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Earl's View

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Earl's View

Tag Archives: FDA

Birmingham Hip Resurfacing Lawsuits | Dallas-Fort Worth Legal Examiner | Dallas-Fort Worth Texas Personal Injury Lawyer

May 7, 2017

Birmingham Hip Resurfacing Lawsuits Posted by Shezad Malik MD JD May 5, 2017 10:40 Birmingham Hip Resurfacing Lawsuits. Rosetta Ventimiglia …

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FDA Seeks Data on Risks of Metal Poisoning from Hip Replacements – AboutLawsuits.com

June 16, 2015

FDA Seeks Data on Risks of Metal Poisoning from Hip Replacements – AboutLawsuits.com. FDA Seeks Data on Risks of Metal …

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Mitigating Migraines – How To Fight Migraines Naturally

October 16, 2014

Mitigating Migraines – How To Fight Migraines Naturally. This looks like a useful site – if you suffer migraines like …

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Global Corporate Crime – DePuy in India

May 26, 2014

India issues recall, commences criminal investigation into defective ASR hip implant Four Corners By Peter Cronau: exclusive Updated 5 hours …

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Medical device firms push to comply with new FDA rules

March 16, 2014

Source & full article: Medical device firms push to comply with new FDA rules. Medical device firms push to comply with …

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Congressional Investigation Finds FDA’s Unprecedented Whistleblower Surveillance Program Was Unlawful

March 1, 2014

Congressional Investigation Finds FDA’s Unprecedented Whistleblower Surveillance Program Was Unlawful | The Dissenter. Congressional Investigation Finds FDA’s Unprecedented Whistleblower Surveillance …

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How does the FDA ‘approve’ medical products? – Medical News Today

February 22, 2014

Source article for full text: How does the FDA ‘approve’ medical products? – Medical News Today. How does the FDA ‘approve’ …

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Vaginal Mesh Implants – Guest Post by Agnes Jimenez

January 14, 2014

Vaginal Mesh Implant: Important Things You Need To Know Before Having a Surgery Vaginal mesh surgery steams has been a …

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Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser | MassDevice

March 24, 2013

Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser | MassDevice. March 11, 2013 by Arezu …

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VICTORY FOR MoM Sufferer – Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com

March 9, 2013

Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com. VICTORY & JUSTICE: J.&J. Loses …

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Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants

March 5, 2013

Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants. FDA Safety Communication: Metal-on-Metal Hip Implants Date Issued: Jan. 17, 2013 Audience: Orthopaedic …

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DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable

March 5, 2013

Trial plaintiff says J&J hips defective, company says not liable. Trial plaintiff says J&J hips defective, company says not liable …

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Oh Really … Why am I not believing you?…. Hip Replacement Device – NYTimes.com

March 5, 2013

Hip Replacement Device – NYTimes.com. Oh Really Mr DePuy – are we as stupid as you look?  Published: March 4, …

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FDA cracks down on all-metal hip replacements

March 4, 2013

http://news.consumerreports.org/health/2013/01/fda-cracks-down-on-all-metal-hip-replacements.html FDA cracks down on all-metal hip replacements Manufacturers who want to keep selling all-metal hips will have to prove …

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Open Letter – Surgeon-industry COI and the CME content of AAOS 2013 addressing MoM hip complications.

March 3, 2013

Surgeon-industry COI and the CME content of AAOS 2013 addressing MoM hip complications. By Stephen Tower, Orthopedic SurgeonAffiliated Professor UAA …

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J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg

March 2, 2013

J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg. J&J Profit Pursuit Led to Defective Hip, Lawyer Argues …

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J&J gambled on hip implant safety, lawyer alleges – latimes.com

March 2, 2013

J&J gambled on hip implant safety, lawyer alleges – latimes.com. J&J gambled on hip implant safety, lawyer alleges Johnson & …

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Metal Debris in Patients’ Bloodstream is “Harmless,” J&J Toxicologists Say

February 28, 2013

The metal debris Johnson & Johnson (J&J)’s DePuy ASR hip implant shed into a man’s bloodstream and tissue is harmless, …

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Smith & Nephew Failure Warning for Birmingham Hip Implant

February 25, 2013

Smith & Nephew Failure Warning for Birmingham Hip Implant. Smith & Nephew Failure Warning for Birmingham Hip Implant September 27, …

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Researchers Say DePuy Hip Ancestry Shows 510(k) Flaws | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

February 23, 2013

Researchers Say DePuy Hip Ancestry Shows 510(k) Flaws | MDDI Medical Device and Diagnostic Industry News Products and Suppliers. Published: …

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Bullshit-R-Us …. J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg

February 23, 2013

J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg. J&J’s Toxicologist Says Metal From Recalled Hip Harmless By Maurice …

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Yeah, right…. J&J’s Floyd Says Hip Sales Halted for Business Reasons – Bloomberg

February 23, 2013

J&J’s Floyd Says Hip Sales Halted for Business Reasons – Bloomberg. J&J’s Floyd Says Hip Sales Halted for Business Reasons …

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DePuy Trial Continues Despite Talks of Settlement – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts

February 21, 2013

DePuy Trial Continues Despite Talks of Settlement – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts. DePuy Trial Continues …

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Some Surgeons Do Speak & Shout – but Those that Should Listen Don’t Hear…

February 19, 2013

By Stephen Tower Orthopedic Surgeon Affiliated Professor UAA WWAMI School of Medicine Earl, Barry Meier’s recent article in the NYT …

