by Spencer Aronfeld | Nov 9, 2015 | Defective Drugs, Defective Products, Low Testosterone
The multi-district litigation brought by men from around the country who have been injured taking low T drugs is now in front of Judge Matthew Kennely, who is a Clinton appointee. He has been on the Federal Bench in the Northern District of Illinois since 1999. This will be Judge Kennely’s first major pharmaceutical case, and he has already ordered limits on the number of depositions that can be taken. On March 1, 2016, the judge will pick six trials. The bellwether cases are set to start sometime next year, selected randomly from 100 cases. Each sider will be able to pick 16 cases and can object to each other’s selection. The first trial will start October 31, 2016 for a thrombotic-event case and then another in February 2017 for cardiovascular-event cases. The primary defendant in this matter is low testosterone drug maker AbbVie. The drug is made in both France and Thailand. Depositions have already started, with AbbVie’s Director of Trade Pablo Hernandez, and many more are scheduled for the next couple of months. The other defendants include Auxilium and Lilly, Actavis, Endo, Testopel, and Pfizer. ANDA representatives have filed motions claiming that their generic low testosterone drugs are preempted by Federal law. The latest developments in the low testosterone cases against the drug makers of low T therapies across the country rely on a number of medical studies, including the Vigen 2013 JAMA study and Finkle study (PLOS One), that showed an increased risk from the use of gels, injections, and patches, doubling the risks of heart attacks in all men over the age of 65, and in...
by Spencer Aronfeld | May 8, 2014 | Low Testosterone
There surely has been a lot of talk in both the media and medical journals lately about American men and our testosterone–or our perceived lack of it. Testosterone is the male hormone produced in the testicles, regulated by glands in our brains, that determines many of a male’s sexual characteristics. According to the Journal of the American Medical Association (JAMA), physicians are prescribing testosterone-replacement drugs for men who suffer symptoms ranging from a diminished sex drive, to depression and fatigue. The only way to accurately diagnose if a man has low testosterone (low T) is by administering a series of blood tests. This condition is now commonly called “Male Menopause,” or more specifically androgen deficiency in the aging male (ADAM). If the blood test reflects this condition, low T drugs are available in a wide variety of forms, ranging from a gel, patch, or injection, to a tablet that is applied to the gums. It is unclear why some men suffer from this condition. Some believe that it is congenital or stems from exposure to certain toxins. The evidence is clear that men who are diabetics (type 2) or who have abnormal cholesterol levels and/or HIV/AIDS are more likely to have low T. Of course, like any drug, low testosterone therapy treatments have some risks. The most common short-term risks include prostate cancer, heart disease, blood clots, and shrunken testicles. The long-term effects are not yet clear. Last month the Food and Drug Administration (FDA) announced that it was investigating the long-term effects of testosterone therapy after two separate studies reported an increased risk of stroke, heart attack, and...
by Spencer Aronfeld | Mar 11, 2014 | Defective Drugs, Low Testosterone
As an Androgel injury lawyer in Miami, I am concerned about the recent reports that men who take Androgel, Axiron, Testim, Foresta, and other low testosterone replacement drugs are at a higher risk for heart attacks and strokes. Our lawyers in Miami for people who want to sue a drug company believe the FDA should now require low T drugs to come with a “Black Box” warning. Black Box warnings issued by the FDA are reserved for drugs that can cause problems leading to death or serious injury. Drugs with the Black box, or “box warning,” carry warnings on the sides of their boxes, and those drugs are not permitted to use reminder ads. The drug warning labels are designed by the pharmaceutical company that actually makes the drug and must be approved by the FDA. BLACK BOX WARNING NEEDED ON LOW T DRUGS We believe there should be a Black Box warning on testosterone boosters after our review of recent reports of patients who have taken low T drugs and then suffered heart attacks and strokes. This should be a serious health concern for the over five million men in America who last year received prescriptions for testosterone products made by Androgel, Axiron, Testim, and Fortesta. Currently almost 13,000 prescriptions are filled for testosterone replacement drugs each day. Some recently published reports and studies show an increased risk of heart attacks and strokes. Ironically, studies funded by the drug industry showed no increased risk, collectively, compared to 14 independent studies which collectively showed a highly significant increase in cardiovascular risk. Yet currently, the FDA-approved labels on the drugs...
by Spencer Aronfeld | Mar 11, 2014 | Defective Drugs, Low Testosterone
Black Box warnings issued by the FDA are reserved for drugs that can cause problems leading to death or serious injury. In January, the FDA announced that it was investigating claims, in large part based upon reports of patients who have taken testosterone replacement drugs and then suffered heart attacks or strokes. In January the FDA issued a “Safety Announcement,” claiming that it is now monitoring the risks of Low T therapy to reassess its safety. This should be alarming news for the over five million men in America who last year received prescriptions for testosterone and who fill nearly 13,000 prescriptions a day for low testosterone, a condition that occurs when the testicles fail to produce testosterone because of genetic problems, injury, or chemotherapy. (Leer en Español) According to the medical literature, testosterone drugs should be used only by men who have a documented condition known as Low T, NOT simply as the anti-aging, sex-drive-increasing panacea depicted in hundreds of advertisements in magazines, on TV, and over the internet. Low T can be diagnosed only by a series of blood tests. Most people do not know that the warning labels on drugs are actually designed by the pharmaceutical companies that make the drugs; those labels must only be approved by the FDA. I am a lawyer who has sued drug companies for more than 20 years, and I believe, based upon these studies, that the FDA should now require Low T drugs to have a “Black Box” warning. As of today, the FDA has not required any Low T drug makers to change their packaging labels. FDA Testosterone:...
by Spencer Aronfeld | Mar 5, 2014 | Defective Drugs, Low Testosterone
Low T drugs are expensive, and they can be unnecessary and even potentially dangerous to take. As a lawyer who sues drug low T drug companies, I find it ironic that most costly prescription drugs, such as AndroGel, also happen have the largest advertising budgets. It is also how these drugs are marketed directly to men that troubles me. Full-page advertisements paid for by the makers or low testosterone drugs are found in men’s magazines. Similar ads pepper internet sports blogs, asking these kinds of intimate questions: “Have you noticed a recent deterioration of your ability to play sports?” “Do you have a decrease in sex drive?” “Do you have low energy?” Most men would say yes, although not to anyone other than to their doctor, which is precisely the aim of the ads. They encourage men (preferably those with good health insurance) to ask their physicians to diagnose them with a newly-minted medical condition called Low Testosterone or more commonly, Low T. One might conclude that Low T is a medical condition made up by drug companies in order to sell a product that was not needed, considering just how much Low Testosterone Drugs cost. According to a recent New York Times article, Axiron, a testosterone gel made by Eli Lilly & Company, retails for over $500 a month. That may explain why Abbott Laboratories, the maker of the Testosterone replacement drug AndroGel, spent nearly $100 million to advertise that product alone, just last year. Risk of Low Testosterone Gels: Are They Bad For You? Testosterone replacement therapy comes in many forms. Perhaps the most common is a...
