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It’s a great question. And I’m glad I asked it for you. Now let me answer it. There are several ways to identify the specific medical device implanted in your body. (A medical device is any manufactured device–like an artificial hip–implanted in the body for the purpose of resolving an injury, curing disease, or improving a person’s health. Medical devices can be artificial joints like hips and knees and shoulders, heart stents and pacemakers, IVC filters, hernia mesh, and hundreds of other examples.)  Some ways of identifying exact product components are better than others. Identifying the medical device several different ways is the best of all.

Product Stickers: The Gold Standard

Product Stickers
It all sort of starts with “product stickers.” These are the identifying stickers that are attached to the box containing the medical device, and they can be peeled off and affixed to a nurse’s hospital note or to another page in the hospital or surgeon’s record for the implant surgery. It goes something like this: the representative for the device maker shows up with the artificial hip components (or other medical device). The surgical nurse or the surgeon will double check that the components are the precise ones needed for the surgery, scan them into the system and note them in the record. The nurse will then peel off the product stickers and attach them to the hospital record and include them with all the other pages of documents explaining details of the surgery. The image at right is an approximation of what the stickers will look like: a bar code, the name of the manufacturer, the specific product name, the Lot and Reference numbers, and other identifying information.

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Smith & Nephew Birmingham Hip Litigation
I have written about artificial hip litigation on this site more than any other area of product liability law, and for a very good reason: there is a lot to write about. Metal-on-metal hips have gravely injured tens of thousands of people, and new victims are undergoing revision surgeries each week to remove defective hips. One current active litigation involves Smith & Nephew “Birmingham” artificial hips. MDL 2775 is the multidistrict litigation court handling hundreds of lawsuits filed against medical device maker Smith & Nephew for these (allegedly) defective artificial hips. There are several artificial hip products involved in MDL 2775:

Birmingham Hip Resurfacing System (BHR). The multidistrict litigation court was first organized to handle these BHR lawsuits. The BHR system is a type of metal-on-metal artificial hip, but in resurfacing procedures the  hip “ball” bone is shaped and resurfaced with a smooth metal covering and a metal shell is implanted into the hip socket, thus creating a metal-on-metal connection or “articulation.” As with most metal-on-metal artificial hips, Smith & Nephew uses cobalt and chromium to construct both of these resurfacing components. These metals have been shown to wear away and leach into the blood and tissue of the patient, causing all kinds of symptoms and problems, including metallosis.

BHR Hip Components Used in Total Hip Arthroplasty (THA). These hip implants are constructed with Smith & Nephew BHR components and non-BHR components, but instead of resurfacing the “ball-bone” with a metal covering the bone is removed and a metal ball component is implanted. MDL 2775 added these Total Hip Arthroplasty (THA) cases to the litigation shortly after the MDL launched.

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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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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.

Plaintiffs' Lawyers Are Consumer Protection Heroes
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.

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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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Artificial Hip Joint Showing femoral head and femoral neck and stem
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.

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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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Oxycontin is one opioid causing addiction
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