Category: MDL

Physiomesh MCL Sets Initial Case Management Conference

By Emily Coxphysiomesh mcl

New Jersey’s Atlantic County Superior Court’s multicounty litigation (MCL) over gruesome and debilitating injuries from Johnson & Johnson and its Ethicon unit’s patently defective hernia mesh has announced that the Physiomesh MCL is getting underway, setting its first case management conference for October.

The Superior Court issued the case management order (CMO) August 20, indicating that the Court will conduct its first telephone case management conference October 18 at 1:30pm. The parties will address specific matters directly affecting the Physiomesh MCL. These include discovery status and the scheduling of future in-person management conferences.

Physiomesh MCL Background

Ethicon’s Physiomesh Flexible Composite Mesh received FDA clearance through the regulatory agency’s 501(k) approval program for use in hernia repair surgery. This fast-track clearance program allows medical device approval on the basis of the manufacturers’ assertion that the device is “substantially equivalent” to a device already on the market without the intrinsic benefits of human clinical trials.

Physiomesh features a unique multilayer design that uses five distinct layers. J&J and Ethicon marketed this design as preventing and minimizing adhesions and inflammation while facilitating incorporation of the mesh into the body. However, plaintiffs in the Physiomesh MCL assert that the design actually prevents incorporation and significantly increases serious and painful complication risks that often necessitate hernia revision surgery to address.

As adverse event reports over significant Physiomesh injuries began skyrocketing, rather than issue a proper recall to ensure patient safety, J&J and Ethicon quietly removed the defective mesh from world market like thieves in the night to save their own skin while continuing to keep patients in the dark about the implants’ serious risks.

The New Jersey Supreme Court consolidated the state’s Physiomesh lawsuits in Atlantic County earlier this month in response to a plaintiffs’ petition demonstrating that the cases shared many similar questions of fact and law, as well as defendants and witnesses. The plaintiffs also strived to include hernia mesh lawsuits involving Ethicon’s Proceed Ventral Patch, Prolene 3D, Proceed Surgical Mesh, and the Prolene Hernia System in the Physiomesh MCL. However, the Superior Court decided to limit the proceeding solely to Physiomesh claims.

 

Hernia Patch Severely Mangles Man’s Insides

By Emily Cox

hernia patch

After numerous hernia repair surgeries with Bard’s Ventrio and Ventralex meshes, a Florida man has stepped forward to take the manufacturers to task for knowingly concealing serious design defects to boost profits, resulting in permanently debilitating injuries from the popular hernia patch products.

Richard Potter filed the complaint August 24 in the District of New Jersey, naming C.R. Bard and its Davol subsidiary as defendants.

In December 2009, Potter first received a Ventrio hernia patch during hernia repair surgery. Eventually, significant chronic pain led to another surgery in August 2017 to address problems with the mesh and a recurrent hernia in the location of the Ventrio hernia patch.

This time Potter received a Ventralex ST hernia patch that was 2.5 inches in diameter. However, even worse complications were not far behind, forcing Potter to undergo yet another surgery in February 2018 due to recurring hernia. Surgeons had to remove the defective mesh that had become entangled with his insides and perform extensive lysis of intra-abdominal adhesions between the bowel and the mesh.

“He was taken to the operating room and unfortunately found to have a conglomeration of mesh and adhesions and bowel wall mangled together under the incision,” he surgeon noted. “The procedure was very difficult to do. It was basically separating bowel from mesh without causing major injuries.”

Hernia Patch Products Caused Irreparable Harm

Despite the intensive surgical intervention, Potter still experiences debilitating complications and chronic pain. Consequently, he will likely require additional surgeries to repair the extensive damage from the two hernia patch products.

According to Potter’s lawsuit, Bard Ventrio and Ventralex hernia patch products cause infection, foreign body response, mesh rejection, poor wound healing, and inflammation among other devastating complications. Although the manufacturers were fully aware of the potential risks from the products’ solid, flat, relatively smooth and continuous surfaces that inherently inhibit the body’s ability to clear toxins, they continued to sell and aggressively market the devices in a desperate push for ever higher profits.

