North Carolina Product Liability Lawyer Blog

Articles Posted in FDA

FDA Issues Warning: Increased Risk of Thigh Bone Fractures With Zimmer Biomet CPT Hip System Femoral Stem

Published on: October 1, 2024 | By Clay Hodges

Artificial hips offer a new lease on life to many thousands of people each year. They provide recipients the opportunity for independent living and mobility they might not otherwise have. Unfortunately, they also come with risks, one of the most prominent being metallosis. But there’s also another potential risk where the femur (thigh bone) could break.

The femur is the largest and strongest bone in the body. Yet the process of implanting an artificial hip, along with the older age of most patients who receive artificial hips, means there’s a greater risk of a thigh bone fracture. If this happens, artificial hip revision surgery may be needed.

The U.S. Food and Drug Administration (FDA) recently issued a safety communication alerting patients with the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper of an increased risk of thigh bone fracture. Let’s take a look at this safety communication and what you should do if you received this implant.

Kratom: Increasing Popularity Reveals Troubling Side Effects

Published on: June 5, 2024 | By James Hodges

Kratom (mitragyna speciosa) is a tropical leaf native to Southeast Asia. While the plant is indigenous to Asia, the use, and abuse, of the plant has become much more common in the United States over the last decade. Today, you can easily purchase products made from kratom leaf online as well as in brick-and-mortar stores. The substance is manufactured into various vehicles of consumption including concentrated powder capsules, chewable tablets and gummies, and liquids. The leaves can also be crushed and smoked, and also brewed into herbal tea.

Common Uses of Kratom

In low doses, the leaf has been known to produce a stimulant effect, with users reporting increased physical energy and alertness. When taken in higher doses, the opposite occurs: the substance produces sedative effects. Kratom is used to self-treat physical pain, coughing, and diarrhea. It is commonly used to aid in treating psychological disorders such as anxiety and depression. The substance is also used to aid individuals with opioid withdrawal, and opioid use disorder.

FDA Issues Warning About the Synovo Total Hip System

Published on: February 29, 2024 | By Clay Hodges

Artificial hips offer many patients the opportunity to live active and full lives, but sometimes they don’t always work as intended. Thankfully, these are relatively rare situations. Unfortunately, if it’s your artificial hip that fails, there’s not much comfort in knowing the artificial hips in most other patients work as designed. Because an artificial hip failure can be such a serious problem, the U.S. Food and Drug Administration (FDA) takes steps to ensure artificial hip medical devices receive adequate review and scrutiny before being approved for use in patients. One such step is to confirm that if a company modifies an already approved product, those changes also receive appropriate FDA approval and oversight. Apparently, Synovo Production, Inc. (Synovo) failed to obtain these necessary FDA approvals after making changes to one of Synovo’s hip replacement products. Let’s take a look at what products are affected and what action the FDA has taken.

Affected Medical Devices

Synovo makes the Total Hip System (also known as the Total Hip Replacement System and the Preserve and Endotec BP), which the FDA cleared for medical use. However, the FDA claims that Synovo has made significant modifications to the following three components of this system: Femoral Resurfacing Cup, Acetabular Fixation Cup and Acetabular Bearing. Some of these components are also stand-alone products.

FDA Criticized for Flawed and Delayed CPAP and BiPAP Recall

Published on: December 22, 2023 | By Clay Hodges

I’ve written extensively about problems with some Philips CPAP and BiPAP machines, including alleged injuries, affected machines, recalls, and potential litigation. That litigation is ramping up, but a new concern has arisen over the FDA’s inadequate and delayed recall process.

Specifically, governmental safeguards designed to protect the public from faulty or dangerous medical devices may not be working properly. Using the Philips recall situation as a prime example, let’s examine what going on with the U.S. Food and Drug Administration (FDA) and why there might be room for improvement in how it handles potentially dangerous medical devices.

The FDA’s Role in Keeping Consumers and Patients Safe

Ethicon Surgical Staplers: Serious Injuries Lead to Recall and Lawsuits

Published on: April 10, 2020 | By Clay Hodges

Image of the ECHELON FLEX ENDOPATH Stapler During the course of surgery, a doctor may need to find a way to connect sections of organs or close wounds. One way to do this is through the use of sutures, a special type of thread. Another way is with the use of surgical staples. The Ethicon surgical stapler is pictured at right.

Doctors commonly use staples over sutures during surgery because they offer several advantages, including:

Lower risk of infection

Zantac: Overview of Recall and Lawsuits Due to Cancer-Causing NDMA

Published on: January 19, 2020 | By Clay Hodges

Many of us suffer from heartburn, and one of the most popular ways to treat it is by taking Zantac. Until recently, Zantac was considered a very safe medication and was available without a prescription.

Given how well it worked, along with its affordable price and the perception of safety, hundreds of thousands of people, if not millions, took Zantac. In the fall of last year, the US Food and Drug Administration (FDA) reported that this popular drug might contain N-Nitrosodimethylamine (NDMA), a likely cancer-causing substance.

The past few months have resulted in mass voluntary recalls and a rush of FDA updates and reports about the possible dangers of taking Zantac and what it means for consumers. This blog post will attempt to summarize what’s going on and briefly discuss what happens next.

Vaping, E-cigarettes, JUUL: Addiction, Illness Lead to Litigation

Published on: September 12, 2019 | By Clay Hodges

Like many parents, vaping and e-cigarettes caught my wife and me by complete surprise. Two years ago we asked our oldest child how many kids he knew in his high school who were vaping. He said, “it will be much faster to list the kids who aren’t vaping.” We were stunned. We knew very little about vaping, and at the time I assumed it was some kind of fringe product used by adults already addicted to nicotine.

Unfortunately, studies indicate that one in five high school kids have tried vaping, but in my unscientific observation I believe the number is higher. Still, there are more than fifteen million kids in enrolled in public high schools in this country, so even if the number is “only” one in five, this means over three million public high school children have either tried or are currently using vaping products like JUUL.

What we do know is that e-cigarettes are extremely popular and profitable for the companies selling the devices. The primary manufacturer, marketer, and seller of these vaping devices is a company called JUUL Labs, Inc.

HBO’s John Oliver Reports on Dangerous Medical Devices and the FDA

Published on: June 4, 2019 | By Clay Hodges

I’ve been writing about dangerous medical devices on this site for four years. Over that time I’ve reached thousands and thousands of people injured by these harmful implanted medical products. John Oliver, host of Last Week Tonight, picked up the subject this week, and I am grateful to him and to HBO because he reached more people in twenty minutes than I have in four years. I want more people to get the word out about the serious problems with medical devices rushed to market and “cleared” through the 510(k) loophole because it’s a public health crisis. Too many companies are pushing too many untested medical devices to market, and the FDA is not doing enough to protect the public from these devices. John Oliver talks about all of this on the latest episode of his show. It’s funny (and profane), but he lays out accurately the way massive profits have driven companies to push harmful medical devices on to an unsuspecting public. You can check it out at the link below:

Warning: This is HBO. Oliver speaks freely: the language is salty and the subject matter adult. Companies and people other than me own the content linked above. The show is the property of HBO and whoever owns HBO. Neither HBO nor John Oliver has any affiliation with my website.

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.

Initial Consultation919-546-8788

★★★★★

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.