More than 4,000 men have filed federal lawsuits, claiming testosterone drugs like Androgel cause a host of severe cardiovascular side effects, including heart attack and stroke.
Inventing “Low T”: Were Millions Duped Into Taking Dangerous Drugs?
Numerous drug manufacturers have been accused of exploiting common male fears, pushing Low T therapies as a cure-all for everything from low libido to “the blues.” Those symptoms, former patients argue, are simply the effects of aging. But testosterone manufacturers saw an opportunity for profit, plaintiffs claim, using patients’ understandable anxieties to create a non-existent medical condition, “Low T.” After convincing men that they had “Low T,” drug manufacturers sold them a drug to “cure” it.
Testosterone products are approved to treat an actual medical condition, hypogonadism. It’s rare, but at hypogonadism’s root is a physical inability to produce sufficient amounts of testosterone. The problem can lie in a patient’s testicles or his brain, but in either case, a true diagnosis requires blood testing. Hypogonadism affects around 4 to 5 million men in the US, according to Boston University’s School of Medicine.
Plaintiffs say Low T companies stretched the definition of that real medical condition beyond its reasonable limits, eventually making “Low T” synonymous with “male aging.” Through marketing campaigns, manufacturers convinced thousands of men that they were suffering from “Low T,” even offering self-diagnosis tests that rely on simple questions rather than any recognized diagnostic test. The ploy worked, critics say. Statistics have shown that as many as half of all men prescribed testosterone replacement therapy (TRT) drugs have never been diagnosed with hypogonadism. 25% of those men never even have blood tests before getting the medications.
FDA: Risks & Benefits Of Testosterone Still Unclear
Federal regulators have been wary of signing off wholeheartedly on Low T drugs for some time. On January 31, 2014, the FDA announced it was looking into the risk of “stroke, heart attack and death” in male patients taking testosterone supplements. The investigation was spurred by 2 papers, both of which suggested a link between testosterone and cardiovascular side effects.
One study, published by the Journal of the American Medical Association, linked testosterone therapy to heightened rates of heart attack and stroke among older patients treated in the VA healthcare system. The other study looked into testosterone’s potential risk of heart attack. Using the health records of more than 55,000 men, researchers from UCLA and the National Cancer Institute found that men 65 or older suffered twice as many heart attacks after being prescribed testosterone. Shockingly, this risk was apparent within the first 90 days of taking the drugs.
Low T Drugs Slapped With Blood Clot Warning
After reviewing relevant medical evidence, the FDA took action. On June 19, 2014, the agency said it was requiring all testosterone manufacturers to include a “general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins.” The warning applied to blood clots in general, including those associated with deep vein thrombosis (DVT), venous thromboembolism (VTE) and pulmonary embolism (PE).
In its press release, the FDA noted that testosterone drugs already bore a warning about these blood clots. But the language of that warning linked the risk specifically to a condition known as polycythemia, an abnormal increase in red blood cells known to occur in some patients taking Low T drugs. After receiving reports of patients without polycythemia who suffered blood clots anyway, the new warning decoupled the two risks.
“Possible Increased Risk Of Heart Attack & Stroke”
Low T manufacturers took another hit in April 2015, when the FDA ordered them to clarify the indications for their products. In effect, the FDA said, “stop marketing these drugs for ‘Low T.’ They’re only approved for true hypogonadism, and the labels should make that clear.” Even more damaging to testosterone sales? A new warning about the possibility of heart attack and stroke, added to all product labeling as of April 15, 2015.
Those warnings have come too late, public health advocates claim. Many patients agree, saying they (and their doctors) were duped into using a drug with serious health risks.
Where Are The Lawsuits Now?
Thousands of men are now pursuing their own testosterone lawsuits, after the first claims were filed in February 2014. Dozens more followed, and the Judicial Panel on Multidistrict Litigation decided to “consolidate” the lawsuits on June 6, 2014, sending multiple claims to the US District Court for the Northern District of Illinois. As part of a Multidistrict Litigation (MDL), current and future Low T lawsuits will continue through pre-trial proceedings together.
AbbVie Bellwether Trials On The Horizon
More than 4,000 lawsuits now sit in Illinois. Discovery, the phase of a case in which evidence is gathered, has already begun. Plaintiffs’ attorneys have even begun to select prospective “bellwether trials,” according to Forbes. Common in most MDLs, bellwether trials are cases that go to trial first. It’s a way of airing evidence and expert testimony before an actual jury, one that the court hopes will inform future settlement negotiations.
