In 2014, a study was published in Annals of Surgical Oncology by BH Lang et al. titled “A Systematic Review and Meta-analysis Comparing Surgically-Related Complications between Robotic-Assisted Thyroidectomy and Conventional Open Thyroidectomy.” that aimed to determine the relative safety of robotic-assisted by conventional thyroidectomy.

For this study, researchers reviewed 11 previously-conducted studies and used statistics to normalize the data and make patients outcomes easy to compare.  Studying 2,375 patients in all, 839 underwent robot-assisted surgery and 1,536 underwent traditional open thyroidectomy.

Doctors write that robotic-assisted surgery (RT) was “significantly associated with longer operating time, … hospital stay, … and higher temporary recurrent laryngeal nerve (RLN) injury”.  While many other surgical outcomes were comparable, this team wrote “Given some of the limitations with the literature and the potential added surgical risks and morbidity in RT, application of the robot in thyroid surgery should be carefully and thoroughly discussed before one decides on the procedure.”

Due to the fact that Da Vinci, the manufacturer of a number of popular surgical robot systems, has failed time and again to adequately warn doctors and patients alike of the increased risk for complications, longer operating time, and longer hospital stay, a number of surgical robots lawsuits have been filed.

If you or a loved one underwent surgery assisted by robot and suffered long hospital stay or operating time, or faced complications as a result, you too may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of surgical robot lawyers at the information provided below.  We have the compassion, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Part I: Destroying Valentine’s Day

Two weeks ago was Valentine’s Day— a holiday that is supposed to be full of romance and heartfelt encounters with those you love. For many lucky people, Valentine’s Day was exactly that this year. Countless couples across the country could be seen on dates, filling restaurants, theaters, and dance-halls to capacity. Recent winter storms inspired hot tubbing rendezvous and even spontaneous trips to various resorts, hotels, and beaches, where an amorous evening awaited.

However, for many women this year, February 14th was a far cry from a joyous occasion. It was like all their other recent days—full of pain, discomfort, and bleeding.  As a result, the holiday seemed only to mock them. These women were in too much pain to enjoy any kind of intimate evening, and too infected to even think about putting on a swimsuit for a night of hot tubbing. For these women, it seemed Valentine’s Day, which was originally named after a martyr, had reverted back to its traditional meaning—a day representing, not romance, but suffering and sacrifice.

The pain that these women are experiencing is due to surgical pelvic mesh devices that were designed, manufactured, marketed, and sold by a variety of companies, including Ethicon Inc. (hereinafter “Ethicon”), a subsidiary of Johnson & Johnson. The devices are pretty much what they sound like—pieces of mesh implanted pelvically in women.  These devices are also referred to as pelvic slings, vaginal slings, and transobturator slings, and are intended to treat stress urinary incontinence and especially pelvic organ prolapse, which can occur in women after birth or surgery. Unfortunately, instead of helping women, some of the devices have only added to the women’s sufferings.

Women who have been injured by these surgical mesh devices have rightfully initiated legal proceedings against Ethicon and other manufacturers of pelvic mesh devices. The multidistrict litigation is still ongoing. The plaintiffs in these actions have mostly complained about two specific product lines: TVT and Prolift. The plaintiffs state that the devices erode internal vaginal tissue, causing bleeding and infection. As if that isn’t enough, plaintiffs are now faced with the cost of surgically removing the devices, or the worse alternative—leaving the devices in and inevitably facing even further injury.

The plaintiffs allege design defects, manufacturing defects, negligence, failure to warn, and breach of express and implied warranties. By now, so many women have been hurt by these faulty products, that literally thousands of additional cases have been joined in the pelvic mesh multidistrict litigation since its initiation.

If you have been injured by any brand of pelvic mesh, including Ethicon, you are welcome to call us for a free consultation. You may be entitled to financial compensation for your pain and suffering and for any medical expenses you incur due to the mesh.

