Androgel Testosterone MDL

Lawsuits against androgel-bottleAbbieVie, Inc. – the maker of Androgel – and four other pharmaceutical companies making testosterone replacement therapy drugs have been centralized into a multi district litigation court (MDL) in Illinois. Some 3,500 product liability cases are filed in the federal court system for claims against makers of the “Low-T replacement therapy.” Plaintiffs include both testosterone therapy users and insurance companies.

 Low T Replacement Therapy

Several forms of testosterone replacement therapy remain on the market. They include oral agents, injectable agents, and topical delivery, typically creams. AndroGel is a topical agent that was approved by the FDA in 2011. It is one of the most popular products designed to treat low testosterone levels. Androgel is primarily prescribed to men who fail to produce sufficient amounts of testosterone themselves. The gel, a blend of synthetic testosterone and alcohol, is applied to the skin once a day. It can cost some $500 per month.

Testosterone Therapy Problems

After testosterone therapy products had been on the market for roughly two years, more and more doctors began to discuss the dangerous side effects. Older men were using Low T therapy to regain youth, boost energy, increase sex drive – reasons for which it was not ostensibly designed. The largest risks associated with testosterone supplementation include an increase in cardiovascular problems such as heart attacks and strokes. Other risks include prostate cancer, larger red blood cells, reduced sperm count, gynecomastia (breast growth), edema, sleep apnea, high cholesterol.

 Androgel / Abbott Lawsuits

Five men aged 50-63 sued Abbott Laboratories and AbbVie, Inc. in 2014 in the U.S District Court for the Northern District of Illinois. They alleged their injuries were caused by AndroGel. Two of the plaintiffs suffered heart attacks, two suffered strokes; all said Androgel caused the problem, and that Abbott and AbbVie failed to warn them about the risks associated with AndroGel. Their petition said the companies knew or should have known about the risks posed by testosterone therapy. Their complaint charges that the company downplayed the known health risks and deceived consumers. Testosterone marketing included testimonials from professional athletes the same ages as the ad-target group.

 Studies show Significant Risks

The founder of Public Citizen’s Health Research group, Dr. Sidney Wolfe, published a piece in the British Medical Journal regarding testosterone therapy. Dr. Wolfe said his research uncovered 27 studies done on testosterone drug safety. The thirteen studies funded by drug companies showed no increased heart risks, but fourteen studies funded independently showed a significant increase in heart risks.

NIH: Testosterone doubles Heart Attack Risk

The National Institutes of Health funded an epidemiologic study based on the records of 55,000 men who had taken testosterone. The NIH found that for men over 65 the relative risk of heart attacks from Low T thereapy for three months doubled the risk they had the year before using testosterone; and the therapy more than doubled the heart attack and stroke risk for men under 65 who had a history of heart disease.

Insurance Companies sue Low T Product Makers

Insurance companies in the MDL allege the defendants created testosterone replacement therapy products to treat a fictitious disease called ‘Andropause.’ The insurance companies claim ‘symptoms’ of the ‘disease’ are only facts of the male aging process; they are therefore non existent or medically unnecessary. The insurers also claim violations of Racketeer Influenced and Corrupt Organizations (RICO) Act. They say Androgel was aggressively marketed despite being ineffective as well as dangerous.

Androgel Testosterone MDL

Defendants for the trial cases seek to set deadlines for complete fact discovery and expert discovery from July 2016 to February 2017. They want deadline for Daubert motions (re: expert witnesses) set from September 2016 to September 2017. Plaintiffs argue that these dates represent significant delays that would needlessly slow the MDL progression. Plaintiffs wish to try these cases as soon as possible.

Related

Share

Testosterone Label Change required by FDA

A testosterone label candrogel-bottlehange has been required by the FDA. In a March 3, 2015 safety announcement, the agency said that it was requiring the label change to inform users of a possible increased risk of heart attack and stroke. The agency also issued an announcement to caution against using testosterone (or Low T) products for low testosterone due to aging.

More

Share

FDA calls for Testosterone Label Change

An FDA Drug Safety androgel-pictureCommunication on March 3, 2014 cautioned that testosterone products used for low testosterone due to aging require a labeling change regarding possible increased risks of heart attacks and strokes. The FDA has also concluded that “based on the available evidence from published studies and expert input from an Advisory Committee meeting, (there) is a possible increased cardiovascular risk associated with testosterone use.”

This information updates the FDA’s Drug Safety Communication issued on  January 31, 2014 regarding the agency’s evaluation of the risk of stroke, heart attack and death associated with FDA-approved testosterone products.

More

Share

FDA says Low T Products must carry Blood Clot Warning

The U.S. Food and Drug androgel-bottleAdministration (FDA) announced on June 20, 2014 that Low T Products must carry blood clot warning information.

