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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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penncourtHere are some interesting malpractice statistics in Pennsylvania for 2013:

  • Doctors won 77% of the medical malpractice cases that went to a jury trial. In fact, there is not a single jurisdiction in Pennsylvania where the plaintiff had a winning record in 2013.
  • 1,546 health care negligence lawsuits were filed in Pennsylvania in 2013.  In 2012, the number was 1,510.  Putting this in context, this is down 43% from 2000-02.  Philadelphia, long considered to be the plaintiffs’ home field in Pennsylvania, filings are down 68% from 2000-02.
  • Speaking of Philadelphia, defendants won more cases than they lost.  Twenty medical error cases went to trial in 2013.  Plaintiffs won 9 of 20.  In 2012, malpractice plaintiffs won 11 of 20. So over the last two years, winning a malpractice case in Philadelphia is statistically a coin toss.
  • There were 6 verdicts in excess of $1 million in the state of Pennsylvania.  There were no verdicts over $5 million.
  • More than half of Pennsylvania’s jurisdictions (34 of 61) had no malpractice verdicts in 2013.
  • Plaintiffs did better in bench trial where the trial judge decides liability and damages, winning 60%.  This is a small sample size (3 of 5) but it underscore

What does this tell you about the value of your own medical malpractice case in Pennsylvania or anywhere else?  Absolutely nothing.  First, you have to keep in mind that the majority of medical malpractice cases settle.   The cases that do go to trial usually go to trial for idiosyncratic reasons.

The door swings both ways on the why this case went to trial.   Sometimes it is because the plaintiff demands to go to trial regardless of the settlement offer or the plaintiffs’ attorney has no clue how to value a case.  Conversely, cases go to trial because the doctor refuses against all logic to agree to the settlement (which can have a persuasive or binding effect depending on the jurisdiction) or the insurance company refuses to see a case clear.   We have had a lot of zero offers in cases where we have gotten millions.   You can’t tell me the settlement value of those cases was zero.  But these insurance companies are not always rational in their approach.

If you cannot rely on jury verdicts to value your case, what can you rely upon to assist you in predicting the trial or settlement value of the case.  On our website, we offer a lot of case summaries of our cases and claims, pursued by other lawyers in different types of medical malpractice cases, that includes both settlements and verdicts.  I think settlements are a better predictor of case value than verdicts.

Then again, those too are impossible to use as a good guide.  There are facts about the case you don’t know, jurisdictional differences you can fully appreciate, and the fact that one side may have dramatically undervalued or overvalued the case.

So what do you do if you are desperate to better understand the value of your case, whether you’re a victim or a lawyer with a case?    I think you look at everything you can.  You do look at jury verdicts and settlement statistics and other cases with the same injuries (or wrongful death).  You are not going to get a value.  But you might be able to piece together a range.

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Xarelto, part of a new generation of anticoagulants, is a prescription medication used to reduce the risk of stroke and blood clots.  It is currently at the center of a new lawsuit filed by the wife of a man who died due to uncontrollable bleeding.  This is just the latest of a rapidly growing number of Xarelto bleeding lawsuits that are currently being filed through the country.   

What is Xarelo and what is the problem?

Xarelto, introduced in 2011, is a joint venture between Bayer and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary. Kind of like Big 3 of the Miami Heat coming together.  But in this case, the goal was not championships but to make gobs and gobs of money.  Intended to replace warfarin (Coumadin), Xarelto has been promoted as superior to warfarin and others like it, because it is easier to take and requires less frequent monitoring to maintain the correct dose.  The downfall?  First it cause excessive bleeding.  Second, there is no good reversal agent or antidote to stop bleeding should an event occur.  While Bayer and Johnson & Johnson have indicated that they are working with a company to develop a reversal agent for Xarelto, there is not one currently available, making the drug unreasonably dangerous and defective.

This latest lawsuit claims that Johnson & Johnson never adequately warned that there was no reversal agent, while competitor medications, such as Warafin, have an antidote to stop bleeding events.  Other lawsuits filed additionally allege that these individuals suffered severe and often fatal injuries as a result of uncontrollable hemorrhaging while taking Xarelto. Some further allege that the benefits provided by the medication do not justify the risks associated with the medication, and that the drug should be recalled.  

In addition to the side effects reported in adverse event claims to the FDA, allegations in pending lawsuits include:

  • Death due to uncontrollable bleeding
  • Brain hemorrhaging
  • Rectal bleeding
  • Intestinal bleeding

Another great concern is the fact that, even after numerous reports of bleeding events that could not be stopped, Xarelto still does not have a “black box” warning – a type of warning that can appear on the package insert of a medication.  The FDA requires pharmaceutical companies to place these boxed warning on the label or literature describing the medication, when a drug carries a significant risk of serious or even life-threatening adverse effects.

