Articles Posted in Featured Lawsuits

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Bring on the trials.  With almost 500 product liability lawsuits filed against Pfizer, U.S. District Court Judge Richard Gergel has issued an aggressive Case Management Order that lays out the organizational structure and timelines for handling the litigation.  Judge Gergel is overseeing the cases which have been centralized as part of an MDL, the creation of which helps to prevent duplicative discovery and conflicting rules from different judges.  MDLs also help to serve the convenience of the witnesses, parties, and the courts.


Trials may be as early as July 2015

What is the problem with Lipitor?

Around since 1985, more than 17 million people having been prescribed Lipitor at one time or another, making it the world’s best-selling drug.  But, like the saying goes, all good things must come to an end.  Lipitor, prescribed to people who have been diagnosed with high cholesterol, has been linked to an increased risk of diabetes.  Medical research indicates that people who have taken Lipitor and other statin drugs, are at an increased risk to become diabetic than those who have not taken the drug. With the increase varying from study to study, some report the increase to be as high 28 percent.

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testosteroneUpdate: there is an MDL.

Federal lawsuits filed by or on behalf of men who allegedly suffered a heart attack, stroke, blood clot, or other injury caused by side effects of low testosterone drugs have prompted the need for centralization of the cases.  But, with more than 74 product liability lawsuits filed in the federal court system against Testosterone drug makers, not quite everyone is on board for the creation of an MDL (multidistrict litigation).

Last month, a Plaintiff filed a motion seeking to centralize all federal AndroGel lawsuits before one judge for coordinated handling during pretrial proceedings.  Most of the cases filed involve Androgel, which accounts for approximately 60% of the testosterone replacement therapy market, though other claims have been filed against AndroDerm, Testim, Axiron, Foresta, and Depo-Testosterione.  Subsequent to the filing of the motion to centralize AndroGel cases, a second motion was filed by a group of plaintiffs, seeking to consolidate all federally filed testosterone drug lawsuits.  In response, Auxilium Pharmaceuticals, Inc., maker of Testim and Testopel, opposed the request indicating that it is only named in seven of the cases, and therefore an MDL is not warranted.

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Doctors are being discouraged from using morcellators

The FDA last week for the first time discouraged doctors from using morcellators when performing hysterectomies.  The FDA also said morcellators should be avoided when removing uterine fibroids. The concern is that if there is cancerous tissue in the abdomen, it will hurt a patient’s chance of recovering from the cancer.  In some cases, surgeons can be stirring up cancer that neither the doctor or the patient even knows exists.   How real of a concern is that? The FDA says that 1 in 350 women who are undergoing a hysterectomy or myomectomy for fibroids have a uterine sarcoma, an  unsuspected type of uterine cancer that can be deadly.

What is a morcellator?

A morcellator is a surgical device that is used to divide and remove tissue masses during laparoscopic surgery.  In a hysterectomy, the device divides the uterus.   It is also frequently used to dissect uterine fibroids during myomectomies/fibroidectomies.

This surgical device cuts the tissue mass into pieces.  The surgeon then pulls out the pieces through extremely small incisions.   There is no question there is an upside to this technique.  It is minimally invasive surgery which means no big scars, shorter recovery time, and less of the other risks that come with surgery.

So the FDA’s announcement is a major development.   Morcellators are being used in massive numbers.  It is used in tens of thousands of hysterectomies each year.

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benicarBenicar, also known as Olmesartan, is used to treat hypertension or high blood pressure.  Used alone or with other medicines, Benicar works by decreasing the effectiveness of a chemical known as angiotensin II, which normally causes blood vessels to narrow or constrict.  As a result, Benicar causes blood vessels to relax, lowering blood pressure.

Recently, Benicar has been linked to some pretty serious side effects.  Our attorneys are now reviewing potential lawsuits against Daiichi Sankyo, manufacturer of Benicar.

Since is was approved in April, 2002, a number of negative side effects of Benicar have come to the surface, including:

  • Sprue-like Enteropathy or Colitis
  • Chronic Diarrhea
  • Weight Loss
  • Nausea
  • Vomiting
  • Dehydration
  • Colon Perforation

Research and studies revealed that consumers taking Benicar were experiencing symptoms similar to celiac disease, including unexplained chronic diarrhea, weight loss, and enteropathy.  But, whereas those with celiac disease can control these symptoms with a gluten-free lifestyle, those taking Benicar/Azor/Tribenzor did not improve until they discontinued their use.  Studies revealed that patients taking Benicar gained an average of 27 pounds after discontinuing their use.

The last problem on that list, colon perforation, is the latest and maybe the biggest.  What happens is a hole develops through the wall of the colon.  We see these cases a lot during surgery when a doctor makes a mistake during abdominal surgery.   Often, the problem has to be solved with surgery.  It is definitely not what you sign up for when you want to take a drug to reduce high blood pressure.
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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.

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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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$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 →