Articles Posted in Featured Lawsuits

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hipreplacement

Stryker hip settlements are being reached

Settlements are being reached in more Stryker Rejuvenate hip replacement cases filed in New Jersey state court.   More resolutions of these cases are likely to be imminent.

The first phase, a group of 10 cases previously selected for early mediation, has resulted in the conclusion of all 10 cases.  Additionally, at least two cases from the second phase have resolved.  This is a harbinger of broad agreements on the remaining cases, not only for the 950 cases pending in New Jersey state court but also for the cases pending in the MDL class action.

What are the Stryker Claims About?

Stryker Rejuvenate hip systems were removed from the market less than two years after the design was introduced. While originally designed to last 15 to 20 years, they began to fail immediately.   So that was the first problem.  The second problem is that the Stryker initially did little to try to cure the problem.

What was the complication with this device?  Consisting of modular neck-stems with two pieces that fit inside of each other, they were designed to allow the surgeon to customize the length of the femoral component.  Traditional hip implants consisted of a single femoral component.  So you can see how this was an innovation.  Why did it so epically fail?   What happened was the rubbing of the neck and stem can releases microscopic metal debris into the body as the chromium-cobalt neck rubs against the titanium femoral stem.  In simpler terms, the debris is caused by the micro motion of the metal joints rubbing in the artificial hip.  That’s not a good sign – or, a good product.
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johnson

$1.2 Million Verdict

After almost two weeks of testimony, a Texas jury has awarded $1.2 million in damages to a woman who suffered severe and debilitating injuries after receiving Ethicon TVT-O transvaginal mesh to treat stress urinary incontinence. Ethicon, a subsidiary of Johnson & Johnson, has indicated that they plan to appeal. They always do.  But one thing is clear: juries looking at these cases are not happy with Ethicon or the other vaginal mesh manufacturers.

While finding the Ethicon TVT-O sling to be defective, the jury did not find that the manufacturer’s actions rose to the level of gross negligence.  As such, the jury declined to levy additional punitive damages designed to punish the manufacturer for their failure to warn consumers and the medical community.  So, in some ways, you can say that getting hit with a $1.2 million verdict was dodging a bullet for Ethicon.

As I’ve continued to say, these bellwether trials tells us about the value of these claims for the rest of the class.  So what are juries telling us?  They are telling us these cases are worth a lot of money.  The big risk for Ethicon at this point is that the class of victims- and their lawyers –  are seeing these verdicts it is driving up the price of tea in China.

The reality is the while plaintiffs are not going to win all of these cases, there are going to win the vast majority.  For reasons that completely escape me, these manufacturers have been willing to test the waters and

What is it all about?

Although the mesh was designed to be implanted to support a failing organic tissue lining, it often eroded itself. The FDA states that some of the common symptoms of a defective vaginal mesh are:

  • Mesh erosion through the vagina
  • Urinary complications
  • Pain (particularly during intercourse)
  • Organ perforation
  • Infection
  • Bleeding

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There  1,300 Zimmer NexGen knee product liability lawsuits are pending throughout the country.  Countless more victims are waiting on the sidelines (maybe to soon lose their rights because of the statute of limitations).   The progress on these cases in recent months can best be summarized by “well, they are coming along.”  Now, at least, there is a more concrete plan to move this litigation forward.

On March 24th, Judge Rebecca R. Pallmeyer, the judge overseeing all of the consolidated federal cases pending in the U.S. District Courts, identified six cases that will be part of the “initial tranche” of Zimmer NexGen bellwether trials. A bellwether trial are test cases that allow the parties to see what a jury will do with a claim that is typical of the class.  Why?  So the parties can get a better idea of just what the value of the cases might be.   These are called bellwether cases, often precursors for settlement talks, are expected to begin in 2015.

First introduced in 1995, NexGen Complete Knee Solution System was one of Zimmer’s most successful knee products.  In 2001, Zimmer attempted to capitalize on the success of this product line by releasing a modified version of the original design, the NexGen Flex line of products, designed to achieve 155 degrees of flexion.  Most components were approved without extensive trials or FDA investigation into their safety through the 510K fast-track approval program.  This FDA program allows medical devices to enter the market without requiring manufacturers to conduct clinical studies. Instead, the manufacturer must only demonstrate the device is substantially equivalent to other similar products already on the market. So the actual product that goes into a patient’s knee is not tested like these medical devices should be tested.

