Category: MDL

Non-Hodgkins Lymphoma Claims Against Monsanto Continue to Mount

By Emily Cox
non-hodgkins lymphoma
Flickr/Mike Mozart

On the heels of the European Union approving the use of the controversial weed killer glyphosate for the next five years, individuals continue to surge forward with claims that the herbicide causes non-Hodgkins lymphoma.

Patricia Lashock filed the most recent of these claims Thursday, claiming severe and permanent harm from the weed killer. She alleges that she developed non-Hodgkins lymphoma after using glyphosate-containing products, including the Roundup, from 1977 to 2010. Lashock joins hundreds of other individuals asserting that Monsanto falsified scientific studies and colluded with worldwide regulators to hide glyphosate’s substantial health risks. Furthermore, internal Monsanto documents indicate that the manufacturer knew Roundup could cause cancer and non-Hodgkins lymphoma.

“If somebody came to me and said they wanted to test Roundup I know how I would react – with serious concern,” a Monsanto scientist confided in a 2001 internal email.

Glyphosate is the primary ingredient in Roundup and the best-selling herbicide in the world. However, this should come as no surprise. Monsanto essentially owns the global seed market. It has made sure that the majority of its seeds are glyphosate dependent, making worldwide agriculture Monsanto dependent.

Consequently, despite substantial indications that glyphosate causes non-Hodgkins lymphoma and even an official carcinogenic classification from the World Health Organization, the EU bowed to this dependency this past week when it voted to extend its authorization for glyphosate for an abbreviated five-year period. However, the deliberations over the extension were unusually lengthy and combative. Monsanto’s tainting of glyphosate scientific reviews with its meddling was a particular point of contention.

France led the opposition to allowing the use of glyphosate to continue. French President Emmanuel Macron announced after the vote that he had requested government officials to come up with a plan to ban the herbicide in his country within three years.

Round-up Non-Hodgkins Lymphoma Federal Litigation

Lashock’s case will join hundreds of other similar cases pending in the federal multidistrict litigation (MDL).  In October 2016, the Judicial Panel on Multidistrict Litigation (JPML) consolidated all Roundup non-Hodgkins lymphoma lawsuits. Judge Vince Chhabria is presiding over the litigation in the Northern District of California. Due the complexity of the litigation and number of plaintiffs, the panel felt that judicial efficiency would be best served through centralization. This reduces duplicate discovery and conflicting rulings that can further bog down these already complicated proceedings.

Judge Chhabria previously agreed to Monsanto’s proposal to bifurcate the federal Roundup litigation. Consequently, the court will first address issues of general causation over the link between Roundup and non-Hodgkins lymphoma. Expert testimony for this portion of the pretrial process begins March 5, 2018. The court will then move on to case-specific issues to determine if Roundup caused the cancer of specific plaintiffs. As a result, it is possible that the first state court trials will begin ahead of the federal trials.

 

 

 

 

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.

 

 

Hip Bellwether Hits J&J with $247M Verdict

By Emily Cox

DePuy Pinnacle Metal Hip BellwetherA federal jury slammed Johnson & Johnson and its DePuy Orthopaedics unit with a $247 million verdict today in the latest Texas hip bellwether trial over grossly defective metal-on-metal hip implants. This is the third consecutive nine-figure verdict in the multidistrict litigation (MDL).

The Texas jury unanimously found J&J and DePuy liable for numerous design and manufacturing defects in the Pinnacle hip line, as well as deceptive business practices and fraud. Jurors ruled that the companies had acted recklessly and maliciously, endangering patients for financial gain. They awarded $90 million and $78 million in punitive damages against J&J and DePuy respectively to punish the companies for their reprehensible behavior.

The jury awarded more than $77 million for medical expenses, as well as pain and suffering, for the six New York plaintiffs. This includes the plaintiffs’ actual past medical expenses and future costs they will incur because of their substantial injuries from the defective metal hips. The hip bellwether jury also awarded four of the plaintiffs’ spouses $1.7 million for loss of consortium damages.

