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.

 

            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.

It was just over a year ago in July when I received the tragic news that one of my dearest friends had lost his teenage son to an opiate overdose.  It absolutely devastated him and his family.  Their 19-year-old son was the treasure of their lives, a straight-A student going into his sophomore year in College.  I would later learn that his opiate addiction stemmed from a surfing injury two years earlier, requiring shoulder surgery, and being sent home with a 60-day prescription of oxy.

His death was shortly after Ohio’s Attorney General filed a lawsuit against all nine major opiate manufacturers alleging that each was responsible for the public and fiscal decimation that was gripping the state.  Thereafter I endeavored to determine the extent of the crisis here in Wyoming.  What I discovered alarmed me.

To put things into context, West Virginia is often considered “ground zero” in the opiate crisis.  The state has been ravaged by opiates so much so that cities and counties have had to literally bring in mobile morgues because the coroner is already at maximum capacity.  The young lives, families and children affected by this epidemic could not be over-exaggerated.

Alarmingly, I would learn that more Oxycontin pills actually come into Wyoming than the state of West Virginia on a per capita basis.  After talking with people all over our state,  I learned of many tragic stories of young lives crushed and destroyed much too early because of this prescription drug.

I knew there were really only two solutions to this crisis.  The first, and best, was our Congress in Washington.  The second, in the alternative, is the private sector where attorneys, with the requisite experience and financial resources to fight Big Pharma (with its untold billions of dollars and a highly paid lobby), agreed to finally attempt to stop this National Health Crisis.

Initially it gave me comfort to know that Wyoming might be at an advantage for rescue with a licensed physician as our senator, Dr. Barasso.  I assumed that our senator would have a learned and therefore intuitive understanding of prescription opiates with their deadly addictive properties propelling this Crisis.

But the US Senate apparently lacks any apprehension of this National Health Emergency or otherwise willfully chooses not to hold accountable Big Pharma—a historically major and reliable political donor to some who serve us in Congress.  The Senate has offered no solution(s) to the greatest public health crisis of our time with the exception of seeking more federal funding.  There needs to be clear-eyed leadership in the Senate to finally hold Big Pharma liable for this moral outrage now killing more Americans each and every year than all who served and died in the 15 year war in Viet Nam

The Opiate Crisis is now claiming more than 170 lives every day.  The CDC announced that life-expectancy has – for the first time – decreased in America because of the prescription opioid crisis.  The US Surgeon General, an anesthesiologist, has publicly announced the need for all adult citizens to carry Naloxone, an opiate reversal agent, for emergency use for family and friends.

The people of Wyoming  – and every citizen of the United States – deserves better.  Change is needed.  Candidates who do not accept funds from Big Pharma may be our only hope.

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].

St. Jude’s Medical, a newly-acquired subsidiary of Abbott Pharmaceutical, was issued a class-2 recall by the FDA for their pacemaker and defibrillator devices. These particular types of pacemakers and defibrillators are placed inside a patient’s chest and administer small shocks of electricity in order to keep the patient’s heart beating properly. Those recalled will either fall under the category of implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-D). They are used to treat chronic, life-threatening conditions, such as ventricular fibrillation and other conditions that affect a person’s heartbeat.

The FDA recall is, essentially, a software update meant to boost the security of the already-implanted medical devices. Physicians are being administered the software by Abbott under order of the FDA. 740,000 different devices have been dispensed to patients that will require the update. (If you or a loved one is implanted with a Saint Jude’s brand pacemaker or defibrillator, then your physician should administer the software update during your next appointment.)

In an effort to reduce invasive procedures, Abbott controls their cardiac devices through radio frequency. This allows one’s doctor to alter the severity and frequency of the shocks without having to even touch the patient. Professionals are concerned, however, that there may be potential cybersecurity issues with the ICDs and CRT-Ds. It is not unthinkable for someone to hack into one’s pacemaker, even with commercial equipment. The hacker could raise or lower the frequency or severity of the shocks to one’s heart or rapidly deplete the device’s battery. Matthew Green, an associate professor of computer science at John Hopkins University, calls this oversight “probably the most impactful vulnerability I’ve ever seen [in a medical device].” Green and other professional believe that those who are vulnerable could be extorted by hackers.

However, there has not been an instance where someone has had their pacemaker manipulated by anyone other than their doctor. The Department of Homeland Security, too, has stated that, while it is possible for one to hack into and control these devices, it would be extremely difficult and require a great deal of expertise.

For more information and specific devices that have been recalled by the FDA, check on the Minnesota Star Tribune article on St. Jude [HERE].

