3M Combat Arms Earplugs May Have Caused Hearing Loss
The Judicial Panel on Multidistrict Litigation (JPML) issued a Transfer Order on April 3, 2019 centralizing lawsuits against 3M relating to allegations of issues regarding the design, testing, sale, and marketing of the dual-ended Combat Arms Earplugs, Version 2. The newly created Multidistrict Litigation (MDL) will be overseen in the Northern District of Florida by Judge M. Casey Rodgers, a federal judge with prior experience handling a large-scale MDL.
In July 2018, 3M announced a $9.1 million payment to resolve allegations that it knowingly sold its dual-ended Combat Arms Earplugs, Version 2 to the United States military without disclosing defects that hampered the effectiveness of the hearing protection device. On the heels of this announcement, individual service members suffering from problems including hearing loss and tinnitus began filing lawsuits alleging their hearing injuries resulted from use of the earplugs.
JPML Coordination of 3M Combat Arms Earplugs Hearing Loss Lawsuits
In early 2019, Plaintiffs requested coordinated pretrial proceedings, otherwise known as the formation of an MDL, over the eight lawsuits filed at the time on the basis that the lawsuits all made similar allegations of wrongdoing against 3M. Less than four months later and on the date the JPML entered the Transfer Order, the Court noted it was aware of 635 related lawsuits (in addition to the original eight) filed in 33 different courts. The JPML granted the Transfer Order after finding the lawsuits “involve common factual questions arising out of allegations that defendants’ Combat Arms earplugs were defective, causing plaintiffs to develop hearing loss and/or tinnitus…[c]entralization will eliminate duplicative discovery; prevent inconsistent rulings on Daubert issues and other pretrial matters; and conserve the resources of the parties, their counsel, and the judiciary.”
Barring objections, all of the related lawsuits – and future lawsuits filed by Combat Arms Earplugs, Version 2 users – will be transferred to the Northern District of Florida. The JPML reviewed suggestions to transfer the cases to other locations including the District of Minnesota – the location of 3M’s corporate headquarters, the Western District of Missouri, the District of Columbia, the Middle District of Georgia, and the Southern District of Florida, among others. It ultimately chose the Northern District of Florida as “a forum with the necessary judicial resources and expertise to manage this litigation efficiently and in a manner convenient for the parties and witnesses.” It is important to note that any lawsuits that are not resolved through settlement, bellwether trial, or motion practice during pretrial proceedings will be transferred back for plaintiffs to have individual trials at the conclusion of the MDL.
JPML Appoints the Honorable M. Casey Rodgers to Preside Over 3M Combat Arms Hearing Loss Cases
The JPML transferred this new MDL to Judge M. Casey Rodgers. The panel noted that Judge Rodgers is “an able jurist with experience in presiding over a large products liability MDL.” Judge Rodgers was previously appointed to oversee MDL No. 2734, In Re: Abilify (Aripiprazole) Products Liability Litigation in October 2016. The Abilify MDL held over 2,000 lawsuits at its height. This MDL arose from lawsuits alleging the drug, an atypical anti-psychotic medication prescribed to treat a variety of mental disorders, can cause impulse control problems in users. A confidential settlement was announced in February 26, 2019, beginning the process of winding down MDL No. 2734.
Judge Rodgers became a United States Magistrate Judge in May 2002. On November 21, 2003, President George W. Bush appointed her to a position as United States District Judge for the Northern District of Florida. She served as Chief United States District Judge for the Northern District from June 2011 to June 2018.
For the 26.9 million sufferers of sinus pain and pressure, nasal sprays are one of the most recommended and effective methods of relief. But one product, labeled as a CVS brand nasal mist, is being pulled off the shelves. Product Quest Manufacturing, a Florida company that manufactures the product, recommends consumers stop using it immediately and either discard or return the spray to the place of purchase.
On August 8, 2018, the U.S. Food and Drug Administration (“FDA”) announced a voluntary recall of the CVS Health 12 Hour Sinus Relief Nasal Mist. Product Quest Manufacturing found a specific lot of their spray was contaminated with bacteria Pseudomonas aeruginosa. According to Product Quest, “repetitive use of a nasal spray containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or immune-compromised.”
The recalled products can be identified by locating the side panel. The side panels are coded with “Lot 173089J” and “EXP 09/19.” 16,896 units are involved in the recall. The units were sold nationwide.
What is Pseudomonas aeruginosa?