After decisions have been reached in the bellwethers, both plaintiffs and defendants will know “where they stand” a little better and can use that information to make decisions going forward. But this litigation is fairly unique since not every testosterone lawsuit has been filed against the same defendant. Major testosterone players, like AbbVie, the manufacturer of AndroGel, are well-represented, but alongside them, smaller companies like Acrux stand accused as well. AbbVie has been selected as the first manufacturer to face a trial. The outcome of that case, whatever it is, won’t be binding on other lawsuits consolidated in the MDL.
Generic Testosterone Lawsuits Dismissed
Some plaintiffs, however, have already suffered a major loss. On November 12, 2015, Law360 reported that the Honorable Matthew Kennelly, the judge appointed to oversee the MDL, had granted a motion to dismiss hundreds of lawsuits filed against the manufacturers of generic testosterone products.
Meanwhile, additional studies have complicated the legal situation. In July 2015, the Mayo Clinic (one of America’s most prestigious health institutions) released a study finding no link between testosterone supplements and venous thromboembolism. The results came little more than a year after the FDA added its “general warning” about the risk of venous blood clots to all approved testosterone medications.
How results like that will affect legal proceedings is an open question, but men haven’t stopped filing testosterone lawsuits yet.
Who Can File?
Anyone who was prescribed a testosterone replacement therapy and then suffered serious side effects may be eligible to file a lawsuit. While most Low T attorneys will put an emphasis on cardiovascular complications like stroke, heart attack and blood clots, any man who believes his health problems were caused by testosterone will benefit from speaking to an experienced lawyer.
Latest Low T Updates
By Laurence P. Banville
September 29, 2017 – Defense Verdict In Illinois Court For AndroGel Trial
Bellwether trials related to heart attacks suffered after starting testosterone therapy are continuing to progress. Currently, there are more than 6,500 AndroGel, Testim, and Axiron lawsuits pending nationwide against the various testosterone therapy makers alleging that the companies failed to provide adequate warnings to consumers and the medical community. Verdicts in previous trials have been split. Millions of damages were awarded in a July trial, but an Illinois court jury verdict went to the defense earlier this month. Bellwether trials continue for testosterone therapy lawsuits with jury selections having started on Sept 18 for another trial centered around AndroGel.
August 29, 2017 – Androgel Testosterone Bellwether Trial Plaintiff Files Motion Following Trial Conclusion
Last month the two-week Androgel Testosterone bellwether trial concluded with the jury awarding $150 in punitive damages but awarding no economic damages for medical expenses or pain and suffering. The plaintiff who had suffered a heart attack which was allegedly caused by side effects of the testosterone therapy filed a motion to amend the judgment on August 21, asking the Court to include $136,408 to cover medical expenses that were incurred from his heart attack. The plaintiff indicates in this motion that if the amendment is not made a new trial should be granted. Meanwhile, AbbVie, the maker of Androgel, has filed another motion to have the Court strike the punitive damages award.
July 25, 2017 – AbbVie To Pay $150 Million In Testosterone Trial
AbbVie suffered their first trial loss over their Low-T drug Androgel and was ordered to pay $150 million in damages. An Oregon man sued the drugmaker and accused the company of hiding the risks of suffering a heart attack when using the testosterone booster. After using Androgel for 4 years, the man suffered a heart attack in 2012. Oddly, the plaintiff was awarded nothing on his claim for compensatory damages from his heart attack but $150 million in punitive damages over the finding of company officials making fraudulent misrepresentations about the drug’s safety profile.
June 22, 2017 – Judge Rejects Defense’s Attempt To Dismiss Testosterone Bellwether Case
AbbVie made an attempt to dismiss the first Androgel bellwether trial, which was scheduled to begin on June 5, due to the statute of limitations and statute of repose. The judge presiding over the testosterone lawsuits dismissed this attempt indicating that these defenses were waived because they were not brought up until the eve of trial. Following this first bellwether trial, additional Androgel bellwether trials are expected to begin on July 5, September 18, and January 8, 2018.