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The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com

February 17, 2013

The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com. Doctors Who Don’t Speak Out By BARRY MEIER Published: …

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Business: Washington Post Business Page, Business News

February 16, 2013

Business: Washington Post Business Page, Business News. J&J’s President Visited Hip Surgeon Before Recall, Jury Told Maurice Possley, David Voreacos …

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Patients victims of untested medical devices – SFGate

February 16, 2013

Patients victims of untested medical devices – SFGate. Patients victims of untested medical devices Victoria Colliver Updated 9:21 pm, Tuesday, February …

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J&J Feared Metal Backlash Would Hurt Hip Sales, Jury Told – Bloomberg

February 16, 2013

J&J Feared Metal Backlash Would Hurt Hip Sales, Jury Told – Bloomberg. J&J Feared Metal Backlash Would Hurt Hip Sales, …

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“What a Mistake,” says DePuy Hip Recipient

February 16, 2013

“What a Mistake,” says DePuy Hip Recipient. “What a Mistake,” says DePuy Hip Recipient February 14, 2013, 01:30:00PM. By Jane …

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What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com

February 12, 2013

What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com. EDITORIAL What a Company Knew About Its Metal Hips Published: …

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DePuy ASR Lawsuit Update: Toxicologist Testifies That Plaintiff Kransky Has High Levels of Metal in His Blood – Yahoo! Finance

February 10, 2013

DePuy ASR Lawsuit Update: Toxicologist Testifies That Plaintiff Kransky Has High Levels of Metal in His Blood – Yahoo! Finance. …

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DePuy ASR Trial Update: J&J Engineer-Suggested Redesign Meant to Minimize Metallic Debris Never Implemented, Parker Waichman LLP Reports – SFGate

February 10, 2013

DePuy ASR Trial Update: J&J Engineer-Suggested Redesign Meant to Minimize Metallic Debris Never Implemented, Parker Waichman LLP Reports – SFGate. …

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Kransky vs DePuy ASR Trial Update – Day 2-4

February 9, 2013

Kransky vs DePuy ASR Trial Update – Day 2-4 guy in charge of testing safety of DePuy ASR was a …

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Howard Sadwin’s Story – Video – Smith & Nephew BHR Hell

February 5, 2013

Here is Howard’s story – told by him

J&J metal hip failed because of toxic debris – expert at trial | Reuters

February 3, 2013

J&J metal hip failed because of toxic debris – expert at trial | Reuters. J&J metal hip failed because of …

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J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg

February 3, 2013

J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg. J&J Failed to Weigh Hip Metal Debris Risk, …

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During Trial, New Details Emerge on DuPuy Hip – NYTimes.com

February 2, 2013

During Trial, New Details Emerge on DuPuy Hip – NYTimes.com. During Trial, New Details Emerge About Hip Maker By BARRY …

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Dangers of toxic hip implants used in Britain kept secret for years – Telegraph

February 2, 2013

Dangers of toxic hip implants used in Britain kept secret for years – Telegraph. Dangers of toxic hip implants used …

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MPs call for criminal inquiry into toxic hip implants – Telegraph

February 2, 2013

MPs call for criminal inquiry into toxic hip implants – Telegraph. MPs call for criminal inquiry into toxic hip implants …

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J&J Had ‘Inappropriate’ Risk Controls for Hip, Jury Told – Bloomberg

February 2, 2013

J&J Had ‘Inappropriate’ Risk Controls for Hip, Jury Told – Bloomberg. J&J Had ‘Inappropriate’ Risk Controls for Hip, Jury Told …

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J&J Failed Own Safety Test in Hip Design, Witness Says – Bloomberg

January 30, 2013

J&J Failed Own Safety Test in Hip Design, Witness Says – Bloomberg. J&J Failed Own Safety Test in Hip Design, …

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Trial underway in hip implant lawsuit – latimes.com

January 27, 2013

Trial underway in hip implant lawsuit – latimes.com. Trial underway in hip implant lawsuit Bloomberg News January 25, 2013, 3:57 p.m. …

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Ed’s Smith & Nephew BHR hell gets worse before better…

January 27, 2013

by Ed Larsen When I first became aware of “Earls View” and contributed to the Blog regarding my personal experience …

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Brooks asks if the orthopaedic companies are above the law?

January 27, 2013

it’s now become apparent that for those of us in the US, and seemingly the rest of the world, for …

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Looks like BS, Smells like BS, Must be BS…. Hip Study: Smith & Nephew touts study results for new metal-on-metal implants | MassDevice – Medical Device Industry News

January 23, 2013

Hip Study: Smith & Nephew touts study results for new metal-on-metal implants | MassDevice – Medical Device Industry News. Hip …

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Laurel’s Story – Smith & Nephew BHR Hip Resurfacing Ruins Another Life

January 21, 2013

In August of 2008 at the age of 49 I had a Birmingham Resurfacing of my right hip.  This hip had …

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Metal-on-metal hip implant risks ‘unique’ – Health – CBC News

January 20, 2013

Metal-on-metal hip implant risks ‘unique’ – Health – CBC News. Metal-on-metal hip implant risks ‘unique’ FDA gives recommendations on how …

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Cardiologist William Maisel (deputy director for science at the FDA) Arrested In Prostitution Sting Operation – Forbes

January 20, 2013

Cardiologist William Maisel Arrested In Prostitution Sting Operation – Forbes. Larry Husten, Contributor I’m a medical journalist covering cardiology news. …

