Articles Posted in medical malpractice

New data published in the Journal of Patient Safety suggests that previous estimates regarding the number of fatal medical mistakes are far too low. If the new estimates are accurate, medical malpractice is the third leading cause of death in America, with only heart disease and cancer killing more Americans.

Our Boston medical malpractice lawyers know that there are many deaths and many more injuries each year because of medical errors. A medical mistake can be fatal for many different reasons and it is important for patients to understand the greatest risks so they can do everything possible to protect themselves from becoming a victim.
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Many veterans receive medical care at VA hospitals because the cost of their care is covered at these facilities. Unfortunately, visiting a VA hospital may be a dangerous choice for patients, as a number of disturbing incidents have led to record highs in medical malpractice payouts.

Our VA malpractice lawyers know that patients have a right to expect a reasonable degree of competence among all physicians and hospital staff. Failures of healthcare providers to exercise reasonable care can cause serious and lasting injury. Incidents at the VA hospital, for example, have led to death in some cases and to expensive medical treatments in others.
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Our Boston medical malpractice lawyers know that malpractice is far too common and that these claims arise as a result of many different types of medical mistakes.

Recently, a comprehensive study by Irish researchers took a close look at the medical errors that primary care physicians make which lead to medical malpractice cases.

Common Causes of Medical Malpractice Claims

According to CBS News, Irish researchers reviewed more than 7,150 journal papers on medical malpractice claims in order to determine the top causes of malpractice cases. The goal was specifically to find the causes of malpractice claims for primary care physicians, since these physicians are often the ones responsible for identifying when symptoms present medical problems that require referral to a specialist.

The researchers reviewed 34 different journal articles and analyzed the underlying causes of primary care malpractice cases as described by the journals. These journal articles included fifteen articles that were based in the United States, nine studies that were based in Britain, seven studies by Australian researchers, two papers by French researchers and one paper by Canadian researches.

Based on the comprehensive review of different journals, the Irish research study determine that the top causes of medical malpractice claims included:

• Missed diagnosis cases, which accounted for between 26 percent and 63 percent of the total medical malpractice claims, depending upon the study that was reviewed. Death resulted in between 15 and 48 percent of misdiagnosis cases and common conditions that were misdiagnosed included cancer, heart attacks, appendicitis, ectopic pregnancy and bone fractures. For kids, the most common misdiagnoses included both cancers and meningitis.
• Drug errors accounted for between six percent and 20 percent of claims that the researchers identified, depending upon the study. Drug errors included problems with steroid preparations, anticoagulants, antibiotics and antipsychotics.

The study also revealed that around one-third of the cases in the United States resulted in compensation for the patients. In the United Kingdom, the study results showed that closer to half of all claims resulted in compensation for patients.

The outcome of the study caused researchers to point out that doctors can sometimes practice defensive medicine, which means increasing diagnostic testing and prescribing unnecessary medication. While this is a problem with some physicians, the fact is that it should not be an issue if doctors do their jobs.

Physicians are expected to perform their duties with reasonable care. A doctor can be liable for medical malpractice for drug errors or for misdiagnosis only if a reasonably competent physician wouldn’t have made the mistakes that the doctor made. As such, a doctor could avoid a claim for malpractice by simply listening to the symptoms that a patient exhibits and making sure to order the proper testing and treatment.

When a doctor makes a drug error or fails to diagnose a medical condition, this error can have serious consequences. The patient should be able to make a malpractice claim and, with the help of an experienced attorney, should be able to recover compensation for losses.
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In January of 2012 the Food and Drug Administration (FDA) ordered 33 manufacturers to conduct post-marketing studies on the safety of transvaginal mesh products. The FDA imposed this requirement because it had become apparent that side effects and complications due to transvaginal mesh products were very common.

Now, Boston Scientific, one of the major manufacturers of transvaginal mesh products, will be conducting further studies. On July 3, 2013, Boston Scientific announced in a press release that a grant of more than $1 million would be given to the Pelvic Floor Disorders Network (PFDN) for a new clinical trial to evaluate the treatment outcomes of two different surgical options for women suffering from a specific form of pelvic organ prolapse.

