Johnson & Johnson Considering $3 Billion Settlement of Hip Implant Cases

johnson-and-johnson-considering-3-billion-settlementJohnson & Johnson is the largest seller of healthcare products. When you consider that fact, $3 billion seems like a drop in the bucket to settle lawsuits over its recalled hip implant cases.

There are up to 11,500 lawsuits pending in the United States against the corporate giant, and to resolve them, it may pay more than $300,000 per case. If these plaintiffs accept their offers, the total amount would exceed $3 billion, which would top the $1 billion paid in 2001 by Suizer AG, a Switzerland-based pump maker, to resolve lawsuits from patients who claimed the company’s hip and knee implants were defective. This was the largest settlement of its kind, so if J&J follows through, its settlement will be a record-breaker.

Johnson & Johnson wants the U.S. cases resolved by early 2014, according to undisclosed sources. In 2010, J&J’s DePuy unit recalled 93,000 implants with 37,000 of those being in the U.S.

This recall came after 12% of these implants failed within five years. However, that rate continues to rise, as do lawsuits from plaintiffs who claim the chromium and cobalt devices caused them pain, metal debris and replacement surgeries.

To date, J&J has spent approximately $993 million on medical costs and informing patients and surgeons about its DePuy ASR metal-on-metal hip implant. According to Lorie Gawreluk, a spokeswoman for DePuy, “Reports about a possible resolution of the litigation are premature and speculative, including any estimates of resolution amounts.”

In its first trial, J&J lost an $8.3 million verdict over the device. This past March, a California jury awarded damages to a retired Montana prison guard. Just six weeks later in a second case, a Chicago jury ruled in favor of DePuy, rejecting a defective design claim by an Illinois nurse.

There are seven upcoming trials filed by plaintiffs blaming the ASR for injuries. The first is scheduled for September 9 in a Cleveland federal court, and was filed by 58-year-old Ann McCracken. After her hip implant, she needed two additional surgeries. U.S. District Judge David Katz will oversee this lawsuit, and about 8,000 federal cases consolidated for the pre-trial collection of evidence. Approximately 2,000 cases are pending in the California Judicial Council Coordinated Proceeding before Judge Richard Kramer in San Francisco. Other trials are scheduled in San Francisco in October, New Jersey in October and January, in West Palm Beach Florida in November, in Chicago in December and in Los Angeles in January.

The J&J hips were made from a cobalt/chromium alloy, which is used in the company’s ASR XL Acetabular System and ASR Hip Resurfacing System. Within five years, 13% of the ASR XL hips failed and needed revisions, and 12% of the ASR Hip Resurfacing System failed.

Lawyers for plaintiffs claim that debris from the metal ball sliding against the metal cup causes tissue to die around the joint and may increase the amount of metal ions in the bloodstream to dangerous levels. J&J runs a worldwide reimbursement program for these hips, and has apparently made thousands of payments to patients for testing and treatment of out-of-pocket expenses.

Metal-on-metal hip implants are known to fail sooner and require replacement faster than other artificial hip products. In fact, the devastating effects of these hips can be horrific to patients. A 2011 New York Times article reported, “As surgeons here sliced through tissue surrounding a failed artificial hip in a 53-year-old man, they discovered what looked like a biological dead zone. There were matted strands of tissue stained gray and black; a large strip of muscle near the hip no longer contracted.”

A New England Journal of Medicine study showed that these hips failed 3 times faster than other artificial hips. But in its usual snail-like fashion, the FDA only recently ordered an in-depth study of metal-on-metal artificial hip systems. And of course, it’s leaving it up to the manufacturers themselves to conduct its study, further demonstrating the ongoing ineptitude of the agency. As Einstein said, “Insanity is doing the same thing over and over again while expecting a different outcome.” The FDA needs to take that quote to heart.

Dallas’s expert medical device attorneys at Reyes Browne Reilley have handled thousands of product liability lawsuits nationwide. If you or someone you know has had a metal-on-metal hip implant and experienced severe problems, consult with one of our attorneys today.