Contact Us

If you have suffered from serious complications of Xarelto such as internal bleeding, or you have lost a loved one or relative as the result of the medication, an attorney can help to determine if you have a potential claim, or if you are entitled to file a wrongful death lawsuit. The time to file a claim is often limited, so it is imperative to act now before the statute of limitations expires in your area.  Contact one of our Xarelto lawyers at 800.553.8082 or online, here.

 

 

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We’ve told you a lot over the past few months about the medical concerns linked to testosterone or “Low T” drugs.   The FDA has now woken up from its slumber on this and is now requiring the manufactures of AndroGel and other testosterone replacement drugs manufacturers to add new warnings about the link between the medications and potential blood clots, including DVT (deep vein thrombosis), pulmonary embolism, or VTE (venous thromboembolism).  If you have been following for this at all, this comes as no surprise.  This was predictable as a new crisis in Kim Kardashian life.  

WHY THESE CASES WILL NOW BE EASIER TO SETTLE

What does it mean?  Well, it is going to make settling these cases a lot easier. Why?  Now we have a new warning.  I’ll bet these cases eventually get divided for settlement purposes in cases where the injury was before the warning and cases where the injury was after the warning.

But why are the settlements going to be easier now?   Okay, sorry.  That was the question.  Settlements will be easier because they don’t need to defend the old warning anymore from a marketing standpoint.  It is really tough to settle cases with the old warning because then you are just inviting new lawsuits for every new injury (or death, of course) case. Now, they can wipe the slate clean when these case eventually do settle.

TESTOSTERONE THERAPY – WHAT’S IT ABOUT?

Testosterone is a hormone that is produced primarily in the testicles and is essential to the development of male growth and masculine characteristics. Production peaks during adolescence and early adulthood, and then drops slightly each year after that. Testosterone plays a key role in the creation of muscle mass and strong bones. While approved for those men diagnosed with hypogonadism, low testosterone levels, many have sought a prescription for a little extra boost and increased sex drive….but, is it worth it?  The answer is probably yes for most of us if there is no possibility of downside risk.  If there was no trade-off, there really would be no reason not to give this stuff a try and see if it makes you look/feel/act a little bit younger.  There are like 5% of us over 40 who are not shooting for this.  But, if there is real risk, the vanity exercise is not work it for most of us.   So all these companies had to do was give us a real choice.   Why didn’t they?  Well, we can’t speak for one of them much less all of them.  But let’s be creative here for a second.  What would happen to sales if everyone knew of the risks of this therapy?  That whole trite “follow the money” thing  always annoys me.   But, you know, follow the money.  Because it is the most likely reason why this information was not provided to us a lot earlier. 

NEW WARNINGS

The new label warning changes the existing blood clot warning from one linking the problem to polycythemia to a more generalized venous thromboembolism warning.  VTE are blood clots that occur in the veins, which can lead to painful clots in the legs, clots known as deep vein thrombosis.  The VTE can also break off and flow to the heart and lungs causing a potential pulmonary embolism, which is often fatal.  The new warning notes that these blood clots appear to be a different problem than those causing the testosterone users to suffer heart attacks and strokes.

LEGAL BATTLE – CURRENT STATUS

The newest FDA concerns come just after it was announced earlier this month that all testosterone drug lawsuits filed in federal courts would be consolidated into a multidistrict litigation (MDL), for the purposes of pretrial proceedings.   The new warning and this development are likely to be the keys to getting these cases resolved when we look back on this litigation years from now. The low T drug lawsuits are primarily filed against makers of AndroGel, but also involve claims against Axiron, Testim, Foresta, AndroDerm, and Depo-Testosterone. No doubt that while all current suits involve common allegations that the medications caused plaintiffs to suffer heart attacks, strokes, blood clots, and other cardiovascular injuries, future suits will certainly include those with claims of venous thromboembolism.  

CONTACT US

If you or a loved one has been hurt or killed from testosterone therapy treatment, contact us for more information and to find out your rights.  You may be entitled to monetary compensation.  Contact us today at 800.553.8082 or online here.

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TestosteroneAll product liability lawsuits involving injuries associated with the use of any testosterone replacement therapy (TRT) will now be centralized in the Northern District of Illinois before Judge Matthew F. Kennelly.

A panel of federal judges has ordered the lawsuits to be centralized as part of an MDL, or multidistrict litigation, in order to reduce the risk of duplicative discovery, avoid conflicting rulings from different judges, and to serve the convenience of parties, witnesses and the courts. The ruling currently affects approximately 45 lawsuits, however any future cases filed will be transferred to the MDL. Plaintiffs are suggesting that the total number of cases we be in the thousands.  So many people have taken this stuff and suffered and injury or died and they (or their survivors) don’t even know that this may have been the cause of the injury/death.

