Category: Personal Injury

Latest Pelvic Mesh Trial Launches in Philly

By Emily Cox
Mesh Trial
Philadelphia Court of Common Pleas (Flickr/Garen Meguerian)

The latest in a deluge of cases alleging Johnson & Johnson’s Ethicon unit designed dangerously defective vaginal mesh products got underway in the city of brotherly love Friday. The pelvic mesh trial jury heard arguments that a pair of the companies’ devices permanently mangled a woman’s urethra, leaving her incontinent.

This is the sixth pelvic mesh trial Ethicon has faced in Pennsylvania state court over its allegedly defective mesh products causing substantial, life-altering injuries. The plaintiff in this mesh trial claims her implant sawed its way into her urethra. Three surgeries later, doctors are still unable to repair all the damage the mesh caused.

“These defective products have literally mangled Ella Ebaugh’s urethra,” her attorney said.  “She’s going to suffer with this for the rest of her life.”

Overwhelmingly, juries have sided with injured plaintiffs in previous pelvic mesh trials. As a result, juries have returned a total of almost $50 million in damages against Ethicon in four out of the previous five trials. And, recently a judge called Ethicon’s sole victory into question. He found that the jury’s ruling was inconsistent with the evidence and its own conclusions. Consequently, there will be a damages hearing to determine the extent of Ethicon’s liability.

Pelvic Mesh Trial Case

Ebaugh indicates she received a TVT-Secur mesh device in May 2007 to treat stress urinary incontinence (SUI). But, her condition did not approve, prompting physicians to implant a second device later that summer.

In 2011, she reported sudden urinary urges and severe pelvic pain. Doctors discovered that the mesh had eroded into her urethra. Due to this, Ebaugh underwent a series of surgical interventions to retrieve as much of the mesh as possible. In one of these operations, she was cut open from “hip to hip.” However, despite these drastic measures, doctors were unable to repair all of the mesh’s damage. Scarring from the mesh implants had permanently propped open Ebaugh’s urethra. Consequently, she is no longer able to control her urine flow.

The first case to go to trial out of the mass tort program yielded a $12.5 million verdict in December 2015. The second pelvic mesh case awarded $13.5 million with $10 million in punitive damages. About two months before Johnson & Johnson’s defense win, another Philadelphia jury returned with a $20 million award. This included $17.5 million in punitive damages. In May, a jury awarded another woman $2.1 million over similar claims.

 

J&J Hid Talc Cancer Risk to Preserve Wholesome Image

By Emily Cox
Talc Cancer
The truth about talc is finally coming out…(Flickr/Austin Kirk)

The latest Johnson & Johnson talcum powder trial reveals that the multinational conglomerate placed consumer perception and profits over consumer safety in hiding substantial talc cancer risks associated with its flagship products, Baby Powder and Shower-to-Shower. Despite knowing the risks, the “Family Company” worked tirelessly to make these dangerous products nursery room staples. Allegations that J&J guided women to use these products on their genital regions aside, these monsters convinced us to use them on our children. They elevated their baby powder to iconic status, making it a hallmark of good parenting. If it wasn’t so sick, it would be awe inspiring.

As the second week of the Los Angeles talc cancer trial drew to a close, plaintiff Eva Echeverria called epidemiologist Jack Siemiatycki to the stand. The University of Montreal and McGill University expert testified on his past work, studying ovarian cancer’s causes. He also offered his opinions on scientific literature on connections between talc use on women’s genitals and ovarian cancer.

Siemiatycki carefully walked the jury through the process of epidemiology. This expertise studies the causes of diseases by evaluating their rates within defined populations and identifying possible risk factors. Siematycki contributed to the International Agency for Research on Cancer’s (IARC) 2006 report that found talc is a “possible human carcinogen.”

Since that report, Siematycki indicates he has changed his mind. He now thinks that it is more likely than not that talc can cause cancer. However, he did concede that he had not examined Echeverria’s case specifically.

Talc Cancer Lawsuit and Trial

Echeverria filed the claim with six other women in July 2016 in Los Angeles County Superior Court. She alleges that she used J&J’s talcum powder for years before developing terminal ovarian cancer in 2007. Echeverria’s case is the first to go to trial out of the hundreds in the Californian complex litigation.

