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].

 

The Food and Drug Administration (FDA) distributed a warning letter to physicians concerning the risks of using Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) on March 18th, 2017. The BVS is a stent placed into one’s coronary artery to widen it and increase blood flow. First, it is placed on a catheter over a balloon, which is inserted into one’s artery through their groin or arm. The balloon fills with air, which, in turn, widens the stent and, by extension, the artery to the desired diameter. The balloon and the catheter are removed, leaving the stent in place. It dissolves after three years. BVS is made of various types of polymers and is used often in coronary bypass surgeries.

Interim five-year clinical study results show that the BVS causes a disproportionate amount of major cardiac events (such as heart failure) and scaffold thrombosis–clotting in the artery–after merely three years. Clotting was found to be over three times higher in patients implanted with the BVS than with the metallic XIENCE drug-eluting stent, which has been approved wholeheartedly by the FDA, does not get absorbed into one’s body, and, coincidentally, is also manufactured by Abbott. XIENCE is implemented in much the same way as the BVS. 13.4% of patients treated with the BVS experienced a major cardiac event three years after their procedure, versus 10.4% of those treated with the XIENCE stent. Other studies show that the BVS fails more often due to suboptimal implantation [READ ABOUT IT HERE]. The clinical trials will persist for the total five years to show the long-term effects of BVS implantation.

Presumably as a result of the startling findings, Abbott has canceled all global sales of the BVS as of September 2017, citing “low commercial sales”. The FDA relayed this news to physicians through another, updated letter, and they recommends the following for doctors who still plan on using their leftover BVSs (These standards are unchanged from their March letter to physicians.):

  • Follow the instructions for target heart vessel selection (e.g., avoiding BVS use in small heart vessels) and optimal device implantation that are included in the BVS physician labeling.
  • Advise patients experiencing any new cardiac symptoms such as irregular heartbeats, chest pain, or shortness of breath to seek clinical care. For more information about risks associated with the BVS, refer to the BVS physician labeling.
  • Advise BVS patients to follow the recommendations for dual antiplatelet therapy (DAPT) prescribed by their health care providers.
  • Report any adverse events related to the BVS that come to your attention. If you suspect a problem with the BVS, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities

Sources:

https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm582728.htm?elqTrackId=5aefb2049a054a1097921600ec4febe4&elq=0982deb115a444c0aa5e26618cc8e735&elqaid=1130&elqat=1&elqCampaignId=643

file:///Users/garrettdowell/Downloads/absorb-bioresorbable-scaffold-dissolving-stent%20(1).html

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm509951.htm

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.

Farming communities are divided over the use of Monsanto’s newest and high-profile product. Dicamba is a genetically-modified soybean that is resistant to pesticides. The seed is meant to be used in conjunction with Monsanto weed-killers, such as RoundUp, to allow for spraying without damaging the crops. Although this is certainly not the first time the company has released a genetically-modified organism (GMO)-their first release was in the early 1990s-this is certainly the most controversial, due to the fact that 25 million acres have already been planted. Many farmers, mainly from the South and Midwest, have joined a class-action lawsuit against Monsanto claiming that dicamba drifted onto their property and damaged their non-GMO crops.

GMOs that are immune to pesticides have potential unforeseen environmental and health consequences. For example, environmentalists are afraid that creating crops immune to such poisons will increase the amount that has to be used. Monsanto’s RoundUp is facing litigation for being a possible human carcinogen [READ ABOUT IT MORE HERE].

Normal, non-GMOs exposed to dicamba have been affected drastically as well. Michael Kemp, a Missouri farmer, stated that the leaves on his regular soybeans have curled, which is known as cupping. He is unsure as to the extent of the damage this will have on his harvest. Other farmers state that even the trees on their property have changed as a result of being exposed to dicamba, with leaves so deformed that they cannot tell the difference between different species.

Farmers face a catch-22 if they wish to not grow genetically modified crops: While they do not want to buy non-GMO seeds, their crops may be damaged or killed by neighbors using pesticides. They feel like they have to purchase dicamba, regardless of whether they actually want to grow it. Additionally, the crop can now be sprayed later in the year when the weather is more humid. The pesticide is then susceptible to “volatility”, in which it turns into a gaseous form and drifts onto other properties. State and local officials, including the EPA, are not sure of the impact this might have on outside crops, but Kevin Bradley, a professor of agriculture at the University of Missouri, suspects that at 3 million acres have been affected.

Arkansas and Missouri both temporarily banned the sale of the seeds over the summer because of the unknown consequences it could have on farmers and the environment. Monsanto responded to the Arkansas ban specifically, stating that 99% of customers are satisfied with the product, and most issues that arise from spraying the crops can be fixed with proper education and oversight. Local farmers saw this rationale as a way to defect liability from the manufacturer onto the users.

Tensions are very high within the agriculture community. A man was even shot and killed because he disagreed with a farmhand over dicamba drift. As the lawsuit persists, hopefully new regulations will make it so those who do not wish to grow dicamba are not subject to its effects.

Read more about the lawsuit and dicamba in the New York Times article [HERE]

A number of cases over the past decade regarding the Ford F150, F250, and F350 forces potential and current customers to ask themselves a serious question: Can my truck withstand the force of a rollover accident? Many may assume when they buy their truck that it can, due to aggressive marketing campaigns by Ford, but it is becoming increasingly apparent that they, in fact, may not.

