News

Director Beth Graham Selected to America’s Top 100 Attorneys®

Beth Graham, leader of G&E’s complex pharmaceutical and medical device litigation practice, has been selected for the Lifetime Achievement award by America’s Top 100 Attorneys®. The honor is bestowed upon only 100 attorneys in each state—less than 0.5% of active attorneys in the United States. Ms. Graham is recognized for her accomplishments and impact on the legal profession over the course of her career, representing plaintiffs in product liability litigation.

FDA Outlines New Steps to Evaluate Long-Term Safety Risks of Essure

Since medical device company Bayer HealthCare announced it would halt sales of its permanent contraceptive Essure in July 2018, the FDA has taken new measures to evaluate the long-term safety risks of the device. Thousands of women have lodged complaints against Bayer citing painful, debilitating complications from Essure such as chronic pain, pregnancy, miscarriage, perforation of the uterus or other organs, and even death. FDA Commissioner Scott Gottlieb issued a statement outlining the regulator’s next steps to revise and strengthen the manufacturer’s postmarket surveillance study. The study will include monitoring women implanted with the device for five years instead of three to capture longer term information about device removals, requiring additional blood testing to detect inflammatory indicators, and requiring Bayer to submit more frequent reports to the FDA on the study’s progress and results.

Cases on behalf of thousands of women have been filed against Bayer, claiming the manufacturer did not warn patients of Essure’s potential severe complications. Grant & Eisenhofer is Co-Liaison Counsel and serves on the Plaintiffs’ Executive Committee leading the litigation. If you have experienced complications from an Essure implant, please call us at 888-985-7228 to speak confidentially with an attorney about your potential claim.

FDA Announces Modernization of System that Approved Metal-on-Metal Hip Replacements

In November 2018, the FDA announced regulatory changes to modernize the way medical devices are tested and approved. The plan intends to ensure that companies use new technology for device designs that meet modern safety and performance criteria, replacing the FDA’s former 510(k) medical device approval standards that Congress legalized 42 years ago.

Metal-on-metal hip replacements were approved for use under the FDA’s 510(k) medical device approval standards, which allowed orthopedic companies like Zimmer Biomet and Johnson & Johnson to use designs from the 1970s. Many hip implant patients now face serious health risks due to metal poisoning and device fracture, sometimes necessitating painful and more complicated revision surgery.

If you or a loved one has experienced complications after receiving a metal-on-metal hip implant, please contact us by calling us at 877-790-3588 for a confidential evaluation of your potential claim.

Stryker LFIT V40 Settlement Reached

On Friday, November 2, 2018, a settlement was reached in Massachusetts federal court between Stryker Corp. and leadership counsel on behalf of plaintiffs seeking restitution from the company’s LFIT V40 hip implant component. The settlement—terms of which are confidential—resolves claims from certain lawsuits filed against the medical device company alleging that its femoral head component contributed to catastrophic side-effects, including painful hip revision surgery.

If you or a loved one has experienced complications after receiving a metal-on-metal hip implant, please contact us by calling us at 877-790-3588 for a confidential evaluation of your potential claim.

Zimmer Hip MDL Established in the Southern District of New York

In early October 2018, the U.S. Judicial Panel on Multidistrict Litigation formally decided to consolidate the over two dozen cases pending against Zimmer-Biomet, Inc. over its M/L Taper and VerSys femoral head—parts of a metal-on-metal hip replacement system. Complaints over the hip implant components similarly allege that the Zimmer M/L Taper Hip Prosthesis and Zimmer VerSys Hip femoral head are faulty and dangerous when implanted together due to corrosion and fretting of the metal. Metallic debris reportedly chipped away from the device during everyday movements and contaminated patients’ blood and damaged surrounding tissue, resulting in the need for device removal. These cases, filed in 10 different U.S. District courts across the country, have been consolidated and centralized before U.S. District Judge Paul A. Crotty in the U.S. District Court for the Southern District of New York for pretrial proceedings.

If you or a loved one has experienced complications after receiving a metal-on-metal hip implant, please contact us by calling us at 877-790-3588 for a confidential evaluation of your potential claim.

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