janssen are batting a thousand in the Xarelto MDL. However, a fourth bellwether trial is still pending. And, it doesn’t look like their victories are assured.

Xarelto Plaintiffs Allegations

The FDA approved Xarelto in October 2011 to reduce the risk of stroke and life-threatening blood clots in patients with nonvalvular atrial fibrillation. The agency also approved Xarelto to treat blood clots, pulmonary embolism, and other cardiovascular conditions. Bayer and Janssen immediately sought to dethrone warfarin (Coumadin) as the standard treatment for these conditions. Consequently, the companies exaggerated Xarelto’s advantages over warfarin. They touted Xarelto’s once-daily regimen and promised patients that regular blood-testing protocols were a thing of the past with the new drug. However, they neglected to mention that Xarelto has no reversal agent to stop its blood thinning effects. Warfarin’s effects can be negated with vitamin K in emergency bleeding situations. Consequently, many Xarelto patients experienced life-threatening bleeding events with no readily available remedy, leading to high mortality rates.

Dangerous gastrointestinal bleeding, requiring blood transfusions, landed Boudreaux in the hospital less than a month after starting treatment with the drug. Orr lost his wife, Sharyn Orr, to a stroke after she started treatment with Xarelto. Both Xarelto plaintiffs allege that Bayer and Janssen misrepresented the safety of the drug to the public and FDA. Furthermore, they question issues surrounding certain clinical trial results. The Xarelto plaintiffs also claim that the companies failed to warn doctors of Xarelto dangers or provide guidance on treatment protocols for bleeding events.

Almost 20,000 Xarelto Plaintiffs Have Lawsuits Pending in Louisiana

Almost 20,000 Xarelto plaintiffs have cases pending in the Eastern District of Louisiana. These Xarelto patients all suffered bleeding episodes like Boudreax’s and Orr’s. These bleeding events include hemorrhage, gastrointestinal bleeding, hemorrhagic stroke, and cerebral bleeding.

Xarelto plaintiffs dispute the blood thinner’s superiority over warfarin, especially in light of no agent to control or stop dangerous bleeding. They further claim that Xarelto patients would benefit from regular blood monitoring. Xarelto plaintiffs also question if Xarelto’s one-size-fits-all, one-daily dosing benefits sales more than it does patients.

Dangerous Antibiotic Created Just to Replace Cipro Profits

By Emily Cox
dangerous antibiotic
Flickr/Conan

According to a new lawsuit, Bayer did not develop Avelox in response to any real medical need. Rather, the multinational behemoth hurriedly created the fluoroquinolone, foregoing appropriate pre-market testing, and aggressively marketed the dangerous antibiotic solely to replace any profits that may be displaced from Cipro’s imminent patent expiration. Avelox quickly became Bayer’s “heir apparent and successor to Cipro,” due to Bayer’s conscious concealment of serious side effects. These side effects including peripheral neuropathy and permanent nerve damage from as little as five days of use.

Kecia Bailey Southerly filed the complaint Monday. Her physician prescribed her Avelox in August 2010 for approximately 10 days. As a result of her Avelox use, she developed peripheral neuropathy and it looks as though she may suffer from the condition for the rest of her life. This condition relates to weakness, numbness, and pain from nerve damage, usually in the hands and feet.

Southerly alleges that Bayer marketed the dangerous antibiotic as “safe and effective” and that it had “a well-characterized safety profile.” Consequently, even though the FDA approved the drug to treat serious infections, such as the plague, Bayer’s fraudulent marketing encouraged physicians to use Avelox to treat more routine illnesses like ear and urinary tract infections.

According to her lawsuit, Bayer’s entire promotional campaign focused on Avelox’s impeccable safety profile. However, the pharmaceutical giant knew that scientific evidence had established a “clear association” between Avelox and an increased risk of long-term and sometimes irreversible peripheral neuropathy.

