Recently in Preventable Medical Mistakes Category

How Spine Implants Cause More Harm than Good

April 16, 2014

6087539168_6117cd51b0_b.jpgStimulation therapy is a growing treatment intended to relieve chronic pain in the spinal cord by sending electrical pulses through an implant. In some patients, the procedure works well and pain is well-managed. In others, the operation turns dire, causing permanent paralysis. Medical device attorneys at Pintas & Mullins look into these implants and who is to blame when a patient is paralyzed.

Spinal stimulator devices are manufactured by a variety of companies, including Medtronic, Boston Scientific, and St. Jude Medical. The devices are implanted into patients near the spinal cord, where a pulse generator sends low currents of electricity into extension wires, which are placed on the spine. The leads then transmit an electrical current onto the spine that distracts the brain from recognizing - and therefore feeling - pain signals.

Patients are typically admitted to hospitals for overnight stays, and can return home shortly after implantation with, ideally, a pain-free life. For dozens of patients, the procedure goes too far, causing partial or permanent paralysis or motor weakness.

In most of these cases, the injury occurs after the spinal cord is punctured or compressed by the electrical conductors, which are inserted into a narrow cavity called the epidural space in the lower spine (this is where an epidural anesthesia is administered during childbirth).

According to the FDA's database, nearly 60 patients were paralyzed by spinal stimulators in 2013 - up from nearly 50 the year before. It is worth noting that the FDA's database is far from complete, and many assert that injuries are vastly underreported.

Who is to Blame?

Doctors highlight a potential cause of the problem - insufficient awareness by doctors on the true risks of operating around the spinal cord, and proper techniques for avoiding the most dangerous areas. Much of the blame, they assert, rests on insufficient training and lack of surgical guidelines that leave physicians unprepared.

Part of the reason for this is that spinal stimulation procedures are conducted by various types of doctors: orthopedic spine surgeons, neurosurgeons, or anesthesiologists. Thus, no one medical society (which are typically responsible for developing training standards and practice guidelines) is held responsible for issuing such standards and performance tracking.

It may sound trite to say that surgical outcomes largely rely on the experience and skills of the doctor - but in spinal stimulation implantations this is particularly true. A physician at the Dartmouth-Hitchcock Medical Center stated that the surgery initially seems straightforward and simple, which attracts doctors who are not familiar with how risky a spine procedure actually is.

Medical device manufacturers like Medtronic claim they monitor adverse event reports and update the product labelling to reflect new or increased risks. Among these include the possibility that scar tissue can form around the device electrodes and cause nerve damage (which is also the site of paralysis). Companies like Medtronic offer weekend-long training sessions, however, experts agree that these courses are not sufficient.

Stimulators can cost between $20,000 and $60,000 each, but about a third of patients experience complications because of the device within a year of implantation. Nearly one in four patients have to undergo additional surgeries to fix the adverse side effects.

Continue reading "How Spine Implants Cause More Harm than Good" »

Another da Vinci Robotic System Approved for Market

April 3, 2014

fort-belvoir-community-hospital-astounds-with-groundbreaking-technology-and-devotion-to-patient-care.jpgIntuitive Surgical, the company that makes the da Vinci Robotic Surgery System, recently announced that it gained approval for a new robotic system, called the da Vinci Xi. Our team of da Vinci surgery injury lawyers takes a closer look at this new system and how it could affect patient care.

Robotic surgical systems are aggressively marketed to hospitals throughout the country as the "new, latest, most advanced" technology. In fact, there are no conclusive studies that show that such robotic systems provide better care for patients - quite the opposite. Hospitals are agreeing to pay millions of dollars (an average of $1.85 million) for these systems only to stay up on the competition.

The new Xi features thinner arms than the traditional da Vinci, and is intended to perform more complex surgeries. It also includes a fluorescent imaging system, nicknamed Firefly, which the company believes will improve patient safety by improving surgeon's seeing ability. Other upgrades include new joints for greater range of motion and improved visual definition.

To use the robots, surgeons sit behind a console and operate the device using a control panel, which includes a screen, pedals and joysticks. The system has raised much controversy since its initial 2009 release, and several lawsuits have been filed against Intuitive by patients seriously, some fatally, injured by the robots.

Adding fuel to the fire, the FDA approved the Xi robotic system through a special process (called the 510(k) approval) that requires minimal testing. What makes this so disconcerting is that Intuitive has been reprimanded by federal authorities for withholding information on how many patients have actually been injured by the robots. All injuries and deaths associated with a certain type of medical device are reported by the hospital directly to the manufacturer. The manufacturer is then required to inform the FDA within 30 days of receiving the report, and is also required to investigate the injury or device malfunction, sending the FDA a report of this investigation once it is completed.

According to lawsuits against Intuitive, the company was systemically underreporting the complications caused by da Vinci robots, along with knowingly misclassifying serious injuries and deaths as "other." The FDA was then never informed of the true injury risks from the da Vinci, and the public was never informed. The company also concealed three separate voluntary recalls from the FDA, which involved defective da Vinci parts. Due to their lack of reporting, dozens of patients were injured - specifically, burned - by malfunctioning parts.

