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Testosterone Low-T GelsTestosterone Treatments Increase Risk of Heart Attack and Stroke

Testosterone Low-T Gels

The FDA re-examined the safety of testosterone replacement treatments after two studies showed a higher risk of heart attack risk and strokes in men who use them. The testosterone treatment lawsuit claims that the men who used testosterone treatments were deceived by a marketing campaign that overplayed the benefits and underplayed the risks despite the fact that the manufacturers knew the risks.

TorHoerman Law is no longer accepting testosterone treatment or Androgel lawsuit cases.

Litigation Updates

Bellwether Cases Proceeding to Trial

August 2018 - Androgel cases are still proceeding to trial for bellwether cases. The Judge has decided that there will be 20 bellwether trials against the makers of Androgel between October 2, 2018, and March 2019. Eleven other Judges will help to try the cases. The results of trials thus far have been mixed with both sides winning trials. Many of those results are being appealed. There are settlements in place for people whose injuries were caused by Testim and Axiron. We are in the process of submitting all the necessary paperwork for those individuals.

AbbVie Wins 5th Bellwether in MDL

June 14, 2018 – On Thursday, an Illinois jury found in favor of AndroGel manufacturer AbbVie Inc. This was the fifth bellwether trial and third complete defense verdict for AbbVie Inc. in the testosterone replacement therapy multidistrict litigation (MDL).

The plaintiff, Robert Rowley, claimed that AbbVie Inc.'s AndroGel caused him to develop deep vein thrombosis in 2013. The jury of the U.S. District Court for the Northern District of Illinois rejected Rowley’s claim and found for AbbVie Inc.

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Jury Rules in Favor of Manufacturer in Fourth Bellwether Trial

May 16, 2018 – In the fifth bellwether trial, an Illinois jury found for AbbVie, resulting in the second loss for the manufacturer.

AbbVie Ordered to Pay $3M in Androgel Retrial

March 26, 2018 – AbbVie, the manufacturer of Androgel, was ordered to pay $3 million to a man after finding the product caused his heart attack.

Tentative Deal Announced

February 26, 2018 – A tentative deal to settle Endo, Auxilium, and GlaxoSmithKline’s cases in the testosterone treatment MDL was announced. A 45-day stay was granted to allow the parties time to agree on the settlement details.

AndroGel Lawsuit Bellwether Found In Favor of Defendant

January 26, 2018 - A Chicago, Illinois federal jury rejected an Arizona man's claim that his pulmonary embolism was caused by AbbVie Inc.'s AndroGel. This bellwether trial marks the third trial in the AndroGel lawsuit multidistrict litigation (MDL) and the first full defense verdict for AbbVie's testosterone replacement therapy drugs.

In the most recent AndroGel lawsuit bellwether, the plaintiff, Robert Nolte, argued that his pulmonary embolism was a result of using AndroGel, and claimed that AbbVie misrepresented the safety and effectiveness of the product.

The Chicago jury rejected his claim.

Nolte began taking AndroGel at 72, after learning from his doctor that he had low testosterone levels. After seeing advertisements, Nolte asked his doctor for testosterone treatments. A few months later, in 2012, he suffered from a pulmonary embolism. Nolte filed a complaint against AbbVie two years later in 2014. Nolte claimed that AbbVie misled doctors and patients about the risks of AndroGel while advertising it as an effective way to remedy normal aging signs.

AbbVie representatives successfully argued that there had not been any scientifically established proof to show that Nolte's injuries were the direct result of AndroGel.

In a rebuttal to AbbVie's argument, Nolte’s attorney, Keith Mitnik of Morgan & Morgan PA, said that AbbVie "preyed on an aging man's natural desire to have his vitality back." Mitnik went on to argue that AbbVie failed to properly conduct clinical studies proving AndroGel to be safe and effective for men of Nolte’s age – the demographic that AbbVie targeted.

But the defendant believes that Nolte's pulmonary embolism was not the result of AndroGel, but of the plaintiff's preexisting medical issues.

