Category: Defective Drugs

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.

Invokana Stroke Risk Highlighted in New Lawsuit

By Emily Cox
Invokana Stroke
Flickr/Viktor Brezinsky

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.

 

 

 

Taxotere Settlement Door is Closing. Potential Plaintiffs Must Act Now.

By Emily Cox
Taxotere Settlement
It’s time for Taxotere survivors to get moving before they get left behind. (Flickr/vizeur_photos)

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.

Taxotere Settlement – Egregious Effectiveness Exaggerations

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.

 

 

Heartburn PPI MDL Over Kidney Injuries Starts to Take Shape

By Emily Cox
Heartburn PPI
Flickr/Chris Dart

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.

Testosterone Trial Punitive Damages Verdicts Send a Clear Message

By Emily Cox
Testosterone Trial Sends Clear Message
Flickr/Mike Lowe

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.”

Testosterone Trial Exposes Significant Androgel Risks

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.

 

Invokana Amputation Side Effects Highlighted in New Lawsuit

By Emily Cox

Some degree of “loss of self” Invokana Amputation is common with any chronic illness. This loss of metaphysical personal identity can be even more damaging than the disease itself. However, a Texas man alleges that it wasn’t his type 2 diabetes that stole his fundamental sense of self. It was his medication, and it wasn’t content with taking only the intangible parts that comprised his identity. Invokana amputation side effects scarcely spared his life but took a toe and some of the bone in his foot along with his sense of identity in its stead. His subsequent permanent disability is a grim testament to the fact that some things lost can never be regained. Furthermore, he alleges that the drug manufacturers knew about the elevated Invokana amputation risks. However, the companies never warned consumers or the medical community to protect profit margins and ensure a substantial return on investment.

Thomas Layton filed the claim directly into the ongoing Invokana multidistrict litigation (MDL) in the District of New Jersey on September 29. He alleges that the drug’s manufacturers Johnson & Johnson and its Janssen Pharmaceutical unit knew about the Invokana’s substantial risk factors. But, they were only keeping their eyes on the bottom line rather than the health and safety of their consumers. Not only did they conceal these significant safety concerns. Unwilling to part with any of their profits, the companies refused to make necessary expenditures to remedy Invokana’s dangerous defects.

“Despite [their] knowledge, Defendants, acting through its officers, directors and managing agents for the purpose of enhancing Defendants’ profits, knowingly and deliberately failed to remedy the known defects in Invokana and failed to warn the public, including Plaintiff, of the extreme risk of permanent injury occasioned by said defects inherent in Invokana,” the lawsuit states.

Invokana Amputation Risks

On May 16, 2017, the FDA issued a safety communication based on the findings from two large Invokana clinical trials. The trials confirmed that Invokana significantly increases the risk of leg and foot amputations. Consequently, in July 2017, the agency mandated a blacked boxed warning for the labels of canagliflozin drugs. This is the strongest warning that the agency can require. The affected medications are Invokana, Invokamet, Invokamet XR.

Unfortunately, these dire Invokana amputation warnings came two years too late for Layton. Manufacturers knew of these risks but never warned the health community or patients, thereby, robbing Layton of his agency to make informed decisions regarding his healthcare. He had several safer alternative diabetes treatment options. However, he didn’t have all the necessary facts to discern these important distinctions. So, Layton began taking once daily Invokana in May 2015. Within five months of starting treatment, he developed a severe diabetic ulcer on his left foot. By October 2015, Invokana had claimed its first victim – the fifth toe on Layton’s left foot. However, the diabetes medication wasn’t finished with Layton quite yet.

In August 2016, Layton had to undergo further treatment to remove bone from his left foot that Invokana side effects had damaged. The scars from these surgeries irrevocably bled over into the heart of Layton’s life and very identity. He now relies on crutches and/or a knee scooter for mobility. Layton also requires assistance from his wife for many daily activities. Activities that barely required a thought before Invokana are now out of reach without substantial help. Returning to work – an impossibility. Invokana has forever changed Layton’s life, and he will never get back much of what he lost to J&J and Janssen’s insatiable greed and negligence.

Invokana Amputation Warnings and Other Regulatory Actions

The controversial diabetes medication is part of a new class of diabetes drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors. Invokamet, Jardiance, Farxiga, Xigduo and others are also members of this drug class. However, Invokana has been the irrefutable superstar since it hit shelves in March 2013.

