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Category: Defective Medical Devices

Lengthy Clinical Trial Process Gets Overhaul by FDA

03/10/2015
Articles
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Safeguarding, streamlining, strengthening the clinical trial process is one of three of the Food and Drug Administration’s primary goals for 2015. So states an 11-page document titled 2014 – 2015 Strategic Priorities. The other two goals focus on 1) striking a better balance between data collection requirements and the time […]

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Third Ethicon Bellwether Trial Set for March 2015

01/19/2015
Defective Medical Devices
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Judge Goodwin is presiding over seven different federal multidistrict litigation established for similar cases filed against various medical device manufacturers, including American Medical Systems, Boston Scientific, Coloplast Corp., Cook Medical, Ethicon , C.R. Bard, and Neomedic. Each of the complaints involves allegations by women who experienced painful complications following the […]

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Punitive Damages Claims May Proceed Against Boston Scientific

01/7/2015
Defective Medical Devices
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Several plaintiffs that were implanted with Boston Scientific’s Obtryx transobturator Mid-Urethral Sling System alleged in their lawsuits that the manufacturer, Boston Scientific, ignored warning that devices containing polypropylene should not be implanted in humans. These plaintiffs assert that Boston Scientific was aware that the polypropylene used in the Obtryx device […]

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New FDA Alert on Power Morcellators

12/1/2014
Announcement
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On November 24, 2014, the Food & Drug Administration made another significant step in improving the safety of women. The FDA issued its latest safety alert relating to the widespread use of power morcellators. A power morcellator is a medical device that is used during a number of gynecological surgeries – the removal of […]

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Endo Agreed to Settle Lawsuit Over Mesh Products

10/18/2014
Announcement
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In October of 2014, Endo International PLC (”Endo”) agreed to settle claims stemming from lawsuits that alleged problems with its vaginal mesh products. In the settlement, Endo asserts that the agreements are not an admission of liability. According to Bloomberg BusinessWeek, Endo agreed to pay “more than $400 million to […]

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Obamacare’s “Open Payments” A Victory for Patients

10/1/2014
Articles
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Information is the cornerstone to modern, 21st century society. Transparency and information gives citizens and consumers the power to make informed decisions on who to vote for or which products to consume. Backroom deals, nepotism and corruption operate in the shade of misinformation, disinformation, and unknowable and incomprehensible processes and […]

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