Avelox’s warning label from 2004 to 2013 indicated that peripheral neuropathy was a “rare” side effect and failed to mention that it could result in irreversible nerve damage like Southerly’s. This significantly debilitating injury was purposefully buried at the bottom of the extensive list of adverse reactions on the Avelox label.

Dangerous Antibiotic Found to Cause Permanent Nerve Damage

Since the early 1990s, there has been evidence of a significant association between fluoroquinolone antibiotics and peripheral neuropathy. “Peripheral Neuropathy Associated with Fluoroquinolones” by Jay S. Cohen was one of the first U.S. studies to address post market experiences with Avelox and neuropathy. The Cohen paper was published in December 2001. Cohen followed-up with forty-five patients who reported adverse events from the dangerous antibiotic. In particular, he noted the presence of severe and persistent nerve problems. More than half the patients’ symptoms lasted for more than a year. Eighty percent characterized their symptoms as severe.

In 2002 and 2003, the FDA put Bayer on notice that high number of reports indicated that Avelox patients were developing long-term disabling peripheral neuropathy. Finally, in August 2013, the FDA decided to intervene in response to mounting evidence of the relationship between the dangerous antibiotic and severe, long-term neuropathy. The agency mandated that the risk for peripheral neuropathy and permanent nerve damage be added to the Avelox’s prominent black box warning.

However, despite stronger warnings, serious side effects continued to persist in alarming numbers. Consequently, the FDA had to step in once again. This time, the agency required that Bayer also release “Dr. Doctor” letters to accompany these even strong safeguards against the dangerous antibiotic. The FDA and Bayer’s letter indicate doctors should reserve Avelox treatment solely for life-threatening situations for patients who have no alternative treatment options. In other words, avoid this treatment at all costs unless it is literally the only option.

Dangerous Antibiotic MDL

Most likely, Southerly’s case will join the ongoing multidistrict litigation (MDL) over Avelox neuropathy.

In August 2015, the Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal neuropathy fluroroquinolone cases in the District of Minnesota for pretrial proceedings. The panel assigned the multidistrict litigation (MDL) to Judge R. Tuhheim. The MDL consists of Cipro, Levaquin, and Avelox cases.

According to an order from Oct. 12, the court has extended the non-expert fact discovery deadline for the MDL until January 26, 2018. However, case-specific discovery for Avelox-only and Cipro-only discovery must be complete by January 19, 2018.

Given Southerly’s timing, her case could be eligible for an early trial date. MDL parties will be submitting bellwether trial candidate recommendations by February 2, 2018. Bellwether trials help parties gauge how juries are likely to react to evidence that will be present throughout the litigation. This also helps both sides determine their relative strengths and weaknesses in the overall litigation.

Bellwether trials for Avelox lawsuits will commence:

  • November 5, 2018
  • January 8, 2019
  • June 10, 2019
  • August 5, 2019

A Cipro-only bellwether trial will begin March 4, 2019.

 

 

Potential Taxotere Plaintiffs Need to Act Now

By Emily Cox
Taxotere Plaintiffs
Flickr/ewvasquez2001

Time is running out for potential Taxotere plaintiffs to participate in ongoing settlement considerations. This window closes today and will leave many breast cancer survivors, who received Taxotere (docetaxel) treatments and experienced permanent hair loss, behind as settlement negotiations continue to move forward. Taxotere lawyers must submit information on all pending and anticipated Taxotere plaintiffs by today to guarantee inclusion in any future settlement. This may be the last chance for many Taxotere victims to receive financial compensation for the taxane manufacturer’s inexcusable greed and negligence in its nefarious marketing of Taxotere – overstating the drug’s effectiveness, hiding side effects, and paying off doctors to prescribe the drug against FDA indications. Taxotere survivors must contact a Taxotere attorney now to secure their right to receive compensation for their injuries.