How Immigration Law Changes Impact Native-Born Workers

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how-immigration-law-changes-impact-native-born-workersDebates over how native workforce is affected by employing undocumented workers is once again a hot subject filled with questions, shedding some light on the impact of immigrant workers in some sectors.

If Congress were to legalize low skilled immigrant labor , how would this affect native workers?

Would they receive lower salaries? Should the less skilled workers occupy empty jobs and in that way assist those with more qualifications? Which of the two would come out benefitted?

All these questions have created opposing sides between journalists, economists, researchers and critics. All express concern about the possible outcome ,but are in agreement over how changes in the Immigration laws could affect native workers.

Sara Murray in her article in “The Wall Street Journal”, analyses the case that occurred in 2006 in Greenley, Colorado when the federal agents raided meatpacking facilities.

In that same year Angel Reyes, Managing Partner of Reyes, Browne & Reilley, presented a federal class action against Swift & Co. meatpacking facility and, as this situation continues still believes that the angle is to focus on the NEED for comprehensive Immigration reform.

This is the case in many meatpacking facilities, where hundreds of illegal workers had been discovered at the plant and were detained and eventually deported, resulting in serious problems for the company, the local population and definitely for those workers.

The evaluation and putting into effect of these reforms should be comprehensive, forceful and clear, creating equality of opportunity and eliminating prejudice.

Do we need a larger workforce? Should immigrants be legalized or not?

That is the question… We are all affected.

Photo Credit: Richard Thornton / Shutterstock.com

C.R. Bard Settles Queen Transvaginal Mesh Case

shutterstock_1215026651-300x199Yesterday, a settlement was proposed in Wanda L. and Greg T. Queen v. C.R. Bard case, the second of four federal bellwether transvaginal mesh cases against against the manufacturer of transvaginal mesh products. Wanda was implanted with the Bard Avaulta Solo Anterior Synthetic Support system during her pelvic organ prolapse surgery. The first federal trial awarded $2 million to Donna Cisson in her case against C.R. Bard. There are currently 28,000 consolidated cases in the court naming six total manufacturers of transvaginal mesh products.

Now we have word that the Queen case has been settled and no trial will be held. In settlement cases, amounts awarded to the plaintiff are usually not available to the general public and the defendant doesn’t admit liability.

It is understandable why C.R. Bard would want to settle, and avoid further punitive damages (like last week’s $2 million jury verdict against bard). Of all the people injured by the transvaginal mesh used in surgeries, Wanda Queen suffered the most. She experienced extreme physical and emotional pain and deformity, as well as impaired physical relations with her husband, Plaintiff Greg Queen. The good news is that a settlement can’t be appealed, and the plaintiff will not have to endure further litigation.

So what does this mean for future transvaginal mesh cases? One could speculate that it means this manufacturer (and possibly others who are also being sued) understands its liability and knows that jurors will find in favor of future plaintiffs. Transvaginal mesh has caused serious physical and emotional damage for thousands of victims who had this product inserted during pelvic organ prolapse surgery or stress urinary incontinence surgery.

Although no amount of money can compensate for the horrible injuries these victims experienced, based on the first two cases, the manufacturer must pay for its wrongdoing. The expert defective medical device attorneys of Reyes Browne Reilley represent almost 300 transvaginal mesh plaintiffs nationwide, and we strongly believe justice will be served for our clients.

Second Trial Against Transvaginal Mesh Manufacturer C.R. Bard Begins Today

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The first federal transvaginal mesh trial awarded $2 million to Donna Cisson last week. Now comes the second of the four bellwether cases. The case, Wanda L. and Greg T. Queen v. C.R. Bard starts today.

So what’s a bellwether case? By definition, it is a legal term for an “indicator of future trends.” Courts will adopt a bellwether approach when there is a large number of plaintiffs with the same type of claims and there is no other way for courts to handle the tremendous caseload. Hence, the plethora of transvaginal mesh cases that will soon be underway.

