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.
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.
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.
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.
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.
Most of the controversial surrounding Invokana involves the rapidly mounting reports of renal failure, as well as kidney disease and injury, caused by the type 2 diabetes medication. However, as Johnson & Johnson (J&J) makes a push for the FDA to expand the drug’s indications to include reducing cardiovascular risks, a former Invokana user is calling foul. Her lawsuit indicates that J&J could be misrepresenting its billion-dollar diabetes blockbuster’s cardiovascular benefits to expand Invokana’s market share, while hiding significant Invokana stroke risks. Furthermore, the study that J&J is relying on to clinch its expanded FDA indications also found that Invokana approximately doubles lower-limb amputation risks. But, in the topsy-turvy world of J&J and its Janssen Pharmaceuticals unit, even limb loss can be a victory as long as the appendage’s pounds are counted toward their Invokana weight loss data.
Patricia Shultz filed the complaint directly into the ongoing District of New Jersey MDL on Wednesday. She alleges that the manufacturers misled the public and medical community about Invokana’s safety, minimizing unfavorable findings while screaming their victories from the rooftops and along the PR newswire to increase sales at the cost of consumers.
Schultz began taking Invokana in October 2015. Within a month, she suffered a debilitating stroke in early November 2015. According to the lawsuit, Schultz’s life will never be the same. There’s no going back to her life before Invokana. She can only try to get some closure and hopefully help force J&J’s hand to strengthen Invokana warning labels.
J&J Knew About Invokana Stroke Risks
From early clinical trial data, J&J knew that there was an elevated Invokana stroke risk. This risk is especially prevalent in older females during the first couple of months of treatment. However, J&J never warned women like Schultz. J&J placed Invokana sales above the lives of the very people the company purports to help. J&J knew many of their lives would be forfeit from its negligent Invokana marketing. But, evidently, these lives didn’t amount to much in the company’s overall cost-benefit analysis. Now, on the heels of the publication of 2013 – 2017 Invokana study, J&J is pushing for the FDA to expand Invokana’s indications to include reducing cardiovascular risks.
On October 3, J&J subsidiary Janssen submitted a supplemental New Drug Application (sNDA) for Invokana to the FDA. Although J&J and Janssen have aggressively marketed Invokana for off-label uses for years, doing it legally is unfamiliar territory for the pharmaceutical companies. They are seeking a new indication for Invokana (canagliflozen) to reduce the risk of major adverse cardiovascular events in adult type 2 diabetics who are at risk for or have cardiovascular (CV) disease. These events include CV death, as well as nonfatal myocardial infarction (MI) and stroke. This sudden interest in going legit with market expansion is due to the findings of the long-term CANagliflozin cardioVascular Assessment Study (CANVAS). However, while J&J is blasting the study’s favorable outcomes, it has completely disregarded pretty much all other data, including serious indications of early cardiovascular events and amputation risks.
Invokana Stroke Risks and Benefits from CANVAS Study
Back in June, J&J could not wait to tell the world of Invokana’s triumphant CANVAS results. The healthcare behemoth hardly waited for researchers to finish presenting their findings at a special symposium before broadcasting Invokana’s miraculous cardiovascular benefits, including stroke prevention. Quite the turn around, considering the study’s preliminary data that gave many at the FDA pause during Invokana’s initial approval.
Like a great deal of J&J’s communications, it balances on that infinitesimal line between lies and the truth. And, J&J is nothing short of an accomplished acrobat when it comes to these maneuvers.
Yes, CANVAS study results do indicate that Invokana does seem to reduce overall risk of cardiovascular death. However, as FDA official Dr. Hyon Kwon notes, there was marked increased incidence of early cardiovascular events. Almost all these cardiovascular events were thrombotic, or ischemic, stroke.
In its boasting over Invokana’s spectacular cardiovascular benefits, J&J only mentioned two specific risks that Invokana seemed to reduce – nonfatal MI and nonfatal stroke. However, the nonfatal stroke benefits don’t quite kick in until 1-6 months after starting treatment. Until then, these risks actually increase. Initial CANVAS data indicated a 46 percent elevated Invokana stroke risk, especially within the first 30 days of treatment. Dr. Sidney Wolfe, an FDA adviser, provided a possible explanation for this phenomenon. He noted that study patients had abnormal increases in the balance of red blood cells to plasma. This is also known as hematocrit.
