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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.

Bayer Paid Doctors Millions in Fees Related to Birth Control Device Essure, Federal Data Shows

Federal data analyzed by CNN shows that between August 2013 and December 2017, Bayer paid $2.5 million to 11,850 doctors for services related to Essure, such as consulting fees. Although these types of payments are legal, they can be extremely controversial. CNN reported that some patients wondered whether their gynecologists were recommending Essure because it was the best birth control option for them, or whether their doctor was receiving payments from Bayer in exchange for implanting the device.

In July 2018, Bayer announced they would discontinue sales and distribution of Essure at the end of this year. The decision comes after FDA imposed restrictions and increased warnings for the device, including a black box warning. Thousands of women have suffered pain and adverse events after being implanted with the device, such as abdominal pain, headaches, perforation of the uterus or other organs, and even death.

If you or a loved one suffered complications after receiving an Essure implant, please contact us by calling us at 888-985-7228 for a confidential evaluation of your potential claim.

Netflix’s “The Bleeding Edge”: A Terrifying Exposé on the $400bn Medical Device Industry

A new Netflix documentary, “The Bleeding Edge,” debuted worldwide on July 27, 2018. The film is an exposé on questionable practices in the medical-device industry. It claims that the U.S. FDA is not doing enough to protect consumers and that many medical devices reach the market without undergoing enough pre-market testing. “The Bleeding Edge” also sheds light on the financial incentives pharmaceutical companies use to coax surgeons to implant devices.

The surgery scenes are not for the squeamish, but the interviews are just as agonizing. Patients recount suffering from poorly researched and regulated medical devices, including hip replacements, vaginal and hernia mesh, and robotic surgery devices.

One of the devices targeted in the film for not undergoing enough pre-market testing or scrutiny is controversial contraceptive device Essure. More than 16,000 lawsuits have been filed against the device manufacturer, Bayer, with women citing complications from organ perforation to hysterectomies. The documentary follows several women who have been adversely affected by Essure. The controversial birth control device was dropped from the market just a week before the documentary’s release.

If you or a loved one are affected by complications from Essure, contact us by calling 888-985-7228.

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