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In July of this past year, Minnesota-based 3M Company resolved a whistle blower lawsuit brought against them by a former employee that alleged 3M had contracted with the US Military selling the military ear plugs, of which they knew were defective but chose not to disclose to the military.

3M agreed to a $9 million settlement in the whistle-blower case, with the whistle-blower receiving nearly $2 million (Federal law allows for any whistle-blower to recover a large portion of any settlement or verdict).

Since the settlement, other military men and women have been coming forward contending they suffered hearing loss as a result of using 3M’s product, when they were otherwise under the impression that the ear plugs were safe to use and properly made to prevent hearing loss.

In the settlement, the U.S. government alleged that 3M and its predecessor, Aearo Technologies, Inc., were aware that the earplugs were too short for proper insertion into users’ ears. As a result, the earplugs could gradually — and subtly — loosen until they did not perform the desired noise cancellation for certain individuals, according to the Department of Justice release.

The United States also alleged that 3M did not disclose this design defect to the military when the contract was finalized.  Read the DOJ press release here.

Service men and women who have legal claims are urged to seek redress before such claims expire.

The House Energy and Commerce Committee, chaired by Rep. Greg Walden (R-OR), concluded its 18-month investigation into opioid distributors and wholesalers in West Virginia just before Christmas, 2018. The committee’s bipartisan report, to say the least, is shocking. (Read it [HERE].)

WV is the state struck hardest by the opioid crisis that has gripped the nation for the last several years. While the source of the problem could only be speculated before now, the report confirms what experts have been suspecting: Many of the issues in WV have been caused by systemic failures on part of opioid distributors and wholesalers. Most shockingly, however, is the revelation that the Drug Enforcement Administration has contributed to what is the worst public health crisis in American history. Over 42,000 Americans died from opioid overdoses in 2016, according to the report. That is more than died from car accidents, gun violence, and many other sources of untimely death.

The report chronicles the three largest opioid wholesalers in the United States and their role in WV’s opioid trade, legal or not — McKesson Corp., Cardinal Health and AmerisourceBergen. This investigation started in March of 2017, along with the probe of the DEA. Two distributors, Miami-Luken and HD Smith, were investigated in that September. The three wholesalers are, as of now, all facing lawsuits from various municipalities all over the country. McKesson just settled a $150 million lawsuit in California federal court for failing to report suspicious opioid orders. It is currently banned from selling in Florida, Colorado, Michigan, and Ohio.

The report found incredible levels of apathy and carelessness from all of the parties involved, which lead to suspicious activity going unnoticed. Wholesalers fill the orders that are given to individual pharmacies. Many of the amounts of narcotics ordered were odd but not reported to the DEA. For example, since 2005, over 900,000,000(!) doses of Hydrocodone and OxyContin have been filled in the state, much of them from rural areas. McKesson shipped nearly 10,000 pills per day to a now-closed pharmacy in the rural town of Kermit, which has a population of 400, in 2007. (Yes, you read that correctly.) This is nearly 36 times the limit the monthly dosage threshold the wholesaler had created that year. By not reporting such behavior, the report states that the wholesalers are complicit in growing black markets, trafficking, and the amount of overdose deaths.

If the wholesalers were to have reported this blatantly-illegal behavior to the DEA, the agency would not have been properly equipped to deal with the situation. As mandated under the Controlled Substances Act, the DEA is required to keep a database of illicit or suspicious orders sent to wholesalers and distributors. The report states that the DEA was not actively using this database until 2010. Additionally troubling, the DEA has not set up a standardized reporting method in order to assess the claims. This means that if the claims are reported at all, they are reported to local offices, which have different, oftentimes haphazard procedures of dealing with them.

The accusations are, on the surface, troubling only for WV, but the report is explicit in stating that the issues found in this state can likely be generalized for the country at large.

Upon the report being released in December 2018, the entities targeted by the investigation released statements ranging from denying responsibility to accepting their culpability in the epidemic. DEA spokesperson Wade Sparks stated that the report was eye-opening and that they want to “make sure what happened in West Virginia never happens again.” McKesson stated that it is working to address the crisis without mentioning its role in the report. Finally, Cardinal Health noted its “limited but vital role” in the opioid supply chain and that it is taking the report’s suggestions seriously.

The reactions from other companies involved were far less graceful. AmerisourceBergen downplayed its responsibility, stating that it has “virtually no interaction with physicians and limited legal ability to gather information on their practices and prescribing behavior.”

