What Price is the American Public Paying for the Sake of Advancing Medical Science

Over the course of the last several days, there has been a flurry of discussion regarding Netflix’s latest documentary, The Bleeding Edge. Much like its predecessors (Making a Murderer, The Keepers, Evil Genius), this hour and forty-minute film (directed by Kirby Dick and produced by Amy Ziering) takes a very raw and uncensored look at the $300 billion medical device industry and how, every year, thousands of innocent people fall victim to its profit-driven agenda; begging the ultimate question, what price is the American public paying for the sake of advancing medical science?

Sadly, The Bleeding Edge is rife with examples of the price Americans are paying for the sake of advancing medical science. Interviews with women having received the Essure permanent birth control device reveal how over 35,000 women have had their lives reduced to chronic pain, autoimmune disorders, and hysterectomies as a result of Bayer’s failure to report the side effects associated with its device. Individuals having received metal hip implants discuss their development of cobalt chromium metal poisoning and the related onset of debilitating neurological deficits. Other women detail the multiple and painful surgeries they have undergone in an attempt to remove the vaginal mesh strangulating their bodies, which had originally been used to help stabilize and reinforce weakened pelvic muscles often caused by childbirth and aging. Even more women discuss how sections of their colon exploded from their bodies following their surgeons’ use of the robotic, da Vinci System.

For years, industry has pushed this idea that newer is better and that new and “innovative” medical devices put us on the “cutting edge” of science. However, The Bleeding Edge most accurately dispels this myth, delving into the world of medical devices, exposing the stark reality of how industry’s push for “innovation,” coupled with a lax regulatory system, actually puts us on The Bleeding Edge of science, as every time a patient agrees to the implantation of a medical device, he or she is unknowingly subjecting his or herself to unimaginable harm, or even death.

THE MEDICAL DEVICE INDUSTRY IS ONE OF THE MOST POWERFUL INDUSTRIES IN THE WORLD

Over the last ten years, 70 million Americans have been implanted with a medical device. These devices are a part of our everyday lives, ranging from dental floss and tongue depressors, to pace makers and catheters. Stryker, one of the leading manufacturers of hip and knee replacement components had a net revenue of $12.7 billion in 2017. Bayer, the manufacturer of several contraceptive devices, including, Mirena and Essure, made well over $40 billion in revenue, and Johnson & Johnson, a manufacturer of vaginal and hernia mesh made over $76 billion in revenue in 2017. The profit margin of the medical device industry is frightening in that it has afforded these companies the opportunity to infiltrate our lives under the guise of medical advancement, all the while exposing us to perilous harm.

THE PROCESS BY WHICH THE FDA APPROVES MEDICAL DEVICES IS SIGNIFICANTLY OUTDATED

The Bleeding Edge highlights the misconception under which many Americans operate – that their medical device has been adequately tested and deemed safe and effective for use by the FDA. Since 1976, it has been the responsibility of the Food and Drug Administration (FDA) to regulate the approval of medical devices. However, since 1976, the complexity, type, and number of medical devices has vastly increased, but whether they are released for public use is still based on a system created over 40 years ago; one clearly incapable of contemplating today’s technology.

98% of all medical devices are not tested prior to approval. Rather, manufacturers are able to acquire approval of medical devices by the system known as the 510(K) process. To obtain approval under the 510(K) process, a manufacturer is only required to show that its device is substantially similar to another (predicate) device that was previously approved by the FDA; absolutely zero safety testing is required. This is true even if the predicate device was taken off the market for safety concerns. Per the FDA, in considering a 510(K) application, it does not check the predicate device for safety issues, or to see if it has been removed from the market; it only looks to confirm that it was actually approved by the FDA. Consequently, much like a genetic mutation, approving a product that is based on the design of a device that has been found to be unsafe, promotes the production of faulty devices in generations to come.       

