MDL Tag Archives — Page 3 of 4 — North Carolina Product Liability Lawyer Blog

Zofran: Fraud Claims Against GlaxoSmithKline Will Move Forward

Published on: June 2, 2017 | By Clay Hodges

Zofran is an anti-nausea drug. It works to prevent nausea and vomiting by blocking the effects of serotonin, a chemical in the body that triggers nausea and vomiting. The drug was designed to help cancer patients dealing with the side effects of chemotherapy but it was also approved by the FDA for those suffering nausea due to radiation therapy, anesthesia and surgery. Nevertheless, GlaxoSmithKline (GSK) eventually pushed to market and sell Zofran to pregnant women. Women who are pregnant are often plagued by morning sickness, and some can suffer from extreme nausea. The problem is, the FDA never approved the use of Zofran for pregnant women; it’s an “unapproved” use of the drug. Unfortunately, “off-label drug use” is very common. I wrote about off-label drug use and its potential dangers here.

By 2013, 110,000 monthly prescriptions of Zofran were issued to pregnant women. If this were an approved use, we could rest easier, as an approved use means the drug has been thoroughly tested and evaluated, with the determination backed up by “strong scientific data.” For unapproved uses there is none of that. If a drug is approved for any use, a doctor can then use his best judgment to prescribe the drug for any other purpose.

Stryker LFIT V40 Artificial Hip Lawsuits Get Multidistrict Litigation Site

Published on: April 13, 2017 | By Clay Hodges

We’ve previously blogged about Stryker LFIT V40 artificial hip problems, discussing a recall made back in August 2016 and how to tell if you have an artificial hip that’s part of that recall. Since those posts a lot has been going on in courthouses across the country, with dozens of lawsuits popping up from individuals who received affected artificial hips made by Striker Orthopaedics and its subsidiary, Howmedica Osteonics Corporation (HOC).

Just recently, approximately 33 pending lawsuits against HOC were consolidated into a multi-district litigation (MDL). In a way, you can think of this consolidation as a “things just got real” moment for HOC. But what’s the big deal about the Stryker LFIT V40 litigation now being in MDL status? Let’s begin by discussing the underlying lawsuits.

Why Are the Plaintiffs Suing?

Fosamax Users With Femur Breaks Win Appeal, Lawsuits Restored

Published on: March 24, 2017 | By Clay Hodges

Osteoporosis is a disease where the human body’s bones become weaker. It is a common issue with women who have gone through menopause. The drug company Merck developed a drug called Fosamax (alendronate) hoping to prevent and treat osteoporosis in postmenopausal women.

As with all other drugs, Fosamax had side effects, one of which was actually increasing the risk of femoral (thigh) bone fractures. Thousands of users of Fosamax suffered this side effect and sued Merck.

Even though there were a lot of plaintiffs suing, many of their cases became consolidated into a multi-district litigation, or MDL, in New Jersey.

Depuy ASR Artificial Hip Settlement Deadlines Extended

Published on: March 15, 2017 | By Clay Hodges

Some late-breaking news: The Depuy ASR Settlement Agreement has been extended to cover injured people who received a revision surgery after January 31, 2015. The extension was announced yesterday. Here’s how it works: if you received a Depuy ASR artificial hip, and then had revision surgery to remove the component between January 31, 2015 and February 15, 2017, you now may qualify to participate in the Settlement Agreement negotiated between plaintiffs and the defendants.

Let’s back up.

Before Yesterday, Where Were We?

Viagra Lawsuit Sets Out Plaintiffs’ Claims For Increased Melanoma Risk

Published on: March 10, 2017 | By Clay Hodges

The Viagra litigation is ramping up. Last April the U.S. Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation site in the Northern District of California for lawsuits alleging injury against Pfizer from the use of Viagra. Since then, the Viagra lawsuits have piled up in California federal court.

The U.S. Food and Drug Administration approved Viagra (sildenafil citrate) for sale in 1998. It set out to fix an intimate and unhappy problem: erectile dysfunction. One study indicated that thirty million men may suffer from erectile dysfunction. And it worked (I’ve heard). Millions of men standing on the sidelines were back in the game.

The reason I know it worked is because Viagra’s manufacturer, Pfizer, Inc., sold $1.8 billion dollars worth of the drug in 2013. Pfizer has self-reported that it has prescribed Viagra to 35 million men. All over the country and all over the world, those 30th wedding anniversary weekends were suddenly a lot more fun. And that’s a wonderful thing.

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.