Judge Asked To Consider Possible FDA Conflicts of Interest in YAZ Litigation

By Martin P. Schrama on Posted in Defective Drugs, Yaz® Yasmin® and Ocella®

Recently, the Plaintiffs’ Steering Committee in the Yaz and Yasmin litigation opposed a motion to exclude the opinions of former Food and Drug Administration (FDA) commissioner, David Kessler, concerning possible conflicts of interest.  The Plaintiffs’ attorneys have asked Judge Herndon, who is overseeing the federal Yaz and Yasmin cases, to allow in evidence showing that conflicts of interest may have tainted the meetings of an independent advisory committee to the FDA that was asked to consider the health risks associated with Yaz and Yasmin.

Specifically, it is alleged that four members of the FDA advisory committee that voted not to remove Yaz and Yasmin from the U.S. market received significant sums of money from Bayer and Bayer Pharmaceuticals, the manufacturers of Yaz and Yasmin.  Ultimately, the FDA advisory committee voted 15-11 to keep the oral contraceptives on the market, concluding that the benefits of Yaz and Yasmin outweigh the risks.  Plaintiffs contend that either Bayer hid the ties to the four members of the advisory committee from its experts or its experts intentionally omitted the ties from their reports.  Not surprisingly, the FDA has defended the findings of its advisory committee.

As previously reported, Judge Herndon recently ordered both sides to mediation, which postponed the initial trial date to April 30, 2012, if mediation is not successful.

If you feel you have experienced any side-effects from taking YAZ® or Yasmin®, 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® or Yasmin®  manufacturers.

Stark & Stark Shareholder Comments on Status of Darvocet & Darvon Litigation

By Stark & Stark on Posted in Darvocet® and Darvon®, Defective Drugs

Kevin M. Hart, Chair of Stark & Stark’s Mass Tort Litigation Group, was quoted in the January 25, 2012 New Jersey Law Journal article, Suits Allege Lilly Failed To Warn of Darvocet’s and Darvon’s Health Risks. The article discusses a recent case in which former Darvocet and Darvon users are claiming that the manufacturer of the drugs, Eli Lilly & Co., failed to warn users of the serious side effects associated with the painkiller, including heart problems such as angina, arteriosclerotic heart disease and mitral regurgitation.

Plaintiffs from all over the country, including Pennsylvania, Texas, California, Mississippi, North Carolina and South Carolina state that propoxyphene, the active ingredient in Darvocet, Darvon and generic versions of the drugs, is only marginally effective for pain relief and that any benefit was outweighed by the risk of cardiovascular problems.

Mr. Hart, who filed the nine suits, also names aaiPharma Inc., of Wilmington, N.C., and Xanodyne Pharmaceuticals of Newport, K.Y. as defendants in the suit. Mr. Hart states that about 175 similar cases are pending in the MDL, and he expects his cases to be moved to Kentucky as well. Additoonaly, Mr. Hart states that the first trials are at least two years away.

Pennsylvania Follows Federal Judge and Sends Yaz cases to Mediation

By Kevin M. Hart on Posted in Defective Drugs, Yaz® Yasmin® and Ocella®

On January 6, 2012, Judge Moss, who is overseeing the state Yaz cases in Philadelphia, followed in Judge Herndon’s footsteps and ordered the parties into mediation.  Like Judge Herndon, who is overseeing the federal Yaz cases, Judge Moss also appointed Professor Stephen Saltzburg of George Washington School of Law as Special Master, for the purposes of mediation.  Judge Moss has ordered the Philadelphia liaison counsel to coordinate with the MDL leadership teams and to participate in all organizational meetings with Professor Saltzberg.

Plaintiffs are hopeful that the sudden push by the Court to mediation will open the doors to a global Yaz settlement.

If you feel you have experienced any side-effects from taking YAZ® or Yasmin®, 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® or Yasmin®  manufacturers.

First Federal Yaz Trial Sent to Mediation, NJ Trials Still On…For Now

By Stefanie Colella-Walsh on Posted in Defective Drugs, Uncategorized, Yaz® Yasmin® and Ocella®

The first federal Yaz trial is not moving forward as planned.  While the highly anticipated trial was originally scheduled to begin the second week of January 2012, Judge Herndon, who is overseeing the federal Yaz cases in the Southern District of Illinois, has now ordered both sides to mediation.

