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The FDA has recently expressed concern about a certain group of medications called SGLT2 Inhibitors. This category of drugs includes popular prescription medications such as Invokana and Farxiga. Although these drugs have been, by all accounts, fairly successful when treating Type 2 diabetes. But they have produced their fair share of side-effects. Specifically, users of drugs such as Invokana are now reporting high levels of blood acid, the effects of which have landed some users in the ER.  While no deaths have been reported, there is no question that if these reports are accurate, these levels of blood acid could cause serious injury and death.  Accordingly, plaintiffs’ lawyers are investigating whether there is a connection between these drugs and these high acid levels and, if so, whether these drug makers knew about these risks and simply failed to inform patients and doctors.   If these dots are connected – and there is reason to think they might be – there are likely to be both serious injuries and lawsuits seeking compensation for those injuries.

The preceding paragraph was written some time ago.  In May 2017, there are 230 lawsuits pending in a federal MDL in New Jersey.

SGLT2 Inhibitors

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pills2New data suggests an association between melanoma skin cancer and Viagra. This has led many patients suffering from erectile dysfunction to question whether the benefits of this drug justify the risk of death that may accompany it.

If you or someone you love has developed melanoma while taking Viagra, you may have an injury or wrongful death lawsuit against Pfizer, who has never adequately warned patients and their doctors of this risk. If you believe you have a claim, call our lawyers for free at 888-322-3010 or get a free Internet consultation. We can discuss your options with you.

The Association Between Viagra and Melanoma

The understanding of the potential risks of melanoma with Viagra took flight in 2014 for the general public when Harvard Medical School released a new study showing that Viagra users were 84% more likely to develop melanoma skin cancer.

The study analyzed data from nearly 26,000 men and found that those who used sildenafil had an 84% higher risk of developing melanoma compared to non-users. However, it’s essential to note that this study showed an association, not a causal relationship. The researchers themselves emphasized that more research is needed to establish a direct causal link.

Since the publication of that study, further research has been conducted, and the results have been mixed. Some studies have supported the potential association, while others have not found a significant link between sildenafil use and melanoma risk.

It is important to note that correlation does not equal causation, and the increased risk observed in some studies may be due to other factors, such as lifestyle or sun exposure, rather than the medication itself. More research is needed to determine whether there is a direct causal relationship between Viagra use and melanoma risk.  Is it something that deserves a lawsuit?  No.  Should people continue to look into it.

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Testosterone supplements have found themselves in the news quite a bit lately. Unfortunately, for manufacturers, this is not good news. Because these lawsuits are on the fast track to being a very big deal.

There is a lot of research coming out with a sudden fury that suggests that testosterone treatments for men can cause an increased risk of heart attacks and strokes that can lead to serious injury and death.  A study published this week in the medical journal Plos One indicated that researchers found a two-fold increase in the risk of a heart attack in the three months after an initial prescription among men aged 65 years and older and a two to three-fold increase among younger men with a history of heart disease.  This is huge, especially considering millions of men are taking these hormonal treatments, and many are learning for the first time of the extent of the risk.

Products in this category are:

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painA Georgia federal jury ruled for the Defendant this week, determining that Mentor Worldwide LLC was not negligent in its design, manufacture, and sale of the ObTape pelvic mesh.

Also known as a vaginal sling, the Plaintiff was implanted with the ObTape in December 2004 to treat bladder prolapse and urinary incontinence.  Six months later, she was diagnosed with vaginitis and a doctor found that the mesh had extruded into her vagina.

She filed suit, claiming that the ObTape caused vaginal erosion and required surgical removal.  She further claimed that the pore size of the ObTape was insufficient to allow for the tissue to become integrated into the device.  She said the mesh created a propensity for infection and/or abscess, resulting in an unreasonably high rate of infection, abscesses, tissue erosion, and mesh extrusion.

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mirenaiudlawsuitMuch to the objection of Bayer Healthcare, Mirena IUD lawsuits at the federal level have been centralized into multidistrict litigation or MDL. The cases will be transferred to a U.S. District Court Judge in the Southern District of New York.  This makes the claim a mini-class action.  What does this mean?  The Mirena lawsuits are consolidated for discovery purposes.  They become one class case for a while.  If a global settlement of these Mirena lawsuits cannot be achieved, they will be sent back to their individual states for trial.

