Recently in Surgical Errors 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" »

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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Uterine Growth Removal Procedure under Scrutiny for Cancer Risk

December 30, 2013

8759177830_2ecb0f9160.jpgThree U.S. teaching hospitals are now examining the safety of a popular surgery to remove uterine growths after reports that the procedure could spread cancer in high rates. Two esteemed hospitals in Boston, along with the Cleveland Clinic, plan to better inform patients of this risk. Medical negligence attorneys at Pintas & Mullins remind women undergoing these types of procedures that they must always be adequately informed of all risks before they consent to a surgery.

The procedure, known as uterine fibroid surgery, is recommended for patients diagnosed with noncancerous growths in the uterus. It is estimated that about three out of four women will experience these types of growths (fibroids) in their lifetime, some without ever realizing it. By themselves, uterine fibroids do not cause cancer and are easily manageable. In a specific subset of patients, however, the symptoms (pain, bleeding) interfere with health to such an extent that surgery is necessary.

Uterine growth procedures are minimally invasive, typically performed laparoscopicly. The number of these types of surgeries has skyrocketed over the past decade, often with positive results. For some women, however, the procedures have turned disastrous and even fatal, because it significantly increases the risk of cancer spreading into the abdomen.

In some women, undetectable cancer cells proliferate in these uterine growths and can spread into the abdomen during or after laparoscopic surgery. This is due to the nature of the surgery, which requires surgeons to "grind" the growths down into small pieces so they are more easily removed. Thus, the cancer cells release into the abdomen and uterus, making the potential for full-blown cancer more likely.

Making matters worse, physicians are currently unable to test the fibroids to determine if the growths are cancerous before the procedure and the American Congress of Obstetricians and Gynecologists explicitly notes that there are not guidelines for how physicians should inform patients of this risk.

Why Women aren't Being Warned

In a study involving 30,000 patients, researchers determined that about one in every 415 women who undergo this procedure have undetected cancerous fibroids. Prior to these findings, which will be published in the New England Journal of Medicine, physicians believed the risk to be much lower - about one in 10,000 - and were therefore understating the actual risks to patients.

Continue reading "Uterine Growth Removal Procedure under Scrutiny for Cancer Risk" »

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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Veterans Affairs Spends $845 Million on Malpractice Claims over Past Decade

November 15, 2013

6348524704_1572a02c0e.jpgA recently-released analysis by the U.S. Department of Veteran's Affairs (VA) showed that the agency paid about $845 million in medical malpractice payments since 2003. This amount of money was paid to over 4,400 veterans who were injured through medical negligence. Medical malpractice attorneys at Pintas & Mullins frequently work on behalf of injured veterans, and know just how damaging the effects of malpractice can be, and that no amount of money can make the victim whole again.

In 2012 alone, the VA settled over 450 cases, totaling more than $98 million. This number is causing Congress, medical experts and public watchdog groups to question whether the VA is learning from its mistakes and improving its practices accordingly. Over the past decade the VA has not enacted or even proposed a major reform program within its hospital systems.

Stories of Fatal Neglect

Dayton Daily News dug deeper into the issue, speaking to families of injured veterans and reporting on their stories (the article may be found here). Among their stories include a 20-year-old who was admitted to a VA hospital for a routine tooth extraction and left in a wheelchair, paralyzed and unable to speak. Another family watched their loved one, a Vietnam War veteran, die of cancer after VA doctors missed the diagnosis several times over three years.

The VA hospital network is one of the largest in the nation - in 2012, it treated about 6.3 million veterans. When malpractice claims are made, the VA settles financially with about a quarter of them (private U.S. hospitals pay out about 20% of claims).

One of the highest recent VA payouts was awarded to the family of a retired Air Force captain, who flew B-52s in the Vietnam War. He was admitted to the Atlanta VA to undergo treatment for a heart arrhythmia (irregular heartbeat). During laser surgery, doctors accidentally punctured his heart, though fortunately he survived and was released shortly after.

In the ensuing months he was hospitalized several times due to dizziness and was prescribed numerous medications. During his last ER visit it became clear his organs were failing, and his heart continued to lead blood, requiring emergency surgery. His wife asked for an autopsy and requested the hospital launch an internal investigation. After the investigation and subsequent lawsuits, the hospital admitted he died from neglect, and settled with his family for $300,000.

How VA Lawsuits Differ

Malpractice lawsuits against the VA hospitals differ in many ways from lawsuits against private hospitals in several ways because the VA is a federal department. In more traditional suits against private hospitals, plaintiffs can hold individual physicians, nurses or other administrators liable for negligence. At the VA that is not possible. Plaintiffs must sue the entire hospital or not at all; individual employees cannot be sued.

