North Carolina Product Liability Lawyer Blog

Invokana Black Box Warning After Studies Show Higher Amputation Risk

Published on: October 27, 2017 | By Clay Hodges

Two recent clinical trials studying Invokana (canagliflozin) shed light on the diabetes drug’s alarming side effects. Canagliflozin is a type 2 sodium-glucose transport inhibitor (SGLT2 inhibitor) marketed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The medication works to lower blood sugar levels in the body by stopping the kidneys from reabsorbing blood glucose. Instead of the blood glucose staying in the body, it is removed with the body’s urine.

The clinical trials were named CANVAS and CANVAS-R, based on long scientific acronyms. The studies examined the effects of canagliflozin on patients with Type-2 diabetes. The trials discovered that leg and foot amputations occurred twice as often in patients taking canagliflozin as those treated with a placebo.

The risk for amputations broke down like this: 5.9 out of every 1,000 patients treated with canagliflozin suffered amputation, as compared to 2.8 out of every 1,000 patients treated with a placebo. Over a year’s time, the risk of amputation was 7.5 out of every 1,000 patients treated with canagliflozin, compared to 4.2 out of every 1,000 patients treated with a placebo. These are statistically significant results, meaning the risk of amputation for those people taking Invokana was large enough to cause alarm in the medical community.

In the clinical trials, amputations of the toe and middle of the foot were the most common; however, amputations of the leg, below and above the knee, also occurred. Some patients had more than one amputation.

Based on this new data, the FDA ordered new warnings, including a prominent boxed warning, to be added to the canagliflozin drug labels to explain and describe this risk. Continue reading

Metal-on-Metal Artificial Hip Victim Recovers From Revision Surgery

Published on: October 24, 2017 | By Clay Hodges

In this post Suzanne recounts her slow recovery from artificial hip revision surgery. Suzanne received a metal-on-metal artificial hip, and four years later the hip was recalled. Suzanne was forced to undergo revision surgery a year later.

Part 3

Sitting on my night stand next to me here at home is a shiny steel sphere resting in rougher textured steel “cup.” When I hold it in my hand my fingers will not close around it and when I pick it up, the shiny steel ball is heavy and rolls back into the cup revealing a flat bottom with a hole in the middle of it. It was attached to an artificial titanium femur in my left leg just three days ago–prior to my revision surgery–and looks and feels so smooth and shiny it is hard to believe that it has wreaked such havoc on my unsuspecting body: staining the surrounding tissues an ugly gray, whipping up metal particles and spewing them into the orbit surrounding my recalled body parts and, worst of all, destroying any and all chances I may have had to develop a “J-Lo” like posterior due to irreparable damage to my gluteus medius and minimus muscles. Truthfully, I am more concerned with my ability to flow into a left legged lunge from a downward dog than to see my butt standing at attention, but that is too much to think about too soon and so instead I turn to my beautiful daughter who is giving me a bedside serenade on her guitar and think about how much I love my family and all my friends and the taste of lime popsicles.

Metal-on-Metal Artificial Hip Victim Prepares for Revision Surgery

Published on: October 19, 2017 | By Clay Hodges

In this post, “Suzanne” describes the days leading up to revision surgery. Suzanne received a metal-on-metal artificial hip in 2006. The hip was recalled in 2010, and Suzanne was forced to undergo revision surgery in 2011.

Part 2

I woke up before the sun feeling wide awake, but not ready to face the day, I forced myself to fall back asleep re-entering the world of dreams and mystery. My dreams have been fraught with intrigue, dysfunction, insanity and all kinds of craziness and no wonder! My life is a bit crazy these days. As crazy as my dreams can be, they are never too crazy for me to say. “Hey, wake up, this has gone too far!” I relish in the scenarios, the unconscious connections between everything that is happening in my life being played out in random dream dramas. It’s better than soaps. Continue reading

Metal-on-Metal Artificial Hip Victim Recounts Her Harrowing Ordeal

Published on: October 16, 2017 | By Clay Hodges

Behind every metal-on-metal (MoM) artificial hip that fails, there is a person and a story. Artificial hip manufacturers may see only a faceless crowd of victims. These defendant companies may attempt to resolve the claims in bulk and move on to market the next blockbuster medical device. But in that crowd of plaintiffs are thousands of individuals uniquely injured by a product that was implanted in their bodies. The product failure often requires revision surgery, and the injuries that result from the artificial hip failures change lives forever: accomplished tennis players no longer play tennis; couples no longer travel or walk together on a beach; others have to resign from jobs they love because they cannot sit a desk for any length of time. Each of these people has a unique story to tell.

In the next three posts, I will share one woman’s story. “Suzanne” [not her real name] received a metal-on-metal (MoM) artificial hip in 2006 after years of pain from arthritis. The hip was recalled in 2010, and Suzanne was forced to undergo revision surgery in 2011. This is her story:

Part 1

Jury Awards Androgel User and Heart Attack Victim $140 Million

Published on: October 10, 2017 | By Clay Hodges

Last Thursday a jury in Chicago found that AbbVie, Inc., the manufacturers of the testosterone product Androgel, must pay the plaintiff, Jeffrey Konrad, over $140,000,000.00 for injuries he suffered after using the company’s testosterone product. The jury found that AbbVie did not adequately test the testosterone roll-on gel product and misrepresented its safety to patients and doctors.

