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FDA Authorizes Vuse Solo E-Cigarette, Shows Benefit for Smokers

Posted on October 20, 2021October 20, 2021

For the first time, the Food and Drug Administration (FDA) has authorized a vaping device, the Vuse Solo e-cigarette. The agency believes that the product, from parent company R.J. Reynolds, can help smokers quit the use of traditional cigarettes. Vuse is the second most popular vaping brand in the U.S. It is responsible for nearly a third of all retail sales and only sells fewer products than JUUL.

Vuse Solo E-Cigarette

The FDA’s recent authorization applies to the Vuse Solo e-cigarette and its tobacco-flavored nicotine cartridges. Released in 2013, Vuse Solo is a rechargeable device that looks like a traditional cigarette. The agency noted that it rejected 10 requests from the company for other flavored products. It is still reviewing the request to sell a menthol-flavored nicotine cartridge.

Data reported by the company shows that the product helps smokers significantly reduce their exposure to dangerous chemicals found in cigarettes. Although the product is now legally sold in the U.S., the FDA stresses that they are not safe nor “FDA-approved.” Additionally, the agency discourages non-smokers from using them.

Current FDA Review

For over a decade, e-cigarettes have been sold in the United States with little government research or oversight. Currently, the FDA is in the midst of a review of vaping products to determine what should be allowed to remain on the shelves. The organization has already rejected applications for more than a million e-cigs and related products, primarily due to the potential appeal to youth. However, regulators have delayed decision-making for most major vaping companies, including JUUL.

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller, director of the FDA’s tobacco center, in a statement. “The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products — either completely or with a significant reduction in cigarette consumption.”

For more information about the investigation into e-cigarettes, contact us today.

Additional Reading:

FDA Requests More Time to Determine Ruling About E-Cigarettes

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

Singulair Asthma and Allergy Medication Linked to Severe Mental Health Side Effects

Posted on October 18, 2021October 18, 2021

The Food and Drug Administration (FDA) has added a stronger box warning to Singulair and its generic montelukast, a popular asthma and allergy medication, after “continued reports of neuropsychiatric events.” Potential side effects include suicidal thoughts and behaviors, agitation, aggression, attention problems, night terrors, depression, confusion, anxiety, hallucinations, memory problems, obsessive-compulsive symptoms, trouble sleeping or restlessness, and uncontrolled muscle movement or shakiness.

Stories of Singulair’s Severe Side Effects

Toni Dye, a mom from Zephyrhills, Florida, says that her daughter Kayla began taking Singulair at the age of 7. Soon after, she started having anxiety, panic attacks, and anger issues as well as nightmares. “She’d wake up in the middle of the night and be running around the house and just screaming,” Dye said. The change was so drastic that Dye and her husband took Kayla off Singulair after only a few weeks.

That was 10 years ago. Now, at age 17, Kayla still suffers from anxiety, depression, and panic attacks. “I say that we lost our child because she’s not the same child anymore,” Dye added. “It hurts really bad. I feel guilty for not really looking into the drug.”

Angela Mitchell had a similar experience with her son, who started taking Singulair at 18 months old for severe allergies. After about eight months, she learned of the potential side effects and took him off. “He had become so despondent, so disconnected,” she shared. Additionally, he started exhibiting aggressive behaviors, including wanting to self-harm and harm others.

Jennifer Brown personally experienced the side effects after only six days of taking montelukast for her asthma. “By the fourth day, I was already picturing myself dying,” she said.

Recent Response From the FDA

All three women said that no one warned them about the risks for severe mental health side effects. In fact, they belong to a Facebook support group of more than 11,000 people with similar stories, many of which are even more severe and involve suicide.

Members of this group have long pushed the FDA to take action. In March, the organization announced the requirement of the new box warning. “We are taking this action after a review of available information led us to reevaluate the benefits and risks of montelukast use,” the FDA said in its Drug Safety Communication. “Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions. However, many health care professionals and patients/caregivers are not aware of the risk. We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts.”