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FDA Action on Metal on Metal Hips – too little, too late…

January 20, 2013

by Howard Sadwin Another Smith & Nephew Birmingham Hip Device friend of mine and I read the new and exciting …

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FDA cracks down on all-metal hip replacements

January 19, 2013

FDA cracks down on all-metal hip replacements.’ Source: http://news.consumerreports.org/health/2013/01/fda-cracks-down-on-all-metal-hip-replacements.html  FDA cracks down on all-metal hip replacements Jan 18, 2013 11:48 AM …

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Dr Tower writes to Senator re concerns about the regulatory malfeasance at the FDA – Metal-on-Metal hip replacement debacle

January 10, 2013

Sunday, January 6, 2013 Dear Senator Begich, I am very appreciative of your personal reply to my concerns about the …

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Howard Sadwin – Video of Howard’s battle with the damage from Smith & Nephew BHR hip

December 22, 2012

Howard has put together a video outlining his problems with the damage to his health and life caused by the …

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Come out front Smith & Nephew – we have had your medicine – time for yours…

December 15, 2012

Why does it appear Smith and Nephew is trying to hide behind the pre-emption laws and not face accountability. Their …

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FDA Executive Summary Memorandum – Metal-on-Metal Hip Implant Systems – June 27-28, 2012 Meeting

December 12, 2012

I.      Introduction and Purpose of Advisory Panel Meeting Hip arthroplasty devices, including metal-on-metal (MoM) hip systems, have been …

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Howard’s View on the FDA’s lack of action on MoM hip studies…

November 11, 2012

What happened to the the FDA‘s request, NOTHING HAPPENED. The FDA gets heat put on them especially in todays enviornment …

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What Happened to the FDA Request for More Hip Implant Studies? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts

November 11, 2012

What Happened to the FDA Request for More Hip Implant Studies? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass …

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The Dangers of Using Transvaginal Mesh

November 1, 2012

By Carlos Santiago Many women who were suffering from Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (STI) sought medical …

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Howard Says – And We Agree – Come Clean Smith & Nephew

November 1, 2012

It is time for Smith and Nephew to be realistic and honest, afterall in their code of ehtics the safety …

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Lorraine – natural treatments may work on artificial joints too?

October 16, 2012

Earl, I read your letters every day.  So many people having difficulties world wide.  I have the Stryker TritonCeramic-on Ceramic Alumina. Recall reasons, contaminated …

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The FDA is there to protect patients? Bullsh*t …

October 11, 2012

The FDA is there to protect patients? Bullsht | MassDevice – Medical Device Industry News. The FDA is there to …

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FDA Asks Judge to Dismiss Spying Suit Filed by Employees – Businessweek

October 4, 2012

FDA Asks Judge to Dismiss Spying Suit Filed by Employees – Businessweek. Bloomberg News FDA Asks Judge to Dismiss Spying …

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FDA warns Zimmer over manufacturing of hip devices – chicagotribune.com

October 4, 2012

FDA warns Zimmer over manufacturing of hip devices – chicagotribune.com. FDA warns Zimmer over manufacturing of hip devices Reuters 4:58 …

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This is AMAZING – Implanted Eye Device

September 30, 2012

FDA Panel Says Yes to Implanted Eye Device. FDA Panel Says Yes to Implanted Eye Device By David Pittman, Washington Correspondent, …

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Medical Devices Vulnerable to Hacking Need Oversight – Businessweek

September 29, 2012

Medical Devices Vulnerable to Hacking Need Oversight – Businessweek. Bloomberg News Medical Devices Vulnerable to Hacking Need Oversight By Jordan …

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Stryker Recalls Neptune Devices After Death Reported – Bloomberg

September 27, 2012

Stryker Recalls Neptune Devices After Death Reported – Bloomberg. Stryker Recalls Neptune Devices After Death Reported By Michelle Fay Cortez …

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FDA Presentation Describes Corrosion of Metal Hip Implants

September 26, 2012

A presentation at a Food and Drug Administration (FDA) meeting about metal-on-metal hip implants covered the life-threatening corrosion that occurs …

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Where are the Transvaginal Mesh Studies Requested by the FDA? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts

September 25, 2012

Where are the Transvaginal Mesh Studies Requested by the FDA? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts. …

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YAHOO — Smith & Nephew Birmingham Hip Lawsuit Filed Over Metal Poisoning – AboutLawsuits.com

September 21, 2012

Source: Smith & Nephew Birmingham Hip Lawsuit Filed Over Metal Poisoning – AboutLawsuits.com. Smith & Nephew Birmingham Hip Lawsuit Filed Over …

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Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process

September 7, 2012

Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process. Neurosurgeon’s Conflict With Spine Device Company Sheds …

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MUST READ – Two MoM Presentations to the FDA on MoM hips

September 1, 2012

  Two very informative presentations to the FDA on Metal on Metal Hips   Click on the links to download …

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» Medical device units recalled in Q2 represent eight-quarter high | MedCity News

August 30, 2012

» Medical device units recalled in Q2 represent eight-quarter high | MedCity News. Medical device units recalled in Q2 represent …

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FDA Aims To Smooth Premarket Review process | Bloomberg BNA

August 24, 2012

FDA Aims To Smooth Premarket Review process | Bloomberg BNA. Wednesday, August 22, 2012 FDA Aims To Smooth Premarket Review …

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FDA Executives Knew About Plan to Spy on Whistle-Blower Scientists

August 23, 2012

FDA Executives Knew About Plan to Spy on Whistle-Blower Scientists. FDA Executives Knew About Plan to Spy on Scientists August …

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FDA SpyGate — New Revelations Challenge The New York Times Investigation of Agency “Enemies List”

August 22, 2012

FDA SpyGate — New Revelations Challenge The New York Times Investigation of Agency “Enemies List,” Raise More Questions About the …

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Stryker Hip Implant Lawsuit | Stryker Trident Hip Recall

August 20, 2012

Stryker Hip Implant Lawsuit | Stryker Trident Hip Recall. New York Woman Seeks $6 Million for Stryker Hip Implant Injuries …

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Cry from the Heart – Where is Mr Smith & his Nephew?