Nolte had previously suffered a pulmonary embolism. He also had suffered from several other cardiovascular issues prior to taking AndroGel.

Because of this previous pulmonary embolism, along with a certain type of antibody found in his bloodstream, Nolte’s odds of suffering a secondary pulmonary embolism were at around 50% if he was not taking a blood thinner. Against his doctor’s recommendations, Nolte was not taking a blood thinner medication at the time of the second pulmonary embolism.

This factor was enough to sway the jury in favor of the defendant.

Nolte's case is one of the thousands of now-conglomerated cases against AbbVie's AndroGel and similar testosterone replacement therapy products.

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Third Trial Ended in Favor of Manufacturer

January 2018 – A third trial ended in favor of the drug manufacturer.

Eli Lilly Settlement Reached

December 22, 2017 - Eli Lilly and Co. reached a global settlement in hundreds of lawsuits over Axiron, a testosterone replacement therapy drug.

$150M Verdict Overturned

December 2017 – The $150 million verdict is overturned by an Illinois federal judge. The retrial is expected to begin in March 2018.

Jury Ruled in Favor of Manufacturer

November 2017 – A jury ruled in favor of Endo, the manufacturer of Testim.

Jury Ruled in Favor of Plaintiff and Awarded $140M

October 5, 2017 – A federal court in Chicago, Ill. ruled in favor of a Tennessee man who claimed AbbVie "misrepresented the risks of its testosterone replacement drug AndroGel." The jury awarded him $140,000 in compensatory and more than $140 million in punitive damages. The verdict is the second in a series of more than 2,400 lawsuits against the drug manufacturer, AbbVie.

The jury found that AbbVie failed to properly test Androgel for contributing to an increased risk of heart attacks in individuals taking the drug and “misrepresented its safety for treating a decrease in testosterone caused by age.”

Jeffrey Konrad sued the drug manufacturer in 2015 alleging that, after use of Androgel, he suffered a heart attack. In addition to his heart attack, Konrad alleges AbbVie failed to adequately disclose the potential side effects, such as a heart attack. He also alleged that AbbVie advertised the drug to treat conditions beyond those listed on the label, such as a decrease in testosterone due to age, rather than Hypogonadism, which is a disorder where testes produce little to no testosterone.

Konrad’s lawsuit is one of 6,000 consolidated causes in a multidistrict litigation against multiple different testosterone replacement drug manufacturers, including AbbVie. Trials will continue to take place throughout the next year.

AbbVie has said that its “marketing of AndroGel adhered strictly to uses approved by the U.S. Food and Drug Administration (FDA) and that it was in full compliance with applicable standards.” AbbVie is expected to appeal the October 5th verdict.

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Unlikely Verdict Reached in AbbVie Androgel Case

July 24, 2017 - On Monday, an Illinois Federal jury issued an unlikely verdict, one that ruled in favor of both the defendant and the plaintiff. The verdict stated AbbVie, the manufacturer of Androgel, a testosterone replacement gel, is responsible for deceptive marketing practices, but not an Oregon man's heart attack.

The jury concluded AbbVie must pay punitive damages of $150 million for failing to disclose necessary safety information but does not have to compensate Jesse Mitchell for the heart attack he suffered in 2012 after taking the drug for four years.

"Plaintiffs across the country should be pleased with this result," Chad Finley, a lawyer at TorHoerman Law said. "The $150 million punitive damages verdict demonstrates that the jury found Abbvie deserved to be punished for their conduct. While Abbvie will likely appeal the $150 million verdict because it was not proven at trial that the Plaintiff's heart attack was caused by Androgel, the verdict demonstrates that Abbvie inappropriately advertised and promoted the drug."

The verdict is the first response to the more than 6,000 consolidated cases filed in Illinois. Over the next year, other cases will be tried, but this particular verdict is a somber foreshadowing of future results for AbbVie.