A black box warning is the strongest warning that FDA can give to a medication. It is meant to increase awareness, especially for prescribing physicians and pharmacists. This label is the first step towards better education about the harmful side effects of Singulair and montelukast.

For more information about Singulair and its generic version montelukast, contact us today.

Florida Jury Awards $8.2 Million Against 3M Over Defective Combat Earplugs

Posted on October 14, 2021October 14, 2021

A federal jury in Pensacola, Florida, ruled that 3M Co. and subsidiary Aearo Technologies LLC must pay over $8 million in damages because of their defective combat earplugs and bear responsibility for a veteran’s tinnitus.

Bellwether Trial Results

U.S. Army veteran Private Brandon Adkins claims that 3M’s failure to disclose the ineffectiveness of its Combat Arms Earplugs, Version 2 (CAEv2) caused his injuries. Specifically, he argues that they were too short to offer necessary protection. Additionally, they often came loose without a solder’s knowledge. Adkin’s case is the fourth test trial in the mass tort litigation.

Bellwether trials gauge the strength of the plaintiffs’ claims as well as the scope of damages. Global settlement negotiations will ultimately depend on these results. The first trial, completed in April, involved three plaintiffs and resulted in a $7.1 million verdict against 3M. The next two test trials were split. The $1.7 million in damages to the third plaintiff were ultimately reduced due to comparative fault. Still, these results bring added pressure to 3M — especially since Adkins was a “defense pick” selected by 3M due to the weakness of his claims.

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

3M’s Defective Combat Earplugs

In 2018, 3M agreed to pay $9.1 million to settle a lawsuit between a whistleblower and the U.S. Department of Justice (DOJ). The plaintiff claimed that the company violated the False Claims Act by knowingly selling defective ear plugs to the U.S. military.

There are currently over 250,000 claims pending in federal court and several hundreds in state court in Minnesota, where 3M headquarters are located. Next month, another bellwether trial will begin.

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

Additional Reading:

3M Earplug Cases Sped Up Due to Backlog

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

FDA Sued Over Inaction on Dangerous Hair Loss Medication Propecia

Posted on October 11, 2021October 11, 2021

In early September, Public Citizen, on behalf of Post-Finasteride Syndrome Foundation (PFSF), filed a lawsuit against the U.S. Food and Drug Administration (FDA) regarding their inaction on a petition submitted four years ago. PFSF asked, in 2017, that the FDA remove Propecia, a popular medication for male pattern baldness, from market. The drug has been linked to increased risk of depression suicidal ideation, and long-term erected dysfunction.

Lawsuit History Between PFSF and the FDA

Prescriptions for Propecia, the brand-name version of 1mg finasteride, have increased in recent years, as the medication as well as its generic versions are often seen in television and online advertisements. As an alternative to the initial request for the FDA to withdraw its approval of the drug, PFSF asked that drug manufacturers revise the safety information on the labels to warn consumers of potential side effects. The lawsuit filed last month argues that the FDA has acted unlawfully by failing to respond on the original petition.

“The FDA needs to act in a timely way to protect the public from the risks associated with use of Propecia,” said Michael Kirkpatrick, who is serving as lead counsel for PFSF. “The FDA’s failure to act exposes consumers to potentially life-threatening harm.”

Risks of Long-Term Use of Propecia

Long-term use of the hair loss medication can lead to post-finasteride syndrome (PFS), which causes sexual dysfunction and psycho-neurocognitive symptoms, including issues related to mood, sleep, stress response, and more. Unfortunately, men with a PFS diagnosis may suffer from these side effects for years after they stop taking the drug.

The increased risk of suicide after taking finasteride has been studied for years. Vigibase, a global database that tracks harmful side effects from pharmacovigilance agencies, reveals 378 cases of suicidal ideation, 39 suicide attempts, and 88 suicides as a result of finasteride use. Moreover, a study from 2020 found that patients under 45 were particularly vulnerable to depression, anxiety, and suicidal thoughts.