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lipitorThe lawyers involved in the federal Lipitor litigation are scheduled to meet this week, in order to discuss the structure and organization of the recently formed Lipitor MDL,.  This is a standard part of any mass tort cases.  The judge is going to work with the parties to figure out how these lawsuits should best proceed as quickly and efficiently as possible.

Getting to this point took some doing.   At first, a panel of federal judges previously denied plaintiffs’ lawyers first attempt to consolidate all of the Lipitor diabetes cases into a class action.  Thankfully and correctly, the judges changed their mind last month.  What flipped them?  One simple thing: these cases are being filed now in massive numbers.

This MDL centralizes the management of the federal Lipitor cases filed by women – just women – who allege the drug maker failed to adequately warn about the risk of diabetes from Lipitor side effects.  Is this a class action suit?  Yes and no.  The MDL make the cases a “class action for a while.”  The parties conduct pre-trial discovery on issues that are central to all of the cases.  After effort to reach a settlement – and perhaps the trial of a few cases – the cases would head back to their home jurisdictions.   The hope, for plaintiffs and for Pfizer I suspect, is that these cases are settled long before we get to the point where these cases are remanded to their home jurisdictions.  

Today, more than 250 lawsuits have been transferred to the U.S. District Court for the District of South Carolina.  I think there will be several thousands of cases filed before this is over.  Continue reading →

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Cases gear up for Summer 2015 trials

Cases gear up for Summer 2015 trials

With more than 600 Stryker Rejuvenate hip cases centralized as part of an MDL in the federal court system [more on the MDL process], U.S. District Court Judge Donovan Frank has indicated that a small group of cases will be ready for trial in Summer of 2015.

This small group of cases, known as “bellwether” cases, are scheduled for early trials designed to get some preliminary data on how juries react to the cases, so that the parties can make informed decisions on settlement.  This is crucial towards moving the litigation forward and ultimately towards resolution.  Cases don’t settle because the parties disagree on the value of the claims.

Trying a few cases helps everyone take an honest look at the merits and the value of the cases.  Practically, many medical device companies have in-house counsel that tries to brainwash the real people making the decisions that plaintiffs’ claims can be defended.  Then you have the defense lawyers who are making plenty of money and have every interest in seeing the cases go on.   I think if the Stryker higher ups see a few verdicts, they are going to stop listening to their in-house counsel and their outside lawyers because the juries will be speaking loud and clear.

So the only really bad news for plaintiffs is that the trials don’t begin until 2015.  There is no arguing with the fact that justice is painfully slow in these cases.

In addition to those cases filed in federal court, there are at least 873 cases pending in New Jersey state court, with additional claims filed in Florida state court.  In New Jersey, all of the Stryker hip lawsuits have been centralized before one Superior Court judge as part of a Multi-County Litigation (MCL).  MCLs consolidate the cases for discovery purposes, as there are similarities between the underlying cases such as witnesses and evidence that will be common to all of these Stryker hip lawsuits. 

Last year, a mediation process was established in an attempt to see if the Stryker Rejuvenate cases could be settled.  At least eight of the nine cases that have gone to mediation have agreed to settle. Continue reading →

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shutterstock_140317615In an old post, I told you that we  are seeing more and more legal claims alleging Risperdal and Invega are causing young men to grow breasts.  The findings of a recent study appear to confirm just that.  Findings were presented at the American Association for Geriatric Psychiatry (AAGP) meeting this month that indicate that males using Risperdal have a significantly higher risk of developing unnatural breast growth, known as gynecomastia, as compared to those who have not taken the drug.

Dr. Mahyar, a pharmacoepidemiologist at the University of British Columbia presented the recent findings, and stated that, “The strength of this study was its large sample size that allowed us to quantify this rare adverse event.”  He concluded that doctors may want to prescribe Seroquel or Zyprexa to male patients instead of Risperdal or Invega.

Risperdal is an atypical antipsychotic medication that was originally introduced for adults with schizophrenia.  But, Risperdal has been widely used by children for bi-polar disorders, autism, irritability, aggression, and behavior disorders.  Risperdal increases the level of prolactin in young men who use the drug.  Prolactin is a hormone that stimulates breast growth.  Researchers found a 69% increased risk of gynecomastia among users of Risperdal and Invega.  When compared to individuals who used other atypical antipsychotics that are part of the same class, the risk was still 41% higher than Seroquel users, and 40% higher than Zyprexa users.