The agency announcement said Low T products must now warn on the label that Low T therapy drugs raise the risk of blood clots forming in the veins.

Testosterone therapy has been extensively and expensively advertised as a way to help aging men improve their sex lives and energy levels by raising what the advertisers call “Low T” levels. These products already do carry a warning about blood clots forming in the veins due to polycythemia, which is an unusual increase in the number of red blood cells that can occur with testosterone therapy treatments.

More

Share

Testosterone Lawsuit filed in Philadelphia

Matthews & Associates filed Testim Gela Testosterone Lawsuit in Philadelphia today before the Philadelphia Court of Common Pleas. The defendant is Auxilium Pharmaceuticals, Inc., the maker of Testim, the testosterone gel product named in the complaint. The firm filed the case in Penn. because Auxilium  maintains an office in Chesterbrook.

The plaintiff is 67-year-old New Jersey native Louis Angelli, a married father of four.  Mr. Angelli suffered two pulmonary embolisms – or emboli – after taking Testim. At 64 in 2010, he  began testosterone therapy with Testim, then suffered his first pulmonary embolism in 2011, approximately one year after he began the Low-T therapy. He spent two weeks in hospital, the first in intensive care, and was sent home after beginning rounds of the blood thinner Cumadin, which his doctor insisted that he take for one year.

More

Share

Generic Low T Injustice from Supreme Court

The FDA has the logo-actavispower to fix the ongoing injustice of those hurt by generic drugs left out in the cold by five corporate-friendly judges who sit on the Supreme Court, yet the agency does nothing. The FDA is culpable, but make no mistake: generic Low T Injustice comes from the Supreme Court.

More

Share

JAMA attacked by Testosterone Money

Like mountain goats locking horns to determine supremacy, testosterone battles are raging between researchers not beholden to Big Pharma and researchers who are.

The Wall Street Journal reported yesterday that researchers paid by companies promoting testosterone therapy have come out in full-throated attack against a study published in Nov. 2013 in the Journal of the American Medical Association (JAMA). The study found that testosterone therapy to boost testosterone increased the risk of heart attack, stroke and other cardio events in men with heart disease history.

The study published in JAMA  referenced the VA records of some 8,700 men diagnosed with low testosterone from 2005 to 2011. It was one study which the FDA said prompted it in Jan. 2014 to announce it was reassessing safety concerns of possible cardiovascular risks associated with testosterone therapies.

That JAMA study has now been heatedly challenged in letters written to the medical journal. JAMA has published those letters, which criticized the study’s design and its authors’ conclusions, but the group who wrote them isn’t stopping there. Some of them have formed what they call the Androgen Study Group, nomenclature derived from the hormones which affect the male reproductive system. The group says it has enlisted the support of dozens of researchers in seeking a retraction of the study from JAMA.

The group says that a recent correction JAMA published and an explanation for it shows JAMA needs to rethink the piece. The group has focused on the specifics of how the study excluded some patients and used that exclusion as a springboard to question the study’s results.

More

Share

Androgel Pay to Delay Lawsuit allowed by Supreme Court

Supreme Court: FTC can challenge Pay to Delay Schemes

An Androgel pay androgel-pictureto delay lawsuit was at the center of a Supreme Court case decided last summer which could eventually affect many other drug cases. The Federal Trade Commission sued the drug maker Solvay over a pay-to-delay play the company tried to make with Androgel.

More

Share

Abbott Androgel Lawsuit

An Abbott Androgel Lawsuit was filed this week in federal court by Stephen Benn against Abbott Laboratories and Abbvie, the makers and distributors of Androgel.

The companies advertised to convince millions of men that natural aging – mood swings, slowing down, lowered libido, that sort of thing – is a sign of testosterone deficiency and can be solved with a testosterone supplement such as Androgel.

More

Share

Testosterone Lawsuit in Supreme Court

A Testosterone Lawsuit in androgel pictureSupreme Court is the subject of a pay to delay case. In March 2013 the U.S. Supreme Court heard a case that concerns most Americans and most of Big Pharma. Like brand-name drug “preemption,” which insulates drug makers from liability lawsuits, as well as the duplicitously titled  “Citizen’s United” decision and many others in recent history, this case pits the rights and the pocketbooks of American citizens against those of international drug makers.

This Testosterone Lawsuit in the high court against the makers of AndroGel was brought because brand-name drug makers want to pay generic drug companies for delaying the time when the generics copy a brand-name drug and put it on the market. Delaying a generic drug’s entry into the market can add billions in profits for pharmaceutical companies, at the expense of people – and/or their insurance companies – who must continue to pay full price for that brand-name drug.

These types of payments have been made before as a form of settlement in patent litigation, though their legality has always been questioned by any consumer groups who happen to be paying attention. Big Pharma began making such payments about ten years ago.

More

Share