Pseudomonas aeruginosa is the most common strain of the Pseudomonas infection to cause problems in humans. Infections with this type of bacteria are generally treated with antibiotics, although the Centers for Disease Control and Prevention notes that some strains – mostly in healthcare facilities – can be multidrug-resistant. Pseudomonas aeruginosa infections associated with healthcare facilities often cause bloodstream infections, pneumonia, urinary tract infections, and surgical wound infections. Exposure to Pseudomonas aeruginosa is seen in hot tubs and swimming pools. These mild exposures in normally healthy people result in ear infections or skin rashes. Symptoms can also mimic the common cold or flu and include sinus pain and pressure, fever and chills, body aches, light-headedness, rapid pulse and breathing, nausea and vomiting, diarrhea, or decreased urination.
Regulation of Over-the-Counter Medications
As an over-the-counter, or nonprescription, medication the CVS Health 12 Hour Sinus Relief Nasal Mist is sold directly to consumers without a prescription. In 1951, the Durham-Humphrey Amendment to the Federal Food, Drug and Cosmetic Act of 1938 established a legal framework for prescription and non-prescription drugs. The Amendment also authorized the FDA to make this prescription/over-the-counter distinction. The FDA states that medications designated as over-the-counter are generally safe and effective when used as directed. However, just because the FDA presumes over-the-counter drugs are safe does not mean they are free of defects. Being vigilant requires reading warning labels, taking medications as directed and watching for recalls such as this one for the CVS 12 Hour Sinus Relief Nasal Mist.
The FDA announcement directs consumers who have been injured by the nasal mist to report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm, by regular mail or by fax.
If you become ill or are injured by an over-the-counter medication, seek the assistance of a physician or health care provider.
Small particles of glass are to blame for the recall of a widely used fluticasone nasal spray that treats symptoms of hay fever in children.
The nasal spray, known by its brand name Fluticasone Propionate Nasal Spray USP and manufactured by Apotex Corp., of Weston, Fla., was pulled voluntarily from the market by the company, which said the glass particles could clog the bottle and cause it to malfunction and, more importantly, abrade the inside of the nose. The U.S. Food & Drug Administration (FDA) said the issue was detected via a complaint.
Glass Particles Found in Spray Bottle
“The glass particles could block the actuator and impact the functionality of the pump,” the FDA said in a safety alert titled “Fluticasone Propionate Nasal Spray by Apotex Corp: Recall – Due to Potential for Small Glass Particles.” “There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out. Local trauma to the nasal mucosa might occur with use of the defective product.”
With the exception of the complaint, Apotex Corp. has not been made aware of any other adverse events as a result of the recall.
“Patients, wholesalers, retailers, hospitals or institutions with Lot# NJ4501 and an expiration date of July 2020, should stop use and distribution of the remaining units and quarantine immediately,” according to the safety alert. “Healthcare Professionals in your organization should be informed of this recall.”
Fluticasone Widely Used for Allergies
Fluticasone Propionate Nasal Spray USP is for patients between the ages of 4 and 17 who suffer from seasonal allergies, sinus pain, sneezing and a stuffy nose. The drug also helps with itchy, watery eyes. It is a corticosteroid. WebMD explains its uses:
“The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or use this drug more often or for longer than directed. Your condition will not improve any faster, and your risk of side effects will increase. You may be directed to start with a higher dose of this drug for the first several days until you have begun to feel better, then decrease your dose. Children may need to use this drug for a shorter amount of time to lower the risk of side effects. If a child is using the over-the-counter product, read the package information to see how long he / she should use it and when you should check with the doctor.”
WebMD notes that the drug does not relieve symptoms immediately.
“You may feel an effect as soon as 12 hours after starting treatment, but it may take several days before you get the full benefit. If your condition does not improve after 1 week, or if it worsens, stop using this medication and consult your doctor or pharmacist. If you think you may have a serious medical problem, get medical help right away.
Precautions Necessary for Fluticasone Use
WebMD describes some of the precautions, as well.
“Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness / injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Though it is unlikely, this medication may slow down a child’s growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child’s height can be checked. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.”
Anyone who has experienced problems with Fluticasone Propionate Nasal Spray USP should contact his or her physician immediately. The affected product’s label reads “50 mcg per spray 120 Metered Sprays.” It was distributed to wholesalers, including Sam’s Club and Walmart, nationwide.