WE CAN NO LONGER RELY ON THE MEDICAL DEVICE COMPANIES AND THE FDA TO DO WHAT IS IN THE BEST INTERESTS OF PATIENTS

Even more, The Bleeding Edge calls attention to the seemingly biased and corrupt workings of the FDA. FDA officials and physicians charged with the responsibility of determining whether a device should be approved, more often than not, have stock or other monetary interests in those exact devices before them for approval. For example, prior to Dr. Scott Gottlieb (current FDA Commissioner) being appointed commissioner, he not only worked as a consultant to a range of medical industries, but he worked for a venture capitalist firm, New Enterprise Associates, that specialized in the investment of startup medical device companies, which has invested $14 billion in over 500 companies, including the development of the very controversial permanent birth control device, Essure.

MEDICAL DEVICE MANUFACTURERS ARE NOT HELD ACCOUNTABLE

Another misconception addressed by The Bleeding Edge is that the FDA has the data it needs to regulate or recall medical devices. Some safety issues with a device do not become apparent until after the device is already on the market. In these instances, a manufacturer has an absolute obligation to monitor and report such safety issues (adverse events) to the FDA. If enough adverse events are reported for a particular device, the FDA will then decide if the device needs: further safety testing; stronger warnings; or to be pulled from the market altogether. However, if the FDA is unaware of the adverse events, it cannot make the decisions necessary to protect us. The disturbing and unfortunate reality of the situation is that only 3-4% of adverse events are reported by device manufacturers, and the more severe an event, the less likely it is to be reported. Thus, the whole idea of the FDA relying on a company to essentially “tell on itself” when something goes wrong with a device, when billions of dollars of profits are at stake, is not only counter intuitive, but a system that completely fails the American people.

Leaders in industry argue that to impose stricter regulations on how medical devices are approved, is to stifle innovation. However, as Bleeding Edge explains, the aim of regulation is not to stifle innovation, but to call real attention to the safety risks that these newer and “innovative” devices pose to patients. After all, innovation doesn’t necessarily mean better. It means “massive adoption of new technology with little evaluation of the outcomes”, or “putting untested devices on the market.”

HOW THE YOST LEGAL GROUP CAN HELP

For years the attorneys at The Yost Legal Group have litigated cases against device and drug manufacturers all in an effort to not only bring awareness to the same issues addressed by The Bleeding Edge, but to hold those same manufacturers accountable for the devastating injuries they have caused our clients. Presently, our firm is involved in the following litigations against various device and drug manufacturers.

• ESSURE PERMANENT BIRTH CONTROL: Currently investigating cases against Bayer, involving women who have had to have a hysterectomy following their implantation of the permanent birth control device, Essure.
• HERNIA MESH:  Currently investigating claims against several manufacturers, including Johnson & Johnson, C.R. Bard, and Atrium Medical, on behalf of individuals having suffered serious complications from synthetic mesh implanted during hernia repair surgery.
• IVC BLOOD CLOT FILTERS: Currently investigating cases against device manufacturers, C. R. Bard, Cook Medical, and Cordis, involving individuals having suffered serious side effects, including death, following their implantation of an IVC blood clot filter.
• SMITH & NEPHEW HIPS: Currently investigating cases against Smith & Nephew, involving individuals who have had to have additional hip replacement surgeries following their implantation of the Birmingham Hip Resurfacing (BHR) System, or the R3 Acetabular System, both of which have multiple components made of cobalt chromium metal.
• STRYKER LFIT V40: Currently investigating claims against Stryker, on behalf of individuals who have had to have additional hip replacement surgeries following their implantation of the Stryker Rejuvenate Modular Primary Hip System, the AGB II Modular Hip System, or the LFIT V40 femoral head, all of which contain metal on metal components.
• MIRENA IUD: Currently investigating cases against Bayer involving women who have been diagnosed with intracranial hypertension following their implantation of the intrauterine device (“IUD”), Mirena.
• DIABETES MEDICATIONS (Januvia, Janumet, Tradjenta, Byetta, Victoza, Onglyza, etc.): Currently investigating claims against various manufacturers, on behalf of individuals having been diagnosed with pancreatic cancer following their use of medications belonging to a class of drugs known as incretins (Januvia, Janumet, Tradjenta, Byetta, Victoza, Onglyza, etc.), prescribed to treat type 2 diabetes.  