According to reports, patients who are obese or who suffer from other serious medication conditions are significantly more likely to suffer an adverse event from the da Vinci. Other studies note that robotic surgery is not at all superior to traditional methods.
The original system was approved for minimally-invasive laparoscopic surgeries on the gallbladder and for gynecologic procedures. It was later approved for more complex procedures, such as chest, cardiac, and urologic surgeries.

Continue reading "Another da Vinci Robotic System Approved for Market" »

Dangerous Doctors, Patient Deaths Reveal Failing Texas Healthcare System

March 11, 2014

299122118_1e0a8cdc8e.jpgDr. Christopher Duntsch arrived in Texas in 2010 to start a neurosurgery practice. By 2013, he had killed two patients from malpractice, paralyzed four others, and had his medical license revoked. Our team of medical malpractice lawyers examines this horrifying story and the problems within the Texas legislature that allowed it to happen.

Throughout the three years he was practicing in Texas, physicians, patients, and malpractice lawyers repeatedly tried to have his license suspended. Their efforts were unsuccessful for so long because of a series of conservative reforms in the Texas court and medical systems. Over the past ten years, these reforms have severely limited the resources and options available to patients injured by negligent physicians.

The medical system in Texas used to be overseen by a connected network between the state medical board, hospital management, and the courts, which prevented and punished cases of medical malpractice. This changed around 2003, when the Republican Texas Legislature set maximum dollar amounts for malpractice lawsuits at $250,000. This is problematic for many reasons that are beyond the scope of this article, but in essence the damage cap does not adequately protect patients who suffer permanent injuries from doctors like Duntsch and deters malpractice lawsuits from being filed.

Other laws were introduced that protected hospitals from being sued for the actions of their doctors. Currently, Texas law states that hospitals may only be held liable for damages if the plaintiff can prove that hospital management knew that the doctor posed an extreme risk to patients and hired them anyway. Compounding this, hospitals in Texas are allowed to keep all their information regarding doctor hiring practices completely private, so neither patients nor plaintiffs can access them.

So, with hospitals deregulated and the court system substantially curtailed, the Texas Medical Board was all that remained to police physicians and protect patients. The board, however, was established to monitor physician licenses and oversee professional standards, not in any way protect the public. The board's intention is to protect physician's rights, and does not revoke medical licenses unless there is overwhelming, inarguable evidence such as a felony conviction or dolling out opioids to addicts.

Dr. Duntsch and His Wake of Destruction

In 2010, Duntsch started a practice, the Texas Neurological Institute and worked at Baylor Regional Medical Center in Plano. Another surgeon at Baylor told the Texas Observer that Duntsch was, by far, the worst surgeon he had seen, even when performing relatively minor procedures.

Reports of serious harm done to patients by Duntsch are long and illustrate consistently dangerous and unconscionable medical care. After the first few botched surgeries Baylor had to bring in senior surgeons to correct the damage done to patients, though most of it was irreparable. Duntsch even operated on a childhood friend, severely damaged his spinal cord, and delayed follow-up tests so long that his friend permanently lost the use of his arms and legs.

Duntsch was suspended for 30 days, after which he was supposed to be supervised during every surgery. This never happened; soon after the first paralysis, a woman named Kellie Martin went to Duntsch to treat back pain. Duntsch recommended a microlaminectomy, a minor surgery which removes part of the spine to relieve pain from nerve pressure.

Duntsch performed the surgery, which was supposed to take 45 minutes, unsupervised. Two hours after she went in the OR, her husband asked to speak with Duntsch, who said there had been some complications and she would have to stay the night. Another few hours later, she was rushed to the intensive care unit. Ultimately, after an excruciating wait, he and his daughters were told Kellie had died.

The medical examiner had to examine her twice because he was so shocked by the state her body was in. It was clear Duntsch severed one of her spinal arteries during surgery (as he had with his childhood friend a month prior), and failed to notice it in time to save her life. She eventually bled to death.

Continue reading "Dangerous Doctors, Patient Deaths Reveal Failing Texas Healthcare System" »

Popular Hysterectomy Surgery Causing Cancer Spread

February 27, 2014

6025359063_81a0b67b4c.jpgDoctors across the country are calling to change standards for a common gynecological procedure, morcellation, which can spread dangerous types of uterine cancer. Many studies have confirmed this risk, forcing the medical community to reevaluate how and when the procedure is done. Medical malpractice lawyers at Pintas & Mullins take a closer look at this procedure and who is most at risk.

Morcellation is a hysterectomy procedure that involves grinding the uterus so tissue can be more easily removed through small incisions. In women with cancerous or pre-cancerous uterine cells, however, the procedure breaks up the cancerous tissue and scatters them into the abdomen or other organs.

What makes the issue particularly dangerous is the inability to test for cancerous uterine cells before the surgery. These cancerous cells can also often appear non-cancerous or non-threatening in initial tests, so the risk is amplified.

Personal Tragedy leads to Public Change

Among the most vocal physicians fighting to curb the use of morcellation is a Harvard-affiliated cardiothoracic surgeon, whose wife suffered the serious consequences of the procedure. He has written dozens of letters to medical journals and media outlets saying that the surgery endangers women, referring to it as a major public health crisis. The surgeon's wife, who is also a physician, underwent a morcellation procedure to treat what her medical team believed were benign (or non-cancerous) masses in her uterus.