The committee suggests many courses of action to fix the abovementioned problems. Highlights include creating a DEA database of prescriptions collected from pharmacies that highlight suspicious doctors. Another is the review of pharmacies that have common ownership with ones with policy violations. (Read a condensed list written by the committee [HERE].)

The committee notes that this problem is multifaceted, and while this is one piece of the chain that must be fixed, there is still much work to do on the opioid crisis on part of the federal and state governments, as well as pharmaceutical corporations.

         The vaping, or e-cigarette, trends has grown at a rapid pace over the last several years. This was mainly brought on by the brand Juul, which looks like a small USB stick and dominates a whopping 75% of vaping’s market share. And how could it have not? Toted as the healthier alternative to traditional smoking, Juul offers many customizable options that allow one to make their experience more enjoyable. The fact that there is no physical smoke or overwhelming stench means that the pod can be smoked easily in public. Until recently, vaping devices were thought to help people wean off of cigarettes and nicotine products altogether. (If you are not familiar with the product, read more about it [HERE].)

These thoughts could not be more misguided. Many governmental investigations have found that Juul and its former parent company, PAX Laboratories, have targeted teens to get them addicted to nicotine – not wean those already addicted to cigarettes off. Their methods are both overt and inconspicuous.

Juul uses dispensable pods filled with nicotine salts in order to give their smoker a high, and these are inserted into the stick, which is the physical Juul product. The salts allow for the nicotine to be more highly-concentrated. Normal tobacco cigarettes contain roughly 1.7% nicotine; Juul’s contain anywhere from 2-5%. Juul e-cigarettes also come in many different flavors.

Positively, this does reduce the smell that comes from regular cigarettes, but many of these flavors are more palatable to children and teens with a sweet tooth. Flavors include mango, crème brulee, and piña colada, among others. These aforementioned flavors all contain 5% nicotine salts, the highest concentration available. Other, milder flavors, such as mint and tobacco, are sold at 3% concentration. These sweeter, varied flavors are also the most heavily advertised, and many of the advertisements feature young people.

Juuls differ from other vaping products because of their convenient use. Prior to 2015 when the Juul was released to the market, it was able to mimic tobacco cigarettes better than the competition without the drawbacks. CEO (now VP) James Monsees stated that a nicotine buzz roughly five minutes after taking a hit of the cigarette was what would provide the most analogous experience to regular smoking. The nicotine salts, in part, allow for this to happen. Additionally, because there is no debris or ash from the cigarette, each puff one takes is just as smooth as the one before. Unlike other similar products on the market,

Juuls are temperature controlled, which allows the flavor to stay consistent, and the salts will not degrade. It, essentially, allows an average person to vape, rather than just those who understand the nuances of the skill set.  These supposed benefits can be taken as a negative when put in the context of teen smokers.

They can be seen as allowing one who would not smoke, try it. The lung damage, while still severe, is not as obviously apparent after inhaling for the first time, and of course, the sweet flavors are appealing to those who would not like the taste of a tobacco cigarette. Finally, Juuls are discrete, so much so that they can be smoked anywhere. It would be impossible for a teen to smoke a cigarette in class because it offends the senses and they would be easily caught, but it would be easy for a high schooler to take a hit outside a school, or even in the bathroom – hiding the discreet device in their pocket or book bag.

So long as the battery is charged, one does not need to carry a lighter with them, and the smoker can remain incognito relatively easily. All of these factors combine to truly have the youth craze make sense; youth vaping has gone up 15-fold between 2011 and 2015.

Defenders of the craze would state that despite the negatives, vaping can help wean those off of cigarettes to an (arguably) healthier alternative. However, the raw data on the phenomenon disputes this. In fact, vaping is causing far less people to wean off of smoking and causing an entirely different group of people to get addicted to nicotine products.

A 2015 study from the Dartmouth Geisel School of Medicine showed that roughly 2,100 people quit nicotine products altogether with the help of vapor products; 168,000 teens began using the products without prior tobacco usage, however. (Keep in mind that these statistics were released before the craze truly began. Juuls were not even on the market until that summer. The numbers are likely much higher now in 2018.)

Most damming, however, is Juul’s prominent social media and email campaigns. Young people, of course, spend much of their time on social media, where Juul targeted people under 18 heavily, according to a recent class-action lawsuit filed in New York Federal Court earlier this year. Additionally, Juul had a clever, albeit devious, way of adding young people to their emailing list. When one goes to the Juul website, they are prompted to enter their email, the last four digits of their social security number, and their birthday. If they are under the age of 18, then the website will deny them access to the online shop, but they will still add them to the emailing list, according to the New York lawsuit.  Over this medium, it is alleged that they will receive promotions, including discounts on the Juul “starter kit” and pods.