In this particular case, Wanda was implanted with the Bard Avaulta Solo Anterior Synthetic Support System during surgery used to treat pelvic organ prolapse. The surgery was performed by Dr. Elizabeth Barbee at Wake Medical Center in Raleigh, NC. Due to the transvaginal medical device implanted in her, Wanda alleges she has experienced horrendous mental and physical pain and suffering – and even physical deformity. Additionally, she “has undergone or will undergo corrective surgery or surgeries and has endured impaired physical relations with her husband, Plaintiff Greg Queen.”

The following counts are the basis for the case:

Count I – Negligence

The manufacturer had a responsibility to “use reasonable care” in designing the product label and packaging, and in selling the product. Due to the negligence of the defendant, Wanda has experienced and will continue to suffer severe personal injuries, emotional distress, financial or economic loss including but not limited to medical services and expenses, present and future lost wages and other damages.

Count II – Design Defect Strict Liability

The product was not reasonably safe for its intended use and was defective. As a result, Wanda suffered severe injuries.

Count III – Manufacturing Defect Strict Liability

The product was defective with respect to its manufacture which was the direct and proximate cause of Wanda Queen’s injuries and future injuries and emotion distress, pain and suffering, financial loss and economic loss due to medical expenses.

Count IV – Failure to Warn

The product was defective in its lack of appropriate and necessary warnings.

Count V – Breach of Express Warranty

C.R. Bard assured the public hospitals and healthcare professionals that the product was safe and reasonably fit for its intended purpose. Due to this assurance, both she and her healthcare provider chose the medical device. C.R. Bard breached these express warranties because the product was unreasonably dangerous and defective and the defendant misrepresented its safety.

Count VI – Breach of Implied Warranty

It was impliedly warranted that the product was “merchantable and fit for the ordinary purpose for which it was intended.”

Count VII – Loss of Consortium

Greg Queen suffered loss of “his wife’s consortium companionship society affection services and support.”

Count VIII – Punitive Damages

The Defendant knew the risks or should have known the product was defective and presented an unreasonable risk of harm to Wanda Queen. The defendants conduct “manifested a conscious indifference to, and /or flagrant disregard of, the safety of those persons who might foreseeably have been harmed by the product, including plaintiff Wanda Queen, justifying the imposition of punitive damages.” They ask for the costs of attorneys’ fees, interest or any other relief that is reasonable.

Jury selection began this morning. (In the Donna Cisson case last week, it took one morning to select six jurors and two alternates.) It is expected that Wanda’s case will begin this afternoon.

This second case is one of four against C.R. Bard that claims the manufacturer knew of the dangers of its defective Avaulta transvaginal mesh used in pelvic organ prolapse surgery, and failed to warn the physicians who performed these surgeries. There are a whopping 28,000 consolidated cases in this court naming six total manufacturers of transvaginal mesh products.

Dr. Anthony Visco is Chief of Urogynecology at Duke University Medical Center and President of the American Urogynecologic Society (AUGS). The organization was found in 1979 and is comprised of 1,400 physicians and allied health professionals caring for women with pelvic floor disorderss, specifically pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Dr. Visco is expected to be called as a witness in the case.

Also, expected to be called as witnesses are implanting physician, Dr. Elizabeth Barbee, Dr. Denniz Zelnoun, assistant professor at the University of North Carolina, Chapel Hill in the Department of Obstetrics & Gynecology and former FDA Commissioner, David Kessler.

Reyes | Browne | Reilley is currently helping hundreds of transvaginal mesh and bladder sling victims and their families recover damages from their devastating TVM complications. If you or someone you know suffered injuries from this product, please call Dallas’s premier medical device attorneys for a complementary and confidential consultation. You are under no obligation to use our services. Call us today at 214-526-7900, or submit the short case review form on the right.

Proposed Safety Rule for Child Car Seats and Weight

shutterstock_1038254151-300x199Currently, rules are in place that require a latch system for child car seats. The word “latch” means lower anchors and tethers. The latch system rule was federally mandated in 2002, and required all new vehicles to have anchor points between cushions so that child car seats would be secured by them instead of seat belts.