The procedure went smoothly, however during follow-up testing showed that the "benign" cells actually contained a rare and extremely aggressive cancer known as uterine leiomysarcoma. The cancerous tissue was spread throughout her abdomen and lungs during the morcellation surgery, inflicting her with stage four cancer.

She is now going through chemotherapy and additional surgeries to remove cancerous tissue, with the support of her husband and six children. She asserts that neither her gynecologist nor her surgeon informed her of the risk of cancer spread before she agreed to a morcellation procedure. At present, the hospital she underwent her procedure, Brigham and Women's Hospital (where her husband also works), has imposed limits on morcellation procedures, including strengthening the informed consent process and adding restrictions for eligibility.

The couple is now criticizing doctors, hospitals, and medical society that they believe underplayed the risks of morcellation. The issue is quickly becoming a hot topic of debate in the field of gynecology, and many other physicians have joined in on the call to curb the procedure. Already, two esteemed medical journals have published critical articles on morcellation.

Very recently, on February 26, 2014, the FDA announced it would begin investigating information and data on morcellation procedures. FDA spokespeople stated that the agency is extremely concerned about the potential of cancer spread in at-risk women.

Since the couple started campaigning against morcellation, many other wives and their spouses, have come forward to say they suffered similar devastating cancer spread from the surgery. They are calling the procedure flawed and are asking researchers to conduct analyses of morcellation studies and the rate of cancer spread.

Risk Factors Include...

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Bariatric Surgery and Children: When Weight Loss Kills

February 17, 2014

childhood-obesity-1_l.jpgThe number of overweight and obese children is rising substantially throughout the United States and the world. This, of course, is a problem in and of itself, however additional concerns are being raised about the prevalence and dangers of pediatric bariatric surgery. Medical malpractice lawyers at Pintas & Mullins take a closer look at this troubling trend and how it could impact our children.

The childhood obesity problem is most prevalent in developed countries, and rates are expected to rise even more over the next decade in affluent Middle Eastern countries. A recent article in the Wall Street Journal profiles one little boy, aged three, who currently weighs in at 61 pounds, more than twice the average for his age. He was just one year old when his parents began noticing health issues associated with his weight, including dangerously slow circulation due to pressure on his airways.

Due to his extraordinary size, his parents recently decided to have him undergo bariatric surgery. The procedure will remove part of his stomach, ideally so he will be unable to eat as much and feel satiated with lesser amounts of food. They hope that this surgery will prevent a lifetime of additional obesity-related health problems, such as diabetes, heart disease, and severe sleep apnea.

Obesity in children is caused by a sedentary lifestyle (excess video games and television time, lack of physical activity) and overindulgence in unhealthy foods lacking in real nutrients. It is now a serious health problem not only in Western countries but other places, such as Saudi Arabia, where over 9% of school-aged youths are obese (about 18% of American school aged children are obese).

Weight-Loss Surgery and Children

U.S. doctors are willing to perform bariatric surgery on teenagers, however such procedures on children under the age of 13 are generally not done. In order to qualify for bariatric surgery, youths must have a BMI of 35 or higher in addition to a serious weight-related health problem. This may include diabetes, sleep apnea, increased pressure inside the skull (pseudotumo cerebri), high cholesterol/blood pressure, or severe liver inflammation.

There is a plethora of other factors doctors should consider before deciding to perform bariatric surgery on a child. Among these include:

• whether or not they have been able to lose weight on their own through diet and exercise

• whether they are finished growing

• understanding that they must be willing to follow lifestyle changes post-surgery

• use of alcohol or drugs within 12 months before surgery

If any of the above-mentioned factors were not considered before surgery, the child may suffer severe, even life-threatening complications from the procedure. Unfortunately, more and more rogue physicians are looking to cash in on this trending market by performing surgeries on children who do not qualify. Parents need to inform themselves on the general safety guidelines for bariatric surgery to avoid a devastating malpractice event.

There is now a global debate over the appropriate age for bariatric surgery. In the U.S., the youngest is typically about 14; abroad, as stated, children as young as three are undergoing the procedure. The World Health Organization points to a total lack of data on the long-term health effects of such surgeries on children, and that surgeons should err conservatively on the age spectrum.

Currently, the issue of highest concern is not the procedure itself but on how the abrupt change in nutritional consumption would affect long-term brain and sexual development. The brain critically needs the proper types and amounts of nutrients to mature properly, which also affects hormones associated with sexual maturation and cognitive functioning. There is currently no data proving weight-loss surgeries do not affect this development.

Continue reading "Bariatric Surgery and Children: When Weight Loss Kills" »

Congress to Tighten Leash on VA after Disastrous Medical Errors

February 10, 2014

6989660347_405bf398c4.jpgIn the wake of the our efforts in Iraq and Afghanistan, the Department of Veteran's Affairs (VA) has been innundated with a new generation of injured troops entirely different than in wars past. The changes in veteran demographic, mixed with the pre-existing American healthcare problems and an array of other factors, is causing disarray in the VA. Medical malpractice attorneys at Pintas & Mullins take a closer look into the disorder and how Congress plans to fix it.

