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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.

Are morcellator cancer cases viable lawsuits?

It is easy for a trial lawyer to say that these are slam dunk lawsuits.  But the reality is we really don’t know yet exactly what the manufacturers knew.   So can I imagine a scenario where they are not responsible for cases where the cancer spreads?  Sure.

But there are some things I can tell you.  First, morcellators were approved under the FDA’s borderline criminal 510(k) procedure in 1995.   This means that they never did real testing on it, they just grandfathered it in based on the fact that a similar device was on the market.

Second, they have almost 20 years of real live data on this.  No one could figure this out over the last 20 years?  It seems utterly ridiculous.  If plaintiffs’ lawyers had jumped on this before the FDA, we would have been shot down as self serving fools.  I can here it now, “C’mon this has been on the market for almost 20 years.  You don’t think someone would have picked up on this by now if it were true?”

What should I do if I think I was hurt by a morcellator?

I think you should call a lawyer, either us or someone like us.   Again, at the risk of being redundant, it is early in these cases.  We don’t know quite how it is going to play out.  But lawyers are jumping on these cases in massive numbers.  Setting aside some very good lawyer jokes, here is a good reason for this.   Some of these I highlight above.  But, in short, where there is smoke there is fire and there are likely viable lawsuits here.

If you think you might have a potential claim, either an injury claim or a wrongful death claim after the loss of someone you loved, call us at 800-553-8082 or get a free online consultation here.

 

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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.

Negative side effects of Benicar can include:

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

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.
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surgeonsNorth Carolina Lawyers Weekly has a good article on a $2 million verdict against a vascular surgeon that I think is of interest to both medical malpractice attorneys and surgical malpractice victims.

Facts of the Case

Plaintiff went to Pitt County Memorial Hospital for vascular surgery.   She had suffered for years with vascular disease that left her with only a half a kidney that was not functioning very well.   She was suffering pain from an aortic aneurysm.  This is a bulge in a section of the aorta which is our main artery that carries oxygen from the heart to the rest of our body.  It is a dangerous condition.  In a nutshell, this woman was frail and having real health issues.

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humirajudgeopinionUnfortunately, most courts around the country have enforced nursing home agreements executed by residents agreeing to forgo civil claims in favor of arbitration for negligence claims.

The game changes in wrongful death cases.  Usually this is for a very simple reason: the parties have changed.  Courts in Maryland and other jurisdictions have largely declined to enforce arbitration agreements between nursing homes and deceased residents because any wrongful death action is not an “asset” of the estate but a claim brought under the plaintiffs’ own right for the loss of their spouse or parent.

There are two new Pennsylvania nursing home cases that favor plaintiffs in these disputes.

Pisano v. Extendicare

In Pisano v. Extendicare Homes, a Pennsylvania intermediate court affirmed the trial court’s motion for summary judgment in a wrongful death and survival action filed against a nursing home.  The nursing home attempted to compel arbitration over both causes of action based on the existence of an agreement to arbitrate all claims against the nursing home, expressly including survival and wrongful death actions.  This was an issue of first impression in Pennsylvania.

The nursing home’s best argument in these cases, which they made in Pisano, is that  a wrongful death claim is a derivative of and defined by the decedent’s rights.   While it is their best argument, it is weak.  The Pennsylvania court agreed using a lot of complicated legal analysis that can best be described as follows:  the parties are different so it is not derivative.

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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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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 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.

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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 →