Now an amendment to the 2014 federal motor vehicle safety standards is being considered which would require that a child car seat be secured by a seat belt and top tether system if the weight of both the child and the seat are over 65 pounds.

Child car seats were lighter in 2002 when the latch system rule was put in place, and only younger children were required to use them. Now there are child car seats that can hold children weighing up to 90 pounds. As a result, it’s questionable whether anchors can hold the weight of both the child and the seat. Advocates backing the proposed amendment want the seats to be clearly marked with the maximum amount of weight.

To date there have been no reported incidents of the latch system failing due to heavier weight. However, safety advocates don’t want to take any chances. Alisa Baer, a pediatrician and childcare car safety expert known as “The Car Seat Lady” said, “We don’t want to find out the hard way that the lower anchors aren’t strong enough.”

Each state has its own child car seat laws, and they can vary greatly. For example, in Florida, children are only required to be in a car seat or booster until age 3. In Wyoming and Tennessee, children must wear them until age 8.

The Juvenile Products Manufacturers Association represents child-restraint manufacturers. The organization has urged the National Highway Traffic Administration to suspend the 2014 seat labeling requirement. Its argument is that the new rule would cause confusion about how to install seats correctly. It also claims that a better alternative would be to increase allowable weight of the lower anchors.

The argument that the change may be confusing may have little validity in light of a study done by the Insurance Institute for Highway Safety published in 2012. The study was conducted by the University of Michigan Transportation Research Institute, and tested parents’ ability to properly install child car seats using the latch system. Surprisingly, only 13% of these parents could install the car seats correctly.

If the new regulations take effect in 2014, it doesn’t mean that parents will have to buy new child car seats, as the ones with the latch system can be attached using a seat belt as well. But the rule is the most stringent one since 2011 when the NHTSA recommended keeping children in rear-facing seats longer.

Although the new regulations are meant to make choosing a child car seat easier, Stephanie Tombrellow, executive director of the nonprofit advocacy group SafetyBeltSafe USA, said that even if the car seat’s maximum weight is labeled, not all parents know their children’s exact weight. She also said, “The less complex the message is, the more likely it is the parent will be able to follow what’s happening.” That seems true enough. Installing child car seats shouldn’t be rocket science, but every possible measure should be taken to ensure children’s safety in vehicles.

If you have been injured in a wreck through no fault of your own, the Dallas-Fort Worth car accident lawyers of Reyes Browne Reilley can help. Call us today for your FREE consultation!

$2 Million Awarded in Transvaginal Mesh Case Against C.R. Bard

Today jurors in the Donna Cisson v. Bard trial awarded the 55-year-old woman $250,000 in compensatory damages, and $1,750,000 in punitive damages, due to severe injuries caused by transvaginal mesh used in her pelvic organ prolapse surgery. This case is called a “product liability case” and was presented to jurors yesterday morning. It only took them twelve hours to render a verdict against the maker of the Avaulta line of polypropylene mesh medical devices, C.R. Bard.

The six jurors found for Mrs. Cisson in her claim that in 2009, the Bard Avaulta Plus transvaginal mesh implanted in her was designed defectively. It was also determined that her surgeon, Dr. Brian Raybon of Toccoa, Georgia, failed to warn her of the dangers of this implant. In addition to her $250,000 victory, the jurors are currently deciding on possible punitive damages that may be awarded to Mrs. Cisson.

This is the first federal case, but just one of over 25,000 pending that also allege the polypropylene mesh was not suitable for human implantation. Bard argued that Donna Cisson’s damages should be mitigated (lessened) because she failed to lose weight and use an estrogen cream as instructed by her doctors, but the jury wasn’t “buying it.”

This past February in Atlantic City, New Jersey, jurors found for the plaintiff Linda Gross in a similar case against Ethicon, (Johnson & Johnson), awarding her $11.12 million in her product liability lawsuit, as well as $7.76 million in punitive damage. The case is now under appeal. A California state case also under appeal is against C.R. Bard, in which the jury awarded a $5.5 million verdict to Christine Scott and her husband over the Bard Avaulta mesh medical device.

