Intuitive Surgical Inc. is confronting new allegations that it failed to provide adequate training for physicians using its da Vinci surgical robot, and may have encouraged less training, thereby increasing the risks to patients undergoing robotic surgery.
No strict training guidelines or requirements currently exist that govern a physician use of the robot on a live patient. The amount and depth of training is currently left within the purview of individual doctors and/or hospitals. Undisclosed personnel from Wentworth-Douglass Hospital in Dover, NH, have stated that their training included only two days of operation on a pig and human cadavers.
Intuitive’s chief medical advisor, Myriam Curet stated that, “The training we do is quite extensive,” and according to Intuitive’s website, “We believe rigorous training standards and support of our System users are essential to establishing and maintaining a successful da Vinci Surgery program.” However, Intuitive’s suggested training regimen hardly seems adequate as it only includes an online quiz consisting of 10 hard-to-fail questions, practice simulators and a one-day training course, as well as a minimal number of proctored cases.
Interestingly, prior to the robot being cleared by the FDA in 2009, the online quiz was 70 questions and the training course was three days long. With regards to adequate training, Benjamin O. Anderson, an FDA panel member at the time, stated that it “is the most important part of what was discussed today.”
In response to a recent lawsuit, Intuitive argued that because “credentialing and privileging for performing surgery at a hospital is solely the responsibility of the hospital,” the case should be dismissed. This particular case was subsequently settled. Nonetheless, lawsuits are continuing to be filed in connection with injuries sustained by patients alleging as causative factors inadequately trained doctors using the robot.
Internal Intuitive emails introduced in a lawsuit filed in Kitsap County, Washington have uncovered a manager’s recommendation to a sales team in connection with meeting sales goals, to not “let proctoring or credentialing get in the way.”
Doctors themselves are voicing their opinions about the learning curve of the robot:
- The American Association of Gynecologic Laparoscopists suggests at least 10 supervised surgeries prior to allowing doctors to use the robot unsupervised.
- Dr. Jim Hu, director of Urologic Robotic and Minimally Invasive Surgery at the David Geffen School of Medicine at the University of California, Los Angeles indicates that, “The robot surgery requires a long learning curve to become good at it,” and specifically referring to prostate cancer surgery, Hu says that proficiency can take up to 200 plus operations to achieve. Dr. Hu assisted on 400 robot surgeries prior to performing them on his own. “None of us would go and get surgery if we knew the guy had done it just a couple of time before,” he says.
- According to a recent study conducted by the Mayo Clinic, published in the Obstetrics & Gynecology medical journal, surgical proficiency “occurs after performing approximately 91 procedures.”
Dr. Anne Kalter, a surgeon from Wentworth-Douglass Hospital, a supporter of robotic surgery, has said that in connection with adequate training, “There is no national standard requirement for this…it will probably be coming in the next couple of years. The technology is so new that every hospital has been finding out on its own what path is comfortable for them to take. “ Unfortunately, the path Wentworth-Douglass chose to take obviously was not adequate. During two routine hysterectomies, a physician accidentally cut the ureters of the patients. Subsequently, the physician performing the surgery and the supervising physician were both required to have remedial training.
Related to lawsuits filed against Fresenius Medical Care in connection with its dialysis products GranuFlo and NaturaLyte, lawsuits are now being filed against the dialysis treatment center, Da Vita Healthcare, in connection with their administration of GranuFlo and NaturaLyte.
GranuFlo and NaturaLyte are drugs used in hemodialysis to treat patients suffering from kidney disease and/or failure. The products were recalled by the FDA in March 2012 mandating revisisons to prescribing instructions to include the health risks connected with the use of these drugs. This was due to an investigation conducted by the FDA with results indicating that use of GranuFlo and NaturaLyte can lead to a heart attack. This risk is due to an ingredient in the drugs that can lead to metabolic alkalosis, which produces high levels of bicarbonate, increasing the risk of heart attack.
The FDA recall was worded as follows:
“The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.
FDA has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.”
