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Philips Breathing Machine Recall Over Potential Cancer Risk, Millions In Need of Substitutes

Posted on September 13, 2021September 11, 2021

People who struggle with sleep apnea or other breathing ailments rely on special machines to ensure that they can breathe safely while sleeping. Unfortunately, in June, the Food and Drug Administration (FDA) recalled more than a dozen devices manufactured by Philips. There was concern that the Respironics machines, which deliver pressurized air through a mask, had faulty components that could lead to heath risks. Now, millions of patients face waitlists of a year or more for their much-needed replacements.

Expanding on their initial declaration, in July, the FDA warned that the risks could be “life-threatening, cause permanent impairment, and require medical attention.” The machines use polyester-based polyurethane foam to dampen sound and vibrations. Over time, it can degrade and result in a user breathing in chemicals or swallowing or inhaling black debris. Possible risks from this exposure include asthma, skin and respiratory-tract irritation, and “toxic and carcinogenic effects” to organs like the kidneys and liver.

Specifically, the recall involves BiPAP (bi-level positive air pressure), CPAP (continuous positive air pressure), and ventilator machines manufactured before April 26, 2021. As the next steps, Philips must submit a repair-and-replacement program to the FDA for the defective parts. However, there are shortages and backlogged orders because of the use of similar devices in hospitals to treat COVID-19.

Breathing Machine Recall Response from Philips

A spokesperson for Royal Philips, the parent company of Respironics, estimates that up to two million of the recalled devices were in use in the United States, largely by the 24 million Americans who struggle with obstructive sleep apnea. He added that the company was working “expeditiously” to find a solution. They are “already producing repair kits and replacement devices” of about 55,000 units per week, although they have not yet been cleared for shipping.

Philips advises current users of the impacted machines to register their products and talk to their doctors. Presently, there is no time estimation for the waiting list, forcing many patients to continue using their dangerous devices. As 72-year-old Donald Camp explains, “I believe any risk of cancer is less than the risk of the serious consequences of sleep apnea.”

How This Recall Impacts COVID-19 Physicians and Patients

Of course, this recall is also problematic for doctors caring for coronavirus patients. “Because the number of people coming into the hospital with severe respiratory symptoms has increased as a result of COVID-19, the demand for these devices has also increased,” explained Dr. David Schulman, a pulmonary and critical care medicine specialist at Emory Healthcare. Without knowing more about the potential risks, it’s impossible for physicians to determine how to best care for patients with breathing issues.

Since the recall, patients in over 20 states have filed about 40 lawsuits against Philips. Unsurprisingly, a multi-district litigation petition has also been filed. Legal experts anticipate that all cases will be consolidated in one state, similar to the handling of lawsuits against opioid manufacturers. Philips set aside about $591 million to cover the repair and replacement orders and other anticipated costs.

For more information about the recall of Philips breathing machines and multi-district litigation, contact us today.

FDA to Make Major Decision About Flavored E-Cigarettes

Posted on September 9, 2021September 8, 2021

The Food and Drug Administration (FDA) is currently reviewing millions of applications from e-cigarette makers and must decide today if flavored e-cigarettes are “appropriate for the protection of public health.”

Use of Flavored E-Cigarettes

A study from the Centers for Disease Control and Prevention (CDC) revealed that roughly 15 percent of adult smokers successfully quit smoking using e-cigarettes. Additionally, a study in the New England Journal of Medicine found that, of those smokers who quit, 18 percent remained cigarette-free after a year.

Despite these positives, e-cigarettes have caused notable harm to public health. Lawmakers and public health advocacy groups focus on vaping’s appeal to teens and even children. A 2020 study from the CDC determined that nearly 20 percent of high school students and 5 percent of middle school students had vaped regularly. These users primarily partake in flavored e-cigarettes.

Because of this usage by America’s youth, several lawmakers and state attorneys general have urged the FDA to ban all flavors, including menthol. The agency has already banned the sale of reusable flavored e-cigarettes sold by companies like JUUL, but it currently allows the sale of disposable flavored products.

E-Cigarettes As A Cessation Device

Most public health experts agree that some kind of e-cigarettes should be available to help wean adults from cigarettes. However, anti-vaping advocates believe that flavors are unnecessary to sell e-cigarettes to individuals trying to quit smoking. After all, they are already familiar with tobacco-flavored products.