In addition to the obvious physical damages, plaintiffs have alleged the psychological effects of Risperdal breast growth can have a devastating impact on the boys’ overall quality of life.  Many plaintiffs have required breast removal surgery, with some that have developed breasts measuring as large as a 38D cup size.

This is not the first time that these medications have been under fire, and linked to potential lawsuits.  A number of studies have found that children who take antipsychotic and/or second-generation antipsychotic drugs (Seroquel, Risperdal, Zyprexa, Abilify) have an increased risk of developing type II diabetes. Continue reading →

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Testosterone

Public Citizen calls for Black Box Warning

Do the health related risks – specifically the cardiac risks – of testosterone replacement therapy necessitate a “black box” warning?  Consumer rights advocacy group Public Citizen thinks so.   This is a big deal because Public Citizen has been out in front on so many bad medicines over the last 30 years long before the FDA figured it out.

Black box warning, the strongest warning that the FDA requires, signifying that medical studies indicate that a drug carries a significant risk of serious or even life-threatening adverse-reactions.   It might was well be the FDA shouting on a box.   This underscores that appreciation for the risk of testosterone is increasing at lightening speed.

It was just last month that the FDA announced that it is investigating potential testosterone therapy risks.  This was prompted after several studies suggested that the side effects of testosterone treatments may increase the risk of heart attacks, strokes, blood clots, and death.  Pretty severe risks considering many men taking the medication aren’t even candidates for testosterone and cannot benefit from the drug.

The Problem

Low testosterone treatments may double the risk of heart attack for young men with heart disease as well as for men 65 years of age and older, even those who have had no heart problems.  That’s the problem in a nutshell.    Additional concerns with the products include the increased risk of deep vein thrombosis (DVT) which can lead to life-threatening complications including pulmonary embolisms.  DVT is where the body develops blood clots in the deep veins, most commonly in the legs.  These blood clots can break off and travel through the body resulting in potentially life-threatening complications. Continue reading →

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gelYesterday, I mentioned how fast the testosterone replacement heart attack litigation is progressing.  Of course, to have litigation you need lawsuits.  Here they come.  A lawsuit has been filed against AbbVie, makers of AndroGel, a testosterone gel that is used to treat conditions in men that result from a lack of natural testosterone.  This won’t be the last claim filed against AbbVie.   They are a big player and they are going to have a target on their back.

Everyone has known there side effects of this medication, such as  nausea, vomiting, headache, dizziness, and change in sexual desire. Heart attacks and other serious cardiac events are a different animal.  

 A North Carolina man has filed a product liability failure to warn lawsuit claiming that the gel caused him to suffer a pulmonary embolism.  Recent studies have found that testosterone therapy increases the risk of deep vein thrombosis (DVT) which can lead to life-threatening complications including pulmonary embolisms.  DVT is where the body develops blood clots in the deep veins, most commonly in the legs.  These blood clots can break off and travel through the body resulting in potentially life-threatening complications.  According to the Plaintiff, he suffered blood clots in his lungs and legs after receiving a prescription for the testosterone gel.

AndroGel is a topical gel that is applied to the upper arms as a testosterone replacement therapy.  It is designed for men suffering from testosterone deficiency caused by medical conditions such as hypogonadism.  It causes the hematocrit level to increase, thereby thickening the blood.  If not monitored and controlled properly, it can lead to serious health issues including pulmonary embolism, deep vein thrombosis, and other blood clots.

Testosterone replacement therapy was never approved by the FDA for any treatment other than to treat men who have medical conditions resulting in lower testosterone than normal, though the Plaintiff in this matter indicates that he began using AndroGel after viewing advertisements that encourage older men to use the testosterone therapy if they are experiencing decreased sex drive, weight gain, depression or lack of energy.  Critics have suggested that the market for these drugs was created by aggressive television advertisements encouraging men to seek prescription treatment for low testosterone if they are suffering from any number of common symptoms that are experienced by men of all age.  In fact, studies have suggested that many men receiving testosterone treatments have no real medical need for the drugs.

Additional Health Risks

In addition to concerns of pulmonary embolism, deep vein thrombosis, and other severe health related issues, the FDA recently launched an investigation into testosterone therapy,  after research revealed an increased risk of heart attack, stroke, or sudden death.  Most testosterone drugs, incredibly, currently carry no mention of an increased cardiac risk in their advertising materials; however, researchers found a two-fold increase in the risk of heart attack in the three months after an initial prescription among men aged 65 years and older, and a two to three-fold increase among younger men with a history of heart disease.    

