13: Making Sense of Medical Device “Adverse Events” with Madris Kinard

I am Clay Hodges, an attorney based in Raleigh, North Carolina. For the past 20 years, I have been representing individuals injured by defective products, problematic medications, and toxic exposures.  Today, I am following up on the Camp Lejeune toxic water litigation. If you, one of your family members, or someone you know suffered extended exposure to contaminated water at Camp Lejeune between 1953 and 1987, it is essential to file an administrative claim with the US Navy before August 10, 2024. That is a firm deadline, so missing it would mean losing out on any chance of compensation.  While filing the claim is not overly complex, I strongly recommend seeking legal guidance from someone well-versed in this type of litigation. Remember the cutoff date, and don’t delay in taking action if you are in a position to pursue a claim. Stay tuned for more!  Show Highlights: The deadline for filing Camp Lejeune water contamination claims is August 10, 2024 How Marine Corps veterans and their families can claim a financial recovery At which time were active duty marines exposed to the toxic water at Camp Lejeune? How the exposure to toxic water at Camp Lejeune may have caused many diseases The various types of cancers and diseases the plaintiffs claim the contaminated water has caused  How the exposure to toxic water at Camp Lejeune may result in a million individual claims  Remember, the deadline for filing Camp Lejeune water contamination claims is August 10, 2024 Links and resources: If you think you may have a litigation case, call Clay at 919-334-6277. Check out Clay Hodges's website     Please note that this podcast is for informational purposes only and is not legal advice nor intended to be legal advice. If you need a legal opinion about your particular case, contact me or another attorney.

A remarkable new law has just been passed that will open a channel to financial compensation for people exposed to toxic water at the Camp Lejeune Marine Corps base in Jacksonville, North Carolina. Those exposed to the toxic water developed serious health problems, including many cancers. Before going to law school, attorney Clay Hodges was an English instructor at Coastal Carolina Community College in Jacksonville. He spent several years teaching US Marines, their spouses, children, and other dependents. He also taught classes directly on the Marine Corps base at Camp Lejeune, so he is very familiar with Camp Lejeune and the Jacksonville area. In August 2022, President Joe Biden signed the new bill that created a federal cause of action related to toxic water at Camp Lejeune between 1953 and 1987. In today’s podcast, attorney Hodges reviews certain parts of the bill, unpacks the language, and dives into the details of the exciting new legislation called the Camp Lejune Justice Act of 2022.  Stay tuned to hear the details of the recently legislated Camp Lejune water act. Show highlights The period between 1953 and 1987 is the most important detail of the Camp Lejeune bill. Attorney Hodges explains who might have a valid case.  What do we know about the contamination of the water at Camp Lejeune? Some of the toxic chemicals found in the water supply at Camp Lejeune. The chemicals found in the drinking water at Camp Lejeune are extremely harmful to human life. Extended exposure to the chemicals in the Camp Lejeune drinking water has been linked to birth defects, various cancers, and other major health problems. As far as we know, the water at Camp Lejeune is now safe to drink. You have only two years in which to submit an administrative petition or file a lawsuit against the federal government if you think you have a claim under the new legislation. Under the new legislation, the exclusive jurisdiction for these cases will be the Federal Court in the Eastern District of North Carolina. Family members of deceased people who qualify under the new law can claim compensation for the wrongful death of the deceased person. Attorney Hodges explains why the new law is so extraordinary. Links and resources: If you think you may have a case, call Clay at 919-546-8788 to discuss further. Check out Clay Hodges's website   

Exactech Inc. has been in business since 1985. The company focuses on developing products for joint replacements, including hip, knee, and ankle replacements. Exactech’s components for joint replacement have been useful, and may have performed well over the years. However, in June of 2021, Exactech Inc. had to issue a series of recalls for several different plastic liner implants that fit within the normal artificial hip, knee, and ankle replacements because they caused a great deal of problems for patients. In this podcast, attorney Clay Hodges gives an overview of the series of recalls that Exactech has issued for its polyethylene liners for hip, knee, and ankle joint replacement surgeries that will lead to litigation. Between 2008 and 2021, more than 89,000 Exactech Connexion GXL Hip Liners from Exactech got implanted worldwide, and since 2004, Exactech has sold 140,732 liner tibial base plates for knee replacements.  Exactech is taking this problem seriously. So if you have had a hip, knee, or ankle replacement done in the last 15 years, stay tuned to find out how to know if you have one of Exactech’s recalled products implanted in your body and what you can do if you have one.  Show highlights: What have studies shown about the polyethylene used to manufacture the plastic liners for artificial hip replacement surgery? Why is the polyethylene liner so important in artificial hip surgery? Some problems that the breaking down of Exactech’s hip plastic liners caused.  Check out your surgical records to see which surgical products were placed in your body if you have been experiencing problems with an artificial hip replacement done in the last 15 years. You might qualify for litigation or need to have revision surgery. Check on the FDA website to see if you have a recalled product implanted in your body. From 2008 to April of 2021, more than 89,000 Connexion GXL Hip Liners from Exactech were implanted in people worldwide. The second group of recalls is related to Exactech’s plastic liners for knee and ankle replacement products. The liners for knee and hip replacements were made from ultra-high molecular weight polyethylene (UHMWP), which has to be packaged in special oxygen-resistant vacuum bags.  One of the key problems with the knee replacement liners was caused by this defective packaging.  The potential problems the recalled models of liner tibial base plates for knee replacements, manufactured and sold by Exactech, could cause. The ankle product is a Vantage fixed-bearing liner. There might be only about 1500 of those products out there. Links and resources: If you think you may have a case against Exactech, call Clay at 919-546-8788. Check out Clay Hodges's website     U.S. Food and Drug Administration

