Mesh Failure Leads to One Meshed-Up Situation

By Emily Cox
hernia mesh failure
That should hold ‘er in. If not, we’ll just add more – Sage advice for hernia repair. (Flickr/Jon Nicholls)

What to do when hernia mesh failure causes irreparable harm, leaving synthetic fragments of the mesh in surrounding tissues – Slap some more of that plastic in there and hope for the best, of course. At least that’s what doctors decided to do to address significant Physiomesh failures. They simply implanted a new defective mesh that continues to plague an Arkansas woman to this day.

According to a new lawsuit, Jo Ann Lax had the misfortune to not only receive Ethicon’s notoriously defective Physiomesh. But, when she experienced the increasingly common mesh failure associated with the product, doctors implanted her with Covidien Symbotex hernia mesh. Symbotex is a relatively new entry into the field of dangerous synthetic surgical mesh products. Consequently, reports of dangerous complications have only recently begun accumulating in significant numbers. However, it appears that it may be just as dangerous as Physiomesh, which has damaged countless lives beyond repair.

Lax filed the complaint this past week in New Jersey Superior Court. She indicates that Johnson & Johnson, its Ethicon unity, and Covidien knowingly sold dangerously defective hernia mesh products. As a result, she continues to suffer lifelong injuries that she will never be able to leave behind even if she ever manages to get the Symbotex mesh removed.

Hernia Mesh Failure Two-Fold

Introducing to the ring, the ultimate tag team – Physiomesh and Symbotex – guaranteed to put patients down for the count.

If these products had human counterparts, then they would probably be a WWE tag team…or at least should be. Alone, these products can inflict impressive damage on the human body. Together, the damage can be staggering.

In October 2014, seeking relief from an umbilical hernia, Lax unwittingly signed up for a medical nightmare when she agreed to receiving Physiomesh to repair her hernia. The mesh didn’t even last a year. By early 2015, Lax was already experiencing the crippling effects of mesh failure.

In May 2015, she underwent surgery again to remove the failed mesh from her body after only seven months. There is little doubt that there wasn’t anything “mere” about those seven months for Lax. The mesh had disconnected and torn from her body, leaving plastic mesh fragments in the surrounding tissue. Upon removing the toxic plastic remains of the Physiomesh from her body, surgeons elected to do the only logical thing – Implant more plastic to replace it!

In terms of dramatic results, Lax’s doctors certainly succeeded in spades but probably at the opposite end of the spectrum they were shooting for.  Unless, of course, continual abdominal pain and sores, accompanied by blisters and stinging sensations were among her treatment goals. Not to mention, the loss of her belly button, which is just the icing on this meshed-up cake. Despite the Covidien Symbotex Mesh failure, it remains inside Lax to this day, wreaking unimaginable havoc sight unseen.

A growing number of individuals echo Lax’s experiences with similar hernia mesh products. Increasingly, these individuals are taking various manufacturers to task for serious injuries. Manufacturers currently facing these substantial product liability claims include Ethicon, Covidien, C.R. Bard, and Atrium Medical.

 

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.

 

 

Opioid Epidemic is Officially a National Emergency

By Emily Cox
opioid epidemic national emergency
Flickr/Gage Skidmore

President Donald Trump declared a national emergency Thursday, thrusting the weight of the White House into the battle against the opioid epidemic that is ravaging the United States with increasing ferocity.

“The opioid crisis is an emergency, and I’m saying officially right now it is an emergency. It’s a national emergency,” Trump said.  “We’re going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis.”

“It is a serious problem the likes of which we have never had… This is a national emergency and we are drawing documents now to so attest,” he continued.

This is the first time that a long-term public health crisis has been officially designated as a national emergency. Consequently, it’s not entirely clear how this designation will play out. However, experts say that the national emergency declaration will allow the administration to allocate essential funds to expand treatment facilities and supply police officers with anti-overdose medication. The designation will also allow the executive branch to waive certain federal rules, including Medicaid restrictions on where recipients can receive addiction treatment. Currently, the federal aid program offers few options for those suffering from addiction. The administration has also expressed interest in reviewing medical privacy regulations to let addicts’ families know about overdose treatment.

The declaration comes on the heels of the White House opioid commission’s impassioned recommendation to declare a national public health emergency to provide immediate aid in battling the deadly epidemic.

“Our citizens are dying. We must act boldly to stop it,” the commission, headed by New Jersey Gov. Chris Christie, said in its interim report.  “The first and most urgent recommendation of this Commission is direct and completely within your control. Declare a national emergency.”

Opioid Epidemic Blazes Out-of-Control

In its report, the opioid epidemic commission indicated that there are 142 opioid deaths every day across the country. Consequently, opioids are claiming as many lives as September 11th every three weeks. Every three days, they are killing the equivalent of a full jetliner crash.