You know something has gone terribly wrong when the least-productive Congress in U.S. history is calling foul on another government agency. Bipartisan members of Congress are launching investigations and working on remedial efforts after reports of serious and devastating problems at VA hospitals throughout the country. To have bipartisan members of Congress frustrated with the agency is extremely telling of its fundamental, deep-rooted problems.

The issues are wide-spread and affect all 1,700 VA facilities in the U.S. Among the problems, legislators are blaming lack of accountability, management errors, and restrictions on performance-based pay for the abundance of medical errors, which are devastating veterans. Congressional members are now considering and will more than likely approve penalties for the VA.

The House Veterans Affairs Committee chairman told the Wall Street Journal that he plans to introduce legislation that will make it easier for poorly performing hospital staff to be demoted or fired. Currently, VA executives receive bonuses based almost exclusively on tenure rather than performance or contribution.

Needless Deaths of our Veterans

Much of the Congressional uproar is in response to an influx of media coverage of the dire, often fatal conditions at VA hospitals in Pennsylvania, Georgia, and South Carolina to name just three. CNN recently published a story on several patient deaths at the Dorn VA Medical Center in South Carolina and the Charlie Norwood Medical Facility in Georgia. CNN reporters investigated the facilities after it became clear that dozens of patients were dying of cancer due to delayed or flat-out denied care.

The report noted that thousands of veterans at these two facilities alone were being forced to wait several months even for routine screening tests such as colonoscopies - within some waiting lists going back as far as 2010. To say this is unacceptable is a dire understatement. Making matters worse, those in charge of these facilities were wholly unable to report remedy and disciplinary action for the backlogs.

VA facilities function differently than traditional privatized hospitals and healthcare clinics. As with any other government agency, the environment within the facilities is extremely enclosed and nepotistic. Inadequate employees are rarely fired; the worst that happens is a transfer to another VA facility, where the cycle of negligence merely continues without discipline or consequence. Additionally, many do not realize that the VA in its entirety is paid for by the American public through taxes.

Among its aims, Congress will explicitly examine each VA executive's history of contribution, action and capabilities. The VA system cares for about 8.75 million patients - from WWII vets to teenagers coming back from Afghanistan - with an annual budget of over $145 billion. There are no current discussions surrounding cuts to this massive budget, only of the VA's performance and lack thereof.

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Court Rules Minor Malpractice Cases not Subject to Statute of Limitations

January 23, 2014

8178804876_04313157fa.jpgWashington's Supreme Court recently decided that statutes of limitation are not applicable to medical malpractice cases involving minors. The suit centered on Jaryd Schroeder, who was injured from negligent medical care when he was nine years old. At age 18, Schroeder decided to sue the physician for medical malpractice, which he attempted to have barred due to the statute of limitation. Ultimately, Washington's highest court ruled such a statute violated the Schroeder's constitutional rights, awarding him a trial.

Our team of medical malpractice attorneys highlights this case to discuss how and when statutes of limitations are used to prevent minors from filing lawsuits later in life. The Washington Supreme Court believes, as do we, that this places an unfair burden on injured children.

Schroeder filed suit against Dr. Stephen Weighall and Columbia Basin Imaging just before he turned 19, for events that transpired ten years prior. When he was nine, Schroader suffered from double vision, nausea, leg weakness, headaches, and dizziness, and went to Columbia Basin Imaging for an MRI. The radiologist, Dr. Weighall, examined the tests and told Schroeder and his family that everything looked normal.

About eight years later, Schroeder underwent another MRI because his symptoms did not subside. These later tests showed that his brain was protruding into his spinal cord, which was causing his debilitating ailments. Less than two years later Schroeder filed suit.

The defendants, Weighall and Columbia Basin Imaging, attempted to have the case barred on basis of the statute of limitations. The initial judge approved and dismissed Schroeder's case. He then appealed directly to the state's Supreme Court, claiming the dismissal violated his constitutional right of equal protection for minors.

The Supreme Court voted 7-2 to revive Schroeder's case. In the majority opinion, Justice Sheryl Gordon McCloud wrote that statutes of limitation laws placed undue burden on children whose guardians are unwilling or unable to pursue a claim on behalf of the child. She went on to say that numerous other courts have reached similar conclusions, and particularly harm children in foster care, children of teenage parents, and neglected children.

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What Fuels Medical Mistakes

January 8, 2014

4727573126_7418a98c6f.jpgAs a law firm specializing in medical malpractice and mistakes, we see firsthand the traumatic and often catastrophic results of malpractice, and its effects on victims' families. Our passion for this field translates into great interest into how and why these mistakes are made in the first place, and what malpractice attorneys and plaintiffs as a community can do to prevent them.

Though much ink has been spilled on this topic, we recently came across an article in the esteemed British Medical Journal (BMJ), in which the author asserts that evidenced-based medicine is damaged. Evidence-based medicine is heralded in the U.S. as the solution to medical malpractice reform. In theory, it sounds ideal: in order to minimize medical errors, physicians should apply therapeutic principals rooted in scientific and medical research when diagnosing and treating patients.