Part II: Destroying Implicating Documents

A lot of us kept diaries or journals when we were teenagers. Now, if your family was anything like mine growing up, you know that keeping a journal is a risky business. After all, a teenager’s journal often proves tempting bait for snooping siblings and concerned parents.

Whenever I was concerned that prying eyes would read something I would prefer to keep private, I would either (1) rip out the particularly incriminating journal entries and destroy them somehow; or (2) hide them somewhere I thought no one would ever look, with the plan to tape them back into my journal later, after the coast was clear. Sometimes when I went with this second option, I hid the journal entries so well that when I genuinely tried to find the pages later, I couldn’t.

Ethicon, the company that sold faulty pelvic mesh devices, recently found itself in a similar, yet much more serious situation.  Due to the vast amount of cases filed against Ethicon, Ethicon’s in-house counsel issued a “Hold Notice” directing employees to preserve all documents pertaining to the TVT and Prolift product lines, as well as other products involved in the ongoing litigation.

Plaintiffs claimed that after the duty to preserve evidence had been triggered, defendant Ethicon lost or destroyed tens of thousands of documents that likely contained information relevant to plaintiffs’ claims. If the missing records are anything like my journal entries, I’m guessing the conveniently missing documents were ones that did not paint Ethicon in a good light.

On February 4th, a federal magistrate judge ruled that Ethicon destroyed or lost documents that should have been preserved in anticipation of litigation involving its pelvic mesh devices. The judge also found that Ethicon’s loss of evidence was negligent, rather than willful or deliberate.

Like my journal entries, whether Ethicon deliberately destroyed the documents, or lost them due to its own negligence, the outcome is the same: The documents are gone. As a result, the judge found that plaintiffs are entitled to monetary sanctions to compensate them for the additional time spent by their counsel piecing together missing custodial files and preparing for depositions of key employees for whom scant information was provided by Ethicon. (In Re: Ethicon, Inc. Pelvic Repair Systems Product Liability Litigation, MDL Docket No. 2327, No. 2:12-md-2327, S.D. W.Va.; See 12/5/13, Page 9).

Further, the federal magistrate judge recommended allowing trial judges to instruct juries to find an adverse inference for missing evidence. Id. An “adverse inference” instruction tells the jury members that they are allowed to assume that the missing documents were in fact harmful to Ethicon’s case.

By destroying, losing, or “losing” documents, Ethicon has shown that it has just as little regard for the plaintiffs’ valuable time, as it does for their injuries. Our law firm, on the other hand, cares a great deal about the pain and inconvenience people have endured due to pelvic mesh. If you have had complications with a pelvic mesh device, we would be honored to work on your behalf, and hope that you will call us for a free consultation.

Over the course of the past several days, Ethicon, a Johnson & Johnson company, has crowed over the fact that it “prevailed” in a lawsuit regarding the pelvic mesh devices it manufactured and promoted. At first glance, the media headlines regarding Ethicon’s recent “triumph” are confusing, and might even make it seem like Ethicon has already won the overall multidistrict litigation. This is far from the truth, so we thought we would set the record straight.

All that has happened is that a federal court has thrown out one woman’s lawsuit. Specifically, on February 18, 2014, Judge Joseph R. Goodwin found that the plaintiff, Carolyn Lewis, failed to show proof of a defective product in her case. As a result, the court granted Ethicon’s motion for directed verdict. See In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-4301, S.D. W.Va.

The lawsuit filed by Carolyn Lewis was the first bellwether trial against Ethicon before Judge Goodwin. “Bellwether” trials are early cases designed to help the parties test how the court and juries may respond to evidence and testimony that is likely to be similar to what is offered in other cases. However, each individual plaintiff has to establish her own case and show that the product caused her injury. The outcome of any bellwether trials are not binding on other cases in the litigation.  (For more on bellwether cases, check out: Vaginal Mesh Cases and Neutered Sheep – What’s the Connection?)