“False information from the FDA leads physicians to dismiss patients, while some even tell them their symptoms are not real,” shared John Santmann, M.D., the head of PFSF. “Without effective treatments for PFS, use of this cosmetic drug can lead to a lifetime of side effects. The drug ruins more lives every day and has no business being on the market.”

For more information about the lawsuit concerning Propecia, contact us today.

Big Drop in Youth Vaping Thanks to COVID School Closures

Posted on October 7, 2021October 7, 2021

While virtual learning during the pandemic has many drawbacks — social isolation and dependence on strong self-motivation, to start — it has at least one notable benefit. A recent government report, completed by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), revealed that youth vaping dropped significantly last year.

Youth Vaping Statistics

Health officials ask that readers use caution as they look at the numbers. Outside experts, however, believe that the decrease is real and makes sense, given that vaping is often done socially. In the national survey, 11 percent of high school students and less than 3 percent of middle school students reported that they had recently used e-cigarettes. These numbers show a 40 percent drop from last year, when almost 20 percent of high schoolers and 5 percent of middle schoolers admitted to recently vaping.

“They found a dramatic drop from last year, and it’s hard to image that doesn’t represent a real decrease in use [among students],” said Dr. Nancy Rigotti of Harvard University, who was not involved in the research. The decline needs to be confirmed by other surveys this year. There is, of course, the fear that the numbers could increase again with many in-person classes back in session.

If these results prove true, it would be the second big drop in a row. Reporting in 2019 resulted in a peak of 28 percent for high school students.

New Federal Restrictions for Youth Vaping

Prior to the pandemic, government restrictions began to limit the underage use of e-cigarettes. Towards the end of 2019, the purchase age for all tobacco and vaping products changed from 18 to 21. Then, the FDA banned nearly all of the flavors for cartridge-based e-cigarettes, which first ignited the popularity of teen vaping. Additionally, some kids stopped using e-cigarettes after an uptick in vaping-related illnesses and deaths. Many of these health concerns were related to a filler in black market vaping liquids that contained THC.

Despite this promising report, government officials believe that roughly two million U.S. teens and pre-teens are still vaping — a number that is much too high. “E-cigarette use among youth remains a serious public health concern,” said CDC specialist Dr. Karen Hacker. In an effort to combat this crisis, the FDA is expected to place even bigger limits on the vaping industry and remove more products from market.

For more information about the investigation into e-cigarettes, contact us today.

Additional Reading:

FDA Requests More Time to Determine Ruling About E-Cigarettes

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

Pharmacies Face First Trial for Role in Opioid Crisis

Posted on October 4, 2021October 4, 2021

This week, a bellwether federal trial begins in Cleveland focused on the role that retail pharmacies played in the opioid crisis, which has resulted in the deaths of nearly 500,000 Americans over the past two decades. The trial, ruled over by U.S. District Judge Dan Polster, is part of 3,000 lawsuits that have been consolidated.

Opioid Crisis in Ohio

In Lake County, between 2012 and 2016, so many prescription painkillers were dispensed that the amount equaled 265 pills for every resident. In Trumbull County, during the same period, it totaled 400 pills for every resident. Efforts to control and address the epidemic has cost each county at least $1 billion. Administrators cite increased costs for their courts, jails, foster care, law enforcement, and addiction treatment.

“People need to realize that drug addiction is a family disease, and everyone in the family is affected by it,” said Trumbull County resident Sharon Grover. Grover’s daughter died after becoming addicted to prescription pain pills and then heroin. “I’m never going to be the same,” she added.

Response from Pharmacies

For the first time, pharmacies — specifically, CVS, Walgreens, Giant Eagle, and Walmart — will have to defend their role as distributors in the ongoing epidemic. Rite-Aid already settled with both counties. Trumbull County received $1.5 million in their settlement, while Lake County was awarded an undisclosed amount.

The trial will focus on the harm to the counties as well as the response by the pharmacy chains. It is expected to last around six weeks. The outcome will set the tone for future lawsuits against pharmacies around the United States.

