Testosterone products, prescribed to treat low testosterone (“Low T”) in men, have become popular among young men seeking physical enhancement, as well as older men who want to counter signs of aging. Research, however, shows that low testosterone treatments may double the risk of heart attack for young men with heart disease as well as for men 65 years of age and older, even those who have had no heart problems. Is it worth the risk if not medically necessary? The FDA says no.
Depression treatment is essential. This is especially true during pregnancy. Untreated depression can have harmful effects on both the mother and the baby. But we are learning more about the use of antidepressants and the increased risk of problems for the baby. We keep wondering: WHY DIDN’T THE DRUG COMPANIES KNOW ABOUT THESE RISK SOONER?
A recent study supports prior findings that women who use Zoloft during pregnancy are at an increased risk of giving birth to an infant with birth defects that could include severe heart or cranial malformations. According to findings published last month in the American Journal of Obstetrics & Gynecology, the use of Zoloft may increase the risk of atrial and ventricular defects by more than 30%, and more than double the risk of craniosynostosis.
As the fight against Bayer and Johnson & Johnson over the controversial drug, Xarelto, wages on, Pennsylvania has organized claims floating around state courts into a mass tort. The anticoagulant (blood thinner), which has already been linked to bleeding and in some cases death, has prompted at least 70 individual suits in Pennsylvania, each claiming that the drug’s manufacturers didn’t warn users about the risks associated with the drug. While Xarelto does its job as a blood thinner, the main concern is that this drug never stops doing that job, and there is no antidote on the market to reverse the effects should a user ever need that to happen. Considering the sheer volume of cases piling up on Pennsylvania’s dockets, the Administrative Judge (judge in charge) of the Court of Common Pleas of Philadelphia, streamlined proceedings into a “mass tort.”
With roughly 300 complaints currently pending before U.S. District Judge Mathew Kennelly, and several thousand expected to be filed before all is said and done, Judge Kennelly of the Northern District of Illinois has appointed four testosterone drug attorneys to serve as liaisons with state courts where dozens of additional cases are pending. In an effort to increase coordination of the litigation, the role of the state-federal court liaisons will be to promote better coordination for the rapidly accumulating host of testosterone lawsuits being filed.
Avelox can cause peripheral neuropathy within days of use. This condition is a type of nerve damage. It is extremely serious. It can cause muscle weakness, numbness and pain that can potentially last a lifetime. We are rapidly learning more about the connection between Avelox and neuropathy and it is leading to lawsuits. If you believe you have a potential claim, call us at 800-553-8082 or get for a free online consultation.
Low testosterone levels have been linked to fatigue, muscle and bone loss, and a decrease in libido. If you are over 35 and these things are hitting you… well, it sucks. But, all too often in 2018, the cure is worse than the original disease. There is a lot of good science out there suggesting that these therapies increase the risk for cardiac injury in a group already prone to heart disease. A lot of lawsuits have followed. This article explains where these class action lawsuits are now and what plaintiff can expect moving forward.
The Premise of These Cases
In January 2014, the Food and Drug Administration (FDA) announced that it was investigating potential testosterone therapy risks. This was prompted after several studies suggested that the side effects of testosterone treatments may increase the risk of heart attacks, strokes, blood clots, and death. The risks may be as much as double for a heart attack in young men with heart disease as well as for men 65 years of age and older, even those who have had no heart problems. Additional concerns with the products include the increased risk of deep vein thrombosis (DVT) which can lead to life-threatening complications including pulmonary embolisms. DVT is where the body develops blood clots in the deep veins, most commonly in the legs. These blood clots can break off and travel through the body resulting in potentially life-threatening complications.
The first lawsuits were filed four days after the FDA announced its investigation. Is that a little too soon? Probably. Does it underscore the idea that lawyers are vultures? Absolutely. But all of this, as I talk about below, distracts us from the real issue: are low T drugs killing people?
Good deal for plaintiffs? Not so much. This comes out to a little over $40,000 a case. Most of the women in these complaints have suffered real injuries with organ damage. So you get painful and often debilitating complications from these surgical mesh implants and you get $40,000? What on earth is happening here besides C.R. Bard’s stock price shooting up after the announcement?
The Method to the Madness
I think C.R. Bard is playing a little psychology trick. It is smart, and it just might work a little unless the victims and their lawyers are smart.