In no way do we minimize the disappointment many feel as a result of the ruling in Ms. Lewis’ case. However, not all is lost for other plaintiffs or potential plaintiffs. The facts of each and every case are different and may therefore have very different outcomes. Prior to this year, at least three other pelvic mesh cases went to trial, including two cases that went before state court juries and one case in federal court. In all three cases, plaintiffs triumphed and received multi-million dollar damage awards from the jury.

With all this said, Ethicon needs to hold off on doing any kind of victory dance. In the grand scheme of things, one motion for a directed verdict in Ethicon’s favor is far from an overall triumph. Ethicon faces months and months of future litigation, as do other manufacturers and promoters of pelvic mesh devices. According to a case list released by the U.S. Judicial Panel on Multidistrict Litigation, Judge Goodwin is currently presiding over 12,992 Ethicon mesh lawsuits, 13,292 AMS mesh lawsuits, 7,617 Boston Scientific mesh lawsuits, 6,172 Bard Avaulta mesh lawsuits, 1,155 Coloplast mesh lawsuits and 152 Cook Medical mesh lawsuits.

We would welcome the opportunity to help any woman injured by Ethicon pelvic mesh.

An article published in the January-February, 2014 edition of Female pelvic medicine and reconstructive surgery titled “Pneumomediastinum after robotic sacrocolpopexy.” reviews a case of pneumomediastinum in a woman who underwent robot-assisted surgery for the repair of posthysterectomy prolapse.  The team writes “Pneumomediastinum is a rare but potential complication of laparoscopy that is related to insufflation with carbon dioxide gas and may lead to life-threatening complications.”

This woman was 76 years old, and underwent surgery “without any apparent intraoperative complications.”  Sadly, after surgery, she developed a rapid heartbeat, was short of breath, “and was found to have subcutaneous emphysema and pneumomediastinum.”

The research team (led by NM Crawford) states in its conclusion that “Pelvic surgeons should understand the risks associated with development of pneumomediastinum as well as associated signs and symptoms. In our case, pneumomediastinum likely developed as carbon dioxide tracked from the peritoneum into the mediastinum during prolonged robotic retroperitoneal surgery.” (emphasis added)

As such, these doctors believe “Surgeons should have a low threshold to obtain radiographic tests in the early postoperative period, as close monitoring is essential to manage potentially life-threatening complications such as pneumothorax and cardiac arrest.”

Due to the fact that the manufacturers of many robotic surgery systems have failed to warn users of the elevated risk for complications and longer hospital stay associated with robot-assisted surgery, a number of surgical robot lawsuits have been filed.  If you or a loved one underwent surgery assisted by robot, you too may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of surgical robot lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

In 2012, an article titled “Use of thiazolidinediones and the risk of bladder cancer among people with type 2 diabetes: a meta-analysis.” was published by IN Colmers et al. in Canadian Medical Association Journal investigating the relationship between Actos and bladder cancer.  Thiazolidinediones are a class of diabetes drugs including pioglitazone, the chemical name for the drug Actos.

This article states “Patients with type 2 diabetes have a 40% increased risk of bladder cancer. Thiazolidinediones, especially pioglitazone, may increase the risk,” and as such, the authors “conducted a systematic review and meta-analysis to evaluate the risk of bladder cancer among adults with type 2 diabetes taking thiazolidinediones.”

To perform this study, the team reviewed a number of previously-conducted studies, both randomized controlled studies, and “case-control studies that reported incident bladder cancer among people with type 2 diabetes who ever (v. never) were exposed to pioglitazone (main outcome), rosiglitazone or any thiazolidinedione.”

Using statistical analysis, the team found that thiazolidinedione use was associated with a 15% increased risk of bladder cancer, and that Actos use was associated with a 22% increased risk of bladder cancer.