Potter joins a growing number of individuals pursuing similar hernia patch lawsuits against Bard and other manufacturers that used non-medical grade polypropylene mesh to create hernia patch implants in recent years, alleging that they never warned the public or the medical community about the substantial risk factors.

Due to the staggering similarities in the lawsuits pending against Bard and Davol in the federal court system, the Judicial Panel on Multidistrict Litigation (JPML) centralized all federal Bard lawsuits earlier this month before District Judge Edmund A. Sargus in the Southern District of Ohio to expedite pretrial proceedings.

The JPML has established similar proceedings for Ethicon hernia mesh lawsuit and Atrium C-Qur lawsuits.  Currently, there are 1,500 Ethicon Physiomesh lawsuits and more than 700 Atrium C-Qur mesh lawsuits pending in their own individual multidistrict litigations (MDLs). The Ethicon federal lawsuits are currently pending in the Northern District of Georgia, while Atrium cases are proceeding in the District of New Hampshire.

 

 

Hand Amputation Spurs Failure-to-Warn Invokana Lawsuit

By Emily Cox

Invokana Hand amputation Invokana Amputation Risks

A new lawsuit indicates that the new-generation diabetes drug Invokana caused numerous significant side effects that ultimately led to a left hand amputation.

Charlotte Nerio filed the hand amputation complaint earlier this month in the District of New Jersey. She alleges that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary deliberately concealed serious Invokana risks from the public and the medical community to maximize the diabetes drug’s marketability and profits. Consequently, Neiro and countless other patients have suffered horrific and irreparable injuries that will follow them throughout their lives to serve J&J’s bottom line.

Neiro first began taking Invokana in 2015. The medication caused her to suffer severe tissue necrosis, dry gangrene, and blackening of her fingers. Eventually, her condition deteriorated to the point that hand amputation became necessary to ensure her survival. Furthermore, she also developed chronic kidney disease from use of the drug.

Neiro’s claim points to numerous serious safety concerns associated with Invokana. She maintains that she would have chosen a different diabetes drug if she had known about the risks. However, J&J and Janssen deprived her of the ability to make an informed decision regarding her healthcare, and she will have to bear the consequences of that deprivation for remainder of her life.

“Despite Defendants’ knowledge of the increased risk of severe injury among Invokana users, Defendants did not warn patients but instead continued to defend Invokana, mislead physicians and the public, and minimize unfavorable findings,” the lawsuit states. “Consumers, including Plaintiff, who have used INVOKANA for treatment of diabetes, have several alternative safer products available to treat the conditions.”

Invokana Hand Amputation and Other Risks

Manufacturers introduced Invokana (canagliflozin) in March 2013. It was the first member of a new generation of diabetes drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors. These drugs work in a unique way to eliminate excess glucose through urination by altering normal kidney functions. Other members of the SGLT2 class include Invokamet, Jardiance, Farxiga, and Xigduo, among others. However, Invokana remains the blockbuster of the class due to J&J’s excessively aggressive marketing strategies despite the drug’s dubious safety profile that the FDA has called into question several times in recent years.

In December 2015, the FDA mandated new diabetic ketoacidosis warnings for Invokana to indicate that the medication increases the risk of this serious condition. This condition generally requires emergency treatment to prevent life-threatening harm. Prior to this update, the Invokana label didn’t warn of the importance of seeking immediate medical attention for symptoms such as fatigue, nausea, abdominal pain, respiratory problems, or vomiting.

In May 2017, the FDA intervened once again, requiring J&J to update Invokana warning labels about the risk of leg and foot amputations. Manufacturers of other SGLT2 inhibitors continue to maintain that this risk is unique to Invokana alone.

Nerio’s hand amputation case will join other federal Invokana lawsuits pending in the ongoing multidistrict litigation (MDL) in New Jersey for pretrial proceedings.

 

 

National Academics Developing New Opioid Prescribing Guidelines

By Emily Cox
opioid prescribing guidelines
flickr/freeimage4life

Federal regulators have announced a plan to develop scientific-based opioid prescribing guidelines to prevent overexposure to the powerful painkillers that are currently linked to more than 40 fatal overdoses every day in the United States.

