Devices

Fitzpatrick House Bid to Kill Medical Device Preemption

Rep. Mike Fitzpatrick (R-PA), who has been championing relief measures for patients injured by power morcellators and Bayer’s Essure permanent birth control device, has introduced an amendment that would overturn the U.S. Supreme Court’s landmark Riegel v. Medtronic decision and allow patients harmed by a PMA device to seek the same redress as anyone else in the courts. The amendment was offered to HR 1927 — Fairness in Class Action Litigation Act of 2015, which is currently being reviewed by the House Committee on Rules.

The one-page amendment would add a new Section 4 titled: “Access To Justice For Victims Of Unsafe Medical Devices.” It essentially would amend Section 521 of the Food, Drug, and Cosmetic Act (21 U.S.C. 360k) to state that “Nothing in this section preempts or limits a civil action, sounding in tort, arising under the common law of the state.”

Currently, the amendment has no co-sponsors, but that doesn’t deter Fitzpatrick. His spokesman said a previous bill from 2009 attempted to overturn the Riegel decision and had 109 cosponsors — 102 Democrats and seven Republicans.

Late last year, Fitzpatrick introduced the “E-Free Act”that directs FDA to withdraw approval of Bayer Essure device. The bill, which was co-sponsored by Reps. Marsha Blackburn (R-TN), Chris Smith (R-NJ) and Gregorio Sablan (D-Northern Mariana Islands), seeks to address the over 5,000 formal complaints the agency has received related to Essure. Patient advocacy against the device has been strong, with over 23,000 women joining together on Facebook to share stories of how they were harmed by the device. “They were told this device was safe,“ a Fitzpatrick press release said, “and there was no way the device caused their pain and other symptoms. But that proved to be wrong.” The bill has been referred to the Energy and Commerce Committee for consideration.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome