Multidistrict Litigation

Mirena IUD Has Caused Fluid Pressure in the Brain, Injuries, Lawsuits

Published on: February 9, 2017 | By Clay Hodges

Female contraception is common these days, with many medications, medical devices and methods available. One popular birth control method is the intrauterine device, or IUD.

There are many companies making different types of IUDs that work in different ways. Some use copper as the primary means of contraception while others use hormones. One of the most popular hormonal IUDs available goes by the brand name Mirena.

How Does the Mirena IUD Work?

Mirena is a hormonal IUD that is inserted into a woman’s uterus. Once inserted, the IUD continuously releases a small amount of the hormone levonorgesterel. The Mirena IUD is extremely effective and works primarily by preventing fertilization from occurring, rather than preventing implantation of the fertilized egg into the uterus.

Another advantage of the Mirena IUD is that it works for a long period of time (three to five years) without any intervention by the woman. And when the effective time period of Mirena passes or the woman decides she wants to try to get pregnant, the Mirena IUD can be removed and fertility restored. Because of these advantages, many women have chosen Mirena as their preferred form of birth control.

What’s Wrong with the Mirena IUD?

Despite its effectiveness as a contraceptive and its popularity, the Mirena IUD has caused some women to suffer from a variety of serious conditions, including the dangerous buildup of cerebrospinal fluid in the brain. This fluid buildup then causes an increase in intracranial pressure and can lead to severe headaches, ringing in the ears, nausea, blurred vision, neck pain, and blindness due to the swelling of the optic nerve.

Many women experience progressively worsening vision as the optic nerve swelling increases. Most of these symptoms are similar to those people suffering from a brain tumor. There are several names to describe this condition, including Pseudotumor Cerebri (PTC) and Intracranial Hypertension (IH).

Depending on the woman, the effects of PTC or IH can sometimes be reversed, but it often results in permanent damage to a woman’s vision. Even if the effects can be reversed, it usually takes years of maintaining normal intracranial pressure in the brain. As a result of these problems, many lawsuits against Bayer, the maker of Mirena, have recently emerged.

Product Liability Law: Litigation, Settlement, and Wellness

Published on: December 12, 2016 | By Clay Hodges

I will publish a new book this week: Product Liability Law: Litigation, Settlement, and Wellness.

The book offers concise chapters on issues you need to be aware of when you first discover that a medical device may have failed in your body, or when a prescription medication is beginning to cause dreadful side effects. Beyond that, I discuss issues that arise when you are involved in product liability litigation, as well as concerns about money: before a product liability lawsuit is filed, during product litigation, and after a product lawsuit is resolved.

If you would like a free copy of Product Liability Law, I ask that you subscribe to the website. It takes twenty seconds to sign up. You will receive a copy of Product Liability Law, and you will receive emails only when I post new articles to the site. Two emails a week, tops.

Depuy Pinnacle Hip Trial: Jury Awards ONE BILLION DOLLARS

Published on: December 2, 2016 | By Clay Hodges

Staggering. It’s really the only word for it. Yesterday a Texas jury awarded six plaintiffs over one billion dollars for injuries sustained following the failure of the Depuy Pinnacle metal-on-metal artificial hip. And that comes out to more than $170,000,000.00 per plaintiff. The verdict was handed down last night following ten weeks of punishing trial.

This trial was the third “bellwether” case in the Depuy Pinnacle MDL (multidistrict litigation). The first Pinnacle bellwether trial ended in a defense verdict, which means the jury did not find negligence on the part of the defendants, Depuy Orthopaedics and Johnson & Johnson, and therefore the plaintiffs received no compensation. The second bellwether trial resulted in a huge $502 million dollar verdict for five plaintiffs, which I wrote about here. In fact, much of the speculation about this third bellwether trial was whether the plaintiffs’ team could put on the same powerful case that they did in the second bellwether trial, or whether the $500 million verdict in March was simply a bizarre outlier, one of those remarkable unicorn verdicts that come along once and never again.

Today, the $500 million dollar verdict seems modest compared to yesterday’s jury verdict. Plainly, juries are sending a huge message to Depuy and J&J that they hurt many people when they marketed and sold the Depuy Pinnacle Hip.

Wright Medical Artificial Hip Settlement: Wrong for Plaintiffs?

Published on: November 22, 2016 | By Clay Hodges

Do you long for the days when you could move your legs and hips with complete freedom of motion in total silence, without pain? If the answer is “yes,” there’s a good chance you are the recipient of a hip replacement implant – and you wouldn’t be alone. Over the past few decades, millions of individuals have received hip replacement surgeries, many of which have been successful. But in recent years, there have been a large number of hip replacement recipients who have suffered problems with their hip implants, especially those receiving metal-on-metal hip replacements.

Lawsuits have been filed, resulting in large, eye-catching verdicts and settlements for plaintiffs. One recent settlement applies to approximately 1,300 lawsuits involving hip implant products made by Wright Medical Technology (“Wright”).

Wright Hip Background

Zimmer NexGen Knee Lawsuits: Now the Good News

Published on: November 11, 2016 | By Clay Hodges

Without question, the Zimmer NexGen Knee MDL is not going all that well for plaintiffs lately. The first bellwether trial ended in a defense verdict in favor of Zimmer. Then Judge Rebecca Pallmeyer issued a Lone Pine Order which imposed a heavier burden on plaintiffs to avoid dismissal of their cases. That Order requires each plaintiff to file an Expert Declarations form establishing that the case meets all the latest requirements to warrant its continued place in the litigation. These requirements include a showing of (1) evidence of loosening of the artificial knee, (2) evidence of knee flexion of 120 degrees, (3) other detailed designations of injury and product failure. You can read more about the Lone Pine Order here.

Then, on October 21, 2016, Judge Pallmeyer ruled that the second bellwether case did not warrant a jury trial. In her Order, she granted summary judgment for Zimmer. You can read about that court decision here, but in a nutshell, Judge Pallmeyer simply rejected the validity of the plaintiff’s key expert witness. She concluded that Dr. Joseph Fetto failed to refer to scientific literature or to “give any explanation for why the implant design, and asymmetric loading generally, causes . . . loosening.” (Order, p. 12) She wrote at length about the reasons why Dr. Fetto’s testimony is unreliable, ultimately concluding that Dr. Fetto has not “given the court sufficient basis to conclude that his opinion is reliable.” (Order, p. 17) Without a reliable expert witness, a plaintiff cannot win a product liability case.

The Judge’s Order was a sledgehammer, but . . .

It’s Not All Bad News

It’s quite awful to select a bellwether case, prepare it for trial, and then, days before jury selection, the judge grants summary judgment on all claims in favor of defendants. After years of litigation, the plaintiff, who was clearly injured, was out of court without compensation. Still, there is reason to believe that future cases may have different results. Judge Pallmeyer admitted as much in the last section of her 43-page order, titled “Potential Differences Between Joas’s Case and Others in the MDL.” Let’s examine a few keys statements in the part of her Order (the italicized statements below were written by Judge Pallmeyer):

How Long Will It Take to Resolve My Artificial Hip Lawsuit?

Published on: November 8, 2016 | By Clay Hodges

I got a desperate phone call the other day. The call came from a man several states away. Let’s call him “Bill.” Bill had hip replacement surgery in 2007. The Depuy ASR artificial hip was implanted. He began to suffer pain eighteen months later, in early 2009, and blood tests showed his cobalt and chromium metal levels were rising at an alarming rate. He was suffering from metallosis. In 2011 Bill underwent Revision Surgery to remove the Depuy ASR hip. A year later he hired an attorney and filed his product liability lawsuit against Depuy Orthopaedics and Johnson & Johnson (the parent company of Depuy) in federal court in Bill’s home state. From there, the case was transferred to the Depuy ASR MDL in the Northern District of Ohio, before Judge David Katz. Judge Katz was the federal judge assigned to handle or manage the pretrial issues associated with the thousands of Depuy ASR cases that were transferred to his court after being filed across the country.

In November 2013, the first Settlement was reached between the Plaintiffs’ Committee and the Defense Team for Depuy and J&J. I have written about this Settlement and its terms here. So six years after the Original Surgery, and four years after the first onset of pain, and two years after Revision Surgery, Bill finally had the opportunity to accept the settlement offer or reject the offer and pursue a jury trial on his specific case. After much deliberation, Bill rejected the settlement offer.

Three years have now passed. Bill’s case is not on a trial calendar. In fact, as far as I am aware no case has yet been tried of any person who rejected the settlement offers. To make matters worse, this summer Judge Katz, in charge of the MDL, passed away. A new judge had to be appointed to take his place overseeing the MDL.

Bill is at his wit’s end. He told me he merely wants his day in court. He is now nine years removed from the Original Surgery, seven years removed from the onset of symptoms, five years from Revision Surgery, and over four years from filing suit. And still no trial date in sight.

Bill is not alone. Hundreds of people in the MDL rejected the settlement. And those people are waiting too.

So how long does it take to resolve your artificial hip case?

Zimmer NexGen Knee: Judge Boots Second Bellwether Case Before Trial

Published on: October 26, 2016 | By Clay Hodges

October 2016 was set to be an important month for thousands of people injured by the Zimmer NexGen artificial knee. The second “bellwether” trial was scheduled. Bellwether trials involve representative cases that are used to educate the defendants and the plaintiffs on what certain juries thinks may be proper results for these kinds of cases. After several bellwether trials, both sides often come together and work out a global settlement based in large part on results from these bellwether trials.

Unfortunately for the plaintiffs in the Zimmer NexGen MDL, the latest bellwether case never reached the jury. On October 21, 2016, Judge Rebecca Pallmeyer, the federal judge overseeing the Zimmer NexGen MDL, granted summary judgment for Zimmer and the other defendants. Which means the case is over.