These drugs work by altering normal kidney functions so that excess sugar is eliminated from the body through urination. However, this puts extra strain kidneys that are already compromised by diabetes itself. In June 2016, the FDA mandated additional warnings about Invokana’s substantial kidney risks. The warnings indicate that the medication can increase the risk of acute kidney injury, kidney failure, and other serious injuries. These complications can evolve even within one month of starting treatment with the diabetes drug.

In May 2015, the FDA issued a safety communication, warning that SGLT2 inhibitors can cause life-threatening ketoacidosis (DKA). These drugs force sugar out of the body. In the absence of these sugars, the body begins to break down fat as fuel which releases a type of blood acids called ketones. The build-up of these acids is extremely dangerous and often require emergency treatment to prevent life-threatening injuries. Consequently, in December 2015, the FDA required J&J to add DKA warnings to Invokana. Previous to this, patients were unaware of the importance of immediate medical attention for symptoms such as abdominal pain, fatigue, nausea, vomiting, or respiratory problems.

J&J and Janssen Knowingly Exposed Patients to Invokana Amputation and Other Risks for Profit

Layton joins a growing number of individuals in serious allegations that J&J and Janssen knew about Invokana’s many life-threatening risks, including Invokana amputation, prior to releasing the drug into the stream of commerce. However, never ones to put research and development dollars to waste even for the sake of patient safety, the companies willfully and fraudulently pushed the defective drug on unsuspecting patients to ensure a return on their mutual investments in developing the drug.

Despite all evidence to the contrary, they misrepresented the drug as a safer, more effective alternative to current treatment options. The companies even insinuated that the medication had weight loss benefits. However, these benefits come from the very mechanisms that cause deadly DKA by depriving the body of sugar, forcing it to turn to fat for fuel.  And, if you don’t lose the weight around your waist, a quick and easy Invokana amputation will take care of some of those extra lbs.

 

 

 

 

 

Xarelto Plaintiff Demands Retrial in Light of New Evidence

By Emily Cox

Xarelto plaintiff

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.

 

Manufacturer Hid Nexium Kidney Risks to Further Profits

By Emily Cox
Nexium Kidney injury
Flickr/Mike Mozart

A new lawsuit alleges that the drug manufacturer, AstraZenca, concealed considerable Nexium kidney injury risks to further its own financial agenda while putting patients at considerable risk to the detriment of many of them.

Clarice Armstrong filed the complaint September 22 in the District of New Jersey. Armstrong alleges that AstraZenca actively hid significant Nexium kidney risks from consumers and the medical community. Consequently, neither she nor her physician knew that the prescription was putting her life at serious risk. Due to AstraZenca’s greed and negligence, Armstrong’s life will never be the same.

“As a direct result of ingesting PPIs, Plaintiff has been permanently and severely injured, having suffered serious consequences from PPI use,” the complaint states.  “Plaintiff requires and will in the future require ongoing medical care and treatment.”

“Plaintiff, as a direct and proximate result of PPI use, suffered severe mental and physical pain and suffering and has and will sustain permanent injuries and emotional distress, along with economic loss due to medical expenses, and living related expenses due to her new lifestyle,” the lawsuit continues.

Armstrong contends that the drug maker knew about the Nexium kidney injury and end stage renal failure risks. However, the company “deliberately failed to remedy known defects” and warn the public in order to maximize profits despite the “extreme risk of injury.” The claim points to several proton pump inhibitor (PPI) studies that show AstraZenca knowingly exposed people to serious danger to line its already fat pockets.

In October 1992, three years after initial FDA PPI approval, University of Arizona Health Sciences Center researches published the first article connecting PPI use with kidney injuries in The American Journal of Medicine. Decades of reports from national adverse drug registries and other studies affirming this association make this connection undeniable.

Nexium Kidney Injury Studies

Nexium (omeprazole) is among the most popular PPIs on the market. Millions of Americans take the medication to treat heartburn and acid reflux. However, other blockbuster PPIs include Prilosec, Protonix, Prevacid, and Dexilant among countless other seemingly benign medications for mild conditions. However, studies have found these drugs carry far more serious risks than the conditions they treat.

In April 2015, CMAJ Open published an independent study. Study researchers found that PPI users were three times more likely to develop acute interstitial nephritis (AIN). AIN is kidney inflammation that can result in serious complications. Researchers also found that users were 2.5 times more likely to suffer acute kidney injury. This involves the abrupt loss of kidney function.