August 20, 2012

Recent comment published on Earl‘sview that deserves more notice: Does Smith and Nephew not hear the cries from victims of …

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Pre Market Approval – Why does the Law shelter Smith & Nephew & others like them?

August 20, 2012

Premarket Approval by the FDA – why do we lose out? Reading this recent law review article by Professor Ralph Hall, …

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Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney

August 19, 2012

Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney. The Smith & Nephew R3 Hip Implant …

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Dems urge FDA to boost medtech recall database | MassDevice.com

August 19, 2012

Dems urge FDA to boost medtech recall database | MassDevice.com On Call | MassDevice – Medical Device Industry News. Dems …

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Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes

August 18, 2012

Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes. Loophole in FDA’s Approval Process for …

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The US Medical Device Market is a Dinosaur – Mike comments

August 14, 2012

The medical device industry is a dinosaur. Sales people getting paid hundreds of thousands who don’t really know anything about …

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Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno

July 29, 2012

Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno. Rival Tried to …

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FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers

July 29, 2012

FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers. FDA Employee Surveillance May Indicate …

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Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com

July 28, 2012

Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com. Protection to paranoia for FDA’s surveillance program Published: July …

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What does the FDA have to Hide? Who do they work for??

July 28, 2012

FDA shouldn’t be spying on whistle-blowers – Tampa Bay Times. FDA shouldn’t be spying on whistle-blowers In Print: Saturday, July …

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Smith and Nephew BHR: Mr. Smith, his nephew, and the incident involving their missing BHR Modular Head

July 26, 2012

I have posted a few things around here and owe a debt of gratitude to Earl, as do we all. …

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Bard Must Pay $5.5 Million Over Vaginal Mesh Implants – Bloomberg

July 25, 2012

Bard Must Pay $5.5 Million Over Vaginal Mesh Implants – Bloomberg. Bard Must Pay $5.5 Million Over Vaginal Mesh Implants …

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Wright Medical Filed Petition to Block Smith & Nephews Metal Implant

July 25, 2012

Wright Medical Filed Petition to Block Smith & Nephews Metal Implant. Wright Medical Filed Petition to Block Smith & Nephews …

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Is the US Medical Device Industry Heading the Way of the Dinosaur?

July 21, 2012

Plastics News – Report calls for changes in medical device sector. Report calls for changes in medical device sector By …

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Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register

July 21, 2012

Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register. …

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FDA surveillance operation draws criticism from lawmakers | Reuters

July 16, 2012

FDA surveillance operation draws criticism from lawmakers | Reuters. FDA surveillance operation draws criticism from lawmakers WASHINGTON | Sun Jul …

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Delays and Difficulties in Assessing Metal-on-Metal Hip Implants – The Law Offices of John David Hart

July 16, 2012

Delays and Difficulties in Assessing Metal-on-Metal Hip Implants – The Law Offices of John David Hart. Delays and Difficulties in …

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Total Hip Modular Necks – Is this the next phase of Hip Failures?

July 15, 2012

Total Hip Modular Necks – Is this the next phase of Hip Failures?. Total Hip Modular Necks – Is this …

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FDA – Overview of Medical Device Regulation > Information about MDUFA III

July 15, 2012

Overview of Medical Device Regulation > Information about MDUFA III. Information about MDUFA III Congress recently authorized the Medical Device …

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Medical Device ID Proposal Unveiled – GovInfoSecurity

July 15, 2012

Medical Device ID Proposal Unveiled – GovInfoSecurity. Medical Device ID Proposal Unveiled FDA Would Create Database of Information By Marianne …

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Smith And Nephew Hip Replacement Recall Lawsuit Attorney

July 15, 2012

Smith And Nephew Hip Replacement Recall Lawsuit Attorney. Saunders & Walker PA 3491 Gandy Blvd. North Suite 200 Pinellas Park, …

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FDA to help medical device sales with expanded pre-market feedback program

July 15, 2012

FDA to help medical device sales with expanded pre-market feedback program. FDA to help medical device sales with expanded pre-market …

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Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions

July 14, 2012

Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions. FDA NEWS RELEASE For Immediate Release: …

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FDA to guide device makers on marketing application – chicagotribune.com

July 14, 2012

FDA to guide device makers on marketing application – chicagotribune.com. FDA to guide device makers on marketing application Ads by …

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Stryker Recalls Two Metal-on-Metal Hip Implants

July 14, 2012

Stryker Recalls Two Metal-on-Metal Hip Implants. Stryker Recalls Two Hip Implants July 9, 2012 — Stryker Corp. announced a voluntary …

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Dr Stephen (Steve) Tower to Join the Earl’sview site – to answer patient questions

July 14, 2012

Earlsview Over the year since I set up Earlsview as part of my “anger management” the site has had nearly …

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FDA – User Fees for Medical Devices: Third Time Lucky?

