When a defective medical device such as a metal hip implant is released on the market, it can cause widespread harm to many users. The manufacturer of the medical device should be held responsible for damages, and each victim can potentially file a lawsuit against the manufacturer. Typically, when this occurs, mass tort lawsuits arise. Consumer Alert Now is a nationwide agency that gives information on potentially harmful medical devices and how to take legal action through mass torts.
What is Metal Hip Replacement?
To understand what a metal hip replacement is, it is essential first to define a medical device. If equipment or a product is used, labeled, or promoted in a way that satisfies the definition below, it is controlled by the Food and Drugs Administration (FDA) as a medical device. It is also subject to both premarketing and post-marketing regulation. According to Federal Food Drug and Cosmetic Act (FD&C), a metal hip replacement is an apparatus, instrument, machine, implant, in vitro reagent, contrivance, machine, or any related article, including an accessory or part that is:
- Recognized in the U.S Pharmacopoeia, National Formulary, or their supplement
- Purposed to diagnose a disease, or cure mitigation, prevention, treatment of a disease in animals or man
- Purposed to alter the function or structure of the body of an animal or man. It should not realize its main purpose through chemical action on or within the body. It does not depend on metabolism to accomplish its intended purpose.
The above definition gives a distinctive difference between medical devices and other Food and Drug Administration controlled products like drugs. If the primary purpose of a product is realized by being metabolized by your body or through chemical action, then that product is a drug.
A Brief Summary on a Metal Hip Replacement
Metal hip replacements were first designed to improve ceramic and plastic hip replacements. It is a total hip replacement and resurfacing where the femoral head (artificial ball) and acetabulum (socket) are metallic. These components are designed to reduce the chances of wearing out.
It promises a bright medical future. Most patients above 50 years of age choose hip replacement surgery while younger patients prefer the durable hip replacement since they are likely to live many years. The boom in the procedure has made it one of the most common surgical procedures in the US. In fact, surgeons conduct approximately 285,000 hip replacement procedures annually.
How Do You Know if You Need a Hip Replacement?
This may seem a stupid question. However, it is crucial to realize that hip replacement is a significant procedure, and you should only consider it if you have run out of options. Your physician may diagnose arthritis in your hip and tell you that hip replacement is the only option, but only you can make a decision that works for you.
Conditions that may necessitate hip replacement include:
- Osteonecrosis- It occurs when the bone deforms and collapses. An inadequate supply of blood to the ball portion of the hip joint causes Osteonecrosis.
- Rheumatoid arthritis- Rheumatoid arthritis is an inflammation that erodes cartilage and underlying bone leading to deformed and damaged joints. An overactive immune system triggers it.
- Osteoarthritis- Also referred to as wear and tear arthritis, osteoarthritis harm slick cartilage that covers the ends of your bones and assists joints to move smoothly
- Hip fracture
You can consider this procedure when you are experiencing a lot of pain and stiffness that can't be treated using any other treatment option. Common symptoms include pain, stiffness, and the following:
- Persists despite taking pain killers
- Hinders the ability to perform your daily chores
- Makes it hard walking even when using a walker or cane
- Experience challenges getting out of a seated position
- Prevents you from climbing stairs
- Affects your sleep
These symptoms may vary daily.
Hip Replacement Complications
Many medical practitioners have touted hip replacement as a noteworthy medical device innovation of the 20th century. It has assisted many patients to recover from painful fractures, arthritis, and boosted their quality of life. According to a Clinical Orthopaedics and Related Research conducted in 2018, patients with hip replacement implant have a better life expectancy than the general population.
However, hip replacement has proved to be a disappointment. Common complications include:
Millions of patients have replaced their hip replacement implants after a few years (metal hip implants are meant to last twenty years). This is primarily because of the friction between the socket, and the metal ball causes your implant to wear quickly.
Also, as the medical device wears out, metallic particles are released into your bloodstream. These particles are incredibly tiny, and each step releases a number of them. According to a study report published in the Journal of Orthopedic Surgery and Traumatology Czechoslovakia, approximately four hundred and seventy thousand particles are released in a hip with a polyethylene artificial and metal hip.
The kind of debris released depends mainly on the implant used. Different material can lead to different difficulties. For instance, a metal-on-metal hip implant releases metal debris known as ions that could result in Metallosis. On the contrary, metal-on-plastic hip replacement releases polyethylene particles which could cause osteolysis.
Other long-term severe complications due to metal ions being absorbed into your bloodstream include:
- Neurological alterations such as visual and hearing impairment
- Affects kidney function
- Skin rash
- Thyroid dysfunction like fatigue, feeling cold, weight gain, and neck discomfort
- Psychological alterations such as cognitive impairment and depression
- Reduced ability of your heart to pump blood (cardiomyopathy)
- Early implant failure
Many people who have undergone a defective metal hip replacement procedure are most likely required to undergo hip revision surgery. During the revision, the metal hip is removed and replaced with a safer model. The revision surgery comes with its risks such as nerve damage and infection.