During opening statement’s last week, Echeverria’s attorney said that J&J knew talc was dangerous. However, the company refused to place a warning label on its Baby Powder and Shower-to-Shower products, because it cared more about its wholesome corporate image than its customer’s safety.

“It’s the safe and gentle corporate image of a mother and baby that the defendants are placing over human life, in this case,” he said.

He went on to detail peer-reviewed scientific studies showing that 10 percent of American ovarian cancer diagnoses and deaths were related to talcum powder use on the genital area. Furthermore, J&J knew about these studies for more than two decades.

The attorney also outlined various categories of studies, regulatory decisions, and internal communications between J&J and its talc supplier. These documents show that not only did J&J know about the talc cancer risk. It actively lobbied federal regulators to keep warning labels off its products.

While this is the first talc cancer trial in California, St. Louis has completed five with verdicts totaling more than $300 million. Out of the five Missouri trials, J&J was only cleared of liability in one. And, this was only after the lead plaintiff attorney fell ill, forcing an impromptu replacement to take his place.

Internal Documents Reveal J&J Knew About Talc Cancer Risks

Internal documents, dating back 30 years, clearly show that J&J knew talc caused ovarian cancer and actively worked at hiding this from government regulators and the public. Among these activities was the formation of the Talc Interested Party Task Force (TIPTF). J&J serves at the forefront of the organization as the primary actor and contributor. The TIPTF’s stated purpose is to pool financial resources of members to defend talc use and prevent regulation. TIPTF reportedly hired scientists to perform biased research. The organization then edited this research before submitting these reports regarding the safety of talc to government agencies.

These documents could hold great sway over the outcome of the California talcum powder trial. This evidence, more than anything, influenced high dollar verdicts during the Missouri trials. One of these memos from a company medical consultant likened ignoring the ovarian cancer risks from feminine hygiene talc use to denying a connection between smoking cigarettes and cancer.

“They tried to cover up and influence the boards that regulate cosmetics,” one St. Louis juror said, adding “They could have at least put a warning label on the box but they didn’t. They did nothing.”

In fact, after IARC’s talc carcinogen classification, J&J’s supplier, Imery’s Talc, began including such warnings on its bulk shipments. These warnings included information from IARC’s and Canada’s talc carcinogen classifications. However, these warnings were never passed on to J&J’s devoted customers. You would think that after working so hard for consumer loyalty, J&J could show some back.

Expert Witness Calls Talc “Toxic”

Expert testimony only backs up what J&J already knew about the talc cancer risks.

Late in the first week of the trial, pharmacology and toxicology expert, Laura Plunkett, took the stand. She testified that talc is toxic and causes cancer. Plunkett said that, based on her training and experience and backed by substantial scientific literature, talc is toxic. When used on a woman’s genital area, it can cause ovarian cancer by migrating into the ovaries, causing chronic inflammation.

“Doses on a daily basis, if they sit in the tissue over time, the more and more body burden that builds up in those tissues can lead to continual toxicity within the tissues, and that’s this chronic inflammation,” she said.

This chronic inflammation can lead to cancerous cell formation.

The approximately 300 Los Angeles talcum powder cases represent a considerably smaller docket than Missouri’s. However, a high-profile plaintiff verdict in the country’s most populous state could expose J&J to a tsunami of new lawsuits. This potential wave of California talcum powder trials could finally finish what the Missouri litigation started. If California talcum powder trial verdicts are anywhere near Missouri’s, then settlement agreements could potentially be on the horizon.

Testosterone Gel $150M Verdict Reveals a Difficult Road Ahead for AbbVie

By Emily Cox
Testosterone gel
Flickr/paul bica

The recent testosterone gel trial verdict should have been a phenomenal victory for pharmaceutical giant, AbbVie. The jury held that the company wasn’t liable for an AndroGel user’s heart attack. Score one for the big guys! Right? Not so much.

The Illinois federal jury may have cleared AbbVie of product liability. However, it awarded $150 million in punitive damages against the drug maker for misleading advertising. The unusual verdict was a deliberate and obvious rebuke against AbbVie, revealing a treacherous path going forward in the multidistrict litigation (MDL).