The reality, of course, is much more complex, varied, and as many argue, broken. The BMJ author declares that drug manufacturers have figured out how to manipulate this evidence-based system to their advantage, conducting research trials as opportunities to tout unnecessary drugs. Once these trials produce "evidence," that certain drugs help certain patients at certain times, physicians are forced to comply, often to the rapid demise of their patients' health.

Overdiagnosis, Overtreatment

Truth be told, the drug industry funds (and therefore controls) the majority of medical research, which leads to massive overdiagnosing and overmedicating. This, many doctors believe, is what is truly fueling medical mistakes in American health centers. Our societal dependence on prescription drugs is immense and steadily increasing. According to the Center for Disease Control and Prevention (CDC), nine out of ten adults in the U.S. report using at least one prescription drug in the past month.

That clinical research is corrupted by the drug industry doesn't make national headlines like egregious medical malpractice lawsuits do, but it is the driving force behind such cases. In order to remedy this, we have to first understand and accept that it is happening, and direct energy toward changing what is broken.

Medical researchers need to focus on what desperately needs to be studied - natural history of diseases, diagnostic criteria, long-term efficacy and safety of drugs. Conversely, we also need to urge researchers, philanthropic organizations, and government officials to tighten regulation of competing interests, predetermined agendas, and Big Pharma influence.

Complex Patient, Understaffed Hospitals

Another major problem affecting every subset of our healthcare system is overworked, underpaid nurses and medical assistants. An article recently published on ProPublica, written by a Harvard Medical School graduate and internal medicine resident, illuminates how difficult it is to keep patients with complex conditions safe in hospitals. The author's mother died of breast cancer after six months in a nationally-ranked hospital, during which time she witnessed a slew of medical mistakes and incidents that hastened her mother's death.

She asserts that, most often, injuries from medical mistakes are not the result of negligence, but of critical information falling through the cracks. Things like medication errors, nutritional regimens, and falls are often caused by seemingly minor incidences, like handoffs between nursing shifts, nearly identical labeling and drug names, and lack of fail-safe systems.

In a word, the author believes complexity is the problem plaguing our health system. As medical advances save and improve lives, it is also creating an influx of new medical devices, pharmaceuticals, and treatments; there are just too many layers to manage, and overbooking physicians is only exacerbating the problem.

How to Help

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One of Six American Deaths Caused by Preventable Hospital Error

December 16, 2013

4726929163_1dc2a8fd75.jpgHealth experts estimate that an alarming number of patients in the U.S. - about 440,000 per year, to be exact - die from medical errors in the hospital. That amounts to about one-sixth of all deaths nationally, and the third leading cause of death overall. Our team of medical malpractice attorneys examines how this could be so in a country so touted for medical advancement.

According to a recent article by the New York Times, the number of patients seriously injured (but not killed) by medical negligence is 10 to 20 times higher than 440,000. The author of that article suggests that the most surefire way to heighten hospital safety is to make information and records more transparent. She affirms that hospitals began tracking safety errors in 2000, and in 2003 the Centers for Medicare and Medicaid Services started collecting hospital safety information.

The website Hospital Compare lists much of this information, and most states run similar websites. Other websites and advocate groups that rank or publish hospital safety information include the U.S. News Best Hospitals, Consumer Reports, and Leapfrog Group.

Among the information that can be mined from these sites include rates of surgical site infection, drug-resistant bacteria infection (such as C.diff), and bedsore and blood clot rates. There is also, however, a significant dearth of information, which is worrisome to say the least, and confirms that hospitals are not comprehensively reporting their data on preventable errors and medical mistake.

The American healthcare system is hotly contested in all its factions, as it affects the lives of everyone in this country: young and old, sick and healthy, rich and poor. The politics in this issue are omnipresent and intrinsic in understanding how and why the reporting system is so colluded. Enter: the National Quality Forum, a federal organization established in 1999 that is influenced by hospital lobbyists just as Congress is. Consumer representatives of National Forum committees told the Times that they are rolled over by lobbyists and hospital administrators "constantly" in deciding core reporting requirements and other issues.

For example, Hospital Compare no longer provides information on surgical instruments left in patients after procedures, or frequencies of air embolism. About 27 states now require public report of hospital-acquired infection rates, however, this is the only government-mandated safety information required, leaving much buried beneath the surface.

Proving Fault in Hospital Error Lawsuits

When medical negligence directly causes serious patient injury or death, a lawsuit is the most efficient and effective way to ensure the hospital corrects the inadequacies that led to the error. Lawsuits may only be filed, however, if it can be proven that the physicians or hospital staff failed to meet the standard level of care in your treatment.

To prove negligence it must be demonstrated that the physician/hospital's conduct fell substantially below the general medical standard of care. This medical standard can be established through testimony by a medical expert practicing in the same field (for example, if the lawsuit is being brought against an OB/GYN, the testimony of another obstetrician or gynecologist from a different hospital would be acceptable).

Continue reading "One of Six American Deaths Caused by Preventable Hospital Error" »

How a Doctor's Apology can Affect your Medical Malpractice Suit

December 6, 2013

7142786591_2f7065d001.jpgWhen a medical mistake or negligent act result in severe injury or harm to a patient, physicians must decide whether they will apologize directly to the patient or their family. The decision is often more complex than it seems - many doctors are coached not to admit they made a mistake, as this confession may later be used in a lawsuit to prove that malpractice was committed. Medical malpractice lawyers at Pintas & Mullins bring to light a few basic laws and tips for how to best handle a medical mistake.