Drugs like Invokana increase urine production to flush dangerously high levels of blood glucose out of the body. However, this increased urination not only puts extraordinary strain on the kidneys. It also can lead to increases in hematocrit. The blood becomes literally thicker. This tends to gunk up the gears, leading to blood clot formation, strokes, and heart attacks.
Beyond Invokana Stroke Risks
Since the FDA approved Invokana in 2013, the agency has revisted the drug’s side effects numerous times. Due to high rates of various injuries, the agency has added several additional warnings to Invokana. And, almost every new warning seems determined to outdo the previous one, as the risks became progressively more horrifying.
In September 2015, the FDA announced that Invokana causes premature bone loss and fractures. Then, in December 2015, the agency warned that Invokana causes diabetic ketoacidosis, kidney infections, and urosepsis. This was followed by March 2016’s warning that Invokana causes severe renal impairment, angioedema, and anaphylaxis. Finally, in May 2017, an Invokana side effect warning was granted the ultimate crowning achievement – its own prominent black box to make sure that patients and doctors cannot help but see it. Invokana-related amputations took top honors for doubling patients’ risk of losing a lower extremity. This side effect isn’t present in any of the other SGLT2 drugs in Invokana’s drug class. It’s truly what sets Invokana apart from the crowd.
Despite the horror show of risks and side effects, Invokana brings in more than $1 billion annually. However, sales fell a little flat at $1.31 billion in 2016. So, J&J is hedging its bets that, if the FDA approves Invokana to prevent CV death, then either patients will ignore the cavalcade of conditions that the drug causes, or that they see the black box warning and are looking to lose 5-20 pounds by any means necessary.
As the Taxotere permanent hair loss multidistrict litigation (MDL) continues to gain momentum with the selection and scheduling of bellwether trials, behind-the-scenes Taxotere settlement negotiations are kicking into high gear. According to a recent pre-trial order, attorneys need to submit information on all pending and anticipated Taxotere lawsuits by Monday, October 16, to guarantee inclusion in any future settlement. This means that women who experienced permanent hair loss after undergoing Taxotere treatments for breast cancer and haven’t already spoken with a Taxotere attorney need to reach out immediately to ensure their places in a settlement agreement.
District Judge Kurt D. Engelhardt issued the pre-trial order September 7 with an original deadline of September 30. Fortunately, the court granted an extension until October 16. But the door is still quickly closing on potential Taxotere settlement participants. However, this doesn’t necessarily mean that the door will actually slam shut this coming Monday. The court requires that lawyers update informational filings with the court regularly, so there still may be some fluidity after the deadline. But, all guarantees are off-the-table. Engelhardt is directly compelling Taxotere lawyers. However, the implications to potential plaintiffs are clear. Attorneys can’t submit information that they don’t have. Plaintiffs need to file now or risk exclusion from Taxotere settlement compensation.
Taxotere Settlement Alopecia Allegations
Thousands of women are currently standing together in the ongoing MDL to take Taxotere manufacturer Sanofi S.A. to task for its greed and negligence. All these women allege that they have experienced permanent hair loss, also known as alopecia, due to Taxotere. Furthermore, if Sanofi S.A., had been honest about the chemotherapy drug’s efficacy and side effects, then most women may never have every chosen Taxotere as a treatment options. According to MDL plaintiffs, Sanofi S.A. concealed Taxotere’s more unsettling side effects, including permanent baldness, to maximize profits while marginalizing these women’s ability to return to a normal life after breast cancer.
According to MDL allegations… and common sense, Sanofi S.A. 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 S.A. 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-Aventis 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.
Hair loss risks aside. Given the choice, any sane woman is going to choose life over hair if it’s her best chance at survival. Sanofi S.A. told the medical community and women who were fighting for their lives that Taxotere was their best shot. It was a great marketing move. But, it was also a complete fabrication. Sanofi S.A. actively concealed unfavorable findings from studies that showed that the less toxic chemotheraphy treatment Taxol was more effective than Taxotere. Despite these post market studies, Sanofi S.A. continued to promote Taxotere’s “superior efficacy” over Taxol. Consequently, Sanofi S.A. exposed thousands of women to the higher toxicity of Taxotere and its side effects for absolutely no personal benefit.
The FDA finally intervened in 2009 and issued a warning to Sanofi S.A. The agency cited the company for “false and misleading” claims of superiority, which constitutes product misbranding – a federal crime. The FDA demanded that the company immediately stop distributing any materials that even hinted at superior effectiveness.