As previously reported by Audet and Partners, LLP, the lawsuit filed against Fresenius Medical Care alleges that prior to the FDA’s recall, Fresenius was aware of the potential risks and failed to inform patients and healthcare providers. “Plaintiffs allege that the manufacturer intentionally, recklessly and/or negligently concealed, suppressed, omitted and misrepresented the risks, dangers, defects, and disadvantages of GranuFlo and NaturaLyte.”
Recent lawsuits filed against DaVita allege that it acted negligently through its alleged knowledge that high levels of bicarbonate can cause heart attack, and that the necessary amount of patient supervision, action to eliminate this risk, and/or appropriate treatment during GranuFlo and/or NaturaLyte administration were not provided.
Johnny Williams of Alabama was treated with these drugs at a DaVita dialysis center in June 2010; one month after treatment began, Johnny suffered a heart attack and died. His wife, Arthurine Williams, as administrator of Johnny’s estate, subsequently filed a lawsuit against Fresenius.
According to DaVita, “As of December 31, 2012, DaVita operated or provided administrative services at 1,954 outpatient dialysis centers located in the United States serving approximately 153,000 patients. The company also operated 36 outpatient dialysis centers located in five countries outside the United States.”
While a decision on Bayer’s Motion opposing the consolidation of federal Mirena lawsuits is yet to be issued, more women are surfacing to share their experiences related to implantation and the subsequent side effects of the Mirena IUD. Consequently, more lawsuits are being filed.
Regardless of the decision to be issued by the court in connection with Bayer’s opposition to federal case consolidation, Bayer will have to account for the allegations being made against them, and the numerous cases of damages suffered by their users.
Entire websites and blogs are being created by victims, detailing their horrific experiences with this particular IUD. Many of the victims have said that they were under-informed about the side effects, which have caused them extreme hardship and in some cases, irreparable damage. These include:
- Migraine headaches
- Weight gain
- Decreased libido
- Extreme fatigue
- Abdominal cramping
One of the Plaintiffs, a Missouri woman, experienced no side effects after the initial implantation; however, approximately one year later, she began experiencing severe cramping. A visit to the ER and an ultrasound revealed that the Mirena IUD had perforated her uterine wall, leading to surgery for its removal. Bayer’s caution in this regard was only in reference to perforation during implantation, not after.
Another startling situation involved a young woman whose Mirena IUD had migrated within her body. Her health care providers were unable to locate the IUD after its migration, and assumed that it had fallen out. Unfortunately, it had not fallen out but remained in her body for years. It was not located until she began experiencing abdominal cramping when she was 12 weeks pregnant, which required a very high risk surgery to remove the IUD.
Infertility as a result of uterine perforation is a possibility. One woman became pregnant shortly after she underwent surgery to remove a Mirena IUD that had perforated her uterine wall. She subsequently suffered a miscarriage and now may be infertile.
As with many pharmaceutical companies, Bayer invested millions in their marketing campaign, targeting “busy moms” who already had children and were looking for a long-term, effective and convenient form of birth control that had the ability to increase a woman’s libido. This campaign was hugely successful. The use of IUDs as an effective means of birth control increased 10.4 percent. Bayer clearly over-promised and under-delivered.
The pending lawsuits allege that Bayer misrepresented the benefits of Mirena, failed to warn about dangerous side effects, understated the product’s complications as “uncommon,” engaged in deceptive marketing, breached implied and express warranty, concealed the harmful side effects of Mirena, failed to provide adequate warnings and instructions, produced and knowingly sold and distributed a defective product, and designed a defective product.
As recently reported, the Federal Communications Commission (FCC) has previously taken steps to protect consumers from text message solicitations otherwise known as “text spam.” Earlier this month, the Federal Trade Commission (FTC) stepped in to file charges against 29 defendants (comprised of text spam operators, “spammers,” and associated website operators involved in the scam) in various jurisdictions around the United States. The targeted defendants allegedly sent 180 million unwanted text messages to unsuspecting consumers. According to Charles A. Harwood, acting director of the FTC’s Bureau of Consumer Protection, “The FTC is committed to rooting out this deception and stopping it…”
This particular scam is in the form of a text spam. It promises the consumer free gifts cards and prizes, such as a $1000 gift card to Walmart, Target or Best Buy. It has been referred to as the “Text Scam Best Buy,” “Target Scam” or “Free Walmart Gift Card.”