May 22, 2017 – Testosterone Heart Attack Lawsuit Set To Begin Next Month
An MDL of over 6,500 pending testosterone lawsuits has been centralized in the Northern District of Illinois. All of the lawsuits have similar allegations against various drugmakers that they failed to warn consumers and the medical community of the possible increased risk of stroke, heart attacks, blood clots and more when taking their testosterone drugs. Androgel is the most popular of the testosterone therapies and therefore, all suits involving its use will be in the first set of trials for the bellwether cases. The first trial is scheduled to begin on June 5 and is expected to last 3 weeks. This suit indicates that the plaintiff suffered a heart attack about 2 months after beginning his Androgel prescription in May 2010.
April 28, 2017 – Diet Could Naturally Increase Testosterone
There are huge numbers of testosterone creams, pills, and injections as well as ads convincing men they are in need of these products. There are also thousands of lawsuits filed against the manufacturers of the various testosterone therapies claiming the drugs caused several severe cardiovascular side effects including heart attack and stroke. With this knowledge, Men’s Journal published an article describing natural ways men can boost their testosterone through diet so as not to take on unnecessary risks. One suggestion made was to increase vitamin D intake which could increase testosterone level. Men should always use caution and discuss diet changes with their doctor.
March 28, 2017 – Parties Propose Order Of Androgel Cases For Bellwether Trials
There are currently over 6,500 pending cases in an MDL which all make similar allegations that drug makers failed to warn consumers and the medical community of the risks men using testosterone drugs face. These risks include heart attack, stroke, pulmonary embolism and more and these federal lawsuits involve numerous brands of drugs such as Androgel, Testim, and Axiron. Androgel is the most widely used testosterone replacement therapy drug and the first set of bellwether trials will be six Androgel cases. The first trial is set to begin on June 5, 2017. Plaintiffs and defendants submitted a joint list on February 27 on which outlined each Androgel claim and the order the cases should go before the jury. After the Androgel trials, the Testim cases are expected to go to trial in November.
February 20, 2017 – Testosterone Replacement Therapy MDL Continues
The plaintiffs’ steering committee has requested that the court compel documents from Dr. Adrian Dobs, who they call a “key figure” in the movement to push testosterone therapy, from AbbVie Inc. The pharmaceutical company told the federal judge that the discovery request was beyond what is proper in an MDL. The steering committee made the motion on January 31 and stated the doctor “has been a paid ‘key opinion leader’ and consultant employed by the company” since Androgel has been on the market. AbbVie has stated that plaintiffs’ have requested documents they know to be in violation of Rule 26, federal disclosure rule.
January 13, 2017 – Judge Rules Besins Healthcare Will Remain In Low-Testosterone MDL
Besins Healthcare SA is a Belgian drugmaker which manufacturers Androgel, one of the many low testosterone drugs on the market. The company has been seeking dismissal from the MDL surrounding testosterone replacement therapies which allege the drugs cause side effects including stroke and heart attack on the grounds that the company didn’t sell the drug in the United States. A federal judge has rejected the company’s attempts, ruling that the plaintiffs provided enough evidence to keep them in the case.
December 20, 2016 – Risk Of Blood Clots For Men Starting Testosterone Therapy
An observational study was completed by researchers in the UK who examined data collected between 2001 to 2013 from 19,000 patients with blood clots and over 900,000 similar men with no history of blood clots. The study suggests that there is an increased risk for blood clots in men after they begin to take testosterone to treat sexual dysfunction. The risk of blood clots seemed to return to normal levels after about six months of treatment but doctors who worked on the study stated that men should still discuss testosterone use with their doctor.
November 21, 2016 – Testosterone Lawsuits Set To Go To Trial In Later Half Of 2017
There are currently 6,000 testosterone lawsuits pending in federal court which have been consolidated into an MDL due to the similarities in the suits’ claims that the drug makers failed to warn consumers of the health risks associated with taking the drug. Recently, the U.S. District Judge who is presiding over the litigation laid out an aggressive trial schedule for the bellwether Androgel lawsuits which should begin in June of 2017 in a series of 6 cases and additional trials beginning every four weeks after that. The outcomes will be watched closely as they may help to gauge future jury responses. Following the Androgel bellwether trials, the Judge is expected to schedule bellwether trials for other lawsuits involving Testim, Axiron, Androderm, and various others.
October 18, 2016 – Research Shows No Proven Benefits To Low-T Therapy
Recently a survey of research was published in the journal PLOS One which analyzed over 200 studies conducted on the effectiveness of testosterone medications vs. a placebo since 1950. The results showed that despite drugs such as Androgel and Testim’s recent popularity there is no scientific evidence that they benefit the user. Furthermore, many of the men using these drugs for symptoms of nothing more than the effects of aging could be putting themselves at serious increased risk for heart attacks, strokes, blood clots, and more. The article does note however that the conclusions of this study do not apply to those men who have been diagnosed with true hypogonadism.
