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litigation 919 articles

Axiron safety label updated

Axiron

The Patient Counseling Information/Patient Information/Medication Guide for the topical testosterone gel Axiron has been updated to include clarifications such as ensuring patients know how to administer the correct dosage as well as understanding that they should not drink the product. Axiron is a testosterone supplement intended for men with low levels of the male hormone due to injury or disease. It is a topical gel that is applied to the armpits. Patients are advised to wash their hands right away with soap and water after applying the gel and, once the solution has dried, to cover the area with clothing to ... Read More

Testosterone heart risk not worth benefit

Low T

Jesse Mitchell was in his mid 40s when he was stricken with lethargy, anxiousness and depression. He started taking AndroGel testosterone replacement therapy, lured by the aggressive marketing campaigns geared directly to consumers informing them that AndroGel could cure so-called Low T. Mitchell said the gel did boost his energy and he continued to use the hormone treatment, Law360 reported. But in 2012, after using the medication for about two years off and on, Mitchell suffered a heart attack. He learned that testosterone treatments had been linked to cardiovascular risks including heart attacks, strokes, blood clots and death, and in ... Read More

Doctor testifies about testosterone heart risks

Low T

There is plenty of evidence to show that testosterone replacement therapy increases the risk for hear attacks, a cardiologist told an Illinois federal jury during the first trial among thousands in a multi district litigation alleging Abbie’s AndroGel causes heart risks, Law360 reports. Dr. Hossein Ardehali, a cardiologist at Northwestern University’s Feinberg School of Medicine, is an expert witness testifying for plaintiff Jesse Mitchell. Dr. Ardehali told jurors that he reviewed several studies involving men who took AndroGel and concluded that there was sufficient evidence to show the testosterone treatment increases cardiovascular risks. For example, he pointed to a 2010 ... Read More

AndroGel needed heart risk warning, witness says

androgel-pump

Peggy Pence, the president and CEO of pharmaceutical consulting firm Symbion Research International Inc., told an Illinois federal jury that there was enough evidence that testosterone replacement therapies may cause heart attacks that warnings should be placed on the hormone treatments’ labels and further testing should be conducted, Law360 reports. Pence told the jury in the first bellwether among thousands in a multidistrict litigation (MDL) to go to trial alleging cardiovascular risks with testosterone treatments that Abbvie had received so many reports of heart problems in patients who had used its AndroGel testosterone gel that further testing was warranted. Pence ... Read More

Generic Axiron now available despite heart risks

Axiron

Perrigo has launched of the testosterone topical solution 30 mg/1.5 mL, the generic equivalent to Eli Lilly and Company’s Axiron topical solution, 30 mg/1.5 mL. The product is intended for men with hypogonadism, a condition in which men do not produce enough of the male hormone due to injury or disease that results in symptoms such as fertility problems. Axiron earned about $248 million in annual market sales for the 12 months ending April 2017. Testosterone replacement therapies have gathered a lot of attention in recent years, first with aggressive marketing campaigns by their manufacturers luring men to try the ... Read More

Xarelto mass tort grows in first half of 2017

xarelto

Lawsuits alleging bleeding risks with the blood thinner Xarelto pending in the Philadelphia Court of Common Pleas increased by 210 cases – or 17 percent – from Jan. 1 to June 14, 2017, according to Law.com. The number of cases jumped from 1,214 to 1,424. The Xarelto mass tort is one of nine pending in the Philadelphia. There are also about 1,600 Xarelto lawsuits that have been consolidated in a multidistrict litigation (MDL) in the Eastern District of Louisiana under Judge Eldon E. Fallon. Two Xarelto cases in the MDL have been heard, with the third scheduled for August. A total ... Read More

Risperdal lawsuits increase in first half of 2017

risperdal

Lawsuits alleging the antipsychotic Risperdal causes disfiguring side effects are not only the largest mass tort program in the Philadelphia Court of Common Pleas. The litigation has nearly tripled in numbers from about 2,000 cases at the beginning of 2017 to more than 5,500 as of June, according to Law.com. Statistics from the court show that Risperdal lawsuits increased from being 31.4 percent of the Complete Litigation Center’s inventory in January to more than half as of June 14 – a whopping 185 percent increase. The caseload jumped from 1,945 in January to 5,548 – an increase of 3,617 cases. ... Read More

Former FDA chief calls AndroGel ads misleading

androgel-pump

AbbVie Inc. misled the public by aggressively promoting its testosterone replacement therapy AndroGel for off-label uses, said the former commissioner of the Food and Drug Administration (FDA). The statement was part of expert testimony in a case of a man alleging AndroGel caused him to suffer a massive heart attack, Law360 reports. David Kessler, who served as FDA commissioner from 1990 to 1997, said that AbbVie promoted its testosterone gel directly to men by fabricating a condition called “Low T” to treat symptoms such as low libido, weight gain and muscle loss. AbbVie understood that those symptoms, as well as ... Read More

Experts in CA trial can testify that talc causes cancer

talc justice

Decisions are still being made prior to plaintiff Eva Echeverria’s trial beginning in California, the first talc case against Johnson and Johnson to be tried in the state. The suit was scheduled to go to trial on July 10, but this week Los Angeles Superior Court Judge Maren Nelson has still been holding hearings that will impact the future of the trial. According to Law360, on Monday, Judge Nelson reversed a tentative ruling she had written the week before saying that she would partially deny co-defendant Imerys Talc America’s motion for summary judgment. Instead she dismissed Echeverria’s claims against the ... Read More

GM Ignition Switch Bellwether Trial Begins

GM recall

A fourth bellwether trial that will help determine the course of litigation for hundreds of lawsuits seeking damages from General Motors (GM) allegedly caused by defective ignition switches opened Monday, July 10, in New York. In the newest trial, plaintiff Dennis Ward claims the ignition defect that GM concealed for years caused his Chevrolet HHR to crash in Tucson, Arizona. He alleges the March 2014 crash left him with a permanent leg injury. According to the New York Law Journal, Mr. Ward claims in court documents that he was traveling on South Kolb Rd. in Tucson when he noticed a ... Read More