July 8, 2012

User Fees for Medical Devices: Third Time Lucky? John R. Graham, Director, Health Care Studies Congress recently passed, almost unanimously, S.3187, …

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FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today

July 8, 2012

FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today. FDA Faces Daunting Task as Health Apps Multiply By …

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FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier

July 8, 2012

FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier. FDA Proposes …

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MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA

July 8, 2012

MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA. MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA Cheryl Clark, …

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Stryker recalls two metal-on-metal hip products for fear of corrosion

July 8, 2012

Stryker recalls two metal-on-metal hip products for fear of corrosion. Stryker recalls two metal-on-metal hip products for fear of corrosion …

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Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2

July 8, 2012

June 28 2012 – Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2 Click the link …

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Biomet M2a Magnum Metal-on-Metal Hip Replacement Lawsuit

July 8, 2012

News Headline Story | equities.com. Biomet M2a Magnum Metal-on-Metal Hip Replacement Lawsuit Alleges Defective Implant Caused Oregon Woman to Suffer …

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FDA releases proposed UDI rule; reaction generally positive

July 8, 2012

FDA releases proposed UDI rule; reaction generally positive | Healthcare Finance News. July 06, 2012 | Rene Letourneau, Editor WASHINGTON …

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Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today

July 8, 2012

Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today. Governmental Oversight of Potentially Dangerous Medical Devices Public and …

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FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments

July 8, 2012

FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments. FDA Proposes Device ID Regulations for …

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Early Clinical Experience With the Use of the Birmingham Hip Resurfacing System | Orthopedics

July 8, 2012

Early Clinical Experience With the Use of the Birmingham Hip Resurfacing System | Orthopedics. Early Clinical Experience With the Use …

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FDA Executive Summary Memorandum – Metal-on-Metal Hip Implant Systems Prepared for the June 27-28, 2012 Meeting of the Orthopaedic and Rehabilitation Devices Advisory Panel Gaithersburg Hilton, Gaithersburg, Maryland

July 8, 2012

FDA Executive Summary Memorandum Metal-on-Metal Hip Implant Systems Prepared for the June 27-28, 2012 Meeting of the Orthopaedic and Rehabilitation Devices …

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SMITH & NEPHEW BHR – FDA Papers – Appendix G: Summary of MoM Hip Resurfacing Post-Approval Studies

July 8, 2012

SMITH & NEPHEW BHR – FDA Papers – Appendix G:  Summary of MoM Hip Resurfacing Post-Approval Studies Source: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309356.pdf. Download PDF …

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Smith & Nephew BHR – Food and Drug Administration, HHS

July 8, 2012

http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol8/pdf/CFR-2011-title21-vol8-sec888-5.pdf. PDF File: Food and Drug Administration, HHS CFR-2011-title21-vol8-sec888-5 Food and Drug Administration, HHS 513(f) of the act) into class III …

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FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, at 12 (Sept. 8, 2005)

July 8, 2012

FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, …

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FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR…

July 7, 2012

FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-pdn0001-vol2.pdf. Dear Mr.  Roberts: Food and Drug …

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Wright Medical’s Response to Smith & Nephew’s Response to WMT request to Deny BHR PMA

July 7, 2012

Wright Medical’s Response to Smith & Nephew‘s Response to WMT request to Deny BHR PMA http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-rc00001-01-vol3.pdf. Click the above link …

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Smith & Nephew’s :Response to Wright Medical Technology’s Citizen’s Petition to Deny PPrIA P040033

July 7, 2012

http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-c000001-01-vol2.pdf. Smith & Nephew‘s :Response to Wright Medical Technology‘s Citizen’s  Petition to Deny PPrIA P040033 Smith & Nephew, Inc.  is …

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FDA Pre Market Approval (PMA) of Birmingham Hip Resurfacing (BHR) System – P040033

July 7, 2012

HOW DID THEY GET APPROVAL? Birmingham Hip Resurfacing (BHR) System – P040033. Birmingham Hip Resurfacing (BHR) System PMA Approval P040033a …

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All the Reasons WHY Smith & Nephew Birmingham Hip Resurfacing Should NOT have gotten PMA from the FDA

July 7, 2012

All the Reasons WHY Smith & Nephew Birmingham Hip Resurfacing Should NOT have gotten PMA from the FDA This makes …

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New FDA guidance on considerations used in device approval

July 7, 2012

New FDA guidance on considerations used in device approval. New FDA Guidance used in Device Approval THURSDAY, MARCH 29. 2012; FDA …

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Antidepressant proves effective in alleviating osteoarthritis pain Depression

July 6, 2012

Antidepressant proves effective in alleviating osteoarthritis pain Depression | Pharmaceutical & Medical Packaging News. Antidepressant proves effective in alleviating osteoarthritis …

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Recipients Injured By Metal-On-Metal Hips Speak Out Against Dangers of MoM Hips – SFGate

July 3, 2012

Recipients Injured By Metal-On-Metal Hips Speak Out Against Dangers of MoM Hips – SFGate. Recipients Injured By Metal-On-Metal Hips Speak …

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WHO CAN YOU TRUST??? Pharmaceutical Giant GSK to Pay $3B in Largest-Ever Health Care Fraud Case

July 3, 2012

Pharmaceutical Giant GSK to Pay $3B in Largest-Ever Health Care Fraud Case – Yahoo! News. Pharmaceutical Giant GSK to Pay …