If you or a loved one has been injured as a result of a faulty medical device or defective drug, The Yost Legal Group may be able to help.  Our team of experienced legal professionals is here to offer you free, individual consultation. We serve as the voice of our clients to hold Big Pharma accountable and obtain the justice each one so rightfully deserves. Call The Yost Legal Group (1-800-YOST-LAW) today. Let us be your voice.

9 months ago Elder Law , Medical Malpractice No comment

Is Nursing Home Abuse Considered Medical Malpractice?

Helping our loved ones transition to the next stage of their lives in a nursing home is difficult for every family. Unfortunately, getting them settled in and Medicare up-to-date isn’t the end of the road of moving into a nursing home.

A report published by the Special Investigations Division of the House Government Reform Committee found that one in three nursing homes in the United States were cited for abuse that may be considered medical malpractice over a two year period.

Approximately 5,283 facilities received 9,000 individual citations from those who report nursing home abuse and medical malpractice. Crimes ranged from inadequate sanitation to malnutrition and dehydration to preventable accidents.

These violations weren’t the result of a bad day: they hurt residents and are illegal.

Your duty as a loved one of a person in a care home isn’t simply to visit: it’s also to report nursing home neglect or abuse in nursing homes that could potentially result in a legitimate medical malpractice case.

What Constitutes Nursing Home Abuse?

Just like elder abuse, nursing home abuse ranges across a broad range of behaviors and isn’t always detectable right away, particularly when the person being abused is suffering from memory issues related to dementia.

The most obvious signs of abuse are physical abuse, which can be committed by staff or other residents. Slapping, pinching, or allowing residents to fall are all types of violence.

Psychological abuse is also illegal. It includes shouting, shaming, or humiliating the patient.

Neglect makes up the bulk of many of the abuse citations, and it often isn’t malicious but the result of poor policies, training issues, or inadequate staffing. Like physical abuse, neglect takes a physical toll and is demonstrable.

Patients may also be sexually abused, which features sexual exploitation or unwanted attention either from a caregiver or another patient. Patients with dementia are particularly susceptible because they’re cognitively compromised.

What Are the Signs of Nursing Home Abuse?

The signs of abuse may manifest physically or in personality. It’s important to pay attention to behavioral changes over time to best determine whether they’re the result of disease or abuse.

Still, any suspicion should be reported. Unfortunately, elder abuse rarely begins and ends with a single patient in a facility.

Here are some of the symptoms:

• Bed sores
• Dehydration
• Malnutrition
• Recurring infections
• Weight loss
• Emotional outbursts
• Reclusiveness
• Poor hygiene
• Bruising
• Caregivers who hover when families visit

This list isn’t exhaustive, and some of the signs can be invisible, so it’s important to check in with your loved one regularly to notice more subtle signs of abuse.

How to Report a Nursing Home for Medical Malpractice

If you believe your loved one or someone else in the nursing home is being abused, then you should report it. Even if it’s not your family member or friend, it soon could be.

You have several reporting options. Start by contacting the U.S. Administration on Aging’s Eldercare Locator at 800-677-1116. They’ll provide you more information on elder abuse laws in your state and explain the proper channels.

Another avenue to report nursing home abuse is via your family member’s primary care physician. In most cases, primary care physicians are required to report suspected abuse in nursing homes – failure to report may be medical malpractice.

If you suspect the damage is threatening the life or immediate wellbeing of your family member, call 911.

Concerned about where to go from there? We always recommend contacting a lawyer who frequently works in elder abuse cases like Zanes Law.

Be Your Elderly Loved One’s Advocate – Report Nursing Home Abuse

While some within the industry suggest that nursing home citations are over-reported because of high and changing standards – elder abuse exists. And it’s often a silent epidemic.

