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Smith & Nephew Birmingham Hip Resurfacing System
As we get older, our bodies weaken, bones become sore, and joints break down. Hip and knee problems are common conditions of aging. In fact, in the past decade millions of Americans have had hip replacement surgeries. Unfortunately, some defective artificial hips have caused patients more suffering than their original hip ailments. For one recent example, many patients who received the Birmingham Hip Resurfacing System by Smith & Nephew have had to undergo revision surgeries to cure new and unanticipated problems relating to the medical device. Many of these people have filed lawsuits.

Smith & Nephew’s Birmingham Hip Resurfacing System

Smith & Nephew designs and markets medical devices. One of the medical devices Smith & Nephew manufactures is a joint replacement system. An example of a joint replacement system is a hip implant. The Birmingham Hip Resurfacing (BHR) System is an artificial hip replacement made of metal components. BHRs have been used since 1997. The FDA approved BHRs for use in the United States in 2006; this approval was conditioned on Smith & Nephew reporting and analyzing adverse events, negative side effects, and complaints regarding the BHR. Just like any other medical device or medicine, the BHR must not provide false information (or false hope) to patients about what the device can accomplish.

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Proton pump inhibitors may cause kidney disease
Millions of Americans have stomach issues, many of which are related to heart burn and acid reflux. Thankfully, there are several medicines available over-the-counter and by prescription that prevent and relieve these discomforts. Some drugs that help with these stomach issues are called proton pump inhibitors.

A proton pump inhibitor (PPI) is a medicine that reduces stomach acid. People take PPIs for heart burn, acid reflux, stomach ulcers, and other related conditions. While many PPIs are available by prescription only, some are becoming more readily accessible over-the-counter; you may have seen or heard of Prilosec, Prilosec OTC, Prevacid, or Nexium. These are all well-known PPIs.

PPIs work by preventing stomach acid from being produced – they stop heart burn, indigestion, and acid reflux before it begins. Many people take them first thing in the morning or take them before meals.

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Should I Fire My Lawyer?Occasionally I get calls from people who tell me they are unhappy with their product liability lawyer and want to fire that lawyer and hire someone else.

So should they? Let’s look at it.

Injury Litigation Can Be Highly Stressful

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Testosterone is approved to treat hypogonadism
As with so many other harmful drugs, the use of testosterone went off the rails when companies pushed the drug’s use for off-label purposes. Although testosterone replacement therapy was approved to treat just two specific conditions, companies eventually pushed their products to treat all kinds of other conditions, uses never approved by the FDA. According to the Third Amended Master Long-Form Complaint filed in the testosterone multi-district litigation (MDL 2545), it was this aggressive off-label marketing and label-expansion that led to many unnecessary injuries, suffering, and thousands of lawsuits.

FDA Approves Testosterone For Treatment of Two Conditions 

In 1953 the FDA first approved a version of synthetic testosterone to treat two conditions: (1) primary hypogonadism and (2) hypogonadotropic hypogonadism. Since that time the FDA has not approved testosterone to treat any other diseases or conditions.

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Have you ever had a problem with a medical device? If you want to bring state law claims against the manufacturer or a doctor, there’s an important legal concept you should know about: federal preemption. In a recent case, the court dismissed several of the plaintiff’s claims against Smith & Nephew, finding that the claims were preempted by federal law. Let’s look at what happened in that case to illustrate how preemption works. Note that while this case involves a hip replacement, the same legal principle could apply to any medical device regulated under U.S. law.

Smith & Nephew Artificial Hip Replacement

Artificial hip replacement and hip resurfacing
By way of background, the hip is a ball-and-socket joint, moving not just forward and back (like a knee joint) but also sideways. In a total hip replacement, part of the upper thigh bone and the ball portion of the hip joint are replaced with metal components. Part of the replacement includes a liner between the ball and the socket that allows the hip to rotate freely. Some patients have hip resurfacing surgery instead, where only the interface between the hip joint’s ball and its socket is replaced with a new surface.

