Stefanie Colella-Walsh - New Jersey Law Blog

Panel Scheduled to Meet Again to Consider MDL Treatment in Darvocet Cases

Stefanie Colella-Walsh — Wed, 27 Jul 2011 12:57:39 -0500

The United States Judicial Panel on Multi-District Litigation (MDL) is scheduled to meet on July 28, 2011, in San Francisco, CA to hear further argument on whether all federal Darvocet and Darvon cases should be centralized, pursuant to 28 U.S.C.§ 1407, for coordinated or consolidated pretrial proceedings, and if so, which federal district is the appropriate forum for these proceedings. The Panel originally met in March 2011, to hear arguments but deferred its decision and scheduled the July 2011, hearing to consider additional information. A granting of MDL treatment would streamline the pretrial discovery process, allowing the parties to avoid duplicative discovery and inconsistent rulings from different judges.

As we have previously indicated, in November, 2010, the FDA announced that it was pulling off the U.S. market the prescription painkillers, Darvon and Darvocet, which combines Darvon with the aspirin substitute acetaminophen, because of scientific evidence the drugs can damage the heart, even at recommended doses, or cause fatal cardiac abnormalities.

Studies have shown that the ingredients contained in Darvocet and Darvon have been linked to various forms of severe side-effects. Reportedly, these side-effects include: heart arrhythmia, heart attack, suicide, accidental overdose and death.

If you feel you have experienced any side-effects from taking Darvocet, Darvon or generic propoxyphene you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the Darvocet or Darvon manufacturers

DePuy Pinnacle Hip Implant To Possibly Follow DePuy ASR MDL

Stefanie Colella-Walsh — Fri, 13 May 2011 12:31:43 -0500

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.

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 (MDL) consider adding the Pinnacle cases to the already pending DePuy ASR MDL, which is centralized in the Northern District Court of Ohio. In April 2011, DePuy responded to the petition, conceding that the cases should be consolidated for discovery purposes, but suggested the MDL take place in the Northern District of Texas. The decision is expected to be made when the Panel convenes on May 16, 2011, in Louisville, Kentucky.

Over 30 federal cases have been filed across 18 districts. Granting MDL treatment will consolidate all federal lawsuits filed across the U.S. into one centralized district. This consolidation will streamline the pretrial discovery process, allowing the parties to avoid duplicative discovery and inconsistent rulings from different judges.

If you are experiencing adverse effects from a defective DePuy Pinnacle hip implant, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against DePuy Orthopaedics.

CEO of DePuy Resigns

Stefanie Colella-Walsh — Mon, 18 Apr 2011 08:01:25 -0500

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.

Now, with the legal pressure continuing to mount, David Floyd, CEO of DePuy Orthopaedics since 2007, has announced his resignation. A spokeswoman for DePuy advised that Floyd “made a personal decision to pursue interests outside of DePuy.”

Johnson & Johnson began selling the metal-on-metal devices outside the U.S. in 2003. The ASR XL was then introduced in the U.S. market in 2005. However, DePuy did not seek FDA approval for the ASR Resurfacing System until June 2007. Instead, DePuy relied on a grandfathering process, which did not require clinical trials as long as DePuy was able to demonstrate that the ASR XL was “substantially similar” to the company’s other metal-on-metal devices.

According to a recent article in Bloomberg Businessweek (April 4- April 10, 2011), following its introduction to the U.S. market, the FDA received 87 reports of adverse incidents in 2007, which subsequently rose to 239 reports in 2008 and to 426 reports in 2009. Not until August 2010, did DePuy finally recall the allegedly defective devices. In March 2011, the British Orthopaedic Association and the British Hip Society reported that preliminary research showed the ASR XL’s failure rate in the U.K. as high as 49% after 6 years.

If you have had a hip replacement, which used one of the recalled DePuy devices, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against the DePuy manufacturers.

