A number of different legal claims have been consolidated into a multi-district litigation regarding Stryker’s LFIT V40 femoral head hip implant. These hip implants have unfortunately been associated with a number of serious side effects and problems, and those plaintiffs who have filed lawsuits allege that they were not adequately warned about the risks when they had these devices implanted.
These LFIT V40 lawsuits have been consolidated into a single multidistrict litigation, in order to streamline the discovery and trial process.
Stryker, the manufacturer of the LFIT V40 system received market approval from the FDA to clear the medical device for sale in 2001 through the 510(k) program. The section 510(k) FDA approval program does not require a full round of clinical studies in order to gain clearance from the FDA, nor does the device have to be tested on any human subjects before being sold on the market. The section 510(k) program is designed to streamline the process for those developers of medical devices who claim that their device is substantially similar to something already on the market.
Unfortunately, after implantation, a number of different plaintiffs with the LFIT V40 model say they suffered serious side effects and problems which they allege to be a result of a defect. These plaintiffs have experienced similar side effects and issues such as fretting, corrosion, and the production and distribution of metallic debris throughout the body.
Stryker issued an urgent medical device recall notification in 2016, affecting many of the LFIT V40 heads manufactured prior to 2011. Many patients ultimately came back to their doctors after having these devices implanted to lodge complaints of corrosion, destruction of tissue, development of fluid collection, and pain and disability, many of which were associated with the need for revision surgery which carries its own risks.
Certain patients are unable to go through this revision surgery after having the LFIT V40 implanted as a result of other medical conditions, meaning that they must learn to cope with the side effects of this Stryker LFIT V40 femoral head. The complaints consolidated in this multidistrict litigation allege that the manufacturer is responsible for developing and promoting these devices as safe for use with plaintiffs around the world.
When a medical device is approved for the market and is later found to have serious problems, it may be recalled. Furthermore, those patients who already suffered the side effects linked to that device may opt to file lawsuits against the manufacturer if the potential side effects were not adequately disclosed to them.
With a hip implantation surgery being an extensive and common procedure, many of the patients who were recommended the Stryker device say they were led to believe that it was a safe and effective way to address painful hip issues.
Unfortunately, however, many of those plaintiffs have had the device replaced entirely or learned to live with the significant side effects and pain. Those patients who have already been affected in this manner may be eligible to pursue a lawsuit.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The hip implant attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, metal hip implant lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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