Earlier this year I wrote a blog post that discussed the recent revelation that Zantac might cause cancer. Scientists found a link between N-Nitrosodimethylamine (NDMA), a likely cancer-causing substance, and ranitidine, the key ingredient in Zantac.
A few things have changed since that blog post, such as the U.S. Food and Drug Administration (FDA) asking all manufacturers to immediately recall drugs containing ranitidine from the market.
Why Did the FDA Ask for a Recall?
These days the e-cigarette headlines mostly involve people who have suffered serious and even mysterious illnesses as a result of vaping devices. And maybe that is as it should be. But for me, one of the more devastating aspects of this e-cigarette nightmare is that today millions of school-age children have become addicted to nicotine, an addiction most of them would have never suffered if e-cigarettes were not marketed to children.
Childhood Nicotine Addiction is No Accident
JUUL Labs, Inc. targeted children in its marketing campaigns. The company spent millions promoting kid-friendly fruit-flavored vape pods. JUUL paid for and developed social media campaigns on Instagram, YouTube, Twitter, and other platforms. Although the main JUUL Instagram account is now inactive, many other JUUL or vape-related sites feature young people exhaling clouds of the white vapor while sitting on a beach, on the bleachers of a school football field, or driving around town. Congress developed evidence last year that JUUL created an “influencer program” with more than 25,000 social media personalities paid to market the JUUL device to teens. And it worked. As the graph at right shows, seven in ten teens were exposed in some form to e-cigarette advertising.
Here is a strange cause and effect: if you don’t keep your weight at healthy levels, you may unwittingly become a victim to a negligent manufacturer selling a defective medical device. Which ultimately means your weight gain may one day lead you to me and to becoming a plaintiff in defective product litigation.
It Works This Way:
Let’s say your job is intense and over the years you begin to neglect your physical fitness. As you get a little older, in this sedentary state, you begin to gain weight. Gaining weight makes you less willing or able to exercise and you gain even more weight. Soon you start to feel aches in your hip or maybe your knees. This pain, over time, gets worse. Finally you consult an orthopedic surgeon, who recommends a total hip or knee replacement. Because you are a trusting soul, and because the hip pain is getting worse, you schedule hip replacement surgery. At this surgery your doctor implants the latest metal-on-metal (MoM) artificial hip components. A year or two later a new kind of hip pain develops, and this hip pain gets severe quickly. Your surgeon does blood work and tells you that your metal levels have spiked in your body and–of yeah, one other thing–you also have a “recalled” artificial hip implanted and that it needs to come out. So you are now forced to undergo revision surgery, and you eventually find your way to me to file a lawsuit over the injuries you sustained from this defective medical device.
I get this question fairly often, and it’s a good one. It usually goes something like this: a person had a total hip replacement several years ago. A few years pass. Then out of the blue the individual receives a letter from the artificial hip manufacturer or from the implanting surgeon explaining that a recall has been issued for the artificial hip components implanted. (And these are the lucky patients; many people who receive an artificial hip that was later recalled never get notification from their doctor, the manufacturer, or anyone. They don’t discover they have a defective artificial hip until the pain, metallosis, or other injury develops.) If I were in this position, and I received a recalled artificial hip, I would want to know: Should I have the recalled hip removed? And should I have the hip removed immediately?
As with most things in life, the answer is not simple.
I have been a product liability lawyer for many years now, and in that time I have spoken with hundreds of people suffering from defective products. I have heard dozens of variations on a similar narrative. While this is neither medical nor legal advice, here are my suggestions:
Hearing loss is awful no matter how it happens. I’m sure it has been stellar to play guitar for The Who, as Pete Townshend has done for decades. Sadly though he now suffers from serious hearing loss and tinnitus. Townshend contracted noise-induced hearing loss (NIHL) after years standing too close to powerful amplifiers projecting extremely loud rock music. Eric Clapton has also suffered hearing loss because of his work as a blues guitarist and rock musician. Townshend and Clapton have had legendary careers, but their suffering today from hearing loss is very real and awful.
The reality is, anyone who works in loud environments can suffer NIHL. Musicians, engine mechanics, construction workers, miners, and farmers are all susceptible to hearing loss from the work they do in loud environments and with loud equipment. (I’ve even read that the squeal of a pig can reach decibels of 115, louder than a power tool!)
