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Endo Pharmaceuticals 27 articles

Three drug makers reach tentative settlement in testosterone side effects MDL

Three manufacturers of testosterone replacement therapies among several in a multidistrict litigation accusing the companies of failing to warn consumers about cardiovascular risks with their products, have notified an Illinois federal judge that they have reached a tentative deal to settle the cases in which they are named. U.S. District Judge Matthew Kennelly told the manufacturers – Endo Pharmaceuticals Inc., Auxilium Pharmaceuticals LLC and GlaxoSmithKline LLC – that he would place a 45-day stay on the cases against them while the details of the settlement are worked out. He also told the remaining defendants – including AbbVie Inc., and Actavis ... Read More

PA schedules 17 testosterone side effects trials through January 2019

Days after Auxilium Inc., settled a lawsuit over claims its testosterone treatment caused an Alabama man to suffer a stroke, a Philadelphia Court of Common Pleas judge scheduled 17 testosterone side effects trials involving multiple testosterone makers to take place between June and January 2019. The Auxilium trial was scheduled to begin Jan. 8, and was filed in 2014. Philadelphia Court of Common Pleas Judge John M. Younge had planned to schedule seven bellwethers during that timeframe, paving the way for a settlement of the nearly 30 cases pending in the court. But instead of making good on a previous ... Read More

Several testosterone side effects trials scheduled through 2019

Three trials involving testosterone side effects have taken place in 2017 and another 10 or 11 cases are scheduled to be tried through 2019, due to U.S. District Judge Matthew Kennelly’s interest in ensuring all plaintiffs and defendants have the benefit of timely bellwethers. The multidistrict litigation is consolidated in the U.S. District Court for the Northern District of Illinois and names a handful of testosterone manufacturers including AbbVie Inc., Eli Lilly & Co., and Auxilium Pharmaceuticals Inc. There are also state cases by Illinois residents against AbbVie. The Cook County judge is coordinating with Judge Kennelly on those cases. ... Read More

Kentucky sues maker of opioid Opana ER

Kentucky Attorney General Andy Beshear is suing Endo Pharmaceuticals alleging the company used fraudulent and deceptive marketing of its opioid painkiller Opana ER, a medication so prone to abuse that the Food and Drug Administration (FDA) pressured the company to pull it off the market. “Endo put its profits above the lives of our people and above patient safety,” Beshear said. The lawsuit states that only two percent of overdose deaths in 2010 were due to oxymorphone, the active drug ingredient in Opana ER. But the following year, that number soared to 23 percent. Beshear said that the deaths were ... Read More

FDA to evaluate abuse potential of opioid oxymorphone

The Food and Drug Administration (FDA) is awaiting results from a commissioned study to evaluate whether the powerful opioid oxymorphone, which is the active drug ingredient in Endo Pharmaceuticals’ painkiller Opana ER, is more likely to be abused than other opioids. “If the scientific results of this study demonstrate that this ingredient has qualities that make it more likely to be abused, the FDA will consider taking regulatory action that could limit patient exposure to oxymorphone,” said FDA Commissioner Scott Gottlieb. Gottlieb made the statement during a speech to the National Press Club in Washington, D.C., during which he also ... Read More

Testosterone makers fight proposed class action lawsuit

Endo Pharmaceuticals and its unit Auxilium Pharmaceuticals LLC filed a motion to compel compliance against UnitedHealthcare (UHC) in an Illinois federal court, arguing that the insurance company should hand over subpoenaed information about its dealings with testosterone replacement therapies if it wants to be part of a proposed class of insurers and third-party payors accusing testosterone manufacturers of fraudulently marketing the drugs. UHC isn’t a party in the litigation but is the largest member of the proposed class, making its information key to Endo and Auxilium, which are fighting against certification. But UHC has been avoiding calls, not returning messages, ... Read More

Endo agrees to pull Opana ER off market

Endo Pharmaceuticals agreed to pull Opana ER, its abuse-deterrent , extended-release formulation of the powerful painkiller oxymorphone, off the market after urging by the Food and Drug Administration (FDA) to stop selling the drug because it not only aggravated the opioid epidemic, it also put abusers at risk of serious health problems. Endo obliged reluctantly, saying it “continues to believe in the safety, efficacy and favorable benefit-risk profile” of the drug. “Nevertheless, after careful consideration and consultation with the FDA following the FDA’s June 2017 withdrawal request, the company has decided to voluntarily remove Opana ER from the market.” The ... Read More

Axiron side effects trial dates set

Two cases among more than 6,000 lawsuits waged against Eli Lilly and Co. over testosterone side effects have been selected by the U.S. District Court for the Northern District of Illinois to serve as bellwether trials in the Testosterone Replacement Therapy Product Liability multidistrict litigation (MDL). U.S. District Judge Matthew K. Kennelly selected the case of Tracy Garner and the case of John Debroka Jr. to serve as bellwethers. Garner claims to have had a heart attack after initiating testosterone therapy with Lilly’s Axiron. Debroka alleges he developed deep vein thrombosis, a blood clot deep in the veins, after taking ... Read More

First testosterone lawsuit ends in mistrial

The much-anticipated first bellwether trial against AbbVie Inc. over alleged adverse cardiovascular side effects with its testosterone replacement therapy AndroGel ended in a mistrial this week after the lead plaintiff’s attorney was hospitalized due to an illness, according to Law360. The trial involved the case of Jeffrey Konrad, a Tennessee man who claims in 2010 he was lured to try testosterone therapy after watching advertisements promoting testosterone treatment for the so-called condition, Low T. The ads assured him that AndroGel could improve Low-T symptoms such as low sex drive, weight gain and depressed mood. Konrad asked his doctor to prescribe ... Read More

FDA asks Endo to remove Opana ER from market

The Food and Drug Administration (FDA) asked Endo Pharmaceuticals to take the reformulated version of its powerful opioid painkiller Opana ER off the market claiming the benefits associated with use of the drug no longer outweigh the risks. This is the first time the agency has requested the removal of a currently marketed painkiller due to the risk of abuse. “We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Scott Gottlieb, M.D., said in a news release. “We will continue ... Read More