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C.R. Bard Faces First Trial Over Defective Hernia Mesh

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C.R. Bard, a subsidiary of Becton, Dickinson and Co., began its first bellwether trial on Monday, August 2nd over claims that its hernia repair surgical mesh is defective. The trial is expected to last over five weeks with testimony from plaintiff Steven Johns, his treating physician, Bard employees, and expert witnesses for both sides. 

Background in Defective Hernia Mesh Lawsuit

Specifically, Utah resident Johns alleges that he suffered “persistent, debilitating pain” and emotional distress after he was implanted with the Ventralight ST hernia mesh patch in 2015 to repair an abdominal hernia. He is bringing claims of negligence, design defect, manufacturing defect, breach of warranty, negligent misrepresentation, and violation of Utah’s consumer protection laws. A spokesman for the manufacturing company declined to comment on the case.

Bard marketed Ventralight and other similar products to support damaged tissue following hernia (a protrusion of an organ through a weak spot in a muscle or collective tissue wall) repair surgery. For Johns, the first surgery was not successful. A second surgery was then done to replace the first Ventralight patch, followed by a third surgery to repair a recurrence of the hernia. He claims that product design is “unreasonably dangerous” and that an anti-adhesive coating used to prevent the mesh from sticking to tissue is toxic and damaging.

Implications of Defective Hernia Mesh Ruling

The ruling of the bellwether trial will show the potential outcome of more than 13,000 lawsuits around the country from plaintiffs who allege the products caused pain, inflammation, and infection. These lawsuits have been consolidated into a multi district litigation (MDL) before Chief U.S. District Judge Edmund Sargus in Columbus, Ohio. It is the third largest MDL in the country. In total, the company is facing more than 25,000 lawsuits, with most of them in a Rhode Island coordinating litigation. 

In 2011, Bard settled about 2,600 lawsuits for $184 million related to an earlier hernia mesh product after losing a bellwether trial. 

For more information about defective hernia mesh repair products, contact us today.

Hernia Mesh

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Purdue Pharma’s Bankruptcy Plan In Response to Opioid Crisis

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The United States Department of Justice (DOJ) is denouncing a proposed bankruptcy plan for Purdue Pharma, the manufacturer of OxyContin. In court filings from mid-July, the DOJ’s Trustee Program, which keeps a close eye on the federal bankruptcy system, describes the settlement as fatally flawed, unconstitutional, and illegal. In a second statement, the office of the U.S. Attorney for the Southern District of New York argued that the plan went against the “constitutional right to due process” for individuals with potential opioid claims. 

Purdue Pharma Opioid Settlement

According to the settlement, which has been negotiated over the past year, the Sackler family, who owns Purdue Pharma, would pay nearly $4.3 billion from their private accounts to help the people and communities negatively affected by OxyContin. In return, members of the family as well as a long list of their associates, would be given “third-party releases,” protecting them from future opioid lawsuits. Although that provision has raised eyebrows, more and more states are agreeing to the plan. 

In his objection, Trustee William Harrington described the settlement as “impermissible.” He blamed the Sacklers, who, by their own calculations, earned more than $10 billion from opioid sales, and their associates of using the bankruptcy system to avoid taking responsibility for “alleged wrongdoing in concocting and perpetuating for profit one of the most severe public health crises ever experienced” in our country. In a separate filing, U.S. Attorney Audrey Strauss said that the bankruptcy plan denies due process to those with potential claims. 

Purdue Pharma as Trigger for Opioid Epidemic

The marketing of OxyContin by Purdue Pharma in the late 1990s is recognized as a primary trigger of the deadly opioid epidemic, which has killed over 500,000 Americans. The company has pleaded guilty twice to federal criminal charges concerning its marketing techniques. Still, the Sacklers believe they have done nothing wrong and acted ethically.

Federal Bankruptcy Judge Robert Drain is expected to approve the settlement at a confirmation hearing planned for Monday, August 9. He believes the plan is “an opportunity to avoid years of costly and uncertain litigation.”

For more information about the opioid epidemic and settlement, contact us today.

Additional Reading:

Tentative Opioid Settlement For $26 Billion Focuses on Treatment, Prevention, and Education

Johnson & Johnson Agrees to End Opioid Business With $230 Million Settlement

Opioids

Tentative Opioid Settlement For $26 Billion Focuses on Treatment, Prevention, and Education

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500,000 Americans have died since the opioid epidemic began more than two decades ago, with nearly 70,000 people overdosing in 2020 alone (a record 191 every single day). Now, the country is making notable strides to end the crisis. Just last week, the biggest penalty for drug companies’ role in the crisis was announced with a tentative settlement worth $26 billion. 