Beyond the Taxotere Settlement
Beyond the potential Taxotere settlement, Sanofi S.A. is also facing allegations from a former employee and the U.S. government for fraudulent marketing practices to increase sales. The FDA only approved Taxotere for the treatment of certain aggressive, late stage cancers after other treatments have failed. However, Sanofi S.A. took extraordinary measures to expand Taxotere’s use…and damage.
In 1996, Sanofi S.A. started paying illegal kickbacks and providing other unlawful incentives to encourage doctors to use Taxotere as first-line treatment for less aggressive cancers. These kickbacks included entertainment, sports, concert tickets, sham grants, speaking fees, travel, preceptorship fees, and fee reimbursement. The company also trained and directed employees to deliberately misrepresent the safety and effectiveness of off-label Taxotere use. Consequently, Taxotere quickly became the most common treatment for all types and stages of breast cancer. And, the breast cancer drug’s revenue skyrocketed from $424 million in 2000 to $1.4 billion in 2004.
Taxotere Settlement MDL
There are currently almost 1,700 women with Taxotere lawsuits pending in the ongoing Eastern District of Louisiana MDL. However, hundreds, maybe thousands, more women like them are out there. Some may not even know that Sanofi wronged them and thousands of other breast cancer survivors just like them. These women deserve retribution, significant compensation, and closure. They’ve all more than earned it. But, time is running short. The time to step up is now.
If you, or a loved one, experienced permanent hair loss after receiving Taxotere treatments for breast cancer, do not hesitate. Call (800)305-6000 now for a free consultation to discuss your legal rights to participate in this settlement. This door closes Monday, October 16. It’s about time that Taxotere victims got some closure too.
Lawyers in the new proton pump inhibitor (PPI) multidistrict litigation (MDL) will have their work cut out for them today. They meet with the MDL’s District Court Judge to flesh out numerous structural and organizational facets that are essential to moving forward in the litigation against numerous heartburn PPI manufacturers over not disclosing significant kidney risks associated with Nexium, Prilosec, Prevacid, and other omeprazole drugs meant to regulate stomach acids to treat heartburn, gastroesophageal reflux disease (GERD), acid reflux, and stomach ulcers. Today’s grueling agenda will help shape the very foundation and core of the fledgling litigation. Everything going forward will be built on from this meeting. Consequently, the decisions made today will set the tone for the litigation moving forward.
Heartburn PPI MDL Gets Down to Business
The MDL parties submitted their Joint Status Report and Agenda this past Friday. The report indicated that lawyers for both sides will be conferring to resolve a number of structural and organizational elements that are necessary for the heartburn PPI MDL to move forward. Much of the attorneys’ work today will involve the creation and coordination of various schedules to make sure that pretrial proceedings are conducted as efficiently as possible. These various schedules include those for pretrial discovery, discovery demands, recurring status conferences, and telephonic conference calls for open court conferences.
They will also be touching on the protocol and timing for a potential “Science Day.” These non-adversarial presentations are common in complex pharmaceutical litigation to educate the court on key technical issues that are at the very heart of the mass tort). Additionally, the lawyers will also try to reach agreements regarding injury diagnosis and product identification records, as well as, Plaintiff and Defendant Fact Sheets.
Meanwhile, Judge Claire C. Cecchi will hear and decide on oral arguments related to proposed orders for dealing with Electronically Stored Information (ESI) and the Privilege Log. She will also review a direct filing order’s status so that lawyers can start filing additional cases directly into the MDL rather than incur costly delays by having to transfer cases from District Courts nationwide.
Heartburn PPI Medication Allegations
Currently, there are almost 300 product liability lawsuits over allegations that popular heartburn PPI drugs caused extensive kidney damage. Allegedly, heartburn PPI drug makers actively concealed significant health risks to further their own financial agendas. They also fostered off-label, long-term use to retain consumers as long as possible. Consequently, countless people with mild conditions are now living with acute kidney injury, acute interstitial nephritis, chronic kidney disease, and even end-stage renal failure. By downplaying these serious concerns, these drug makers put patients at considerable risk for permanent injury and even death.
