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Actavis Inc. 10 articles

Actavis poised to settle testosterone side effects lawsuits

Actavis Inc., a pharmaceutical company named in a multidistrict litigation (MDL) alleging failure to warn of cardiovascular risks with testosterone replacement therapies, has reached a memorandum of understanding on a potential global settlement concerning its testosterone treatment Androderm. Actavis is the latest testosterone manufacturer to make a move toward exiting the MDL, following similar measures by Auxilium Pharmaceuticals LLC, Eli Lilly & Co., Endo Pharmaceuticals PLC, and GlaxoSmithKline LLC. AbbVie is the only drug company in the MDL that has yet to make an effort to resolve outstanding cases. The AndroGel manufacturer also faces the most lawsuits in the litigation. ... 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

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

Testosterone Replacement Therapy trial requires Doc to reveal payments

A Boston-area doctor notorious for pushing testosterone replacement therapy to his patients for the past three decades was ordered to turn over his tax records indicating how much money he was paid by manufacturers of testosterone drugs. The order was made by U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois regarding a multidistrict litigation (MDL) accusing testosterone replacement therapy manufacturers of promoting testosterone treatment for so-called Low T without revealing that use of the hormone can cause serious medical problems, including life threatening heart attacks, strokes and blood clots. AbbVie is in the hot seat for ... Read More

Actavis signs consent decree to resume making Digitek

Actavis Inc. has signed a proposed consent decree agreeing to fix the manufacturing problems at its New Jersey plant where it produced and sold the heart drug, Digitek, a brand of digoxin, according to the Canadian Medical Association Journal. Digitek was cited by the Center for Public Integrity as the “primary suspect” in 667 deaths reported between April 1, 2008 and June 30, 2008. Digitek is prescribed for various heart conditions such as atrial fibrillation, atrial flutter and sometimes heart failure. An incorrect dosage or overdosage can be dangerous and even fatal to heart patients taking the medication, causing even ... Read More

Texas woman sues Digitek manufacturer for husband’s death

A woman from Texas claims that her husband died in January 2007 as a result of his Digitek medication containing twice the active ingredient. On Jan. 23, 2008, Vickie Butts, representing the estate of her deceased husband, Donnie Butts, filed a product liability lawsuit against Actavis, the drug manufacturer, and Mylan, the distributor. The Southeast Texas Record states, “According to the original complaint, just a year after acquiring the business of manufacturing Digitek, the defendants received a warning from the U.S. Food and Drug Administration that they had failed to provide periodic safety reports from its solid oral dose manufacturing ... Read More

Actavis N.J. plant agrees with FDA

Actavis Inc. has made an agreement with the FDA not to issue any drugs from its Totowa facilities in Morristown, N.J., where Digitek is produced. According to the Philadelphia Inquirer, the agreement says Actavis cannot resume its practices until it conforms to “the agency’s good manufacturing practice.” Actavis must improve its labs, facilities, and equipment. Actavis has faced numerous lawsuits over the recalled drug Digitek. One such lawsuit includes the death of a patient and claims that Digitek is an unsafe and flawed drug. Actavis would not comment if the FDA agreement had influenced the Digitek lawsuits or not. ... Read More

Digitek believed responsible for 667 deaths

According to reports filed to the FDA and consumers, the Center for Public Integrity has found that Digitek is responsible for 667 consumers’ deaths from April through June 2008. Pharma Live says health experts believe the FDA should have made more “aggressive warnings” to the public. The number of deaths associated with Digitek consumers have increased since the last reporting period.Because all Digitek consumers already have heart disease, the issue is whether or not Digitek has caused an increase in death from heart problems. In April of this year, Digitek pills were recalled due to a suspicion of Digitek pills ... Read More

Actavis comments on lawsuit

The Department of Justice, on behalf of the FDA, has filed a compliant against Actavis and is asking for a permanent injunction against its subsidiary. Actavis claims that it has been dedicated to ensuring the value and integrity of its manufacturing since May 2008, which is after the FDA inspected Actavis because the company manufactured Digitek pills that were twice as thick as they ought to have been. According to Market Watch, “The company views the filing of this complaint as one step in a long regulatory process, and is fully committed to working collaboratively and openly with the FDA ... Read More

U.S. attorneys sue makers of Digitek, seek to close facilities

U.S. Attorneys in New Jersey are moving to close three Actavis Inc. plants, the company that manufactures Digitek, until they comply with FDA regulations. According to the Associated Press, the suit requests the court to not allow Actavis Inc. and Actavis Totowa to manufacture drugs until the company complies with FDA regulations for testing, quality control, and test response. The company must also stop selling unapproved and misbranded drugs. Filed by U.S. Attorney Christopher Cristie and the Department of Justice’s Officer of Customer Ligation, the suit states Actavis’ facilities in Totowa and Little Falls, N.J., have not only continued to ... Read More