Category Archives: Medical Devices

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New Bill Could Restrict Medical Device Approval Process

By Stefanie Colella-Walsh on Posted in DePuy ASR®, Medical Devices

A recent Bloomberg article, reported that House Democrat Edward Markey (MA) has sponsored a bill that would prevent manufacturers from asserting that their new medical devices are “substantially equivalent” to existing, approved devices, under certain circumstances.  While the bill was apparently developed as a result of a 1999 recall of vaginal mesh manufactured by Boston… Continue Reading

Johnson & Johnson Continued Marketing FDA Rejected Hip Device in Europe

By Craig S. Hilliard on Posted in DePuy ASR®, Medical Devices

According to a recent New York Times article, Johnson & Johnson continued to market an artificial hip replacement in Europe, despite the Food and Drug Administration (FDA) rejecting its sale in the United States, based on safety concerns.  The company also continued to sell a similarly designed device in the United States, the articular surface… Continue Reading

First Trials in Nuvaring Litigation Expected in 2012

By Kevin M. Hart on Posted in Medical Devices, NuvaRing®

As we have previously reported, Nuvaring, manufactured by Organon USA, was initially marketed in the United States in July 2002, after receiving FDA approval in late 2001. However, studies have shown that the ingredients contained in the birth control product NuvaRing may be linked to various forms of severe side-effects such as: heart attack, stroke,… Continue Reading

DePuy ASR Joint Management Conference Conducted in Bergen County, New Jersey

By Kevin M. Hart on Posted in DePuy ASR®, Medical Devices

On June 1, 2011, Judge Martinotti hosted a joint MDL/State Case Management Conference in Bergen County, New Jersey, along with the Honorable David A. Katz, U.S.D.J., who is presiding over the federal cases in the MDL in Ohio. As previously discussed, centralizing the state and federal cases will streamline the lawsuits, allowing the parties to avoid duplicative discovery and inconsistent rulings from different judges.

DePuy Pinnacle Hip Implant Consolidated in Texas

By Martin P. Schrama on Posted in DePuy ASR®, Medical Devices

As we previously reported, in March 2011, a petition was filed to consolidate all federal DePuy Pinnacle cases in either the Southern District of Texas or the Central District of California. Alternatively, the petition also asked that the United States Judicial Panel on Multi-District Litigation consider adding the Pinnacle cases to the already pending DePuy ASR MDL, which is centralized in the Northern District Court of Ohio. On May 16, 2011, a hearing was held by the U.S. Judicial Panel on Multidistrict Litigation (“JPML”) to consider the consolidation.

DePuy Pinnacle Hip Implant To Possibly Follow DePuy ASR MDL

By Stefanie Colella-Walsh on Posted in DePuy ASR®, Medical Devices

DePuy Orthopaedics, a subsidiary of Johnson & Johnson, has yet to issue a recall for its Pinnacle system. However, similar to the recalled ASR models, there are concerns that the Pinnacle Acetabular Cup System, also a metal-on-metal implant device, might have significant design defects leading to a higher than normal failure rate. DePuy has reportedly sold over 150,000 Pinnacle hip implant systems, largely outselling the ASR models. As of last month, the FDA had received more than 1,300 “adverse events reports” with regard to the Pinnacle system.

DePuy ASR New Jersey State Cases Centralized in Bergen County

By Kevin M. Hart on Posted in DePuy ASR®, Medical Devices

As we previously discussed, on December 9, 2010, a Notice to the Bar was issued by Judge Glenn A. Grant, Acting Administrator of the Courts, advising that an application had been made, pursuant to Directive #7-09, “Revised Mass Tort Guidelines,” requesting designation of all New Jersey state-court litigation involving DePuy ASR™ hip implants as a mass tort and assignment for centralized management in Middlesex County. The federal cases have already been consolidated in the Northern District Court of Ohio.

CEO of DePuy Resigns

By Stefanie Colella-Walsh on Posted in DePuy ASR®, Medical Devices

As we have previously reported, DePuy Orthopedic, Inc., a subdivision of Johnson & Johnson, Inc., issued a recall in August 2010, for the ASR XL Acetabular System and the ASR Hip Resurfacing System after data suggested that about one out of every eight may fail within only five years. Specifically, the recall targeted individuals who received the implants after July 2003.

Possible New Defendant in NuvaRing® Mass Tort Litigation

By Stefanie Colella-Walsh on Posted in Medical Devices, NuvaRing®

The Hon. Rodney W. Sippel, U.S.D.J., presides over the federal multi-district litigation in the Eastern District of Missouri addressing claims against NuvaRing®. Judge Sippel held a case management conference on February 14, 2011 at 3:30 p.m. wherein Plaintiffs addressed the possibility of naming an additional defendant, NV Organon. Judge Sippel Ordered Defendants to respond to Plaintiffs’ stipulation by March 16, 2011.

NuvaRing® Case Management Conference Scheduled

By Martin P. Schrama on Posted in Medical Devices, NuvaRing®

Judge Martinotti, who presides over the NuvaRing® mass tort cases in the Superior Court of New Jersey – Bergen County, will hold a case management conference on March 11, 2011. At this conference, the judge will hear Defendants’ motion to dismiss Millian v. Organon. Defendants claim the statute of limitations has expired and the action is barred. Underlying the statute of limitations issue in this motion is a choice of law issue. The Court will address whether to apply the statute of limitations of Virginia, the plaintiff’s home state where her injuries were diagnosed, or New Jersey, the state where the action is filed. The Court’s decision will likely apply to the remaining matters filed in this mass tort.

