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Much 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.

Should all transvaginal mesh products be recalled?

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.

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.

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:

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.

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.

Tylenol is one of the most commonly used drugs in the United States. The active ingredient in Tylenol is a drug called acetaminophen. Acetaminophen-containing products such as Tylenol are used by over 50 million Americans weekly to treat conditions such as pain, fever, and the aches and pains associated with the common cold and flu. If taken at recommended doses, Tylenol (acetaminophen) causes very few side effects; however, taking more than the recommended dose can cause severe liver damage, acute liver failure, and even death. Overdoses can result when patients accidentally take more than the recommended dose of Tylenol (or another acetaminophen product) or take over one acetaminophen-containing product simultaneously.

• The Tylenol class action lawsuit for autism is taking off in 2023

Liver Failure

Numerous studies have demonstrated that acetaminophen overdose is a leading cause of liver damage and liver failure in the United States. The FDA notes that “the extent of liver failure cases reported in the medical literature provides an important signal of concern.” The Agency also concedes that ingesting even a small amount of Tylenol (acetaminophen) over the recommended total daily dose may lead to liver injury. It even acknowledges that “currently recommended doses and tablet strengths of acetaminophen leave little room for error…”.

Widespread Use

In addition to Tylenol, acetaminophen is an active ingredient in over 600 over-the-counter and prescription medications. As such, individuals may inadvertently use over one acetaminophen-containing product at the same time. For example, acetaminophen is a common ingredient in many multiple-ingredient medications, such as Sudafed Triple Action™ and NyQuil. Someone who takes Tylenol for a headache and subsequently takes one of these combination medications to treat the aches and pains associated with the flu may unknowingly consume more than the recommended daily dose of acetaminophen.

Unclear Labeling

Further complicating the picture for consumers is that acetaminophen may be challenging to identify as an ingredient. Some prescription medications that contain acetaminophen label the ingredient simply as “APAP.” The lack of clear labeling may also lead consumers to accidentally ingest more than one product that contains acetaminophen.

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In September, Topamax lawsuits pending in federal courts throughout the country were consolidated in Pennsylvania. The lawsuits allege birth defects in children whose mothers took Topamax. This blog post discusses these suits. If you have an interest in discussing a potential Topamax lawsuit, call 888-322-3010 or get a free online consultation.

Topamax is an antiepileptic medication. It is often prescribed, off label, as a mood stabilizer for patients with bipolar disorder. Topamax lawsuits claim that birth defects such as cleft lip, cleft palate, genital malformations, and other birth defects in children were caused by their mothers taking Topamax (topiramate).

Topamax and topiramate (generic) are manufactured by several companies. The lawsuits allege that manufacturers failed to warn both the public and regulatory agencies about the potential for birth defects if used during pregnancy. To give you some idea of who the bad guys are in this story, consider this: Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals agreed to pay more than $81 million dollars in fines in 2010 for illegal promotion of Topamax related to off-label psychiatric use. History is replete with the choice of profits over patients.

Earlier this year, the FDA issued a warning and required label changes to list oral clefts as a possible side effect of its use during pregnancy. Risk is the highest if used during the first trimester of pregnancy. Data from the North American Antiepileptic Drug (AED) Pregnancy Registry show that infants exposed to antiepileptic drugs have a 0.38 to 0.55% prevalence of oral clefts, however, those exposed to topiramate have a 1.4% prevalence of oral clefts, nearly 3-4 times higher than other anticonvulsants.

Cleft palate is a condition in which the infant has a gap on the roof of the mouth which interferes with the normal functioning of the mouth including chewing and talking. To correct the birth defect, surgery is required. Surgery is generally required between 6 and 12 months of age and can take several surgeries, and years, to correct.

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The C.R. Bard Avaulta vaginal mesh lawsuits allege that mesh surgically implanted to treat pelvic organ prolapse may be defective. As a result, an unbelievable number of women are at risk for internal injuries and urinary problems.

The FDA recently expressed an even graver concern that the placement of surgical mesh through the vagina to repair pelvic organ prolapse may expose women to greater risks than other available options.

Bard Avaulta mesh lawsuits allege that the defective design of the mesh implant may increase the risk of infection, erosion, and other painful complications. Plaintiffs’ lawyers are bringing lawsuits against C. R. Bard, Inc., which makes and sells Avaulta Plus and Avaulta Solo synthetic surgical mesh tissue supports, and a host of other manufacturers.

These lawsuits are multiplying quickly. But there are a lot of women who are not going to bring a vaginal mesh lawsuit because they perceive a privacy invasion. This is understandable, but it underscores a general misconception about what a claim will entail.

These are national mass tort cases. Frankly, mass torts are rather impersonal and are handled by national lawyers – attorneys you likely will ever meet. Many vaginal mesh lawsuits have already settled for pretty decent sums of money – life-changing for many people. In many ways, it is about filling out some paperwork and waiting and you always have the option of just dropping your case if you don’t like where it is going in terms of your privacy or your need to be involved in the case.

Ultimately, some women will read the preceding paragraph and say “I don’t care, I’m not putting myself out there in any way.” I can’t really argue with this. I’m just trying to provide the full context to potential clients.

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A Chantix murder/suicide lawsuit has been filed in Pennsylvania alleging that Chantix caused a man to kill his wife and then himself. The victims’ families claim there was not an adequate warning that Chantix could cause this extreme level of aggressive behavior. Obviously, the claim is that Chantix was a causal factor in the murder-suicide.

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