Local governments and attorneys are starting to see the dangers of modern-day big tobacco. New York and California have made flavored Juul pods illegal to dissuade young people from buying the products, and several class-action lawsuits have been brought against Juul specifically. Due to several advertising and health violations, the company has sparred openly with the FDA. Nevertheless, the industry continues to grow at an astonishing rate. Juul was valued at $38 billion this November – great news for those investing in the company – and Altria Group, makers of Marlboro cigarettes, recently invested $12 billion in the company. Unless legal action is taken in many cases, no doubt remains that the industry will continue to take advantage of teens around the country.

Mesothelioma has been known for decades to be the signature lethal disease caused by inhaling microscopic asbestos fibers into the lungs.  In fact, it has been well documented in Navy shipyard workers, underground miners, building construction and other such endeavors.  But now, with the discovery of asbestos in talculm powder, the very thing that women and babies use to keep themselves feeling fresh and clean is now the subject of the deadly disease.  And at the center of the controversy is Johnson & Johnson’s Baby Powder.

Nearly 12,000 lawsuits have been filed across the country against Johnson & Johnson alleging that the company’s baby powder not only has the deadly fibers, but that the company has known for years.

It has been known for decades that asbestos and talc often occur together in the earth, but J&J has always denied that their baby powder contains any asbestos.

But thanks to unrelenting plaintiffs’ lawyers, who refused to accept J&J’s denials, the truth is finally starting to surface, and surface big it is.

This past week Reuters published an in-depth and well-researched article entitled, “Special Report: J&J knew for decades that asbestos lurked in its baby powder.”  The report, which carefully combed through countless internal documents and depositions of key individuals – all of which occurred and was accessible because of the ongoing litigation – concluded that from at least 1971 to the early 2000’s the company knew that their product would sometimes test positive for asbestos.  The report reads in part:

A Reuters examination of many of those documents, as well as deposition and trial testimony, shows that from at least 1971 to the early 2000s, the company’s raw talc and finished powders sometimes tested positive for small amounts of asbestos, and that company executives, mine managers, scientists, doctors and lawyers fretted over the problem and how to address it while failing to disclose it to regulators or the public.

Today, lawsuits are proceeding against the company for mesothelioma, and also ovarian cancer, which has been linked to asbestos for decades in the scientific literature.

Juries are getting angry, and lawsuits are giving the public the rightful disclosure they deserve.

Earlier this year in St. Louis, a jury returned a verdict of $4.69 billion for 22 plaintiffs who contended their ovarian cancer was caused by Johnson & Johnson’s baby powder.  The verdict included a billion plus dollar punitive verdict, which serves to “punish” defendants for their conduct.

In Federal Court, three trials are set for early 2019.

With additional cases in the wings, additional truth about what Johnson & Johnson chose to hide will no doubt finally see the public’s eyes.

 

So implies Monsanto in the ongoing In RE Roundup litigation venued before Judge Chhabria in San Francisco, as well as a state-court consolidated filings in St. Louis, Missouri.

To date, only one case has been tried and the case resulted in a $289 million verdict, which included a large punitive damages award for what the jury believed to be Monsanto’s punitive conduct regarding their knowledge of the carcinogenic potential when exposed to their Roundup weed killer.  The verdict was later reduced to just more than $70 million.  See more here.

The next trial is around the corner set for March of 2019.  This trial, like the first, has been expedited (available under California law if one can show they have less than six months to live).

Front and center in the litigation is whether Roundup causes non-Hodgkin’s lymphoma.

Plaintiff’s experts point to, among other things, a 35-year old mouse study that was undertaken by Monsanto in 1983 for regulators.  The study is titled “A Chronic Feeding Study of Glyphosate (Roundup Technical) in Mice.”

The study involved 100 mice who were exposed to either various levels of Roundup or none at all (the control group).  Some mice exposed to glyphosate, the active ingredient in Roundup, developed tumors at statistically significant rates, with no tumors at all in non-dosed mice.

The Huffington Post reported that a February 1984 memo from  Environmental Protection Agency toxicologist William Dykstra stated the findings definitively:  “Review of the mouse oncogenicity study indicates that glyphosate is oncogenic, producing renal tubule adenomas, a rare tumor, in a dose-related manner.”  Researchers found these increased incidences of the kidney tumors in mice exposed to glyphosate worrisome.  Monsanto discounted the findings, arguing that the tumors were “unrelated to treatment” and showing false positives, and the company provided additional data to try and convince the EPA to discount the tumors.  Read more here.