“When inhaling nasal spray, glass probably tops the list of things you hope aren’t accidently in the bottle,” Healthcare Packaging states in an article on its Web site titled “Nasal Spray Recalled After Packaging Found to Contain Glass Particles.” “According to a recent FDA news release, Apotex Corp. has voluntarily recalled one lot of Fluticasone Propionate Nasal Spray for just that reason.”
Consumers who have questions about the recall are encouraged to reach out to Apotex Corp. at (800) 706-5575 or at email@example.com. Healthcare professionals are encouraged report adverse events to the FDA MedWatch program at fda.gov/medwatch A form also can be obtained by calling (800) 332-1088.
One trillion dollars. That’s how much the country spent on the opioid epidemic between 2001 and 2017, according to a report released by the nonprofit institute Altarum, a consulting group focused on improving public health.
The cost of the crisis trickles both up and down and impacts corporations, governments and insurance companies, as well as families, local businesses and neighborhoods.
“The greatest cost comes from lost earnings and productivity from overdose deaths – estimated at $800,000 per person based on an average age of 41 among overdose victims,” the report states. “This figure is largely made up of lost wages of workers and productivity losses of employers, but it also weighs on government in the form of lost tax revenue. It has increased in recent years as the epidemic has transitioned away from older people to younger ones and from prescription opioids to illicit drugs.”
Opioid Epidemic Results in High Costs to Society
More than 42,000 deaths were caused by opioid overdoses in 2016, according to the U.S. surgeon general’s office. In 2010, the death toll was 21,000. The startling spike spurred the office to take action, with Dr. Jerome Adams issuing an advisory: “Be prepared. Get naloxone. Save a life.” Naloxone is an easily administered nasal spray that quickly reverses the deadly symptoms of an overdose.
“Health care costs related to the opioid crisis reached $215.7 billion from 2001 to 2017,” the report states. “This stemmed largely from emergency room visits to treat and stabilize patients after an overdose, any associated ambulance and Naloxone use required, and related indirect health care costs associated with the increased risk of other diseases or complications.”
And the costs have nowhere to go but up.
“An additional $500 billion is estimated through 2020 if current conditions persist,” the report states.
Governing magazine, a nonpartisan news outfit, reports that Middletown, Ohio, spent $1 million-plus on ambulance dispatches for overdoses between October 2016 and October 2017. It also reports that Pennsylvania will spend $5 million this year on naloxone alone. In Nebraska, the epidemic costs $465 per resident. In West Virginia, it costs $4,793 per resident. The state has one of the highest rates of opioid overdoses in the country.
“The costs build up slowly over time, so you almost don’t even notice it,” Nashville lawyer Mark Chalos told the magazine in an article titled “How Much Is the Opioid Crisis Costing Governments?” “But when our people really started to dig into the budgets, they realized the costs are more significant.”
Geographic Factors in Opioid Epidemic
The American Enterprise Institute, a public-policy think tank, conducted a study on “The Geographic Variation in the Cost of the Opioid Crisis” and found the costs of the opioid epidemic are disproportionate at state and local levels, as exemplified by the Nebraska / West Virginia comparison.
“The types of costs attributable to opioid abuse – health care costs, criminal justice costs, and lost productivity, for example – are fairly well understood, as is the economic impact of the crisis at the national level,” the study states. “However, the economic burden of the opioid epidemic is unevenly distributed across the country, with many communities especially hard hit. As federal, state, and local policymakers and stakeholders seek to curb the epidemic, it is vitally important that they know how these costs are distributed.”
VSL – Value of a Statistical Life – A New Way to Measure Cost of Opioid Epidemic
Enter the White House’s Council of Economic Advisers, or CEA. The federal agency compiled a paper in November 2017 that used a metric called the Value of a Statistical Life, or VSL, to gain insight into the costs of the opioid epidemic. The VSL essentially puts a price tag on one’s willingness to lower his or her death risk. It is helpful for shaping policies and programs that reduce fatalities.
“CEA finds that previous estimates of the economic cost of the opioid crisis greatly understate it by undervaluing the most important component of the loss – fatalities resulting from overdoses,” states the executive summary of the paper, titled “The Underestimated Cost of the Opioid Crisis.” “CEA estimates that in 2015, the economic cost of the opioid crisis was $504.0 billion, or 2.8 percent of GDP that year. This is over six times larger than the most recently estimated economic cost of the epidemic.”
The paper states that though this is the first of its kind to be published, it will not be the last.