The FDA is preemptively trying to eliminate such threats from other medical appliances that use radio frequencies. Earlier this April, the FDA announced a comprehensive plan to combat cybersecurity threats to the medical industry. Titled the Medical Device Safety Action Plan, new devices would be equipped with software/firmware that would allow them to be updated at will by the FDA. This would allow them to be renovated as the technology and threats change on an ongoing basis. In tandem, the FDA has requested to fund a CyberMe. Safety Analysis Board for the 2019 fiscal year. This new board would be specifically formed to scrutinize cybersecurity safety risks in new and existing medical devices. Interestingly, the board will be formed via a public-private partnership, with industry experts taking part in the design of the software.

 

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.

          Producers of intragastric balloons, which are used in non-invasive weight loss procedures, are coming under investigation for a total of twelve deaths attributed to their use.

These balloons are placed in one’s stomach through an endoscopic procedure via the patient’s mouth. They are then filled with saline to take up space in the patient’s stomach, making them eat less, feel fuller, and helping them loss weight. The balloons are removed after six months, usually resulting in a 5%-10% loss of the patient’s total body weight.

The two products in question are the Orbera Intragastric Balloon, manufactured by Apollo Endosurgery Inc. and the Integrated Dual Balloon, which is manufactured by ReShape Lifesciences.

One of the twelve deaths can be linked to esophageal perforation. Four of the twelve suffered gastric perforation, but the seven others do not have a particular cause of death. That being said, there are several complications with intragastric balloons that may be the culprit. One of these is over-inflation. This is where the balloon is overfilled with saline during the surgery, and it causes the stomach to stretch, leak acid, or rupture as a result.

These other symptoms can be ascribed to over inflation of intragastric balloons. If you or a loved one has experienced any of the following, consult your physician immediately:

  • Vomiting
  • Difficulty breathing
  • Stomach pain
  • Tenderness

Severe abdominal and back pain have also been reported with the use of these balloons, although they have not been traced to any of the twelve deaths. Furthermore, these symptoms are not currently on the balloon’s warning label, which means that doctors have a harder time attributing the problem to it. Lastly, the balloon has been known to cause acute pancreatitis (inflammation of the pancreas) by “the compression of gastrointestinal structures created by the implanted balloon(s).” A diagnosis of pancreatitis would mean that the balloon was not implanted in the patient properly. This, too, has not been traced back specifically to any of the twelve deaths.

The FDA released warnings to health care providers about the potential risks of such intragastric balloons in February, 2016 and again in August, 2016. [READ THEM HERE AND HERE]

San Diego-based Acadia Pharmaceuticals released their first and only drug, Nuplazid, to the market in June of 2016. Coined a “breakthrough therapy” at the time, the medication sought to relieve Parkinson’s disease patients of hallucinations and psychosis. Nuplazid was approved by the FDA through a special expedition process, which required fewer clinical trials. In fact, the drug was approved after only a six-week test of 200 patients. The FDA committee who approved the drug was swayed by testimonies from people whose loved ones were suffering from horrible hallucinations and distorted realities.

However, since Nuplazid was not properly tested, the panel had no way of knowing that the drug could be dangerous. Three of the studies presented to the FDA showed that the drug was not effective at treating what it was intended to.

Nevertheless, it went to market, where vulnerable patients soon found this out about unknown side effects. These included insomnia, vomiting, falling, and other dangerous complications.

Many doctors later contended that it worsened their patients’ conditions.

Worst of all, more than 700 patients have died since the drug was approved by the FDA. Some have opined that patients are twice as likely to die from Nuplazid than a placebo.

In the time since their drug’s approval, Acadia has made hundreds of millions of dollars. They have fired back at their critics, giving a number of rationales for Nuplazid’s unusually high amount of deaths.

Parkinson’s patients who do suffer from psychosis are, generally speaking, in the developed, most-severe stages of the disease. This means that they are at a higher chance of death as is. Additionally, these patients are suffering from other aliments associated with the disease and are taking other drugs with Nuplazid.

This may raise the mortality rate and complicate finding the true cause of death. This being said, professionals are rightfully concerned.

Thomas Moore, a senior scientist at the Institute for Safe Medical Practices, stated that the drug “might do more harm than good.”

CNN broke the story about Nuplazid’s high number of deaths. Read it [HERE].

Recently reports have arisen linking the risk of vehicles with keyless ignition systems and carbon monoxide poisoning.

Vehicles installed with the “on / off” button that automatically turns the vehicle on or off with a push of a button were placing consumers at risk of carbon monoxide poisoning and death in the event a consumer were to park their car in the garage, and exit the vehicle without remembering  to turn the vehicle off.

Deaths have occurred as a result, and lawsuits have followed.

Car makers are required to protect consumers from foreseeable dangers, and industry experts contend that the risk of a driver forgetting to turn off their vehicle is real, and certainly foreseeable.

Industry experts suggest an automatic “shut-off” needs to be implemented as standard in such vehicles, and many vehicles include such devices today, however, older vehicles with no shut-off device have not been recalled – placing consumers at increased risk of danger.

Consumers are urged to take their vehicle into a local dealer and find out if a automatic shut-off device has been installed, and if not, to do so immediately.

See more about this story here.