Contact Us

There is no doubt that Testosterone Replacement Therapy (TRT) is big business.  It has brought huge profits for companies with sales in the billions of dollars.  Over 5.3 million prescriptions were written for these drugs in 2011.  But huge profits shouldn’t come with a huge price to pay for the consumer.  If you or a loved one has used one or more of these products, and have suffered any ill effects, call our attorneys at 1.800.553.8082 or online here.  Our attorneys are currently reviewing potential lawsuits and we want to talk to you.

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testosteroneTestosterone therapy lawsuits are quickly gaining steam.  These cases seemed like a plaintiffs’ lawyers reach just a few months ago.  Now the science on these cases is coming together faster than anyone could have imagined.

Weeks ago, the FDA announced that it is investigating potential testosterone therapy risks.  This is a big deal.  The FDA does not stick its nose into an approved product unless it is pretty concerned.

Testosterone is approved for the treatment of hypogonadism due to known diseases of the testes, pituitary and hypothalamus. Although the use of testosterone therapy is increasing, the FDA indicated that the products were never approved for any use other than to treat men who have medical conditions resulting in lower testosterone than normal.

In response to the recent developments, a group of endocrinologist experts is calling for large scale studies of testosterone replacement therapy (TRT) medications such as AndroGel, Testim, and AndroDerm.  Recent developments include a  just published November 2013 study in the Journal of the American Medical Association, found that testosterone drug side effects were linked to increased risks of hearth attacks, strokes, and even death among older men with certain pre-existing heart problems.  That study was followed by another one, published in PLOSOne, that indicated that low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.

The experts, Endocrine Society, are calling for the development of more large-scale randomized controlled trials to determine the true risks and benefits of testosterone therapy in older men.  They have released a statement recommending that middle-aged and older men who are considering testosterone supplementation for age-related declines should be informed of the potential cardiovascular risks.  They are further concerned that it may be prudent not to administer testosterone therapy to men who have had a cardiovascular event (such as myocardial infarction, stroke or acute coronary syndrome) in the preceding six months.

What was known about testosterone replacement therapy?

Critics of TRT have suggested that the manufacturers of these medications knew or should have known about the risks, and as such, conducted additional studies.  A study in 2009, comprised of more than 200 older, frail men, was ended early after researchers determined that individuals receiving TRT had a spike in heart attacks. While this information was discovered in 2009, millions of men who have been taking hormonal treatments are learning for the first time of the extent of the risk between this medical treatment and these sometimes fatal heart conditions.

TRT is big business.  The use of these drugs has exploded in the last few years, with nearly $2 billion in sales in 2012 alone.  Over 5.3 million prescriptions were written for these drugs in 2011.  As such, we anticipate the number of injury lawsuits filed will be huge.  How many men would not have had the treatment if they had known of the potential side effects?  The exact answer is unknown.  But if you assume as at least one study has suggested that it doubles the risk of a heart attack, the number of claims are going to be extraordinary.

What should you do now?

If you suspect that you or a loved one has had an adverse reaction from any of these medications, our attorneys are currently reviewing potential lawsuits that allege that these companies knew that the risks greatly outweighed the benefits for many patients and failed to adequately warn doctors and patients of the potential risks. If you believe you may have a case, call our attorneys at 1.800.553.8082 or online here.

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TestosteroneTestosterone replacement drugs are ubiquitous.  It is hard to sit through an afternoon of TV without hearing a commercial for a drug that helps men fight “Low T” or “Low Testosterone.”   We are seeing even more commercials now.  These new commercials are from lawyers talking about testosterone replacement lawsuits.  Probably not the best way to find a lawyer.  Call 800-5538082 for a free consultation or reach out to us confidentially online.

The Passion for Testosterone

Getting older, I can testify, is not fun.   We are easy prey to the lure of testosterone supplements.   These drugs promise to inject, if you will, a sense of youthful vigor back into both the physicality and sexuality of men.  It is, as the commercials say, for energy and libido, among other things. 

These advertisements, which market familiar brands such as AndroGel, Androderm Testim and Axiron, have been extremely effective.  Accordingly, the use of these drugs has exploded in the last few years, with nearly $2 billion in sales in 2012 alone.  In fact, over 5.3 million prescriptions were written for these drugs in 2011.  At present, nearly 4% of men over 60 are taking a testosterone booster.  Men cite the fact that these drugs are effective in treating bone density issues and muscle mass deficiency, as well as with sexual performance  But are they aware that these drugs may cause heart attacks? Continue reading →