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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.

          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.