Plus, many of these businesses don’t play by the rules. “No one has attempted to file applications or legally market these products [before now]. No one has filed applications to make modified risk claims legally,” explains Desmond Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law. “The whole idea that e-cigs are a cessation device — why has no company filed a drug application to say it’s a cessation device?”

For more information about the investigation into flavored vaping products, contact us today.

Additional Reading:

FDA Removes 55,000 Flavored Vaping Products From Market

North Carolina Takes Legal Action Against JUUL

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

Judge Approves $10 Billion Plan in Purdue Pharma Opioid Lawsuits

Posted on September 6, 2021September 6, 2021

Last week, a federal bankruptcy judge tentatively approved a $10 billion plan submitted by OxyContin manufacturer Purdue Pharma. The plan will resolve lawsuits related to the company’s role in the opioid crisis — an epidemic that has killed 500,000 Americans during the last 20 years. The settlement was reached with both individual victims and thousands of state and local governments.

Details of the $10 Billion Plan for Purdue Pharma

U.S. Bankruptcy Judge Robert Drain noted that his approval of the plan is contingent upon two technical changes. While he does not have “fondness for the Sacklers (owners of Purdue Pharma) or sympathy for them,” collecting money from them through litigation would be challenging.

Under the new terms, the Sackler family will release ownership of the company and contribute $4.5 billion to the plan but will be absolved from any future opioid lawsuits. They were not, however, given immunity from criminal charges, although there is no reason to believe they will face any. Additionally, a compensation fund will pay sufferers of drug addiction between $3,500 and $48,000 each.

Meanwhile, Purdue Pharma will be reorganized into a new company. The board will be determined by public officials, and the company will contribute its profits to efforts to prevent and treat opioid addiction.

The Opioid Epidemic

It’s been nearly two years since the drug manufacturer filed for bankruptcy after over 3,000 lawsuits were filed against them. These cases accuse the company of fueling the opioid epidemic through aggressive marketing of the addictive prescription painkiller.

For more information about the opioid crisis 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

FDA Removes 55,000 Flavored Vaping Products From Market

Posted on September 2, 2021September 2, 2021

Last week, the Food and Drug Administration (FDA) ordered three small e-cigarette makers to pull their products from the market, signifying the beginning of a larger agency crackdown on vaping products. JD Nova Group LLC, Great American Vapes, and VaporSalon must pull 55,000 existing or future flavored products from stores. These products include flavors like Apple Crumble, Dr. Cola, and Cinnamon Toast Cereal.

FDA Crackdown Against Flavored Vaping Products

According to regulators, the companies failed to provide “sufficient evidence” that their products offer a net public health benefit for adult smokers when compared to the “threat posed by the well-documented, alarming levels of youth use” of flavored vapes. These FDA orders mark the agency’s first marketing denials for e-cigarettes. “We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed,” Janet Woodcock, acting commissioner of the FDA, said in a statement.

Of course, the agency’s orders come during a broader fight against the future of vaping. Public health advocates believe that e-cigarettes, especially flavored ones, have spurred an epidemic of nicotine-addicted youth rather than helping adults quit smoking. The FDA will determine the future of about two million vaping and other non-cigarette tobacco products by September 9th.

Vaping advocates, however, are alarmed at the FDA’s decision and shared a warning that the broader industry is in danger. As one tweet stated, “FDA bans 55,000 flavored e-cigarette products, crippling three vape companies. FDA clams applicants failed to demonstrate they are a net benefit to public health. No worries though, people can just switch back to smoking! #publichealth”

E-Cigarettes and America’s Youth

The focus here lies in potential danger to America’s young people. As the FDA prepares to rule on JUUL and other major companies, a regulator stressed that the agency would be carefully considering the potential risk to children. “Companies who want to continue to market their flavored [e-cigarette] products must have robust and reliable evidence showing that their products’ potential benefit for adult smokers outweighs the significant known risk to youth,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said.

For more information about the investigation into flavored vaping products, contact us today.

Additional Reading:

Judge Advances Bellwether Lawsuit Against JUUL for Deceiving Marketing Tactics

North Carolina Takes Legal Action Against JUUL

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

3M Earplug Cases Sped Up Due to Backlog

Posted on August 30, 2021August 27, 2021

In an effort to lessen a backlog of over 250,000 cases, a federal judge in Florida has ordered that thousands of lawsuits between veterans and earplug manufacturer 3M be scheduled for trials. Judge Casey Rogers in the Northern District of Florida called to move up 1,358 cases in the first wave and between 10,000 and 20,000 in later waves. The cases are part of the nation’s largest multi-district litigation (MDL).