The surprising monetary award in the July 24 verdict seized nationwide headlines. However, it’s not even clear if it’s enforceable, since AbbVie was found innocent of product liability…in a product liability trial. Also, punitive damages aren’t traditionally standalone verdicts. They’re intended to supplement compensatory damages to punish companies for immoral behavior. In fact, Illinois has a long history of disallowing punitive damages without their compensatory counterparts.

Testosterone Gel Marketing

During the trial,  Plaintiff Jesse Mitchell pointed to AbbVie-funded advertising and consumer questionnaires. These marketing materials indicated that testosterone gel could treat symptoms like lethargy and depression. Mitchell said this was evidence that the company ignored the specific conditions that the FDA approved AndroGel for to snatch the market for aging men instead.

Mitchell further claimed that AbbVie ignored its testosterone gel’s cardiovascular risks when targeting middle-aged men. The company’s marketing claimed that AndroGel could treat a condition called “Low T.”

“Low T” merely describes the normal male aging process. And AbbVie created it and expended vast resources to ensure millions of men thought they had it. AbbVie willfully targeted at risk men, exploiting insecurities over lost muscle tone and sex drive to drive sales.

The company’s due diligence paid off big-time. Its testosterone sales skyrocketed from $324 million in 2002 to nearly $2.3 billion in 2012. Now, this strategy may cost the company big time.

 Anger Over AbbVie’s Behavior Could Be a Deciding Factor in Testosterone Gel Trials

It’s clear that even though the jury felt it couldn’t be proven that AbbVie’s product caused harm, they also felt that AbbVie needed to pay for its actions. Consequently, while AbbVie may avoid a payout, the jury’s decision to punish the company for advertising the cleared testosterone gel could weigh heavily in future trials.

“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.”

The jury clearly agreed with AbbVie that Mitchell’s risk factors before ever using testosterone gel negated any product liability and negligence claims. But, they also clearly still wanted to punish AbbVie. Plaintiff lawyers say that this is very encouraging for future cases.

Fixing plaintiff problems is far easier than fixing the jury’s outrage over AbbVie’s ads. While plaintiffs change case-to-case, AbbVie’s marketing strategy will remain the same.

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

Despite the fact that the issue of these cases is whether the drug caused a person’s injury, the incendiary response that AbbVie’s behavior ignites could hold sway over any jury decision regardless of the actual strength of the plaintiff’s case.

The jury’s drive to take AbbVie to task for its behavior despite finding in its favor came at the end of a three-week trial. The trial examined Mitchell’s claim that AndroGel caused his nearly fatal 2012 heart attack. His lawsuit is one of more than 6,000 over testosterone gel products in the Illinois federal MDL.

Testosterone Gel Punitive Damages Likely Won’t Stand

Since the jury’s award did not come with compensatory damages, it probably won’t survive post-trial motions.

Illinois state law governs the outcomes of Mitchell’s case. There is a strong state precedent that juries cannot award punitive damages without compensatory ones. The Seventh Circuit has also affirmed this precedent in a 2015 appeal.

“Obviously, the verdict couldn’t stand,” Judge Richard Posner said of the jury’s decision.

“Punitive damages can’t lawfully be awarded when no compensatory damages are awarded.”

The next AndroGel trial will begin this September. It’s a redo of the first case to go to trial, since it ended in a mistrial in June after five days of testimony.

Both sides face challenges in making their respective cases. And, neither is showing any signs of backing down either.

Defective Hip Implant Caused Untold Misery and Numerous Surgeries

By Emily Cox

DePuy Pinnacle Hip Defective HipPatients fully expect hip surgery to be transformative…for the better. Greater mobility and freedom from pain ensure a new lease on life. A new lawsuit claims that Johnson & Johnson and its Depuy Orthopaedics unit designed a grossly defective hip implant that certainly transformed one man’s life…into a series of painful, debilitating surgeries with no end to his suffering in sight.

Cory Paul Smits filed the complaint Thursday in the Northern District of Texas as part of the ongoing multidistrict litigation (MDL).  In late February 2016, Smits underwent left total hip replacement surgery. He had the misfortune to receive a Depuy Pinnacle hip. The defective hip would go on to steal 2016 from Smits, leaving only pain, suffering, and constant hospitalizations in its stead. Within a week, the defective hip failed, requiring revision surgery in early March 2016. Another revision surgery would follow a week later with a third in April 2016.