These heartburn drugs are some of the leading brand medications on the U.S. market. PPIs, as a whole, are among the most commercially successful groups of medications in the U.S. Between 2008 and 2013, prescription PPIs raked in more than $50 billion dollars. And, this number doesn’t even include over-the-counter (OTC) drug sales. Nearly every one of these prescription medications have OTC counterparts. Millions are using these OTC Heartburn PPI drugs indefinitely to treat heartburn at the encouragement of companies that have not seen patients as actual people in a long time.
Heartburn PPI MDL
In August, the Judicial Panel on Multidistrict Litigation (JPML) granted the plaintiffs’ renewed federal consolidation request. The JPML had denied a previous request due to issues with the number of manufacturers involved in the litigation. However, as plaintiffs continued to come forward, the JPML finally conceded to centralize the litigation before District Judge Claire C. Cecchi in the District of New Jersey.
Consolidation can bee an invaluable tool in streamlining these types of mass torts. Limiting nationwide federal lawsuits to one court and one judge helps eliminate stumbling blocks inherent to a scattered litigation. Different districts and different judges introduce a whole host of variables in how these cases are approached. Consequently, pretrial rulings can be contradictory, which does nothing to further the litigation as a whole. Furthermore, discovery takes a great deal of resources for all parties. Without centralization, lawyers doing this separately in different courts for each case. With consolidation, parties can pool their collective resources to serve judicial efficiency.
Heartburn PPI Bellwethers
Going forward, Judge Cecchi will likely set the wheels in motion for a bellwether program. Generally, all parties will confer and agree to an early trial schedule. These early trials will consist of small groups of Nexium, Priloxec, Protonix, and other heartburn PPI cases. The court will allow both sides to submit trial candidate nominations. An equal portion of candidates from each side will prepare for early trial dates. If plaintiffs are overwhelmingly successful during the bellwether process, then settlement agreements may be on the table. However, this is never a guarantee. Regardless, these early trials help everyone involved get a feel for how the litigation could likely play out in the future. It also helps juxtapose the relative strengths and weaknesses on both sides of the v.
Due to the massive popularity of PPIs, experts expect that MDL plaintiffs will ultimately number well into the thousands.
In the latest testosterone trial, a federal jury ruled Thursday that AbbVie must pay more than $140 million in punitive damages for aggressively expanding Androgel’s market share through insidious machinations and flagrant misrepresentations of the testosterone gel’s safety.
This is the second testosterone trial in the multidistrict litigation (MDL) over manufacturers specifically targeting and exploiting aging men to increase sales despite serious cardiovascular risks. The plaintiff, Jeffrey Konrad, alleged that AbbVie had evidence connecting testosterone to significant cardiovascular events but never warned the medical community or general public. Instead, AbbVie put its desire to grow Androgel’s market before patients’ very lives. On its website, AbbVie claims that patients are what matter most. Where was this ideology when AbbVie was promoting its testosterone gel to aging men without mentioning the risks, conducting proper testing, or even getting FDA approval for expanding indications?
Konrad sued AbbVie five years after suffering a heart attack while using Androgel. However, the jury did not find AbbVie liable for his heart attack. But, it did find AbbVie guilty of negligence, intentional misrepresentation, and misrepresentation by concealment. The jury awarded Konrad $140,000 in compensatory damages. These cover $40,000 for medical care following his 2010 heart attack and an additional $100,000 for pain and suffering. However, these compensatory damages are merely a footnote in the punitive damages the jury levied against AbbVie.
The jury ordered AbbVie to pay $140 million dollars in punitive damages for its “reprehensible” behavior. Punitive damages punish companies for immoral business practices in the hopes that these companies will rectify these behaviors and at least try to act in a manner consistent with normal human beings rather than soulless corporate monsters that only see patients in terms of sales potential.
Testosterone Trial Punitive Damages Speak Volumes About Depths of AbbVie’s Depravity
Currently, there are almost 7,500 testosterone trial cases pending against AbbVie and other drug companies in the ongoing MDL in the Northern District of Illinois. Konrad’s trial concluded mere months after the MDL’s first bellwether trial. The first testosterone trial involved Jesse Mitchell’s heart attack while using Androgel. Like Konrad, the jury found that Mitchell already had significant pre-existing cardiovascular risk factors that negated product liability claims…in a product liability case. In fact, the jury did not even award any compensatory damages for Mitchell’s injuries. However, it did levy a $150 million punitive damages verdict against AbbVie for its outrageously misleading advertising. Unfortunately, it’s still unclear if punitive damages are even enforceable without accompanying compensatory ones. But, regardless, juries are sending a clear message about the morality of AbbVie’s business practices with these punitive damages verdicts.
