Articles Posted in Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a rare “black box warning” on power morcellation devices for laparoscopic surgery to remove uterine fibroids or to perform a hysterectomy.

The warning cautions women considering undergoing fibroid removal surgery with the devices. The warning tells women that they may wish to choose an alternative type of surgery because surgery with the device could inadvertently spread undetected cancer.

The Wall Street Journal answers five questions about the device warning. You can read more here: 5 QUESTIONS ABOUT THE FDA WARNING ON MORCELLATORS, UTERINE FIBROIDS

According to the FDA, it is estimated that one in 350 women who undergo hysterectomy or fibroid removal surgery has a uterine sarcoma, a kind of cancer. Morcellators are devices that dissect the uterus or fibroids using a spinning blade. However, if the blades come into contact with a malignant cancer, cancer cells can spread in the pelvis and abdomen worsening a person’s likelihood of surviving.

If you or a loved one has had an onset of cancer after power morcellation surgery, you should contact a faulty medical devices attorney about the possibility of filing a lawsuit.

The Farber Law Group, a personal injury law firm in Bellevue, Washington, has represented cases involving faulty medical devices. Call us today for a free and confidential case evaluation.

Contact The Farber Law Group at 1-800-244-9087 or to schedule a free and confidential case evaluation. Our Bellevue office is here to assist you.
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Seattle DePuy Hip Replacement LawyerThe Farber Law Group, a personal injury law firm located in Bellevue, Washington, represents people who have been seriously injured by the now-recalled DePuy ASR hip replacements. We have been closely monitoring the couple of cases that have gone to trial and the settlements that each of the victims received.

DePuy may be considering settling cases rather than taking them trial after a Los Angeles jury awarded a plaintiff $8.3M.

In reading several blogs and reports in Bloomberg News and The National Law Journals, it appears that DePuy Orthopedics Inc., may be close to settling more than 10,000 lawsuits brought against it. Bloomberg News says that Johnson & Johnson, DePuy’s parent company, may have set aside $3 billion to compensate the victims of the defective implants.

Some blogs are even suggesting that several cases that were slated for trial have already been settled on the QT. One such case scheduled for California court appears to be settled and one in New Jersey has been recorded as resolved and the cases were removed from Bergen County District Court trial calendar.

In Ohio where several federal cases were consolidated, the September 24 trial date has been postponed. Perhaps there may be settlements in the works before this case goes to trial.

We will keep you apprised to what we learn about case settlements and are keeping our clients abreast of the fast changing legal landscape.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. Call us today for answers to your questions about your hip implant and your legal standing in regards to filing a lawsuit.
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A jury in Kitsap County Superior court is deciding the outcome of a lawsuit, Estate of Fred. E. Taylor v. Intuitive Surgical Inc., filed by the widow of Fred Taylor who was seriously injured during robot-assisted prostate surgery performed using a da Vinci robotic system made by Intuitive. The jury heard five weeks of testimony before going into deliberations yesterday.

Taylor’s estate seeks $8.45M in damages from Intuitive Surgical Inc.

Taylor, who was 67 years old at the time of his surgery, suffered serious injuries during the robot-assisted surgery. His urologist, Dr. Scott Bildsten, was using the da Vinci robotic system unassisted for the first time since training when Taylor was injured. His injuries included a torn rectum, kidney and lung damages, memory loss, incontinence and a stroke. He lived for four years after the surgery but was unable to return to his normal life.

Previously, Bildsten had performed 100 prostatectomies using conventional surgery before Taylor’s botched surgery.

Taylor’s estate has already settled a medical malpractice case with the surgeon and hospital. The estate filed this lawsuit claiming that Intuitive was negligent in 10 different ways including misleading surgeons into thinking that surgery using a robot was easy and required but a day of training and providing inadequate training.

This is the first case of 26 lawsuits against Intuitive to go to trial and the outcome of the case is being closely scrutinized.

Robotic Surgery

There are approximately 400,000 robot-assisted surgery performed every year and the FDA is correspondingly receiving adverse event reports as there are more robot-aided surgeries before. Since 2012, there have been 500 adverse event reports including the deaths of five patients and reports of several patients suffering serious injuries.

A robotic surgery machine is a costly investment for a hospital. With a price tag of almost $1.5M and maintenance service agreements of $100K annually, there is an incentive for hospitals and surgeons to use the devices to recoup costs.
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The Food and Drug Administration (FDA) is considering changing the 510(k), accelerated device approval process, which currently provides medical device manufacturers a “fast track” in obtaining FDA approval to bring a new device to market after an Institute of Medicine Report (IOM) made the recommendation.

Currently, medical device manufacturers are able to issue a Premarket Notification which claims that a new medical device is “substantially equivalent” in design, material, intended use and manufacturing than an existing device, then the device is cleared to come to market without lengthy testing.

The 510(k) process has come under fire from consumer groups after devices like the DePuy ASR XL hip implant system had a high failure rate. Many feels that the 510(k) process has brought defective devices to market without adequately testing them, putting patient’s health at risk.

In the case of the DePuy hip implant, the implants shed metal in some patients when the metal-on-metal components rubbed against each other causing a serious condition called metallosis. Patients also had other complications including fractures and severe pain.

The DePuy hip implants are not the only devices that have used a fast pass through the system. Other products including pacemakers, stents, bandages and artificial knees have also used the 510(k) approval process which substantially reduces costs for the manufacturer.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We are a personal injury law firm and we represent the product liability claims of people who have been injured due to defective medical devices.

Related Posts:

DePuy hip implant recall shows the need for National Joint Registry in the U.S.

U.S. Senate hears testimony from patient with defective DePuy hip implant

Congress and FDA discussing medical device review process
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