North Carolina Product Liability Lawyer Blog

Articles Tagged with MDL

Court Rulings in Zantac Litigation Could Toss Many Cases: What This Means for You

Published on: January 20, 2021 | By Clay Hodges

After news broke that Zantac (the brand name for ranitidine) was linked to cancer, a large wave of lawsuits started making their way into state and federal courts. Many of these cases have been consolidated into the Zantac multi-district litigation, or MDL 2924.

The Zantac MDL is still in the early stages of litigation, but the court just handed down two major decisions that could dramatically undermine a majority of the cases and claims.

We’ll go over these two decisions, but before we do, we need to provide a little context. We’ll start with outlining the defendants and claims in the Zantac MDL, then discuss a legal concept called “preemption.”

Help! I Don’t Like My Product Liability Settlement Offer!

Published on: October 16, 2019 | By Clay Hodges

I get these calls fairly often. The caller will explain that her lawyer just called out of the blue with an offer to settle an artificial hip or prescription drug case. The person believes the offer is too low. Well, is it? That’s a complex question, and it may be, but there are distinct reasons why the person believes the offer is too low. Let’s take a look at what may be happening:

What We Have Here is a Failure to Communicate

Often, the problem starts with the lawyer’s failure to communicate. People will tell me that they never hear from their attorney, and then suddenly, after many months or even years have passed, the lawyer will call and quickly explain the terms of a settlement offer then hurry off the phone. This is a mistake. The lawyer should take as long as necessary to fully explain why the settlement number is what it is. In fact, it is important for the lawyer to keep the client updated on developments throughout the litigation. For example, if another plaintiff in the larger litigation loses an important bellwether case, the lawyer should call and report the loss and what it may mean for the litigation and how it might impact settlement (obviously, it’s not good for all plaintiffs if a bellwether case is lost). If the client understands generally how the multi-district litigation is progressing, the client will be more prepared when a settlement offer finally arrives.

Beware Big Business Spin: A Defense of “Ambulance Chasers”

Published on: December 21, 2018 | By Clay Hodges

Let me see if I have this straight: There is a huge medical device manufacturer that earns over $75 billion dollars each year. This corporation decides to market and sell a new medical device. The corporation refuses to do extensive testing on the device because that would take too long and cost too much money. In fact, preliminary studies showed problems with the device, and the company believes extensive clinical testing may reveal more problems, further slowing its path to the market (and to big profits). Instead, the company seeks fast-track approval of the device. The company argues that because the device looks similar to a device already on the market, it should be allowed to sell the new device without extensive testing. This process is known as the 510(k) pathway, and I’ve written about it a ton on this site, including last week. In the application the company reassures the FDA: “and don’t worry, we will keep an eye on the device and the patients who receive the device and if problems arise down the road we will let you know.”

So the FDA gives the multi-billion dollar corporation 510(k) approval to sell the device. In the first year the company sells one billion dollars’ worth of the device. In the second year it sells $1.5 billion in new devices, but it also begins to receive an alarming number of “adverse event” reports. This means patients are reporting problems and injuries after receiving the device. The company undertakes an internal study but does not report its findings to the FDA. In the third year it sells even more devices, but by now hundreds of adverse reports are rolling in. The injuries finally get the attention of the FDA, and the company reluctantly hands over its data on the many serious injuries caused by the new device.

In the fourth year a woman with the implanted device is forced to undergo “revision surgery” to remove the device, and her recovery is lengthy and painful. She calls me and tells me her story. It is awful. She was once a competitive tennis player, but now she walks with a cane. She hasn’t played tennis in two years. She had to take time away from her job. Even with decent health insurance she has thousands of dollars in out-of-pocket medical bills related to the failure of the device.

C.R. Bard IVC Filter Trial: Injured Woman Wins $3.6 Million Jury Verdict

Published on: April 12, 2018 | By Clay Hodges

Victims of C.R. Bard’s IVC filters got some great news two weeks ago. An Arizona jury in the first bellwether trial awarded a woman $3.6 million for injuries she suffered after Bard’s “G2” IVC filter broke into pieces in her inferior vena cava vein, requiring open heart surgery to remove the broken pieces.

The plaintiff, Sherri Booker, was implanted with Bard G2 IVC filter to prevent blood clots from reaching the heart and lungs. The problem was, the G2 moved inside her inferior vena cava (it is not supposed to move), then it broke apart. In 2014, she had to undergo open heart surgery. The surgeon was not able to retrieve all the broken pieces.

The Jury’s Verdict

Smith & Nephew Birmingham Hip Lawsuits: Some Claims Survive Preemption Defense

Published on: April 3, 2018 | By Clay Hodges

As we get older, our bodies weaken, bones become sore, and joints break down. Hip and knee problems are common conditions of aging. In fact, in the past decade millions of Americans have had hip replacement surgeries. Unfortunately, some defective artificial hips have caused patients more suffering than their original hip ailments. For one recent example, many patients who received the Birmingham Hip Resurfacing System by Smith & Nephew have had to undergo revision surgeries to cure new and unanticipated problems relating to the medical device. Many of these people have filed lawsuits.

Smith & Nephew’s Birmingham Hip Resurfacing System

Smith & Nephew designs and markets medical devices. One of the medical devices Smith & Nephew manufactures is a joint replacement system. An example of a joint replacement system is a hip implant. The Birmingham Hip Resurfacing (BHR) System is an artificial hip replacement made of metal components. BHRs have been used since 1997. The FDA approved BHRs for use in the United States in 2006; this approval was conditioned on Smith & Nephew reporting and analyzing adverse events, negative side effects, and complaints regarding the BHR. Just like any other medical device or medicine, the BHR must not provide false information (or false hope) to patients about what the device can accomplish.