Last week, we told you that similar consolidation was being reconsidered at the state level, where more than 60 Mirena IUD lawsuits are currently pending.  Currently, there are only about 40 lawsuits in federal court, however, it is anticipated by some plaintiffs’ attorneys that several thousand cases will be filed by women who have experienced complications from Mirena IUD.

If you used Mirena and experienced complications, including surgical removal, infection, or Pelvic Inflammatory Disease (PID) and want to inquire as to whether you have a lawsuit, contact our Mirena defect lawyers at 1.800.553.8082, or online here.

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Should all transvaginal mesh products be recalled?

transvaginalmesh

Should we get rid of the vaginal mesh product completely?

It is a fair question. These products – and we see juries starting to prove this point – are a train wreck.  These companies – all of them, it seems – were chasing profits and ignoring the harm they were causing women.  It really is as simple as that.

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Pfizer’s lawyers took their best shot at winning these cases with the only strategy that will work: keep the cases away from a jury that will weigh the evidence.

This strategy took a hit on Tuesday when the MDL judge overseeing the 2,500 Chantix lawsuits in federal court shot down Pfizer’s motion to exclude the general causation and liability opinions of five plaintiff experts.

Judge Inge Prytz Johnson ruled that while Pfizer has interesting arguments, they are jury arguments, not “the expert should be excluded” arguments. I’m not sure a jury will be too impressed with hypertechnical attacks on these experts’ methodology as long as they swallow the big picture: these drugs put users at risk for homicidal and suicidal behavior that they would not have committed if there were not on the drugs. It is that simple.

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The idea of an MDL is to consolidate discovery, figure out what the cases are about, and whether they can be settled without a gazillion trials. So you do some discovery and, more often than not, you try a few cases and see if you can limit or even eliminate trials getting sent back to their home jurisdictions for trial.

But in any piece of mass tort litigation, the quality of the individual cases is going to vary wildly. There are a lot of reasons for this that are case-specific, but one value driver thread that runs through every case is the quality of the plaintiff. There is no question that juries are going to pay more (and may even be more likely to find liability) in cases where you have a plaintiff that the jury likes and respects. So that begs the question: which cases get tried first? Plaintiffs’ lawyers look for good facts with a Mother Teresa-like plaintiff and defendants look for confounding facts Idi Amin-like. This we know.

So which cases are chosen to go first? One of the authors of the defense-oriented Drug and Device Law Blog crashed the plaintiffs’ attorneys’ seminar, Mass Torts Made Perfect, and listened to what the judges who spoke there had to say. This was their summary:

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Novartis got successive wins last week in jury trials in Kentucky and Missouri, in the Zometa lawsuits. Plaintiffs in both cases alleged that Zometa caused osteonecrosis of the jaw (ONJ), which is just an awful condition that can lead to chronic pain and disfigurement. It is also difficult to treat.

The battlefield in both of the lawsuits, as is often the case in drug cases, was the adequacy of the warning. Novartis apparently convinced these jurors it had properly warned about the osteonecrosis of the jaw side effect that has come for thousands with intravenous bisphosphonate medications like Zometa and Aredia.

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Studies have suggested that taking statins, which are medications used to lower cholesterol levels, may increase the risk of developing diabetes, particularly in women. However, the overall risk of developing diabetes is still low and the benefits of taking statins, such as reducing the risk of heart disease, stroke and other cardiovascular events, typically outweigh the potential risks.

Statins, often called wonder drugs, are medicines taken to lower cholesterol levels. Zocor, Lipitor, and Crestor are the most popular of these medications that reduce the risk of heart disease and stroke. Tens of millions of Americans take these medications, but a recent study that followed over 150,000 women over the age of 50, with and without heart disease, found that those taking statin drugs had a 48 percent greater chance of developing type 2 diabetes. Doctors say that don’t know why statins increase diabetes and that the research does not implicate any single brand. These findings seem to confirm prior smaller studies.

Now, I’m not saying that anyone should panic and stop taking their medication since heart disease is one of the major complications of diabetes, but the risk is certainly something to consider and, ultimately, discuss with your doctor. Does the benefit outweigh the risk? It will depend on the patient.