North Carolina Product Liability Lawyer Blog

Articles Posted in FDA

MRI Gadolinium-Based Contrast Agents (GBCA) Can Harm Your Health

Published on: November 2, 2018 | By Clay Hodges

I’ve been representing people injured by defective medical devices and harm drugs for many years. Because I study these types of products on a daily basis, I have become leery about putting anything inside my body, whether it is an artificial joint like a hip or knee, or a prescription medication. As I often tell people–mostly joking but not completely–these days I am uncomfortable taking a baby aspirin.

Of course that’s not rational. Please hear me: there are important, helpful drugs and medical devices which improve lives, extend lives, and save lives. Paranoia is not your friend when you are facing a serious health issue. That said, it is always prudent to double check anything put into your body when a medical procedure is performed. Read about the product, get a second or third opinion.

In the past few years studies have identified troubling health problems in patients following the administration of gadolinium-based contrast agents (GBCAs) used during MRIs. Some people have gotten debilitating symptoms from these GBCAs. Let’s take a look:

The Bleeding Edge: Film Examines Dangers of Medical Device Industry

Published on: August 27, 2018 | By Clay Hodges

For more than three years I have been writing about the dangers of certain implanted medical devices. These devices include artificial hips, hernia mesh, IUDs, IVC filters, and others. And some have caused massive human suffering: neurological problems, sexual dysfunction, immobility, infertility, headaches, pain, even death. If you are reading this sentence then you discovered my site because of your interest in medical devices and the problems they can cause. And if you are interested in this subject, you must see the new Netflix documentary The Bleeding Edge.

The Bleeding Edge is a remarkable film investigating the public health crisis caused by our current medical device industry. It examines the two main causes permitting the manufacture and sale of defective medical devices: corporate greed and inadequate FDA oversight. It is a tragic story, particularly when the film takes a close look at many of the actual victims of these harmful medical devices. It’s one thing to hear that the Essure birth control device has injured thousands of women; it’s quite another when you see a woman on screen explain how she has given up on her hope to find love because she can no longer have intercourse due to permanent internal injuries. It is deeply sad to hear these stories. And it may have you writing your member of congress. Which you should.

I urge you to check out the film. Here are a few key takeaways:

Essure Birth Control Device: A History of Pain, Injuries, Lawsuits

Published on: August 15, 2018 | By Clay Hodges

Bayer’s Essure birth control device is coming off the market, thanks to a public campaign aimed at raising awareness about its dangers. After years of silence, in which women were told that their pain wasn’t real, and years of incident reports that went unheeded, the U.S. Food and Drug Administration (FDA) finally agreed that Bayer needed to do more to warn patients about the risks of the birth control device.

Now that women are making informed decisions, use of the birth control device has dropped off so precipitously that Bayer is ending its production. Let’s look at what Essure is and why it’s so dangerous.

The Essure Birth Control Implant

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.

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

Opioid Epidemic: Is Massive Litigation Inevitable?

Published on: August 9, 2017 | By Clay Hodges

Over the past few years, an opioid epidemic has caused horrific problems for many regions of the country. In 2015 alone, the US Department of Health and Human Services estimated that 12.5 million people misused prescription opioids, causing over 33,000 overdose deaths. In 2013, the opioid epidemic resulted in $78.5 billion in economic losses. In response to this tragic loss of life and the economic strain placed on many state and local governments, several lawsuits have begun.

What Exactly Are Opioids?

Opioids are synthetic or semi-synthetic forms of opiates (like morphine). Opiates are derived directly from the poppy plant while opioids are manufactured chemicals that are very similar to opiates.

Textured Breast Implants Linked to Anaplastic Large Cell Lymphoma (ALCL)

Published on: May 26, 2017 | By Clay Hodges

According to the American Society of Plastic Surgeons almost 280,000 breast augmentation procedures took place in the United States in 2015. Given the popularity of breast implants, a wide range of breast implant products have been released in the United States and the rest of the world. One such product is the textured breast implant.

Why Are Breast Implants Textured?

The purpose of adding texturing to the breast implant surface is to help the body keep the implant in place and avoid it from shifting. Another reason is to prevent a complication called capsular contracture, which occurs when the scar tissue that forms around the implant become painful and hard.

“Off-Label” Drug Use: Pursuing Profits at the Expense of Safety?

Published on: February 17, 2017 | By Clay Hodges

Let me state the obvious: companies sell you stuff with one purpose in mind, to make money. McDonald’s doesn’t sell you quarter pounders because the company believes what you need to live a better life is to eat more quarter pounders. The NRA doesn’t advocate gun ownership because it believes you need to own five Glock 9s (you don’t), but rather so the gun makers can sell more guns. Mercedes doesn’t make expensive cars because its board of directors hope to improve the world by selling you cars with heated leather seats. Every company sets out first to last to make money. And the more money the better.

So it goes with pharmaceutical companies. The general public may sleepwalk through the concept and lazily presume that the primary motivation for drug companies is to develop medications which cure diseases or which minimize the suffering from diseases. But in fact the motivation for pharmaceutical companies is to make money, and a lot of it. This is rather obvious and not a controversial point, and I’d like to believe that every “BigPharma” corporate board would agree with me. But it helps to keep this profit motive in mind when doing research on drugs you have been prescribed or which you are currently taking. And to be hyper-vigilant about assessing any new “wonder drugs” which hit the market.

“Off-Label” Drug Promotion

FDA Chief Urges Politicians to Respect Science in Drug Testing

Published on: January 24, 2017 | By Clay Hodges

Dr. Robert Califf is a cardiologist and the departing Commissioner of the Food and Drug Administration. He resigned his post last Friday, on Inauguration Day. Recently he gave a speech regarding his thoughts on the future of prescription drug testing, and he urged lawmakers to respect the value of science in approving and marketing prescription medications. According to Matthew Herper in Forbes magazine, Dr. Califf believes “the way forward requires putting science above politics and focusing on creating new ways to prove medicines help patients without causing undue side effects. Throwing out the standards that made the U.S. a global hotspot for medical innovation is not an option.”

Dr. Califf offered remarkable insight on the high failure rate of clinically-tested medications, as well as the urgent need for medications to do no harm:

“The most recent empirical data that we have at the FDA is that approximately 92% of drugs that go into human testing don’t make it to market because they have unacceptable toxicity, they actually don’t work for the intended purpose, or they can’t be manufactured at scale safely. Of the 92% of drugs that don’t make it to market, “100% had a lot of really smart people who thought they were going to work. If you were just going to start guessing about drugs you would do a lot of harm, because most of them would do more harm than good.”

21st Century Cures Act: Faster Approval of Devices and Drugs a Public Health Threat?

Published on: December 14, 2016 | By Clay Hodges

If you’ve kept up with politics even a little bit, you know how much gridlock exists in Congress. It’s amazing that anything can get done in Washington. However, a new law called the 21^st Century Cures Act just passed with tremendous bipartisan support; this law must be really good, right?

21^st Century Cures Act: The Good

The 21^st Century Cures Act has the potential to save lives. For instance, it will provide funding for cancer research, fight painkiller drug abuse, advance Alzheimer’s research and improve mental health treatments.

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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.