Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Friday, September 5, 2014

Dallas Federal Court Trial Begins: J&J DePuy Pinnacle Hip

National hip implant trial begins in Dallas

Byron Harris, 1:51 p.m. CDT September 4, 2014
Plaintiffs claim the DePuy Pinnacle hip was not properly tested before being marketed to orthopedic surgeons

DALLAS — A national court case involving thousands of hip implant patients suing a subsidiary of Johnson & Johnson is now underway in Dallas.
The focus is the DePuy Pinnacle hip, which the company quit selling in August 2013.
The pool of plaintiffs is so large that a handful of so-called "bellwether" plaintiffs have been selected from more than 6,000 people who have filed suit. This smaller pool of cases will be argued before juries, and the verdicts will be used to determine settlements against Johnson & Johnson.
Opening arguments in Kathleen Herlihy-Paoli vs. DePuy began Wednesday before U.S. District Judge Ed Kinkeade in downtown Dallas.
Paoli, of Missoula, Montana, got a DePuy Pinnacle implant in 2009. She has now had a combined total of five implants on both her hips, and was hurt by metal-on-metal wear in the DePuy devices that were placed in her body.
Metal-on-metal wear of chrome and cobalt components can create adverse health effects in some patients.

Paoli's attorney, Mark Lanier of Houston, argued that DePuy did not properly test the Pinnacle device before releasing it to the market. Under an FDA provision called 510K, medical devices that substantially resemble other devices already on the market can be released with less stringent testing than original designs.
Lanier told the jury that DePuy ignored failures of the Pinnacle device, and made hundreds of millions of dollars in profits while marketing the device to orthopedic surgeons.
DePuy's attorney, Richard Sarver of New Orleans, said Paoli's problems were caused by improper implantation of the device. He also contended that DePuy never improperly paid physicians to use its devices, and that the medical community has long known of the risks of metal particles.
Joleen Chambers of the Failed Implant Device Alliance has been arguing for increased scrutiny of medical devices for years.
"Before these companies get to market their product, they should have post-market surveillance in place so we can track the devices in real time, permanently," she told News 8.
Chambers has been a vocal opponent of the FDA's role in approving hip implants. "It's [the FDA] not working to prove that these devices are safe before they go to market," she said.
The trial is expected to continue for several weeks.
Last fall, Johnson & Johnson settled a case for $2.5 billion relating to another DePuy hip design involving 8,000 patients.


Director, Federal Affairs, Medical Devices
Johnson & Johnson - Washington, DC, US
Posted September 4, 2014

Job description
Director, Federal Affairs, Medical Devices-8659140703

Johnson & Johnson is currently recruiting for a Director, Federal Affairs, Medical Devices. This position is located in Washington, DC and requires up to 25% travel.

Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

With $71.3 billion in 2013 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 127,000 people in 60 countries throughout the world.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Director, Federal Affairs will be responsible to develop, implement and direct federal lobbying activities in support of the corporation’s medical device legislative and policy priorities primarily focused on J&J’s Global Orthopedics business (world’s largest orthopedics company).

A key component of the position is to represent the corporation both internally and externally on federal affairs matters relating to the Centers for Medicare and Medicaid Services, Food and Drug Administration, congressional relations, Administration outreach, relevant trade associations and affiliated patient and physician stakeholder organizations. Some of the official assignments may also require coordination with additional business partners including the pharmaceutical and consumer operations within the Enterprise.

The Director, Federal Affairs will work internally and externally on matters relating to the specific medical device & diagnostics businesses in collaboration with specific franchises as well as represent federal affairs on numerous broader-based healthcare issues and activities. He or she will also work on health care policy and corporate priority assignments within US Government Affairs as determined by managers, such as building relationships with identified stakeholders i.e.: congressional caucuses, patient, physician and other professional societies and stakeholder organizations.

This position requires the incumbent to interact with internal J&J colleagues including US Government Affairs, International, Health Policy Group, J&J Corporate Communications, Law, J&J operating company and Corporate personnel and senior management – specifically J&J’s Global Orthopedics business. External customers including: Members of the US Congress, Administration, state officials and additional J&J customers. This position will report to the Senior Director, Federal Affairs, Medical Devices & Diagnostics.


A minimum of a Bachelor’s Degree is required. An MBA, Masters, JD and/or equivalent graduate degree is preferred with concentration in healthcare policy, political science, communications or business administration preferred. A proven record of success in policy development and advocacy is required. A minimum of 10 years of experience in government affairs or public policy is required. A minimum of 5 years of health policy experience is required. Thorough knowledge of communications, Federal and/or State government policy and legislative process is required. Candidate must be a self-starter with exceptional initiative and ability to work effectively with minimal supervision. Excellent oral and written skills are required.

BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-District of Columbia-Washington
Organization: Johnson & Johnson Services Inc. (6090)
Job Function: Government Affairs

Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

EEO is the Law
EEO is the Law GINA Supplement
About this company
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Our Family of Companies comprises:

The world's premier consumer health company.
The world's largest and most diverse medical devices and diagnostics company.
The world's third-largest biologics company.
And the world's sixth-largest pharmaceuticals company.

We have more than 250 operating companies in 57 countries employing 120,200 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Recent Updates
         Johnson & Johnson J&J Careers is on Twitter. Follow us at @JNJCareers and @JNJuniversity for career tips, J&J news and inside information on what it is like to work at J&J.


No comments:

Post a Comment