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You go to the doctor to get help, not to be hurt. And you take medicine to be healed, not to be harmed. However, some prescription drugs, like Actemra, may do the latter – hurt you instead of help you.

Rheumatoid Arthritis and Actemra
If you or a loved one have rheumatoid arthritis, you may have been prescribed or heard of Actemra. Rheumatoid arthritis (RA) is an autoimmune disorder that causes the joints to swell and become painful. Actemra, also known as tocilizumab, is a prescription drug that is injected weekly or infused monthly to aid patients with their symptoms and slow the progression of RA.

Recently, Actemra has also been prescribed to “help” those with giant cell arteritis. Giant cell arteritis (GCA) is a blood vessel disease that causes the vessels, primarily those in the scalp and head, to swell and become inflamed.

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As we saw in the previous post, the “Birmingham plaintiffs” submitted a 160-page Master Complaint in August 2017, alleging many Smith & Nephew misrepresentations that led to the introduction of an unreasonably dangerous product into the marketplace. In this post we continue our deep dive into the Smith & Nephew Birmingham Hip Master Complaint. (Part 2 in a series.)

“Apples to Oranges”

Smith & Nephew Birmingham Hip Like Other MoM Hips
In a stunning marketing document directed at surgeons titled “Apples to Oranges,” Smith & Nephew announced boldly that the Birmingham Hip Resurfacing system “is not your average ‘metal on metal.’ It’s BHR.” Depicted in the advertisement is an apple with the names of other artificial hip products: ASR, Durom, Cormet, Conserve. It is rather astonishing, suggesting that the BHR was better and safer than these other MoM hips. I guess the BHR is the orange.

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This is the story about the Smith & Nephew Birmingham Hip Resurfacing Device, the patients harmed by the metal-on-metal artificial hip, the lawsuits that followed, and the massive Master Complaint filed last August against Smith & Nephew.

But First, How Do We Get to a “Master Complaint”?

Smith & Nephew lawsuits moved to MDL
This is how product liability multidistrict litigation begins: a product (like an artificial hip) hits the market. The artificial hip is implanted in thousands of patients. A year passes, then a few more. Patients complain of aches, pains, inflammation, noises, maybe even neurological symptoms. Doctors notify the manufacturer and their patients of these bad outcomes. Post-market studies are done. Problems are discovered with the product (in the case of metal-on-metal artificial hips, those problems included metallosis, loosening, pseudotumors, and many other “bad outcomes”). Injured people file lawsuits in courts around the country. The Judicial Panel on Multidistrict Litigation (JPML) eventually realizes it needs to designate one court to handle pretrial issues with the hundreds of cases being filed, so a multidistrict litigation (MDL) site is chosen, and the lawsuits are transferred to that MDL court. From there, the plaintiffs consolidate their efforts, and eventually a Master Complaint is carefully drafted and filed.

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Leukemia patient is prescribed drug Tasigna
If you have a specific type of leukemia—Philadelphia chromosome-positive chronic myeloid leukemia, or Ph+ CML—you may have been prescribed the chemotherapy drug Tasigna (nilotinib). Tasigna offers promise for some patients and may even be associated with remission of their disease—but it’s not without risks.

What’s more alarming, the drug’s manufacturer, Novartis Pharmaceuticals Corporation, may have known about those risks and failed to disclose them to you. People who have been harmed or lost loved ones due to Tasigna have sued Novartis. Here’s what you need to know.

What Is Tasigna?

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Advocating for compensation for DePuy ASR plaintiffs
This is my pitch: People who had to undergo revision surgery because their DePuy ASR artificial hip failed should be compensated for their injuries, even if the revision surgery occurred beyond the ten-year anniversary date of the original implant surgery.

Let me admit the obvious: It’s a bit self-serving for me to argue this point. I am an attorney and I represent individuals injured by the failure of the DePuy ASR device. But I have read a lot about these cases, over many years, and the more I understand the science behind these metal-on-metal (MoM) hips (or the lack of science), I am more convinced that thousands of people have been unfairly injured, even if those injuries did not become obvious for several years. Even ten years.

The DePuy ASR Settlements