As shocking as this statistic is, the report is actually a significant understatement. The commission based its estimate on the number of overdoses in 2015. However, new federal data for the first nine months of 2016 shows that the death toll jumped significantly from 2015’s numbers. There could be almost 10,000 more deaths in 2016 than 2015. The 20 percent increase is a clear indication that, despite growing efforts, the epidemic continues to blaze unfettered, consuming all in its path. Furthermore, even these numbers don’t account for the totality of the epidemic’s devastation. These are only overdose deaths.

The American Journal of Public Health published a study this past month indicating that the number of drivers killed in car accidents who tested positive for opioids had increased 700 percent from 1995 to 2015.

In 1995, only one percent of fatally injured drivers tested positive for these drugs. By 2015, this number had risen to seven percent. Given that one out of three Americans took prescription opioids in 2015, this isn’t entirely surprising. If this number remained constant for 2016, this indicates that as many as 3,000 fatally injured drivers were under the influence of opioids.

There’s no question that there is no quick fix to extinguish the devastating epidemic. However, declaring a national emergency makes the opioid epidemic the government’s top priority. The designation will infuse desperately needed funds into hard-hit areas and bolster resources for the long battle ahead.

 

 

 

Mesh Mass Tort Could be in Big Trouble

By Emily Cox
Mesh Mass Tort
Justice is blind, and Big Pharma is making sure it stays that way. (Flickr/Valerie Everett)

Big Pharma wasted no time in applying a new landmark Supreme Court ruling limiting personal jurisdiction to undermine numerous important mass torts that are endeavoring to take these companies to task for causing widespread, unspeakable harm with their bottomless greed and negligence. Now, it has the pelvic mesh litigation in its crosshairs. The judge overseeing the pelvic mesh mass tort in Philadelphia has agreed to revisit the state court’s jurisdiction over numerous cases pending there.

Philadelphia Court of Common Pleas Judge Arnold New granted Johnson & Johnson’s motion on the matter earlier this month. J&J is seeking to strike 91 cases from the mass tort program, citing the Supreme Court’s game-changing Bristol-Myers Squibb (BMS) decision. This is the first time Big Pharma has used Bristol-Myers to target a Philadelphia mass tort program. But, if J&J succeeds, it will surely not be the last. It could very well be open season on out-of-state plaintiffs.

Mass Tort Jurisdiction Ruling

In its 8-1 June ruling, the Supreme Court severely restricted access to plaintiff-friendly jurisdictions. The High Court determined that plaintiffs must meet specific criteria to file product liability lawsuits out-of-state. Nonresidents now need to have been injured, received treatment, or received the product itself in the state to participate in mass torts in plaintiff-friendly jurisdictions. If plaintiffs don’t meet these criteria, then defendants need to be “at home” in the state or have conducted business in direct connection to the defective product. However, most of these companies avoid these connections to plaintiff-friendly states for this very reason.

The ruling decimates many state-level provisions that helped level the playing field between injured individuals and corporations with unfathomable resources. These provisions allowed out-of-state plaintiffs to attach claims to residents’ lawsuits if they suffered similar injuries and the defendants had a nationwide presence.

Consequently, the ruling could scatter and shrink mass torts. Many plaintiffs will have no option but to engage these powerful defendants on their home turf. These may be the only courts with enough plaintiffs to effectively pool resources to stand against these global conglomerates. Otherwise, they will have to go into battle alone or with a much-diminished arsenal to pursue claims at home.

Shock waves from the ruling hit the St. Louis talcum powder litigation against Johnson & Johnson first, resulting in a mistrial within mere hours of the decision. Bayer quickly followed suit to toss all but eight claims from an Essure lawsuit involving more than a hundred women. These women allege that the birth control device caused chronic pain, severe injuries, hysterectomy, and even death.

Now, J&J has turned its sights on women who have suffered debilitating complications from pelvic mesh implants, including mesh erosion, organ perforation, chronic pain, incontinence, chronic infections, adhesions, scarring, and more.

Is the Philadelphia Mass Tort in Jeopardy?

New issued the six-page order August 1. It vacated a March 2015 ruling that found Philadelphia had jurisdiction over the pelvic mesh cases. He called for parties to submit more briefings on the issue to the court over the next month.

According the order, the pelvic mesh mass tort program is helping injured women from all corners of the country seek justice for egregious injuries caused by J&J’s Ethicon unit’s dangerously defective vaginal mesh. J&J and Ethicon have their primary places of business in New Jersey. This makes the litigation a prime candidate for Big Pharma to invoke the BMS ruling.

The pelvic mesh mass tort grew seven percent this past year, climbing from 164 to 176 women. Despite almost incomprehensible injuries and continual pain, these women have somehow found the strength to fight for what’s right. However, BMS could wipe out more than 50 percent of these claims from the face of the litigation. Furthermore, it would set a dangerous precedent for the entirely of Philadelphia’s mass tort program.