THL congratulates our friends that represented the Plaintiff at trial: Troy Rafferty, (Levin Papantonio Thomas Mitchell Rafferty & Proctor, P.A.) David Buchanan, (Seeger Weiss, LLP) and Chris Tisi (Ashcraft & Gerel).

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Second AbbVie Trial Ended in $150M Verdict Against Manufacturer

July 2017 – The second AbbVie trial ended in a $150 million jury verdict against the manufacturer. The verdict was later overturned in December 2017.

First AbbVie Trial Ended in Mistrial

June 2017 – The first AbbVie bellwether trial ended in a mistrial due to an attorney's medical emergency.

Androgel: Tennessee Man Alleges Drug Caused Heart Attack

June 8, 2017 - On Monday the first Androgel jury trial in the country began. In the upcoming weeks, an Illinois federal jury will hear evidence that Androgel, a popular drug that is supposed to be used to treat hypogonadism, caused a Tennessee man's heart attack. His case is one of the over 2,400 cases that have been filed against AbbVie alleging that they promoted the drug beyond its intended use and did not accurately list the potentially deadly side effects.

The trial is expected to last three weeks.

 

Lawsuits Consolidated Into MDL

June 2014 – All federal testosterone treatment lawsuits are consolidated into a multidistrict litigation.

Motion Filed to Consolidate

March 2014 – A motion was filed to consolidate all federal testosterone treatment lawsuits.

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What are Testosterone Treatments?

Testosterone replacement therapy, used clinically since 1937 and approved by the FDA in 1953, has been used to improve testosterone levels in men with lower than normal testosterone levels. The number of testosterone prescriptions given to American men has tripled since 2001. Since testosterone treatments have exploded in popularity, the treatment is now administered in at least five forms, including patches, gels, and injections.

Testosterone gels are applied once daily to intact skin of the shoulders or upper arms. AbbVie’s AndroGel currently accounts for 66% of the prescriptions in the gel market. The top manufacturers of testosterone treatments include AbbVie, Eli Lilly & Co, Pfizer Inc., and Endo International, but there are others that produce the products. A majority of the lawsuits are filed against the aforementioned.

The following is a list of other testosterone treatments that are looking to expand with the continued push in the market for the treatment of “Low T:”

• Androderm Patch
• Axiron Gel
• Bio-T-Gel
• Delatestryl Gel
• Depo-Testosterone Gel
• Fortesta Gel
• Striant Gel
• Testim Gel
• Testopel Gel

Testosterone treatments have long been used to treat the medical condition known as hypogonadism in which the body does not produce enough testosterone. Hypogonadism is tested by looking at the testosterone levels in the blood. This measures the patient’s hormone levels and allows the doctor to rule out other conditions. It is estimated that up to one-quarter of the testosterone treatment prescriptions are dispensed without a blood test, and often there is little or no re-testing or dose adjustment after the initial prescription.

The lack of testing has permitted many testosterone products to be administered to patients who may not have hypogonadism, but rather, simply experience low testosterone due to the natural aging process. This has put many aging men at risk of suffering a heart attack, embolism, or stroke due to the testosterone treatment.

 

Disease Mongering Leads to Testosterone Treatment Lawsuit

The manufacturers of testosterone replacement gel have manipulated and coerced men into seeing their doctor to see if they suffer from “Low T” by asking a variety of questions through advertisements including, “Do you have a decrease in sex drive? Lack of energy? A decrease in strength and/or endurance? A loss in height? Have you noticed a decrease in your enjoyment of life? Are you sad or grumpy? Are your erections less strong?”

Well produced advertisements show aging men who claim to be “back in the swing of things” after using the gel. These marketing materials did not carry the warning of increased risk of heart attack, embolism, or stroke.

Critics now question this marketing tactic. Testosterone levels have always declined naturally by age, but men’s average testosterone levels have been dropping from historical levels by at least 1 percent a year, according to a 2006 study in The Journal of Clinical Endocrinology and Metabolism. The reasons for this decline seem to be tied to drugs like steroids, an increase in weight, chemicals like bisphenol A (BPA) that is found in plastic food containers, and diseases like Type 2 diabetes.