Possible New Defendant in NuvaRing® Mass Tort Litigation

Stefanie Colella-Walsh — Fri, 04 Mar 2011 09:12:43 -0500

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.

As we have discussed in previous posts, studies have shown that the ingredients contained in the birth control product NuvaRing® have been linked to various forms of severe side-effects including: heart attack, stroke, deep vein thrombosis (also known as DVT or blood clots), internal organ damage, myocardial infarction and pulmonary embolism.

At Stark & Stark we pursue claims throughout the nation against drug manufacturers, so they can be held accountable when the drugs they market are proven to be defective or cause catastrophic injury to the people who use them. Contact Stark & Stark to speak with one of the Mass Tort/ Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the manufacturers of NuvaRing®.

New Developments in DePuy Hip Recalls: The Pinnacle System

Stefanie Colella-Walsh — Mon, 31 Jan 2011 08:06:57 -0500

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.

Recently, it has been thought that DePuy’s other metal-on-metal implant line, the Pinnacle system (Pinnacle Acetabular Cup System), might also have significant design defects. As of now, DePuy has not issued a voluntary recall on the Pinnacle system, but there are concerns that the Pinnacle system also has an increased failure rate. In 2010, the FDA Adverse Event Reporting System received over 500 complaints from people who had experienced adverse effects from the Pinnacle system. Similar to the ASR XL Acetabular and ASR Hip Resurfacing Systems, the DePuy Pinnacle Acetabular Cup System was fast-tracked through the FDA’s medical device approval process because it was similar to already-approved devices.

While over 100 lawsuits have been filed as a result of the DePuy ASR recalls, a small number of suits alleging fault with the DePuy Pinnacle system have also been filed. According to one suit, filed in December 2010, in the U.S. District Court for the Western District of Washington, the plaintiff has undergone six surgeries as a result of metal poisoning he developed after receiving a Pinnacle hip implant in 2007. A second suit, filed in November 2010, in the U.S. District Court for the Central District of California alleges that another plaintiff has been suffering from an abnormal gait, nerve pain and other problems since receiving the Pinnacle device in 2004.

Update on YAZ® Case Management Conference

Stefanie Colella-Walsh — Thu, 23 Dec 2010 08:04:43 -0500

On December 16, 2010, counsel attended a Case Management Conference before Judge Martinotti in Bergen County Superior Court in Hackensack, New Jersey. It was agreed that counsel will continue to work together to depose, or question, the necessary witnesses from defendant Bayer Corporation, both domestically and internationally. Additionally, plaintiffs were granted authority to file a motion with the Court, seeking to compel the production of foreign personnel files from employees noticed for deposition, which the defendants argue is prohibited under German law. The motion is expected to be heard in early 2011.

The next Case Management Conference is currently scheduled for February 3, 2011. At that time, counsel is hopeful that we can construct a time-line to identify the bellwether cases, as already done in the Federal MDL, and move toward scheduling trial dates.

If you feel you have experienced any side-effects from taking YAZ® or Yasmin® (or the generic brand, Ocella®), you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the YAZ®, Yasmin® or Ocella® manufacturers.

YAZ® Lawsuit Update: Bellwether Trials in the Federal MDL Scheduled

Stefanie Colella-Walsh — Tue, 23 Nov 2010 16:09:31 -0500

A large number of YAZ® lawsuits were designated as Mass Tort or Multidistrict Litigation (MDL) cases over the past several months. Just recently, the three initial bellwether trials in the federal MDL were scheduled. Courts utilize a bellwether approach when there are a large numbers of plaintiffs proceeding on the same theory or claim, such as in the Yaz ® cases. Typically, a group of plaintiffs are chosen to represent all the plaintiffs with the same alleged ailment. The purpose is that common issues, such as causation and liability, are settled among all the plaintiffs without having to go to trial repeatedly. These representative plaintiffs proceed through a normal trial, including discovery and pretrial motions. Following the trial, the results act as the bellwether for the other plaintiffs’ trials. The verdicts from these bellwether trials are extrapolated to the remaining plaintiffs’ cases.