Federal law states that primary responsibility for preventing illegal distribution of pharmaceutical painkillers falls to three major companies: McKesson, Cardinal Health, and AmerisourceBergen. They have been accused of ignoring the fact that billions of pills entered the black market and contributed to the epidemic. The new deal includes payment from these companies of $21 billion over 18 years with the remaining $5 billion paid out over 9 years by Johnson & Johnson (J&J). It’s important to note that J&J was once responsible for supplying much of the raw material for opioids and sold some painkillers but no longer does in either the United States or Canada. 

Opioid Settlement Details

The deal would settle more than 3,000 lawsuits, which were consolidated into one of the largest and most complicated civil litigation battles in U.S. history. Currently, the main contributor to the epidemic is illicit fentanyl manufactured in labs abroad, rather than the legal medicine distributed in the country. According to the Centers for Disease Control and Prevention, opioid prescriptions have dropped from a high of 255.2 million in 2012 to 153.2 million in 2019. 

The settlement money will go towards treatment, prevention, and education as well as other costs of the epidemic, including nearly $2 billion to private attorneys. However, none of the families who have lost a loved one or any sufferers of substance-use disorders will receive payment. Some money may be set aside in an escrow fund as early as September.

A group of 10 state attorneys general involved in the case said in a statement, “We look forward to bringing much-needed dollars home to our states to help people recover from opioid addiction and to fundamentally change the opioid manufacturing and distributing industries so this never happens again.” 

Of course, the harm done by the epidemic far surpasses the proposed settlement, but the agreement is a step towards improvement. “Getting this deal struck now and getting this money distributed fairly quickly — this is going to start to save people’s lives right away,” said Gary Mendell, whose son Brian passed away in 2011 after battling addiction. Mendell, who is also the founder of Shatterproof, a non-profit working to end the addiction crisis, added that a critical component of the deal is guaranteeing that funds go towards evidence-based treatment and prevention programs. 

For more information about the opioid epidemic and settlement, contact us today. 

Additional Reading:

Johnson & Johnson Agrees to End Opioid Business With $230 Million Settlement

Opioids

Atrium Medical ProLite Hernia Mesh Lawsuit Cleared for Trial

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Atrium Medical Corp. faces trial for a plaintiff’s claims that a hernia mesh repair product resulted in severe infection and that the company didn’t warn doctors about the possibility of contamination during manufacture. 

The case began in October 2017 with a complaint from Randy J. Africano. The patient alleged that a non-sterile patch of ProLite mesh, which was used during a hernia repair surgery, caused an infection and serious injuries. 

The Food and Drug Administration (FDA) has warned Atrium about sterility and safety issues at some of its manufacturing facilities since 2012. In October 2021, the agency sent a warning to the company after facility inspections, noting a number of violations. In February 2015, a federal court in New Hampshire went as far as blocking the company from the distribution of several products made at its manufacturing buildings in New Hampshire, including the ProLite Mesh. 

During pretrial proceedings, Atrium filed a motion of summary judgment and asked to have the case dismissed. However, in early June, U.S. District Judge Mary M. Rowland issued a memorandum opinion and order. She threw out Africano’s claims about defective design but allowed the lawsuit to move forward with his charges of manufacturing defect and failure to warn. 

Atrium Hernia Mesh Litigation

Atrium currently faces thousands of product liability lawsuits related to its C-Qur hernia mesh products, which are currently pending as a federal multidistrict litigation (MDL). Allegations include issues with an omega-3 fatty acid gel coating used on the products. While it was intended to reduce scar tissue build-up and encourage attachment of the mesh to the abdominal wall, plaintiffs argue that it actually led to an increased risk of inflammatory response, bowel adhesions, and other serious complications that often required additional surgery. 

Early trials begin this month, which will help parties better understand how juries may respond to testimonies and evidence throughout the upcoming thousands of individual cases. 

For more information about Atrium’s defective hernia mesh repair products, contact us today.

Hernia Mesh

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Jury Awards $926,000 Against Bard in IVC Filter Case

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In May, a Portland jury awarded $926,000 to a plaintiff in an IVC filter case against Bard Peripheral Vascular and C.R. Bard, Inc. 38-year-old Justin Peterson was wounded when a Bard Eclipse IVC filter perforated his vena cava and duodenum. The injury caused massive bleeding and required open abdominal surgery to remove the filter and fix the damaged blood vessel and small intestine. 

Active Case

Peterson initially received the filter after his deep vein thrombosis (DVT) diagnosis in 2010. In 2015, he experienced severe bleeding as well as lightheadedness and abdominal symptoms, all of which were caused by the filter puncturing his duodenum. His wife immediately took him to the hospital where surgery was then performed. 