On December 31, 2011, Judge Herndon appointed Professor Stephen Saltzburg of George Washington School of Law as Special Master, for the purposes of mediation.  Professor Saltzberg previously handled the mediation in over 25,000 Seroquel lawsuits.  In his Order, Judge Herndon opined that the interests of the plaintiffs and defendants will be “better served” by entering into mediation.  He further ordered the parties to meet with Professor Saltzburg without delay and to negotiate in good faith.  Pending the outcome of the mediation, Judge Herndon’s December 31, 2011, Order has stayed the scheduling in the balance of the bellwether federal cases.

However, Judge Martinotti, who is overseeing the New Jersey Yaz cases in Bergen County, New Jersey, has advised counsel for both parties to continue with bellwether discovery, including depositions.  While probably hopeful that the mediation in the federal case will have a positive effect on all Yaz cases, nationwide, Judge Martinotti likely does not want to delay the New Jersey cases, in the event that a settlement is not reached.  A Case Management Conference is currently scheduled for February 2012.

Interestingly, the alternative plan to send the parties to mediation comes on the heels of the Food and Drug Administration (FDA) voting 21 to 5 that the label on Yaz and Yasmin did not adequately warn users about the risk of blood clots, which is higher than other oral contraceptives.  The FDA further found that the label did not adequately warn about the increased risks for those users who smoke or are overweight.

If you feel you have experienced any side-effects from taking YAZ® or Yasmin®, 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® or Yasmin®  manufacturers.

FDA Concludes Yaz Label Inadequate

By Craig S. Hilliard on Posted in Defective Drugs, Yaz® Yasmin® and Ocella®

In early December 2011, an advisory panel of the Federal Drug and Administration (FDA) convened for 9 hours of hearings concerning the increased risk of blood clots for users of Yaz and Yasmin.  It was reported that several independent studies found women who took Yaz and/or Yasmin were more likely to suffer a blood clot than women taking other forms of birth control, which do not contain the hormone drospirenone.  Following testimony, the panel voted 21 to 5 that the label was inadequate and should be changed by Bayer to explain the increased risk.  Eleven experts also voted for a Yaz recall, but were out-voted by the other 15 members who opined that the benefits outweighed the risks. To date, Bayer has failed to issue a voluntary recall.

As previously reported, other possible side effects of Yaz and/or Yasmin also include heart attack, pulmonary embolism and stroke.

Currently, more than 10,000 suits have been filed nationwide.

If you feel you have experienced any side-effects from taking YAZ® or Yasmin®, 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® or Yasmin®  manufacturers.

Multi-District Litigation Granted in Actos Bladder Cancer Litigation

By Martin P. Schrama on Posted in Actos®, Defective Drugs

The United States Judicial Panel on Multi-District Litigation (MDL) met on December 1, 2011, in Savannah, Georgia, to hear arguments regarding whether all federal Actos cases should be consolidated into multi-district litigation (MDL) and, if so, where the cases should be consolidated.

As we have previously reported, recent studies allegedly show that diabetics taking Actos may be at an increased risk of developing bladder cancer.  Particularly at risk are those individuals who took Actos for more than twelve (12) months.

On December 29, 2011, the Panel decided that all federal Actos cases would be centralized in the Western District of Louisiana with the Honorable Rebecca F. Doherty.  The granting of multi-district litigation (MDL) treatment will streamline the lawsuits, allowing the parties to avoid duplicative discovery and inconsistent rulings from different judges.  Additionally, MDL treatment will provide more convenience for the witnesses, the parties and the court.

If you feel you have experienced adverse side-effects from taking Actos, 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 manufacturers of Actos.

Still Waiting on MDL Decision in Actos Litigation

By Kevin M. Hart on Posted in Actos®, Defective Drugs

The United States Judicial Panel on Multi-District Litigation (JPML) met on Thursday, December 1, 2011, in Savannah, Georgia, to hear arguments regarding whether all federal Actos cases should be consolidated into multi-district (MDL). Recent studies allegedly show that diabetics taking Actos may be at an increased risk of developing bladder cancer. The JPML has yet to issue a ruling, but a decision is expected early next year. Considering that the attorneys for manufacturer, Takeda Pharmaceuticals, have recently agreed that the cases should be consolidated, it would come as a surprise if the JPML denied Plaintiff’s motion.