Metal-on-metal artificial hip devices have been available for more than twenty years. Years ago, product manufacturers thought that metals like titanium, cobalt, and chromium used in the construction of artificial hips would last a lot longer than the regular shelf life of other artificial hips using plastics and ceramic materials, particularly for athletes and active people. Unfortunately, those metals have caused many problems, like metallosis, which happens when metal particles grind away from the artificial hip and leach into the bloodstream and surrounding tissue, causing pseudotumors, high levels of metal in the blood, and other problems. Various manufacturers developed different metal-on-metal artificial hips. In most cases, it did not go well for the thousands of patients who had hip replacement surgery. Hundreds of thousands of those patients have subsequently become plaintiffs in litigation against all those companies.  In this podcast conversation, Attorney Clay Hodges updates on the Smith & Nephew Birmingham hip litigation, which has been going on for several years. The litigation has become quite active lately, with many new cases filed. Stay tuned to hear the details, and find out what it could mean for you if you have had a hip replacement done in the last ten to fifteen years. Show highlights: Smith & Nephew first began to sell the Birmingham Hip Resurfacing device in the United States in 2006.  The different types of surgery required for the two Birmingham hip systems at play in this litigation. With the first type of Birmingham Hip Resurfacing System, Smith & Nephew provided the resurfacing components only. That was approved by the FDA in 2006. Smith & Nephew described the Birmingham Hip Resurfacing System as a good choice for more active patients because the company said it would last longer than other systems. While companies like Zimmer and DePuy were having trouble with their own MoM artificial hips, Smith & Nephew claimed that its Birmingham hip was a different type of metal hip implant that could be distinguished positively from those causing problems. The Birmingham hip components used as part of a total hip replacement were the second type of Smith & Nephew hip that has led to litigation. The S&N Birmingham THA components did not get FDA approval. All brands of metal-on-metal hips have caused problems, injuries, and symptoms. That is why they are mostly no longer in use today. Smith & Nephew lawsuits began for similar problems occurring with the Birmingham hip components soon after Zimmer and DePuy started dealing with litigation for their metal-on-metal hip systems. The results of the S&N bellwether trial that took place for one of the first Smith & Nephew cases last June.  What does this litigation mean for you if you have had a hip replacement done in the last ten to fifteen years? Links and resources: If you think you may have a possible S&N Birmingham case, call Clay at 919-546-8788. Note: The information in this podcast episode is for informational purposes only. All the information in this episode was derived from media reports, public court filings, and other publicly available resources. Any opinions presented are mine alone. The information provided is not intended to be and should not be construed as legal or medical advice.

CPAP, BiPAP, and ventilator machines are used to alleviate the symptoms of sleep apnea and other conditions. Millions of people rely on those devices to keep their airways open throughout the night so that they can get a good night’s rest and avoid other health issues. Recently, the Phillips family of companies issued a massive recall for several CPAP, BiPAP, and ventilator machines. In this conversation, Attorney Clay Hodges gets into the details of the CPAP Recall. Between three and four million machines have been affected by it, and it could take a year or more to repair or replace them all. This subject is very important, so if you or anyone you know uses any of these devices, tune in to this episode to find out more! Show highlights: What are CPAP and BiPAP machines? What are CPAP and BiPAP used for? The difference between the CPAP and the BiPAP machines. How obstructive sleep apnea affects people. The reason for the recall. The PE-PUR foam Phillips used to manufacture their machines. Two main problems that can result from the foam used by Phillips in the manufacture of their machines. Brand names of devices that were recalled. The potential injuries that can result from using the recalled devices. Some suggestions for what you can do if you believe you have a recalled machine or have injuries resulting from a defective device. Links and resources: If you think you may have a case for litigation, call Clay at 919-546-8788.

