Osteolysis is the destruction of bone tissue. Our bones are actually rigid organs that support and protect our vital organs, produce red and white blood cells, store minerals, support our muscles and ligaments and give us the ability to move. Thus, osteolysis is a very threatening medical condition which is also silent—meaning that that there are no symptoms. Osteolysis can be caused by a hip or knee replacement device. Therefore it is critical that patients get checked regularly for bone loss.
Metallosis is a physical illness believed to be caused by the build-up of metal debris in the soft tissues of the body. Scientists hypothesize that metallosis can occur when the metal parts of an implanted medical device such as a hip or knee replacement abrade against each another. This abrasion causes metal ions to dissolve and be released into the body and subsequently be absorbed by soft tissue. The symptoms and injuries of metallosis include pain around the area of the implant, bone loss, pseudotumors which are a mass of inflamed cells, and necrosois, or tissue death presenting as a rash.
A metal-on-metal hip implant consists of a ball and cup made of a cobalt and chromium alloy. Originally developed as a more durable alternative to implants with ceramic or plastic components, metal-on-metal implants proved to have a much higher failure rate than implants made of other materials – a problem attributed to bone erosion (osteolysis) in the hip joint, which leads to the artificial joint loosening and the need for revision surgery.
A hip resurfacing is a reshaping of the damaged surface of the femoral ball, which is then covered with a circular metal cap. This procedure will only work for bone that has not been very damaged by arthritis.
In a total hip replacement the surgeon removes the entire femoral ball and adds a metal stem anchor at the top of the thigh bone. The stem fits entirely into the canal area for stability and is capped with a ball, which may be fabricated from a variety of materials including polyethylene, cobalt-chrome alloy and ceramics.
Some patients undergo revision surgeries, which are more challenging, invasive, painful and costly than the initial surgery because the faulty device must be removed and the new device implanted. Revision surgeries can cause muscle or nerve damage, bone loss, infections, and other serious complications. Some patients must undergo revision surgery if the original implant severely damaged surrounding bones.
The useful life of an implant depends on what joint is being replaced, the device’s design, the patient’s lifestyle, age, weight, physical health and other factors. Generally speaking, knee replacements can last more than 20 years. Hip replacements can be expected to last 15 – 20 years.
A medical device is any apparatus, appliance, software, material, or other article—whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application—intended by the manufacturer to be used for human beings for the purpose of:
Medical devices vary according to their intended use and indications. Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers which assist in the conduct of medical testing, implants, and prostheses. The design of medical devices constitutes a major segment of the field of biomedical engineering.
The FDA’s Black Box Warning directly alters pharmaceutical and medical device labeling to draw attention to significant risks and life-threatening side effects.The is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks.
When a faulty implant, drug or other medical device is recalled, the manufacturer must fix the defect or stop selling it. Be aware that the manufacturer is not required to notify patients that have the implant in their bodies. If fact, they do not have any way of knowing who they are! Nor do the doctors who implanted them or the hospitals and medical facilities where the surgeries occurred. It is up to the consumer to check on the safety of their device. This is why it is critical that patients see their physician if they experience any pain, illness, injury and even mental or cognitive issues after they have been implanted with any kind of device or use any new drug.
The FDA is responsible for issuing a recall, or ordering the manufacturer to recall a faulty or dangerous medical implant or device. However, the FDA has been criticized for rarely doing so and placing the responsibility on the manufacturer. According to McKinsey, the cost of a recall to the manufacturer can be as much as $600,000 and can damage a company’s reputation and stock valuation. Thus, leaving recalls and alerts to the manufacturer’s discretion creates a huge conflict of interest and ultimately puts the patient at risk.
An adverse event report is a report that is filed with the FDA’s MedWatch program when he or she experiences a serious reaction, product quality issue, or product use error with a human medical product such as a drug, medical device, dietary supplement or other product regulated by the FDA. It is important to note that adverse event reporting is voluntary in the U.S. for some products. A patient may ask their health care professional to file an adverse event report with MedWatch on their behalf, or they may file it directly online.
To ensure a medical device remains safe and effective once it is in-market, a manufacturer can conduct a medical post-market surveillance. This collection of processes and activities are implemented to monitor the performance of a medical device, thereby obtaining continuous real-world feedback and data on the product’s efficacy and safety.