So should you treat this natural decline? Is this a new condition? “Low T,” as this condition has been labeled by the testosterone replacement manufacturers, isn’t nearly as common as they would have you believe. Pharmaceutical companies have seized on the decline in testosterone levels as a marketing objective designed to coerce men into asking for the treatment.

Pharmaceutical companies aim to convince men that common effects of aging like slowing down a bit and feeling less sexual actually constitutes a new disease and that they need a prescription to cure it.

Aggressive marketing of “Low-T” to the public and doctors has resulted in a boom for testosterone treatments manufacturers. Testosterone gels represent 89% of the overall $2.1 billion testosterone replacement therapy market. Sales of all testosterone-boosting drugs are projected to accumulate to $3.8 billion in 2018.

Avoiding taking medication to increase testosterone levels may be in the best interest of many and anyone considering taking testosterone boosting drugs should speak to their doctor about the benefits and risks. There are also natural ways to increase testosterone levels such as an improved diet, natural supplements, exercise, or getting enough sleep.

 

Testosterone Treatments Increase Risk of Heart Attack and Stroke

The problem with testosterone drugs is that it doesn’t just give your testosterone levels a boost – it may also increase your risk of heart attack. In some men, it increases aggression and irritability. Children who accidentally come in contact with the hormone (because their father applies it topically) can develop unwanted pubic hair and genital changes.

New research has found that testosterone treatments could cause many unwanted side effects, including an increased risk of stroke, heart attack or even death which has led to a testosterone treatment lawsuit. According to studies, men younger than 65 with known heart disease had a two-fold increase in the risk of a nonfatal heart attack shortly after initiation of testosterone therapy. Older men with a history of heart disease were 30% more likely to suffer from an adverse event such as a stroke, heart attack or even death.

The link between the drugs and deadly consequences have resulted in a testosterone treatment lawsuit.

 

Testosterone Treatment Lawsuit Filed

Testosterone lawsuits have been filed by men who suffered heart attacks and strokes while using testosterone treatments. The FDA re-examined the safety of testosterone replacement treatments after two studies showed a higher risk of heart attack risk and strokes in men who use them. The testosterone treatment lawsuit claims that the men who used testosterone treatments were deceived by a marketing campaign that underplayed the risks despite the fact that the manufacturers have known the risks.

Timeline

FDA Announced Investigation

January 31, 2013 – The FDA announced it began an investigation into the risk of stroke, heart attack, and death in men taking prescription testosterone drugs. The move was based on the studies published that suggested an increased risk of heart attacks in men who take testosterone.

+ - References

Banville, Laurence. "Eli Lilly Settles 400+ Testosterone Lawsuits Ahead Of First Axiron Trial." The Legal Herald, 5 Jan. 2018, legalherald.com/eli-lilly-testosterone-settlement/.

Bellon, Tina. "U.S. Jury Orders AbbVie to Pay $3 Million in AndroGel Retrial." Reuters, Thomson Reuters, 26 Mar. 2018, www.reuters.com/article/us-abbvie-lawsuit-androgel/u-s-jury-orders-abbvie-to-pay-3-million-in-androgel-retrial-idUSKBN1H22UD.

Mayo Clinic Staff. "Testosterone Therapy: Potential Benefits and Risks as You Age." Mayo Clinic, Mayo Foundation for Medical Education and Research, 13 Dec. 2017, www.mayoclinic.org/healthy-lifestyle/sexual-health/in-depth/testosterone-therapy/art-20045728.

"Projection of United States Annual Testosterone Drug Sales 2018 | Statistic." Statista, www.statista.com/statistics/320301/predicted-annual-testosterone-drug-revenues-in-the-us/.

Weintraub, Arlene. "Endo Scores a Victory in Its First Testosterone Bellwether Case." FiercePharma, Questex LLC, 17 Nov. 2017, www.fiercepharma.com/legal/endo-scores-a-victory-its-first-testosterone-bellwether-case.

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