FDA Commissioner Scott Gottlieb issued a statement August 22 to announce a new study to help provide evidence-based guidelines for opioids to create more rational prescribing practices.

The FDA also announced that the National Academics of Sciences, Engineering, and Medicine (NASEM) will help develop the new scientific-based and indication-specific opioid prescribing guidelines by reexamining how physicians are currently prescribing opioid analgesics and when these medical professions consider them an appropriate course of treatment.

NASEM plans to conduct a consensus study to identify and prioritize medical procedures and conditions that have incumbent acute pain that medically necessitates opioid prescriptions and determine the length of time that opioids are necessary to regulate that pain.

Opioid Prescribing Guidelines in Response to Ongoing Crisis

The United States opioid epidemic continues to ravage the country, killing more and more people each year. The FDA and the Centers for Disease Control and Prevention (CDC) have indicated that deaths related to the opioid crisis are at an all-time high with fatal overdoses increasing nearly 140 percent. From 2015 to 2016, drug overdoses increased 21.5 percent, causing 64,000 deaths with more than 66 percent, or 42,000, of those involving the prescription painkillers.

Most individuals who become addicted to opioids are first prescribed these powerful synthetic medications through physicians. An analysis of current prescribing practices indicates that most individuals are given a 30-day supply of prescription opioids when the patients only theoretically require the potent drugs for a few days. Officials suggest that patients can develop opioid addiction within the first couple days or weeks.

Excess opioid medications commonly wind up on the illicit market, abused, or misused by family members and friends of those with opioid prescriptions. Patients who receive prescriptions for more opioids than medically necessary can also find themselves more prone to abusing or misusing the drugs, leading to overdoses.

The organization will hold a series of public workshops and meetings over the next couple months for stakeholders to collaborate on ideas and analyze current opioid prescribing guidelines to further develop better prescription policies that more closely adhere to clinical need while reducing patients’ overexposure to the highly addictive drugs.

 

$4.7B Baby Powder Verdict Upheld in Missouri

By Emily Cox
baby powder verdict
flickr/Mike Mozart

A Missouri state court judge affirmed the recent $4.69 billion baby powder verdict against Johnson & Johnson, indicating that the women’s award this past month over developing ovarian cancer from asbestos contamination in the company’s prized Baby Powder and other talcum powder products will stand.

There is no doubt that J&J will appeal the verdict to a higher court. However, the trial judge’s decision to uphold the baby powder verdict for 22 plaintiffs is yet another indication of the strength of evidence against the healthcare giant and the crippling liability that the company could face as the litigation continues. Currently, J&J is facing off against a woman in Pasadena, California in the latest trial over asbestos contamination, alleging that J&J and its talc supplier, Imerys Talc America Inc., bear the responsibility for her mesothelioma, a terminal cancer of the lungs’ lining caused by asbestos exposure.

Baby Powder Verdict Litigation

Currently, there are almost 11,000 J&J Baby Powder and Shower to Shower lawsuits pending against J&J across the country. The lawsuits all have strikingly similar allegations that the company deliberately concealed cancer risks to protect its wholesome corporate identity at the cost of human lives. Many of these are women who developed ovarian cancer from using talcum powder products around their genitals. However, in a new line of attack, many plaintiffs who developed mesothelioma after asbestos exposure from J&J’s talcum powder are beginning to come forward to take the massive corporation to task for putting consumers in harm’s way.

Several prior Missouri juries have already hit J&J with massive multimillion dollar verdicts. However, this most recent Baby Powder verdict was by far the largest to date with $550 million in compensatory damages for the 22 women and another $4.14 billion in punitive damages to punish the company for maliciously endangering lives for profit.

Supreme Court Jurisdiction Ruling’s Impact on Talcum Powder Litigation

The baby powder verdict stems from the first talcum powder case to go to trial in Missouri since a landmark Supreme Court decision in 2017 that limited the jurisdictional reach of state courts to preside over nonresidents’ product liability injury claims.