In the past, physicians have avoided apologizing for accidents during the course of treatment due in no small part to the fear that the apology could be used in a malpractice lawsuit. Dozens of states recognized this ethical dilemma and established "apology laws" to ease the legal consequences of apologizing and admitting an error. To date, 36 states and the District of Columbia have provisions allowing medical professionals to apologize without liability.

If a malpractice case arises from the error, these laws allow defendants (the individual doctor or hospital) to exclude apologetic statements from evidence. In 1999, the Institute of Medicine released a report detailing how prevalent medical mistakes really are: at least 44,000 (and as many as 98,000) people die every year in U.S. hospitals from preventable medical errors. The highest error rates occur in operating rooms, intensive care units, and emergency departments.

Despite this increase in transparency and legislative effort for disclosure encouragement, medical mistakes are still shrouded in silence. Physicians remain fearful of admitting their misdeeds not only to their patients, but to their peers as well.

How an Admission of Guilt can Influence your Case

In order for a medical malpractice suit to be argued successfully, plaintiffs must demonstrate four key factors:

1. There was a set and applicable standard of care expected
2. That standard of care was breached or unmet
3. An injury or ailment occurred
4. Evidence that the breach of medical duty caused the injury

As stated, most state's apology laws prevent an apology made by the physician after-the-fact from being submitted into evidence. If your case is brought in a state with more lax, or nonexistent apology laws, an apology can be used to prove the standard of care was in fact breached and caused your injury.

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Catholic Hospital Sued for Mishandling Miscarriage

December 3, 2013

5834126983_bbb11ac925.jpgMercy Health Partners in Michigan was recently named in a lawsuit for placing religious beliefs over patient safety. The plaintiff was 27-years-old when she was admitted to the hospital, the only medical center in her county, after her water broke prematurely. She was 18 weeks pregnant at the time, and was sent home twice before eventually miscarrying. Medical malpractice attorneys at Pintas & Mullins highlight this case to emphasize how and why some doctors and medical institutions may compromise patient safety.

The case was filed on behalf of the mother by the American Civil Liberties Union (ACLU), against the U.S. Conference of Catholic Bishops, which actively bans abortion. The ACLU argues that certain stipulations of the Conferences' directives compromise women's health, safety, and access to information.

The woman at the center of this suit visited Mercy Health Partners in 2010 after her water prematurely broke. Upon the first visit, she was given pain medication and sent home. She returned a second time, was given the same medication, and again sent home. During her third visit, she miscarried, delivering her four-and-a-half-month-old child in a breech delivery.

As stated, Mercy's religiously-guided medical directives explicitly prohibit abortions, so physicians may not terminate pregnancies even if such measures are necessary to protect the health of the mother. In this case, it was the safest and wisest treatment option to terminate the pregnancy and induce labor, however, the mother was never informed of this. Nor was she informed that her child had virtually no chance of surviving in a breech delivery, which she was forced to undergo anyway.

As a result, the mother suffered extreme trauma along with severe physical, mental and emotional harm. Her situation is not dissimilar from many other women admitted to Catholic-sponsored hospitals throughout the country. According to NBC News, Catholic systems operate about 630 hospitals in the U.S., all of which are governed chiefly by religious - over medical - directives. This causes immense conflict among OB/GYNs in particular.

Proving Medical Negligence

One survey notes that more than 52% of all OB/GYNs employed by Catholic hospitals have experienced conflicts with religious policies and patient care. One case outlined by the American Journal of Bioethics Primary Research further explains the nature of these conflicts, conducting interviews with hundreds of OB/GYNs in Catholic settings. Physicians interviewed in this study relayed instances when they were shocked by the way the Catholic directives impacted their ability to treat women in obstetric emergencies.

Three cases were explained in detail, the first of which involved a pregnant woman who was diagnosed with cancer and who needed emergency chemotherapy, which required her to terminate her pregnancy. She did not initially want to abort the child, but ultimately agreed due to the extent of her cancer. Her physicians petitioned the ethics committee to approve the termination, however, the request was denied. The ethics committee recommended the pregnant cancer patient terminate her pregnancy elsewhere, despite the medically complex and life-threatening situation. Her doctor told the committee that forcing her to do so would threaten her safety and cause immense emotional distress, however, they refused to allow him to terminate her pregnancy.

In order to prove negligent medical malpractice, patients like the above-mentioned expectant mothers must demonstrate four elements:

1. That the physician owed a duty of care to the patient
2. That the physician violated the standard level of care in their treatment
3. That the patient suffered a compensable injury
4. That the injury was caused by the substandard care of the physician

Continue reading "Catholic Hospital Sued for Mishandling Miscarriage " »

FDA, Plaintiffs Warn Against Unapproved IUDs

November 4, 2013

3756923820_4406f711bf.jpgMirena attorneys at Pintas & Mullins remind women implanted with an IUD contraceptive or thinking of having one implanted of the still-present problems over unapproved, or "black market" IUDs. This issue was first raised in 2010, when the FDA issued letters to health professionals stating that using unapproved IUDs could constitute fraud and counterfeiting lawsuits.