Generally, liability is kind of crucial in a product liability case. Based on the name itself, one could argue that it’s pretty much the foundation of these kinds of cases. And, so far, plaintiffs are batting a thousand despite losing at trial over product liability claims. It is a true testament to the very depravity of AbbVie’s business practices. These verdicts indicate that there is a fundamental immorality in AbbVie’s motivations and actions that run contrary to our most basic moral sensibilities.
Testosterone Trial Jurors’ Outrage Over AbbVie’s Egregious Behavior Could Be Decisive in Overall Litigation
The juries in both trials concluded that that they could not attribute the plaintiffs’ injuries to the testosterone gel. But, their mutual decisions to punish the company for the morality of its actions could shape up to be an insurmountable obstacle for AbbVie 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 the jury’s outrage over AbbVie’s actions. While plaintiffs change case-to-case, AbbVie’s marketing strategy will remain the same throughout the litigation.
“Correcting the anger, that’s the bigger mountain to climb,” a plaintiff attorney said.
Consequently, the incendiary response that AbbVie’s behavior ignites could weigh heavily into any jury decision regardless of the actual strength of the case at hand.
Testosterone Trial Indicates AbbVie Created Market for Androgel
Before the FDA even approved AndroGel, AbbVie was already pouring millions to raise awareness for a condition the company called “Low T.” Low-T’s symptoms are remarkably similar to those of the normal male aging process. Occasionally grumpy? Not as strong as you were 20 years ago? Have you ever fallen asleep after dinner? Good news! You’re not old. You just have Low-T, and, luckily, testosterone gel will fix all that and more! AbbVie didn’t just create a market for Androgel with its premarketing messages. It created a medical condition.
Before AbbVie raised awareness for Low-T, losing muscle and/or sex drive were undesirable but predictable signs of aging. AbbVie blatantly preyed on older men’s insecurities and took them straight to the bank. IMS Health data shows testosterone sales skyrocketed from $324 million in 2002 to nearly $2.3 billion in 2012.
However, the FDA never cleared AbbVie’s testosterone gel for treating Low-T. And AbbVie even had evidence linking testosterone to serious cardiovascular events. However, these kinds of mundane considerations had absolutely no bearing on AbbVie’s determination to get its testosterone gel into the hands of as many occasionally tired men as possible.
AbbVie began marketing the drug aggressively to doctors and consumers as the miracle solution to Low-T after the company won FDA approval to market the medication to treat hypogonadism, or primary testicular failure. Despite clear FDA indications, television and print ads suggested that the testosterone therapy could also be used to treat typical signs of aging.
The company was far more aggressive in its marketing to the medical community. AbbVie experts and direct sales staff flooded medical conferences, convincing drug company employees that Androgel was “the fountain of youth.”
“Everywhere doctors went…[they got] AbbVie’s message,” a plaintiff attorney told the jury. “That’s how you build a billion-dollar market.”
T therapy was initially just for men who can’t produce enough testosterone due to testicle injury, cancer, or genetic defects. However, AbbVie opened the flood gates, convincing countless men to take the hormone to feel and look younger. Critics say that this exposes otherwise healthy bodies to serious side effects.
The Journal of American Medical Association published a study in 2013. Researchers found a 30 percent jump in the risk of stroke, heart attack, and death among men undergoing testosterone therapy. Testosterone therapy also makes the body shut down its own production of the hormone. Consequently, testicles may shrink, effectively creating life-long customers, while increasing the toll on patients’ bank accounts and physical health exponentially.
AbbVie Tries to Dodge Accountability for Hiding Risks
At trial, AbbVie tried to claim that there was no evidence of testosterone gel-related cardiovascular risks until a trio of studies were published in 2013 and 2014. Following these publications, the FDA investigated and updated the label for all testosterone therapy drugs to include a warning about the risk of “major adverse cardiovascular events.”
However, attorneys to the plaintiffs were quick to point out the multitude of other studies from before 2013 that AbbVie consciously ignored. These studies revealed a substantial connection between Androgel and heart attacks. AbbVie also never performed its own cardiovascular studies before pushing the drug on an at-risk population. Other cases in the ongoing testosterone MDL accuse AbbVie and other companies of hiding pulmonary embolism and stroke risks, as well as cardiovascular ones.
