Archive for February 2012

Industry Doesn’t Want Medical Device Tax, GOP Freshmen Help

Feb 9th, 2012 | By
Industry Doesn’t Want Medical Device Tax, GOP Freshmen Help

An article in DOTmedNews reports that GOP freshmen are aligning with industry to oppose a 2.3 percent excise tax on the medical device industry set to go into effect January 2013. Industry says it will hurt profits and drive jobs and innovation oversees. As the deadline gets closer, the opposition is growing louder. Monday, February
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Consumers Union on Improving the Safety of Medical Devices

Feb 8th, 2012 | By

  Improve the safety of medical devices An overview of Consumers Union’s Safe Patient Project Initiative Medical devices, like eyeglasses and contact lenses, are a part of our everyday lives and are a growing part of the health care we receive. Complex devices like artificial hip joints, surgical mesh, and cardiovascular stents, are permanently implanted
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Sen. Grassley Comes to Defense of One Whistleblower in Letter to Hamburg

Feb 8th, 2012 | By
Sen. Grassley Comes to Defense of One Whistleblower in Letter to Hamburg

February 9, 2012 ~ “Whistleblowers point out fraud, waste and abuse when no one else will, and while they do so while risking their professional careers, they are often treated like skunks at a picnic,” Grassley wrote. “Whistleblowers have played a critical role in exposing harmful government actions and retaliation against whistleblowers should never be
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140 Mesh Injury Lawsuits to be Consolidated in 3 MDLs in West Virginia

Feb 7th, 2012 | By
140 Mesh Injury Lawsuits to be Consolidated in 3 MDLs in West Virginia

February 7, 2012 ~ Breaking News!   Within the hour the Judicial Panel on Multidistrict Litigation (MDL)  ruled that three pending and separate MDL actions against three synthetic mesh manufacturers should be heard in the Southern District of West Virginia. The MDL claim 2187 is being heard by Chief Judge Joseph R. Goodwin in the Southern
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Hernia from Hell Treated with Biologic Mesh

Feb 7th, 2012 | By
Hernia from Hell Treated with Biologic Mesh

February 6, 2012 ~ James Fico had a problem. The Sarasota Herald-Tribune (here) reports on the North Port man’s basketball-size hernia that protruded from his belly for more than five years. (Caution- the photos in this article are not for the weak of heart). Unfortunately for Fico, 62, he had had a major heart attack
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Consumers Union’s Safe Patient Project Brings Eight Activists to Congress

Feb 6th, 2012 | By
Consumers Union’s Safe Patient Project Brings Eight Activists to Congress

February 6, 2012 ~ Consumers Union is bringing eight patient activists to Washington, D.C. to meet with lawmakers and press for strengthened medical device oversight. The timing is important. The Food and Drug Administration’s budget will be determined by the Medical Device User Fee Act (MDUFA) and the medical device industry is pushing for faster
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Device Maker Smith & Nephew Pays $22 Million to Settle Bribery Case

Feb 6th, 2012 | By
Device Maker Smith & Nephew Pays $22 Million to Settle Bribery Case

Medical device maker, Smith & Nephew has been in the news lately as one of the manufacturers of metal-on-metal artificial hips. Now AP (here) reports the London-based company has agreed to pay $22.2 million to settle claims that its U.S. and German subsidiaries bribed public doctors in Greece for more than a decade to increase the
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Sheri Ragan Still Suffering from Biologic Hernia Mesh

Feb 3rd, 2012 | By
Sheri Ragan Still Suffering from Biologic Hernia Mesh

Sheri Ragan is playing the waiting game – waiting for a hospital in Ormond Beach, Florida to decide when and if it will take Medicaid so she can have an infected biologic mesh implant removed by the doctor of her choice. At 42, Ragan still doesn’t know how she ended up with six years of
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Sound Medical Devices Act- Dems Want FDA to Block Approvals When Similar Device is Recalled

Feb 2nd, 2012 | By
Sound Medical Devices Act- Dems Want FDA to Block Approvals When Similar Device is Recalled

  February 1, 2012 ~ Bloomberg reports on a bill  introduced this week that would put the brakes on the approval of a medical device that claims to be similar to another approved device that’s been recalled or found to be defective. The bill was introduced by Democratic lawmakers including Rep. Edward Markey (D-MA) on
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Medical Device Makers Will Double Fees for Faster FDA Reviews

Feb 1st, 2012 | By
Medical Device Makers Will Double Fees for Faster FDA Reviews

Medical device makers want to get their products into the marketplace faster. The U.S. Food and Drug Administration (FDA) needs more operating capital to review medical devices. The two have formed an informal agreement that was leaked to Bloomberg on Wednesday, February 1 (here). Under the proposed plan, medical device makers would pay $595 million
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.