At the same time, VA hospital personnel are consistently given pay raises and transfers even if their conduct has resulted in serious injury or malpractice claims. A federal report confirmed that, in 2011, the VA awarded performance bonuses and awards in the amount of $160 million to staffs without properly associating the bonuses with esteemed performance. Many of the bonuses even went to administrators who oversaw massive adverse events at their respective hospitals, including fatal outbreaks of Legionnaires disease, veteran suicides, and sterilization oversights.

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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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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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Orthopedic Surgery Patient Awarded $2.85 Million for Malpractice

September 25, 2013

honduras-1_l.jpgMedical malpractice attorneys at Pintas & Mullins report on a recent malpractice case that recently concluded in a $2.85 million jury award to a plaintiff in Myrtle Beach, South Carolina. The plaintiff sued his orthopedic surgeon after a delay in surgery left him paralyzed.

The jury determined that the orthopedic surgeon, Dr. Wayne Bauerle, negligently sent the patient to receive a CAT scan despite his unstable vital signs. The patient, Randy Green, was in a pre-operative holding area at Grand Station Regional Medical Center when the incident occurred. Green also received a confidential settlement with Grand Station.

Green was involved in a severe auto accident in 2004, after which he was taken to Grand Station to treat severed arteries in his forearm. He was to undergo surgery in order to stop the bleeding, however, while he was being prepped for the operation the orthopedic surgeon ordered him to receive a knee CAT scan, which was also injured in the crash. The CAT scan order caused a half-hour delay in surgery, triggering cardiac and respiratory arrest.

The patient was resuscitated in the emergency room by an ER doctor and an anesthesiologist, however, the 30-minute delay resulted in partial-death of his spinal cord. Green is now permanently paralyzed from the waist down.

At the time Dr. Bauerle ordered the CAT scan, Green's blood pressure had dropped to 72 over 65. Medical experts called to testify at the malpractice trial stated that this number is considered dangerously low in the medical field, which Bauerle would have known but ordered the CAT anyway. Those doctors who testified were from Harvard Medical School, Connecticut, and Charleston, South Carolina.

Blood pressure numbers that low often indicate that a patient is on the verge of a cardiac arrest, and the jury agreed that interrupting Green's treatment was negligent and grounds for malpractice. Testifying doctors stated that the patient should never have been diverted from pre-op with such dangerous vital signs.

In related news, a surgical malpractice lawsuit was recently filed against a podiatrist in Texas. The plaintiff claims her physician negligently failed to warn her about the various risks of surgical procedures he performed on her foot.

The plaintiff underwent foot surgery in 2007 after experiencing a constant burning sensation between her toes when she walked. The doctor is located in an area known as Texarkana, because it is located near the border of Texas, Arkansas and Louisiana. The plaintiff is a resident of Arkansas though her suit is filed in the Eastern District of Texas.

In July of 2011 the plaintiff underwent the first of numerous surgeries on her right foot, which she now believes were unnecessary and caused serious, permanent damage. In her complaint the woman alleges that her podiatrist, Dr. Petty, described the procedures as minimal, simple incision surgeries from which she would swiftly recover.

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NFL Doctor Sues Smith & Nephew over Botched Hip Surgery

September 13, 2013

4436226247_370169ec52.jpgMetal-on-metal hip device lawyers at Pintas & Mullins affirm that the team physician for the NFL's San Francisco Chargers recently sued Smith & Nephew, the hip device manufacturer, after a medical malpractice lawsuit cost him $2.2 million. Dr. David Chao used a Smith & Nephew hip device during that botched surgery, and claims that the patient's injuries were caused by the defective device rather than his own negligence.

Dr. Chao claims that the injuries caused to his patients were the direct result of Smith & Nephew's inadequate training and defective surgical scissors for the Birmingham Hip Resurfacing implant. The patient underwent hip surgery in 2007, during which she suffered a lacerated femoral artery, vein and nerve. This caused her to walk with a limp and live with chronic pain.

It is worth noting that in that same year Chao was ordered to enroll in an ethics program and medical record-keeping class after an unrelated incident revealed he did not disclose a DUI conviction on state forms, as is required. The state medical board also filed a complaint against him regarding this matter, along with a $1,000 fine.

An arbitration panel ultimately awarded the hip patient $2.2 million, finding Chao negligent in this patient's care. The decision was unanimous, as the 54-year-old patient was clearly in pain, with prescriptions to take four different medications per day and walking with a permanent limp.

Chao now wants British manufacturer Smith & Nephew to pay for the settlement, claiming that it failed to properly train him on the Birmingham Hip Resurfacing device implantation procedure. He says the company trained him to push the scissor tip into tissue in such a way that cause the surgeon to lose sight of the scissor tines (also known as 'blind cuts,') which led to him lacerating his patient's artery.