“A better understanding of the economic causes contributing to the crisis is crucial for evaluating the success of various interventions to combat it,” it concludes. “CEA will conduct further economic analysis of actual and proposed demand- and supply-side interventions; consider the impact of public programs such as Medicare and Medicaid; and explore the important role of medical innovation in combatting the crisis.”
Janssen Pharmaceuticals’ type 2 diabetes medication is under new scrutiny. This new scrutiny follows confirmation from the Food and Drug Administration (FDA) that use of the drug canagliflozin, sold as Invokana and Invokamet, potentially increases the risk of amputation of the feet or legs. Most of these amputations have involved the toe and middle of the foot. Amputations of the leg, both above and below the knee, have also been necessary in some cases.
New Clinical Trials Show Dangers of Invokana
The FDA initially highlighted this alarming side effect last year following results from two clinical trials. These clinical trials indicated that Invokana and Invokamet XR potentially caused patients to be twice as likely to require an amputation than those who received a placebo. The initial trial, CANVAS, demonstrated that 5.9 of 1,000 patients taking Invokana had an amputation within a year. Meanwhile, the number of individuals who had amputations from those taking a placebo was 2.8 out of 1,000. A second trial, CANVAS-R, was conducted with similar results. Out of 1,000 people, 7.5 taking the drug had an amputation while the amount of those who received an amputation while on a placebo was 4.2.
On Tuesday, the FDA stated that these medications will now receive mandatory black box warnings. This is the strictest type of warning issued by the FDA, indicating significant health risks and detrimental side effects for patients. Janssen also announced that a majority of patients who had undergone amputations would likely require additional surgery. In response to the recent FDA studies, Janssen issued a statement saying, “Patient safety is our highest priority. We are working with the FDA to include this information in the prescribing information for canagliflozin and look forward to the presentation of the full CANVAS Program results at the American Diabetes Association Scientific Sessions in June.”
Other Side Effects Associated With Invokana
Aside from the correlation with amputations, the drug also has other negative effects. These negative side effects include decreased cardiovascular health and an increased chance of bone fractures and urinary tract infections. Researchers encourage doctors to look at pre-existing conditions that could be exacerbated when patients take the drug. The potentially exacerbated pre-existing conditions include peripheral vascular disease, neuropathy, diabetic foot ulcers, and previous amputations.
An announcement of this magnitude has many industry insiders wondering what this could mean for Invokana’s competitors. The competing drugs that fall into this specific class of diabetes treatments are known as sodium-glucose cotransporter 2 inhibitors. This class of diabetes drugs includes well-known names like Farxiga and Jardiance. Seamus Fernandez, an analyst at the healthcare-specialized investment bank Leerink Partners, has predicted that Jardiance in particular will benefit from the market losses that are projected for Invokana. Mr. Fernandez believes that many doctors will likely switch patients away from Invokana immediately.
Investors in Johnson & Johnson (J&J) are also wondering if they should be worried about this new research. Janssen is the pharmaceutical arm of the American multinational manufacturer. However, Fernandez believes that they do not have much cause for concern. He doubts that the class of drugs overall will suffer a substantial setback. Regardless, adding the FDA’s strongest safety warning to Invokana’s packaging will undoubtedly create issues for this J&J company.
In April of 2016, the Judicial Panel on Multidistrict Litigation determined that coordination of federal court lawsuits involving men who developed melanoma after taking Viagra was appropriate. MDL No. 2691, styled In Re: Viagra (Sildenafil Citrate) Products Liability Litigation Viagra, was then established before Judge Seeborg, a federal court judge, in the Northern District of California, San Francisco Division. Nearly a year later, more than 100 individual personal injury and wrongful death lawsuits have been filed by patients alleging that Viagra, manufactured by Pfizer, was defectively designed, inadequately tested, and improperly marketed as patients and prescribing physicians were not properly informed that Viagra use can cause or promote the growth of melanoma cancer cells. Recently, the MDL judge expanded the Viagra melanoma litigation efforts to also include claims against Eli Lilly & Company for patients who ingested Cialis (or both drugs) and developed melanoma.
Viagra Melanoma Is One Of Deadliest Cancers
According to the American Cancer Society, melanoma accounts for only about 1% of skin cancers, but, sadly, is one of the most deadly cancers. It is estimated that 87,110 new cases of melanoma skin cancer will be diagnosed in the United States in 2017, with men being diagnosed more frequently than women. Nearly 10,000 patients are projected to die from melanoma in 2017. The rates for melanoma have been rising for the last 30 years, with melanoma cancer rates being much higher in Caucasians and in patients who are over age 60.
