Articles Posted in Health & Wellness

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Orthopedic surgeon discussing revision surgery for recalled artificial hip
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:

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Female soldier wearing 3M Earplugs suffers hearing damage
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.

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Hearing Loss For Soldier Wearing 3M 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.

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iStock-812590884-300x200We 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.

War veteran injured by 3M Combat Arms EarplugsThe 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.

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Roundup weedkiller with glyphosate can cause cancer
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.

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FDA Considering Changes to 510(k) Process
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.

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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 RecallValsartan 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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MRI with gadolinium-based contrast agentI’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:

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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

Orthopedic Surgeon Steven TowerSteven 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.

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Some drug companies pay doctors, who then prescribe the company's drugsYou scratch my back, I’ll scratch yours. Favors are often exchanged among friends and family. But what most people don’t know, or don’t want to know, is that questionable “favors” are also exchanged in professional and business relationships. Over the years, there have been reports that favors, or benefits, are too often exchanged between drug manufacturers and doctors and hospitals who prescribe medicines.

Recent studies have explored this relationship and compared data to see if drug makers are, effectively, paying doctors to prescribe their medications.

In 2010, the Affordable Care Act included a section called the Physician Payment Sunshine Act. This Act requires drug and device manufacturers to report any and all payments made to physicians and hospitals. Since 2013, 40.74 million records have been published and $24.92 billion dollars have been given to doctors and hospitals from drug and device manufacturers. The Sunshine Act has been successful at exposing these payments.