Navigation Links
Johnson & Johnson Settlement Resolves Metal Hip Lawsuits But Weak Oversight Of Medical Device Industry Leaves Hundreds of Thousands of Patients Vulnerable

TOLEDO, Ohio, Nov. 19, 2013 /PRNewswire-USNewswire/ -- Johnson & Johnson announced today that it has reached a multi-billion dollar settlement for victims of the company's flawed all metal hip implant.  The problems patients have experienced with the device demonstrate the need for stricter implant safety testing and show why medical implant makers should provide warranties to back their products in the event of failure, according to Consumers Union, the policy division of Consumer Reports.

"The horrendous injuries suffered by tens of thousands of metal hip implant patients are a terrible reminder of how current oversight of the medical device industry fails to protect the public," said Lisa McGiffert, manager of Consumers Union's Safe Patient Project (  "Patients shouldn't serve as unwitting experimental subjects for medical implants that haven't been thoroughly tested by industry for safety and effectiveness.  We need to require stricter safety testing of all implants before they are allowed on the market.  And medical device makers should stand by their products by providing a warranty to patients."

Earlier this year, Consumers Union called on the top manufacturers of hip and knee implants to provide a 20 year warranty to patients.  Consumers Union has developed standards for a fair warranty that would cover the full cost of replacing a flawed device, including the device, surgeon and hospital costs as well as related patient out-of-pocket costs.  Under Consumers Union's proposed warranty, patients would retain the right to sue the manufacturer to recover other damages. 

Consumers Union is pushing device makers to equip patients with warranties to give them a better understanding of how long an implant is expected to last and a clear process to follow in the event that it fails prematurely.  Ultimately, warranties will encourage companies to make their devices safer and more durable, according to Consumers Union. 

Most hip and knee implants are allowed on the market without being reviewed for safety and effectiveness by the Food and Drug Administration (FDA).  Instead, under current law, the companies simply have to demonstrate that the devices are "substantially equivalent" to a product already being sold.  Since most new hip and knee implants are similar to ones already on the market, manufacturers are able to gain approval through the FDA's fast track 510(k) clearance process without having to prove the device is safe and effective. 

Consumers Union and other patient safety groups urged Congress to require more pre-market testing of devices like hip and knee implants during last year's reauthorization of the Medical Device User Fee Act.  But those efforts were blocked by the politically powerful medical device industry. 

Over 750,000 Americans got metal on metal hip implants during the past decade, which were supposed to last longer than devices made with a combination of ceramic, metal and plastic.  But unusually high failure rates have been documented in metal hip implants in Australia, England, and Wales where devices are tracked through national registries.  The data from these countries showed that one in eight of the Johnson & Johnson DePuy ASR XL metal hip implants failed within five years. 

Some patients have experienced debilitating symptoms from metal debris that flakes off the device over time, including cardiomyopathy and neurological problems.   Due to the significant problems experienced with metal on metal hip implants, the FDA has proposed that they be subject to a more rigorous review process but has yet to finalize this policy, thus keeping the door open for fast track review of future metal hip implants.  Consumers Union has urged the FDA to finalize this requirement as soon as possible. 

Further, the FDA should be doing more to inform the hundreds of thousands of people who have metal hips of the steps they should take to regularly monitor the way the device may be affecting their health, according to Consumers Union.  The agency has information on its website but many people with implants are unaware of the danger the devices could pose to their health.

"The FDA advises surgeons to follow up with their patients – whether symptomatic or asymptomatic – every one to two years for the long term and the FDA should regularly remind the public to do so," said McGiffert. 

SOURCE Consumers Union
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Johnson & Johnson (China) Investment Ltd. Acquires Guangzhou Bioseal Biotechnology Co., Ltd.
2. Johnson & Johnson Expects to Incur Special Charge in Second Quarter for Previously Disclosed Legal Matters
3. N.J. Woman Sues Johnson & Johnsons Ethicon Unit Over Vaginal Mesh Injuries, Says The Lanier Law Firm
4. Johnson & Johnson to Host Analyst Conference Call on Second-Quarter Results
5. GHX CEO Bruce Johnson Recognized as Ernst & Young Rocky Mountain Region Entrepreneur of the Year 2012
6. Johnson & Johnson Provides Notice Of Proposed Settlement Of Shareholder Derivative Actions, Final Settlement Hearing, And Right To Appear
7. Johnson & Johnson Announces Discontinuation of Phase 3 Development of Bapineuzumab Intravenous (IV) in Mild-to-Moderate Alzheimers Disease
8. EFJohnson Announces Impact Partner Dealer Program
9. Johnson Health Tech Statement on Lance Armstrong
10. Robert G. Savage, Former Worldwide Chairman, Johnson & Johnsons Pharmaceuticals Group, Joins Board of Nuovo Biologics, LLC
11. Johnson & Johnson Announces Plans to Establish Innovation Centers
Post Your Comments:
(Date:11/24/2015)... FRANCISCO , Nov. 24, 2015  Thanks to ... Dignity Health St. Mary,s Medical Center,s Sister Diane Grassilli ... breast imaging capabilities in San Francisco ... an anonymous friend, stepped forward with a gift of ... for Breast Digital Mammography with Tomosynthesis and Whole Breast ...
(Date:11/24/2015)... TX and VANCOUVER, Nov. 24, 2015 /PRNewswire/ - ... NASDAQ: EPIX ) announced today that the first ... study of EPI-506 as a treatment for metastatic castration-resistant ... and Canada.  --> ... --> In the Phase 1/2 clinical trial, ESSA ...
(Date:11/24/2015)... --> --> According to ... Type (Bone Graft, Bine Graft Substitute, Platelet Rich Plasma, BMAC), ... Fusion), End User, and Geography - Global Forecast to 2020", ... Billion in 2014 and is expected to reach $2.4 Billion ... period of 2015 to 2020. Browse 55 market ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... 25, 2015 , ... Students and parents have something to be thankful for ... Real Impact awards. California Casualty is proud to support the contest designed ... and reckless driving, the number one killer of young drivers. , Almost 1,000 ...
(Date:11/24/2015)... PA (PRWEB) , ... November 24, 2015 , ... ... now certified to offer their patients the many benefits of the revolutionary BIOLASE ... the sharp cutting and scraping tools traditionally used by a dentist in ...
(Date:11/24/2015)... ... November 24, 2015 , ... Young patients with a wide ... Angela Wolfman and Dr. Kedar S. Lele, who are pediatric dentists in Tucson, ... fillings, the WaterLase iPlus 2.0™ system causes minimal discomfort and bleeding to the patient ...
(Date:11/24/2015)... , ... November 24, 2015 , ... In an ... restrictions and variables that determine which patients are or are not eligible for bariatric ... have a BMI over 40, are more than 100 pounds overweight, or have a ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... ... national leaders when it comes to several aspects of orthopedic care. They have ... replacements, orthopedic surgeries and general orthopedic care. , Becker's Hospital Review selected ...
Breaking Medicine News(10 mins):