C.R. Bard and other manufacturers of transvaginal mesh medical devices could be in big trouble, as this was the first of thousands of similar cases filed. There are five other defendants and approximately 20,000 cases consolidated in the same court, and awaiting their day at trial. The other defendants include Ethicon (Johnson & Johnson), Boston Scientific, American Medical Systems, Coloplast and Cook. In total, there are 4,193 cases pending against C.R. Bard and more than 28,000 filed naming all six defendants.

All of the women who filed these suits have suffered severe physical and emotional injuries, and claim that the mesh implants can erode, cause infection, enormous pain, bleeding and even additional surgeries to remove the mesh product. But often the mesh can’t be completely removed in these surgeries because the device is so deeply implanted in the victims. Ironically, that’s exactly what the mesh was designed to do – function as a permanent implant.

The next trial, Wanda Queen v. C.R. Bard will begin August 19 in the same federal courtroom. There will be a total of four trials occurring back-to-back that name C.R. Bard as the defendant, alleging the mesh is defective in design and doctors failed to warn their patients of the dangers in advance.

These transvaginal mesh medical devices have literally destroyed the lives of thousands of women. We can only hope justice is served in these cases. If you or someone you know has had a transvaginal medical device implanted during surgery, contact Dallas’s expert medical device attorneys at Reyes Browne Reilley. Call us today at 214-526-7900, or submit the short case review form on the right.

If you’re one of the hundreds of transvaginal mesh victims currently represented by Reyes | Browne | Reilley, call or email your attorney to learn how this landmark jury verdict might impact your case.

FDA Moves Against Alternative Diabetes Treatments

In The News

fda-logo1-300x143The Food and Drug Administration sure is busy these days. Currently, it’s out to stop U.S. Sales of almost 24 products claiming to be alternative diabetes treatments. The agency says these treatments are illegal and can be ineffective, counterfeit or even dangerous. Fifteen companies’ dietary supplements and purported natural cures are being targeted.

The agency sent warning letters to these companies, and if they don’t comply, they may seize their products and even prosecute those who don’t take corrective measures. These products stem from an alternative health system that evolved in India and include herbs and special diets. Many of the drugs also include unapproved versions of prescription medications, including metformin and Januvia. Diabetes sufferers can buy these treatments online or at retail stores.

Howard Sklamberg, director of compliance at the FDA’s center for drug evaluation and research said that if patients have diabetes, they should be treated by a doctor, not a so-called natural cure. He went on to say that the FDA was protecting consumers by its actions, and urged them not to buy these products.

The following are companies and products the FDA has singled out:

  • Enhance Nutraceutical’s Diaberex
  • Glytain Internal Remedies’ Glytain
  • Health King Enterprise & Balanceuticals Group Inc.’s Sugar Balancer
  • Magni Co.’s MagniLife Diabetic Neuropathy Foot Cream
  • Nature’s Health Supply Diabetes Daily Care
  • Naturecast Products’ Eradicator

Almost 26 million Americans suffer from diabetes, which can cause heart disease, blindness and kidney failure. If left uncontrolled, patients may also undergo lower-extremity amputations. Many of these products claim to both prevent and treat diabetes without any need for medical treatment. Some include ayurvedic medicines and prescription drugs for diabetes sold by online pharmacies without a prescription.

I in no way endorse or recommend these products. In fact, I applaud the FDA’s efforts. However, I do find it ironic that the agency relies on many prescription drug makers to do their research for them, while taking a hard line on alternative methods. For example, time after time, Big Pharma labels have either understated or completely ignored serious side effects of the drugs they peddle. But the FDA has taken a hard line stance on the lack of warnings on these alternative drugs’ labels. I’m all for that, and hope they will step up their efforts with prescription drug manufacturers as well.