Viagra Has Been On The Market Since 1998
Viagra was first approved for sale in the United States in March of 1998 by the Food & Drug Administration. The drug entered the market with quite a lot of fanfare in 1998, and has been aggressively promoted by Pfizer ever since for the treatment of erectile dysfunction. It was one of the first drugs introduced to treat erectile dysfunction, a condition that affects an estimated 30 million men in the United States. Erectile dysfunction (which is often referred to as “ED”) can be caused by a number of common medical conditions: diabetes, high blood pressure, heart disease, smoking, alcoholism, obesity, prostate problems, low testosterone, and as a side effect of other medications. In just 2013, Pfizer enjoyed approximately $1.8 billion in sales of Viagra worldwide.
Cialis (also known as tadalafil) is another erectile dysfunction drug that is very similar to Viagra. It is currently sold by Eli Lilly and Company, an international pharmaceutical company based in Indianapolis, and was initially developed through a partnership between Glaxo Wellcome (now GlaxoSmithKline) and ICOS. Cialis was first approved by the FDA in 2003, and was the third drug approved for sale in the PDE5 inhibitor drug class (with Viagra being the first and Levitra (also known as vardenafil) being the second). Cialis has a longer half-life than Viagra, which means that the drug is able to continue working in the body for a longer period of time. This longer half-life may also be part of the liability case against the drug manufacturer in the pending lawsuits, as it is theorized that this longer half-life may also make Cialis more likely than Viagra to promote the growth of cancer cells. Hopefully, ongoing scientific studies and internal documents (once they are produced in the consolidated litigation efforts) will shed some light on this critical issue.
Both Viagra and Cialis treat erectile dysfunction by inhibiting the secretion of phosphodiesterase type 5 (“PDE5”), an enzyme responsible for the degradation of cyclic guanosine monophosphate (“cGMP”). When the cGMP is not degraded by the PDE5, smooth muscles in the corpus cavernosum relax; this, in turn, permits an inflow of blood to the corpus cavernosum, creating an erection. Some recent studies published by independent scientists have shown that this same mechanism of blocking the production of PDE5 can lead to the creation of melanoma cells and promote melanoma cell invasion. This potential link to cancer was not included in the warning labels or advertising materials for the drugs, and is a key focus of the pending lawsuits.
Progress in Viagra Melanoma Lawsuits
Over the past 12 months, Judge Seeborg has held regular hearings to obtain reports on the progress of the litigation. The attorneys who represent the injured patients are seeking the production of millions of pages of documents from the drug companies involved in the development and marketing of Viagra and Cialis to help prove the plaintiffs’ claims that the manufacturers should have known of the link to cancer many years ago and provided proper warnings to the patients and their doctors (if the drugs should have ever been approved at all by the FDA). It is estimated that it will likely take another 6 to 12 months to complete the production of documents from the drug companies, which are anticipated to be tens of millions of pages of documents that were produced by employees in the United States as well as overseas. Once the document production is complete, dozens of depositions will need to be taken of drug company employees who played critical roles in the development of the drug, interaction with the FDA and other drug safety regulatory agencies, marketing of the medication to doctors and directly to consumers, conducting and monitoring scientific studies, and surveillance of adverse event reports to determine whether there were potential signals of safety issues associated with the ED medications.
Cialis Claims Added
Since the Cialis claims were added to the litigation effort just recently, it is likely that the first cases that will be ready for jury trials in the coordinated proceedings will involve ingestion of Viagra. Judge Seeborg has not yet scheduled for first trials for the litigation, but will likely do so in the coming months. Once the judge selects individual cases to be included in the MDL bellwether trial process, those plaintiffs, their family members, and their treating doctors will provide sworn testimony in depositions. Experts hired by both the plaintiffs and the defendants will be required to file detailed reports with regard to scientific and medical issues and provide sworn deposition testimony as well. The plaintiffs are hopeful that the first Viagra and perhaps Cialis cases will be tried in 2018 or 2019. Prior to any jury trials, Judge Seeborg will also be required to rule upon a number of legal issues, including admissibility of scientific testimony and evidence.
The drug and medical device lawyers at Searcy Denney have represented patients who developed melanoma after ingesting Viagra and/or Cialis and are still accepting new cases in the pharmaceutical litigation. Sadly, since both drugs have not been recalled and many patients remain unaware of the potential link to cancer, it is likely that the litigation could persist for years as new patients are diagnosed with melanoma.