Additionally, you should rest and take recuperation following the surgery. That means you will be required to incur bills that aren't covered in your medical insurance policy as well as take time off work to receive physical therapy.
As noted earlier, Metallosis is caused by the release of metallic ions from a metal hip replacement into your soft tissues. A study conducted in the European Journal of Radiology Open in 2014 discovered that this condition was diagnosed in five percent of metal-on-metal implant patients. The researchers went ahead to report that this is a decline as most medical experts have stopped recommending metal-on-metal procedures.
Metallosis can lead to grey discoloration of the tissue around your implant. Usually, this is an indication that the tissue is dying and oxygen-starved. This can cause metal poisoning in patients with metal sensitivity.
During the procedure, your doctor will remove the dense and thick tissue, which is around the joint and holds your hip in place. This can permit dislocation to take place. Proper metal placement is essential to the metal implant remaining in place for long. To avoid other complications, you may also be required to change your lifestyle.
Dislocation failing will most likely occur months after the procedure. Typically, the condition is fixed by closed reduction, which avoids the entire procedure. In other cases, the complication requires a revision procedure.
Heterotopic ossification is a common side effect that occurs when a bone forms outside the skeleton and the soft tissue is hardened. The complication in question happens in areas where severe trauma occurred.
You are likely to experience side effects such as a reduced range of motion, tenderness, or swelling. Heterotopic ossification could be treated using anti-inflammatory medication or low-dose radiation.
Inflection is a devastating complication of hip replacement. Luckily, it occurs occasionally. According to the American Academy of Orthopaedic Surgeons, the risk is 1%.
Although the chances of getting infected are minimal, the long-term effect is catastrophic. If it is discovered within four weeks following the procedure, your doctor could reopen your wound, clean it, and inject antibiotics.
If that doesn't work or the infection is discovered later, the medical device will be removed and then re-implanted after treating the infection. Re-implantation should occur after three months to avoid bone degeneration and scar tissue.
In extreme cases (the infection can't be controlled), your leg, including hip joint, will be amputated and replaced with a prosthetic limb.
Early Implant Failure and Component Loosening
Metal hip components can become loose over time. Component loosening is a severe enduring complication; it's an indicator that you require a revision procedure. It occurs either because the components have worn out or the cement is not holding the implant in place.
Moreover, hip implant loosening can be a sign of a defect in the medical device or Metallosis. If you suspect loosening, consult your doctor immediately. The doctor will conduct an X-ray to determine the component's movement as well as the necessary corrective action.
A periprosthetic fracture occurs when a bone breaks around the medical device. Typically, the bone surrounding the implant is weakened by pressure from the medical device, medication, or osteoporosis.
It is a rare complication that happens years after undergoing the procedure.
According to a study published in the Journal of Bone and Joint Surgery, American Edition, cardiovascular disorder within ninety days is the leading cause of death following the procedure. Other causes include complications in the digestive system, respiratory system, and malignant neoplasms.
What are Mass Torts?
A mass tort is a series of civil lawsuits or claims filed by many plaintiffs who are claiming similar types of injuries against one or more defendants. It is essential to understand that a mass tort is different from a class action. When it comes to a class action, many plaintiffs join hands to form one claim. In mass torts, on the other hand, every plaintiff maintains their separate claim.
Generally, mass tort trials revolve around injuries originating either from deadly drugs, product liability, or defective medical devices. Once enough claims are brought, the cases are reconsolidated into a multi-district litigation (MDL). Multidistrict litigation is a federal court that is tasked with managing and overseeing the entire litigation process.
To create a guideline of how much a claim is worth in the multidistrict litigation, similar claims are filed to the trial. These cases are picked from the rest of the claims in the MDL on the grounds on their similarity to the rest of the claims. They are then used to test for the remaining lawsuits. Usually, bellwether trials with a considerable verdict for the victims and plaintiffs often result in larger settlements compared to other lawsuits in multidistrict litigation.
The next step involves settlement, which takes place when both parties reach negotiations to settle the lawsuits. Any proposed agreements are presented to the plaintiffs to determine whether they will accept the offer or proceed to trial.
For a defective metal hip replacement tort to win in a court, the lawyers should prove that the defect led to the victim's injury. With mass torts, it is possible to offer an incredible amount of proof to verify that the accused is liable for the injury. Nevertheless, proof of evidence is paramount. An attorney hired by more than one victim can present the case and show that the defective medical device caused the injuries through instructed or standard use.
Additionally, mass torts use experts, witness testimony, and proof from every incident with the plaintiff. Claims with physical harm should have evidence that supports defective design or material. In instances where the metal hip replacement implant didn't have any defect initially, it could involve a situation where the point of implant led to the problem. It is, therefore, essential to find the responsible party. This will not only ensure damages come from the responsible party but also increase the chances of a successful lawsuit. The attorneys should investigate the case fully and interview all victims and witnesses before your case goes to court.
How Long Does a Mass Tort Take?
Unlike a single personal injury lawsuit that speeds through a court system within a couple of weeks or months, a mass tort, given the huge number of victims, is more complicated. That means it takes significant time investigating and collecting evidence that will prove every plaintiff's injury. This could result in many years being invested in one mass tort.