How it Works
1. The text scam entices consumers with a text spam message instructing them to follow the link provided for redemption of a free gift card or prize.
2. When the link is followed, it leads to particular websites at which personal information is requested e.g., address, phone number, birthdate, social security number. This information is sometimes requested under the pretense of “shipping” information for the free gift card or prize.
3. Consumers are further directed to different websites where, in order to receive the gift card or prize, they are required to sign up for other offers that require credit card information or applications for credit cards.
4. Finally, after the consumer has completed the exhaustive process, they are informed that in order to receive the gift card or prize, they must find three other individuals to complete this same process.
Once the spammers have obtained the personal information, it is sold to third parties for marketing purposes. The spammers are also paid by the operators of the associated websites according to the number of consumers that enter personal information, subscribe or apply. This deception is a form of text fraud and a threat to the consumer. Not only is personal information sold to third parties, but additional injury may result as follows
• Personal information may fall into the hands of identify thieves
• Credit card applications required as part of the scam may negatively impact credit
• Malware may be installed on the phone
• Unwanted charges may be billed to the phone account
• Phone performance is slowed and memory space is occupied
Text Spam Violation
The FTC has determined that the defendants have violated specific FTC regulations by failing to fully disclose all terms and conditions associated with obtaining the gift card or prize. As such, this practice involving text spam constitutes a “deceptive” and “unfair practice” under applicable FTC regulations.
What You Can Do
Any consumer wanting to block unsolicited spam texts should not reply to them, as a reply verifies that the number is valid and malware could be downloaded.
If you or someone you know has received an unwanted spam text message, contact a Spam Text Lawyer at Audet and Partners, LLP for a free consultation to learn more about your rights. You can request a free consultation by completing and submitting the confidential form to the right of this page or at our spam text website at http://audetlaw.com/spam_text/, or call us toll-free at (800) 965-1461.
National Shoe Store Finish Line, Inc. May Be Held Accountable for Videotaping by Store Manager of Employee Restroom and Customer Change Room
In another victory for employees and privacy rights, a ruling issued this week against Finish Line, Inc. will further establish employer liability in cases involving illegal videotaping of employees by a store manager. In Antonelli v. Finish Line, Inc., ADRS Case No. 12-5331-JCI, a binding arbitration ruling denied Finish Line, Inc.’s Motion for Summary Judgment on most claims brought by Plaintiff employees, including specific statutory violations, as well as invasion of privacy and infliction of emotional distress.
The Plaintiffs, represented by William M. Audet and Joshua C. Ezrin of Audet and Partners, LLP, have alleged that a Finish Line, Inc. store manager, David Meyer, mounted a security camera in the employee restroom and customer change room in 2009. Mr. Meyer has claimed that he used the hidden camera as part of a loss prevention investigation.
Finish Line, Inc., an athletic apparel retailer with 660 stores in 47 states, had argued that an employer cannot be held liable for the intentional or criminal conduct of its employees. The arbitrator, Hon. James C. Emerson (Ret.), disagreed, holding that “triable issues of fact” exist as to whether the company “actually induced” or “actually caused” the alleged videotaping. Under the legal doctrine of respondeat superior, employers are traditionally liable for the acts of employees provided those acts were within the scope of their employment.
Audet and Partners, LLP is a national plaintiff’s firm based in San Francisco, CA with practice areas including Employment Law, and individual privacy rights. To learn more about this case, please contact Audet and Partners, LLP at (800) 965-1461, or click here to submit our online inquiry form. You can click here to learn more about our employment law practice.
The United States Supreme Court is set to decide a series of cases this year that could have a dramatic impact on the future of class action litigation. The way the nation’s highest court rules in these cases could impact class action litigation in a litany of cases that cover such diverse topics as unsafe pharmaceuticals, defective medical devices, consumer fraud claims, defective consumer products claims and other cases that are often pursued as a class action lawsuit. The key cases that the Justices will hear on class action issues include:
Genesis HealthCare Corp. v. Symczyk: This case is not actually a class action case, but the ruling could provide a powerful tool to defendants facing the possibility of a full blown class action case. The Supreme Court will consider whether a defendant corporation’s offer to pay all claims brought by an individual plaintiff renders any prospective class action moot. If the court determines that defendants may legitimately use this strategy and moot class actions, defendants may find it far less expensive to satisfy the claims brought by an individually-named defendant than deal with the potential exposure and litigation expense of defending against a class action lawsuit.