He claimed that he exactly followed the company's training on the Birmingham Hip Resurfacing, and states that if Smith & Nephew had developed reasonably safe procedures and related surgical equipment, his patient would not have been harmed and he wouldn't have to pay her $2.2 million.

Since 1998, Chao had been named defendant in at least 20 medical malpractice lawsuits, many of them filed by patients suffering catastrophic injuries. Two separate juries found liable Chao liable for malpractice, negligence and fraud, awarding one former patient $460,000 and another $5.6 million. At least six other suits have ended with payments to patients for their injuries, though most of the amounts are undisclosed.

In 2010, DEA officials searched Chao's home after it was confirmed he had been writing illegal prescriptions to the former Charger's physician, leading to his dismissal and several lawsuits from former players. Many Charger's players alleged they were physically or permanently harmed by the physician, who preformed procedures while under the influence of narcotics. Federal authorities found over 100 prescriptions written by Chao in his home, listing himself as the patient.

Last year, in 2012, Smith & Nephew issued a warning on its Birmingham Hip Resurfacing implants, informing the FDA, physicians and patients on new data showing that the devices fail at much higher rates in patients than other hip devices. Metal-on-metal devices like the Birmingham can easily wear down in patients, and the constant movement and friction between the all metal components cause metal debris to release into the blood. This condition, known as metallosis, can cause tissue and bone death near the implant site, as well as toxic amounts of metal ions in the bloodstream.

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Veteran's Malpractice Payouts Reach 12-Year High

September 13, 2013

Medical malpractice lawyers at Pintas & Mullins report that veterans' medical malpractice payouts are steadily rising as more soldiers require care. The U.S. government made more than 400 payments in 2012 to resolve malpractice suits against Veteran's Affairs hospitals, costing it nearly $92 million.

2920376476_b4befd25b7.jpg One of these cases, filed by Christopher Ellison, recently resulted in a $17.5 million judgment for him and his family. He went to the Philadelphia veteran's medical center in 2007 to have eight teeth removed, however, what should have been a routine visit left him physically incapacitated for the rest of his life.

Other cases against the VA resulting in permanent disability have been the result of delays in or missed diagnoses, and surgeries performed on wrong body parts. Though these types of medical mistakes are often found in the general public's healthcare system, the significant rise in VA malpractice claims illuminates deep flaws in the system's practices.

A Representative from Florida told Bloomberg that these rapid malpractice judgments reflect the pattern of preventable deaths of soldiers at VA hospitals. He asserted that what the VA is most lacking, is not money or resources, but accountability. The Representative, Jeff Miller, is also Chairman of the Committee on Veteran's Affairs.

On September 9, 2013, Representative Miller and the House Committee on Veteran's Affairs held a hearing to examine the most recent preventable mistakes at VA medical centers nationwide, including an outbreak of Legionnaires' disease a few years ago that killed at least five veterans. The inspector general of the VA is currently conducting a criminal investigation into that incident, which was caused by bacterial infections spread through the water supply, and which we reported on in March of this year.

At least one family, that of John Ciarolla, filed a wrongful death lawsuit against the Pittsburg VA. They were not even aware of the outbreak until over a year and a half after Ciarolla's passing. Families of the other veterans who died of Legionnaires' were very outspoken about the length of time it took the VA to contact families about the outbreak, prompting the investigation.

One son whose father died from the outbreak said that his father was permitted to shower, wash and drink hospital water for sixteen days without any warning of a potential health problem. He died from the bacterial exposure. His son also plans to file a claim against the VA.

There are currently about 1.2 million American soldiers that are due to become veterans before 2017, more and more of whom are being diagnosed with complex diseases, such as post-traumatic stress disorder, that frankly, physicians do not know a lot about yet. Others suffer from injuries that would have been fatal in Vietnam or World War II. The median age of these new veterans is between 25 to 34 years old - comparatively, the median age for Vietnam, World War II and Korean War eras was 65 and older.

The VA system must learn to change and adapt to the new generation of veterans, who suffer from vastly different ailments, conditions and require alternative treatments, including psychological care. Relatedly, medical malpractice payouts are now larger because the life expectancy of injured veterans is now decades longer.

In clearer terms, if a VA surgeon accidentally cuts off the wrong leg of a 70-year-old Vietnam War vet, whose life-expectancy is around 75, that patient is entitled to five years of damages. If that same surgeon accidentally cuts off the wrong leg of someone whose just come back from Afghanistan, who is perhaps 25, the payout will be much larger because he or she is entitled to at least 50 years of damages.

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