Intuitive Surgical Value Declines After da Vinci FDA Warning Letter

shutterstock_116910856-300x225Since 2006, Intuitive Surgical Inc., the manufacturer of the controversial da Vinci Robotic Surgical System, has experienced 20 or more percent growth in revenue each year. In 2012, its revenue grew to a whopping $2.18 billion. However, in February of this year, U.S. regulators began surveying surgeons due to reports of up to 70 deaths since 2009. In fact, FDA records show that injuries involving robotic surgery procedures doubled in the first six months of 2013 alone.

Since the FDA inquiry news broke, Intuitive Surgical’s value has dropped a staggering $7 billion. Earlier this month, the FDA issued a warning letter based on it’s provider surveys. On July 18th, Intuitive admitted it had received an FDA warning letter, and afterward, cut its 2013 revenue projections by half!

Last week, Intuitive’s shares fell by 6.8 percent to $392.67. The company has lost 32 percent of its market value since February 27, the day before Bloomberg News reported that the FDA was surveying surgeons about the product’s safety.

According to Erik Gordon, a business professor at the University of Michigan in Ann Arbor, “They enjoyed some easier, boom years when doctors and patients were awed by the thought of surgical robotics turning surgeons into super-surgeons,” Gordon said in an e-mail. “Now, the people who pay for the surgery are stepping in and questioning whether the robots are worth the extra cost.”

Over 1,300 hospitals currently use the da Vinci system robots, which cost $1.5 million each. In 2012 alone, 367,000 procedures were performed in this country using this system. The da Vinci is the main product of Intuitive Surgical Inc., and has been used for cancer surgery, hysterectomies and gall bladder removals, among other procedures including prostate surgeries. Because of the severe injuries associated with this system, it has been involved in lawsuits filed by patients injured after these surgeries.

In April and May of this year, the FDA found several of deficiencies and said the company hadn’t reported certain device corrections and adverse reactions to patients. Both safety and cost-effectiveness of the robotic surgical system have been scrutinized since the announcement of the FDA’s review. With the Affordable Care Act coming, it is speculated that hospitals will reconsider whether to continue using this system to the extent they have… or at all.

Although the company operates internationally, 80 percent of its revenue is in the U.S. Intuitive’s second quarter sales increased in Asia and Europe but it is highly uncertain if this trend will continue.

In this high-tech age, perhaps there are some lessons to be learned. No doubt, robots will continue to play an integral role in this world’s future, but to what extent and at what cost? Serious consideration should be given to whether machines should take precedence over people – especially when human lives are at risk.

The DFW medical device attorneys at Reyes Browne Reilley are currently helping da Vinci Surgical Robot victims and their families recover damages from their devastating complications. If you or someone you know suffered injuries from a procedure performed with the da Vinci robot, please call us for a complementary and confidential consultation. You are under no obligation to use our services. Call us today at 214-526-7900, or submit the short case review form on the right.

Illinois Lawsuit Over Medtronic’s Infuse Will Proceed

infuse1-300x207Medtronic Inc’s motion to dismiss a medical malpractice and product liability lawsuit was denied by an Illinois state court judge recently. The lawsuit is over Infuse, an off-label bone graft manufactured by Medtronic Inc. The plaintiff, Karl Sanda, is suing Medtronic for negligence, strict liability, breach of warranty and willful and wanton conduct. Additionally, the lawsuit charges Northwestern Memorial Hospital, Northwestern Orthopedic Institute LLC and Dr. Mark T. Nolden with negligence claims.

Sanda experienced severe complications after initial and additional surgery and is now permanently disabled.

Although the U.S. Food and Drug Administration (FDA) approved Infuse for use in spinal fusion on the lower spine and for specific dental procedures, it was not approved for use in the cervical spine, which was where Sanda’s surgery occurred. In 2008, the FDA warned that the product could cause serious side effects and injures when used in cervical spine fusion surgeries, including swelling of the neck, difficulty breathing, constricted airways, swallowing difficulties and even nerve damage. Recent studies indicate that Infuse has even been linked to more severe injuries, including male sterility, infections and cancer.