The June 2017 Supreme Court decision resulted in an immediate mistrial in another Missouri state court trial over talcum powder causing ovarian cancer. J&J quickly removed thousands of cases in the Missouri state court system to the federal court system. The Judicial Panel on Multidistrict Litigation (JMPL) has centralized these federal claims in a multidistrict litigation (MDL) before District Judge Freda L. Wolfon in the District of New Jersey.

In late November 2017, a Missouri judge affirmed a $110 million baby powder verdict against J&J in one of the earlier trials. The judge determined that the Supreme Court jurisdiction ruling does not prevent the state court jury from awarding damages for failing to warn a nonresident about ovarian cancer risks as there were adequate business connections between defendants and Missouri.

Experts indicate that more high-dollar rewards in early trial dates suggest troubling signs for J&J as the talcum powder litigation continues, showing that juries are not buying what J&J is selling in these cases.

 

Baby Powder Warning Label Lawsuit to Stay in Federal Court

By Emily Cox
baby powder warning
flickr/Mike Mozart

A California federal judge denied a request Thursday to remand a lawsuit, claiming Johnson & Johnson is violating state warning label and false advertising laws by selling asbestos-laden talcum powder products without including a baby powder warning label back to state court, ruling there is “no doubt” the case belongs in federal court.

At the beginning of the downtown Los Angeles hearing, District Judge George H. Wu issued a four-page tentative ruling to deny the remand motion from the seven plaintiffs, who opened a new battlefront in the ongoing legal fight over J&J’s talc by presenting claims that the healthcare giant’s product contamination and lack of baby powder warning labels violate California’s False Advertising Law, Unfair Competition Law, and Proposition 65. Prop 65 explicitly requires all business to provide cancer warnings if their services or products could expose consumers to carcinogens.

Judge Wu flatly rejected the women’s “somewhat surprising” assertion that they do not have federal Article III standing for their allegations as they are not bringing claims over any injuries to themselves but to protect the public in general.

“Notwithstanding the relative oddity of plaintiffs’ principal contention, defendants point out a problem with plaintiffs’ attempted maneuver: plaintiffs have actually pled that they did suffer an injury-in-fact (at least with respect to certain of their claims),” Judge Wu wrote.

Baby Powder Warning Label Remand Hearing

During the hearing, the plaintiffs’ attorney asked Judge Wu to reconsider his tentative ruling, saying that the party of interest in the lawsuit is the state of California and not the individual plaintiffs, since they are seeking an injunction for all Californians and not just individuals.

Judge Wu conceded that he understood the plaintiffs’ line of reasoning. However, he found that it was contrary to the Ninth Circuit and U.S. Supreme Court’s precedent for these matters.

“You’re making an argument that is, as it’s sometimes said, above my pay level,” Judge Wu said. “I don’t think this is a subject where I think district judges should be pontificating.”

Consequently, Judge Wu declared he was making the tentative ruling his final ruling in denying the remand motion.

Margaret Reed, Brenda Versic, Becky Canzoneri, Jeanette Jones, Hermelinda Luna, and Ethel Herrera, as well as Alexandra Hanks behalf of the estate of Tania D. Hanks, filed the lawsuit against J&J and its Johnson & Johnson Consumer Inc. unit in Los Angeles Superior Court in March.

They claim that J&J’s Baby Powder and Shower to Shower, a scented talcum powder, products contain asbestos, which is a known carcinogen. Consequently, they are in clear violation of Prop 65’s warning label requirements and deceived customers who they promised the talc was a pure and safe product in their advertising. The lawsuit is looking for injunctive relief, a baby powder warning label, and statutory penalties of $2,500 per day for each J&J talc product sold without a warning label.

Baby Powder Warning Label and Prop 65

The nonprofit Council for Education and Research on Toxics thrust California’s Prop 65 into the spotlight when it sued Starbucks and dozens of other coffee retailers and roasters, claiming they were in violation of the Prop 65 provisions by not warning consumers of acrylamide, a carcinogen that is present in low levels in coffee.