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Howard Sadwin’s Suffering from Metal-on-Metal Hip Implant | Mesh Medical Device Newsdesk

July 1, 2012

Howard Sadwin’s Suffering from Metal-on-Metal Hip Implant | Mesh Medical Device Newsdesk. Suffering in Silence: Howard Sadwin’s Story of Metal-on-Metal …

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FDA Reports16,800 Metal On Metal Hip Implant Adverse Events

July 1, 2012

FDA Reports16,800 Metal On Metal Hip Implant Adverse Events | The Legal Examiner Phoenix. FDA Reports16,800 Metal On Metal Hip …

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DePuy Pinnacle Hip Implant Failure Initiative Considered “Vital”

July 1, 2012

DePuy Pinnacle Hip Implant Failure Initiative Considered “Vital”. The U.S. Drug Watchdog has a goal of identifying every single one …

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FDA panel sees little use for metal-on-metal hips | CTVNews

July 1, 2012

FDA panel sees little use for metal-on-metal hips | CTVNews. The Associated Press; Published Friday, Jun. 29, 2012 8:25AM EDT This …

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FDA Probes Safety Issues Associated with Metal Hip Implants | Qmed

June 30, 2012

FDA Probes Safety Issues Associated with Metal Hip Implants | Qmed. FDA Probes Safety Issues Associated with Metal Hip Implants …

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FDA to study growing failure rate of metal hip devices – USATODAY.com

June 30, 2012

FDA to study growing failure rate of metal hip devices – USATODAY.com. The Food and Drug Administration is meeting with …

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Pennsylvania woman to address FDA panel on husband’s hip-replacement recall – Philly.com

June 30, 2012

Pennsylvania woman to address FDA panel on husband’s hip-replacement recall – Philly.com. Pennsylvania woman to address FDA panel on husband’s …

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FDA probes safety issues with metal hip implants

June 30, 2012

FDA probes safety issues with metal hip implants – Rolla, MO – The Rolla Daily News. WASHINGTON — Metal hip …

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Suffering of Thousands Prompts FDA Hearing about Hip Implants

June 30, 2012

Suffering of Thousands Prompts FDA Hearing about Hip Implants. Suffering of Thousands Prompts FDA Hearing about Hip Implants Thousands of …

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FDA Considers Metal Hip Injuries — A Bit Too Late for Some Victims – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts

June 30, 2012

FDA Considers Metal Hip Injuries — A Bit Too Late for Some Victims – Florida Mass Tort Attorneys, Lawyers | …

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J&J Sold Transvaginal Mesh Implants After FDA Ordered Company To Cease Marketing – SFGate

June 30, 2012

J&J Sold Transvaginal Mesh Implants After FDA Ordered Company To Cease Marketing – SFGate. J&J Sold Transvaginal Mesh Implants After …

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Medical Device « The Senate Passes Unparalleled Medical Device User Fee Act

June 30, 2012

Medical Device « DePuy Recall Blog. The Senate Passes Unparalleled Medical Device User Fee Act When the Senate passed the resolution …

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FDA panel sees little use for metal-on-metal hips – SFGate

June 30, 2012

FDA panel sees little use for metal-on-metal hips – SFGate. FDA panel sees little use for metal-on-metal hips MATTHEW PERRONE, …

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FiDA Failed Implant Device Alliance

June 26, 2012

FiDA Failed Implant Device Alliance. Failed metal on metal hips: U.S. lab rats! FDA probes safety issues with metal hip …

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FDA PMA – how this hides the guilty and stops The Damaged and Suffering from getting Justice – Smith & Nephew

June 17, 2012

Smith & Nephew BHR – How can a device manufacturer be denied by the FDA on a 3/2 vote in …

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Howard’s Lament – Lawyers dodge the tough jobs!

June 1, 2012

I am sharing my latest experience with a large law firm that did represent me up until yesterday. I received …

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Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year | ExpertRECALL | Recall Management, Product Retrieval, Recall Logistics

May 22, 2012

Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year  Mike Rozembajgier 05-14-2012 By Mike RozembajgierMedical device …

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FDA’s $6.4 Billion Plan for Quick Reviews Moves to Senate – Businessweek

May 22, 2012

FDA’s $6.4 Billion Plan for Quick Reviews Moves to Senate – Businessweek. Medtronic’s capsure sense lead, a device that is …

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Long Term Use of Bone-Strengthening Drugs Could Lead to Weaker Bones | Virtual-Strategy Magazine

May 13, 2012

Long Term Use of Bone-Strengthening Drugs Could Lead to Weaker Bones | Virtual-Strategy Magazine. Saturday, May 12th 2012  (PRWEB) May …

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Whitehall man with two defective hip implants wants to be heard by the FDA – mcall.com

May 12, 2012

Whitehall man with two defective hip implants wants to be heard by the FDA – mcall.com. By Milton D. Carrero, …

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Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG

May 12, 2012

Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG. Medical Implant Recalls Raises Questions about 510K Review …

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Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery – Hip Implants – Zimbio

May 12, 2012

Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery – Hip …

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MoM Hip Victim Stories to the Orthopedic and Rehab Devices Panel of Med. Devices Advisory Commitee

May 1, 2012

I just want to emphasize how important it is for as many of us as possible to send in our …

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June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

April 27, 2012

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0293] Orthopaedic and Rehabilitation Devices Panel of the …

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Metals from hip replacements present toxic risk for millions, investigation warns