The eight-person jury unanimously agreed that Bard was guilty of negligently designing the filter and failing to warn doctors about the defective device. The filter first appeared on the market in 2010 as a replacement device for Bard’s second generation G2 and G2X filters, which were pulled from shelves. 

Other Problems with IVC Filters

Over the years, multiple problems have been associated with the IVC filters, including practice, migration, and perforation. Bard was also the defendant in an 8000-person MDL that came to a close in 2019. Peterson’s case is the first to be tried since then, with hundreds of remanded cases on file across the country and many already set for trial. 

For more information about Bard’s defective IVC filters, contact us today.

Additional Reading:

IVC Filter Commonly Asked Questions
IVC Filter Medical Issues and Complications
IVC Filters: What you need to know

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

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In a recent filing from lawyers representing over 70,000 former users of Zantac, Sanofi is accused of “widespread” email deletion related to its 2019 recall of the heartburn medication, which preceded the Food and Drug Administration’s (FDA) full ban in 2020. Lawyers claim that this tampering “resulted in the delay and/or postponement of many key Sanofi depositions.” They have asked for more time to prepare for these trials, which are set to begin next year. 

Active Case

A spokesperson for Sanofi revealed that the company “did not intentionally destroy any emails related to the Zantac litigation. Any suggestion to the contrary is false. Sanofi has provided hundreds of thousands of pages of relevant discovery to the plaintiffs, including internal emails, test results, safety assessments, and correspondence with regulatory authorities.”

Zantac Recall Timeline

In late 2019, Sanofi agreed to recall over-the-counter Zantac in the United States and Canada due to possible contamination with suspected carcinogen N-nitrosodimethylamine (NDMA). By April 2020, the FDA had removed the drug and all generic versions from shelves. In August 2020, Sanofi shared that it was the focus of a Department of Justice probe over potential violations of the False Claims Act in relation to the Zantac recalls. 

Other drugmakers, including GlaxoSmithKline and Boehringer Ingelheim as well as multiple generic companies, are also accused in the Zantac lawsuits of failing to alert customers to the potential harm. 

For more information about the Zantac recall and lawsuits, contact us today.

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk
Zantac Lawsuits & Updates
Zantac (Ranitidine) Commonly Asked Questions
Zantac Cancer Risk

JUUL Settles North Carolina Youth Vaping Case for $40 Million

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At the end of June, Attorney General Josh Stein announced that JUUL settled with North Carolina for $40 million. The state alleged that the e-cigarette company aggressively marketed its products to young people through social media advertisements and other outlets, leading to a notable increase in youth vaping. 

Active Case

Underage E-Cigarette Use and Marketing Tactics

“For years, JUUL targeted young people, including teens, with its highly addictive e-cigarette,” Stein shared in a statement. “It lit the spark and fanned the flames of a vaping epidemic among our children — one that you can see in any high school in North Carolina.”

Under the consent order, JUUL must adhere to several marketing restrictions, including little to no social media advertising, no outdoor advertising near schools, and no sponsorships of sporting events and concerts. While the e-cigarette company has voluntarily adhered to many of these rules, it’s now considered the law in North Carolina. The company also agreed to stop the sale of sweet and fruity flavored e-cigarettes in the state unless given permission by the Food and Drug Administration (FDA).

Youth Vaping Across the Country

Although North Carolina is the first state to reach a settlement with JUUL, an additional 12 states and Washington D.C. have also sued the company. From a national perspective, Stein encouraged the FDA to prohibit all non-tobacco flavors, including menthol, in e-cigarettes; to limit the level of nicotine in e-cigarette products; and to impose strict marketing guidelines to prevent attracting young people.  

Youth vaping has been on the rise since 2017, with JUUL at the center of the e-cigarette controversy from the beginning. In fall 2019, the company stopped selling flavored vaping pods, excluding tobacco and menthol. 

Even so, the e-cigarette manufacturer denies any wrongdoing and liability. In a statement, spokesperson Josh Raffel said that the agreement with the state of North Carolina “is consistent with our ongoing effort to reset our company and its relationship with our stakeholders, as we continue to combat underage usage and advance the opportunity for harm reduction for adult smokers.”

For more information about the investigation into JUUL, contact us today.