Summary Judgment

Summary judgment is a final judgment entered by the judge prior to trial. Essentially, the judge determines that no material factual issues remain in dispute and that one side is entitled to judgment “as a matter of law.” For the most part, summary judgment is a defensive tool, and defense lawyers will file a motion for summary judgment and will argue to the court that even taking the facts in a light most favorable to the plaintiff, the defendant is still entitled to judgment without the need for a jury trial.

This is exactly what happened last week on the eve of the second bellwether trial in the Zimmer NexGen MDL. In a 43-page Order, Judge Pallmeyer held that the plaintiffs failed to present adequate evidence that the design of the Zimmer NexGen knee caused the plaintiff’s alleged injury, and that the plaintiffs failed to show that the warnings accompanying the medical device were inadequate.

Bair Hugger Forced-Air Warming Blankets May Cause Serious Infections

Published on: October 20, 2016 | By Clay Hodges

The Bair Hugger forced-air warming blanket originally seemed like a great idea. Developed by an anesthesiologist, Dr. Scott Augustine, Bair Hugger was a forced-air warming blanket that is draped across a patient during and after surgery. The theory is that warm air against the body stimulates faster recovery and reduces bleeding. I believe the results have shown that Bair Hugger has sped recoveries for patients. Unfortunately, patients also began to suffer from infections. Some of these infections have been significant and caused serious injury in patients.

In fact, Dr. Augustine has reversed field on his invention and now believes it should no longer be used during and after surgeries. He believes it is particularly dangerous for patients receiving medical device implants like artificial hips and knees, according to an article in The New York Times. The risk of infection is allegedly caused by the forced-air within the blanket which can spread bacteria often found in hospitals. Consumer advocates allege that the forced air pushes bacteria and other contaminants into open wounds of patients during and after surgery, which can increase risk of infections. Some individuals have suffered from very serious or even life-threatening infections. The scientific theory suggests that in artificial joint surgeries the immune system is not triggered as readily, such that bacteria introduced into the body is much more dangerous to the patient than under normal conditions. As a result, the bacteria in the patient’s body can cause much more damage and be life-threatening. In some cases, patients have had to undergo revision surgeries at the site of the artificial joint implantation; in rare cases, amputation was necessary because of the severe infection.

However, as I discuss below, Arizant Healthcare, Inc., the manufacturer of the Bair Hugger blanket, disputes that any increased risk of infection occurs with Bair Hugger. The medical device is still on the market and is still used in many surgeries.

Melanoma Victims Suing Cialis Maker Seek to Join Viagra MDL

Published on: October 12, 2016 | By Clay Hodges

In April 2016 the Judicial Panel on Multidistrict Litigation created a multi-district litigation (MDL) court for lawsuits against Pfizer, the maker of Viagra. That MDL is No. 2691. Plaintiffs in those cases allege that taking Viagra increased the risk of developing melanoma, a potentially deadly skin cancer. MDLs are created when many lawsuits are filed alleging very similar facts against the same defendants for similar injuries. One consolidated court permits a more efficient pre-trial process, where discovery can be organized, consolidated, and “shared” among all parties. Now men who allege they developed melanoma from taking Cialis have asked to join the Viagra MDL.

The Motion

On September 28, 2016, several plaintiffs who have filed suit against Eli Lilly and Co., the maker of Cialis (another erectile dysfunction drug), asked the judge presiding over the Viagra MDL to permit all plaintiffs suing Eli Lilly to transfer their cases to MDL 2691. The plaintiffs alleging injury from Cialis argue that the science behind the Cialis cases is essentially the same as the science behind the cases involving Viagra. According to the motion, the Cialis Plaintiffs allege that their injuries “were caused by Cialis through the exact same mechanism of action.”

Depuy Pinnacle Hip: Third Bellwether Trial Underway in Texas

Published on: October 7, 2016 | By Clay Hodges

The latest Depuy Pinnacle Hip bellwether trial is underway in Dallas, Texas. All bellwether trials are important, but this one is more important than most. After all, this trial follows an astonishing result in the second bellwether trial, where a jury awarded five plaintiffs more than $500,000,000.00 in damages for injuries caused by the Depuy Pinnacle hip. More about that case in a moment. But this third bellwether trial is critically important to Depuy and Johnson & Johnson (the Depuy Pinnacle manufacturers) who desperately need a court victory after the second bellwether trial. Another large verdict for the plaintiffs will most likely change the fate of any global settlement with the eight thousand plaintiffs who still have cases against Depuy and Johnson & Johnson.

Third Depuy Pinnacle Bellwether Trial

Judge Kinkeade, the federal judge in Texas overseeing the Depuy Pinnacle multidistrict litigation, selected seven individual cases to be consolidated in the current bellwether trial. The plaintiffs are Marvin Andrews, Kathleen Davis, Sandra Llamas, Rosa Metzler, Judith Rodriguez, Lisa Standerfer, and Michael Weiser. All the plaintiffs are from California. Their cases were transferred to the Depuy Pinnacle MDL in Dallas, Texas.