Allegedly, J&J and Ethicon knew their pelvic mesh products were exceptionally dangerous but continued to market the devices anyway for financial gain. They sentenced these women  to a lifetime of pain, while continuing to feast on device profits. Now, they want to walk out on the bill for the lives they ruined with their insatiable appetites. And, the Supreme Court may have handed them the means to do so.

And, given trial verdicts in Philadelphia so far, the companies certainly have plenty of motivation to limit their liability. So far, Philadelphia juries have returned with four out of five plaintiff verdicts with damages totaling almost $50 million. Also, Judge New recently decided to revisit the one defensive victory in a damages hearing, ruling that the jury’s verdict was contradictory.

$775M Pelvic Mesh Settlement Reached to Resolve U.S. Claims

By Emily Cox
mesh settlement
All the blood money in the world won’t undue the irreparable harm caused by pelvic mesh (Flickr/Damian Gadal)

Endo International PLC has agreed to a pelvic mesh settlement to resolve “virtually all known” U.S. vaginal mesh lawsuits over its American Medical Systems (AMS) unit’s defective devices.

The company announced the pelvic mesh settlement earlier this week. It indicated that it would reserve an additional $775 million to settle remaining U.S. claims. This brings Endo’s total bill for the dangerously defective devices to $2.6 billion to cover transvaginal mesh settlements.

Paul Campanelli, Endo’s President and Chief Executive Officer, indicated that he believed that this should put the U.S. litigation against AMS to rest.

“We believe it is a very important milestone for Endo to have reached agreements to resolve virtually all known U.S. mesh product liability claims,” Campanelli said.  “While it remains possible that additional claims will be filed, we believe today’s announcement will assist most mesh claimants to move forward with their lives and will permit Endo to move forward with an even greater focus on executing against our core strategic priorities,” he added.

According to the new agreements, Endo will begin making payment installments in 2017’s fourth quarter. These payments will continue through the fourth quarter of 2019.

The pelvic mesh settlement will cover approximately 22,000 U.S. pelvic mesh lawsuits pending against American Medical Systems. Plaintiffs are claiming horrifying injuries and serious complications from the devices eroding into the vaginal wall. Most of these claims are pending in the federal multidistrict litigation (MDL) in the Southern District of West Virginia.

Behind the Pelvic Mesh Settlement

As far as Endo is concerned, this pelvic mesh settlement resolves the damage that it has caused. However, for the tens of thousands of women that the company sentenced to a lifetime of unspeakable pain and irreparable damage, the matter will never be truly resolved. For many, there is no dollar amount that could ever make this right.

Vaginal mesh products were once largely the surgical treatment of choice to treat pelvic organ prolapse and stress urinary incontinence. However, since 2008, the FDA has issued several alarming public health alerts. The agency has repeatedly detailed life-altering complications from the implants. These debilitating complications include mesh erosion, organ perforation, chronic pain, incontinence, chronic infections, adhesions, scarring, and more.

Finally, in 2011, the FDA declared that serious complications from vaginal mesh products were not rare. Furthermore, the agency indicated that there was little evidence that pelvic mesh offered any additional benefits over traditional non-mesh prolapse repair. Consequently, these women were saddled with unending agony for no reason further than to line device manufacturers’ coffers.

In 2016, the FDA finalized new regulations regarding these dangerous devices. Among other things, the agency reclassified pelvic mesh as a high-risk medical device. The FDA also barred the devices from its 510(k) clearance program. Previously, these devices could come to market without undergoing human clinical trials first. So, women seeking help were used as guinea pigs instead.

Pelvic Mesh Settlement Litigation

While most AMS cases will soon reach resolution as far as the court is concerned, the overall transvaginal mesh litigation is far from over. Johnson & Johnson and its Ethicon unit still face around 55,000 vaginal mesh claims pending nationwide. In fact, the companies are currently embroiled in their sixth Philadelphia trial over their vaginal mesh literally mangling a woman’s urethra. So far, Philadelphia juries have returned with four out of five plaintiff verdicts with damages totaling almost $50 million.

Other device manufacturers involved in this massive litigation include C.R. Bard, Inc, Cook Medical, Inc, Boston Scientific Corp., Coloplast Corp., and Neomedic.

 

 

 

 

Benicar Patients Can Still File Claims for $300M Settlement

By Emily Cox
Benicar Patients
The clock is ticking for Benicar patients to participate in settlement. (Flickr/frankieleon)

The $300 million Benicar settlement was announced this past week, but it’s not too late for Benicar patients to file claims and participate in the settlement. However, the window to file is steadily sliding shut. Benicar patients have only two more weeks to retain counsel if they want a piece of the hefty settlement to atone for grievous gastrointestinal issues from the controversial blood pressure medication.