Theoretically, manufacturers recall a medical device when they become aware of a problem caused by a defect in its design, manufacture or marketing. The term “recall” is used by the FDA when a manufacturer acts to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to a patient’s health, or both.
Sometimes a manufacturer or distributor recalls a medical device voluntarily. In addition, the FDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death.
There are many types of medical device actions that can be taken by the manufacturer, distributor or the FDA. Not all of these actions result in the device being pulled from the market.
When large numbers of plaintiffs are pursuing legal action on the same theory or claim and there is no other feasible way for the courts to handle the huge caseload a bellwether case is often used. In a bellwether proceeding, a group of plaintiffs is chosen to represent all the plaintiffs; their common claims are addressed during trial. The verdict from this grouping is extrapolated to the remaining plaintiffs’ cases and actual results may be used to value groups of claims in settlements. The plaintiffs can also choose to continue with their own individual trial.
In early 2019, in an Indiana bellwether trial a federal jury awarded $3 million to a woman who alleged that Cook Medical’s Celect IVC filter came apart in her body and sent broken pieces of the device into her thigh and near her spine.
DePuy Orthopaedics, a medical device division of Johnson & Johnson was ordered to pay $246 million over its Pinnacle metal-on metal hip implants. The jury in this Texas bellwether trial found J&J liable for product defects and fraud.
Multidistrict litigation (MDL) is a type of federal case that groups together similar cases from across the U.S. that share similar issues. By consolidating them and not having each plaintiff conduct the same interviews (known as discovery) when they could be done simultaneously, the process moves much faster. Medical device lawsuits often are conducted as MDLs, because there are usually a large number of patients who are experiencing complications from the same implant or product.
Class action and mass tort lawsuits are often confused because they both cover large numbers of plaintiffs with the same or similar grievance(s) against a common entity. The difference lies in how the plaintiffs are treated.
In a mass tort lawsuit, each plaintiff is treated as a unique individual and must prove certain facts specific to their grievance. For example, in a defective hip implant case the plaintiff must provide evidence of their specific injuries caused by that implant. Typically, mass tort claims are filed when large numbers of patients are seriously harmed or have died due to a bad drug or a defective medical device. Individual reactions to the same medical product can vary greatly, thus cases involving medical devices or drugs do not fit into the class action criteria which require similar factual situations among all individuals.
A class action is a lawsuit in which one of the parties is a group of people who are represented collectively by a member of that group. In a typical class action, a plaintiff sues a defendant or a number of defendants on behalf of a group, or class, of absent parties.
Although standards differ between states, class actions are most common where the allegations involve a large number of people who have been injured by the same defendant in the same way. Instead of each injured person's bringing his or her own lawsuit, the class action allows all the claims of all class members—whether or not they know they have been harmed—to be resolved in a single proceeding.
A mass tort is a civil action involving numerous plaintiffs against one or a few corporate defendants in state or federal court. Law firms sometimes use mass media advertising, such as TV, radio or online to sign up additional plaintiffs.
In addition, mass torts have these common characteristics:
The three main categories of mass torts include:
Defective medical device mass torts fall under the product liability category.
In U.S. federal courts, mass tort claims are often consolidated as multidistrict litigation. In some cases,
mass torts are addressed through class action.
A statute of limitations is a law which sets the maximum time allowed to begin legal proceedings from the date of an alleged offense or event. The length of time the statute allows for a victim or plaintiff to bring legal action against the alleged wrong-doer can vary from one jurisdiction to another.
Typically, the time allowed under a statute of limitations depends on the seriousness of the offense. The more severe the crime, the more time the plaintiff has to file a lawsuit or bring legal action. Product liability and personal injury cases often have a two year statute of limitations; the clock starts ticking when the person was injured or “date of occurrence”. If you are considering filing a lawsuit against a medical device manufacturer, be sure to consult with an attorney to determine the statute of limitations in your jurisdiction.
To find a superior lawyer for any matter, start by asking colleagues, friends and family members for a referral. You should also check your state bar association’s website for a list of the association’s leaders. If you know any good attorneys who practice on other areas, ask them who the best is in product liability law. It is also critical that your attorney be very skilled in mass tort litigation. Good attorneys know who the best are in different practice areas.