Standard Fire Insurance Co. v. Knowles: The Justices will consider whether a stipulation by a class representative that damages are below the threshold for removal to federal court can prevent defendants from transferring the case to federal court pursuant to the Class Action Fairness Act. An amicus brief has been filed in this case claiming that state courts do not subject proposed classes to “meaningful scrutiny” as required under the federal rules and utilize procedural mechanisms that facilitate nuisance claims. Another objection by a defendant in this case is that permitting a class representative to stipulate to a damage amount below the $5 million threshold to avoid removal could also expose corporations to defending overlapping class action in state courts in many jurisdictions.
Comcast v. Behrend: This pending matter involves revisiting a matter addressed by the Court in Wal-Mart v. Dukes decided in the previous Supreme Court term. The question at issue is the appropriate degree of scrutiny to be applied by the District Court when evaluating evidence on the merits and deciding whether to certify a class action. The Court noted in Wal-Mart that it was the largest class action ever certified, and the number of claimants involved in the class in Comcast is even greater. The parties in this case disagree on whether the District Court was sufficiently rigorous when evaluating an expert report on the scope of damages alleged by the members of the class. The Court during argument in this case seemed to be focused on whether the rigorous standards of Daubert v. Merrell Dow Pharmaceuticals must be met regarding expert witness testimony on damages. The defendants contend that if Daubert is not applied, defendants could be forced to defend a class action even if there is no evidence that a remedy could be provided on a class wide basis.
While it is too early to determine how the Supreme Court will rule on these cases, the rulings could substantially impact pending and future class action cases. Audet and Partners, LLP represents clients in multi-district litigation and class actions involving defective medical products and unsafe pharmaceuticals. We offer a free consultation so that we can evaluate your legal claim and advise you of your options. We invite you to call us at (800) 965-1461, click here to submit our confidential online inquiry form, or visit our class action blog at http://www.class-action-blog.com.
Bayer Healthcare Pharmaceuticals has taken a position opposing consolidation of legal actions brought against the medical device manufacturer for the Mirena IUD that can only be described as schizophrenic. Bayer opposed the motion filed in the U.S. District Court of Ohio to proceed by consolidating these claims in Multidistrict Litigation (MDL), which is similar to a class action. MDL involves coordinating cases for pre-trial purposes such as conducting discovery and hearing of pre-trial motions.
The plaintiffs moved for consolidation of all existing and future cases against Bayer for injuries caused by the Mirena intrauterine device on January 16, 2013. The plaintiffs requested the cases be heard in front of Judge Patricia A. Gaughan in the United States District Court for the Northern District of Ohio, Eastern Division. There are currently a couple dozen Mirena lawsuits pending against Bayer for Mirena IUD related injuries. Most of the cases were filed during the last twelve months and involve post-insertion injuries caused by the Mirena IUD system. The motion for consolidation argues that consolidation will prevent redundant overlapping discovery, preserve judicial resources and prevent conflicting rulings.
While Bayer asserts a number of legal theories to support its opposition, one of the main claims is that the cases pending do not allege common questions of fact. This position is contrary to that asserted by Audet and Partners, LLP attorney for several individual Mirena plaintiffs, and ironic given that Bayer filed a motion for consolidation of Mirena cases in a Middlesex, NJ state court in August 2012. Although Bayer has completely reversed its prior position, the manufacturer of the Mirena IUD claimed consolidation was appropriate based on the premise that many of the claims involved common issues of law and fact.
The medical device company now also opposes consolidation on the grounds that it has engaged in extensive pre-trial preparation in a case filed in South Carolina. Bayer argues that consolidating the cases would negate the extensive work and financial investment already performed in defending that case including production of 1.7 million pages of relevant documents.