Due to the fact that the manufacturers of Actos have failed time and again to make clear the risk for bladder cancer, a number of Actos bladder cancer lawsuits have been filed.  If you or a loved one used Actos and suffered bladder cancer, you may be entitled to significant financial compensation for your injuries.  For a free, no-obligation case consultation, contact our team of Actos bladder cancer lawyers at the information provided below.  We have the compassion, experience, and resources required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

In the December, 2013 edition of European Urology, a team of researchers led by RK Kumar published the results of a study titled “Robot-assisted Partial Nephrectomy in Patients with Baseline Chronic Kidney Disease: A Multi-institutional Propensity Score-Matched Analysis.” that aimed to evaluate the relative safety of robot-assisted nephrectomy, as compared with a traditional approach that surgery.

This study included a total of “1197 consecutive patients who underwent [robot-assisted partial nephrectomy (RPN)] at five academic institutions between 2007 and 2012” and from that group, “A total of 172 patients who underwent RPN with preexisting [chronic kidney disease (CKD)] … were identified. Perioperative results of 121 patients were compared against propensity score-matched controls without CKD”.

After a great deal of analysis, the researchers determined that patients who underwent robot-assisted surgery faced “a higher risk of surgical complications and a longer hospital stay.”  The change in complication rate was not small, either – 21% rate of complications among robot-assisted surgeries, and only about 10% among patients who underwent traditional surgery.

Due to the fact that Da Vinci, the manufacturer of a number of popular robotic surgery systems, has failed to adequately warn users for the risk for an elevated rate of complications and longer hospital stay, a number of Da Vinci surgical robot lawsuits have been filed.  If you or a loved one underwent surgery by surgical robot and faced complications or longer hospital stay, you too may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of surgical robot lawyers at the information provided below.  We have the compassion, resources, and experience required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

A recent article published in the January 2014 edition of Obstetrics and Gynecology titled “Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled trial.” lives up to its title and compares the safety and efficacy of robot-assisted to traditional sacrocolpoplexy.

The team, led by JT Anger, writes “Laparoscopic and robotic sacrocolpopexy are widely used for pelvic organ prolapse (POP) treatment” but that “Evidence comparing outcomes and costs is lacking.”  Accordingly, this study made just that comparison.   The patients studied were female, and totalled 78 – thirty-eight traditional surgeries and forty robot-assisted surgeries.

In general, this small study found the procedures to be fairly comparable, but it was found that robot-assisted surgery resulted in longer operating time and patients suffering from higher pain scores one week after surgery.  Further, the cost of robotic surgery was significantly higher than  the traditional laparoscopic procedure.

While the safety and efficacy of robotic surgery is ever increasing, it is important for patients to be fully aware of risk and complication rates associated with this still-novel procedure.  Due to the fact that Da Vinci, the manufacturer of many popular surgical robot systems, has failed time and again to adequately warn users of the risks associated with robotic surgery, a number of Da Vinci Surgical Robot lawsuits have been filed.

If you or a loved one underwent a robotically-assisted surgery and suffered complications or unintended side-effects, you too may be entitled to significant financial compensation from the manufacturer of the device used.  For a free, no-obligation case consultation, contact our team of Da Vinci surgical robots lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

In 2014, an article by AM Coker et al. titled “Outcomes of robotic-assisted transhiatal esophagectomy for esophageal cancer after neoadjuvant chemoradiation.” in Journal of Laparoendoscopic & Advanced Surgical Techniques aimed to “determine if [robotic-assisted transhiatal esophagectomy (RATE)] could be performed safely with good outcomes for esophageal cancer in a more recent series of patients”.

The authors write “This was a retrospective review of patients with adenocarcinoma of the distal esophagus or gastroesophageal junction who underwent RATE between November 2006 and November 2012 at a single tertiary-care hospital.”  In all, the study consisted of 23 patients – 20 men and 3 women.

“Complications included seven strictures, two anastomotic leaks, and two pericardial/pleural effusions requiring drainage. One patient required pyloroplasty 3 months after esophagectomy.” And sadly, “One patient died from pulmonary failure 21 days after surgery (30-day mortality rate of 4%).”

Due to the fact that this procedure is indeed quite complicated, these researchers purport that “RATE can be performed safely with good oncologic outcomes following neoadjuvant chemoradiation in patients with esophageal cancer”.  What is important however, is that patients be informed of the risk for complications associated with any procedure.