A prime example of this lack of transparency occurred when a college student in Texas rolled his 2002 Ford F150 into a ditch in an attempt to avoid another driver that had abruptly pulled from a driveway into the student’s path. The roof collapsed onto the boy’s head, pinning his chin to his chest and leaving him unable to breathe properly. He was deprived of oxygen for several minutes before emergency medical personnel could assist him. He slipped into a coma shortly after being transported to the hospital. He died a week later.

In another tragic example, a border patrol agent named Luis Pena was driving his Ford F250 to a narcotics incident. The truck flipped and the roof collapsed, causing him major spinal injuries and rendering him a quadriplegic. Court documents express that Ford did not conduct “real world” safety testing on the subject’s model of the truck, including drop tests and dynamic rollover tests.

In general, trucks are more prone to rolling over because their center of gravity is not as low as other vehicles on the road. External entities have put pressure on Ford and other vehicle manufacturers to cut weight from automotive designs. This effort to make them lighter will make the trucks more fuel efficient and attract potential customers. Manufactures have taken off some of this weight by hollowing out the pillars that connect the roof to the rest of the truck. This, of course, makes the top more likely to be crushed in the event of a rollover, and also makes front airbags useless in the event of such an accident.

When buying a truck or car, check to make sure that it is equipped with side airbags, cushioned seats and headrests, and has a functional electronic stability control (ESC) sensor. This sensor helps to adjust braking on certain wheels, which is especially helpful in the event of a tire blowout. They are standard in most new cars.

There are 220,000 rollover crashes in the United States every year. Many are fatal.

Timing is a factor in rollover litigations. Parts of the trucks must be preserved for forensic analysis.

See more here.

 

In a warning letter sent to Pfizer Inc., the Food and Drug Administration (FDA) threatened potential legal action over their negligent manufacturing of the emergency allergy treatment, EpiPen. The letter was drafted due to violations of “good manufacturing practices” at Pfizer manufacturing plants in Missouri between February and March of 2017. However, there are many more underlying issues, according to the letter. Pfizer subsidiary, Meridian, had been ignoring complaints about the functionality of the device. Their inaction had led to a number of serious injuries and deaths, although the exact number was not specified.

The pens’ distributor, Mylan, is the company that came under fire recently for unnecessarily hiking the price of the EpiPen six-fold.

The FDA’s initial interest in Pfizer was peaked in early 2016. Meridian found that a crucial component of the EpiPen, the portion that delivers the antihistamine, was defective. In some cases, the drug would leak out of the pen, rendering it useless. Other times, the drug simply would not inject properly or at all. The company continued to manufacture the same, flawed product while they were investigating the issue. They would later have to recall 260,000 EpiPens in the March of 2017 after being pressured to do so by the FDA.

Not surprisingly, both Meridian and the FDA received complaints during the period of this investigation concerning the drug not administering properly. Meridian dismissed these because they felt they were infrequent and, therefore, did not require attention. Pfizer also stated that “…it’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals”.

Between 2014 and 2017, the company received 171 complaints of improper injection, but they investigated “very few” of the claims and disassembled just as many potentially-broken product samples. Meridian did not offer an explanation for this inaction.

The letter was sent to Pfizer on September 5th. They must have a plan to address safety risks fifteen days from when the letter was sent. Not doing so could lead to legal action and other adverse consequences.

The Food and Drug Administration (FDA) has issued a recall for nearly 500,000 pacemakers manufactured by St. Jude Medical (SJM), a subsidiary of Abbott. Pacemakers are implanted in one’s chest to control strange heart rhythms. In an effort to avoid superfluous surgeries, once the pacemaker is implanted, it is controlled through a radio frequency. However, Abbott has discovered that the frequency can be accessed with commercial equipment. Hackers who are within 50 feet can tamper with the device, and they have the potential to drain the battery or accelerate the patient’s heartbeat, which could kill.

The obvious question arises: Why would someone take the time to hack someone else’s pacemaker? While this seems like a rather obscure reason to recall half-a-million medical devices, these individuals are prone to the new phenomenon, ransomware. In this scenario, one’s pacemaker is hacked. The hacker threatens to alter the patient’s heartbeat unless they pay a large amount of money.

Most medical professionals and Abbott have downplayed this threat; too many pieces must fall into place, such as location and motive, for any damage to be done. Matthew Green, an assistant professor of computer science at John Hopkins University, disagrees. He believes that extortion attacks on both patients and manufacturers are prevalent, and that they must be addressed. This threat is growing every day.

A possible solution, professionals suggest, would be to password protect the radio frequencies. This may seem like a good idea upon first inspection, but if the patients were to go to the hospital for a pacemaker-related medical emergency, the physicians there would have to spend extra time getting access to the device. This process would waste crucial time that could be spent helping the patient. If they cannot communicate the password to their doctor, the extra time could prove lethal.

Pacemakers cannot be simply removed due to the risk of complications. Because of this, Abbott has developed a new firmware update that attempts to heighten security. In an unlikely event, the update may cause the pacemaker to fail. Patients must be in a hospital to receive the update, and they are encouraged to meet with their cardiologist to weigh the risks of installing the update versus cyberattacks.

The issue in Abbott’s design was originally discovered by MedSec, a cybersecurity firm that specializes in finding flaws in medical equipment and publically disclosing them. This is not the first defect they have found in SJM’s pacemakers. In 2016, they disclosed the information to an investment firm, Muddy Waters Capital, who then proceeded to short the stock, in an effort to make a profit when the news became public. MedSec apparently did this to put financial pressure on SMJ and Abbott to make the changes quickly.

Six different varieties of pacemakers are prone to hacking. Read Abbott’s open letter to doctors regarding the issue [HERE] for more information.

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].