North Carolina Product Liability Lawyer Blog

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.

FDA to Manufacturers: Don’t Base 510(k) Medical Device Approval on Old Technology

Published on: December 13, 2018 | By Clay Hodges

At some point in your life, a medical device will likely become a necessary part of your medical care. You may need external items such as hearing aids, blood glucose meters, insulin pumps, or feeding tubes. You may also need the help of surgically implanted medical devices like artificial hips, heart pacemakers, breast implants, spine screws, rods, artificial discs, intrauterine devices, metal screws, pins, plates and rods, artificial knees, or coronary stents. No matter what type of medical device you need, you deserve safe devices of only the best quality that are responsive to technological updates. As a patient, you should have the right to make a fully informed decision about whether you want to use a newer or older version of a particular medical device. The FDA is now considering making changes to its (infamous) 510(k) medical device approval process.

FDA Pressures Medical Device Manufacturers to Utilize Newer Technologies

You only have to look at the evolution of cell phone technology to appreciate the abundance of technological changes that have occurred over the past decade. So, why should you be provided with the medical device equivalents of flip phones? That’s one of the key focuses of the proposed new changes to the 510(k) Approval Program the U.S. Food and Drug Administration (FDA) which would be incorporated in 2019. The 510(k) Approval Program, put in place originally in 1976, has provided an approval “short-cut” for medical devices which are based on medical devices currently on the market. I have written about the 510(k) process often on this site. The medical device currently on the market, upon which the new product is based, is known as a “predicate device.” Historically, there have been no restrictions concerning the age of the predicate device. This is about to change.

Carcinogens Found in Valsartan Drugs Lead to Massive Recall

Published on: December 5, 2018 | By Clay Hodges

On November 27, 2018, Teva Pharmaceuticals announced a huge recall of all products containing the medication valsartan. The prescription medications containing valsartan may contain chemicals that are considered possible carcinogens.

So What is Valsartan?

Valsartan is a drug used to treat hypertension, high blood pressure, congestive heart failure, and other conditions. It also improves health outcomes in people who have suffered a heart attack. Valsartan is part of a group of drugs called angiotensin receptor blockers (ARBs). The drug works in part by relaxing blood vessels to permit easier blood flow, which leads to lower blood pressure. Lower blood pressure leads to fewer strokes, heart attacks, and kidney problems.

Settlement Reached in Stryker LFIT V40 Femoral Head Hip Litigation

Published on: November 9, 2018 | By Clay Hodges

Stryker Orthopaedics has announced that it reached a national settlement in the multidistrict litigation focused on the Stryker LFIT V40 femoral head. The LFIT V40 femoral head is one component of Stryker’s artificial hip system. This settlement announcement is a bit surprising, as the MDL was created for the LFIT V40 femoral head in April 2017. As medical device multidistrict litigation goes, this is a very quick path from formation of the MDL to settlement. One reason for the speed is that this MDL is smaller than other artificial hip MDLs based on the number of injured plaintiffs. The LFIT V40 settlement involves approximately 125 cases in the federal court MDL and an additional 140 cases in New Jersey state court.

In any event, for those people hurt by the LFIT V40 femoral head, this is good news. The terms of the settlement have not been released. I will certainly update this website when the settlement agreement is made available. As for now, all discovery and trial preparation have been stayed (or stopped). The first bellwether trial, scheduled for September 2019, will be removed from the trial calendar. The focus now will be on processing individual settlements for plaintiffs.

Remember that each plaintiff in this or any other medical device litigation is not required to accept the settlement. Although it is often reasonable for the plaintiff to accept the terms of settlement, no plaintiff will be compelled to accept any settlement. As with any litigation, it is important for individual plaintiffs and their attorneys to slow down, review all the terms of settlement, and make a careful decision on whether to participate in the settlement.

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:

Dr. Steven Tower Is Trying to Save the World from Chrome Cobalt Artificial Hips

Published on: October 16, 2018 | By Clay Hodges

If you have any interest in artificial hips, you need to follow the work of Dr. Steven Tower. An orthopedic surgeon in Anchorage Alaska, Dr. Tower has built a one-man research laboratory studying the horrifying health effects of chrome and cobalt hip components. While hip manufacturers have been slow to produce meaningful studies on the ill-effects of metallosis on the human body, Dr. Tower decided to study his own patients. What he discovered could save lives.

Dr. Tower’s Backstory

Steven Tower’s story is remarkable. He is featured in the Netflix medical device documentary The Bleeding Edge. Dr. Tower is an avid cyclist and needed a hip replacement several years ago. He chose the DePuy ASR metal-on-metal artificial hip because it was marketed to “exceptionally active individuals.” Several months after his hip replacement surgery, however, Dr. Tower noticed a tremor in his hand. His ears started ringing, his thinking became confused and he began repeating himself when he spoke. One night while attending a medical conference Dr. Tower had a mental breakdown and trashed his hotel room. He wrote all over the walls with sharpies and pens, and wrote on the hotel mirrors with soap. When he returned home he measured the metal levels in his blood, and the test results revealed 100 times the normal amount of cobalt that should be in his body. Dr. Tower soon arranged to have his metal hip components removed in a revision surgery. Within a month his thinking cleared and his other symptoms mostly disappeared. He was relieved, but also intrigued.

Children and Infants Born Opioid-Dependent Seek Their Own Multidistrict Litigation

Published on: September 27, 2018 | By Clay Hodges

One year ago a multidistrict litigation site (MDL 2804) was chosen as the venue for cities, counties, and states to bring civil actions against the makers of opioids. As I wrote about then, the opioid crisis has created huge burdens on states and municipalities. State and local governments have shouldered much of the cost of caring for individuals addicted to opioids. The federal government estimated that, in 2015 alone, 12.5 million people misused prescription opioids, and 33,000 people died from opioid overdose. In 2013, opioid abuse resulted in over $78.5 billion in economic losses. Cities, counties, and states have picked up much of that staggering cost. These government entities in MDL 2804 are fighting back, and many have filed lawsuits against the makers of opioids to recoup the billions of dollars lost in this ongoing crisis.

And while MDL 2804 is critically important, and overdue, other groups of opioid victims do not necessarily “fit” within the concept of an MDL focused on government plaintiffs. Among other victims, huge numbers of infants have been born addicted to opioids. Starting life this way creates layers of physical, mental, and emotional challenges. These children are the ultimate “innocent victims,” and they deserve an MDL court dedicated to ensuring a fair and full opportunity to seek compensation for their injuries.

Opioid-Addicted Infants Present Unique Claims

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

Opioids: Lawsuits Filed by Individual Victims Taking Shape

Published on: July 6, 2018 | By Clay Hodges

Most of you have heard reports about the devastating effects of opioids. Millions of people have become addicted, and many of those people have overdosed and died while taking the addictive pain medication. Even in cases when death does not occur, addiction has caused job losses, ravaged families, and cost billions of dollars in treatment for victims.

Up to this point, most of the recent litigation involving opioids has involved lawsuits against the makers of opioids on behalf of states and local governments. The essential complaint is this: [Blank] State has incurred millions of dollars in losses because citizens in the state became addicted to opioids and required government assistance in the form of hospitalization, treatment programs, unemployment, welfare, and other governmental expenditures.

But what about individuals? It is plain to see how a state or county can articulate damages from the direct and indirect costs of widespread opioid addiction, but individuals have been injured as well. In 2018, do these individuals have valid claims? Increasingly, it appears the answer is yes. And if so, this litigation will eventually be massive.