The best thing you can do for your loved one is to be there even after they transition into their new home and keep a sharp eye out for signs of abuse. You can ensure every older adult receives the dignity they deserve.

10 months ago Medical Malpractice , Wrongful Death No comment

How to File a Wrongful Death Lawsuit

Undergoing medical procedures is hard and scary enough, let alone the fact that medical errors are probably the third leading cause of death in the United States.

If you or a loved one is suffering from a serious medical issue, then the expertise of medical professionals is something you dearly rely on.

When carelessness leads to a wrongful death, though, you might be the survivor left in the wake wondering what you should do.

If you’re wondering what exactly is a wrongful death suit or how one is begun, then we have some important information to get you on your way.

What is a Wrongful Death Suit?

It sounds simple: a death that shouldn’t have happened.

An important distinction between wrongful death cases and something like murder cases is that “wrongful death” falls under personal injury law.

“But how can someone’s death be considered injury?” you may be asking the screen.

A lawsuit like this is based on the negligence or misconduct of another. It’s not necessarily the same as with criminal cases like murder.

While a wrongful death lawsuit may come out in the aftermath of a criminal case, these types of suits tend to be associated with particular instances, such as:

• Medical malpractice
• Vehicular accidents
• Occupational hazards
• Death during a supervised activity
• and more

For example, if you or a loved one were to have died while flying on a plane, is it possible that the pilot was negligent in handling the aircraft? Therefore, would the plane company also be responsible for hiring the pilot in the first place?

If your child died while out on a field trip, is it the chaperone, teacher, or another supervisor who was negligent in watching out for and caring for your child? Could it even be the school itself?

Medical malpractice is another common instance. Mistakes happen. If you’re dealing with a very large hospital, it’s not unheard of that a nurse may give the wrong medication to a patient or a surgeon may receive the wrong information leading up to a surgery.

The point is, someone or something is very possibly responsible for the negligence that led to the death in the first place.

Who Can Make a Wrongful Death Claim?

These claims are made by someone who represents the estate of the one who died.

Who can initiate this claim, though, tends to be different from state to state.

In general, a parent can make a wrongful death claim of their child, a child can of their parents, and an individual can file for their spouse, but it gets trickier when you’re dealing with adults and their adult children or distant family.

Whether the people involved are related or not, it doesn’t necessarily guarantee that the individual can sue for the wrongful death.

It’s important to check your state’s statutes to understand who can make this kind of claim.

What Comes out of a Wrongful Death Suit?

Grieving for a loved one is consuming. You may need to consider or want to consider what could come out as a result of a wrongful death claim.

It’s important to understand what may have been lost by the death, such as:

• Lost wages
• Lost support
• Lost prospect of inheritance
• Medical expenses
• Funeral expenses
• and more

Punitive damages are intended to punish the defendant and to discourage this type of behavior in the future. Whether or not you are entitled to punitive damages from suing for wrongful death is, again, based on your state.

Regardless, you may be entitled to some of these damages as a result, and whether or not you want to even think about it now, your future self and family may be happy that you did.

How Long Do You Have to File a Wrongful Death Suit?

If you’re mourning the loss of a loved one, it may be difficult to even think about a timeframe.

Time is important in a case like this, though.

As with many claims, including personal injury claims, your state will have a statute of limitations devoted to how long after a wrongful death a claim may be made.

This can still depend on a number of factors, such as which state you are in, who you are claiming as the defendant, and when the death occurred.

How long you have may not necessarily start from when the death occurred, though.

For example, if you’re dealing with medical malpractice, the death of your loved one may have been declared natural. Some time down the line, new evidence may determine that medical malpractice was the real cause of death.

Specific situations like these can change the timeframe in which you have to file a wrongful death lawsuit.

How to File a Wrongful Death Suit

Based on your state’s statutes and the specific circumstances surrounding the death, you may find that you are eligible to file.

You may not even be the person benefiting from the suit, but you can still possibly file on behalf of them.