The real question for the JPML is where to centralize the cases. The filing Plaintiff requested that the cases be consolidated in the Southern District of Illinois before Judge G. Patrick Murphy, while Takeda Pharmaceuticals has requested that the cases be consolidated in either the Northern District of Illinois or the Western District of Louisiana.

As we have previously discussed, granting MDL treatment will consolidate all federal Actos 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 feel you have experienced adverse side-effects from taking Actos, 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 manufacturers of Actos.

Panel Scheduled to Meet to Consider MDL Treatment in Actos Litigation

By Craig S. Hilliard on Posted in Actos®, Defective Drugs

The United States Judicial Panel on Multi-District Litigation (MDL) is scheduled to meet on December 1, 2011, in Savannah, Georgia to hear arguments on whether all federal Actos 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.  As we have previously advised, new studies show that diabetics taking Actos may be at an increased risk of developing bladder cancer.

A motion was initially filed by a plaintiff in August 2011, requesting that all Actos lawsuits filed in the various federal district courts throughout the United States be centralized in the U.S. District Court for the Southern District of Illinois before Judge G. Patrick Murphy.  Currently, more than a dozen lawsuits have already been filed against the manufacturers of Actos with hundreds more expected in the near future.

Just recently, the attorneys for manufacturer, Takeda Pharmaceuticals, filed a response with the United States Judicial Panel on Multi-District Litigation, advising that they agree with plaintiffs that an MDL should be formed, but requested that the cases be consolidated in either the Northern District of Illinois or the Western District of Louisiana.

Granting MDL treatment will streamline the lawsuits, allowing the parties to avoid duplicative discovery and inconsistent rulings from different judges.  Additionally, MDL treatment will provide more convenience for the witnesses, the parties and the court.  During the pretrial litigation, the MDL judge will manage discovery and likely select a group of cases for early trials, also known as bellwether cases.

If you feel you have experienced adverse side-effects from taking Actos, 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 manufacturers of Actos.

Actos Class Action Filed in Louisiana

By Stefanie Colella-Walsh on Posted in Actos®, Defective Drugs

A class action was filed in September 2011 against Takeda Pharmaceuticals and Eli Lilly, the manufacturers of the diabetic drug, Actos.  The lawsuit was filed in the U.S. District Court for the Eastern District of Louisiana on behalf of two individuals who developed bladder cancer after taking Actos. The complaint also seeks class certification to include coverage for the millions of individuals who used Actos in the United States since it was marketed in 1999.

If you feel you have experienced adverse side-effects from taking Actos, 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 manufacturers of Actos.

Diabetes Drug, Actos, Linked to Bladder Cancer

By Martin P. Schrama on Posted in Actos®, Defective Drugs

As of August 2011, Actos (Pioglitazone), manufactured by Takeda Pharmaceuticals, was the best selling Type 2 diabetes drug in the world. Introduced to the U.S. market in July 1999, the popularity of the drug has steadily increased over the years, generating over $4 billion in sales in 2010.  However, in June 2011, a study of more than 1 million diabetics was commissioned by the French government. The study, consisting of approximately 155,000 on Actos and 1.3 million on other medications, found that Actos patients demonstrated nearly a 22 percent higher risk of bladder cancer when compared to those taking other medications. Additionally, the risk of bladder cancer was highest in those individuals receiving a cumulative Actos dosage of 28,000 mg or more during the study period.  Immediately following this study, sales of Actos were suspended in France and Germany, while the FDA issued new bladder cancer warnings for individuals taking Actos in excess of one year.

Another study, based on data obtained from the Kaiser Permanente Northern California Health Plan, found that diabetics over 40 years old who had taken Actos for longer than 12 months had a 40% increased risk of bladder cancer when compared with patients who had never taken the drug.

Notwithstanding the FDA’s very recent decision, many are alleging that Takeda Pharmaceuticals did not provide proper notice of the risk of bladder cancer to potential users of the drug.

If you feel you have experienced adverse side-effects from taking Actos, 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 manufacturers of Actos.