Last October, the U.S. Senate Finance Committee found Infuse’s research to be suspect. Their investigation showed that Medtronic paid $210 million in royalties, consulting fees and other forms of compensation to doctors who co-authored company research studies of Infuse. Senate investigators claim that Medtronic manipulated data in order to minimize the side effects and injuries from Infuse.

To redeem the company’s reputation and its product, Medtronic funded an independent study of Infuse. Two research teams determined Infuse offered no significant benefit over grafted bone taken from the patient’s own body.

It will be interesting to see how this lawsuit unfolds. Here is yet another glaring example of how major medical equipment companies will do whatever it takes to sell their products, including falsifying or manipulating data and having no regard for patients’ well-being.

If you or someone you know suffered injuries from Infuse, please call us for a complementary and confidential consultation – You may have a claim and may be due compensation. You are under no obligation to use our services. Call the premier DFW medical device attorneys of Reyes Browne Reilley today at 214-526-7900, or submit the short case review form on the right.

Cirugía Robótica da Vinci, ¿ Obra Maestra o Gran Error?

Medical Devices

La mayoría de nosotros hemos experimentado la ansiedad y frustración de un computador, celular smartphone, iPad o el mal funcionamiento de otro dispositivo. Pero ¿Qué haríamos si nuestras vidas dependieran de un dispositivo electrónico que funcione perfectamente?

Eso no es una analogía exacta para una máquina quirúrgica robótica, pero como muchos de nosotros no somos dueños de robots, es lo suficientemente cerca. Hay literalmente cientos de miles de cirugías robóticas desarrolladas en Estados Unidos, y la mayoría son realizadas en forma segura. Sin embargo, mientras más de estas máquinas son usadas, más lesiones son reportadas.

Desde el 2007, la Administración de Alimentos y Medicamentos de los EE.UU ha recibido más de 200 reportes de quemaduras, cortes, infecciones y cerca de 100 muertes después de cirugías robóticas. Además, motivado por un reciente estudio que encontró que los doctores que usan costosos robots para desarrollar cirugías no producen mejores resultados para los pacientes que los procedimientos regulares y menos caros, el Congreso Americano de Obstetras y Ginecólogos habló en contra de la utilización de robots para cirugías, que a menudo son histerectomías.

Una histerectomía es el procedimiento más común para las mujeres. De hecho, una en nueve mujeres experimentará una en toda su vida. Ahora más y más mujeres están optando por los procedimientos asistidos por robot en lugar de grandes incisiones abdominales o cirugías laparoscópicas que implican solo pequeñas incisiones en el abdomen.

El más popular entre estas máquinas es el Sistema Quirúrgico da Vinci y así es como funciona: El cirujano se sienta a cierta distancia del “robot” en una consola y utiliza herramientas quirúrgicas unidas a los brazos del robot para desarrollar el procedimiento en sí. Piense en eso por un segundo. Las manos de un buen cirujano se suponen son precisas y la mayoría aprendió como perfeccionar esa técnica médica con las manos en la escuela de medicina. En vez de eso, ahora ellos están optando por una máquina para hacer el trabajo por ellos. Hace que te preguntes, ¿no es así?

Lo mismo ocurre con muchos críticos de da Vinci. La AAM es actualmente investigando si el rápido número de lesiones reportadas es porque más cirugías robóticas están siendo desarrolladas, causada por la máquina en sí o por los cirujanos que no tienen entrenamiento adecuado. Intuitive Surgical, el fabricante de da Vinci, requiere que los cirujanos tomen entrenamiento por internet. Ellos también deben practicar la cirugía robótica en la compañía en Sunnyvale en California. En primer lugar, la práctica se lleva a cabo en objetos inanimados. Luego ellos pasan a cadáveres o animales. Correos electrónicos internos de Intuitive han mostrado un deseo de acortar el tiempo de entrenamiento requerido para los cirujanos. La conclusión es que las críticas de la cirugía robótica se preocupan de que los cirujanos no reciban suficiente entrenamiento, y no están desarrollando procedimientos actuales. Después de la práctica en un cadáver o animal, al cirujano se le da un certificado de finalización y luego depende del entrenamiento y proceso de certificación del hospital para decidir si un cirujano tiene las habilidades robóticas a la par.