Following this surgery, Smits was given a small reprieve from his constant hospitalizations but not from his pain. Eventually, this pain would drive him back into anesthesia’s hypnotic embrace. In November 2016, Smits underwent a fourth revision surgery to repair the defective hip. Finally, as the eventful year drew to a close, Smits hit the operating table one last time for his fifth revision surgery at the end of December 2016.

His yearlong dance with death has inexorably altered Smits’ life. Instead of a new lease on life, Depuy sublet his life to the damage inflicted by its defective hip implant. Smit continues to suffer from loss of mobility and motion range, as well as physical and mental anguish. He indicates that these injuries are permanent. Furthermore, if the manufacturers hadn’t hidden substantial design defects, he never would have chosen the implant in the first place.

J&J and Depuy Profited from Defective Hip, Knowing Patients Would Get Hurt

Despite being fully aware of how dangerous the defective hip implant was, manufacturers continued to market and sell the metal-on-metal implant, trafficking in patients’ trust and profiting from their pain. Disregarding thousands of reports of serious complications from the implant, these companies continued to downplay the risks. Plaintiffs claim the defective hip injured them after friction from the device’s metal socket and metal ball head released metal particles into their bodies.

If manufacturers had not concealed the device’s known defects, early failure rates, complications, and risks, the companies would certainly be facing far fewer lawsuits from individuals like Smit who suffered unspeakable pain from the Pinnacle hip. Currently, almost 10,000 individuals stand against J&J and Depuy for their greed, negligence, and misrepresentations.

And, if early trial results are any indication, then the litigation does not bode well for J&J and company. A federal jury returned with a more than $1 billion verdict in the most recent bellwether trial in December 2016. In the trial, evidence of an $84 million deferred prosecution agreement J&J entered into to end an illegal kickbacks investigation held great sway over the jury. A witness testified that J&J paid the settlement to make a “headache” go away. This played a central role in the plaintiffs’ closing argument. The jury’s $84 million-per-plaintiff punitive damages award appeared to directly reflect this as well. The jury also awarded $32 million in compensatory damages to six hip implant recipients and some of their spouses. The previous bellwether saw damages of $502 million levied against the defendants. However, the court later reduced this to about $150 million.

Despite all evidence to the contrary, J&J steadfastly denies any wrongdoing. Denial…more like delusional.

 

Monsanto Emails Reveal Significant Roundup Regulatory Issues

By Emily Cox
Monsanto Emails
Flickr/Floris Looijesteijn

New documents released Tuesday in the ongoing litigation against Monsanto highlight extensive attempts to influence scientific research, regulation, and the news media. Monsanto emails reveal an internal debate over the safety of its flagship product, Roundup.

Roundup’s active ingredient, glyphosate, is the most common weed killer in the world. This is due, in large part, to the fact that Monsanto is the largest seed producer on Earth and flooded the global market with crops tailor-made for the herbicide. Most regulatory agencies have upheld Roundup’s relative safety. However, hundreds of lawsuits from farmers, landscapers, agricultural workers and other customers regularly exposed to the popular weed killer are calling foul. They allege that Monsanto didn’t provide adequately warnings Roundup’s cancer risks, and they paid for it with their health and sometimes their lives, while Monsanto raked in the profits.

The World Health Organization’s Internal Agency for Research on Cancer (IARC) classified glyphosate as a probable carcinogen in 2015. This classification sparked global concerns about Roundup’s safety, igniting the current litigation.

In October 2016, the Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Roundup non-Hodgkin’s lymphoma cases for pretrial proceedings. JPML centralized the claims before District Judge Vince Chhabria in the Northern District of California to serve judicial efficiency. The multidistrict litigation (MDL) has compelled the release of more than 75 documents, including Monsanto emails. The documents highlight the disturbing lengths that the agrochemical giant has gone to protect its image, products, and profits.

Monsanto Emails Prove Undue Influence in Research and Media

The troubling Monsanto emails show a trend to exert influence and even manufacturer favorable news and research. Documents show that Monsanto reached out to Henry I. Miller, an academic and proponent of genetically modified crops, to write an article attacking the IARC’s glyphosate carcinogenic classification. When asked to write the article, Miller replied, “I would be if I could start from a high-quality draft.”

This “draft” is essentially the article Forbes’ published under Miller’s name on its website in 2015 with the assertion that “opinions expressed by Forbes Contributors are their own.”