The Second Testosterone Bellwether Trial

Mr. Konrad was in his late forties when he began using Androgel in 2010. He was prescribed testosterone to treat a decrease in his testosterone levels. Two months later he suffered a heart attack. He filed suit years later, alleging that AbbVie knew about the link between testosterone use and heart attacks but sold the product anyway, and without sufficient warnings. The jury did not find that Mr. Konrad proved the connection between his use of Androgel and his heart attack. Other factors, such as Mr. Konrad’s obesity, high blood pressure, and family history, could have caused his heart attack. Nevertheless, the jury found that AbbVie was liable for damages based on AbbVie’s negligence and misrepresentation.

Opioid Lawsuits Heading to Centralized Multidistrict Litigation (MDL 2804)

Published on: October 4, 2017 | By Clay Hodges

I blogged previously about the United States opioid crisis and how many local and state governments were looking to the courts to help deal with it. Specifically, these governments have brought lawsuits against manufacturers and distributors of opioids.

When we last wrote about the opioid crisis, I explained how these lawsuits had only just begun. The following post is an update on how these lawsuits are progressing. But before we get to that, let’s discuss why opioids are generating these lawsuits.

The Legal Basis for Suing Opioid Manufacturers and Distributors

Depuy ASR Artificial Hip: Plaintiff Carol Strum Gets New Trial

Published on: October 2, 2017 | By Clay Hodges

A woman who lost her case involving injuries from the Depuy ASR metal-on-metal artificial hip has been awarded a new trial.

In 2013, a Chicago jury found that Depuy was not responsible for Carol Strum’s injuries following the failure of the ASR hip. The jury found that the hip components manufactured by Depuy Orthopaedics did not cause the injuries to the plaintiff. Ms. Strum had sued DePuy in Chicago in 2011, alleging that the DePuy ASR implanted in January 2008 failed and required painful revision surgery. She also claimed that she suffered from metallosis.

On September 19, 2017, Judge Mary Dooling in Chicago granted Ms. Strum a new trial on the grounds that a surgeon and joint replacement scientist was unfairly prevented from testifying on behalf of the plaintiff in the original trial.

With Third Depuy ASR Settlement Deadline Past, Do I Still Have a Viable Claim?

Published on: September 28, 2017 | By Clay Hodges

I get calls from people all over the country worried that they may have missed a deadline for participation in the Depuy ASR Artificial Hip Settlement. I understand the alarm. It would be dreadful to have the ASR metal-on-metal hip implanted, suffer mysterious pains and then elevated metal levels in the blood, discover the artificial hip components failed, go through a painful revision surgery, and then find that the settlement deadlines have all passed. The reality is this: at the moment, all the deadlines have passed. But many viable ASR claims against Depuy and Johnson & Johnson are still out there, and they should be fairly compensated like all the injured people that have come before.

Third Settlement (Second Extension)

In the most recent extension of the ASR Master Settlement Agreement, the deadline to enroll in the settlement was July 19, 2017. This second extension of the Master Settlement applied to individuals who had the ASR hip removed in revision surgery between between January 31, 2015 and February 15, 2017. The reason for this specific set of dates is that the settlement committees for plaintiffs and defendants wanted to include victims who had revision surgery somewhat late in the game. Recall that the Depuy ASR hip was first sold in 2005, twelve years ago. It was sold aggressively for five years, until it was finally recalled on August 24, 2010. Thousands of people were implanted with the ASR hip in that five-year period. Most of them were forced to undergo revision surgery before August 31, 2013, the deadline for participation in the first settlement. But hundreds of people did not undergo revision surgery until after August 31, 2013. Therefore, a first and then a second extension of the original agreement was established.

After Noisy August, Fourth Depuy Pinnacle Hip Bellwether Trial Underway

Published on: September 22, 2017 | By Clay Hodges

Some of my clients have been asking me what is going on with the fourth Depuy Pinnacle bellwether trial. Non-clients have also been calling to inquire about the status of the trial. Did it start this week? Was it postponed? What is the deal with Depuy and Johnson & Johnson trying to stop the trial? Let’s take a quick look:

Fourth Bellwether Trial Underway

The short answer is yes, the fourth bellwether trial began on Monday (September 18, 2017). Six plaintiffs injured by the Depuy Pinnacle hip (and four spouses) are bringing their claims against defendants in Dallas, Texas before Judge Kinkeade. You can read about previous Pinnacle bellwether trials and their huge jury awards here and here.

Taxotere and Permanent Hair Loss: Is There a Cure?

Published on: September 13, 2017 | By Clay Hodges

Hair loss, or alopecia, is a common condition for many people, especially when they age. The exact reason for the hair loss can vary, but one particularly unpleasant cause is chemotherapy. However, not all patients will be affected the same way during chemotherapy, even when taking the same chemotherapy drug to fight the same type of cancer.

For example, some patients may only experience a slight change in hair color, while others will have thinning hair. Others may have hair loss, although the amount and areas of hair loss can differ among patients. For some unlucky patients, the hair loss is permanent. One such chemotherapy drug that causes permanent hair loss is Taxotere.

What Is Taxotere?

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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.