Hip Bellwether Trial Verdicts

The verdict comes after a two-month trial. Plaintiffs alleged that the companies concealed substantial defects and risks to profit from the dangerous metal hip implants. This was the fourth hip bellwether in the ongoing MDL. The federal litigation has more than 9,000 cases that claim Pinnacle Ultamet’s design defects caused painful and debilitating injuries. In 2016, federal juries found in favor of two groups of plaintiffs from Texas and California. Jurors awarded them $502 million and more than $1 billion damages respectively. However, the court later reduced these verdicts to $150 million and $543 million. In the first hip bellwether, the jury sided with J&J against a singular Montana plaintiff.

Specifically, the jury found the companies liable for design defects, negligent design, deceptive business practices, inadequate warnings, negligent manufacturing, manufacturing defects, and negligent misrepresentation. They also found J&J and DePuy intentionally misled surgeons and fraudulently concealed hip defects from patients and surgeons. Furthermore, jurors found J&J guilty of negligently undertaking of a duty to provide services to DePuy and aiding and abetting the subsidiary in its abhorrent conduct. The jury did not find that the company had intentional misrepresented the hips’ safety directly to patients.

Hip Bellwether Trial

During the hip bellwether, plaintiffs told jurors they’d suffered an array of serious injuries. These include severe tissue damage that caused permanent muscle loss, intense pain, loss of hip movement, and permanent disabilities. They also alleged the defective Pinnacle hip shed metallic debris into their bodies. These debris caused substantial side effects like heavy metal poisoning, pseudotumors, and hip failure. J&J and DePuy never warned surgeons of these risks and could have avoided them with a safer design.

The hip bellwether plaintiffs claim J&J and DePuy valued marketing above research and development. The companies rushed the defective hip into production without human clinical trials to capture a greater market share. Instead, they used unwitting patients as guinea pigs. Furthermore, they lied to surgeons that the Pinnacle product was 99 percent successful to increase sales. J&J and DePuy also used cheaper, less safe alternatives in manufacturing the hips to keep costs down and profits up. The resulting defects in the metal implants turned patients’ hips into “ticking time bombs.”

During closing arguments, plaintiffs’ counsel urged the jury to punish J&J “for being indifferent to our health” with a massive punitive damages award to send a message to other companies that they can’t expect to get away with selling “poison” and marketing it as candy.

Despite overwhelming evidence to the contrary, J&J continues to deny putting profits above patient safety.

Mirena Pseudotumor Litigation Hits Critical Phase

By Emily Cox
Mirena pseudotumor
Bronze cast of Mirena IUD (Flickr/Sarah Mirk)

The Mirena pseudotumor cerebi multidistrict litigation (MDL) over serious harm caused by Bayer’s hormone coated device is now entering the discovery phase with lawyers taking a multitude of first-round depositions over the next month in Finland, London, and New Jersey. Due to the MDL’s aggressive track, the next twelve months could be critical for Mirena pseudotumor plaintiffs.

Bayer continues to maintain that its Mirena intrauterine device (IUD) is a safe and effective method of birth control. However, hundreds of young women are claiming the device caused pseudotumor cerebri (PTC), also known as intracranial hypertension (IH).

Mirena is a T-shaped plastic device coated with levonorgestrel, a synthetic progestogen hormone. Physicians insert the device into the uterus to prevent pregnancy for up to five years. However, no one is exactly sure how Mirena accomplishes this. According to the MDL’s statement of claim, “it is not known exactly how Mirena works, but Mirena may thicken cervical mucus, thin the uterine lining, inhibit sperm movement and reduce sperm survival to prevent pregnancy.”

Consequently, lawyers are now taking depositions from Bayer representatives with knowledge of the company’s IUD product. Hearings to qualify expert witnesses, known as Dalbert Hearings, will begin in early 2018.