In 2015 the World Health Organization’s International Agency for Research on Cancer (IARC) declared glyphosate a probable human carcinogen based on a review of scientific literature.  California regulators would announce thereafter that they would add glyphosate to a list of known carcinogens.

Today there are over 9,000 lawsuits that have been filed alleging the development of non-Hodgkin’s lymphoma is the result of repeated exposure to Roundup.

And though Monsanto continues to downplay the relevance of the 1983 Mouse study, they no less tried to keep the study quiet in the underlying federal litigation before Judge Chhabria in California.

Judge Chhabria didn’t buy it, and ordered that the study would be fair game at the hearings on general causation.  In his Order, he stated, “It is difficult to understand how Monsanto’s mouse study from 35 years ago could justifiably remain confidential in this litigation.  At the hearings on general causation, the plaintiffs will be permitted to elicit testimony about the study without restriction.  If Monsanto truly believes the study should only be admitted under seal, it can use its time during the hearings to explain why that’s the case.”  Read the Order here.

            On a September afternoon in 2016, Benjamin and Kristi Reavis of Dallas, Texas were traveling south on North Central Expressway with their 3-year-old son and 5-year-old daughter in the sedan’s back seat.

While stopped in traffic, they were hit from behind by a motorist in a Honda Pilot and within seconds their children, safely belted in child safety seats in the back, suffered life-long and permanent head, brain and skull-crush injuries.

The impact from the rear-end collision caused both the front seat backs to collapse, forcing mother and father’s heads back and directly into the heads and skulls of their two small children behind them.

A Dallas jury would find clear and convincing evidence of gross negligence against Toyota, the parent company of Lexus finding that Toyota failed to warn consumers that the front seats can collapse backwards in certain types of rear end collisions and propel front seat passengers into the second seat.  According to CBS This Morning, internal documents showed the cost to fix the front seats were around a dollar.

Please research your car for any seat back failures, research its seat back safety on the internet and on NHTSA’s website here, and see this video for more information.

While the opioid crisis has been dominating national headlines for months, denoted as one of the worst public health crises in the US’s history, children born addicted to opiates are hardly discussed. If a woman uses prescription painkillers while their child is in utero, the child has a substantial chance of developing neonatal abstinence syndrome. This is a generic term for those born addicted to drugs. Common symptoms include physical and neurological deformities, as well as long-term developmental problems.

Although it is impossible to establish exactly how many children are born in the United States with neonatal abstinence syndrome due to different reporting guidelines from state to state, it cannot be disputed that the number has been increasing throughout the last two decades. In 2013, more than three times as many kids were being treated for the condition than in 1999, as the opioid epidemic stated to sweep the country.

Litigators blame the practices of large pharmaceutical corporations and distributors for the increasing rate of neonatal abstinence syndrome and the nationwide opioid epidemic at large. Although the mothers used the drugs themselves, they were targets of predatory marketing practices, according to several lawsuits filed by state Attorney General offices around the country. Opioid distributors and manufacturers did not adequately tell potential users about the addictive nature of the medications. This, in part, led to some mothers giving birth to babies addicted to drugs. Some of these corporations include Purdue Pharma and Abbott Laboratories. Claims against corporate giants, such as these, have been filed in 8 states thus far.

Medical costs to care of neonatal abstinence syndrome is astronomical. Medical professionals estimate that it can cost an average of $260,000 in the first year alone. This costs only increases as the child gets older. They may start to develop psychological or social problems, which may require counseling and medication. Having a fund to help these children dramatically offsets the cost, especially considering the fact that the mothers were victims of unethical marketing practices.

For more information, as well as stories concerning individual children born addicted to opioids, read the cleveland.com article [HERE].

 

Plastic surgeons are noticing more and more women contracting anaplastic large-cell lymphoma (ALCA), a rare type of cancer distinct from breast cancer, in those that have received breast enhancement surgeries. In 2011, the FDA noticed this trend but stated that one’s chance of contracting the disease was extremely low. This statement has since changed as the medical community has seen the rate go steadily upward, and surgeons suspect that textured breast implants are to blame. Unfortunately, insurance does not cover cosmetic surgery or related complications, so many women have held off on seeing their providers when symptoms of lymphoma arise. The most common symptom is swelling of the surgical spot. More disappointingly, if the cancer is caught early enough, it can be cured by removing the implant. 513 women have been diagnosed worldwide with the disease. 16 have died thus far worldwide from ALCA.