Los defensores de los reclamos por la cirugía asistida por robot dicen que es mínimamente invasiva y resultan en menos pérdida de sangre, dolor y recuperación posterior más corta que la cirugía tradicional. Sin embargo, es también más costosa. Un estudio de 260,000 pacientes con histerectomías encontró que el costo promedio de la cirugía asistida por robot es de $8,868 comparado con $6,679 para una histerectomía laparoscópica.

Dado que los costos de estos gigantes de alta tecnología son más de $1.5 millones, los hospitales que lo poseen definitivamente lo usarán. De hecho, entre 2007 y 2010, las histerectomías asistidas por robot aumentó de 0.5 por ciento a 9.5 por ciento, y representaron el 22.4 por ciento de todas las histerectomías después de tres años que los hospitales compraron el equipo.

Angela Wonson, una portavoz de Intuitive Surgical, la compañía que fabrica el sistema da Vinci, dice “Como una herramienta, la cirugía robótica ayuda a los cirujanos a superar las limitaciones [mínimamente quirúrgica invasiva] de las técnicas tradicionales para ofrecer una opción menos invasiva y evitar costos descendientes y complicaciones de un procedimiento abierto.” Pero de acuerdo al Dr. Francois Blaudeau, un abogado y practicante de ginecología en Alabama y sirviendo como el abogado de los demandantes principales en varios casos sobre las lesiones de da Vinci, “Más procedimientos robóticos se llevan a cabo sin ningún contratiempo, pero hay un creciente número de quejas y demandas que alegan complicaciones e incluso muertes por la cirugía con da Vinci.”

Solo el año pasado, 450,000 personas se sometieron a cirugía asistida por robot, lo que ha hecho que las acciones de Intuitive Surgical se disparen. Pero hay mucha controversia sobre estas máquinas, junto con un creciente número de demandas. Varias de las lesiones reportadas son quemaduras y otras relacionadas a ardor en los intestinos, uréteres, los intestinos, vagina y otros órganos vitales. El Dr. Blaudeau dice que las lesiones no son a menudo por días después del procedimiento. El da Vinci usa energía mono polar, la cual puede causar chispas que dejan daño residual. Para reducir las críticas a su producto da Vinci, Intuitive ha introducido nuevas puntas cubiertas para sus instrumentos.

“Así que la verdadera pregunta es – ¿es seguro? En las manos de un buen cirujano, si, dice el Dr. Marty Makary, un cirujano de Johns Hopkins en Baltimore. “En las manos de alguien que no tenga habilidades avanzadas, podría ser un verdadero peligro.” El buen médico parece afirmar lo obvio. También motivo de preocupación es la motivación de lucro en Intuitive Surgical, quien ya ha mostrado la habilidad para poner las ganancias por delante de la seguridad del paciente empujando a la reducción de periodos de entrenamiento en el hospital. Además, usted tiene que preguntarse qué viene después – enfermeras robóticas asistiendo a cirujanos robóticos, ¿quién está usando los equipos de cirugía robótica para desarrollar cirugías? Uno solo espera que no eliminen por completo a los humanos del proceso. Todo es posible en esta era y época.

Los abogados expertos en dispositivos médicos de Reyes | Browne | Reilley están actualmente ayudando a las víctimas del Robot Quirúrgico da Vinci y sus familias a recobrar daños debido a sus devastadoras complicaciones. Si usted o alguien que conoce sufrió lesiones por un procedimiento desarrollado con el robot da Vinci, por favor llámenos para una consulta complementaria y confidencial. Usted no está bajo ninguna obligación a usar nuestros servicios. Llámenos hoy al 214-526-7900, o envíe el pequeño formulario de revisión del caso que está a la derecha.