April 25, 2012

Metals from hip replacements present toxic risk for millions, investigation warns Ryan Jaslow (CBS News) Millions of people with metal …

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Howard shares more views

April 25, 2012

Medical News: has 2 articles, reiteration, (daily.headlines@medpagetoday.com). People must learn about this or nothing will happen other than the medical …

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Judge consolidates Wright Conserve hip replacements into MDL | Consumer Drug Report | For Informed Drug Consumers

March 24, 2012

Judge consolidates Wright Conserve hip replacements into MDL | Consumer Drug Report | For Informed Drug Consumers. Judge consolidates Wright …

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What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs

March 24, 2012

What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs. What is the Status of …

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Rottenstein Law Group Incensed–But Not Surprised–by News That Johnson & Johnson Marketed Vaginal Mesh Implant Without FDA Approval

March 24, 2012

Rottenstein Law Group Incensed–But Not Surprised–by News That Johnson & Johnson Marketed Vaginal Mesh Implant Without FDA Approval. Rottenstein Law …

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FDA Confirms Johnson & Johnson Prolift Pelvic Mesh Product Sold for Over 3 Years without Necessary FDA Clearance

March 24, 2012

FDA Confirms Johnson & Johnson Prolift Pelvic Mesh Product Sold for Over 3 Years without Necessary FDA Clearance. The FDA …

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Senators Introduce Safe Medical Devices Act

March 24, 2012

Senators Introduce Safe Medical Devices Act. Senators Introduce ‘Safe Medical Devices Act’ A bipartisan group of U.S. senators is pushing …

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FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra

March 24, 2012

FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra. …

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Gynecare Prolift Mesh Sold by J&J Without FDA Approval | InjuryBoard Fort Worth

March 24, 2012

Gynecare Prolift Mesh Sold by J&J Without FDA Approval | InjuryBoard Fort Worth. Gynecare Prolift Mesh Sold by J&J Without …

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Consumer Reports Poll: Consumers Support More Medical Device Oversight

March 21, 2012

Consumer Reports Poll: Consumers Support More Medical Device Oversight Posted: 20 Mar 2012 07:38 AM PDT CONSUMERS UNION NEWS RELEASE     …

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Consumer Reports taps ire over bad medical devices

March 14, 2012

(Reuters) – Consumer Reports, the 76-year-old publication best known for its reviews of automobiles and refrigerators, is trying to galvanize …

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DePuy ASR – Make Your own mind up – Document – 2009 E-Mail on Hip Device – NYTimes.com

February 23, 2012

Document – 2009 E-Mail on Hip Device – NYTimes.com. Document: 2009 E-Mail on Hip Device Published: February 21, 2012 RelatedIn …

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Anon. replies to Katie’s Smith & Nephew BHR torment…

February 2, 2012

Hi Katie, I too am living in BHR MOM hell at present, and I am awaiting results on trace metal …

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FDA warns J&J’s DePuy unit over joint replacements – AlertNet

January 19, 2012

FDA warns J&J’s DePuy unit over joint replacements – AlertNet. FDA warns J&J’s DePuy unit over joint replacements 18 Jan …

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Johnson & Johnson hit with FDA warning letter | MassDevice – Medical Device Industry News

January 14, 2012

Johnson & Johnson hit with FDA warning letter | MassDevice – Medical Device Industry News. Johnson & Johnson hit with …

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Biomet Receives FDA Clearance for Two New Products

January 12, 2012

Biomet Receives FDA Clearance for Two New Products: E1(R) Humeral Bearing for the Comprehensive(R) Reverse Shoulder System and the Comprehensive(R) …

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China Kanghui Holdings Receives FDA Approvals for Hip and Knee Systems – MarketWatch

January 7, 2012

China Kanghui Holdings Receives FDA Approvals for Hip and Knee Systems – MarketWatch. Jan. 6, 2012, 7:31 a.m. EST China …

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Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

January 7, 2012

Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and …

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FDA probes JNJ, Bard and others on transvaginal mesh risks | MassDevice – Medical Device Industry News

January 7, 2012

FDA probes JNJ, Bard and others on transvaginal mesh risks | MassDevice – Medical Device Industry News. FDA probes JNJ, …

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Howards View on the FDA and Medical Device Failures

January 7, 2012

Recent Information from the FDA on Failures This information came from FDA news. The FDA says approximately 44% of device …

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Howard View – on a few things

December 30, 2011

Great to see the activity pick up re: metal on metal hip devices, and yes they can be hazardous to …

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FDA – Priorities, staffing impede inspections of drug, device makers – JSOnline

December 29, 2011

Priorities, staffing impede inspections of drug, device makers – JSOnline. Priorities, staffing impede inspections of drug, device makers Some not …

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FDA seeks to include more women in medical device trials

December 20, 2011

FDA seeks to include more women in medical device trials. FDA seeks to include more women in medical device trials …

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Howard Sdwin: What isn’t being published is the truth regarding the medical device world

December 17, 2011

What isn’t being published is the truth regarding the medical device world. by Howard Sadwin Howard’s Opinion: If we obtained …

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Howard Gets A New Hip – But Still Wants Justice

November 23, 2011

For those of you who have been following this blog for some time, you will recall the story of Howard …

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How Ions May Cause Metal-on-Metal Hip Implants to Go Bad

October 7, 2011

How Ions May Cause Metal-on-Metal Hip Implants to Go Bad Home › MPMN › Medtech Pulse Blog › How Ions May Cause Metal-on-Metal Hip Implants …