Other factors that may affect a mass tort's timeline include
- Investigation and gathering of evidence such as manufacturer documentation and medical records
- The need to travel (for instance, when required to depose and locate witnesses)
- Locating expert witnesses such as economists, physicians, drug company researchers, and scientists
How to Join a Mass Tort
When you want to join a mass tort case, you could talk with attorneys attached to the case or even contact an attorney unconnected as a point of reference. You should wait until one of the lawyers interviews you. The information of your injury from the defective metal hip replacement implant should have a relevance to the mass tort claim theme. If the hurt or circumstances surrounding the injury don't have a relation or direct connection, you may require filing a lawsuit against the manufacturer separately.
Evidence is critical, and medical records about your injury or damages caused by the defective medical device form the basis of the connection to the mass tort or counter any relation. Before becoming a victim or witness, you should have a related case. For instance, if the medical device has a defect that heat and burns patients, a new addition should have a similar defective device or injury. If yours burns you in another way, this is enough deviation that disqualifies your connection to the mass tort.
Popular Mass Tort Against Metal Hip Replacement: Smith & Nephew Hip Claims
Smith & Nephew Hip manufactures medical devices that are used in hip replacement surgical procedure. The implants are used to repair as well as replace parts of the hip such as femur and socket. One of the most popular implants includes the Birmingham Hip Resurfacing System and the R3 Acetabular System.
The implants with a metallic design (both pelvic socket and femoral cap) have been reported to have a higher failure rate compared to other designs. Also, the metal linings grind against one another, releasing metal shards into the patient's bloodstream and surrounding tissues resulting in metal poisoning. Patients with these implants who require revision surgery endure severe suffering and trauma before the operation takes place. They also experience
- Extreme pain in the groin and hip area
- Reduced mobility
- Uncertainty about mobility
- Countless doctor's appointments
Moreover, the revision surgery can come with other potential complications such as mental anguish, infection, physical pain resulting from the procedure, and substantial medical expenses.
After three years of use in the United States and approximately four thousand medical devices, Smith & Nephew recalled all R3 System implants in 2012. This was because of the revision rate of six percent annually. In 2015, the manufacturer went ahead to recall all Birmingham Hip Resurfacing System as well with a claim of high revision rate.
Despite the fact that the manufacturer's claimed that high revisionary procedure rates drove its decisions, metallic implants have shown to pose a higher risk of metal poisoning. The metals used by the manufacturer to make the implants are chromium and cobalt. These metals are popularly known for releasing cancer-causing ions into the blood.
According to The Bleeding Edge, a documentary featured in the Netflix, complications that originate from exposure of the heavy metal ions include blood poisoning, inflammation, metal toxicity, chronic pain, necrosis in surrounding tissues and cardiomyopathy.
Because of the injuries suffered by people, many claims have been brought against the manufacturer for damages resulting from their implants. The lawsuits claim that the manufacturer manufactured defective implants and didn't issue adequate warning to doctors and patients about the risk of using the implants.
Manufacturers are required by the law to design products in a manner that does not lead to unreasonable injury to patients. That means that when a manufacturer designs unsafe products, they ought to be held responsible for injuries that result from that decision.
The claims against Smith & Nephew argued that the choice of using chromium and cobalt metal in implants led to a substandard product. The company advertised its products as stronger than conventional hip implants that were made of ceramic. However, the claims filed argued the risk posed by the medical devices outweighed the benefits. The lawsuits also argued that the compromise between stronger material and increased threat of toxicity was negligence and sought to hold the manufacturer liable.
Moreover, the lawsuit claimed that the company defectively warned patients and physicians about the danger of the implants. By failing to notify patients about the dangers of the medical devices left patients not able to protect themselves. Doctors, on the other hand, were not in a position to make wise decisions for patients.
Since many patients were injured in the same way by the Smith & Nephew metal hip replacement and the injuries were due to the manufacturer's one course of conduct, claims against the manufacturer were consolidated into a mass tort. By May 15, 2019, there were five hundred and eighty-seven lawsuits combined into an MDL in the District of Maryland.
The mass tort against Smith & Nephew's seeks damages that will compensate each plaintiff their:
- Previous medical expenses
- Future medical costs related to a revision hip replacement procedure and metal toxicity enduring effects
- Lost income
- Loss of consortium
- Pain and suffering
Also, the lawsuits claim that the punitive damages need to be addressed since the manufacturer's defective warning and design were egregious.
Find a Mass Tort Lawyer Near Me
It can be both frustrating and painful when the metal hip replacement implant that is supposed to heal you do the exact opposite. When a manufacturer fails to warn you of potential complications or sell dangerous and defective medical devices, they should be held responsible for the negligence. A mass tort lawsuit can assist you in getting compensation for damages incurred as well as protect other patients from future injuries. If a defective metal hip implant has injured you, our nationwide mass tort lawyers at Consumer Alert Now can help you. Contact us at 800-511-0747 to book your initial consultation.