September 21, 2016 – New Study Suggests Light Therapy Could Boost Libido And Testosterone Amid Low T Lawsuits
As lawsuits claiming Low T therapy drugs are responsible for causing heart attacks and strokes in men who used them continue to be filed, the European College of Neuropsychopharmacology has made some promising new discoveries. New research has shown that exposure to bright light can increase testosterone levels in men which in turn can increase sexual desire. The study was conducted on men who were diagnosed with hypoactive sexual desire or sexual arousal disorder, which causes the individual to lack interest in sex. The results of the study showed a more than three-fold increase in sexual satisfaction after receiving active light treatment.
August 18, 2016- Indiana Woman Files Wrongful Death Lawsuit Against Androgel Manufacturers
A woman from Indiana has filed a wrongful death lawsuit on behalf of her deceased husband, against the manufacturers of AndroGel, AbbVie Inc. and Abbott Laboratories. The lawsuit was filed in the U.S. District Court for the District of Pennsylvania. The woman has stated that her husband died from side effects that he suffered after he took the testosterone replacement drug. Her husband was prescribed AndroGel for symptoms related to low testosterone in 2010. She states that both her and her husband, as well their doctor were not aware of the side effects this drug can have such as heart attacks, stroke, and pulmonary embolism at the time he was prescribed the drug. Four years later, he suffered from cardiac arrest, which led to his death. She is seeking in excess of $150,000 in damages.
June 16, 2016- Schedule Set For First 8 Androgel Bellwether Trials In Illinois Court
Following the U.S. Judicial Panel on Multidistrict Litigation’s (JPML) consolidation of all testosterone replacement lawsuits into one court in the Northern District of Illinois in June 2014, the two sides are in the process of selecting a group of potential cases for early trials. Discovery of the select cases by both sides is supposed to be completed by July 6, 2016. July 20, 2016, is the date set to submit proposals for the Court’s selection of the initial bellwether trial cases.
May 31, 2016- Low T Lawsuits Increasing Including Claims Of Heart Attacks And Strokes
Almost 5,000 Testosterone lawsuits have been filed against drug manufacturers, AbbVie Inc., Auxilium Pharmaceuticals, and Endo Pharmaceuticals Inc. in the Northern District of Illinois, by men who have used testosterone replacement drugs. The drugs included in the lawsuits are Androgel, Axiron, and Fortesta, where complainants allege that the drug makers marketed these testosterone replacement therapy (TRT) drugs that are liable to cause injuries that include heart attacks or stroke.
April 22, 2016- Low T Drug Lawsuits Face Mass Tort Status Rejection
Philadelphia Administrative Judge Jacqueline F. Allen recently rejected a petition that sought mass tort designation of Low T lawsuits. The denied petition was the In re Testosterone Replacement Therapy Products Liability Litigation. A petition was filed in February 2016, in Hoehl v. Auxilium, with 31 cases stating that testosterone medication usage led to heart attacks, stroke, and embolism, pending in the Philadelphia Court of Common Pleas. Plaintiffs saw it fit to consolidate the cases in order to be efficient and the defendants were also on board with this request. Unfortunately, judge Allen denied the petition without outlining her reasons for the rejection.
March 18, 2016- Manufacturers Of Generic Testosterone Also Facing Lawsuits
Manufacturers of generic testosterone have not been immune to seeing lawsuits filed against them by plaintiffs. Plaintiffs who used generic testosterone allege that they were not given enough warning about the dangers linked with testosterone therapy products. In Illinois, the federal judge overseeing the testosterone therapy lawsuit is allowing plaintiffs to continue with allegations stating fraudulent off-label marketing, rather than failure to warn allegations.
February 26, 2016- Consumers And Insurers Filing Lawsuits Against Low T Pharmaceutical Companies
Pharmaceutical companies that manufactured a number of testosterone replacement therapy drugs are currently backing their products in a multi-district litigation (MDL) in the U.S. District Court for the Northern District of Illinois. Pharmaceutical companies are defending their products which both consumers and insurers are filing complaints about. Consumer plaintiffs have stated that pharmaceutical companies did not adequately warn them of possible side effects caused by products such as AndroGel. Insurers are filing suits on behalf of an implied class of third-party payors who allege that they suffered economic injuries.