Forbes removed the story for its website Wednesday. The publication indicated that it ended its relationship with Miller due to these revelations. The opinion pages of The New York Times has also run Miller’s work.

Monsanto emails show this trend extending into academic research. John Acquavella, an academic on Monsanto’s payroll, was writing research for Monsanto. Acquavella expressed concerns that his roll with the company was at odds with his scientific integrity. In a 2015 email to a Monsanto executive, he wrote, “I can’t be a part of deceptive authorship on a presentation or publication.”

“We call that ghost writing and it is unethical,” he concluded.

The documents also reveal that A. Wallace Hayes, the former editor of the Food and Chemical Toxicology journal, had a contractual relationship with Monsanto. While he was still editor in 2013, Hayes retracted a key study that could have damaged Monsanto. The study found that Roundup, and GMO corn, could cause cancer and early death in rats.

Monsanto Emails Also Show Internal Conflicts Over Roundup’s Safety

Monsanto has continually defended Roundup’s safety to the public, declaring it “safer than table salt.”

However, Monsanto emails reveal a company at war with itself over the issue.

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

This is related to the debate about the relative safety of glyphosate and Roundup, which contains other chemicals. Many academics and pending lawsuits claim that Roundup is far more dangerous than glyphosate on its own. Apparently, many at Monsanto share this opinion.

In a 2002 email, one Monsanto executive wrote, “What I’ve been hearing from you is that this continues to be the case with these studies – Glyphosate is O.K. but the formulated product (and thus the surfactant) does the damage.”

Another Monsanto executive tells others in a 2003 email, “You cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement.”

However, she does provide a loophole. “We can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

As more evidence continues to come to light as the litigation presses forward, experts expect that thousands more individuals will come forward to take Monsanto to task for its insidious deeds.

$300M Benicar Settlement Reached in MDL

By Emily Cox
Benicar Settlement
Flickr/Hans Splinter

Parties in the high-profile litigation have finally reached a Benicar settlement agreement. The drug’s manufacturers, Daiichi Sankyo and Forest Laboratories, agreed to pay $300 million to settle claims in state and federal courts that the companies failed to warn of the blood pressure drug’s dangerous gastrointestinal risks.

Both sides signed a master Benicar settlement agreement during a Tuesday morning conference. District Judge Robert B. Kugler presided over the signing in Camden’s New Jersey federal court.

The lawsuits claimed that Daiichi designed Benicar (olmesartan) defectively. Forest Laboratories promoted Benicar alongside Daiichi. Both companies were allegedly aware the drug could cause diarrhea, nausea, malnutrition, dehydration, weight loss, and even death. However, the companies never warned users or physicians of these serious side effects. According to the master complaint, they hid these risks to protect profits from users who may not want to incorporate diarrhea into their blood pressure regulation regimen.

“Defendants’ conduct is motivated by greed and the intentional decision to value profits over the safety and well-being of the consumers of Defendants’ olmesartan products… enriching themselves financially to the serious detriment of Plaintiffs’ health and well-being,” the master complaint states.

In 2013, the FDA warned that Benicar could cause a condition known as spruelike enteropathy. This condition includes severe and chronic diarrhea. Consequently, the agency required changes to the drug’s warning label to include the condition. Unfortunately, these label changes came too late for many patients. Court documents indicate that about 1.9 million patients received a prescription in 2012 alone.

When the FDA made its Benicar warning, it had identified 23 severe cases of late-onset diarrhea among users of the drug in its adverse event reporting system.

The Road to Benicar Settlement

In April 2015, the Judicial Panel on Multidistrict Litigation (JPML) centralized 15 suits against the drug companies. JPML transferred them to New Jersey federal court before District Court Judges Robert Kugler and Joel Schneider.

Word of Benicar manufacturers’ duplicitous actions in hiding the drug’s risks continued to spread. Eventually, the litigation had swelled to almost 2,000 strong as more and more victims discovered the drug companies caused their serious injuries. These plaintiffs allege that Benicar caused up to 20 diarrhea attacks per day, leading to malnutrition and extreme weight loss. There are still others that suffered malnutrition complications like cataracts and infections. Some patients even died as a result of the serious nature of these issues and complications.

