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FDA Warns Against Laparoscopic Power Morcellation in Uterine Surgery

The U.S. Food and Drug Administration (FDA) has warned that laparoscopic power morcellation, a device used during uterine surgery in the vast majority of women, should be avoided.

Nearly 50,000 women a year in the United States undergo power morcellation surgery. The devices have been widely used in surgeries to remove fibroid tumors from the uterus, or to remove the entire uterus. Morcellators cut fibroid tissue into small pieces so they can be easily removed from the body, according to The New York Times (Times). More FDA Warns Against Laparoscopic Power Morcellation in Uterine Surgery

Knee Replacement Surgery does not Offer all Patients Relief from Pain and Disability

Knee replacement surgery may not be appropriate for everyone with knee problems. Many patients go through the pain and recovery of the surgery only to experience minimal improvement, and younger patients may have to undergo more than one replacement procedure in their lifetime.

The number of knee replacement surgeries surged to 600,000 in 2012 from 250,000 just 15 years ago, but not all of those patients regained their mobility and a pain-free life. An increasing number of younger people are opting for the surgery, according to the American Academy of Orthopaedic Surgeons. The number of knee replacements in people between 45 and 64 rose by 205 percent between 2000 and 2012; among people 65 and older, the number increased only 95 percent, The New York Times (The Times) reported. More Knee Replacement Surgery does not Offer all Patients Relief from Pain and Disability

Stryker Pays $1 Billion to Settle Thousands of Lawsuits Over its Rejuvenate and ABG Hip Replacement Devices

Medical device maker Stryker announced Monday that it has settled thousands of lawsuits over its Rejuvenate Moduler-Neck and ABG II Modular-Neck hip replacement devices. The company said it settled the cases for about $1 billion.

The deal will be one of the largest amounts paid in the last year by an implant manufacturer to resolve suits brought by patients who allege they were injured by a metal-on-metal (MoM) hip device. Stryker said that it allotted $1.45 billion to settle the claims but that it expected the expenses to rise. Johnson & Johnson’s (J&J) DePuy unit settled 8,000 lawsuits over its ASR hip implants last November for about $2.5 billion, according to The New York Times (The Times). More Stryker Pays $1 Billion to Settle Thousands of Lawsuits Over its Rejuvenate and ABG Hip Replacement Devices

Some Gynecologists are Still Using Power Morcellation to Remove Uterine Fibroid Growths Even After the FDA Warned They Could Spread Cancer

Many gynecologists continue to use power morcellators to remove fibroid tissues despite warnings from the U.S. Food and Drug Administration (FDA) that the devices can spread unseen cancer.

Power morcellators cut fibroid tissues into small pieces that can be extracted through small incisions. The laparoscopic (minimally invasive) surgical technique is supposed to allow patients to recover more quickly with fewer complications and less blood loss. About 50,000 morcellation procedures are performed each year. In April 2014, the FDA asked surgeons to place a moratorium on morcellators in a safety advisory, but some doctors have ignored the agency’s pleas, saying the risks are overblown, according to EmpowerHER.com. More Some Gynecologists are Still Using Power Morcellation to Remove Uterine Fibroid Growths Even After the FDA Warned They Could Spread Cancer

Appeals Court Revives Medtronic Infuse Lawsuit

A special appeals court found Monday that off-label promotion claims related to a Medtronic-related lawsuit are not preempted, thus reviving a man’s lawsuit filed over Medtronic’s Infuse bone growth product.

The man alleges he suffered serious injuries after his surgeon inserted the Infuse device in an off-label manner during 2007 surgery to treat back pain. The U.S. Food and Drug Administration (FDA) approved Infuse to be inserted in an anterior approach, but the patient claims his surgeon inserted the device in a posterior approach at the urging of Medtronic, the product’s manufacturer, Law360 reported. More Appeals Court Revives Medtronic Infuse Lawsuit

DePuy Moved Forward with its Pinnacle hip Device Despite a lack of data About the Implant’s Possible Risks

DePuy Orthopaedics did not analyze any human studies that looked at the health effects of metal debris for the company’s Pinnacle hip implant before 2001 because none existed, an executive for the Johnson & Johnson (J&J) subsidiary told a jury on Monday.

Pamela Plouhar, the worldwide vice president of clinical research at DePuy, testified in defense of the company in the first trial of more than 6,000 lawsuits filed over the Pinnacle metal-on-metal (MoM) implant. The cases have been consolidated before U.S. District Judge Ed Kinkeade in the U.S. District Court for the Northern District of Texas in Dallas. The lawsuits allege DePuy failed to comprehend and warn patients and doctors about the dangers of the device, marketing them as safe, Reuters reported. More DePuy Moved Forward with its Pinnacle hip Device Despite a lack of data About the Implant’s Possible Risks

Woman Alleges Pinnacle Hip Implants are Defective

A Montana woman who filed a lawsuit against Johnson & Johnson subsidiary DePuy Orthopaedics alleging her metal-on-metal Pinnacle hip implant was defective and caused her to endure substantial pain is the first Pinnacle hip implant case to go to trial.

The trial is taking place in the U.S. District Court for the Northern District of Texas in Dallas. U.S. District Judge Ed Kinkeade is presiding over the case. More Woman Alleges Pinnacle Hip Implants are Defective

The First of 6,000 Pinnacle Hip Lawsuit Cases is Underway in the Texas District Court

The first of 6,000 cases  related to the Pinnacle hip implant device went to trial on September 2, 2014 before U.S. District Judge Ed Kinkeade in the U.S. District Court for the Northern District of Texas in Dallas.

The lawsuit was filed on behalf of Kathleen Herlihy-Paoli, a Montana woman who claims she was implanted with two Pinnacle hip devices in 2009. Shortly after the surgery, Herlihy-Paoli said she began experiencing pain and had to have the devices removed in 2011, court records show. According to the lawsuit, the Pinnacle hips leaked a large amount of metal debris into the woman’s body, causing an infection. More The First of 6,000 Pinnacle Hip Lawsuit Cases is Underway in the Texas District Court

Johnson & Johnson’s Ethicon Unit Will Pay $3.27 Million to Woman Injured by TVT-O Transvaginal Sling

A woman who alleged she was seriously injured by a TVT-O transvaginal sling made by Johnson & Johnson’s Ethicon unit was awarded $3.27 million by a West Virginia federal court jury last Friday.

After only three hours of deliberation, the panel found that Ethicon’s TVT-O transvaginal sling was defectively designed and that the company didn’t warn of the device’s potential risks. The jury found in favor of Jo Huskey on all counts, including strict liability, design defect, failure to warn and negligence, according to Law360. More Johnson & Johnson’s Ethicon Unit Will Pay $3.27 Million to Woman Injured by TVT-O Transvaginal Sling

Recall of Jawbone Lengthening Plate is Johnson & Johnson’s Twelfth Class-I Recall Since 2012

The U.S. Food and Drug Administration (FDA) announced last week that Johnson & Johnson’s DePuy Synthes subsidiary recalled some lots of its Craniomaxillofacial Distraction System jawbone lengthening  plate.

The agency is concerned the Craniomaxillofacial Distraction System could cause serious injury or death in patients fitted with the devices because they may reverse direction post-operatively.  The systems are used to lengthen and/or stabilize the lower jawbone and the side of the lower jaw in pediatric and adult patients to correct congenital or post-traumatic defects of the jaw by gradually lengthening the bone, the FDA said on the agency’s website. More Recall of Jawbone Lengthening Plate is Johnson & Johnson’s Twelfth Class-I Recall Since 2012