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.

In a recent statement, Weyerhaeuser Timber said it would recollect all TJI-joists that were manufactured after December 1st, 2016.

  • TJI is Weyerhaeuser’s branded joist.
  • Joists are a type of lumber that is supposed to resist warping and allow for faster installation. They are used in most new homes, specifically in basements.

These products were covered with a new formula of Weyerhaeuser-brand Flak Jacket fire-resistant coating, which contains a “formaldehyde-based resin”. Having such a coating is supposed to help bring the houses up to federal and state fire regulations. This particular coating causes the houses’ basements to smell like pickles, according to Customer Reports.

This defect has affected roughly 2,200 homes, but most of these are not yet habited. Weyerhaeuser estimates that collecting the unused product and replacing those that have already been implemented will cost $50-60 million. In a press release, the company states that “[it] is working proactively with its customers to address this situation and will cover the cost to either remediate or replace affected joists.”

Weyerhaeuser collected approximately $9 million by selling Flak Jacket products in 2016. The company made a net profit of $6.4 billion during the same year.

Expenses and remediation regarding the defective products were set-aside for the second quarter of 2017.

Weyerhaeuser has been in the legal spotlight recently for illegally cutting retiree benefits. Read about it via Bloomberg News [HERE].

If Weyerhaeuser products were purchased for your home and you have noticed a pickle-like odor, you may be entitled to compensation. Contact the Ochs Law Firm today for a consultation.

A lawsuit filed in the Superior Court of California in Los Angeles County last week resulted in a verdict against Nissan of America and its brake manufacturer, Continental Auto Systems, for $25 million for faulty brakes. Plaintiffs claimed that Nissan and Continental knew of the issues and did not let customers know or issue a recall, in order to avoid bad press. Because of this, Plaintiff Solomon Mathenge slammed into a minivan in his 2004 Nissan Infiniti QX56, killing a mother and her two daughters.

The lawsuit alleged that the brakes failed when the delta stroke sensor stopped working in the vehicle due to a software error. Attorneys argued that Nissan knew of this fault as early as 2003 but made no effort to correct it or disclose it. They further argued that the same software failure can be seen in their Titan and Armada models, too. The public was first alerted to this deadly blunder in the class-action case Banks v. Nissan, where Defendants were ordered to pay $800 to each buyer of the aforementioned models. Mathenge did not know of this payout, and by association, the sensor failure, because he bought his car used in 2012.

Mathenge was originally the target of the lawsuit. He was driving with a suspended license at the time, and his ability to drive was brought into question due to the fact he was 74-years-old. Police charged him with vehicular manslaughter at the crash scene. Hilario Cruz, the father of the daughters involved in the crash, and Araceli Mendez, Cruz’s surviving child, charged Mathenge with a wrongful death lawsuit. However, they dismissed the charges against him when it was revealed that his car was affected by the same software error as in the class-action suit above. Mathenge, who was injured himself, joined Cruz and Mendez in their lawsuit against Nissan. The judge found that, although Mathenge was negligent in his driving practices, Nissan and Continental were completely responsible for his accident.

Due to the minimal public information available for this potentially deadly defect, many purchases of these vehicles to this day may have no idea of the danger.

For more information, read the complaint [HERE].

The US has been hit very hard by the recent opioid crisis. Deaths from opioid-related overdose have quadrupled since 2003, with 33,000 deaths in the nation last year alone. But nowhere in the US has been affected as drastically as Indian Country. To paint a picture, Native American high school students abuse OxyContin at twice the national average. The Cherokee Nation, which, is represented by 14 counties in northeastern Oklahoma, is taking a stand by filling a lawsuit against the US’s top pharmaceutical distributors, following in the footsteps of Ohio and Mississippi, among other states (read about it here). There have been 350 overdose-related deaths in these Oklahoma counties between 2003 and 2015. Cherokee officials knew it was time to take action.

The numbers regarding opioid prevalence in the Cherokee Nation speak for themselves:

  • 845,000,000 million milligrams worth of drugs were distributed to the 14 counties in 2015
  • This means that every opioid addict in the area had roughly 360 to 720 pills
  • 6 percent of American Indian 12th graders have tried heroin, twice the national average

Attorneys representing the Cherokee Nation hope that their lawsuit accomplishes two objectives. Number one, it will compensate those affected by the opioid crisis, as much as a lawsuit can. Financial penalties from these companies will go toward law enforcement costs and reimbursing the child welfare service, which has had to cope with the influx of addicted babies. The money currently being spent by the state could be going towards other families without these issues.

Secondly, the Cherokee Nation’s attorneys hope that the lawsuit will change the behavior of the pharmaceutical distributors named as defendants. These include:

  • Walmart
  • CVS Pharmacies
  • Walgreens

As well as the nation’s three largest distributors:

  • AmerisourceBergen
  • McKesson
  • Cardinal Health

Plaintiffs allege that the named defendants did not take the necessary steps to stop their drugs from getting into the hands of the black market. For example, they turned a blind eye to doctor shopping and filling multiple opioid prescriptions at once, both of which violate the Controlled Substances Act. Distributors should, under the act, file any suspicious activities, such as these, with the federal government. The Cherokee Nation’s attorneys state that the crisis boils down to the simple problem of market oversaturation. There are more drugs, ones that should be rare and difficult to get in the first place, in the market than there should be. They have ignored known issues in their supply chain to get to this point.

Defendants, however, contest that they have done nothing wrong. As Courtney Tobin, a spokesperson for Cardinal Health, puts it:

Cardinal Health is confident that the facts and the law are on our side, and we intend to vigorously defend ourselves,” Tobin wrote. “We believe these lawsuits do not advance the hard work needed to solve the opioid abuse crisis – an epidemic driven by addiction, demand and the diversion of medications for illegitimate use.

All of the defendants who could be reached for comment by The Rolling Stone felt similarly about the case.

The suit was filed in tribal court on April 20th, 2017. While the defense will likely ask the judge to move jurisdiction to a federal court, a tribal court will allow plaintiffs to get access to corporate records sooner.

Like the rest of the country, Wyoming’s Indian population has been hit hard by the opioid epidemic. State officials are sensitive to the issue and have been working to address it. For example, in Fremont County, drop boxes for unneeded drugs can now be found at clinics and city halls. These have been added to combat the spike in opioid overdoses over the last several years and decades.

Fremont County has a large Native American population at 20% and is home to the Wind River Reservation. Learn move about the drop boxes and other initiatives [HERE].

Regardless of the trials outcome, we at the Ochs Law Firm hope for relief and will join the fight for all of those affected by the epidemic in the Cherokee Nation and Wyoming.