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MMsLogoThere is a recall of some ounce Theater Box M&M’s because they may be peanut butter M&Ms even though they are not marked that way.

What happened?  I don’t know.  The FDA says theater boxes labeled as “milk chocolate” actually contained “peanut butter” M&Ms.  Of course, peanut butter is not listed as an allergen on the outside box for regular M&Ms.
The boxes included in the recall were shipped to 30 states, including West Virginia, between May 8th, and July 1st of this year.  How long do theaters hold on to this stuff?  Who knows?

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testosteroneThese low T drug lawsuits have helped push the country towards taking a real look at the risks of these treatments and for me looking for a little fountain of youth.  It is sad that we need lawsuits to trigger a critical look at medical treatments that might be killing us, just like it is depressing that we need Adrian Peterson and Ray Rice to start a conversation about child abuse and domestic violence.  But not matter how we got here, it is good we are having the conversation.

This post will look at the FDA’s recent look at testosterone drugs and look at recent data indicating that Low T medications may increase the risks of catastrophic injuries, most notably heart attacks and strokes.  If you have a low T drug claim and want more information, we can do that for you in a very low stress, low pressure way.  Contact us online or call 800-553-8082.

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MirenaIUD

Mirena Lawsuits Gearing Up for Trial

With 600 Mirena IUD lawsuits already having been centralized in the federal MDL before Judge Cathy Seibel in the Southern District of New York, and over 1,000 more pending in state court, progress has been made to move toward trial in late 2015 (update: this has been revised to early 2016 – see below).

Does 2015 sound like forever from now?  It does.  But that is the way mass torts in the MDL proceed.  There is a lot of discovery we need to do to find out:

  1. What Bayer HealthCare Pharmaceuticals knew about the risks associated with IUDs in general and, specifically, with Mirena?
  2. Why didn’t the company do a better job of communicating the risks of uterine perforation and migration?
  3. What Bayer tried to do to make its IUD as safe as possible?
  4. Were profits the motive to avoid making the warning more clear?

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airbagThe mother of all recall was the Great Toyota Recalls of 2009-2011 when over 10 million Toyota vehicles were recalled for “unintended acceleration.”

Takata may have a more significant recall on tap for the problems it is having with its airbags.  Serious injuries and at least 2 deaths have been linked to these airbags, leading to a recall of a whopping 14 million vehicles manufactured by 11 different automakers between 2000 and 2011.

Now your first thought has to be relief because you are not driving a Takata car.  But that is the big difference between the Toyota debacle and this one.  This one involves a part supplier that made a component part for the vehicles.  So while you may not have heard of Takata, you have heard of Honda which was Takata’s biggest client.  That gets your attention.  Chances are, you or someone you love is driving a Honda. 

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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.

xareltoI’ve been watching The Wire again of late.  I thought of this exchange when I found out that in spite of 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 in spite of 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. Continue reading →

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lipitorJudge Gergel, the judge appointed to oversee the multidistrict litigation (MDL) for Lipitor diabetes lawsuits, is scheduled to meet with lawyers this week for a status conference.  Their focus will be on preparing a small group of cases for early trial dates, known as bellwether cases.

A bellwether case allows the parties to see what a jury will do with a “garden-variety, run of the mill” claim in order to determine where the stand.   Parties tend to see cases through rose colored glasses — we are do — so trying a few cases gets everyone more realistic.

There are currently about 1,000 product liability lawsuits filed in the federal court system, all involving similar claims regarding Lipitor side effects. Allegations include that Lipitor caused women to develop diabetes, and that Pfizer failed to adequately warn consumers of this risk.  But these claims are really just exploding.   By the end of this year, it is estimated that several thousand lawsuits will be pending by the end of this year.

Bellwether cases are often precursors for settlement talks; however, they aren’t expected to begin until at least next summer.  Though bellwether outcomes are not binding on any other lawsuits, they help facilitate negotiations in order to reach a Lipitor settlement agreement which may avoid the need for hundreds of individual trials to be held throughout the country. Continue reading →

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tuftsThere are a lot of differences between good hospitals and bad hospitals.  It is an all too common trope to claim that one thing encapsulates the differences between good and bad.  It is always more complicated than that one little thing.  That said, if you watch hospitals closely, it is amazing how often you see the best hospitals – the Mayo Clinic, Hopkins, the Cleveland Clinic – owning up to their own mistakes and trying to figure out new ways to conquer them.

Tufts Medical Center also appears to be on that list although maybe more reluctantly and with a bit more dragging of them then we might want.  Specifically, Tufts is attacking a problem that causes malpractice that last November, unleashed hospital and government inquiries that have led to widespread safety improvements in Tufts operating rooms this year and highlighted medical errors involving “cognitive bias” — an area of growing interest among researchers. Continue reading →

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shutterstock_138095450Drug induced liver injuries can develop following the use of a wide range of drugs, including over-the-counter drugs like Tylenol and Hydroxycut, and prescription drugs such as:

  • Levaquin
  • Strattera
  • Nizoral
  • Propylthiouracil
  • Pemoline
  • Felbatol
  • Tasmar
  • Zyflo

As we will talk about below, not all of these drugs are bad drugs.  There are many conditions for which the risk of the underlying condition makes the liver injury risk acceptable.  But, for some drugs, they never should have been put on the market because they were not properly tested to determine whether there was a risk of injury to the liver.

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gelFor 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 concern, the FDA has now stepped in and asked two of its advisory committees to evaluate the potential heath 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 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 takings something and your problem goes away and then it reappear when you use it again, there is like 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 the committees to evaluate the risks and make recommendations about the potential cardiovascular risks with use of the popular “Low T” drugs.  

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surgicalinstruments2Everyone 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 me 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 follow 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 is 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 have 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.

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