Posts Tagged ‘
DePuy ’
Mar 8th, 2013 |
By Jane Akre
March 8, 2013 ~ Johnson & Johnson must pay the plaintiff who brought the first DePuy metal hip implant device to trial $8.3 million in damages, a Los Angeles jury decided this afternoon. This is the first of 10,750 product liability lawsuits against J&J’s DePuy unit which makes the ASR XL hip replacement device. The
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Posted in Feature |
1 Comment »
Tags: 510(k), all-metal hip, ASR XL, DePuy, DePuy Orthopedic, Ethicon, Ethicon unit, Food and Drug Administration, Johnson & Johnson, Loren Kransky, metal-on-metal, MoM, product liability, Prolift transvaginal mesh, punitive, punitive damages, substantial equivalent
Feb 22nd, 2013 |
By Jane Akre
February 22, 2013 ~ As the jury deliberates for its fourth straight day in the Linda Gross v. Ethicon trial, news broke from Bloomberg/Businessweek (here) around noon today of a government investigation of metal hips and surgical mesh made by the healthcare products giant. The U.S. Department of Justice (DOJ) has launched, and J&J confirmed,
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Posted in Legal News |
1 Comment »
Tags: Bloomberg, deceit, Department of Justice, DePuy, DePuyASR XL, DOJ, false claims, Johnson & Johnson, Justice Department, lawsuit, misrepresentation, product liability, Prolift mesh, trials
Sep 4th, 2012 |
By Jane Akre
Public Invited to FDA meeting on Postmarket Surveillance September 4, 2012~ Every modern day vehicle comes complete with a VIN number, an identifier number that stays with the car during its lifetime. If there is an auto recall the owner is notified and an auto dealership can easily identify a vehicle that might fall under
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Posted in FDA |
No Comments »
Tags: 510(k), DePuy, FDA, least burdensome, medical device, metal hips, postmarket surveillance, section 522, UDI, Unique device identifiers, vin number, whistleblowers
Aug 31st, 2012 |
By Jane Akre
Mesh 101: The Basics For reporters looking for a way to get started on the transvaginal mesh story, here are some highlights to shortcut your research. This is not a lawyer-generated story! There are real women suffering devastating injuries from the use of plastic mesh and it continues today! “We were very shocked and
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Posted in Mesh Reading Room Resource |
9 comments
Tags: Abdominal mesh, American Medical Systems, Bard, Covidien, DePuy, Dr. Donald Ostergard, Endo Pharmaceutical, Ethicon, GAO, gynecare, Institute of Medicine, Johnson & Johnson, kugel mesh, Markey, Mentor, metal-on-metal, not inert, Ob Tape, POP, ProteGen, Sound Devices Act, SUI, transvaginal mesh
Jul 20th, 2012 |
By Jane Akre
July 19, 2012 ~ Is more corporate oversight needed by Johnson & Johnson? After years of defective medications, contaminated children’s cold products, three closed manufacturing plants still in FDA hands , defective recalled metal hips, dangerous synthetic vaginal mesh the focus of thousands of lawsuits, kickbacks to docs to speed up sales, and illegally promoting
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Posted in Feature |
No Comments »
Tags: Alex Gorsky, Bill Weldon, DePuy, Ethicon, gynecare, Janssen, Johnson & Johnson, metal hips, synthetic vaginal mesh
Jun 20th, 2012 |
By Jane Akre
Next Wednesday, June 27 and Thursday, June 28, the U.S. Food and Drug Administration (FDA) will convene one of its expert panels – this one on patient complications after a metal-on-metal hip implant. It is a gathering called by the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee within the FDA. The
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Posted in FDA |
No Comments »
Tags: 510(k), A.S.R, acetabular component, advisory panel, Ann Morrison, BBC, birmingham Hip Resurfacing, British Medical Journal, chromium, Class II, Class III, cobalt, DePuy, FDA, Howard Sadwin, Johnson & Johnson, Medtronic, metal ions, metal-on-metal hips, MoM, recall, resurfacing system, Smight & Nephew, total hip replacements, transvaginal mesh
Mar 23rd, 2012 |
By Jane Akre
March 23, 2012 ~ This has not been a good week for Johnson & Johnson. First word that it sold the transvaginal surgical mesh, ProLift, without getting any sort of FDA approval in advance (see background story here). Now the New York Times (NYT) (here) is reporting that J&J began phasing out the DePuy defective
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Posted in FDA |
No Comments »
Tags: Articular Surface Replacement, ASR, DePuy, Johnson & Johnson, Metal hip
Mar 21st, 2012 |
By Jane Akre
March 21 ~ Bloomberg is reporting (here) that major medical device maker Johnson & Johnson (J&J) sold the Gynecare Prolift surgical mesh for three years before it was approved by the U.S. Food and Drug Administration (FDA). The mesh is now the subject of more than 550 lawsuits, reports Bloomberg. Prolift is a pre-cut mesh
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Posted in Media Reports |
1 Comment »
Tags: 510(k), Bloomberg, defective product, DePuy, FDA, Gary Pruden, Gynecare Prolift, illegal marketing, Johnson & Johnson, lawsuits, MAUDE, MDND, mesh, nonabsorbable polymer, Prolift M, Sheri S. McCoy
Mar 21st, 2012 |
By Jane Akre
March 23, 2012 ~ The SAFETY OF UNTESTED AND NEW DEVICES (SOUND DEVICES) ACT OF 2012 is a critical step to stop others from being harmed by untested, unsafe medical devices like synthetic surgical mesh, say patients harmed by synthetic surgical mesh. The Sound Devices Act, introduced by Rep. Edward Markey (D-MA) will give the
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Posted in Feature |
No Comments »
Tags: 510(k), ASR, Bay Area Pelvic Surgery, bladder sling, Boston Scientific, DePuy, Edward Markey, FDA, Food and Drug Administration, J&J, pelvic organ prolapse, ProteGen Sling, Sound Devices Act, Tom Margolis, Truth in Medicine
Mar 9th, 2012 |
By Jane Akre
*Editors Note: “Betty” wrote this opinion piece. She is a woman who is represented by a lawyer who does not want her speaking up but she still wants to express herself so is doing so anonymously. Many women and men feel the same way. They want to share their experience so others don’t have to
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Posted in Op-Ed |
2 comments
Tags: complication rate, DePuy, Ethicon, Injuries, pelvic organ prolapse, POP, streee urinary incontinence, SUI, surgical mesh, synthetic mesh, TVT-O, urology today