Additional Reading:

North Carolina Takes Legal Action Against JUUL

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

Jury Verdict for Plaintiffs in Latest 3M Earplug Lawsuit

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Last month, in Pensacola, Florida, a federal jury awarded $1.7 million to Lloyd Baker of Wyoming, one of over 230,000 members of the United States military who has sued 3M because of their defective Combat ArmsEarplugsVersion 2 (CAEv2). In one of the largest mass torts ever, the jury ruled in favor of Baker’s “failure to warn” claim about the risks associated with the 3M earplugs. They declared that 3M was 62 percent responsible for Baker’s hearing damage, with Baker himself 38 percent liable, meaning he will ultimately receive around $1.1 million. 

3M’s Response to Jury Verdict

3M noted that the jury rejected four other claims by Baker. In a press statement, the company declared: “We are exploring our appellate options with respect to the remainder of the jury’s verdict. [This] outcome, as well as our win in the last bellwether trial, affirms our confidence in our case, and we will continue to defend ourselves in this litigation.”

So far, 3M has lost two of three bellwether trials in this legal battle with the military over defective earplugs. As Bryan Aylstock, a Pensacola-based attorney for the plaintiffs, pointed out, “Ultimately, 3M cannot escape the fact that a jury has entered a verdict in favor of four out of the five service members to go to trial to date.”

Were You Issued 3M Combat Arms Earplugs and Now Suffer Tinnitus and/or Hearing Loss?

In the first trial, held in April, a jury gave $7.1 million, primarily in punitive damages, to three veterans. In the second trial, held in May, a jury rejected the plaintiff’s claims. At least two more trials are scheduled for September and October.

Ultimately, given that over 200,000 cases are pending, 3M could be liable for hundreds of billions of dollars in damages. These lawsuits are tied together in a multidistrict litigation (MDL) case, meaning that the bellwether trials will determine the resolution for all claims. The less variation among the trial results, the more likely a settlement.

For more information about the 3M MDL and most recent settlement, contact us today.

Additional Reading:

Update: Tort Lawsuit Against 3M Begins This Month in Pensacola

3M Earplug Hearing Loss Trial Scheduled for Spring 2021

Johnson & Johnson Agrees to End Opioid Business With $230 Million Settlement

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Johnson & Johnson has agreed to a $230 million settlement with New York state to prevent the promotion and sale of opioids within the United States. Over the last few decades, the opioid epidemic has killed nearly 500,000 people in the country, prompting years of lawsuits against major pharmaceutical companies. 

The agreement includes the resolution of opioids-related claims with payment allocation over the next nine years. The company could also pay up to $30 million more in the first year if the state executive chamber passes new legislation for an opioid settlement fund. 

The Opioid Epidemic

The company stopped marketing the drugs in 2015 and fully ended the business in 2020. Local governments believe that companies over-prescribed the drugs, leading people to become addicted, while companies argue that they distributed the necessary product amount to address medical issues. 

“The opioid epidemic has wreaked havoc on countless communities across New York state and the rest of the nation, leaving millions still addicted to dangerous and deadly opioids,” said New York Attorney General Letitia James. “Johnson & Johnson helped fuel this fire, but today, they’re committing to leaving the opioid business — not only in New York but across the entire country.” Additionally, New York state will focus on opioid prevention, treatment, and education efforts to prevent future tragedies. 

The New York opioid lawsuit trial against other defendants began at the end of June.

For more information about the Johnson & Johnson opioid settlement, contact us today.

Additional Reading:

Opioids

Johnson & Johnson

Pfizer Halts Sales of Chantix Due To Possible Carcinogen Contamination

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Last month, Pfizer announced a pause in the distribution of smoking-cessation drug Chantix (varenicline) after identifying levels of nitrosamines, a potential carcinogen. The levels in drugs aren’t supposed to exceed an excess cancer risk of 1 in 100,000. The manufacturer is recalling multiple lots of the drug for the same reason.

In 2020, the Food and Drug Administration (FDA) discovered high amounts of NDMA (N-nitrosadimethylamine) in numerous drugs, including the diabetes drug metformin. In 2019, heartburn medication Zantac was also recalled due to NDMA contamination.

The History of Chantix

Chantix, which is used for 12 to 24 weeks, was initially approved by the FDA in May 2006 to help adults 18 and over quit smoking. Pfizer indicated that they were stopping distribution “out of an abundance of caution” and would continue investigations. They haven’t revealed which nitrosamines were discovered in the pills or how they got there. 

Prior to the sales halt, the drug was already facing issues. Sales recently dropped 17 percent — from $1.1 billion in 2019 to $919 million in 2020 — due to the COVID-19 pandemic and the loss of patent protection in the United States in November.

As company spokesperson Steven Danehy told Reuters, Pfizer believe “the benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime.” It’s important to note that the potential carcinogen is also found in water and grilled meat. 

For more information about the halted distribution of Chantix, contact us today.

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