In New Jersey, less than 2% of licensed attorneys are Certified Civil Trial Attorneys, who have a recognized level of competence in specific legal practice areas. In products liability matters, your attorney should not only be highly knowledgeable, but should also be a skilled litigator and negotiator. Both John E. Keefe, Jr. and John E. Gregory Jr. are New Jersey Certified Civil Trial Attorneys and focus on personal injury, products liability and mass tort litigation.
First, it is important to know the difference between filing a claim and filing a lawsuit. In some product liability cases, the parties may agree to settle out of court rather than proceed to a jury trial, whether the case is a mass tort or an individual matter. In any event, the first step is to file a claim.
After you have done your research and identified your top choices to represent you, you will need contact the first attorney on your list. At this point, a paralegal will do an “intake”, typically by phone. An intake is a series of questions about your matter as well as general information about you. This conversation may take up to an hour. Be sure to have all of your information handy before you call.
The attorney then reviews this information. If he/she would like to take your case, a conflict check is done to ensure that there are no conflicts of interest between the lawyer/law firm and the defendant/manufacturer. If everything is good to go, you will be asked to sign a retainer agreement.
You attorney will collect all of your information relevant to your case. This includes medical records and documentation of lost work, wages, etc. Your lawyer will also consult with experts such as physicians, medical device scientists, sales representatives and product marketers. These experts may also testify should your case go to trial.
In many—if not most situations, your attorney will negotiate a settlement amenable to both parties with the manufacturer’s law firm. The settlement amount should be based on the extent of your injuries, treatment, and length of recovery plus your monetary losses.
You must consent to file a lawsuit. You attorney will prepare both you and the evidence to present the best case possible to a judge and jury. This is why it is critical that you hire a skilled product liability and litigation attorney from the outset.
After your lawsuit is filed, the discovery process begins and depositions are taken. A deposition is essentially a question and answer session in which the attorneys for both parties ask questions of any witness, who must answer under oath. Your lawyer will thoroughly prepare you for your deposition. There are no winners or losers in a deposition—think of it as information gathering in preparation for the trial.
The trial can last anywhere from two to five days; however it can take several years to get a trial date and obtain a decision and award. Be aware that the defendant may also appeal the decision, which can delay payment.
In most product liability cases, there is no charge to the plaintiff for legal services. This is because product liability cases are handled on a contingency basis. The lawyer is paid on a percentage of the settlement amount or jury trial award. A common contingency structure in product liability cases is one-third, or 33% of the award. There are expenses incurred during the case litigation that will need to be paid from the award; be sure to carefully read your agreement which will spell out complete details.
This is the most frequently asked question in defective products and personal injury cases. Each case involving a defective medical device is unique and there are several factors that will affect the amount of the settlement or jury award. A thorough case review from a skilled trial attorney with deep experience in products liability can provide you with an estimate of the potential value of your case, based on outcomes of cases similar to yours. He or she will take into account:
If you have been injured, become ill, endured medical complications or lost a family member because of a defective medical device, you may have a valid claim for compensatory and punitive damages. Product liability law requires that a plaintiff prove these elements of their matter.
These elements may vary by state, so be sure to consult an experienced product liability attorney if you are thinking about pursuing legal action.
A defective medical device lawsuit is a products liability matter because the essence of the case is that the plaintiff suffered injury, illness or death due to an inherently defective and unreasonably dangerous product. There are three ways in which a product can be deemed defective:
Multiple entities in the defective medical device supply chain can be sued. In addition to the manufacturer the manufacturers of the product’s component parts, the wholesaler, and the retailer can be held liable for a defective medical device.
People sue over knee and hip implants for various legal reasons. The most popular reasons are the following:
Knee and hip replacement lawsuits generally fall under an area of law referred to as defective products or products liability.
60 Minutes : Gynecological Mesh: The Medical Device That has 100,000 Women Suing
ICIJ Implant Files is the website of the International Consortium of Investigative Journalists (ICIJ). This team works with with hundreds of journalists around the globe to report on the testing, approvals, marketing and monitoring on implanted medical devices. This site is a great source of intelligence regarding medical implants used all over the world.
ICIJ Medical Device Database allows users to search more than 90,000 recalls, safety alerts and notices worldwide.
FDA Medical Devices gives information on safety, news, recalls, warning letters and much more.
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Medical Device Watch is sponsored by Keefe Law Firm. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.LEARN MORE