Articles Posted in Artificial Hip

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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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For more than three years I have been writing about the dangers of certain implanted medical devices. These devices include artificial hips, hernia mesh, IUDs, IVC filters, and others. And some have caused massive human suffering: neurological problems, sexual dysfunction, immobility, infertility, headaches, pain, even death. If you are reading this sentence then you discovered my site because of your interest in medical devices and the problems they can cause. And if you are interested in this subject, you must see the new Netflix documentary The Bleeding Edge.

The Bleeding EdgeThe Bleeding Edge is a remarkable film investigating the public health crisis caused by our current medical device industry. It examines the two main causes permitting the manufacture and sale of defective medical devices: corporate greed and inadequate FDA oversight. It is a tragic story, particularly when the film takes a close look at many of the actual victims of these harmful medical devices. It’s one thing to hear that the Essure birth control device has injured thousands of women; it’s quite another when you see a woman on screen explain how she has given up on her hope to find love because she can no longer have intercourse due to permanent internal injuries. It is deeply sad to hear these stories. And it may have you writing your member of congress. Which you should.

I urge you to check out the film. Here are a few key takeaways:

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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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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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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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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

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Surgeon implanting artificial hipIt’s nice to see that I may be out in front of a national publication like The New York Times. For two and a half years I have been writing on the dangers of metal-on-metal artificial hips and the deeply-flawed 510(k) medical device approval process. On Saturday Jeanne Lenzer published a very informative piece in the Times on the potential dangers of hip replacement surgery: Can Your Hip Replacement Kill You? Ms. Lenzer examines the way too many medical devices reach the marketplace without proper clinical testing. It is a subject I have written about often. Most people don’t realize how easy the FDA has made it for companies to release new medical products, but it is important to be aware of this weak regulatory system before you allow any surgeon to implant a device in your body. Federal courts across the country are littered with multidistrict litigation involving dozens of failed medical devices. In my view the 510(k) process is the reason for much of this litigation and misery. With proper testing and analysis, many of these serious injuries from dangerous products could be avoided.

One chilling statistic in the NYT article: medical interventions–including artificial hip and other medical implant surgeries–are the third leading cause of death in the United States.

By the way, Jeanne Lenzer recently published a book that you should read: The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It. I just bought a copy, have already begun reading it, and will discuss in a later post.

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For many years my clients with failing artificial hips have asked me about the health effects of high cobalt and chromium levels in the body. These questions usually arise after clients get blood work done and the test reveals abnormally high metal levels. If you are reading this article, you probably already know that cobalt and chromium are two metals used in the construction of most metal-on-metal (MoM) artificial hip systems. In fact, cobalt and chromium are used to make artificial hips that are not metal-on-metal but instead use polyethylene liners, or ceramic heads, or other non-metal components. When metal components grind together, as they naturally do when a MoM artificial hip is implanted in a person, very small metal particles can be released into the tissue and the bloodstream. I wrote about the health effects of metallosis on the body over a year ago. You can check out that article here.

Cobalt poisoning from artificial hip implants
Dr. Steven Tower, an orthopedic surgeon in Alaska, recently gave a fascinating (and alarming) talk about the many neurological problems he has observed in hip patients with elevated cobalt levels in the body. For years the focus following hip replacement surgeries has been on the physical condition of the hip itself. Dr. Tower has concluded that this approach is wrong, or at least incomplete, and he has seen that often the first signs of trouble with hip replacement patients are neurological symptoms. He has even given it a name: Arthroplasty Cobalt Encephalopathy, or ACE.

What is Arthroplasty Cobalt Encephalopathy (ACE)?

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On November 16, 2017, yet another Texas jury Huge Verdict in Fourth DePuy Pinnacle Trialdelivered a huge verdict to the victims of the DePuy Pinnacle artificial hip. In this fourth bellwether trial, the jury awarded $247,000,000.00 to six plaintiffs and their spouses. According to news reports, after a two-month, hard-fought trial, the jury found that DePuy Orthopaedics and parent company Johnson & Johnson were liable to plaintiffs for the Pinnacle’s design and manufacturing defects. But the jury went further, concluding that the actions of the companies were fraudulent and deceptive, and that they had acted recklessly and maliciously in manufacturing, selling, and promoting the flawed products.

These last terms have special meaning in law: findings of fraud, deception, recklessness, and malice indicate that the companies went beyond mere negligence, that the defendants misbehaved intentionally or with a reckless disregard to the fact that their actions would harm innocent people. Because of these special findings, the plaintiffs were entitled to receive “punitive damages” from DePuy and J&J, which are money damages intended to punish defendants for especially bad behavior.

The jury awarded $90 million dollars in punitive damages to be paid by J&J, and $78 million in punitive damages to be paid by DePuy. That’s $168 million in total punitive damages. It is a lot of money.