A Los Angeles Superior Court judge ruled that the coffee companies were in violation of Prop 65. However, the court has not required them to apply warning labels or assessed statutory penalties yet, because the companies have asked the court to wait while a state environmental health agency considers a rule that would make the warnings unnecessary.

In May, J&J removed the baby powder warning label case to federal court, stating in its motion for removal that the suit belongs there because the plaintiffs are California residents, while J&J has its headquarters in New Jersey. Furthermore, the company argued that the amount in controversy well exceeds the $75,000 minimum threshold, as the plaintiffs are seeking “hundreds of millions of dollars” in disgorgement, as well as statutory penalties.

The women’s lawsuit represents a new tactic in the barrage of lawsuits, accusing J&J of selling talcum powder with asbestos in it. These suits themselves were a new attack front on the talcum powder products after thousands of women and their families have filed lawsuits during the past several years, claiming the talcum powder itself causes ovarian cancer when used around a woman’s genital region.

 

 

 

Unresolved Claims Disclosures Ordered in Invokana Settlement

By Emily Cox

Invokana Amputation Invokana risks Invokana settlement

In the wake of the recent success in reaching an Invokana settlement in the ongoing multidistrict litigation (MDL) over claims that the manufacturer deliberately concealed the type II diabetes drug’s diabetic ketoacidosis, kidney injury, and amputation risks, the District Judge presiding over the federal litigation is ordering new and existing plaintiffs with unresolved claims to submit documentation regarding their cases.

District Judge Brian Martinotti issued the Invokana settlement administrative order August 16. Judge Martinotti acknowledged the “tremendous efforts of the parties to achieve resolutions for various injuries claimed in this complicated multidistrict litigation” but indicated that plaintiffs who had no reached a resolution for their claims must produce specific information for the court.

The order requires plaintiffs to notify treating physicians and pharmaceutical dispensaries to preserve evidence and provide any available medical, pharmacy, and death records, as well as fact sheets pertaining to their claim. These requirements go into effect immediately for new cases. However, the court is staying the order until October 30 for existing plaintiffs.

Side Effects Behind Invokana Settlement

Johnson & Johnson and its Janssen Pharmaceuticals unit released Invokana (canagliflozin) in March 2013. It was the first member of a new class of diabetes medications, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. These eliminate the body’s excess glucose through urination by altering normal kidney functions. Other members of the class include Invokamet, Jardiance, Farxiga, Xigduo, and others. However, J&J and Janssen’s aggressive marketing has kept Invokana at the head of the pack in terms of sales.

As Invokana’s sales skyrocketed, so did the steady stream of significant, life-altering health concerns from post-marketing adverse event reports. Consequently, the FDA has required the manufacturers to update warning labels several times over the past few years.

In December 2015, the FDA mandated new diabetic ketoacidosis warnings for Invokana. The serious medical condition typically necessitates emergency treatment to avoid life-threatening injuries. Before this update, Invokana warnings didn’t alert patients about the importance of seeking immediate medical attention for symptoms such as abdominal pain, fatigue, nausea, vomiting, or respiratory problems.

In June 2016, federal regulators required additional Invokana label warnings about kidney risks to inform patients of the risk of acute kidney injury and other severe health problems from the medication.

In May 2017, the FDA mandated still more Invokana warnings. This time it was regarding the risk of leg and foot amputations. Manufacturers of other SGLT2 inhibitors continue to maintain that this risk is unique to Invokana and does not apply to their drugs.

Invokana Settlement MDL

J&J and Janssen have faced hundreds of product liability lawsuits recently over deliberately concealing substantial Invokana side effects to bolster sales growth.

Due to inherent similarities in lawsuits pending in the federal court system, the Judicial Panel on Multidistrict Litigation (JPML) centralized the federal litigation to expedite pretrial proceedings in the District of New Jersey.

As the court began establishing a bellwether program to prepare a small group of representative Invokana cases for early trial dates to help parties evaluate the relative strengths and weaknesses in their cases, the manufacturers began negotiating for an Invokana settlement with several law firms involved in the MDL.

If the drug makers fail to resolve the cases remaining in the MDL, Judge Martinotti may set additional trials for remaining cases or start remanding lawsuits back to District Courts across the country for separate trial dates.

