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ethicon 9/25
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Experts Say Ethicon Didn't Disclose Pelvic Mesh Dangers
Sep 24, 2015 | Law 360
By Jess Davis
Johnson & Johnson's Ethicon unit allegedly didn't disclose to doctors all the risks and complications associated with its Prosima vaginal mesh product, expert witnesses testified Thursday in Texas state court. -
Trial Gets Underway in Texas Ethicon Gynecare Prosima Transvaginal Mesh Action
Sep 24, 2015 | Harris Martin Publishing
Trial is underway in a Texas state court action in which a woman claims she suffered multiple injuries as a result of Ethicon’s allegedly defective Gynecare Prosima Pelvic Floor Repair System, which was implanted to treat her pelvic organ prolapse. -
Mass tort filings decrease significantly this year, as of August
Sep 24, 2015 | Pennsylvania Record Report
By Nicholas Malfitan
...Last year, 987 lawsuits over the drug Risperdal and 694 filed over pelvic mesh products led to 2,095 new lawsuits. As of Aug. 2, the CLC contains an inventory of 5,238 cases, with Risperdal accounting for 1,420 of them (27.1 percent), and Pelvic Mesh Litigation totaling 183 (3.5 percent).
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Experts Say Ethicon Didn't Disclose Pelvic Mesh Dangers
Sep 24, 2015 | Law 360
By Jess Davis
Johnson & Johnson's Ethicon unit allegedly didn't disclose to doctors all the risks and complications associated with its Prosima vaginal mesh product, expert witnesses testified Thursday in Texas state court.
In the first trial involving Ethicon Inc.'s Prosima device, Dallas County District Court jurors were shown internal Ethicon documents that experts in U.S. Food and Drug Administrationregulation and in urogynecology said showed the company was aware the product presented more risks and potential complications than Ethicon told doctors about. Plaintiff Carol Cavness alleges the Prosima was defectively designed and says she has dealt with chronic pain since she was treated with the mesh.
In the trial's second day of testimony, two expert witnesses told the jury research studies funded by Ethicon showed that a long-existing procedure that uses natural tissue was safer and more effective in treating pelvic floor prolapse than using the Prosima system, which includes a piece of mesh that's permanently implanted and a temporary vaginal support device. They said doctors weren't told the Prosima had a higher risk of needing a second operation than the natural tissue surgery but were instead left to find that information through independent research.
Regulatory expert Peggy Pence said an Ethicon study showed dozens of "red flags" about the Prosima device, including complications like bleeding, tissue erosion, infections and adhesion, but that those risks weren't disclosed to doctors in information that accompanied the device.
Urogynecologist Bruce Rosenzweig said Ethicon's own medical director had questioned why anyone would spend money on a device like the Prosima when they could get the same results from using native tissue.
"Prosima is defective," Rosenzweig said. "The risks outweigh the benefits. It is unreasonably dangerous."
Rosenzweig said Ethicon's "instructions for use" document provided to doctors was dishonest about the Prosima's side effects and potential complications when compared to information in studies of the mesh. He said the instructions disclosed only that patients could experience temporary pain from mesh, when in reality, patients could experience chronic pain; that the instructions falsely claimed the mesh would not degrade inside the body; and that doctors weren't informed about adverse reactions like scarring and the distortion of the mesh itself.
Rosenzweig said it would have been feasible at the time Prosima was introduced for Ethicon to have used a lighter weight, less stiff and partially absorbable mesh called Ultrapro instead of the Gynecare mesh used in the Prosima device.
Ethicon attorney William Gage of Butler Snow LLP said the company's publicly released studies identified the risks associated with the Prosima. He said Ethicon's internal documents reflected discussion among doctors about whether pelvic mesh should be implanted in initial treatment of pelvic organ prolapse or if it should be reserved as a backup if an initial natural tissue repair failed.
"There's a debate," Gage said. "Should a woman have a natural tissue repair or a mesh repair?"
Gage pointed out to jurors that Rosenzweig had never worked with Prosima, nor had he ever tested Ultrapro mesh in the same configuration as the Prosima device. He also pointed out there is no data on the potential utility of Ultrapro for treating advanced stages of pelvic organ prolapse.