Given the preponderance of evidence against the drug companies, the Benicar settlement was practically a foregone conclusion. It was almost just a matter of when. The companies would have risked far greater restitution in a jury trial over their fraudulent and malicious misrepresentations.

 

Composix Mesh Judge Smashes Manufacturer’s Time Limit Argument

By Emily Cox
Composix SOL Claims
Flickr/col_adamson

A federal judge has struck down C.R. Bard’s attempts to dismiss a lawsuit involving serious complications with its Composix hernia mesh, rejecting the company’s arguments that the claim was not filed in time.

Kenneth E. Brugger filed the complaint in January 2017 in the District of South Carolina. He alleges that the manufacturer knew Bard Composix L/P Mesh with Echo Positioning system was defective. However, Bard continued to sell the mesh without warnings to maximize profits at the expense of public health and safety.

According to the complaint, Brugger received the Composix mesh during hernia surgery in December 2011. Within a year, he began experiencing debilitating complications that would require multiple surgical interventions. In August 2013, physicians determined that he had developed a recurrent hernia, cellulitis, and a hernia abscess from the mesh. Despite undergoing surgery to repair the damage, Brugger began experiencing acute symptoms that required hospitalization in November 2013. A mere two months later, he was back in the hospital and remained there for most of January 2014. During this hospitalization, he underwent abscess draining and an abdominal resection. The lawsuit contends that Brugger will continue to suffer severe health consequences due to the excessive damage caused by the Composix mesh.

Brugger alleges that the Composix mesh’s substantial design defects directly caused his extensive injuries. The mesh encourages infection and device migration, as well as organ damage and perforation among numerous other serious life-threatening injuries. Furthermore, Bard knew and recklessly disregarded these risks, protecting its bottom line rather than patients.

Bard Sought to Toss Composix Lawsuit on Statute of Limitations Grounds

So, did Bard express any remorse when faced with the extent of horrific damage its boundless greed and self-interest caused innocent people? Of course not. Instead, the company tried to get the lawsuit tossed on technical grounds. Bard filed a motion to dismiss, arguing that Brugger knew that Composix caused his injuries as early as August 2013. South Carolina statute of limitations laws require that individuals file claims within three years of injury or discovery.

Since Brugger first noticed complications in August 2013 and underwent a CT scan, Bard claimed that this is when the statute of limitations clock started running. Consequently, the company claimed Brugger waited too long to file. However, doctors did not link the recurring injuries to his Composix mesh until January 2014. So, Brugger argued that this is when the clock started ticking.

Composix Order and Opinion Denying Motion to Dismiss

District Judge Cameron McGowan Currie released an order and opinion on the matter on July 20. He agreed with Brugger that his lawsuit was just within the three-year statute of limitations. Additionally, the judge noted that Bard recalled the Composix mesh in June 2014, and the FDA issued a safety communication in October 2014. Both these events could affect discovery time frames and fall within the three-year time limit.

“In sum, accepting the allegations of the Amended Complaint as true and drawing all inferences in Plaintiffs’ favor, the court holds a reasonable fact finder could conclude Plaintiffs’ claims arose, at the earliest, between January 24 and 27, 2014,” Judge Currie ruled. “These are the dates when the mass containing the mesh was removed and a pathology report confirmed the mass, in fact, included surgical mesh.”

Brugger joins a growing number of people filing hernia mesh lawsuits over dangerous design defects of several popular hernia repair products. Most of the cases involved Atrium C-Qur hernia mesh and Ethicon Physiomesh. However, the size and scope of the litigation is continually widening.

 

Benicar Litigation Continues to Press Forward Despite Hurdles

By Emily Cox
Benicar Litigation
Good Thing She Wasn’t Taking Benicar…             (Flick/Phil Roeder)

Despite some early 2017 stumbling blocks, the Benicar litigation continues moving forward with tomorrow’s in-person status conference. The ongoing multidistrict litigation (MDL) involves claims that the blood pressure drug’s manufacturers, Daiichi Sanky and Forest Laboratories, failed to warn the medical community, patients, and federal regulators of the drug’s substantial gastrointestinal risks.

In a departure from the Benicar litigation’s protocol regarding these types of meetings, the conference will take place on August 1, the first Tuesday of the month. The monthly status and discovery conferences generally convene on the last Wednesday of each month. There’s still no word on the reasoning behind the timing divergence. However, some are speculating that this could indicate a departure of more than just the date. It could mean that internal developments forced the conference to either be moved forward or back. This is the first such conference since April.