Bayer also argued that consolidation would encourage plaintiffs with weak claims to come forward, which would prejudice Bayer. According to the opposition paperwork filed by Bayer, the cases filed to date are without merit because the labeling of the Mirena IUD warns of the risk of perforation. However, the plaintiffs have responded by indicating that the label does not warn of any risk of post-insertion perforation or spontaneous migration that may cause the post-insertion perforation. This means that women may have been lulled into a false sense of security because no symptoms would have been immediately noticeable if the perforation injury did not occur during insertion of the medical device.
The objections raised by Bayer to consolidation are common in this type of litigation. The hearing on the MLD consolidation request is scheduled for later this month – March 21, 2012 in San Diego, CA. The judicial panel will rule on whether the cases should proceed as MDL and determine the location of the consolidation.
If you have suffered injury caused by a Mirena intrauterine device, our experienced Mirena IUD injury attorneys at Audet and Partners, LLP offer a free consultation so that we can evaluate your legal claim and advise you of your options. We invite you to call us at 800-965-1461, e-mail our confidential case inquiry form on the right side of this page, or visit our Mirena IUD website at http://www.MirenaComplaints.com.
The first jury verdict against Johnson and Johnson (J&J)’s Ethicon subsidiary has resulted in a powerful statement regarding the pharmaceutical company’s lack of adequate warnings of the health risks posed by the transvaginal mesh implants. A New Jersey jury awarded a nurse from South Dakota a total damage award of $11.46 million, which was comprised of $3.35 million in compensatory damages and $7.76 million in punitive damages. The plaintiff suffered serious medical complications after receiving a Prolift Transvaginal Mesh implant that required her to undergo eighteen corrective surgeries. In light of the jury’s findings, if you or one close to you has suffered physical problems associated with transvaginal mesh, you are urged to contact Audet and Partners, LLP at (800) 965-1461.
The jury verdict was rendered in a New Jersey court where 2,500 other transvaginal mesh injury lawsuits are currently pending. The massive number of transvaginal mesh lawsuits is pending against several manufacturers, which include Boston Scientific, C.R. Bard, Johnson and Johnson and American Medical Systems. The lawsuits generally allege that the manufacturer of the medical device failed to provide adequate warnings to surgeons and patients of serious complications that may result from implantation of the surgical mesh. After the jury rendered its compensatory damage award, the judge considered whether to permit the jury to consider a punitive damage award. The judge’s decision to authorize a punitive damages award and the substantial amount awarded could significantly impact the thousands of other pending transvaginal mesh injury lawsuits throughout the Unted States.
While the transvaginal mesh product that was the subject of the lawsuit has been recalled, it was previously surgically implanted in thousands of women who suffered from pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Vaginal mesh was used to treatment incontinence caused by weakening of ligaments caused by childbirth, hysterectomies, and menopause. The medical device was recalled in part because the FDA warned that the mesh could breakdown after implantation, resulting in infections, complications of the bowel and urinary tract, pain and other serious medical complications. The most dangerous risk posed by transvaginal mesh also is the most common complication. When the material erodes (sometimes referred to as “mesh extrusion”), the rough edges of the material may perforate the vaginal lining or other organs in the proximity of the implant.
The FDA issued a notification to the public warning of the serious potential complications associated with transvaginal mesh in 2008. The federal agency indicated that defects involving the medical device could necessitate revisionary surgery but that such a risk was a rare occurrence. In 2011, the FDA revised its prior advisory to indicate that serious complications associated with transvaginal mesh were not rare. Manufacturers of the medical product were later directed to undertake safety studies. While the post-market safety studies were eventually ordered, approval for transvaginal mesh implants was obtained via the FDA’s fast track approval system, which does not require testing prior to the medical device being placed on the market.
Call Audet and Partners, LLP at (800) 965-1461 for your free consultation
If you have suffered injury caused by a transvaginal mesh implant, our experienced transvaginal mesh injury attorneys at Audet and Partners, LLP offer a free consultation so that we can evaluate your legal claim and advise you of your options. We invite you to call us at (800) 965-1461 or complete and submit our confidential case inquiry form to the right of this page. You can also learn more about problems associated with Vaginal Mesh by visiting http://www.vaginalmeshlaws.com.