Since Da Vinci, the manufacturer of many popular robotic surgery systems, has failed time and again to make the risk rates clear to users, a number of Da Vinci surgical robots lawsuits have been filed.  If you or a loved one underwent robot-assisted surgery and suffered complications, you too may be entitled to significant financial compensation for your injuries.  For a free, no-obligation case consultation, contact our team of surgical robot lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

In a 2013 article published in the December issue of Journal of Gastric Cancer titled “Emerging Role of Robot-assisted Gastrectomy: Analysis of Consecutive 200 Cases.”, a team of researchers led by JY Park “aimed to evaluate whether gaining experience in robotic gastrectomy could improve surgical outcomes in the treatment of gastric cancer.”  In recent years, surgical robots (particularly those by Da Vinci) have become increasingly common in the operating room, and this study wanted to evaluate their safety and efficacy for gastrectomy – surgical removal of all or part of the stomach.

In this study, researchers evaluated how well the procedure went for the first 100 patients seen at a certain center (while surgeons were still learning to use the surgical robots) and another 100 patients who were operated upon once surgeons were better trained with surgical robots.

Results showed that “Twenty patients developed postoperative complications. Thirteen were managed conservatively, while 6 had major complications requiring invasive procedures. One mortality occurred owing to myocardial infarction.”

Research demonstrating rates of complications as high as 20% demonstrates that though sometimes robotic surgery is safe, it is absolutely not in all cases.  It was in fact shown by this paper that rates of complication and length of surgery time and hospital stay decreased with surgeon training, but regardless, these rates of complications are exceedingly high.

Due to the fact that Da Vinci, the manufacturer of many popular surgical robots has failed to adequately warn of the risk for complications without extensive surgeon training, merely “recommending” that surgeons be trained, a number of Da Vinci surgical robot lawsuits have been filed by patients who faced complications after surgery.

If you or a loved one underwent surgery in which Da Vinci surgical robots were used, you may be entitled to compensation for injury or undue risk of injury you endured.  For a free, no-obligation case consultation, contact our team of Da Vinci Surgical Robot lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

An article published earlier this month (February 2014) titled “Systematic Review and Meta-analysis of Robotic vs Conventional Thyroidectomy Approaches for Thyroid Disease.” by GH Sun et al. in Otolaryngology provides us with helpful insight into the relative safety and efficacy of surgical robots, which have become increasingly prevalent in the modern operating room, at least for certain procedures.

This article compares the outcomes for traditional thyroidectomy and robotically-assisted thyroidectomy “for thyroid nodules and cancer.”  For data, this study team “examined relevant controlled trials, comparative effectiveness studies, and cohort studies for eligible publications” and “calculated the pooled relative risk for key postoperative complications, mean differences for operative time, and standardized mean differences for length of stay (LOS) using random effects models.”

Using a total of 11 studies comprised of a total of 726 patients who underwent robotic surgery and 1205 patients who underwent conventional surgery, the team used a series of statistical analyses to determine which procedure was more safe and effective.  Sun et al. (2014) write “Mean operative time for robotic thyroidectomy exceeded open thyroidectomy by 76.7 minutes”, but note that “There were no significant differences in hematoma, seroma, recurrent laryngeal nerve injury, hypocalcemia, or chyle leak rates.”

However, the team concludes that “Transaxillary and axillo-breast robotic and open thyroidectomy demonstrate similar complication rates, but robotic approaches may introduce the risk of new complications and require longer operative times.” (emphasis added)

Due to the fact that Da Vinci, the manufacturer of many popular surgical robots has failed to warn users of the increased risk for complications associated with its products, a number of Da Vinci surgical robot lawsuits have been filed.  If you or a loved one underwent surgery in which Da Vinci surgical robots were used and faced complications, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Da Vinci surgical robot lawyers at the information provided below.  We have the compassion, experience, and resources required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us