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Earl – Update – Surgeon Says Problem is only with Zimmer Metal on Metal

October 4, 2011

Letter from Surgeon So all good with my Zimmer device…   MY View: I would be extremely bloody unlucky if …

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Earl – Update – Hope I didn’t get the short straw – FDA Recalls Zimmer Trabecular Metal Modular Acetabular System

October 3, 2011

MY View: I would be extremely bloody unlucky if this particular batch number was used in my revision operation! If …

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Vaginal / Pelvic Mesh lawsuits pile up for C.R. Bard

October 2, 2011

Mesh lawsuits pile up for C.R. Bard September 29, 2011 by MassDevice staff Lawsuits accusing C.R. Bard of selling defective …

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FDA Recalls Zimmer Trabecular Metal Modular Acetabular System

October 1, 2011

FDA Recalls Zimmer Trabecular Metal Modular Acetabular System Published on: September 30th, 2011 12:02am  This Press Release (OPENPRESS) September 30, …

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The rate at which FDA issues 483s and warning letters is going up, up, up.

August 25, 2011

The rate at which FDA issues 483s and warning letters is going up, up, up. Source: FDA email circular advertising …

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Sadwin gets to the heart of the Issues with FDA 510(k)

August 14, 2011

Sadwin gets to the heart of the Issues with FDA 510(k) I spend a good part of my day keeping …

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U.S. advisers call for new medical device regime

July 31, 2011

U.S. advisers call for new medical device regime Andrew Seaman Reuters Full Edition July 30, 2011 WASH­INGTON (Reuters) – An …

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Expert group calls for new way to clear medical devices

July 31, 2011

Expert group calls for new way to clear medical devices Christine Mai-Duc | Tribune Washington Bureau Source: ongo The Tennessean …

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Sadwin Comments on Washington Post Article – Letter to Authors

July 31, 2011

Refer to: Advisory panel calls for revamping FDA approval process for medical devices Good morning: I just read your article …

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Sadwin Doesn’t buy the BHR Story …

July 29, 2011

Howard is currently sitting around minus a hip, lucky to be alive post BHR – little wonder… After reading article ” …

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Veterans are Put through Another War – Hip Recall

July 28, 2011

Veterans from America’s wars that have been through hip implant surgical treatment in VA hospitals or in other places might …

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Sadwin Raises More Questions – Will They Ever Be Answered?

July 25, 2011

Why don’t we hear more from those with defective Smith & Nephew Hips? Earl, you are right, are people afraid of speaking …

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New Stryker Hip Replacement System looks Good

July 23, 2011

Stryker MDM X3 Hip Replacement System Gets US Green Light by Gene Ostrovskyon Feb 11, 2011 • 9:54 am Source: …

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Kohl: FDA’s Post-Market Review of Hip Implants Welcome, But More Scrutiny Needed

July 17, 2011

Kohl: FDA’s Post-Market Review of Hip Implants Welcome, But More Scrutiny Needed [Targeted News Service] WASHINGTON, May 24 — The …

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Wireless data collected directly from patients during normal physical activities could enable the development of better knee implants

July 17, 2011

Published: Sat, Apr 7, 2007 – 01:00 am Materials – Knee Implants Wireless data collected directly from patients during normal …

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Another Smith & Nephew BHR Problem

July 12, 2011

Received Overnight from Another Person Suffering with Smith & Nephew Birmingham Hip Resurfacing I have removed the person’s identity as …

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Patients are the cobblestones on the path to doctors profits

July 12, 2011

Patients are the cobblestones on the path to doctors profits (Earl Stevens, 2011) by Earl Stevens on Monday, 11 July …

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FDA Letter to: Smith & Nephew Orthopaedics Gmbh 12/21/10

July 10, 2011

FDA Letter to: Smith & Nephew Orthopaedics Gmbh 12/21/10 Department of Health and Human Services Public Health ServiceFood and Drug …

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Smith & Nephew Warned Over Hip Implant Facility

July 10, 2011

Smith & Nephew Warned Over Hip Implant Facility Date Published: Wednesday, December 29th, 2010 The U.S. Food and Drug Administration …

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What the FDA has to say About Metal on Metal Hips

July 10, 2011

What the FDA has to say About Metal on Metal Hips FDA Website – click here Metal-on-Metal Hip Implants Hip …

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DePuy ASR Hip Implant was Untested

July 10, 2011

DePuy ASR Hip Implant was Untested Date Published: Monday, April 4th, 2011 Could the controversial recalled DePuy hip replacement devices …

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Senate Hearing on FDA Medical Device Approvals

July 10, 2011

DePuy Hip Implant Recall to be Featured at Senate Hearing on FDA Medical Device Approvals Date Published: Wednesday, April 13th, …

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FDA 510K Process for Medical Devices Let Unsafe Devices Through

July 10, 2011

FDA Again Criticized for Medical Device Oversight Date Published: Wednesday, April 13th, 2011 Thousands of medical devices are approved annually …

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Hip Manufacturers Required by FDA to do Safety Studies

July 10, 2011

Makers of Metal-on-Metal Hip Implants Ordered to Conduct Safety Studies Date Published: Wednesday, May 11th, 2011 Federal health regulators have …

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FDA Approval for Corin – 510K Approval

July 6, 2011

Corin Gets 510(k) Clearance for Cross-Linked Polyethylene Liners, Large Diameter Heads Source: Device Daily Bulletin 5 July 2011 Corin has …

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