During closing statements, a plaintiff attorney reminded the jury that AbbVie is responsible for the drugs it sells. AbbVie was too concerned with its financial security that it lost sight of patient safety and ignored signs that called Androgel’s safety into question. Instead of testing to evaluate these signs, the company pushed the drugs on ever more men, stealing their ability to make informed medical decisions by hiding significant health risks. Instead, their desire to expand market share was put before everything – including patient health. Now, juries are making sure they pay.
A Mississippi Xarelto plaintiff whose case was selected as part of the litigation’s bellwether trial process is seeking a new trial, citing a recent study co-authored by “leading Bayer scientists.”
Dora Mingo’s case went to trial this past month in Mississippi federal court. According to Mingo’s claim, she took Xarelto to treat deep vein thrombosis (DVT), following hip replacement surgery in 2015. While taking the controversial blood thinner, Mingo nearly lost her life to severe gastrointestinal bleeding. She alleges that Xarelto’s manufacturers knew about the drug’s bleeding risks. However, they failed to warn patients and doctors in order to protect their mutual pecuniary interests in the blockbuster anticoagulant. Ultimately, the jury found against the Xarelto plaintiff, returning with a verdict for Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals unit.
Mingo filed a motion this past week with District Judge Eldon E. Fallon of the Eastern District of Louisiana, requesting a new trial. She argued that a study released as her trial was wrapping up directly contradicted Bayer’s testimony. During the trial, Bayer testified that doctors can’t monitor Xarelto’s anticoagulant effects with standard laboratory testing. However, the new study indicated that a medical test called PT Neoplastic is effective for detecting excessive bleeding in Xarelto patients. Furthermore, Bayer scientists co-authored the study.
“Thus, defendants were telling the Court and jury in the Mingo case that PT is dangerous, useless and meaningless, while simultaneously saying something completely different in the medical literature,” the filing argues. “This evidence was not available to cross-examine these witnesses, which further prejudiced Ms. Mingo.”
Johnson & Johnson and Bayer’s Billion Dollar Baby
Upon receiving FDA approval in July 2011, Johnson & Johnson and Bayer aggressively marketed Xarelto to replace warfarin (Coumadin), which has been the standard anticoagulant since the 1960s. The manufacturers touted Xarelto as a convenient, once-size-fits-all alternative to the older blood thinner. The drug makers highlighted the oral anticoagulant’s single dose, assuring doctors that blood monitoring wasn’t necessary. Warfarin patients have to continually test and monitor their blood to ensure the dose is reducing clotting risk but isn’t causing the blood to thin too much in an intricate balancing act between eliminating clotting risk and not bleeding out. While studies have found that blood monitoring could have helped prevent dangerous bleeding in Xarelto patients, Johnson & Johnson and Bayer’s strategy was literally money in the bank.
Xarelto made $582 million in sales during its first full year on the market. In 2013, the figure rose $2 billion for the fiscal year. Xarelto is now Bayer’s top-selling product, bringing in $3.24 billion in sales in 2016 and $2.5 billion in 2015. It is third on Johnson & Johnson’s product roster, generating $2.29 billion for the company in 2016.
Like many meteoric climbs to come before it, sacrifices were made. Unfortunately, these sacrifices may have been the health of the very patients Xarelto was purportedly designed to help.
In 2017, the Institute for Safe Medicine Practices (ISMP) reported that Xarelto accounted for more adverse event reports in the second quarter of 2016 than any other drug in several categories. The blood thinner accounted for the most domestic reports of serious injury at 6,262. It was also responsible for 614 patient deaths. The report concluded that oral anticoagulants are among the highest-risk outpatient drug treatments in medicine today.
Xarelto Plaintiff Litigation
More than 18,500 individuals have come forward along with Mississippi’s Xarelto plaintiff to take manufacturers to task for their greed and negligence. All federal claims involving the medication’s alleged serious bleeding risks are now pending before Judge Fallon in the Eastern District of Louisiana for coordinated pretrial proceedings.
These individuals dispute that the drug offers any benefits over warfarin. They point out that vitamin K can stop warfarin’s internal bleeding. However, there is no way to reverse Xarelto hemorrhaging. Xarelto plaintiffs also allege that patients would benefit from a regular blood monitoring regimen. However, defendants continue to claim that this testing is unnecessary.