3M Combat Arms Version 2 Dual-Sided Earplug

Plaintiffs claim that 3M sold earplugs to the military that loosened from the ear canal, causing hearing loss and/or tinnitus, a ringing in the ears. The earplugs in question are 3M’s Combat Arms Version 2 dual-sided earplug, where were used by the military until 2015. The product was never recalled. In fact, version 4 of the earplug is still used by the military, according to 3M.

Judge Rogers believes that moving cases to the active docket will accelerate discovery and ongoing bellwether trials, which provide useful information for a jury in order to potential reach a settlement for all cases. He has reached out to other judges in Florida’s Northern District for help during the bellwether trials scheduled for October and December. Meanwhile, 3M declined to comment following this recent change.

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

Legal History Between 3M and Veterans

So far, the cases of five veterans have been heard in three jury trials, all presided over by Judge Rogers. The first trial, which took place in April, resulted in a $7.1 million award to three Army veterans. 3M won the second trial in May. During the third trial, held in June, a jury found 3M partially liable, awarding one veteran $1.05 million.

Additionally, a trial scheduled for September has been dismissed, as the veteran’s injury was “unreleased to noise-induced hearing loss or 3M.” The Minnesota-based earplug company added, “Simply because a case is filed does not mean it has any merit. Large, multi-district litigations, like this one, often see allegations that have no basis in fact simply to increase the number of claims against companies.”

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

Additional Reading:

Jury Verdict for Plaintiffs in Latest 3M Earplug Lawsuit

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

3M Earplug Hearing Loss Trial Scheduled for Spring 2021

Alabama Announces No Involvement in $26 Billion Settlement Over Opioid Crisis

Posted on August 26, 2021August 26, 2021

The state of Alabama will not take part in a $26 billion settlement concerning lawsuits against drug companies for the opioid crisis. “Alabama is not a party to the multi-state opioid settlements,” Mike Lewis, communications director for Attorney General Steve Marshall, said. “Instead, the state continues to pursue its own legal strategy to best address the impact of the opioid crisis on Alabama.”

Alabama’s Legal Strategy

Alabama’s lawsuit against manufacturer Endo Pharmaceuticals and distributor McKesson Corporation was originally filed in 2019. It is set to begin trial on November 1st in Montgomery Country Circuit Court. Alleging deceptive marketing tactics, the lawsuit states, “Defendants needed to transform the medical and public perception to one that would permit the use of opioids not only for acute and palliative care but also for long periods of time to treat more common aches and pains, like lower back pain, arthritis, and headaches.” The state is requesting civil penalties, restitution, and punitive damages.

Reuters reported that other states that have not agreed to the settlement are Georgia, New Mexico, Oklahoma, Washington, and West Virginia. New Hampshire agreed to the settlement with the distributors but not with Johnson & Johnson.

The Opioid Crisis

According to the Associated Press (AP), in 2012, distributors shipped enough of the addictive painkillers to give every person in the country a 20-day supply. Both prescription and illegal opioids (like heroin and fentanyl) have been linked to the more than 500,000 deaths nationwide since 2000.

The AP first reported the multi-state opioid settlement in July. It is expected to involve more than 40 states and covers thousands of lawsuits filed by both state and local governments against three drug distribution companies as well as Johnson & Johnson. In the lawsuits, both state and local governments argue that drug companies did not adequately control the supply of opioids. The companies continue to deny they are to blame.

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

Additional Reading:

Purdue Pharma’s Bankruptcy Plan In Response to Opioid Crisis

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

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

Combined Verdicts for IVC Filter Lawsuits Reach $7 Million

Posted on August 23, 2021August 23, 2021

At the end of July, a federal jury in Dallas, Texas determined that C.R. Bard Inc’s (Bard) inferior vena cava (IVC) filters, intended to prevent blood clots, are defective and to blame for injuries and complications. This decision brings the total winnings for lawyers at Martin Baughman, who are representing several hundred patients, to over $7 million. Since May, the firm has won four out of six personal injury lawsuits, with the largest verdict being $3.3 million.