Surgeons and other medical professionals argue about the benefits and drawbacks of textured breast implants. Generally, there are two schools of thought. One group believes that there is an inherent benefit to using textured breast implants over their smooth counterparts. This school of thought originated in the 1990s when the texturing technique was introduced, which is done through a chemical scoring procedure. It is thought that tissue will grow into the crevices, which will prevent the implant from rotating or moving.

Those in the other school of thought state that grooves are prone to cause chronic inflammation, which in turn can cause ALCA after long periods of time (roughly 9 years). Some go so far as to state that there are no benefits to using textured breast implants; they are only more dangerous. As such, a small but growing group of surgeons, such as David A. Hidalgo, a professor at Weill Cornell Medical College believe that the products should be pulled entirely from the market. He states that “…if you remove the products, the risk goes to zero…Personally, I think they shouldn’t be on the market.”

There are currently cases pending in state and federal courts in Pennsylvania and across the country on behalf of women who have contracted lymphoma as a result of their breast implants. None of these cases have been decided.

Read the Philadelphia Inquirer’s comprehensive article [HERE].

Johnson & Johnson (J&J) was ordered by a jury in the Circuit Court of the City of St. Louis to pay $4.14 billion in punitive damages and $550 million in compensatory damages to 22 women. The plaintiffs allege that their use of J&J brand talcum powder led to them contracting ovarian cancer. Talcum powder is a popular cosmetic that is used mainly on the bottoms of young children. It can, however, be used as a feminine hygiene product due to its drying properties to reduce odor. When used by older women, the plaintiffs claim that talc can enter into the woman’s ovaries, causing tumors. The trial lasted six weeks.

Lawyers for the 22 women argued that J&J covered up evidence of asbestos – a known carcinogen – in their talc products. Talc, when inhaled in its natural, mineral form, is known to contain asbestos and potentially cause lung cancer. Johnson & Johnson contended that there is questionable evidence, however, as to whether or not refined talc causes cancer when applied to one’s genitals.

A 1982 Harvard study concluded that talc causes ovarian cancer.

Researchers found traces of talc in the women’s ovarian tumors.

J&J noted the apparent lack of scientific evidence in their public statements early Thursday. Spokespeople for J&J stated that they are “deeply disappointed in the verdict” and that they plan to appeal the decision as soon as they can. This tone is very much different than the feeling of the courtroom, which as the New York Times reports, was very emotional. Six of the women had died before the verdict was given, but their families were in the courtroom. One of the women was undergoing chemotherapy and was too ill to attend.

The verdict follows a more than $417 million verdict against J&J in Los Angeles for ovarian cancer alleged to have been caused by talcum powder.  The case was reversed on appeal, and the Plaintiff has since passed away.

J&J is expected to appeal the verdict, but regardless of the appeal result, the Missouri jury clearly intended to send a very strong message to J&J.

Pharmaceutical giant AbbVie was threatened by the FDA in December, 2017 for not properly handling complaints that its drugs had been the cause of several deaths that had not been reported to the agency. The FDA had conducted an inspection of AbbVie’s main manufacturing plant in Chicago earlier in 2017, where they learned of five deaths tracible to the company’s best-selling drugs. Eight to eleven more deaths per drug can now be attributed to AbbVie’s top sellers, plus the five that the FDA was already aware of, according to the Form 483 report obtained by STAT (Read their article about it [HERE]). The drugs under scrutiny are Humira, a drug used to treat arthritis, and Venclexta, which is used to treat chronic leukemia. Venclexta is usually used in conjunction with Rituxan as a supplemental form of therapy.

The company is criticized for not investigating these claims thoroughly enough, and this is mirrored through the conduct at the Chicago manufacturing plant. Many of the practices taking place in the factory were not up to the FDA’s standard. For example, AbbVie employees failed to test reserve samples of their drugs to see if the active ingredients were still functioning properly. They were also scrutinized for having no documentation of investigating the death complaints that the plant had received.

The FDA termed AbbVie’s handling of the complaints “inadequate.” A spokesperson for the drug company stated “[they] investigated all complaints where a death has occurred during the use of our products.” This, however, is clearly contradictory to the FDA’s reporting.

Humira is AbbVie’s best-selling drug; it made the company $18.5 billion of the company’s total revenue of $28.2 billion in 2017(roughly 65%). The arthritis medication is only slated to go up in consumption over the next several years.

Despite the malfeasances of AbbVie, the FDA has not formally sanctioned them, and it is unknown if they plan to at this time.