New Developments in DePuy Hip Recalls: The Pinnacle System

By Stefanie Colella-Walsh on Posted in DePuy ASR®, Medical Devices

In August of 2010, DePuy, a Johnson & Johnson company, announced a global hip replacement recall of two devices: the ASR Hip Resurfacing System and the ASR XL Acetabular System. Data from a recent study concerning XL Acetabular metal-on-metal hip replacement system showed that the 5 year failure rate of the product is approximately 13%, or 1 in 8 patients. It has identified component loosening, component malalignment, fracture of the bone, dislocation, infection, metal sensitivity and pain as the reasons for the failure of the hip replacement system.

Mass Tort Application in DePuy Orthopedic, Inc. Hip Recall Lawsuits

By Kevin M. Hart on Posted in DePuy ASR®, Medical Devices

On December 9, 2010, a Notice to the Bar was issued by Judge Glenn A. Grant, Acting Administrator of the Courts, advising that an application had been made, pursuant to Directive #7-09, “Revised Mass Tort Guidelines,” requesting designation of all New Jersey state-court litigation involving DePuy ASR™ hip implants as a mass tort and assignment for centralized management in Middlesex County.

Multi-District Litigation granted in DePuy Hip Recall

By Martin P. Schrama on Posted in DePuy ASR®, Medical Devices

In December 2010, the United States Judicial Panel on Multi-District Litigation (MDL) ruled to consolidate all federal district cases in the Northern District Court of Ohio. The MDL 2197, In re DePuy Orthopaedics, Inc. ASR Hip Implant Products, will be handled by Judge David A. Katz who will manage all pre-trial issues for all federal DePuy hip implant recall cases.

Update on NuvaRing® Litigation

By Stark & Stark on Posted in Medical Devices, NuvaRing®

The NuvaRing® Mass Tort is presided over by Judge Brian R. Martinotti, in the New Jersey Superior Court – Bergen County. Previously, counsel for both plaintiffs and defendants had chosen ten initial bellwether cases for case specific discovery and trial. On, March 3, 2010, Judge Martinotti held a Case Management Conference. During that conference, Judge Martinotti determined that the discovery deadline on the initial bellwether cases would be March 15, 2011, culminating in proposed trial dates some time in May 2011.

Courts in the United States Have Consolidated NuvaRing® Lawsuits on Both the State and Federal Levels

By Craig S. Hilliard on Posted in Medical Devices, NuvaRing®

As we have discussed in previous posts, pending lawsuits against the manufacturers of NuvaRing®, state that the birth control product has led to severe side-effects such as: heart attack, stroke, deep vein thrombosis (also known as DVT or blood clots), internal organ damage, myocardial infarction and pulmonary embolism.

Defendants in NuvaRing® Litigation Files Motion To Dismiss Plaintiff’s Claims

By Martin P. Schrama on Posted in Medical Devices, NuvaRing®

As we have discussed in previous posts, NuvaRing®, the combined contraceptive vaginal ring that is supposed to provide month-long birth control, is currently involved in a Multi-District Litigation (“MDL”) in the United States District Court for the Eastern District of Missouri. Recently, defendants filed numerous motions to dismiss certain plaintiff’s claims for failure to provide a timely or complete “Plaintiff Fact Sheet” (also known as a “PFS”). In pharmaceutical cases with Mass Tort or Multi-District Litigation designations, plaintiffs are required to submit a detailed PFS.

Defendants in NuvaRing® Litigation Files Motion For Entry of Lone Pine Case Management Order

By Kevin M. Hart on Posted in Medical Devices, NuvaRing®

NuvaRing®, the combined contraceptive vaginal ring that is supposed to provide month-long birth control, is currently involved in a Multi-District Litigation (“MDL”) in the United States District Court for the Eastern District of Missouri. Plaintiffs have advanced claims that NuvaRing® is responsible for injuries in some individuals.

Court Denies Motion By Defendants to Dismiss NuvaRing® Complaints

By Stark & Stark on Posted in Medical Devices, NuvaRing®

The Court recently denied a motion by Defendants to dismiss the Master Consolidated Complaint in the MDL. On August 17, 2009, Defendants filed a motion for certification of an interlocutory appeal. Defendants seek the Court’s permission to challenge the denial of Defendants’ motion to dismiss. In plain English, this means that Defendants are attempting to appeal in the middle of the ongoing case.

Court Dismisses Class Action Claims in NuvaRing® Litigation

By Craig S. Hilliard on Posted in Medical Devices, NuvaRing®

In a recent blog post, it was reported that NuvaRing® plaintiffs had filed a master consolidated complaint in order to supplement the complaints in the individual NuvaRing® litigation cases. On May 19, 2009, the Court dismissed the class action claims in the Master Consolidated Complaint. The Court noted that such claims are usually not appropriate for personal injury lawsuits based on pharmaceuticals.

NuvaRing® Plaintiffs File Master Consolidated Complaint

By Kevin M. Hart on Posted in Medical Devices, NuvaRing®

NuvaRing®, the once-a-month combined contraceptive vaginal ring which is supposed to provide month-long birth control, is currently involved in a Multi-District Litigation (“MDL”) in the United States District Court for the Eastern District of Missouri based on claims that NuvaRing® is responsible for injuries in some individuals.

Update on NuvaRing® Litigation Status

By Kevin M. Hart on Posted in Medical Devices, NuvaRing®

NuvaRing® is marketed as a once-a-month, combined contraceptive vaginal ring that provides month-long birth control. It is sold in the United States by Organon USA Inc., a New Jersey corporation with its principal place of business in Roseland, New Jersey, and Organon International, Inc., headquartered in the Netherlands