However, this break in protocol could be due to something as inane as scheduling conflicts. The Benicar litigation’s Daubert hearing has already been postponed twice due to such conflicts. During this hearing, parties will present any challenges to the admissibility of certain expert witnesses. Originally scheduled for spring 2017, the hearing is now scheduled for August 21.

Furthermore, prior to the end of 2016, the Benicar litigation was holding status conferences multiple times per month. So, perhaps the scheduling of this one after four months of little activity, is indicative that the litigation is picking up steam once more, and the court is more eager to get the ball rolling again than keeping with general protocol.

Benicar Litigation

The FDA approved Benicar back in 2002 to treat high blood pressure. However, since then, reports have linked the hypertension drug to cases of sprue-like enteropathy. This condition causes chronic diarrhea, weight loss, and other severe gastrointestinal problems. Lawsuits in the Benicar litigation all indicate that the drug makers knew about the connection between Benicar and gastrointestinal distress. However, they hid the risk for years to maximize profits while also maximizing patient health issues.

Plaintiffs in the Benicar litigation allege that Benicar caused up to 20 diarrhea attacks per day, leading to malnutrition and extreme weight loss. There are still others that suffered malnutrition complications like cataracts and infections. Some patients even died as a result of the serious nature of these issues and complications.

In July 2013, the FDA required the drug makers to update Benicar’s warning label. The agency indicated that there was irrefutable evidence that the drug may cause severe diarrhea problems.

In 2015, the Judicial Panel on Multidistrict Litigation (JPML) centralized all federal Benicar lawsuits in the District of New Jersey. District Judges Robert Kugler and Joel Schneider are presiding over the litigation.

Hopefully, the litigation is back on its feet and will not suffer from any further delays or scheduling conflicts. Once the Daubert hearing is complete, the court can finally start scheduling some early bellwether trials. These early trials will help parties gauge the relative strengths and weaknesses of their cases.

Taxotere Settlement Conference Scheduled

By Emily Cox
Taxotere Settlement
Taxotere users face a not-so-hairy situation. (Flickr/JD Hancock)

The judge presiding over all federal Taxotere hair loss lawsuits has scheduled a Taxotere settlement conference next summer before the first bellwether trial goes before a jury in September 2018.

Currently, there are approximately 1,250 product liability lawsuits pending against Sanofi-Aventis. The company faces allegations of failing to warn about Taxotere’s permanent hair loss risk. Other, equally effective breast cancer treatment problems do not carry this same risk. Consequently, these women allege they may have chosen a different treatment option if they knew the risks.

Chemotherapy causing hair loss isn’t exactly a revelation. Far from it, in fact. However, cancer patients generally expect their hair to grow back following treatment. Taxotere’s labeling also indicated that hair regrows after treatment. But, this is not the case for many women.

Many women would undoubtedly face the permanent hair loss risk head-on if Taxotere provided their best chance for survival. Sanofi fraudulently assured patients and the medical community that this was the case. However, in 2009, the FDA sent a letter to the company, warning that its claim that Taxotere works better than far less toxic Taxol was false. The letter indicated that this amounted to misbranding, which is a federal crime. Consequently, thousands of women were exposed to the higher toxicity of Taxotere and its side effects for absolutely no reason other than to line Sanofi’s already considerable coffers.

Taxotere Settlement Conference and Bellwether Trials

In October 2016, the Judicial Panel on Multidistrict Litigation (JPML) centralized the litigation Judge Kurt Engelhardt in the Eastern District of Louisiana. As part of pretrial proceedings in the Taxotere multidistrict litigation (MDL), Judge Engelhardt established a bellwether process. As part of this process, parties will prepare a small group of cases for early trial dates to gauge how juries may respond to evidence and testimony that appears throughout the litigation. The court has already selected 10 cases for potential bellwether trials.

According to the case management order, Judge Engelhardt released on July 21, the first trial will begin on September 24, 2018. But, before the trial, the parties will meet with a magistrate judge for a Taxotere settlement conference by June 29, 2018. They will submit a Joint Confidential Status Report following settlement negotiations by July 6, 2018. If the parties cannot reach a Taxotere settlement to resolve the lawsuits, the bellwether trials will proceed so that they can gauge the relative strengths and weaknesses of their cases.