The pharmacies argue that their pharmacists were simply filling prescriptions written by physicians for medical needs. Attorneys for CVS believe that the allegations “are completely unfounded. The evidence presented at trial will show not only that CVS met the legal requirements for distributing prescription opioid medications in Lake and Trumbull Counties but that it exceeded them.”

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 Requests More Time to Determine Ruling About E-Cigarettes

Posted on September 30, 2021September 30, 2021

The Food and Drug Administration (FDA) asked for additional time before declaring the outcome of the final e-cigarette ruling, which ultimately determines whether or not e-cigarettes can remain on shelves in the United States. On the deadline date, the agency revealed that it had acted on 93 percent of the submitted applications. “However, there’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation’s youth from the danger of all tobacco products,” the regulators said in a statement.

Flavored E-Cigarettes Removed From Shelves

In total, more than 500 companies filed applications for some 6.5 million products by the September 9, 2020 deadline. The FDA’s official order is to authorize vaping products only if the manufacturing company can demonstrate the items are in the interest of public health. In other words, the FDA must compare the potential good of adult cigarette users switching to a less-dangerous option to the potential harm of young people getting addicted to nicotine.

Thus far, the FDA has ordered more than 946,000 flavored products be removed from shelves. For these vaping liquids, which include flavors like apple crumble and cinnamon toast cereal, the agency believes that manufacturers failed to provide sufficient evidence that the products benefit adult smokers enough to outweigh the potential appeal to young people.

The biggest e-cigarette manufacturer in the U.S. is JUUL. A spokesperson for the company said, “We respect the central role of the FDA and the required thorough science- and evidence-based review of our applications. We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use.”

Reshaping the Market with Final E-Cigarette Ruling

This sweeping review could reshape the e-cigarette market. If products are authorized to remain on the market, manufacturers should expect stricter controls on marketing. This sort on control has already proven beneficial: Youth vaping fell significantly last year after laws raised the legal purchase age to 21 and removed fruity-flavored e-cigarette cartridges from the market.

The agency hasn’t revealed when its review will be completed but did share that many applications are in the final stages of review.

For more information about the investigation into e-cigarettes, including JUUL 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

Eli Lilly, Sanofi, and Novo Nordisk Questioned About ‘Unacceptably High’ Insulin Prices

Posted on September 27, 2021September 27, 2021

Last month, House Energy and Commerce Committee leaders sent letters to the executives at Eli Lilly, Sanofi, and Novo Nordisk expressing their concern over the “unacceptably high” insulin prices. The committee first inquired about the topic in 2019. Now, they want to know what actions these companies have taken since then in an effort to decrease the cost.

Insulin Prices 10 Times Higher in U.S.

According to the letters, written by committee chair Frank Pallone (D-NJ) and subcommittee chair Diana DeGette (D-CO), the price of insulin in the United States is more than 10 times that of 33 other countries. The leaders are pushing to decrease the cost of the diabetes treatment — a particularly important endeavor considering that these three companies control 99 percent of the world’s insulin supply.

Specifically, Pallone and DeGette shared that many of the 34 million American diabetes patients are without the option of insulin due to its price. “We are committed to increasing access to affordable medicines and fighting the rising cost of insulin,” the Democratic leaders wrote. “Given your company’s representations in 2019 that this is a shared concern, we are interested in learning what has been done to alleviate this issue since that time.”

Specific Requests of Committee Leaders

The Committee leaders requested more information from Eli Lilly, Sanofi, and Novo Nordisk by September 17th. They asked for an explanation of any list or net price increases as well as the gross revenue and net profit by product and year. Additionally, they want a description of the steps the companies have taken to improve accessibility and decrease cost. Lastly, they asked for an explanation of the effect of the COVID-19 pandemic on any products.

Also, in the note to Sanofi CEO Paul Hudson, lawmakers reference a 2021 pricing report from the drug manufacturer, which states that the average out-of-pocket costs for insulin users have increased 82 percent since 2012.

For more information about the high cost of insulin, contact us today.