The HIV medication tenofovir has been prescribed for years to delay the progression of HIV, the virus that causes AIDS. Studies are now showing serious problems from this medication, including toxicity to kidneys, bone loss, and bone injury. Join us on this episode to learn more about tenofovir and its problems. We are joined by my friend and fellow product liability lawyer, Whitney Butcher, an attorney with Hilliard Martinez & Gonzales. Whitney has a long history of representing individuals injured by harmful medications and defective medical devices. In today’s conversation, we discuss tenofovir and the brand-name medications (like Truvada) that have been developed from this compound, the problems that have been discovered, and the litigation that has followed.  Show Highlights: How antiretroviral drugs target HIV cells and keep them from replicating Tenofovir: a compound found to be effective in preventing the replication of HIV cells but also nephrotoxic How tenofovir began in IV form but was then put in pill form around 2001 with specific delivery agents The TDF combination developed by Gilead Sciences that hit the market in 2001 under the brand names Viread, Truvada, Atripla, Complera, and Stribild How TDF can damage the kidneys Why TAF is safer than TDF and more stable in the body, leading to less systemic exposure and toxicity How Gilead allegedly prioritized TDF medications over safer TAF options to maximize profits for 14-15 years Why warning labels about TDF were stronger in Canada and European Union countries than in the US How TDF leads to bone injury and stress fractures in patients The lawsuits against Gilead in state and federal courts in CA and how they differ from class-action lawsuits   Resources: https://www.northcarolinaproductliabilitylawyer.com  

Paraquat is a popular chemical used as a pesticide for many farms and vineyards in the United States. Unfortunately, many consumers are unaware of the harmful and deadly effects this toxic chemical can have on their health.  In this conversation, Clay Hodges shares the inside scoop on Paraquat and reveals the many deadly side effects this product can have. If you or anyone you know has come in contact with this chemical, tune into this episode to learn more! Show Highlights:  What is Paraquat  Where can you get Paraquat and why you have to have an RUP Why has Paraquat gotten more popular  Who would be using Paraquat  What is Paraquat used on  Connections between Paraquat and Parkinson's disease  What regulations have been put on Paraquat  What to do if you’ve been exposed to Paraquat    Links:  https://www.northcarolinaproductliabilitylawyer.com

We all try to be conscious of what we eat, so shouldn’t we be conscious of what medical devices are implanted in our bodies? Unfortunately, most people can’t make sense of the millions of adverse events filed with the FDA.  Today’s guest, Madris Kinard, left the FDA after years of seeing patients not get the data they need and started Device Events. Device Events is a subscription-based service that provides stakeholders with accessible information on products. Join Clay Hodges in this interview for more information on the gaps in the FDA, changes being made, and what Device Events does differently.  Show Highlights:  How Madris started Device Events and the primary purpose of the service  What was not working with the FDA that made this service needed  How does Device Events work and what makes it a valuable service  What could the FDA do to make data more accessible  The timeline and process of recalls  Why devices should stop being put on the market based on a grandfathered device  Public panels the FDA has held for individuals to express issues  Why it’s important to know what materials are in devices  The medical devices Madris is currently examining Issues with current dental implants and reported injuries  Problems with breast implants and symptoms they cause    Links:  https://www.deviceevents.com https://www.northcarolinaproductliabilitylawyer.com

In this week’s episode, Clay’s friend and former client shares her experience from recovering from not one, but three hip replacement surgeries. “Amy” discusses her journey from discovering her need for hip replacement surgery, to having the surgery, to how she knew the product was defective, and through her recovery process. This conversation is full of important information if you have or think you may need a hip replacement. Join Clay Hodges in this episode to learn more about Amy’s experience with a defective hip replacement.   Show Highlights:    Amy shares what her physical activity looked like before her hip replacement   When and how Amy realized she needed surgery  Amy shares when she got her first surgery and what her recovery was like   How Amy found out her hip replacement was defective   The rehab process after the revision surgery vs the initial surgery   Amy shares her experience with pain management and medicine   The differences between each revision surgery   Amy shares how she’s worked to get active again   Why it takes diligence to recover and build strength back  The importance of seeking out support     Links:   https://www.northcarolinaproductliabilitylawyer.com 

While many of us think critically and “do our own research” when it comes to our healthcare, that often is not enough when the media we consume is inaccurate and driven by profit. Today’s guest, Dr. Jerome Hoffman, is a professor of medicine and emergency medicine at the UCLA School of Medicine, who is passionate about the problems of over-diagnosing and over-treating patients.    Dr. Hoffman discusses the power of profit in the pharmaceutical world and how it impacts our medical treatment. Dr. Hoffman wants to see change in the medical field by teaching people to be more thoughtful and careful about their own healthcare. Join Clay in this insightful and highly informative episode to learn more about what really goes on behind the scenes of American healthcare.  Show Highlights:  Why is healthcare so expensive in the United States? The “myths” of American healthcare Common mistakes the medical system makes when over-diagnosing  What drives over-diagnosis in America  How money influences Big Pharma  Ways that gifts are used to build bias  The power of “friendship” within companies  How to stay ethical in the medical field  Why are blockbuster drugs problems for patients  How pharmaceutical companies decide what goes on the market How the American healthcare compares to other countries  Reforms Dr. Hoffman believes would improve the healthcare system  Links:  https://www.northcarolinaproductliabilitylawyer.com