 

Xarelto “Greatly” Increases Brain Bleeds Risks

By Emily Cox
brain bleeds
flickr/A Health Blog

A new study indicates that Xarelto use is connected to much higher risks of brain bleeds compared to aspirin, spiking concerns about the new-generation anticoagulant’s safety.

JAMA Neurology published the Taiwan researchers’ findings this past week. They found that Xarelto use carries three times the intracranial hemorrhaging risks as aspirin. But, the elevated brain bleed risks appear to only be associated with 15mg to 20mg doses.

Xarelto (rivaroxaban) is the leading drug in a new generation of oral anticoagulants. Manufacturers continue to aggressive market them as superior alternatives to drugs like Coumadin (warfarin) to prevent blood clots with atrial fibrillation and other conditions even though the drugs have been linked to tens of thousands of reports over uncontrollable and fatal bleeding events when doctors were unable to reverse the drugs’ blood thinning effects.

Xarelto Brain Bleeds Study

In this most recent study, researchers analyzed data from clinical trials that lasted three months or longer from multiple databases up to May 2018. They compared patient outcomes and brain bleeding events with Xarelto, Pradaxa, and Eliquis compared to those taking aspirin.

Researchers indicate that only 15mg to 20mg daily doses of Xarelto increased brain bleeds risks. However, this risk was triple that of the risk of daily aspirin use. Researchers did not observe the same risks with 10mg Xarelto.

“A 15-mg to 20-mg dose of rivaroxaban once daily is associated with substantially increased risks of intracranial hemorrhage, while smaller daily doses of rivaroxaban and (Eliquis) were not, implying that risk increase is dose dependent,” the researchers concluded. “It may be worthwhile to conduct randomized clinical trials comparing specific NOACs in specific doses and aspirin in patients without atrial fibrillation, but with potential sources of cardiac emboli that could cause stroke.”

The study comes on the heels of the New England Journal of Medicine’s publication of a study that showed that Xarelto does not even outperform aspirin at preventing blood clots.

Xarelto Internal Hemorrhaging and Brain Bleeds Litigation

Incidents of severe bleeding have led to tens of thousands of injury and death reports from Xarelto patients and their families. Currently, there are more than 20,000 Xarelto lawsuits pending in the sprawling multidistrict litigation (MDL). District Judge Eldon Fallon is presiding over the MDL in the Eastern District of Louisiana.

The MDL claims all raise similar allegations that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary, as well as Bayer consciously concealed Xarelto’s significant bleeding risks to boost sales of their billion-dollar baby.

After a handful of bellwether trials to help parties evaluate the relative strengths and weaknesses in their cases and hopefully help them navigate settlement agreements, parties still have not made any progress in resolving the Xarelto litigation.

Consequently, Judge Fallon recently ordered the parties to identify 1,200 Xarelto cases for discovery. The court may then remand these cases back to District Courts nationwide for individual trial dates later this year.

 

Opioid Lawyers Renew Bid for NAS Babies Track in MDL

By Emily Cox
opioid lawyers NAS
flickr/Daniel Lobo

Opioid lawyers representing babies born to mothers who took prescription painkillers during their pregnancies relaunched their initiative Tuesday for a separate track in the sprawling opioid multidistrict litigation (MDL), asserting that the plaintiffs’ executive committee is overtly hindering their attempts to secure justice.

The opioid lawyers are requesting to file a new motion for a separate MDL track, claiming that the current plaintiffs’ committee still has not dedicated a representative for babies born with neonatal abstinence syndrome (NAS) and that the committee is singularly composed of local government and institution attorneys who interests clash with those of the infants. Furthermore, while discovery is underway, the committee is officially refusing to inform babies’ opioid lawyers if it involves or relates to any of their claims.

Since the Judicial Panel on Multidistrict Litigation (JMPL) formed the MDL in December, the court has created separate tracks for third-party payors and Native American tribes. Much like the local governments, these parties generally claim that opioid manufacturers and distributors fueled the opioid crisis by downplaying opioid risks and refusing to report suspicious orders.