Is it a class action?  For all practical purposes, it is a class action for discovery and, hopefully, settlement.  The cases are consolidated as the plaintiffs’  attorneys get information that can be applied to all cases.  At this point, both parties should understand the strengths and weakness of the case and be able to make a reasonable settlement offer.

 What’s all the fuss about?

According to the research, men with signs of heart problems such as high cholesterol, plaque buildup, and artery blockage are at a risk of being 30% more likely to suffer from a heart attack, stroke, or even die while undergoing Low-T Treatment. Also affected are young men with pre-existing heart disease.  The problem is that everyone and their brother who is over 40 was taking this stuff and there were no warnings to let people know the risk they were taking.  That is lack of notice is the crux of these lawsuits.  Why didn’t they provide a warning?  Good question.  A warning tells people they might not want to take this product if they really don’t need it.  Now, what percentage of people do you think really needed to take this stuff?   I’m suggesting to you that the vast majority took testosterone replacement therapy just because they wanted a little boost of youth.    Who wouldn’t?  I’m sure I would have tried it if I had ever gotten around to it.  But if you know of the risk, are you really going to want that boost?   So if you tell men, this stuff might kill you, sales would have plummeted (which is exactly what we are seeing now that the cat is out of the bag).  Lost profits equals lost money equal careers that don’t jump top floor… it is not hard to see what happened here.

Who’s involved and what’s being claimed?

The low T drug lawsuits are primarily filed against makers of AndroGel, the most widely used testosterone treatment, but also involve claims against Axiron, Testim, Foresta, AndroDerm, and Depo-Testosterone. All suits involve common allegations that the medications caused plaintiffs to suffer heart attacks, strokes, blood clots, and other cardiovascular injuries.

Various options on how to manage the mounting low T drug lawsuits were proposed to the panel of judges who ultimately ordered the MDL. While some of the plaintiffs and many defendants wanted all of the testosterone cases to be centralized as part of one proceeding, others called for only AndroGel lawsuits to be included in the class action MDL.

Who’s involved and what’s being claimed?

The low T drug lawsuits are primarily filed against makers of AndroGel, the most widely used testosterone treatment, but also involve claims against Axiron, Testim, Foresta, AndroDerm, and Depo-Testosterone. All suits involve common allegations that the medications caused plaintiffs to suffer heart attacks, strokes, blood clots, and other cardiovascular injuries.  There are many claims but the gist of it is what we already talked about above: the failure to warn people that this stuff could cause serious injury or death.

Various options on how to manage the mounting low T drug lawsuits were proposed to the panel of judges who ultimately ordered the MDL. While some of the plaintiffs and many defendants wanted all of the testosterone cases to be centralized as part of one proceeding, others called for only AndroGel lawsuits to be included in the MDL. Reality is that a number of plaints have used more than one testosterone replacement therapy. The panel, while admittedly hesitant to centralize litigation on an industry-wide basis, thought it was the best solution in this matter.

Contact us

Our attorneys are now reviewing potential lawsuits against these companies, alleging that they knew that the risks greatly outweighed the benefits for many patients and that they failed to adequately warn doctors and patients of the potential risks. If you believe you or a loved one has been adversely affected the use of a low testosterone drug, contact our attorneys at 800.553.8082 or online here.

 

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viagraIf you want an erection, Viagra seems to work. Over 23 million men a year can’t be wrong.  It is easy to joke about but it is obviously a great thing for many men.  But for the last 16 years since Viagra received FDA approval in 1998, we have been trying to figure out what side effects Viagra has.  Because people have a right to balance their desire to keep an erection – and also consider the other drugs they might use – and the medication’s side effects.   We have heard lots of discussion of  vision-threatening complications and hearing loss.  Now there is a new deadly concern:  melanoma.

Sildenafil citratre, more commonly known as Viagra, is used to treat erectile dysfunction (ED) by relaxing muscles and increasing blood flow to particular areas of the body.  Now, in a study recently published online in JAMA Medicine, it has been reported that men who have used Viagra for ED had a significantly elevated risk of melanoma.  Melanoma, the most dangerous type of skin cancer, is the leading cause of death from skin disease.  While melanoma accounts for less than 2% of skin cancer cases each year, it makes up the majority of skin cancer fatalities.  

The study, involving researchers from Harvard and Brown Universities, compared the medical charts of 26,000 men to see if cancer rates differed among those who took Viagra and those who did not.  The study revealed that men who had taken Viagra for erectile dysfunction had double the risk of developing melanoma than men who had not taken the drug.

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