Joint Replacement: What Patients Need to Know

Joint replacement involves surgical removal of a damaged joint – usually a hip or knee – and replacing it with a new, artificial one. The surgery is undertaken by a physician known as an orthopaedic surgeon.

There are some cases in which the surgeon may not remove the entire joint, but instead will only seek replacement of damaged parts. As the American Academy of Orthopaedic Surgeons (AAOS) notes, the procedure is recommended when the joint – where the ends of two bones meet – is a source of pain or disability.

These procedures can offer phenomenal results to some patients, some of whom report a greatly improved quality of life with less pain, improved motion and increased strength.

But as the joint replacement lawyers at Jeffrey Glassman Injury Lawyers well know, there has been a major downside to these medical procedures. In the rush to meet heightened consumer demand for joint replacement products, a number of manufacturers have failed to provide safe, quality medical devices. Instead, they have marketed replacement hips and joints that not only fail or need replaced, but also result in severe side effects and disastrous complications.

Some of those complications include:

• Loose parts/ “nonconforming geometry”/ collapse
• Allergic reaction to metallic debris
• Pseudotumors (soft tissue masses appear in reaction to excess metallic debris)
• Chromium or cobalt poisoning
• Limited range of motion
• Increased joint pain
• Partial failure of the replacement
• Total failure of the replacement
• Hip cup components too shallow, leading to failure
• Swelling
• Device fractures
• Corrective surgery

The majority of these issues are a result of defect product design. The U.S. Food & Drug Administration (FDA) has been less than proactive on this issue, though the agency has been the driving force behind a rising tide of joint replacement device recalls over the last decade.

These complications, combined with the evidence of defect provided by officials recalls, have resulted in a tsunami of litigation against joint replacement device manufacturers. Those pursuing legal action are asking courts to order compensation for:

• Medical bills
• Lost wages
• Pain and suffering
• Ongoing physical therapies and medications
• Diminished life quality
• Mental and emotional anguish
• Loss of consortium

Understanding your rights is the first step toward recovering for these losses. Our experienced, compassionate Boston injury attorneys understand many joint replacement plaintiffs are reeling from both the physical pain and emotional turmoil of the entire ordeal. We can help.

Although generally characterized as a “low-risk” procedure with minimal chance of complications, joint replacement surgery comes with a substantial chance of corrective surgery for removal and/or replacement of the device due to complications.

When asking, “How Real is the Problem?” it’s worth it to point out the sheer volumes of these surgeries being performed.

According to the AAOS, there were nearly 1 million total joint replacements performed in the U.S. in 2011. Most commonly, these involved:

• Hips
• Knees
• Ankles
• Wrist
• Shoulder
• Elbow

A 2014 study by the AAOS revealed the number of total knee replacement surgeries tripled between 1993 and 2009. Meanwhile, the number of total hip replacements doubled over that same time period.

• We can expect to see an increase in these procedures for two reasons:
• Our population is aging. According to the U.S. Census, the 65-and-older population will double between 2012 and 2050, increasing to 83.7 million adults, which will be almost 1 in 5. Baby boomers are expected to live in many cases to 85 years and beyond. Older people are more likely to need joint replacement.
• As a 2014 study in the Journal of Bone and Joint Surgery noted, the U.S. accounts for 95 percent of the increased demand for knee and hip replacements, owing largely to our expanding waistlines. Obesity is one of the primary reasons younger patients require joint replacement.

It’s expected that by 2050, there will be 4 million joint replacement surgeries undergone annually.

The failure rate of these devices is significant. The error rate of these devices has been pinned at anywhere from 7 to 43 percent. Although this has resulted in hundreds of recalls and a growing number of lawsuits, the companies keep making them. Doctors keep implanting them. And we continue to see innocent patients suffer the consequences of dangerous and poorly-designed products.

Metal-on-metal hip replacement devices have an unusually high failure rate.

Evidence presented in some trials indicates the failure rate is as high as 43 percent in some models. In fact, the Great Britain National Health Service has enacted a ban on the products, which officials referred to as “toxic.”

Although several joint manufacturers in the U.S. have recalled their metal hip implants, those actions often came too late for the tens of thousands of people already suffering complications. That’s where we are seeing the majority of lawsuits, particularly against Depuy Hip and Stryker Hip manufacturers.

It’s estimated nearly 100,000 people globally with Depuy Hip implants are suing the company for damages. This product has been used in about 10 percent of all hip replacement surgeries.

In 2012, Stryker recalled its Rejuvenate, ABG II and Accolade stems, citing an increased rate of “adverse local tissue reaction,” resulting primarily from complications involving inflammation of the tissue in and around the implant.

Other manufacturers of these devices include:

• Biomet
• Centerpulse
• Corin
• Encore Orthopedics
• Exactech
• Smith & Nephew
• Write Medical Technology
• Zimmer Holdings

It’s estimated by the Consumers Union that 4.4 million Americans are currently living with knee implants. In just 2011, more than 711,000 knee replacement surgeries were performed. Most of these followed a diagnosis of knee osteoarthritis.

Unfortunately, the industry has failed to make a product that is largely safe, resulting in a flood of Knee Replacement Lawsuits. In fact, only one company offers a warranty for the product, and its estimated as of September 2013, nearly 540,000 Americans who had undergone knee replacement surgery have had to undergo revision procedures to replace the implants.

Consumers Union reports that 2003 and 2013, there have been 709 devices recalled by six knee implant manufacturers, including:

• Biomet – 75 recalls
• DePuy – 277 recalls
• Smith & Nephew – 11 recalls
• Stryker – 118 recalls
• Wright – 4 recalls
• Zimmer – 224 recalls

This often leaves many patients worse off than before. Legal action is sometimes the only viable recourse.

