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Ethicon 94 articles

Physiomesh Marketed without Adequate Testing

Physiomesh, a hernia mesh device made by Johnson & Johnson and its subsidiary, Ethicon, was approved by the FDA in a 510(k) process, which allows the company to fast-track the product onto the market without adequately testing the product for safety and efficacy, according to The Ring of Fire Network. Many lawsuits have been filed alleging failed Physiomesh devices are connected to serious injuries. Claims have been filed by a Florida woman who says she suffered excruciating pain as a result of the mesh, a Canadian woman who describes her pain as if her “insides are going to explode,” and a Louisiana woman who ... Read More

Lawsuit alleges Physiomesh failure

A Florida woman filed a lawsuit in January against Johnson & Johnson and subsidiary, Ethicon, alleging the failure of its Physiomesh hernia repair mesh device required a patient to undergo revision surgery. The Daily Hornet reports that on Feb. 3, 2016, Sarah Ann Gilman had a Physiomesh device implanted laparoscopically to repair a ventral hernia. After the surgery, Gilman began experiencing significant pain, and returned to have doctors check for any issues. She was found to have complications allegedly linked to the hernia mesh, including an abdominal bulge, a recurrent hernia, and mesh adhesion failure. Revision surgery was required, but the issue can never ... Read More

Hernia Mesh Is Defective, Lawsuit Claims

A Lackawaxen, Pennsylvania, couple is suing Johnson & Johnson and its subsidiary, Ethicon Inc., claiming injuries related to a defective hernia mesh product. Robert Mead and Patricia Mead filed a lawsuit on May 8 against the medical device manufacturing giant alleging the company produced a defective product for hernia treatment that has resulted in chronic pain, the Pennsylvania Record reports. The complaint, filed in the U.S. District Court for the Middle District of Pennsylvania, states that Robert Mead, who received Ethicon’s composite mesh for hernia treatment, has experienced serious physical injuries caused by the hernia mesh. Robert and Patricia want J&J and Ethicon ... Read More

First Physiomesh Lawsuit Goes to Trial in 2018

The first lawsuit filed against Johnson & Johnson and subsidiary Ethicon Inc. over complaints the companies’ Physiomesh device failed is scheduled to go to trial in 2018, according to the Daily Hornet. In June of 2016, Ethicon Inc. issued a market withdrawal at a global level for Physiomesh Flexible Composite Mesh due to the high rate of revision surgery required. “Analysis of unpublished data from two large independent overseas hernia registries (Germany and Denmark) has shown that laparoscopic ventral hernia repair using Ethicon Physiomesh Flexible Composite Mesh has a higher rate of recurrence/reoperation compared to the average rates of other similar products among patients…” ... Read More

Ethicon loses appeal in $3 million pelvic mesh verdict

Johnson and Johnson unit Ethicon is unhappy with and petitioning against the Fourth U.S. Circuit Court of Appeals’ recent decision to uphold a $3.27 million jury verdict in the second Ethicon pelvic mesh bellwether trial. This was the first of the 31,676 lawsuits to go to trial in the New Jersey multidistrict litigation against Ethicon related to the mesh devices. The trial, which concluded on Sept. 5, 2014. involved plaintiffs Jo and Allen Huskey, who alleged that because of a design defect in Mrs. Huskey’s TVT-O sling she experienced severe pain. The sling had eroded and surgery could not completely remove ... Read More

Multiple hernia mesh implant manufacturers face lawsuits

Johnson and Johnson subsidiary Ethicon is already being sued by plaintiffs who are accusing the company of selling a defective hernia mesh implant. Physiomesh™ Flexible Composite Hernia Mesh was removed from the American market in May and recalled in Europe and Australia because studies comparing it to similar devices found that Physiomesh had higher rates of recurring hernias and need for re-operation. The mesh has also been linked to more post-operative pain than similar devices and an increased risk of additional surgeries, organ perforation, mesh migration, sepsis and even death. A trial date is set for Jan. 22, 2018, in ... Read More

Bellwether verdict against J&J pelvic mesh upheld by NJ Supreme Court

Mass Tort Nexus reports that the New Jersey Supreme Court has upheld an $11.11 million verdict from a February 2013 bellwether trial against Johnson & Johnson unit Ethicon, Inc. over its Gynecare Prolift mesh product used to treat pelvic organ prolapse and adverse effects related to the product. The Supreme Court refused to hear an appeal by the company, which had previously had post-trial motions denied by New Jersey Superior Court Judge Carol E. Higbee. Also in March this year a three-judge appellate panel of the state appeals court heard the defendant’s oral arguments challenging Judge Higbee’s decision to uphold ... Read More

Studies linking Ethicon’s Physiomesh to recurrent hernias and re-operations lead to recall, market withdrawal

The Daily Hornet reports that American consumers were not warned by the FDA in May that Johnson and Johnson subsidiary Ethicon was removing Physiomesh™ Flexible Composite Hernia Mesh from the market rather than correcting issues with the product. Physiomesh was recalled in Europe and in Australia, but in the United States the company issued a “market withdrawal” of the product, which did not require FDA announcement as a recall would. Physiomesh was originally approved by the FDA in April 2010 through a 510k submission, which bypassed the extensive safety and efficacy testing required of new products and allowed the product ... Read More

2016: a bad year for Johnson and Johnson

The Legal Intelligencer says a Johnson and Johnson attorney overseeing products liability litigation said “2016 just happened to be a bad year for trials.” In spite of having “an arsenal of trial teams” Johnson & Johnson, which expects worldwide sales this year to surpass $72 billion, has lost an attention-getting number of high-profile cases. Both Johnson and Johnson and DePuy were found liable for negligent design defect, negligent failure to warn, strict liability failure to warn, failure to recall, negligent misrepresentation, intentional misrepresentation and fraudulent concealment. “After the verdict was read, U.S. District Judge Ed Kinkeade urged the parties to appoint a settling ... Read More

Will other power morcellator makers move to settle lawsuits?

Johnson & Johnson’s Ethicon, maker of about three quarters of the power morcellators on the market, has made efforts to settle almost all of the lawsuits alleging its device caused the spread of undetected uterine cancer. The company hasn’t said why it’s taken such swift measures to resolve the lawsuits, but manufacturers of other power morcellators are sure to take note. Power morcellators are surgical tools used for laparoscopic hysterectomies and myomectomies (uterine fibroid removals). The tools are fitted with a long, tube-like blade that shreds entire uteruses or uterine growths within the body and removes them through a small ... Read More