Martin Baughman’s Approach to Proposed Settlement

In the latest case, jurors declared that Bard’s Recovery IVC filter led to serious complications for plaintiff Debra Branch when the device fractured after being implanted. The verdict resulted in $386,250 in damages. “Once again, jurors have heard the facts and agreed that these filters are dangerous,” partner Laura Baughman said. “After recklessly marketing these products and placing profit over safety, it’s time for Bard to acknowledge how risky they are.”

Martin Baughman initially rejected a proposed settlement in order to pursue these individual trails for its clients. “We didn’t feel that [the group settlements] adequately took into account the serious nature of our clients’ injuries,” Baughman explained. The firm, which includes 13 attorneys who focus on injury and malpractice cases, has a full schedule of individual trials across the country throughout the rest of the year. Their strategy focuses on two legal theories: design defects and failure to warn.

Bard’s Response to IVC Filter Jury Verdict

Following the decision, Bard is considering appeals options. Spokesman Troy Kirkpatrick explained that all implantable medical devices, including IVC filters, come with inherent risks. “Our IVC filter products are cleared for use by the FDA and continue to offer life-saving benefits that have helped tens of thousands of patients for more than 15 years,” he shared. He added that their IVC filter complication rates are below the guidelines of the Society of Interventional Radiology.

Bard, a subsidiary of Becton, Dickinson and Co., faced more than 8,000 lawsuits, which were eventually consolidated into a multi district litigation in a federal court in Phoenix, Arizona.

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

Additional Reading:

IVC Filters: What you need to know

IVC Filter Medical Issues and Complications

IVC Filter Commonly Asked Questions

Judge Advances Bellwether Lawsuit Against JUUL for Deceiving Marketing Tactics

Posted on August 16, 2021August 16, 2021

E-cigarette company JUUL is facing a bellwether lawsuit that argues its top executives intentionally deceived customers about the addictive qualities of vaping products. Specifically, the suit blames the company’s founders and board members as well as their biggest investor, Altria, of using marketing campaigns to target young people and create a new generation of nicotine addicts.

Plaintiff Claims in E-Cigarette Bellwether Trial

At the end of July, U.S. District Judge William Orrick III refused to throw out most of the claims filed by 19 bellwether plaintiffs from 14 states in the multi-district class action lawsuit. Ultimately, he advanced both conspiracy and fraud claims, bringing the lawsuit closer to trial.

The plaintiffs are between the ages of 15 and 27 with some claiming they got hooked on e-cigarettes as young as 12 years old. They say that the e-cigarette company failed to warn consumers that their products were highly addictive. Allegedly, JUUL even falsely claimed in ads and on product labels that the pods contained 5 percent nicotine (that same amount in a pack of cigarettes) when, in truth, the levels are much higher. Additionally, they believe that JUUL marketed its vaping products as a “safer alternative” to cigarette smoking.

The Response of JUUL’s Top Executives

JUUL founders and top executives James Monsees and Adam Bowen asked the federal judge to dismiss claims of fraud, negligence, negligent misrepresentation, strict product liability, and medical monitoring, arguing that they were not personally involved in the testing, design, marketing, or sale of the vaping products. However, Judge Orrick rejected their claims, believing that the plaintiffs “adequately alleged that both Monsees and Bowen engaged in acts that had the intent and impact of misleading the public and plaintiffs about the dangers of JUUL.”

The judge also refused to let three board members — Nicholas Pritzker, Hoyoung Huh, and Riaz Valani — off the hook for fraud and negligence, finding them to have a direct role in the alleged wrongdoing.

In an earlier court decision from April, Judge Orrick ruled that Altria and JUUL’s board members could potentially be held liable under the Racketeer Influenced and Corrupt Organizations Act. These claims are the result of the belief that the defendants treated JUUL like an illegal enterprise and conspired to target young people and create a generation of nicotine addicts, omit necessary information about nicotine content, and mislead government regulators in an effort to continue selling to children.

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

Bayer Loses Third Consecutive Appeal of Roundup Cancer Verdict

Posted on August 12, 2021August 12, 2021

Bayer AG’s Roundup faces another setback as it loses a third consecutive appeal of a jury finding that its weed killer causes cancer. The company has averaged nearly $50 million in damages for each consumer.

An appeals court in San Francisco refused to overturn the 2019 verdict that awarded more than $2 billion to a couple who claimed they fell ill after more than three decades of using the herbicide. The verdict was the eighth-largest product-defect award in U.S. history. The appeals court agreed with the trial judge’s decision to reduce the amount to $86.7 million.