Inevitably, that is exactly what happened. In September 2010 the Rhode Island Department of Health opened an investigation after a class action lawsuit was filed on behalf of women who received unapproved IUDs. The lawsuit named over 50 health care providers as defendants, all of whom worked for group practices targeted by FDA investigations - Bayside OB/GYN, Center for Obstetrics and Gynecology, and OB/GYN Associates.

Black Market Mirena and Paraguard

According to an article in Pediatric News, most of the claims submitted in the class action involved unapproved Mirena implantation. One health provider was using both Mirena and Paraguard illegally, however it was not immediately clear if any other devices were used. The womens' lawsuit argues that defendants implied that the IUDs were approved by the FDA to be used in the United States when that was not the case.

Instead, the IUDs were purchased for discounted prices through Canadian websites. Since the substitutes were not approved by the FDA, their integrity, purity, source, handling and identity could not be verified. For a product that is inserted into a patient's internal organs, this type of substitution is egregiously unacceptable.

Plaintiffs argue that they received a device to which they did not consent, alleging offensive contact and battery among their grievances, and requesting a jury trial. The women claim they were intentionally placed in harm's way by the defendants, suffering immense embarrassment, emotional distress, and inconvenience, among other injuries.

In a Press Release, the Rhode Island Department of Health estimated that between 400 and 500 women received the counterfeit IUDs, which were implanted beginning in January 2009. All patients who may have been implanted with a non-FDA approved IUD should have been notified in the summer of 2010.

Putting Patients at Risk - Know Your Rights

With the exception of rare circumstances, any use of a medical device or drug not approved by the FDA is against the law. Likewise, using a drug or medical device for uses not explicitly listed on its labels may also be grounds for a lawsuit. Healthcare providers are well aware that both federal and state law requires them to use only drugs and devices purchased through FDA-approved sources, and ambiguous suppliers out of Canada is clearly not one. Legitimate online pharmacies display a seal from the National Association of Boards of Pharmacy (known as a VIPPS seal). A comprehensive list of approved, legal internet pharmacies may be found here.

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Wrongful Death Suit filed after Fatal Reaction to CT Scan Dye

October 25, 2013

ct-scan-1_l.jpgWrongful death attorneys at Pintas & Mullins report on a lawsuit recently revived against the federal government, after a man died at a federal clinic in Kentucky. He was seeking treatment for persistent pneumonia and passed away from a severe allergic reaction from CT contrast scan dye.

The man was admitted to the federal clinic, Mountain Comprehensive Health Corporation in Whitesburg, Kentucky, in January 2009, and died the same day. His medical chart specifically noted his allergy information, flagging a similar reaction to CT scan dye one month earlier. At the time of his death, his attending physician informed his wife that he died of natural causes from aspirating (suctioning out) a blood clot.

When a coroner arrived, however, emergency personnel told a completely different story, and an autopsy was ordered. The autopsy revealed the true cause of her husband's death: severe allergic reaction. She presented her claim to the U.S. Department of Health and Human Services (as the medical clinic is federal agency) in 2011, however, the HHS denied her claim because it arrived four days too late. The statute of limitations in Kentucky is two years, and because her husband died in January 2009, the statute would have expired in January 2011.

Since, however, the wife did not receive her husband's autopsy report until April 2009, she subsequently filed a lawsuit against HHS, and an appeals court decided her claim did not expire until the date she received the autopsy. The Supreme Court has previously ruled that medical malpractice statute claims only begin when the plaintiff knows both the existence and cause of injury.

The appeals court confirmed that the statute of her claim depended on the date she was alerted of the possibility that the medical center caused her husband's harm and consequent death. Since the physician initially informed her that her husband's death was due to a blood clot, the appropriate date was actually when she received the autopsy.

Medical malpractice lawsuits arise from an array of complex situations. A similar suit was recently filed in Beaumont, Texas, after a woman was treated with a drug she was allergic to. The woman, Laura Laday, sought treatment at Fannett Medical Center for lower back pain, body aches, and swollen feet when she was administered Bactrim D.S., a sulfa drug.

Laday suffered a severe allergic reaction to Bactrim causing physical impairment, disfigurement, and deterioration of her physical and mental conditions. Additionally, according to her complaint, the injuries she suffered adversely affected her capacity to earn money.

Like the man in Kentucky, Laday's allergen to Bactrim and all sulfa drugs was well-documented in her medical charts. Despite this clear indication, physicians at Fannett Medical prescribed and administered her a sulfa. When patients enter a medical center they assume their medical charts and information are up-to-date and available for review. They assume, rightly, that nurses and physicians do not administer drugs without first checking that an allergic reaction would occur, and when this trust is broken, the results can be catastrophic.

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Cardiac Stents One of Most Overused Medical Procedures

October 24, 2013

polygon-medical-animation-angioplasty-procedure_l.jpgMalpractice lawyers at Pintas & Mullins report on several recent studies and news articles highlighting the massive overuse of cardiac stents in the United States. Over seven million Americans have been implanted with stents in the past decade, costing them and the healthcare system more than $110 billion.