Parties in the high-profile Benicar multidistrict litigation (MDL) reached a settlement agreement August 1, following months of the drug manufacturers and marketers dragging their feet to delay the looming Daubert hearings. Daubert hearings determine the admissibility of expert witnesses. Depending on expert witness testimony, these hearings could have turned the court of public opinion against Daiichi Sankyo and Forest Laboratories before the companies ever went before a jury.

According to the settlement, the $300 million fund will not be paid out until 95 percent of all MDL members opt-in to the settlement under various terms. But, it’s not too late to still file a claim. Benicar patients who suffered significant gastrointestinal problems while on the hypertension medication can still participate in the settlement. However, they need to have a retainer in place with a qualified attorney by August 23. In two short weeks, the window for this opportunity slams shut.

Drug Companies Show Little Empathy For Benicar Patients Suffering Enteropathy

Daiichi and Forest may have agreed to the Benicar settlement to resolve state and federal lawsuits. However, they never admitted liability for any wrongdoing. Even in the face of thousands of patients who suffered egregious harm from Benicar, they continue to maintain that the claims have no merit. Furthermore, Daiichi even admits that the settlement has little material impact on the companies that harmed so many. Insurance proceeds are primarily funding the $300 million settlement. Company funds will only supplement shortfalls. Consequently, Daiichi and Forest will go on their merry way, continuing to market Benicar (olmesartan) as an effective blood pressure medication, while downplaying its substantial risks.

Benicar patients allege 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. 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 and infections. Some patients even died from these serious issues and complications. Even the FDA indicates that the association between olmesartan and sprue-like enteropathy goes far beyond mere speculation.

In 2013, the FDA mandated a Benicar warning label to address the drug’s irrefutable gastrointestinal risks. However, these warnings came too late for many Benicar patients. According to court documents, 1.9 million patients received a Benicar prescription in 2012 alone. These Benicar patients suffered, while Daiichi and Forest gleefully raked in the profits. It will be some time before these companies will offer financial restitution again for the harm they have caused. Consequently, experts are urging Benicar patients to file as soon as possible to receive compensation for their injuries.

PPI Lawsuits Over Kidney Injuries Granted Centralized Litigation

By Emily Cox
PPI Lawsuits
Flickr/Will Culpepper

The Judicial Panel on Centralized Litigation (JPML) has determined that the size and scope of PPI lawsuits against the makers of Nexium, Prilosec, Prevacid, Protonix, and other proton pump inhibitors (PPIs) qualifies the litigation for centralization before one New Jersey federal judge for coordinated pretrial proceedings.

Currently, there are at least 161 PPI lawsuits pending in 28 different district courts. These lawsuits allege that Pfizer, Teva Pharmaceuticals, AstraZeneca, and other heartburn drug makers knew PPIs caused kidney damage and concealed the risks. Plaintiffs claim these drugs caused kidney failure, chronic kidney failure, and acute interstitial nephritis, among other forms of kidney damage.

The JPML rejected a previous request to centralize PPI lawsuits in February. The panel indicated that there were too few cases involving too many different drug manufacturers to justify establishing a multidistrict litigation (MDL) to coordinate discovery and pretrial proceedings.

However, as the litigation has continued to swell, plaintiffs filed a second request for consolidation in May. Consequently, the JPML heard oral arguments for the request late last month.

Drug makers originally fought consolidation. However, as PPI lawsuits continued to flood the federal court system, both sides agreed that centralization was necessary for judicial efficiency. The MDL will reduce duplicate discovery and conflicting rulings from different courts. Consequently, all parties save time and money.

PPI Lawsuits Centralization Order

The JPML issued the transfer order this past week. The judicial panel centralized all of the PPI lawsuits before District Judge Claire C. Cecchi in the District of New Jersey.

“In support of this new motion, plaintiffs, AstraZeneca, and Pfizer argue that the number of involved actions, districts, and plaintiffs’ counsel has increased significantly since Proton-Pump I, that many more cases likely will be filed, that there are now a significant number of related state court actions, and that informal coordination and cooperation are not practicable to manage litigation of this scope,” the JPML wrote.  “After careful review of the record, we agree with this assessment.”

The PPI lawsuits indicate that the heartburn drug makers hid the significant dangers of Nexium, Prilosec, and other PPIs. Boundless reports have linked these seemingly benign medications to life-threatening kidney injuries. These injuries include renal failure, chronic kidney disease, acute kidney injury, acute interstitial nephritis, and other substantial injuries.

Given the popularity and over-the-counter availability of these dangerous medications, this litigation could reach astronomical proportions.

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 back down either.

Send Us a Text Message!

Contact Us

Free Consultation

Fields marked with an * are required