Our Boston transvaginal mesh lawyers know that most studies have shown that transvaginal mesh provides minimal or no benefits over other treatment methods and creates significant complications. This further study will focus more in depth on the differing treatment outcomes in order to provide more information on whether vaginal mesh products are worth the risk.

New Study on Pelvic Mesh and Treatment Methods

According to the Boston Scientific press release, the new clinical trial is called SUPeR. The study will involve 180 women who are considering surgery for uterine prolapse and who do not intend to have any more children. The children will be randomly assigned to one of two different treatment methods: a uterine-preserving transvaginal mesh repair that makes use of the Boston Scientific Uphold® LITE Vaginal support system or a traditional surgery that does not use a mesh product and that instead includes a vaginal hysterectomy.

The study will involve a randomized trial to determine which of the patients has the better outcome in order to evaluate each of the differing treatment methods. The patients will be evaluated by researchers every six months for as long as five years in order to assess the success of the surgery; to determine how safe the patients are; to assess the cost-effectiveness of the surgery; and to get an idea of the quality of life that each patient is enjoying following the treatment.

The initial data from the clinical trial is expected to become available in 2017 and there will be a follow-up a year later. The study will be conducted by the Pelvic Floor Disorders Network (PFDN), which is funded by the National Institutes of health and which has eight different medical centers located throughout the United States.

Determining the Effectiveness of Vaginal Mesh Products

Different types of pelvic organ prolapse have differing treatment methods and not all women wish to undergo a hysterectomy as a method of treating their condition. Still, vaginal mesh is a dangerous product and many women have experienced serious complications because of the vaginal mesh that was used in treatment procedures.

Those who use vaginal mesh products face significant risks including a danger of mesh erosion, recurrent prolapse and significant pain during intercourse. Hopefully those women who are involved in this clinical trial will not experience unexpected and dangerous side effects due to the Boston Scientific transvaginal mesh.
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It is a long-standing and well-accepted rule that doctors need to obtain informed consent before providing treatment to patients. When a patient is unable to give his consent, family members or those with medical power of attorney need to be consulted. These rules exist to ensure that people understand the risks of receiving medical care and can make choices about how they want to handle their own health issues.

Unfortunately, our Boston brain injury attorneys know that patients who suffer some of the most severe injuries are not able to give informed consent when they need treatment. Those who are brought to the hospital after suffering head trauma from a car accident, slip and fall, work accident or other incident are often unconscious as a result of head injuries.

Because brain injuries often occur in trauma situations, patients may not have their family with them either. These brain injury victims need treatment right away to have the best chance of avoiding brain damage, but there is that issue of informed consent to think about.

Boston Doctors Seek New Solution for Brain Injury Patients

A group of Boston doctors is currently seeking permission to try out a new solution in treating brain injury patients. According to the Boston Globe, the doctors are hoping to join a national trial that is intended to assess the impact of administering the hormone progesterone to a brain injury patient in the hours immediately following the injury. Doctors want to be able to provide the hormone treatment to patients through injections that are given right away, entering them in the trial without waiting for informed consent.

This is a departure from the traditional rules associated both with providing medical care and with putting patients into clinical trials. Usually, patients need to be told of the risks of participating in trials or studies and need to be given the chance to refuse enrollment. However, because doctors in this clinical trial would be giving the hormone injections right away to unconscious patients, there generally would be no chance to say no.

If the Boston doctors are given permission to enter into the study, this would be the first time that an exemption was made at a Boston hospital on the issue of informed consent since the FDA created rules in 1996 allowing such exemptions. The law permits exemptions in situations where emergency care is necessary.

When a brain injury occurs, every second counts when it comes to treatment because a “secondary cascade” of harm occurs to the brain after the initial trauma. The secondary cascade refers to the fact that swelling, metabolic changes and fluid build-up can result in cells continuing to die until the brain is stabilized. The more cell death that occurs, the more cognitive and neurological impairments a patient experiences. The cell death is permanent and cannot be cured or reversed, so the only hope for staving off serious brain damage in head trauma cases is prompt treatment.