As with many cases, you have the right to represent yourself, but as clearly shown there are so many factors that determine whether or not you can even file in the first place.

Not only that but as the one making the wrongful death claim in the first place, the burden of proof falls on you alone.

Being a civil case, the burden of proof for a wrongful death suit is generally less than proof beyond a reasonable doubt.

It’s typically called “preponderance of the evidence” in this kind of case, which means the proposition being made is more likely to be true than not.

In general, hiring or at least consulting with a wrongful death lawyer, such as Chester Law Group, is strongly advised.

A quality lawyer will already know many of the factors leading up to your case, such as who can file, when you can file, and what will happen when you do file.

More Information on Wrongful Death Cases

Being the survivor of a wrongful death is hard enough.

There is a lot to consider, and your head may not be clear enough to even start the process. Hopefully, the information here gave you a step in the right direction.

If you have more questions or concerns about a wrongful death suit or want to know more legal advice and details, feel free to check out more on our blog.

10 months ago Medical Malpractice , Personal Injury Lawyers , Wrongful Death No comment

Miami Based Attorney Scott Sandler on Medical Malpractice – More Common Than It Should be

The loss of any loved one is tragic. Whether it’s due to injury or sickness, death is often a catastrophe. Yet there’s a bitter irony when the cause of death comes from within the hospital, not from outside it.

We’d like to think that in the 21st century, medical error is disappearing. Unfortunately, that’s just not the case. In fact, according to a recent analysis published in the BMJ, one of the world’s leading medical publications, medical error is the third-leading cause of death in the United States. That’s why it’s important to understand just what medical error (also known as medical malpractice) is.

According to Martin A. Makary and Michael Daniel of the John Hopkins University School of Medicine, medical malpractice is “an unintended act or one that does not achieve its intended outcome.” This can be an error of planning, of execution, or an outright deviation from the proper medical process. In other words, medical malpractice can take many forms, and its effects can be trivial as well as severe.

To illustrate their point, they cite a case history that showcases the role of malpractice in a patient’s death:

A young woman left the hospital after a successful transplant operation, but she suffered from pain and was readmitted to the hospital. Doctors decided to run a variety of tests, many of which were unnecessary, to identify the problem. One of the tests was a pericardiocentesis, which samples fluid from space that surrounds the heart.

She was then released from the hospital and told to wait for the test results. A few days later, the unfortunate young woman checked into the hospital with a hemorrhage and cardiac arrest, and she passed away.

The autopsy showed that the syringe had peirced the skin during the pericardiocentesis slightly hitting the liver, which caused her death. Yet instead of listing the cause of her death as a medical error, the certificate simply blamed it on her cardiovascular system.

We know that medical error happens – after all, mistakes are unavoidable. But just how widespread is it? It’s difficult to identify the exact numbers, partly because “medical error” is never included on a death certificate – this would be too risky for doctors to admit. However, studies from the Harvard Medical School, the US Inspector General, and the Agency for Healthcare Research & Quality calculate that anywhere from about 140,000 to 195,000 people die each year because of medical error. What’s more, these studies are likely understating the problem, because of the limited data available to researchers.

Yet even with those understatements, medical error ranks as one of the leading causes of death in this country. Until doctors start including information about medical error on death certificates, it’s up to ordinary patients, and ordinary citizens, to identify cases of malpractice. We need to understand that this problem affects all of us and that each patient must be aware of the possibility that medical malpractice is the true cause of death.

About attorney Scott Sandler:

Scott Sandler is an experienced trial lawyer representing personal injury victims for over 30 years. Founding attorney of The Law Office of Scott M. Sandler, Sandler’s dedicated and forceful approach has allowed him to obtain many multimillion-dollar verdicts and settlements.

Visit http://www.scottsandlerlawoffice.com/firm-profile for more information

Source: https://www.hcp.med.harvard.edu/sites/default/files/methodsmakarydaniel_2016_bmj%20%281%29.pdf

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