DOJ: False Claims Top $4.7 Billion in 2016

Naloxone device, used to combat opioid overdose, recalled; distributed in Harford County

http://foxbaltimore.com/news/local/naloxone-device-used-to-combat-opioid-overdose-recalled-distributed-in-harford-countyThe recall comes in response to Teleflex Medical Inc.’s medical device recall for specific lots of MAD Nasal Intranasal Mucola Atomizer Devices.

Those were recalled and the defect can risk “under-dosing” naloxone during administration.

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Justice Department: False Claims Top $4.7 Billion in 2016

Of the $4.7 billion recovered, $2.5 billion came from the health care industry including drug companies, medical device companies, hospitals, nursing homes, laboratories, and physicians, according to the report.

The $2.5 billion … For example, L-3 …

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FDA nod makes Vericel’s MACI 1st tissue-engineered autologous cell scaffold

Vericel’s MACI (autologous cultured chondrocytes on porcine collagen membrane) to repair symptomatic single or multiple full-thickness cartilage defects of the knee, with or without bone involvement, in adults.

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University Professor and Co-Defendants Respond to Defamation Charge From Medical Device Maker

https://www.chicagomaroon.com/article/2016/12/14/university-professor-co-defendants-respond-defamat/According to Bone, “St. Jude just recently announced a potentially lethal design defect [in another medical device] that may affect up to 350,000 of its users—two years after learning of it, apparently.”

Bone adds that the defendants aimed to protect …

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FDA Confirms Link Between Actos and Increased Risk of Bladder Cancer

We are pleased that the agency is taking steps to further clarify this important public health matter,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective medical devices, drugs and …

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Three Essure Stories – and Why Women Are Turning to Congress For Help

https://trofire.com/2016/12/12/three-essure-stories-women-turning-congress-help/That law would take away federal protection from lawsuits on defective medical devices that have gotten FDA approval – which should never have happened for Essure.

Meanwhile, Bayer is unrepentant.

In a statement, the company said,. “Patient safety and …

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Ohio Man Files Bard G2® IVC Filter Lawsuit

https://dailyhornet.com/2016/ohio-man-files-bard-g2-ivc-filter-lawsuit/Another 27 deaths were linked to the Recovery.

Hundreds of lawsuits have been filed by people who were injured by these two filters.

Lawyers say C.R. Bard knew or should have known they were defective, but failed to issue recalls of warnings about risks.

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Cures Act: a good bill flawed by critical omission

http://www.theintell.com/opinion/op-ed/cures-act-a-good-bill-flawed-by-critical-omission/article_52c70802-0b18-5fd3-84fe-017908b746ff.htmlIn the time that followed, we learned about similar cases of defective medical devices, which harmed patients and went unreported to federal regulators.

We have seen evidence, most recently from an FDA hospital report, that there is a lack of …

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