Smith & Nephew Birmingham Hip: Master Complaint Alleges “Lies”

Published on: February 23, 2018 | By Clay Hodges

As we saw in the previous post, the “Birmingham plaintiffs” submitted a 160-page Master Complaint in August 2017, alleging many Smith & Nephew misrepresentations that led to the introduction of an unreasonably dangerous product into the marketplace. In this post we continue our deep dive into the Smith & Nephew Birmingham Hip Master Complaint. (Part 2 in a series.)

“Apples to Oranges”

In a stunning marketing document directed at surgeons titled “Apples to Oranges,” Smith & Nephew announced boldly that the Birmingham Hip Resurfacing system “is not your average ‘metal on metal.’ It’s BHR.” Depicted in the advertisement is an apple with the names of other artificial hip products: ASR, Durom, Cormet, Conserve. It is rather astonishing, suggesting that the BHR was better and safer than these other MoM hips. I guess the BHR is the orange.

Smith & Nephew Birmingham Hip Master Complaint: Allegations of Rampant Misrepresentations

Published on: February 14, 2018 | By Clay Hodges

This is the story about the Smith & Nephew Birmingham Hip Resurfacing Device, the patients harmed by the metal-on-metal artificial hip, the lawsuits that followed, and the massive Master Complaint filed last August against Smith & Nephew.

But First, How Do We Get to a “Master Complaint”?

This is how product liability multidistrict litigation begins: a product (like an artificial hip) hits the market. The artificial hip is implanted in thousands of patients. A year passes, then a few more. Patients complain of aches, pains, inflammation, noises, maybe even neurological symptoms. Doctors notify the manufacturer and their patients of these bad outcomes. Post-market studies are done. Problems are discovered with the product (in the case of metal-on-metal artificial hips, those problems included metallosis, loosening, pseudotumors, and many other “bad outcomes”). Injured people file lawsuits in courts around the country. The Judicial Panel on Multidistrict Litigation (JPML) eventually realizes it needs to designate one court to handle pretrial issues with the hundreds of cases being filed, so a multidistrict litigation (MDL) site is chosen, and the lawsuits are transferred to that MDL court. From there, the plaintiffs consolidate their efforts, and eventually a Master Complaint is carefully drafted and filed.

Testosterone Litigation: Axiron Settlement Reached; Androgel Jury Award Tossed

Published on: December 27, 2017 | By Clay Hodges

There have been two major developments in testosterone replacement therapy litigation in the past week. Last Thursday Eli Lilly & Co., the maker of the testosterone product Axiron, announced to Judge Matthew Kennelly in Illinois that an agreement had been reached to settle claims by people injured by Axiron testosterone. In the second development, the same judge tossed a jury verdict awarding $150,000,000.00 in punitive damages to a man who suffered a heart attack while taking Androgel testosterone.

Let’s take a quick look at both litigation developments:

Axiron Testosterone Global Settlement

Invokana: A History of Profits, Ketoacidosis, Amputations, and Lawsuits

Published on: December 19, 2017 | By Clay Hodges

Invokana is a drug prescribed to treat people with Type 2 diabetes. The medication lowers blood sugar levels by preventing the kidneys from reabsorbing blood glucose. I’ve written often about Invokana and the studies that have identified problems with the drug, which you can read about here. I thought it may be useful to give you a history of key dates in the life-cycle of the drug, from its market release through the latest developments in the multidistrict litigation, where currently 1,000 lawsuits have been filed.

May 31, 2012. On this date Janssen Pharmaceuticals, a drug company owned by Johnson & Johnson, submitted an application to the FDA for approval of Invokana.

March 29, 2013. The FDA approves Invokana for sale. Janssen and J&J begin selling the drug.

Three DePuy Pinnacle Hip Trials Yield One Hundred Million Per Plaintiff

Published on: November 27, 2017 | By Clay Hodges

In the last three DePuy Pinnacle artificial hip bellwether trials, three juries awarded the following amounts of money: $502,000,000.00, $1,041,311,648.17, and $247,000,000.00. That’s a total of $1.79 billion dollars. The juries awarded plaintiffs compensatory damages (or actual damages) and punitive damages (to “punish” the defendant companies). Remember that these juries settled on these huge amounts of money based on their findings in three separate trials that DePuy and Johnson & Johnson were liable for design and manufacturing defects, that the defendants failed to warn plaintiffs about the risks of the defective artificial hip, and that defendants acted recklessly, intentionally, and even maliciously in marketing and selling the flawed DePuy Pinnacle hip. These last findings permitted the juries to award punitive damages.

In the bellwether trial in March 2016, a jury awarded more than $500,000,000.00 to five plaintiffs. On December 1, 2016 a jury awarded more than one billion dollars to six plaintiffs and four spouses. And finally, just two weeks ago, a jury awarded six plaintiffs (and four spouses) $247,000,000.00 in compensatory and punitive damages. Compared to the total awards, the amounts awarded to the spouses of the hip victims were modest, and appear to have totaled around $6,700,000.00.

Let’s do a little math:

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I was involved in a case for the faulty hip replacements. Clay Hodges represented me. I can't say enough about how much he has helped me. Clay was able to win multiple settlements on my behalf with most of them being the maximum amount able to be awarded. Matt J.

Clay, thank you sir for making a disheartening experience at least palatable, you and your staff were honest, caring and understanding through the entire process of my wife’s hip replacements, while monetary settlements never make the pain and suffering end, it sometimes is the only way people can fight back to right a wrong. J. V.

We are absolutely pleased with how Clay Hodges handled my husband’s hip replacement claim. He always kept us informed of the progress. And, his work resulted in a settlement which we are extremely pleased. Thank you, Clay! Carol L. & Norm L.