Bayer’s Response to Roundup Cancer Verdicts

Bayer recently set aside an additional $4.5 billion to address thousands of Roundup lawsuits, which means its total reserves for the cases is over $16 billion. Additionally, the company’s Monsanto unit will remove the current version of Roundup from the market in 2023.

In 2018, the company inherited the legal issues related to Roundup when it purchased Monsanto for $63 billion. Monsanto began manufacturing Roundup in the 1970s.

“We respectfully disagree with the court’s ruling as the verdict is not supported by the evidence at trial or the law,” Bayer said via an email statement. “Monsanto will consider its legal options in this case.”

Bayer plans to ask the U.S. Supreme Court to look at another case the company lost in 2019, hoping that it will determine that the company should be absolved of any wrongdoing because federal regulators determined that glyphosate isn’t a carcinogen.

What’s Next for Bayer

A fourth trial began last week in San Bernardino, California’s state court. 70-year-old Donnetta Stephens allegedly developed non-Hodgkin’s Lymphoma after using Roundup for more than 30 years. Before the trial began, the manufacturing company’s lawyers persuaded the judge to throw out claims that the company hid Roundup’s health risks, which may make it easier for Bayer to win the case.

For more information about lawsuits related to Roundup, contact us today.

Bladder Cancer Linked to Zantac Use in Recent Study

Posted on August 9, 2021August 9, 2021

Hundreds of plaintiffs have filed lawsuits arguing that, after years of using heartburn medication Zantac (ranitidine), they were diagnosed with bladder cancer. Now, a recent study supports their claims: The American Journal of Gastroenterology published research that indicates that users of Zantac products may face a higher chance of developing bladder cancer.

Link Between Ranitidine Use and Bladder Cancer

The new study looked at information from patients diagnosed with bladder cancer in Scotland between 1999 and 2011. Researchers matched the participants up with controls based on their age, gender, and general practice records. They ultimately gathered data on 3,260 cases of bladder cancer and 14,037 controls, showing that ranitidine users have a 22 percent higher risk of bladder cancer than non-users. The risk increased further if patients used the drug for over three years.

It’s important to note that these risks were not seen with proton pump inhibitors, another class of heartburn drugs. Examples include Nexium and Prilosec.

Although research linking Zantac and bladder cancer is in its early stages, there have been other studies that look at how ranitidine may increase levels of known carcinogen N-nitrosodimethylamine (NDMA) in the body. In a study from 2016, researchers collected urine samples from adult volunteers over a 24-hour period, both before and after taking 150mg of ranitidine. They then reviewed the samples for residual ranitidine, NDMA, and other nitrosamines. After ranitidine intake, urinary levels of NDMA increased 400-fold, while total N-nitrosamines increased 5-fold. Study authors noted that these rates “equaled or exceeded those observed in patients with schistosomiasis, a disease in which N-nitrosamines are implicated as the etiological agents for bladder cancer.”

FDA Recall of Ranitidine Products

In April 2020, the U.S. Food and Drug Administration (FDA) recalled all ranitidine products after studies revealed that storage time and high temperatures may increase the level of NDMA.

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

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

Breathing Machine Recall Response from Philips

How This Recall Impacts COVID-19 Physicians and Patients

Use of Flavored E-Cigarettes

E-Cigarettes As A Cessation Device

Additional Reading:

Details of the $10 Billion Plan for Purdue Pharma

The Opioid Epidemic

Additional Reading:

FDA Crackdown Against Flavored Vaping Products

E-Cigarettes and America’s Youth

Additional Reading:

3M Combat Arms Version 2 Dual-Sided Earplug

Legal History Between 3M and Veterans

Additional Reading:

Alabama’s Legal Strategy

The Opioid Crisis

Additional Reading:

Martin Baughman’s Approach to Proposed Settlement

Bard’s Response to IVC Filter Jury Verdict

Additional Reading:

Plaintiff Claims in E-Cigarette Bellwether Trial

The Response of JUUL’s Top Executives

Additional Reading:

Bayer’s Response to Roundup Cancer Verdicts

What’s Next for Bayer

Link Between Ranitidine Use and Bladder Cancer

FDA Recall of Ranitidine Products

Additional Reading:

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