In February 2016, JAMA Internal Medicine published a study that found that PPIs carried a substantial risk of chronic kidney disease (CKD). The study indicated that PPI users may be 50 percent more likely to develop the condition than non-users.

In April 2016, Department of Veterans Affairs researchers found that PPI users could be 96 percent more likely to develop renal failure and 28 percent more likely to develop CKD after five years of use.

The PPI Empire

AstraZenca and other PPI manufacturers promote their medications as safe and effective with few serious side effects. Consequently, many people take the drugs long-term, using them for years without attempting to reduce reliance… or dosage, making them exceptionally valuable to the market’s bottom line. PPI makers may have disregarded their core customers’ health and lives. But, they have worked very hard to keep them loyal by actively hiding risks.

To be sure, PPI manufacturers could give billions of reasons for concealing the life-threatening risks lurking behind their drugs. PPIs are one of the most commercially successful groups of medications in the U.S. According to Armstrong’s lawsuit, between 2008 and 2013, prescription PPIs had sales of over $50 billion dollars. And, the weight of these profits has crushed the lives of countless people.

Armstrong joins a growing number of people trying to take PPI manufacturers to task over their unbridled greed. In August, the Judicial Panel on Multidistrict Litigation (JPML) consolidated all Nexium kidney injury lawsuits along with similar PPI lawsuits in New Jersey federal court for pretrial proceedings. Hopefully, if enough individuals stand against these companies, the PPI empire will start protecting its most important denizens – its consumers – instead of its profits.

 

Injured Patients Urged to Find Legal Representation Before $300M Benicar Settlement Deadline

By Emily Cox
Benicar Settlement Deadline
Flickr/Karoly Czifra

The door is quickly slamming shut on high blood pressure patients who suffered serious gastrointestinal injuries and indignities to participate in a recent Benicar settlement.

Benicar drug manufacturers and marketers have agreed to pay $300 million to settle the current multidistrict litigation (MDL). This substantial settlement doesn’t only apply to plaintiffs already in the MDL New claimants can still receive compensation in this settlement now…but the Benicar settlement deadline is fast approaching. In less than two weeks, this window will close, leaving injured individuals without any recourse for a very long time. The Benicar settlement deadline is August 23. All individuals who retain counsel after this will likely have to wait years to receive any resolution for their grievous injuries.

After spending the better half of 2017 trying to postpone and prevent critical scientific evidence from coming before the court, Daiichi Sankyo and Forest Laboratories have finally come to heel. Fortunately, there was a concession to unfiled claims. However, the Benicar deadline for filing a settlement claim is unsettling close.

Benicar Wrecked Havoc on Thousands

Overwhelmingly, patient reports indicate that olmesartan, which is in Azor, Tribenzor, and Benicar HCT, causes sprue-like enteropathy. The hallmarks of this chronic condition are nausea, chronic diarrhea, dehydration, and malnutrition. Despite FDA intervention to disclose gastrointestinal risks and the substantial settlement agreement, these drug makers and marketers continue to allege that their hypertension medication is perfectly safe.

Back in 2013, the FDA mandated new Benicar warning labels once the gastrointestinal risks became irrefutable. However, these warning came much too late for many Benicar patients. According to court documents, 1.9 million patients received a Benicar prescription in 2012 alone.

Benicar patients suffered up to 20 diarrhea attacks per day, leading to malnutrition and extreme weight loss. There are still others that suffered malnutrition complications like cataracts, infections, and even death.

Reports indicate that the manufacturers and marketers were fully aware of these risks. However, they hid them from the medical community and patients to protect their mutual financial interests. These companies were willing to sacrifice countless people to protect their bottom line.

Why Plaintiffs Need to Beat the Benicar Settlement Deadline

Plaintiffs need to retain representation in the litigation before August 23. After the Benicar settlement deadline, injured hypertension patients could wait for years to see any resolution. The current settlement was years and thousands of claims in the making. It will likely take a similar show of force to produce another settlement agreement. Nationwide lawyers are urging Benicar victims to take their rightful place in claiming retribution for the harm the drug manufacturers have caused. Because it will be a long while before these corrupt companies extend such offers again.

Despite thousands of reports of serious Benicar gastrointestinal issues, FDA concerns, and thousands of lawsuits, these companies indicate that they will continue to sell Benicar, endangering patients and profiting off their suffering. Consequently, there’s no doubt that Daiichi and Forest will end up in this position again, but it will take years for another litigation to amass the strength to force a settlement again.

 

 

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