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TestosteroneRecently, we told you that there is a lot of research suggesting that testosterone treatments for men can cause an increased risk of heart attacks and strokes, leading to serious injury and death.  European drug regulators have jumped on board and have now launched their own investigation into the heart risks associated with low testosterone drugs.

Unfortunately, many men lose the ability to produce testosterone as they age, and their testosterone levels decrease. Testosterone plays a key role in the development of male reproductive tissues, as well as promotes secondary sexual characteristics such as increased muscle, bone mass, and the growth of body hair.

Without adequate testosterone, a man may lose his sex drive, experience erectile dysfunction, feel depressed, and have difficulty concentrating.  In steps treatment for low testosterone.  Unfortunately, with this treatment, in steps the risk for problems. Continue reading →

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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. Continue reading →

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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

Continue reading →

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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 is a 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. Continue reading →

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GM2General Motors appears to be in the hot seat this week, with all kinds of craziness going on.  I know everyone and their mother has chimed in on this story.  So I though one more take couldn’t hurt.

By now, you know the deal. GM has issued a recall that affects 1.3 million vehicles.  The problem – The vehicle could experience a sudden loss of electric power steering assistance.  In the event of a power steering loss, the car will revert to manual steering.  The steering can be maintained, but it will require greater effort from the driver at low speeds. Continue reading →

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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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051413_Force_popUpBanner_grey_oFitbit, makes of a very cool product that tracks you activity level by counting your steps  has announced the call of their Fitbit Force wrist band, affecting almost 1 million units in the U.S., and another 28,000 units in Canada.  The problem?  Rashes.  Approximately 1.7% of Force users reported cases of skin rashes after wearing the device.

The Force, a silicon wristband pedometer, was released in October 2013.  The wireless device contained a small display and sensors for measuring motion, and tracked the wearer’s number of steps, calories burned, distance traveled, and sleep patterns.  The device then syncs the information to a computer or smartphone.

The company first acknowledged complaints last month and offered a full refund or replacement tracker to anyone who experienced skin irritation.  It is believed that some users have allergic reactions to the stainless steel casing, materials used in the strap, or adhesives used to assemble the product.  The reaction results in redness, rashes, or blistering where the skin has been in contact with the tracker.  The company has received about 9,900 reports of the wristband causing skin irritation and about 250 reports of blistering. 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 →