In Choosing an Attorney for a defective joint replacement lawsuit, understand that what you are seeking is a legal team that is well-versed in both medical malpractice and product liability law.

In some cases, defendants are not the surgeons or medical team involved (depending on the circumstances, and if there was post-surgical infection or other complications). Instead, issues largely stem from the fact that devices themselves were defectively designed. For that reason, it’s the manufacturer and distributors who are named as defendants.

Recognize that these are wealthy medical device companies, which means your legal team has to have the knowledge, skill and the resources to properly work your case. These cases are complex, and the evidence required is highly technical.

Some factors to consider:

• Attorney’s reputation and experience;
• Attorney’s ability to communicate clearly and listen to you;
• Your comfort level in divulging your medical history;
• How thoroughly attorney explains the pros and cons of action in your specific case;
• Whether the law firm has successfully negotiated settlements and/or taken similar cases to trial.

Americans spend an estimated $150 billion annually on medical devices, including hip and knee replacement implants. Approximately 1 million people undergo joint replacement surgeries every year, and that number is rapidly increasing.

One would think this would prompt federal authorities to initiate a tough vetting process with tight controls. Unfortunately, the FDA Approval Process is, if anything, becoming more lax. That’s because there has been a massive push by device manufacturers lobbyists to “streamline” FDA approval. The argument goes that the process results in excessive costs and delays, which is detrimental to the public.

But of course, the public suffers incredibly when there is a lack of oversight on the quality of these joint replacement products, resulting in high rates of failure. Just between 2005 and 2009, there were 700 recalls every single year of joint replacement products.

In general, the process is supposed to take about 12 years, and involve:

• Research and development phase (average 1 to 3 years)
• Clinical research and development phase (average 5 to 10 years)
• Post-marketing surveillance phase (2 years)

However, many medical devices have been “fast-tracked,” without going through this kind of rigorous testing and examination.

There is unfortunately no getting around the fact that these cases are costly to pursue, and hiring a lawyer with the requisite experience is crucial.

But the good news is our Boston joint replacement attorneys offer our product liability lawsuit services on a contingency fee basis.

Contingency fee agreements call for a lawyer to receive a percentage of a client’s recovery. There are generally no upfront costs to the client, and there is no attorney fee for the client if the case is unsuccessful. That gives attorneys a great incentive to pursue strong cases and to then to work those cases aggressively.

Mass. Gen. Law ch. 231 § 60I places a limitation on contingency fees. Most contingency fee agreements are about one-third of the total recovery, though there are factors that may cause variation. But in general, contingency fees in Massachusetts can’t exceed:

• 40 percent of the first $150,000 recovered
• 33 and 1/3 percent of the next $150,000 recovered
• 25 percent of the next $200,000 recovered
• 25 percent of any amount by which recovery exceeds $500,000

The Statute of Limitations is a limit on the timeframe in which those wronged can bring legal action. It applies to all different areas of law.

The failure of a medical device, such as a hip replacement or knee replacement system, is a type of personal injury, subject to Mass. Gen. Law. ch. 260 § 2A. This law allows victims of personal injury to seek recovery within 3 Years of the date the “cause of action accrues.”

Generally, we would consider the “cause of action” to be the date of injury. So in a car accident, it would be the date of the crash. But it’s not so simple in defective medical device cases because often, people are unaware the product is defective – and thus harmful – until long after the surgery.

For them, the “cause of action” doesn’t “accrue” until such time they knew or should have known of the injury and/or its cause. This is called the “discovery rule,” and it grants some leeway for victims of defective knee and hip replacement products.

Filing a lawsuit for knee replacement and hip replacement device failures serves the purpose of alerting consumers, the FDA and manufacturers of a serious problem.

Beyond that, the goal of litigation is to help victims obtain Damages. These include compensation for:

• Medical bills
• Lost wages
• Pain and suffering
• Ongoing physical therapies and medications
• Diminished life quality
• Mental and emotional anguish
• Loss of consortium

Where plaintiffs can show manufacturer acted with gross negligence or willful disregard for public safety, punitive damages may be appropriate.

Because of the seriousness of consequences suffered, the stakes are high.

For example, DePuy, a subsidiary of Johnson & Johnson, agreed in 2013 to pay $2.5 billion to settle an estimated 8,000 lawsuits pending in federal court for the failure of its ASR hip devices. That was while the company still faced an additional 5,000 lawsuits for its Pinnacle hip implants.

Although relatively few problems arise in the immediate wake of knee replacement and hip replacement surgeries, it’s the Long-Term Medical Complications that are most problematic.

Some of these include:

• Stiffness/ loss of motion
• Infection
• Continued pain
• Instability
• Neurological problems
• Cardiomyopathy
• Cobalt or chromium poisoning
• Loosening of metal components

Many of these issues are a direct result of prosthetic problems and implant failure, which are most likely because the device is defective.

Although there are a number of different ways makers of dangerous products can be held liable, most Product Liability Against Medical Device Manufacturers will focus on a theory of negligence known as “Defective Design.”

Medical device manufacturers owe a duty to ensure their products are safe before they are placed on the market. As we have seen time and again, they do not always do this.

In order to prove defective design, which is a type of Breach of Warranty of Merchantability, one must show:

• Product poses a foreseeable risk of danger when consumers use the product as intended;
• Plaintiff was injured as a result of proximate defect;
• It was possible for manufacturer to adopt a reasonable alternative design.

The number of successful settlements and verdicts against top joint replacement manufacturers is steadily rising. Our experienced legal team is on the forefront of these cases, fighting for you.