Ethicon, which denies liability in the case, has told jurors Cavness' injuries stem from pelvic floor disorder and were not caused by her treatment with the Prosima device.
Cavness is represented by Bill Blankenship of William F. Blankenship III PC, Tim Goss and Rich Freese of Freese & Goss PLLC, Richard Capshaw of Capshaw & Associates, Kevin Edwards and Peter de la Cerda of Edwards & de la Cerda PLLC, and Julie Rhoades and David Matthews of Matthews & Associates.
Ethicon is represented by William Massie Gage and Helen Kathryn Downs of Butler Snow LLP and Kat Gallagher of Beck Redden LLP. The doctor is represented by Philipa Remington and Cathryn Paton of Thiebaud Remington Thornton Bailey LLP.
The case is Cavness v. Kowalczyk et al., case number DC-14-04220, in the 95th District Court of Dallas County, Texas. -
Trial Gets Underway in Texas Ethicon Gynecare Prosima Transvaginal Mesh Action
Sep 24, 2015 | Harris Martin Publishing
Trial is underway in a Texas state court action in which a woman claims she suffered multiple injuries as a result of Ethicon’s allegedly defective Gynecare Prosima Pelvic Floor Repair System, which was implanted to treat her pelvic organ prolapse.
Judge Ken Molberg of the 95th Judicial District of Texas is presiding over the trial, which began on Sept. 21.
In April 2012, Dr. Teresa Kowalczyk implanted Carol Cavness with the Gynecare Prosima Pelvic Floor Repair System, which consists of polypropylene mesh that is tethered in place in the vaginal wall by two arms that extend up through ...
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http://harrismartin.com/article/19929/trial-gets-underway-in-texas-ethicon-gynecare-prosima-transvaginal-mesh-action/
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Mass tort filings decrease significantly this year, as of August
Sep 24, 2015 | Pennsylvania Record Report
By Nicholas Malfitan
Mass tort lawsuit filings in Philadelphia’s Complex Litigation Center (CLC) have, so far, decreased significantly from 2014 to 2015.
A statistical analysis provided by the CLC, which handles lawsuits in 12 mass tort areas, showed filings are not on pace to approach last year's mark of 2,095.
As of Aug. 2, there have been 671 lawsuits filed in the CLC.
The analysis also shows that lawsuits against pharmaceutical makers have so far returned to a fairly low amount of 556, after last year’s spike of 1,827.
Last year, 987 lawsuits over the drug Risperdal and 694 filed over pelvic mesh products led to 2,095 new lawsuits. As of Aug. 2, the CLC contains an inventory of 5,238 cases, with Risperdal accounting for 1,420 of them (27.1 percent), and Pelvic Mesh Litigation totaling 183 (3.5 percent).
A new program for Xarelto, a prescription blood thinner which seeks to prevent clotting in patients, has already jumped 14 percent with 44 filings, resulting in 347 cases pending as of Aug. 2. Those cases account for a total of 6.6. percent of the CLC’s current inventory.
In 2012, only 816 new mass tort cases were filed and 1,803 concluded. That continued in 2013, when 813 were filed and 1,908 concluded. In 2014, the figure jumped to 2,095 and 1,318 were concluded.
This year to date, 864 have concluded. There are 4,630 pharmaceuticals cases pending as of Aug. 2, a virtually negligible decrease from the figure of 4,643 at the beginning of the year.
For pharmaceutical filings, the latest statistics reveal out-of-state plaintiffs continue to count for the vast majority in that category. Out of the 556 new pharmaceutical cases, 485 (87 percent), came from out-of-state plaintiffs.
The figure of 87 percent matches up with the court’s history. The lowest percentage was 2005’s 81 percent.
The figures also show that 115 new asbestos cases were filed in the CLC as of Aug. 2.
Figures from 2005-11 reflect new filings, as well as cases transferred into the CLC program. From 2012-15, only new filings are counted.
First Judicial District CLC Director Stanley Thompson said he did not at all express surprise at the statistics, and did not see “any notable rise in the numbers with any of the programs.”
As to which firms are filing significant numbers of the mass tort cases, Thompson said he did not know, but that such information may vary from program to program.
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