Behind the Taxotere Settlement Conference

Taxotere (docetaxel) is a high potency cancer drug. Sanofi introduced the taxane-based drug as a superior alternative to existing low-potency taxanes like Taxol. However, the FDA and various studies revealed the drug is actually no more effective at treating breast cancer. Furthermore, it carries a permanent hair loss risk that Taxol does not.

According to Taxotere lawsuits, Sanofi withheld reports of on-going hair loss from patients and physicians in the U.S. In fact, Taxotere warning in several other countries included information about the permanent hair loss risk. However, American women and doctors received no such warning. As early as 2005, studies found that Taxotere has a substantial permanent hair loss risk. Findings indicate that one out of every 10 Taxotere patients suffered long-term to permanent hair loss.

Prevacid and Nexium Makers Knew but Did Not Warn of Kidney Risks

By Emily Cox
Prevacid Kidney Damage
eLife/Lindstrom et al

According to a new chronic kidney disease lawsuit, Nexium and Prevacid manufacturers knew that there were significant kidney damage risks associated with long-term use of these heartburn drugs but failed to warn consumers.

Geraldine Griffin filed the complaint in the District of Arizona on July 21. She named Takeda Pharmaceuticals and AstraZeneca as defendants.

According to her claim, Griffin used Prevacid from May 2006 to January 2009. She took Nexium from April 2013 to October 2016. The proton pump inhibitors (PPI) caused Griffin to develop chronic kidney disease (CKD). She received the diagnosis in August 2014.

Prevacid and Nexium belong to the same class of drugs, PPIs. These are commonly used to treat heartburn and peptic disorders, such as gastroesophageal reflux disease (GERD), peptic ulcer disease, and gastropathy caused by nonsteroidal anti-inflammatory drugs (NDAIDs). Manufacturers have aggressively marketed these drugs as safe with few serious side effects. This marketing strategy has exposed millions of Americans to substantial kidney damage risks.

“Defendants have had notice of serious adverse health outcomes regarding kidney disease associated with their Nexium through case reports, clinical studies and post-market surveillance,” the lawsuit states.

“Specifically, Defendants had received numerous case reports of kidney injuries in patients that had ingested Nexium as early as 2001. As such, these reports of numerous kidney injuries put Defendants on notice as to the excessive risks of kidney injuries related to the use of Nexium.”

Consequently, the lawsuit concluded, “Defendants knew of the significant risk of kidney damage that could result from long-term Prevacid and Nexium use, but Defendants did not adequately and sufficiently warn consumers, including Plaintiff, Plaintiff’s physician or the medical community in a timely manner.”

Prevacid and Nexium Manufacturers Hid Lack of Long-Term Benefits

Griffin suggests that the makers of Prevacid and Nexium concealed the lack of long-term benefits of these drugs. Given Big Pharma’s avaricious reputation, this isn’t entirely surprising. The drugs may not have long-term benefits for consumers. However, surely the financial benefits of long-term customers did not escape these companies’ notice. Furthermore, the companies failed to conduct adequate post-marketing research.

Numerous independent studies have found that PPI users face a variety of kidney risks. These include acute kidney injury (AKI), chronic kidney disease (CKD), end stage renal failure, acute interstitial nephritis (AIN), and other serious complications. Besides Prevacid and Nexium, other popular PPIs include Prilosec, Protonix, Dexilant, and others.

Griffin joins a growing number of individuals attempting to make Prevacid and Nexium manufacturers take accountability for causing substantial harm for financial gain. They claim that these drug makers withheld important safety information to drive long-term use and sales. Other PPI manufacturers face similar claims.

Earlier this year, the Judicial Panel on Multidistrict Litigation (JPML) rejected a request to consolidate the federal litigation. The panel concluded that there were too many different drug makers involved to justify coordinated pretrial discovery. However, plaintiffs filed a second request in June. They indicated that the size of the litigation continues to grow. It now involves at least 172 cases spread across 30 different districts.

The JPML heard oral arguments this past week to reconsider whether to centralize nationwide cases. Given that this litigation has the potential to eventually include thousands of lawsuits, it could benefit from the judicial efficiency centralization provides.

 

 

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