The hope is that the progesterone will be effective at stopping the secondary cascade of injuries if administered promptly after the trauma because the progesterone can stop cell death. If the doctors at Boston-area hospitals are allowed to go forward and enter the trial to study the effects of progesterone on brain injury patients right after a trauma, patients will have a reason to hope that brain injury treatment will be more effective at preventing permanent harm.
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Dialysis patients are dependent upon a number of drugs to help ensure that their bodies stay healthy and functioning even though their kidneys do not work. Unfortunately, the very fact that dialysis patients are dependent upon drugs makes them vulnerable to many health risks.

Our Boston dialysis injury attorneys know that many people suffered cardiac events and were harmed as a result of dangerous dialysis drugs produced by Fresenius Medical Care. However, this is just one of many examples of dialysis patients who have been put at risk or who suffered harm as a result of the drugs that were administered to them. Only recently, for example, a pharmacist was found to be misbranding dialysis drugs and providing cheaper medications to patients.

Dialysis Drugs Misbranded

According to KSN.com, a pharmacist confessed to distributing misbranded dialysis drugs to patients. The pharmacist reported that he had substituted a Chinese-made drug for an FDA approved medication. The drug that the patients were supposed to receive was an iron sucrose drug that the U.S. Food and Drug Administration approved for dialysis patients.

Unfortunately, the pharmacist wanted to make some extra money and to earn a larger profit so the pharmacist decided not to give patients the drugs they needed. Instead, patients received the misbranded Chinese drug that had no FDA approval and that may very well have been a different drug, a placebo or a dangerous chemical substance.

Dialysis patients, especially, could be vulnerable to problems with dangerous medications since their bodies are unable to filter out waste on their own. A patient undergoing dialysis needs to take the recommended drug therapies as advised by a doctor in order to maintain strength and in order for the dialysis regimen to be effective in keeping the patient healthy.

Unfortunately, this means that administering the wrong medication to a dialysis patient could have devastating consequences. The pharmacist who was dishonest and who prevented people from getting the medications they need has thus committed a very dangerous and immoral act.

The pharmacist who distributed the mislabeled drug provided the medications to dialysis patients in Kansas, but this type of problem could happen anywhere and at any time. The pharmacist is facing criminal charges, will be required to pay around $849,000 in restitution, and will spend as long as 48 months in jail. He faces these penalties as he has been charged with distributing a misbranded drug as well as with healthcare fraud.

Hopefully, these penalties will be enough to deter others from providing mislabeled drugs to dialysis patients. Unfortunately, it seems that greed often gets the best of those who are in the healthcare business. This pharmacist was not the first to put the lives of dialysis patients at risk. When Fresenius failed to issue a widespread warning to patients or healthcare providers despite knowing that GranuFlo and NaturaLyte increased the risk of a cardiac event, the actions of Fresenius were every bit as egregious and dangerous as the actions of the pharmacist who provided the wrong drug to patients just to make a buck.
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For patients with kidneys that do not function properly, dialysis is a way of life. Dialysis is a process used to clean the blood in cases where the kidneys are not able to filter out waste. While dialysis can allow a person to live with failing kidneys for a long time, it is not without complications, including the potential that a dialysis patient will be injured by a defective drug during treatment.

For those patients undergoing dialysis routinely, progress is being made by scientists to find a solution that could allow for an escape from the dialysis cycle. As Reuters recently reported, scientists have now successfully made a rat kidney that does everything a natural kidney can do. Our Boston dialysis injury attorneys know that this is a promising development for patients that may provide hope for the future.

Dialysis Patients Hope for Solutions
Dialysis is a remarkably effective treatment for most patients and can allow patients to live for many, many years even once their kidneys have failed. However, like with any medical procedures, things can go wrong when a patient has to undergo any type of medical treatment. With dialysis, which often occurs multiple times per week, patients are thus naturally at greater risk of complications or problems since they are submitting so often to medical treatment.

Numerous issues in recent years have shown just some of the risks that dialysis patients face. For example, we recently wrote about dialysis patients who were exposed to viruses during their dialysis treatment. We are also representing many patients or surviving family members of patients who were injured by defective dialysis products made by Fresenius.