Perhaps the worst cruelty occurs when members of our armed services suffer hearing loss. These are people who volunteer to keep us safe. These are people who choose a career which may call for them to go to war and fight and possibly die to protect the rest of us. Of course you would expect that the least we would do as a nation is to send these men and women out to train and serve with the safest possible equipment. Sadly, though, news reports are emerging that military service members were issued defective earplugs that may have caused permanent hearing damage to hundreds of thousands of soldiers. These earplugs were developed by the Aearo family of companies, which was then bought out by 3M Company. The earplugs were called Dual-Ended Combat Arms Earplugs (CAEv2). And between 2003-2015, Aearo and 3M sold millions of pairs of these earplugs to the branches of the armed forces. If you served in the military during this period and were issued dual-sided earplugs (with a distinctive olive and yellow color), you got the Combat Arms Earplugs.
In my last post I introduced the 3M Earplugs and the (alleged) defects that caused hearing loss in thousands of military service personnel. I thought it would be helpful to bullet point some of the key allegations made by injured soldiers in lawsuits filed against 3M related to these earplugs.
First, I refer to this product simply as the 3M Earplugs. However, the product’s official name is the Dual-Ended Combat Arms Earplugs (CAEv2). So if in your reading you see 3M Earplugs or Combat Arms Earplugs, it is most likely the same product.
Second, I need to provide some clarification on the defendants involved in this expanding litigation. The 3M Earplugs were originally developed and manufactured by Aearo Holding Corporation (which became Aearo Holding LLC) along with the involvement of Aearo Technologies LLC, Aearo Intermediate LLC, and Aearo LLC. It may be a bit confusing, but it’s not uncommon for a company to have subsidiary companies handling research, or development, or the manufacture of a product. In any case, 3M Company bought Aearo Holding LLC in 2008 and with the purchase acquired the Combat Arms Earplugs. The Earplugs were thus placed under the 3M brand, and 3M became entitled to the profits flowing from the earplugs but also became responsible for the liabilities of the product. Thus, 3M Company is the primary defendant in this litigation.
We rely on safety equipment to do what it was meant to do: protect us. But this is precisely what 3M earplugs have failed to do for our troops. The specific product at issue? 3M’s now discontinued Combat Arms earplugs issued to U.S. military servicemen and women from 2002 until 2013. The fundamental flaw with the earplugs? They were too short and therefore could not adequately provide hearing protection to our troops while they were in combat situations or were involved in training activities. The result? Many members of our military now have to deal with irreparable, but completely avoidable, hearing damage from a defective product. Combat situations are dangerous enough as it is. Service members should have the peace of mind that basic safety equipment will be free of fundamental defects and will function properly.
These Combat Arms earplugs got the attention of the United States government. In 2016 the Justice Department accused 3M of knowingly providing defective earplugs after the government learned of 3M’s activities thanks to whistle-blower activities by another earplug maker, Moldex-Metric, Inc. In the summer of 2018, 3M paid approximately $9.1 million to settle the claims made by the government. Justice, however, is far from complete. There are countless veterans and current active duty military now dealing with the hearing damage from relying on these faulty products for hearing protection. These individuals, however, are not seeing a penny from the 2018 settlement. Individual lawsuits against 3M are therefore necessary for those damaged to obtain compensation for the preventable damage done to their bodies.
The Combat Arms earplugs at issue were originally developed by Aearo Technologies; 3M later acquired the company and its products. These earplugs had a two-sided design that was supposed to provide ear protection no matter which side was inserted into the ear. The yellow side was supposed to provide protection against high-level impulsive noise while still allowing the wearer to hear talking, commands and other lower level noises. The other side, the green side, was intended to block out all sounds. According to several lawsuits brought by injured service members, the earplugs did not work as designed, largely because they did not stay in place properly due to their length. Internal documents linked to 3M allegedly suggest that 3M was on notice of the defect and failed to take action. Now, our veterans are paying the price.
Herbicides have become a way of life. For some, like farmers and ground maintenance men, herbicide application is part of making a living. For homeowners, herbicides are used to grow the perfect weed-free lawn. For all of us, herbicide usage is closely linked to the production of our food. The most common herbicide? Glyphosate-based herbicides. The most well-known brand? Roundup. The alarming part? Glyphosate exposure has been alleged to increase the risk of cancer. More particularly, glyphosate is allegedly related to the increased risk for non-Hodgkin’s lymphoma and other blood cancers. Glyphosate-based herbicides are still widely used in our country.
Glyphosate discovered in the 1970s
In 1970, a chemist working at Monsanto within the herbicide screening program named John Franz discovered glyphosate, an organophosphate compound which would become the active ingredient in Monsanto’s Roundup herbicide. By 1972, Roundup was marketed to the public as an environmentally friendly herbicide that is safe for both human and wildlife alike. Roundup was produced commercially starting in 1974. It would quickly become one of the most popular herbicides of all time.
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.
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.
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