|J&J Marketed Mesh Implant Without U.S. Approval; Align Announces Shareholder Lawsuit Dismissed|
|By Staff and Wire Reports|
|Wednesday, 21 March 2012 19:59|
Johnson & Johnson (NYSE:JNJ) sold a vaginal mesh implant for three years before U.S. regulators approved the device, now the subject of more than 550 lawsuits by women who claim it injured them.
J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles. The U.S. Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.
Enlarge image J&J Sold Vaginal Mesh Implant Without Regulatory Approval
Johnson & Johnson’s unauthorized sales might cost it more to resolve lawsuits over the product.
The company, the world’s second-biggest health-care products maker, said it could market the Prolift without approval because it was so similar to an approved device, the Gynecare Gynemesh, Morgan Liscinsky, an FDA spokeswoman, said in a March 16 e-mail. “FDA disagreed with this assertion,” concluding distribution began “without appropriate” clearance, she said.
J&J’s unauthorized sales might cost it more to resolve lawsuits over the product. J&J already has endured recalls of artificial hip implants and over-the-counter drugs. Three J&J units have pleaded guilty in the past two years to bribery or illegal marketing of drugs. A fourth agreed to plead guilty in a marketing case.
“They were initially able to put the Prolift on the market without even telling the FDA,” said attorney Adam Slater, who is suing J&J on behalf of more than 100 women. “Even though Johnson & Johnson supposedly lives by a credo to put the patient first, this is an example of fast-tracking a product to market quickly rather than going to the FDA first.”
The conduct by Ethicon also raises questions about the FDA’s approval process, which lets companies introduce products without human testing if the agency decides they’re similar to devices already for sale, or so-called predicates.
Congress has been pushing for changes to the system in response to industry complaints about slow reviews and inconsistent standards. The FDA also has faced criticism after high-profile recalls, including J&J’s withdrawal in 2010 of 93,000 hip prosthetics with higher-than-expected failure rates.
In 2007, the FDA required J&J to submit a so-called 510(k) application to review the Prolift, Liscinsky said. The FDA learned of the Prolift after J&J cited it in July 2007 as a predicate for a follow-on device, the Prolift+M, she said.
J&J introduced the original Prolift in March 2005 after “applying the relevant FDA guidance and based on the safety and effectiveness” of Gynemesh, Matthew Johnson, a spokesman for the New Brunswick, New Jersey-based company, said in an e-mail.
Align Technology, Inc. (Nasdaq:ALGN) announced on March 14, 2012, Lead Plaintiff Plumbers and Pipefitters National Pension Fund dismissed with prejudice its shareholder lawsuit against the Company and President and CEO, Thomas M. Prescott, filed in August 2009 in the United States District Court for the Northern District of California, Case No. 3:09-cv-03671-MMC.
The case was dismissed pursuant to a stipulation between the parties that prevents them from seeking or asserting any claims against one another for fees, expenses, costs, or sanctions. The stipulated dismissal with prejudice terminates the matter and follows the Court's previous dismissal of plaintiff's second amended complaint for failure to state a claim on February 3, 2012.
Abiomed Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced the appointment of Susan Vissers Lisa, CFA, as Senior Director of Investor Relations and Corporate Development.
Astex Pharmaceuticals, Inc. (NASDAQ:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, today announced the Agenda for its Annual Analyst and Investor Day webcast, to take place from 10 am to 12 pm ET on Tuesday, March 27th in New York.
Baxter International Inc. (NYSE: BAX) and The Baxter International Foundation, the philanthropic arm of Baxter, today announced combined charitable giving of more than $80 million in 2011.
Bioline, The PCR Company, a wholly-owned subsidiary of Meridian Bioscience, Inc. (NASDAQ:VIVO), today announced that it has received clearance from the Therapeutic Goods Administration (TGA) for its illumigene Group B Streptococcus (GBS) test, the newest molecular product on the illumigene platform.
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced additional analyses from the ARISTOTLE and AVERROES clinical trials will be presented at the American College of Cardiology’s 61st Annual Scientific Session, March 24-27, 2012, in Chicago.
Cerus Corporation (NASDAQ: CERS) announced today that it has submitted an IDE supplement to the U.S. Food and Drug Administration (FDA) for the company’s proposed Phase III trial of the INTERCEPT Blood System for red cells in patients receiving chronic red cell transfusion support for sickle cell disease (SCD) or thalassemia.
EasyMed Services, Inc. (CNSX:EZM) (OTCBB:EMYSF) (MUN:EY6), a leading provider of mobile technology solutions for the healthcare industry, reported today after the successful completion of its Easy SmartCare deployment in IIM clinic (one of the largest radiology clinics in Geneva) outstanding results on absenteeism and clinic management.
GE Healthcare, the healthcare business of GE (NYSE: GE) announced today the official opening of its expanded Fast Trak Training Center in Shanghai, China.
Today, the third and final day of BIO-Europe Spring® 2012, Index Ventures announced the launch of a EUR 150 million life science investment fund with heavy backing from GlaxoSmithKline (GSK) and Johnson & Johnson (J&J).
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics, will present a corporate overview and update at the Maxim Group Growth Conference being held on Monday, March 26, 2012 at The Grand Hyatt Hotel, Grand Central Station, New York.
Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and commercialization of molecular diagnostic tests for cancer, will announce its fourth quarter and full-year 2011 financial results and an operational update in a press release to be issued before the market opens on Tuesday, March 27, 2012.
Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that Nancy A. Simonian, M.D. has been appointed to the company’s Board of Directors.
Stellar Pharmaceuticals Inc. ("Stellar") (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF), a Canadian public company) announced on Monday, March 19, 2012 the Company would host a conference call at 4:00 p.m. Eastern Time to discuss the details of the approval of CAMBIA®, (diclofenac potassium for oral solution) for the treatment of migraine attacks with or without aura in adults, by Health Canada as noted in the press release dated Friday, March 16, 2012.
Techs Loanstar, Inc. (OTCQB: TCLN) (PINKSHEETS: TCLN), d/b/a Quture, Inc., the future in global health and healthcare quality, patient safety and value, announced today that the company's senior management team is in attendance at the 2012 InterSystems Global Summit in Orlando.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it is transferring the listing of its American Depositary Shares (“ADSs”), each representing one ordinary share of Teva common stock, to the New York Stock Exchange (NYSE) from the NASDAQ Global Select Market (NASDAQ).