In the Yaz lawsuits, the Court designated the initial groupings as follows: pulmonary embolism cases; gallbladder cases and thromboembolic cases. The remaining ailments, such as stroke and heart attack, will be considered subsequently. At the time of the Court’s decision in October 2010, there were in excess of 3,700 filed cases in the federal MDL. In an effort to move the litigation forward, the Court has set the following dates:

The first trial is set September 12, 2011. This will be a pulmonary embolism (PE) case.
The second trial is set January 9, 2012. This will be a gallbladder (GB) case.
The third trial is set April 2, 2012. This will be an additional thromboembolic (VTE) case.

If you feel you have experienced any side-effects from taking YAZ® or Yasmin® (or the generic brand, Ocella®), you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the YAZ®, Yasmin® or Ocella® manufacturers.

Claims against the makers of YAZ®, Yasmin® and Ocella® Will Be Consolidated Before Judge Moss in Philadelphia County, Pennsylvania

Stefanie Colella-Walsh — Tue, 12 Jan 2010 08:09:59 -0500

A large number of claims against the makers of defective birth control products, YAZ®, Yasmin® and Ocella®, for injuries ranging from internal organ damage to deep vein thrombosis have been designated as Mass Tort cases in state court, to be consolidated for case management and discovery purposes before Judge Moss in Philadelphia County, Pennsylvania. In the Mass Tort, counsel recently argued before Judge Moss regarding discovery issues.

Defendants seek information on Plaintiffs’ use of any forms of contraceptive devices or medications. Plaintiffs object to providing such information, as it would force minor Plaintiffs to reveal their sexual history, thus discouraging Plaintiffs from proceeding with litigation. Plaintiffs also argue information, such as the use of condoms, is not relevant to the injuries suffered allegedly from the use of YAZ®, Yasmin® and Ocella®. Those discovery issues remain to be decided.

If you, or someone you know, has suffered injuries as a result of taking YAZ®, Yasmin® or Ocella®) contact one of Stark & Stark’s Mass Tort Attorneys today for a free case review.

YAZ® Birth Control Linked to Serious Side Effects, Including Deep Vein Thrombosis

Stefanie Colella-Walsh — Wed, 02 Dec 2009 08:07:02 -0500

As we have discussed in previous posts, studies have shown that the ingredients contained in YAZ®, Yasmin® and Ocella® have been linked to various forms of severe side-effects. Reportedly, these side-effects include: heart attack, stroke, deep vein thrombosis (also known as DVT or blood clots), internal organ damage (including gallbladder damage), myocardial infarction and pulmonary embolism. Recently, a large number of YAZ® lawsuits have been designated as Mass Tort or Multidistrict Litigation (MDL) cases.

Studies show that one of the more serious YAZ® side effects, Yasmin® and Ocella® use is Deep Vein Thrombosis, which is commonly known as DVT. DVT is a condition characterized by the presence of a blood clot in a vein, usually in the legs or pelvis. DVT does not always show symptoms, but may cause swelling and pain in the affected extremities. If the blood clot dislodges and travels to the lungs, it may cause a Pulmonary Embolism - this potentially fatal condition is commonly known as a PE. Studies also show that DVT and PE sufferers have a heightened risk of long-term complications and multiple DVT and PE episodes, which can, in turn, lead to the need for continuing treatment. Further, DVT and PE sufferers have a much higher incidence of arterial thrombosis, heart attack and stroke.

Stark & Stark’s Mass Tort/Pharmaceutical Litigation Team pursues claims throughout the nation against drug manufacturers, so they can be held accountable when the drugs they market are proven to be defective or cause catastrophic injury to the people who use them. If you feel you have experienced any side-effects from taking YAZ® or Yasmin® (or the generic brand, Ocella®), you can contact Stark & Stark and speak to one of the Mass Tort/ Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the YAZ®, Yasmin® or Ocella® manufacturers.