Mirena Pseudotumor Allegations

Peer-reviewed scientific evidence in the litigation indicates a number of distressing complications from Mirena pseudotumor cerebri. The most serious of which is permanent blindness. However, the condition also comes along with severe headaches, dizziness, blurred vision, neck stiffness, nausea, vomiting, and ringing in the ears. Along with varying levels of permanent vision loss, many Mirena users also experience weight gain. However, most physicians and consumers are not aware of the connection between the device and their symptoms. Bayer warns against Mirena stroke risks. But, the label does not mention any of these additional complications. Consequently, there could still be a significant number of potential plaintiffs that do not know that Mirena caused their injuries.

The FDA first approved the Mirena IUD for birth control in 2000. The agency expanded the device’s indications to include heavy menstrual periods in 2009. Approximately two million women in U.S., and 15 million more around the world use the IUD for birth control.

Recently, another Mirena MDL fell apart when the judge rejected plaintiffs’ expert witnesses. This MDL alleged the device could migrate, causing serious injury or ectopic pregnancy. However, the current MDL over Mirena’s potential to cause pseudotumors is a completely different litigation and moving forward.

Bayer is also facing more than 10,000 lawsuits over its Essure birth control device. These women allege that the permanent birth control device caused truly debilitating injuries. These include severe pain, heavy bleeding, organ perforation, depression, weight gain, nickel sensitivity, infection, allergic reaction, ectopic pregnancy, and even death. In addition to these problems, it is next to impossible to remove the device alone. Consequently, many young women face hysterectomy to remove the Essure coils.

Recently, congress members reached out to the FDA’s commissioner to request a meeting to address the agency’s inaction regarding Essure.

 

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?

 

Stryker Hip Implant Litigation Sets First Trial

By Emily Cox

stryker hip

The Stryker hip implant federal multidistrict litigation (MDL) over serious injuries from the company’s defective LFit v40 component is pressing forward with preparing for the first trial to go before a jury in September 2019.

The Stryker hip litigation centers on the company’s LFit v40 femoral head that was used in several hip replacement systems. The company removed the implant from the market this past year as disturbing complications from the Stryker hip component skyrocketed. Specifically, taper lock failures with the cobalt-chromium femoral head caused significant problems. These included metal poisoning, significant pain, inflammation, loss of mobility, disassociation, and the need for dangerous revision surgery. Plaintiffs in the litigation continue to suffer to this day despite undergoing additional invasive procedures. They allege that Stryker misrepresented the safety of the device to the detriment of thousands.  Now, they are out for justice against the negligent manufacturer.

Judge Indira Talwani issued the critical case management order on October 25. The order outlines essential future communication protocols and the process for selecting a group of cases for early trials. Parties are to submit a proposed order to address procedures for identifying cases and for case-specific discovery by December 1. They need to identify these specific cases by February 2, 2018, and complete common fact discovery by October 4, 2018. Then, the parties will engage in expert discovery, filing pretrial motions on evidence admissibility by March 2019. Finally, if Stryker hip settlements have not been reached following the discovery process, the Court will proceed with the first bellwether trial on September 16, 2019.

Stryker Hip Litigation

As the number of individuals filing lawsuits continued to escalate, the Judicial Panel on Multidistrict Litigation (JPML) centralized the litigation earlier this year before Judge Talwani in the District of Massachusetts in order to avoid duplicate discovery and conflicting pretrial orders that would further hold up the litigation.

This is not the first time that such measures have been necessary for defective Stryker hip systems and components. The JPML established similar proceedings following the 2012 Stryker Rejuvenate and ABG II recall. However, before these lawsuits could go to trial, the manufacturer agreed to settle the litigation. The company paid more than $1 billion in Stryker hip implant settlements to resolve cases for thousands of individuals who required revision surgery after the recalled implants failed.

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.

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