If you ask the average vaginal mesh victim how much they expect to get in a settlement, the numbers would range from a few thousand dollars to millions. No one is given any guidance on what the values of these cases are, or even the ranges of values. Lawyers talk themselves into circles when asked about the settlement value of the case. No one wants to give a straight answer because no one wants to be wrong. If you were to guess the outcome of the average settlement of a mass tort case from the beginning, you would probably be very wrong. I like tracking the pay-per-click costs of drug injury cases. They make the stock market seem stable. The expected values of these cases rise and fall and rise and fall and where it stops, no one knows.
Malik ‘Poot’ Carr: It’s a cold world, Bodie.
Preston ‘Bodie’ Broadus: Thought you said it was getting warmer, man.
Malik ‘Poot’ Carr: World going one way, people another.
I’ve been watching The Wire again of late. I thought of this exchange when I found out that despite the Xarelto lawsuits being filed and the massive number of television commercials you are seeing from personal injury lawyers talking about the risks of Xarelto, Johnson & Johnson and Bayer intend to move forward with plans to push the FDA drug for additional uses. This comes despite all of these excessive bleeding lawsuits and the fact that the FDA has already shot down these attempts on three separate occasions. The litigation (and justice?) world is going one way, the business people at these drug companies are going another.
The game plan to conduct three studies to investigate the efficacy and safety of Xarelto in people who have had an embolic stroke of undetermined source, people with peripheral artery disease undergoing peripheral artery interventions, and individuals who have had an acute coronary syndrome.
Note: There is an important January 2015 update below.
For months, we have been talking about the increasing concerns over testosterone replacement therapy and the accompanying potential side effects, a topic that was buried under a rug for years because no one ever told us about the risks. In light of all the recent concerns, the FDA has now stepped in and asked two of its advisory committees to evaluate the potential health risks.
A joint meeting of the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee has been scheduled for mid-September. The hearing, announced just days after the Canadian drug regulators announced that they had completed their own review (the FDA always seems to be a step behind), found strong links between testosterone drugs and heart problems. It was determined that some of the cardiovascular problems disappeared after the use of the testosterone drugs was stopped, only to return once the product was used again. Sometimes science can be real complicated. But our intuition on this holds scientific water: if you stop taking something, your problem goes away. But if it reappears when you use it again, there is likely to be a connection.
The FDA launched its investigation in January after several studies suggested that men using the Low T treatments may face an increased risk of heart attacks, strokes, and sudden death. The FDA is looking for committees to evaluate the risks and make recommendations about the potential cardiovascular risks with the use of the popular “Low T” drugs.
Everyone now agrees that power morcellators as used now are not safe because they increase the risk of cancer in women. Experts at the FDA disagree as to whether or not they should be banned or continue to be used, but with stronger warnings.
The question is simple: should we ban morcellators and pull them off the market? An FDA panel of independent advisers met last week in Bethesda, Maryland to discuss exactly this. The experts were split as to whether the medical devices should be banned outright, or whether the option should still be made available, with informed consent.
Let’s back up. What’s all the concern about?
The history here is stunning. In December of last year, the FDA and, let’s be honest, most of the world has been sleeping on the issue of whether these morecellators can spread cancer that otherwise might have laid dormant. Five months later, in April 2014, the FDA issued a statement urging doctors to stop using power morcellators for uterine fibroid removal and hysterectomies.
As someone who follows the history of how the science unfolds in mass tort medical device cases, the speed of this discovery of what has always been there to be seen was breakneck. Yet it was in front of the FDA and morcellator manufacturers’ faces all along: these morcellators are cancer spreaders.
How so? Doctors have no way to know whether the fibroids they are breaking up with a morecellator have cancerous cells. It is estimated that one in 350 women who undergo uterine fibroid surgery have unsuspected sarcoma contained within the uterus, while another one in 400 has the even deadlier, leiomyosarcoma (LMS). These cancer cells can be hidden inside of the uterine fibroids. If a fibroid contains cancer cells, the cutting of the uterus with the power morcellator will cause cancer cells to spread throughout the peritoneal cavity, posing an extremely serious risk to a woman’s health. The spreading of these cells can quickly ignite the spread of the cancer.