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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.

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:

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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Last month, I took exception to a Drug and Device Law Blog post and wrote a semi snarly retort on the topic of the confidentiality of discovery documents.

Bad move. The Drug and Device Law Blog fired back a response pretty much took my post and beat me over the head with it. Adding insult to injury, they did it with good writing and good humor. I hate it when the bad guys are good and funny. It makes them seem almost human, an idea that fits in poorly with my worldview.

I thought they got some substance just dead wrong and there was lots of room for a good counterattack. But to find the time to write a cogent, witty response to rival theirs? They spit that response out in an hour; I bet. It would take me all day to come up with something and it still would not have been as well written.

Thankfully, my brother jumped in to stand up for me. My brother? Yes, for our purposes here, my brother. Justinian Lane stepped up and wrote the response I wanted to write (link since deleted, unfortunately). Even better, actually.

So instead of beating this topic any further, I’ll comment off-topic to the core issues in this debate and address another fascinating point Justinian makes about the economic disparity between plaintiffs’ lawyers and defense lawyers:

In DDL’s first post, they made a quip about plaintiffs’ lawyers buying Maybachs, and now they’re complaining that “plenty” of plaintiffs’ lawyers have private jets. While I don’t think that the authors of DDL are green with envy over the financial success of a few plaintiffs’ lawyers, plenty of their readership is. By and large, defense lawyers go to better schools than plaintiffs’ lawyers, earn better grades, write better briefs, and I’ll say it – are better lawyers. And they know it. It therefore irritates them to no end that lawyers who they perceive as being inferior to them are more financially successful than they are.

I don’t know that defense lawyers are better trial lawyers than plaintiffs’ lawyers in mass tort cases. Plaintiffs’ lawyers get more reps because, typically, plaintiffs’ lawyers have more trial experience. A lot of great mass tort defense lawyers can go a career without trying a case. I’m not saying they can’t do it effectively when called upon but, like with most things, experience counts. Pharmaceutical companies hire great trial lawyers but if cases are remanded all over the country, they don’t have as deep of a bench as plaintiffs’ lawyers.

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The Drug and Device Law Blog has an articulate rant about plaintiffs’ lawyers jerking around defendants on whether certain documents produced should be deemed confidential. The core of their argument is that plaintiffs’ interests in the battle over confidential documents are either for (1) sport or (2) to shop documents obtained in discovery to the press.

There is some measure of truth to almost the entire post. But it is as if Tiger Woods told the following story: “I was looking forward to a nice Thanksgiving weekend with my family but on Sunday my wife just left. Didn’t say goodbye or anything.” That’s a true story.

Similarly, the Drug and Device Law Blog leaves out a little fact of the story: mass tort defense lawyers are the undisputed kings of making plaintiffs’ lawyers work for pure sport. Plaintiffs’ lawyers in drug and device cases largely just want to get from Point A to Point B as quickly as possible. I think this is a function both of the personality types attracted to these very different jobs (and I’ve done both) and fundamental economics: plaintiffs’ lawyers get paid for success while defense lawyers get paid for working, even if they are just creating work.

Two contrasting Accutane lawsuit updates in the news today:

First, some background. Accutane is used to treat severe acne and has been associated with a host of problems: birth defects, inflammatory bowel disease, injuries to the liver, kidneys, nervous system, and pancreas, dermatological reactions, and even suicide. Roche stopped selling it last year after a 27-year run, citing competition from generics and the 5,000 pending Accutane lawsuits.

Plaintiff’s Verdict: $25.16 Million

In May 2007, Andrew McCarrell emerged victorious in a New Jersey Superior Court Accutane lawsuit against Roche Holding AG. Mr. McCarrell developed inflammatory bowel disease caused by Accutane. (View the full original trial on video, purchase required). That victory was short-lived, as the verdict was appealed and overturned because the trial judge should have allowed the defendants to present statistical evidence—that there were five million drug users.

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As you remember, Fosamax, Merck’s osteoporosis drug, is the subject of much litigation. The question presented is whether the drug causes osteonecrosis of the jaw, which is the death of jawbone tissue.

Judge Keenan, ruling over the federal Fosamax cases from his bench in the U.S. District Court for the Southern District of New York (Manhattan), decided that Merck was not entitled to dismissal of the Louise Maley case on the issue of specific causation (essentially, Merck argued that plaintiff could not prove that Fosamax caused her injury. This is different from general causation, which is the argument that Fosamax can cause injuries of this type). The plaintiff did not argue against the dismissal of her strict liability and warranty claims, however. Her case will proceed on a failure to warn claim. See the Order (hat tip: Shearlings Got Plowed). The Maley case will go to trial on April 19, 2010.

So, Plaintiff Maley survived where Bessie Flemings could not—Judge Keenan dismissed her case (set for trial this month) last November on specific causation grounds.

Remember Wyeth v. Levine, U.S. Supreme Court decision that held federal approval of labels drug warning labels does not preclude lawsuits under state law claiming inadequate warnings? Well, the government, through the FDA, has now added a final chapter to that story.

Facts of Wyeth v. Levine

Wyeth v. Levine was a landmark U.S. Supreme Court case that involved a Vermont musician named Diana Levine who had her right hand amputated after being injected with Phenergan, an anti-nausea medication made by Wyeth, a pharmaceutical company that was later acquired by Pfizer.