Stents are implanted around the heart to prop open heart attack patients' arteries and restore blood flow. About half of those implanted with stents use them for this purpose, which is incredibly effective and usually very necessary. The other half, however, are electing to have the procedure done based on their doctors' recommendations, despite being in overall stable health.

There have been several widely-publicized scandals regarding the overuse of stents, largely focusing on catastrophic premature deaths and certain doctors performing stent surgeries in astronomical numbers. The medical devices are not inherently bad; they are partly responsible for the drastic decrease in cardiovascular disease deaths over the last forty years or so, and, nationwide, stents are required to be implanted in heart attack patients within 90 minutes of their ER arrival.

The benefit of stents in cardiac arrest patients is irrefutable. Their benefits in stable patients with chronic heart disease, however, are far less known. Unfortunately, this has not stopped physicians from prescribing them over less dangerous treatments, such as aspirin, beta blockers and other medications, which are just as effective.

Health care reformers and the public are now voicing their concern about stent overuse and the motives behind it. A heart specialist in Louisiana recently put a face on the issue when he was convicted of 51 counts of billing for medically unnecessary surgeries and sentenced to ten years in prison.

Though one stent can save a life, several stents do not equate to better results. One patient, Bruce Peterson, went to see a cardiologist for chest pain and subsequently implanted with 21 coronary stents, one of which tore a blood vessel. His physician put five stents in a single artery, which weakened his heart and exposed him to severe complications that ultimately took his life.

His doctor was fined just $10,000 for Peterson's death, along with two years of oversight. While it is important not to demonize outright all cardiologists who recommend more than one stent, it is equally important for patients to ask physicians why exactly they believe what they're doing is right. There are some doctors who over-treat patients in pursuit of profits - the Louisiana cardiologist, for one, enjoyed a $6 million income in 2003 thanks to the stent procedures. He now earns $5 dollars per month as a supervisor of his prison's cleaning crew.

As a result of his malpractice, some of his patients require regular blood transfusions; others have needed remedial surgeries, or suffered heart attacks and strokes. Several died, after which their families sued him and the two Lafayette hospitals where he worked, obtaining a $15.1 million class-action settlement. The man himself was getting about $2,600 per stent, and used to boast that he could implant ten a day. At any one time he would have between 6,000 and 7,000 patients under his care. He would schedule 40 appointments in a two-hour period, sometimes recommending they undergo stent surgery, literally, on his way out the door.

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Laser Surgery Injury Lawsuits on the Rise

October 17, 2013

dr-braun-performing-laser-hair-removal_l.jpgSurgical injury lawyers at Pintas & Mullins report that more and more patients are filing lawsuits against non-physicians after being burned or otherwise injured during laser surgery. The first comprehensive study conducted on this topic was recently published in JAMA Dermatology.

The majority of lawsuits being filed are against non-doctors, typically nurses and other technicians, who performed the surgeries outside traditional settings, like in "medical spas," where other procedures such as Botox are often advertised. Researchers found that, in the short time between 2008 and 2011, the number of lawsuits involving medical assistants, interns, nurses, or technicians more than doubled.

Laser surgery uses beams of light to remove diseased tissue, hair, wrinkles, birthmarks, sunspots, or bleeding blood vessels, among other applications. There are several types of surgical procedures that can include laser, including spine and eye surgeries. In laymen's terms, lasers are focused on very small areas to heat skin cells until they rupture.

Like any other procedure, laser surgery is not inherently safe; possible risks include extensive bleeding, infection, burn, scarring, and skin color changes. Each individual state determines who can perform laser surgeries and where, and the requirements between states varies substantially. In Maine, for example, only licensed physicians can perform laser hair removal, while in Nevada, there are literally no restrictions on who can wield a laser. Likewise, there are currently no federal laws dictating who can operate lasers or what kind of training or supervision is required.

The comprehensive study was headed by researchers at the University of California, Los Angeles, who examined data regarding liability claims for laser skin surgery (which excludes more serious procedures, such as for glaucoma or on the spine). They found that in 2008, just over 35% of laser skin surgery claims involved non-doctors; by 2011, that percentage jumped to 78%, and by 2012 had reached 85%.

Far and away the most common claims involved people injured during laser hair removal, followed by rejuvenation (a facial procedure common in medical spas) and treatments for scars and leg veins. This rise in legal claims suggests and very nearly proves that undergoing a laser procedure in a non-medical setting by a non-medical doctor is incredibly dangerous.

It should be noted that this data only includes liability claims that make it to court; there are many, many other laser injury claims not included here that are settled out of court or injuries not pursued legally by the victim. The American Society for Dermatologic Surgery Association (ASDSA) stated that laser procedures, when done by a non-physician, are to at least be physically overseen by a medical doctor, to respond to or correct any problem that may occur.

Medical officials are now hoping to urge policymakers to render laser surgery a medical procedure, to only be conducted by a licensed physician. States can enact this requirement by defining laser procedures as "practicing medicine," which will directly determine how patients are treated and protected.

The ASDSA, for one, defines the practice of medicine as any act or procedure that uses a mechanical device and could capably damage living tissue. Skin-related laser surgeries are among the most popular elective procedures in the U.S., and states and regulators need to keep up with this demand to keep citizens safe.

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