These products, GranuFlo and NaturaLyte, caused the body to have too many bicarbonates, which created many complications including an increased risk of heart attack. Thousands of patients suffered cardiac events because of GranuFlo and NaturaLyte, and some of those patients died as a result of the harm that they endured.

Tragically, these dialysis complications are far too common among those who need to routinely undergo this type of treatment. While many patients will be able to undergo dialysis successfully, there is always a risk of these complications and it would be a better alternative if a long-term solution was found that eliminated the need for dialysis entirely.

The hope is that the development of the artificial rat kidney will soon open the door for the creation of a human kidney that can do what the body’s kidneys can do. Reuters reports that several labs are competing with each other to develop the most efficient ways of producing full functioning artificial kidneys and other organs, making use of 3D printing technologies.

Hopefully, these labs will be able to find a solution and come up with a kidney that works in people. While this will come too late for the thousands who died as a result of GranuFlo and NaturaLyte, allowing patients an alternative to dialysis could save lives and prevent further complications due to bad drugs or unsafe medical practices in the future.
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The highest possible level of recall – Class 1 – has been issued for a surgical device used in knee replacement operations.

Our Boston defective medical product attorneys want to make sure we get the word out. Just because while the device hasn’t been available on the market since last fall, doesn’t mean there isn’t ongoing potential for patients to experience problems with the implanted devices. There is a high probability that a lot of people who have had knee surgery over the last couple of years may be suffering the negative affects of their surgeon using this device during the procedure.

The ShapeMatch Cutting Guide is produced by a company called Stryker Corp., which manufactures a host of medical device and equipment. The product in question is a single use cutting guide that surgeons purchase in order to help position the components of a knee replacement operation, formally known as an arthoplasty. It would allow the doctor to guide in the marking of the bone before anything is actually cut.

Sometime last fall, the company became aware of a digital defect in the computer software used to make the devices. The firm now says that defect resulted in the displayed depth parameters of cut, angle and resection to be unmatched to the cutting guides that were provided.

What that basically means is that a surgeon’s cut would not be as precise as he or she believed. In the end, that has the potential to result in a number of very serious complications. Those would include fractures, joint instability, limitations in mobility, chronic pain, the possible need for revision surgery or all of the above.

So in November, the company issued a warning letter to field locations, surgeons who were registered and also imaging centers, advising them to immediately stop using this device in the course of surgery.

Then in January, the company issued another letter to these same entities, as well as hospitals, warning them of the problem and ways to potentially mitigate the risks for current patients.

However, it wasn’t until April 10 that the company finally issued an Urgent Medical Device Recall. The FDA terms this a Class 1. This designation is reserved for products that are either defective or dangerous that could predictably cause serious health problems or death. It is the highest level of recall. Class 2 and Class 3 recalls are considered less serious.

As of this month, the U.S. Food & Drug Administration reports that it has received nearly 45 reports of adverse events, which include at least three injuries and 41 malfunctions.

Patients may not even know whether the device was used during the course of their knee surgery, so we would recommend asking your physician. If so, consider contacting our Boston law offices to learn more about your potential rights of recovery.
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The Massachusetts Board of Registration in Medicine has been alerted to an increasing number of injuries tied to robotic surgery, prompting health officials to demand more training, a higher level of oversight and clear disclosure to patients about the risks they may face when undergoing such a procedure.

Our Boston medical malpractice attorneys know that while state officials haven’t listed the exact number of robot-assisted surgery injuries in the state, they did cite three examples with devastating consequences.

One of those involved a patient whose rectal tissue was mistakenly left inside the abdomen following a surgery to correct ulcerative colitis.

Another patient who had undergone robotic surgery for ovary removal and hysterectomy suffered major damage to one of her ureters and the bowel, which mandated she undergo a number of painful corrective surgeries to fix.

The state board issued an advisory to the public, warning that surgery with the assistance of robots, like any other surgery, can have serious complications and outcomes that are poor. The state cautioned too that surgeons should be rated by patients not on the basis of how many surgeries they have completed, but rather the surgeon’s proven proficiency and competency.

State officials never specifically called out any one company in their warning. However, Intuitive Surgical Inc., which is based out of California, is the only firm with a robot system that has been approved by the U.S. Food & Drug Administration for soft tissue surgeries in America.