“The court created the Native American track so that they would not be marginalized,” the attorneys said. “Here the [neonatal abstinence syndrome] babies are currently marginalized completely.”

Opioid Lawyers Fight for Separate NAS Track

NAS can cause low birth weight, short-term withdrawal symptoms, such as seizures, and long-term cognitive difficulties. So far, seven proposed class actions for NAS babies have been transferred into the MDL.

Since the opioid lawyers first requested a separate track for the infants in May, more than 5,000 babies have been born with NAS. However, in late June, District Judge Dan Polster shot down the request in a text order.

“Judge Polster considered most if not all of the arguments made by the representatives when they made their original motion,” plaintiffs’ executive committee member Paul Hanly said. “The PEC believes that his decision not to create a separate track or add PEC members was and remains correct, but it is the Court’s decision, not that of the PEC.”

The opioid lawyers for the infants indicate that the infants represent the largest category of plaintiffs and are “undisputedly free of fault and critically the most vulnerable in this litigation due to their inability to speak for themselves.”

Initially, NAS attorneys argued for the court to create a trust to fund research and treatment for the syndrome. They also pushed for direct compensation for the victims with some of it relating to out-of-pocket expenses for opioid-weaning treatment after babies are born.

“Voiceless children deserve to have separate counsel and these NAS babies deserve to be heard and represented in this opioid crisis,” one of attorneys representing the babies said.

“Despite thousands of NAS babies being born each year, the states and local governments have done little to address this epidemic or the life-long issues which follow these children.,” he continued. “We are hoping the court reconsiders its position, recognizes the plight of these children and allows them a clear voice in the multidistrict litigation.”

Internal Documents Could Be J&J’s Undoing in Talc Litigation

By Emily Cox
internal documents
flickr/Mike Mozart

Johnson & Johnson’s own internal documents could prove to be the key to taking down the healthcare behemoth in the massive talc litigation by backing up devastating claims that its iconic Baby Powder contained asbestos and J&J knew it.

Earlier this year, attorneys representing New Jersey plaintiffs Stephen Lanzo III and his wife used these documents to support allegations that J&J knew that the deadly mineral was in its talc, took steps that failed to solve the serious health issues, and developed a purposefully faulty testing protocol that could only detect asbestos above certain thresholds, while lying to the FDA, the medical community, and consumers about its baby powder’s serious health risks.

According to Lanzo attorney Moshe Maimon, the internal documents represented the plaintiffs’ entire case, which yielded a $117 million verdict from the jury.

“They could not get away from…their own words,” Maimon said.

In April, jurors found that J&J’s talc products, including its signature baby powder, contained asbestos. Furthermore, they determined that Lanzo’s exposure to the toxic fibers in J&J’s products between 1972 and 2003 played a significant role in him developing mesothelioma.

On June 29, a New Jersey judge rejected J&J’s motions to toss the jury’s verdicts against J&J and Imerys Talc, totaling $37 million in compensatory damages and $80 million in punitive damages.

According to Jean Eggen, a noted emeritus professor at Widener University Delaware Law School, exposing these internal communications during the trial likely influenced the substantial verdict.

“The difficult thing in these cases is to show that there actually was asbestos in the talc,” Eggen said. “That means that these internal documents are going to be really critical.”

“It certainly could be more powerful evidence when it’s coming … directly from the defendants than … when it’s merely coming from the plaintiffs’ experts,” she continued.

Internal Documents Could Provide Talc Litigation Roadmap

Eggen indicates that victories at trial like the Lanzos’ could provide essential guidance to other plaintiffs’ lawyers for how to “get a win.”

While the damaging internal documents don’t ensure plaintiffs’ success in other trials with different juries and judges, this roadmap could provide “a winning strategy to help plaintiffs’ attorneys out in these difficult cases.”

Although the Lanzos’ lawyers had other materials that indicated that J&J’s talcum powder contained asbestos before filing the couple’s lawsuit in December 2016, the legal team hadn’t received internal documents from the company yet.

