According to recent reports, the FDA is considering new labeling requirements for the manufacturers of generic drugs, which could lead to a change in a company’s responsibility to consumers. Currently, generic manufacturers are required by federal law to have the same labels as the branded version. As a result of this federal law, the United States Supreme Court held in Pliva v. Mensing that generic manufacturers could not be held liable in state court for failure to warn claims. According to a 2011 petition by Public Citizen, a national consumer organization, approximately 90% of all prescriptions issued in 2010 were for generic drugs. The proposed revision would allow the generic manufacturer to change the label warnings without FDA approval, thereby eliminating the legal loophole currently available to generic manufacturers.

The Court’s decision in Mensing has had devastating effects on thousands of plaintiffs nationwide who have had their claims dismissed, in cases such as the Darvocet litigation, because they had ingested the generic version of the drug rather than the branded version. As it stands, these plaintiffs are essentially left without any legal recourse for injuries allegedly sustained as a result of these generic drugs.

On April 18, 2012, Judge Danny Reeves, who is overseeing all federal Darvocet cases centralized in Kentucky, dismissed defendants, Endo Pharmaceuticals Holdings, Inc. and Endo Pharmaceuticals, Inc. (“Endo Defendants”), from the litigation because the Court lacks specific or general jurisdiction over them.

On approximately December 1, 2010, just eleven days after the propoxyphene products were pulled from the U.S. market, the Endo Defendants acquired Generics International (US Parent), Inc., which was the owner of various companies that had previously manufactured or distributed propoxyphene. In many of the Complaints, plaintiffs allege that the Endo Defendants may have assumed responsibility for the omissions, acts and liabilities of the acquired companies. In response, the Endo Defendants filed motions to dismiss.

Previously, Judge Reeves dismissed all of the plaintiffs’ claims with respect to the manufacturers of generic propoxyphene, concluding that they are preempted by the controversial Supreme Court holding in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). However, in response to the Endo Defendants recently filed motions to dismiss, Judge Reeves also concluded that the Court lacks specific jurisdiction over these defendants because many of the plaintiffs failed to allege specific facts sufficient to establish specific jurisdiction. In addition, Judge Reeves opined that because the original entities still existed, and, in fact, were sued in this litigation, the Endo Defendants could not also be held liable under the theory of successor liability. Finally, Judge Reeves held that the Endo Defendants did not have the necessary contact with the plaintiffs’ states to establish general jurisdiction.

If you feel you have experienced any side-effects from taking Darvocet or Darvon, 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.

Bills were just recently introduced in the US House of Representatives and the US Senate which would effectively overrule the Supreme Court’s decision 2011 decision in Pliva v. Mensing by “allow[ing] generic drug companies to be held liable under state tort law for failing to update warning labels with known dangers.” In a 5-4 split, the Supreme Court’s decision in Mensing held that generic drug-makers are not liable for label warnings because they are legally required to use the same label as brand-name makers. In the dissent, Supreme Court Justice Sonia Sotomayor noted, “As the majority itself admits, a drug consumer’s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic. The majority offers no reason to think – apart from its new articulation of the impossibility standard- that Congress would have intended such an arbitrary distinction.”

As expected, the 2011 decision created uproar with concerned and affected consumers as well as with the legal community. Following the ruling, generic drug-makers have been successfully moving to be dismissed from mass torts and class actions across the country, including the Darvocet multidistrict litigation currently centralized in Kentucky. It appears that the new legislation would require generic drug-makers to follow the same guidelines that brand name makers use for updating product safety on their labels. “The Mensing decision creates a troubling inconsistency in the law governing prescription drugs,” said Senator Patrick J. Leahy (VT), who sponsored the bill along with six other Democrats, in a statement on April 18, 2012. Some argue that the likelihood of the bill passing in the House, which is controlled by Republicans, is slim.

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. Additionally, Mr. Hart states that the first trials are at least two years away.

As we previously reported, the United States Judicial Panel on Multi-District Litigation (MDL) met in March 2011, in San Diego, CA, to hear arguments regarding whether the Darvocet and Darvon cases should be given MDL treatment. In April 2011, the Panel announced that it needed more time to consider the arguments for and against consolidating the federal cases. As such, the Panel scheduled an additional hearing for July 2011, in San Francisco, CA, to consider further arguments.

On August 16, 2011, the Panel decided that all federal Darvocet and Darvon cases would be consolidated in the Eastern District of Kentucky (Covington Division) and assigned to the Honorable Danny C. Reeves for pretrial proceedings. 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.

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.

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.

As we previously reported, the United States Judicial Panel on Multi-District Litigation (MDL) met on Wednesday, March 30, 2011, in San Diego, CA, to hear arguments regarding whether the Darvocet and Darvon federal cases should be given MDL treatment. One of the main sources of contention among the parties is where to centralize the cases.  The proposed locations include: the Eastern District of New York, the Northern District of Illinois, the Eastern District of Louisiana, the Western District of Louisiana, the Southern District of Ohio and the Eastern District of Kentucky.

On April 11, 2011, the Panel announced that it needed more time to consider the arguments for and against consolidating the federal cases.  A decision is now not expected until after a July 2011, hearing where additional arguments are expected to be made.  The Panel noted that plaintiff, Karen Esposito, who filed the initial motion for consolidation back in December 2010, alleged four actions against defendant, Xanodyne Pharmaceuticals.  However, since Esposito’s filing, there are an additional eighteen (18) alleged actions involving more than a dozen defendants.  These additional defendants have not had an opportunity to comment on whether the cases should be consolidated.

Judge John G. Heyburn II, chairman of the Judicial Panel on Multi-District Litigation advised that, “Consideration of this Section 1407 motion so soon after a handful of actions were filed, where the contours of the litigation are in flux, leaves the Panel with less than ideal information to make the best possible decision. This is a potentially complex case. Our desire to make the most informed possible decision counsels further deliberation.”  In the interim, the Panel has advised that the cases can continue in the transferor courts.

As we have previously reported, in November, 2010, the FDA finally 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, overdose and even death.

As we have also previously reported, the United States Judicial Panel on Multi-District Litigation (MDL) met on Wednesday, March 30, 2011, in San Diego, CA, to hear arguments regarding whether the Darvocet and Darvon cases should be given MDL treatment. 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.  The seven-judge panel, headed by the Honorable John G. Heyburn II of the Western District of Kentucky, has yet to issue a ruling.  However, a decision is expected shortly.