Additional Reading:

Novo Nordisk Recalls Samples of Insulin Medication for Diabetes

Pfizer Recalls Smoking Cessation Drug Chantix Due to Increased Cancer Risk

Posted on September 23, 2021September 23, 2021

Earlier this month, Pfizer voluntarily recalled the smoking cessation drug Chantix for high levels of nitrosamine, a carcinogenic compound. The notice posted to the Food and Drug Administration (FDA) website included all lots of 0.5 mg and 1 mg varenicline tablets. It also noted that long-term ingestion can lead to a “potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication.”

Smoking Cessation Drug Recall

Pfizer first recalled some lots of Chantix in July and added additional lots in August. Recalled drugs include those distributed in the United States, Virgin Islands, and Puerto Rico from May 2019 to September 2021.

The FDA recognized that the current recall may cause a drug shortage. To lessen this impact to patients, it will allow certain manufacturers to distribute “varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit of 37 ng per day but below the interim acceptable intake limit of 185 ng per day until the impurity can be eliminated or reduced to acceptable levels.”

In a follow-up notice, the FDA encouraged patients to continue using their current medication until their doctor or pharmacist provides a replacement treatment. Ultimately, the heath benefits of stopping smoking outweigh the cancer risk from nitrosamine in varenicline.

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

Additional Reading:

Pfizer Halts Sales of Chantix Due To Possible Carcinogen Contamination

Bayer Roundup Trial Goes Virtual Due to COVID-19 Concerns

Posted on September 16, 2021September 15, 2021

A California trial between an elderly cancer victim and Monsanto owner Bayer AG switched to virtual proceedings in late August due to concerns about the spread of COVID-19.

Technical Difficulties for the Virtual Trial

On the first day, thanks to various technical problems, lawyers for plaintiff Donnetta Stephens only presented abbreviated testimony from Charles Benbrook. Benbrook is a former research professor who was once the executive director of the National Academy of Sciences agriculture board. As a key witness, he testified about topics including the history of scientific submissions to the U.S. Environmental Protection Agency (EPA) by Monsanto as well as failed regulatory shortcomings.

Unfortunately, the proceedings for Stephens indicated that both sides may be significantly challenged in trying to share evidence and testimony in a virtual format. Some issues faced during this first session include: a court reporter who couldn’t fully hear the exchanges between lawyer and witness; jurors who had trouble using their computer cameras (a requirement); and poor audio transmission for Judge Gilbert Ochoa. Despite the technical difficulties, the judge noted that they made history by holding the court’s “first Zoom trial.”

The History of Bayer Roundup Trials

The case is being tried in the Superior Court of San Bernardino County in California. It is the fourth Roundup cancer trial to take place in the United States — the first since 2019. For the three previous trials, juries ruled in favor of the plaintiffs. They agreed that Monsanto’s glyphosate-based weed killers, including Roundup, cause non-Hodgkin lymphoma and that Monsanto spent years hiding the risks and failing to warn consumers.

Tens of thousands of plaintiffs filed lawsuits against Monsanto after the World Health Organization’s cancer experts determined that glyphosate is a probable human carcinogen with a link to non-Hodgkin lymphoma.

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

Vuse Solo E-Cigarette

Current FDA Review

Additional Reading:

Stories of Singulair’s Severe Side Effects

Recent Response From the FDA

Bellwether Trial Results

3M’s Defective Combat Earplugs

Additional Reading:

Lawsuit History Between PFSF and the FDA

Risks of Long-Term Use of Propecia

Youth Vaping Statistics

New Federal Restrictions for Youth Vaping

Additional Reading:

Opioid Crisis in Ohio

Response from Pharmacies

Additional Reading:

Flavored E-Cigarettes Removed From Shelves

Reshaping the Market with Final E-Cigarette Ruling

Additional Reading:

Insulin Prices 10 Times Higher in U.S.

Specific Requests of Committee Leaders

Additional Reading:

Smoking Cessation Drug Recall

Additional Reading:

Technical Difficulties for the Virtual Trial

The History of Bayer Roundup Trials

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