Weekly Mass Torts Bulletin 2024-December-12
Zimmer Biomet Gets FDA Approval for Cementless Partial Knee
Zimmer Biomet announced it has received supplemental FDA premarket approval (PMA) for the Oxford Cementless Partial Knee, making it the only FDA-approved cementless partial knee implant available in the U.S.
FDA investigational device exemption (IDE) study and non-clinical testing
This approval follows safety and efficacy data from an FDA investigational device exemption (IDE) study and non-clinical testing.
Oxford Cementless Partial Knee
The Oxford Cementless Partial Knee offers improved fixation, enhanced long-term implant survival, and increased surgical efficiency compared to its cemented counterpart. Unlike traditional partial knee replacement (PKR), which relies on bone cement for implant stability, the cementless approach enables natural bone growth to secure the implant. This promotes better long-term fixation and stability, according to the company.
Design of the system
Featuring a mobile bearing design, the Oxford system allows the femoral component to move naturally through a full range of motion, providing a more natural feel and improved knee function. The system’s tibial and femoral components are coated with titanium and hydroxyapatite to encourage bone integration into the implant.
Launch in 2025
Zimmer Biomet highlights the system’s 20 years of clinical use globally, with over 300,000 procedures performed in more than 50 countries. The company plans to launch the Oxford Cementless Partial Knee nationwide in the U.S. in early 2025.
What did the company official say?
“Cementless knee replacement procedures are increasingly preferred by surgeons seeking improved surgical efficiency,” said Zimmer Biomet’s President of Knees. “The Oxford Cementless Partial Knee offers a less invasive alternative to total knee replacement, retaining more healthy anatomy and improving outcomes. We’re excited to meet the U.S. demand for this proven technology.”
This innovation is poised to address unmet needs for less invasive and durable knee replacement options, backed by decades of clinical success worldwide.
Court Names Special Masters for Bard Mesh Claim Settlements
The U.S. District Judge overseeing the federal litigation involving Bard hernia mesh lawsuits has appointed two Special Masters to facilitate the resolution of claims through an “Intensive Settlement Process” (ISP).
Aim of the Process
This process aims to provide financial compensation to individuals injured by defective surgical mesh patches sold by C.R. Bard over the past several decades.
More than 21,000 product liability lawsuits
C.R. Bard has faced more than 21,000 product liability lawsuits in the U.S., each alleging that design defects in Bard hernia mesh products, including the Ventralight, Ventralex, Perfix Plug, and 3D Max systems, caused painful and debilitating injuries. These claims have been consolidated under a federal multidistrict litigation (MDL) for pretrial proceedings.
Agreement announced in October 2024
Following mixed results in early bellwether trials meant to gauge jury reactions to evidence and testimony, a global Bard hernia mesh settlement agreement was announced in October 2024. This settlement is expected to resolve most claims over the next several years. However, claimants retain the option to participate in the settlement program or opt-out to pursue mediation or jury trials.
Case Management Order
In a case management order issued on November 21, the Judge appointed experienced mediators as Special Masters to oversee the ISP, designed to address claims not resolved through the global settlement. The Special Masters will organize court-supervised mediation sessions and provide quarterly updates on progress. The ISP is expected to continue until mid-2029, with unresolved cases addressed through monthly conferences beginning in January 2027.
Rules to Negotiate & Settle
Claimants who opt out of the settlement, reject prior offers, or remain unresolved will attend in-person mediation sessions led by a chosen Special Master, with costs shared between the parties. Both sides must attend these conferences with full authority to negotiate and settle the case. Lawyers representing unresolved claimants can select their preferred Special Master for mediation.
The ISP will remain active until the Special Masters certify to the court that all unresolved claims have been addressed. Until that certification, individual plaintiffs cannot request their cases to be set for trial.
The appointment of Special Masters and the launch of the ISP represent significant steps in resolving the complex Bard hernia mesh litigation. Initial settlement payouts will occur over the next few years, while mediation efforts under the ISP will continue for cases outside the global settlement, ensuring all claimants have an opportunity for resolution.
Baltimore Wins $266M in Opioid Case Against Drug Distributors
Baltimore has secured a $266 million victory in its lawsuit against major drug distributors McKesson and Cencora (formerly AmerisourceBergen), accusing them of fueling the opioid crisis.
The Verdict
A jury in the Circuit Court for Baltimore found McKesson liable for $192 million and Cencora for $74 million in compensatory damages, concluding a nearly two-month trial. The verdict addresses the harms caused by the companies' alleged negligence.
Impact on Baltimore
Baltimore, severely impacted by the opioid epidemic, opted out of national opioid settlements to pursue greater compensation independently. In 2022, the city, with a population of around 569,000, recorded 904 opioid overdose deaths, far exceeding the national average of 25 deaths per 100,000 people.
The City seeks additional funds
The city plans to seek an additional $9 billion in abatement funds next month to cover the ongoing costs of addressing the crisis, a legal remedy separate from the awarded damages. Baltimore alleges that McKesson and Cencora ignored clear warning signs that the opioids they distributed were being diverted into illegal channels.
Companies' stand on the verdict
Both companies deny wrongdoing and have announced plans to appeal the verdict. McKesson argued that the decision misrepresents its limited role as a pharmaceutical distributor, while Cencora claimed the ruling complicates its efforts to balance medication access with preventing substance abuse.
Baltimore’s legal team celebrated the verdict as a step toward recovery for the city, which has been one of the hardest-hit communities in the nation. The ruling is part of Baltimore’s broader legal efforts against various entities involved in the opioid supply chain. Including prior settlements with companies such as Walgreens and Johnson & Johnson, Baltimore has now secured more than $668 million in total compensation.
Past Lawsuits
McKesson, which supplied about half of Baltimore’s opioids between 2006 and 2019, has faced similar legal challenges in the past. In 2017, it reached a $150 million settlement with the U.S. Department of Justice, admitting to failures in preventing illegal opioid sales. Cencora is also under scrutiny, facing a separate civil lawsuit from the Department of Justice for its alleged role in the opioid epidemic.
3,000 lawsuits & 800,000 lives claimed by opioids
The Baltimore lawsuit is among more than 3,000 filed by local governments, Native American tribes, and states against drug manufacturers, distributors, and pharmacies nationwide. While most of these cases have been resolved through national settlements totaling approximately $46 billion, Baltimore’s independent approach underscores the significant financial and societal toll of the opioid crisis, which has claimed over 800,000 lives in the U.S. since 1999, according to the Centers for Disease Control and Prevention.
The opioid crisis has been haunting the U.S. for ages now, and lawsuits against drugmakers developing it are growing at a rapid pace. Stay updated about the latest developments in opioid litigation by subscribing to our newsletter.
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