However, several months later, J&J turned over more than a million pages of documents from its initial discovery production in the case. Furthermore, the Lanzos received additional J&J documents as well as Imerys ones, filling in the missing pieces in the plaintiffs’ case against the companies.

“We already knew from the outside pieces, so to speak, that there’s asbestos in the talc,” Maimon said. “Now from the inside pieces, it tells us the internal story: They knew that there was asbestos in the talc, what did they try and do to remove it, [and] once they couldn’t remove it, what did they do as far as how to deal with it, both internally and externally.”

J&J Internal Documents Revelations

Maimon indicates that the documents show that, as early as the late 1960s, J&J became “acutely aware of the dangers of having asbestos contamination in their talc” and attempted to resolve the issue in various ways.

Initially, the company tried to find alternative talc sources that were free of asbestos contamination. However, J&J was unable to secure pure sources for its talcum powder. Consequently, J&J then attempted to “basically clean the talc and remove the contaminants from it,” but the company was unable to get rid of the asbestos entirely.

According to Maimon, some of the most critical documents in the talc litigation came from this time period.

Among these documents was a 1969 memo from a J&J doctor while the company was searching for alternative talc sources. Maimon said that the memo explicitly addressed significant health concerns due to asbestos contamination, concluding that “this could result in litigation.”

A 1974 report from J&J’s mining company about efforts to remove or suppress the asbestos in the talc echoed these concerns. The report referred to the toxic mineral’s presence in the talc as “a severe health hazard.”

“As far as I’m concerned, that’s the most important document that’s there,” Maimon said.

At the time of this report, Lanzo was merely 1 ½ years old.

Internal Documents Reveal Purposefully Faulty Asbestos Detection Testing

After it became clear that J&J would not be able to remove the asbestos, “they came up with a testing protocol which they knew would miss the asbestos that was there,” Maimon stated.

Under this faulty-by-design methodology, analysts would only identify talc samples as containing asbestos if five fibers of a singular type of asbestos were discovered during a two-hour testing window. If analysts failed to find five such fibers within this time limit, the talc was deemed asbestos free.

This testing protocol allowed “hundreds and hundreds of millions of asbestos fibers to be present which you’re reporting as…no quantifiable amount of asbestos,” Maimon said.

While rebuking defense arguments that extensive testing determined J&J’s talc was asbestos-free, the Lanzos’ attorneys highlighted J&J testing methodology’s significant shortcomings.

“It’s designed to be negative,” Maimon said. “It’s like letting the students write the test for their final grade. Of course, they’re going to pass. They will make the test that they can pass.”

The Lanzos’ lawyers also used the internal documents to show that J&J withheld information from and flat-out lied to the FDA about its testing results.

For instance, J&J informed federal regulators in 1976 that the company tested the talc and never found any asbestos fibers.

“[But], if you look at the internal reports and the internal documents…they found the asbestos,” Maimon said.

Maimon and his co-counsel also provided evidence that tissue samples from Lanzo’s lymph nodes had asbestos that matched the specific types found in J&J’s Baby Powder. This material confirmed the plaintiffs’ expert testimony that Lanzo’s asbestos exposure came from the talc. However, Maimon said he would have tried the case in light of the exceptionally damaging evidence within the internal documents even without this evidence.

“Internal Admissions Always Mean Something”

“I think the documents are so clear that ultimately … there’s no way for them to get around them,” Maimon said of J&J.

“The thing about the case, the same thing about the legal system, is that it’s really the only mechanism by which these types of documents come out into the public,” he continued. “If it weren’t … for this system, there’s no way anybody would know any of this.”

As another member of the plaintiffs’ bar put it – “Internal admissions always mean something.”

…and sometimes they can mean everything…

By showing that testing proves asbestos was in the talc, the internal documents support the plaintiffs’ allegations and directly contradict J&J’s position that its talc does not contain asbestos.

The overarching implications of the Lanzos’ win with the internal documents is that it gives people the courage to fight.

“Each case is gonna be judged on its own merits, but it does give injured people the courage to stand up and … take on a company of that size and stature,” the plaintiffs’ bar attorney said.

 

 

 

 

 

 

 

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