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Researchers from Louisiana State University’s Health Science Center and Seattle Children’s Hospital were given a five-year federal grant by the National Institutes of Health (NIH) to study whether muscle power training exercises can improve the walking abilities of children with cerebral palsy (CP).

Is this exciting? It really is.  Anything that can advance the ball for people with cerebral palsy is wildly exciting.

How will this study be conducted?

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This page is about the Bair Hugger lawsuits that were filed claiming the product caused infections. But these suits did not go very far and I don’t know of any lawyers filing warning blanket lawsuits in 2021. Not all mass tort lawsuits work out and these Bair Hugger lawsuits certainly did not.

Let’s back up first to the start of this litigation.  I’m backfilling this first the original post…

As of September 2018, there are over 1,500 Bair Hugger warming blanket lawsuits pending in the MDL in Minnesota.

In one typical case, a New York couple claims that a surgical warming blanket used after the husband’s hip replacement operation caused severe infections, resulting in four additional surgeries. A man and his wife filed a lawsuit in New York on Nov. 25, 2015, against 3M, the manufacturer of the Bair Hugger forced-air warming system. Medical facilities commonly use this blanket during knee and hip replacement operations. In addition to 3M, the lawsuit lists Arizant Healthcare, Inc. and its subsidiaries as Defendants.

The value of surgical blanket lawsuits is still being determined

The value of surgical blanket lawsuits is still being determined, but many of these infection cases involve serious injury and death.

During the surgery on Oct. 24, 2012, medical personnel used a Bair Hugger on the man’s left hip, supposedly to help regulate body temperature. However, the warming blanket might have introduced bacteria into the surgical site, resulting in infection. Plaintiff received five surgeries within 16 months, including the original surgery, and he now struggles with mobility and needs crutches to walk.

Per the lawsuit: “Due to the infection, Plaintiff needed four additional surgical procedures to remove the implant and clean the infected area within sixteen months from the original implant surgery, and he continues to suffer limited mobility, requiring crutches to ambulate.”

According to diverse news reports, this Plaintiff is far from alone; many consumers across the nation have taken legal action after illnesses they’ve acquired after using the Bair Hugger, following hip and knee surgeries.

The Plaintiffs noted that 3M sent a letter to the FDA way back in June 1997, which warned of possible contamination issues with this product.

 

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Xarelto is a new-generation blood thinner that was initially approved by the U.S. Food & Drug Administration in October 2011.  Xarelto is intended to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis (DVT) and pulmonary embolism (PE). The drug is also to reduce the risk of recurrence of DVT or PE, and for prophylaxis of DVT for patients undergoing hip and knee replacement surgery.

This drug has made Bayer and Johnson & Johnson a fortune.  It has also left them as the defendants in 21,400 Xarelto bleeding lawsuits from patients or surviving families allege they have suffered gastrointestinal and cerebral hemorrhages, hemorrhagic strokes, and other types of bleeding issues that have caused injury or death.   Xarelto carries a significant risk of severe, and sometimes even fatal, internal bleeding – and there is no reversal agent available if serious bleeding occurs with Xarelto use.

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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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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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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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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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