Those familiar with robotic surgery know that it essentially works like this: A surgeon will sit at a console in front of a high-definition screen. Similar to a video game, the surgeon will be able to manipulate hand and food controls to position the mechanical arms of the device, which are affixed with various surgical tools. On the screen, the doctor views a 3-D image of the work as it is being done.

The idea is to improve precision. In theory, it’s great. However, the actual outcomes have in some cases been less-than-stellar. That’s not to say that surgeons don’t make mistakes when they are performing such operations by hand. However, a strong argument has been made that these machines aren’t any better or more effective than regular surgery and that the rate of error fails to justify the enormous cost associated with these machines.

Patients are often not informed of this, however, because hospitals tend to exaggerate the effectiveness of these devices. Researchers with Johns Hopkins University School of Medicine conducted a study in 2011 that found nearly 9 out of 10 hospital websites that made mention of robotic surgery asserted that such procedures were superior to regular surgery, though none of those websites detailed any of the risks.

In the last year, nearly a dozen lawsuits have been filed alleging major injuries from robotic surgery, and nearly all of those make mention of the fact that surgeons aren’t being adequately trained on the devices.

Federal regulators right now are working to compile information regarding this recent increase in adverse reports, which include at least 70 deaths in the last four years.
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Our Boston injury attorneys know that dialysis patients are dependent upon receiving regular medical care multiple times per week. Because the kidneys of a dialysis patient no longer work properly, the patient must regularly visit a designated dialysis clinic for hours at a time multiple times weekly in order for a dialysis machine to clean the blood.

At a dialysis clinic, the idea is that the patient will sit in a chair while the dialysis machine works to clean the blood. The patient will be given appropriate medication and supplements to help improve health and to ensure that the dialysis process doesn’t do any damage to the body. Unfortunately, things don’t always work that way and dialysis patients can experience many complications. Five patients in Boston recently found that out when they were informed that they had been exposed to a virus.

Dialysis Patients Exposed to Hepatitis B
According to the Nephrology News and Issues, five patients who had undergone dialysis at the Boston Medical Center (BMC) received a telephone call after they underwent their dialysis procedure.

According to one of the patients who received the phone call, the contact came only a few hours after the dialysis treatment had finished for the day. The caller was an administrator from BMC who had bad news.

The BMC administrator indicated that the medical center had become aware that some of the dialysis machines had not been properly cleaned. As a result of the dirty and contaminated machines, some of the patients undergoing dialysis at the treatment center ended up being exposed to the Hepatitis B virus. In total, there were five patients who were potentially at risk of becoming ill as a result of the exposure to the virus from the dirty machines.

Because of the exposure, the patients who were affected and potentially at risk were informed that they would need an injection of gamma globulin. Gamma globulin is a substance that is made up of antibodies that help the body to fight the Hepatitis B virus. Boston Medical Center sent someone to the home of at least one of the affected patients to administer the shot.

Unfortunately, when anyone is exposed to any type of virus, there can be devastating consequences to that person’s health. For patients undergoing kidney dialysis who are already struggling with medical issues and whose bodies cannot effectively remove waste products, the effects of this type of exposure could be even worse. A virus could undermine the health of the dialysis patient, making the patient sicker. This can be a major problem, especially if the patient is undergoing dialysis while awaiting a kidney transplant, since a patient can no longer have such a transplant once he or she becomes too sick.

Tragically, exposure to a dirty machine is not the only time dialysis patients have been put at risk. A number of other medical malpractice issues and dangerous drug issues can also endanger dialysis patients. For example, many dialysis patients are given the wrong antibiotic medication according to studies published in Nephrology News. In other cases dialysis patients may be given a medication intended for their care such as GranuFlo or NaturaLyte but the drugs themselves will turn out to be dangerous and to increase the chances of a heart attack.

These mistakes and the harm that come to dialysis patients are simply inexcusable. Drug manufacturers, clinic operators and healthcare providers all need to do better to ensure that the dialysis experience is one that promotes and maintains health rather than an experience that compromises health and makes things worse.
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