Sanofi Exposed Taxotere Plaintiffs to Danger for Financial Gain

Taxotere’s manufacturer, Sanofi S.A., bribed physicians to prescribe the highly-toxic chemotherapy treatment for less aggressive cancers against FDA recommendations; lied about the drug’s superior effectiveness over less toxic treatments; and hid permanent hair loss risks. Sanofi’s…creative…Taxotere marketing launched the controversial taxane to the top of its drug class. It’s time to take back some of what Sanofi has taken from so many women as they balanced on the precipice of losing everything.

Many people think that the Taxotere litigation boils down to vanity. But, it’s not about permanent hair loss, in and of itself. It’s about making Big Pharma take accountability for their actions and responsibilities. It’s about showing these companies that patients are more than data points in quarterly sales reports. Most of all, it’s about doing everything possible to stop these companies from doing this to future patients. Sanofi preyed on these women when they were at their most vulnerable for financial gain. The company denied them the ability to make an informed decision regarding their care, wrenching away one of the last vestiges of control that these women had and took it straight to the bank. Sanofi took that choice away when it hid the risk of permanent alopecia, misrepresented the drug’s effectiveness, and illegally incentivized doctors to recommend Taxotere.

Taxotere Plaintiffs – Background

Taxotere is a high-potency chemotherapy drug, manufactured and marketed by Sanofi S.A. Other taxanes include Taxol (paclitaxel) and Abraxane (albumin-bound or nab-paclitaxel). Taxanes interfere with the ability of cancer cells to divide. Taxotere is usually given in combination with other chemotherapy drugs.

The FDA approved Taxotere in 1996 to treat advanced or metastatic breast cancer after other chemotherapy treatments have failed. However, somehow doctors treat the majority of breast cancer cases in the U.S. with Taxotere, indicating that the drug is also being prescribed as a first line treatment for less aggressive cancers rather than its approved uses. With about 300,000 breast cancer cases diagnosed each year, Taxotere is the most prescribed drug in its class despite the fact that studies show that less-toxic Taxol is more effective. In 2009, Sanofi made more than $3 billion from Taxotere before losing patent protection.

Not only is Taxol more effective and less toxic than Taxotere. It also doesn’t have the same permanent side effects as Taxotere. Studies have linked Taxotere with about a 10 percent occurrence of permanent hair loss. Sanofi knew about this side effect and hid it from its most profitable market – American women.

Sanofi knew about Taxotere’s alopecia risk since at least 2005. This is when the company updated Canadian warning labels to specifically include this risk. Sanofi would go on to update European warning labels in 2012. Somehow, the U.S. must just have gotten lost in the shuffle, because warning labels would not include this warning until the end of 2015. This was more than a decade after Sanofi became aware of a GEICAM study showing that 10 percent of Taxotere patients suffered permanent hair loss. Even the company’s own studies indicated more than a nine percent rate for permanent alopecia occurrence.

Taxotere Plaintiffs MDL and Allegations

The Judicial Panel on Multidistrict Litigation (JPML) consolidated all Taxotere plaintiffs in Louisiana federal court in late 2016. At the time, there were less than three dozen such cases. Since then, the multidistrict litigation has swollen to almost 1,700 women determined to take Sanofi to task for the irreparable harm the company has caused. These women’s allegations include:

  • Selling Taxotere without disclosing dangers or risks
  • Manufacturing a dangerous drug
  • Concealing information from consumers
  • Marketing Fraud
  • Providing illegal kickbacks and financial incentives for doctors to prescribe Taxotere off-label
  • Misleading the public in advertising and marketing
  • Downplaying the drug’s dangers
  • Failing to properly warn doctors and patients
  • Failing to determine if the drug was safe
  • Selling the drug without properly testing it

If you, or a loved one, experienced permanent hair loss after being treated with Taxotere for breast cancer, you need to get in touch with a lawyer today to take Sanofi to task for the irreparable physical, emotional, and financial harm the company has caused thousands of American women when they were at their most vulnerable. Call (800) 305-6000 today to secure your place in a future Taxotere settlement. Don’t let this door close. There may not be another.

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