Below are common words, phrases, and names that often pop up in discussions of artificial hips, knees, and other medical devices. These definitions may assist you as you read through the articles on this site. Of course, you are always welcome to contact me directly for further explanation.
Bellwether Cases. A representative set of cases to be tried to juries. When many cases are filed in courts which involve the failure of a single product (or drug), and which have caused similar injury to many individuals, a single court may be chosen to consolidate most of the cases into one “multi-district litigation.” Committees of plaintiffs and defendants then choose a representative sample of those cases to be tried to a jury, which must be approved by the presiding judge. These cases typically contain broad characteristics in common with many of the remaining cases. After the jury verdicts are reached in these bellwether cases, the committees for the plaintiffs and defendants can use these trial results to negotiate a global settlement structure.
DFU. Acronym for “directions for use.”
Health Insurance Subrogation. Subrogation is the substitution of one person or entity for another with respect to an insurance claim or debt, and the entity substituted will obtain all the rights associated with the insurance claim or debt. In product liability and other personal injury cases, your health insurance carrier pays for your health care and then directly pursues reimbursement of those health care payments against the negligent third party or the third party’s insurance provider.
MDL. Acronym for “multi-district litigation.” When many cases are filed in courts across the country, all of which involve the failure of a single product (or drug), and which have caused similar injury to many individuals, a single court may consolidate most of the cases into one multi-district litigation. From this one court the designated judge will manage the large caseload, hear motions, resolve disputes, preside over bellwether trials, and monitor global settlement discussion.
Preemption. When federal and state laws are in conflict, federal law trumps or “preempts” state and local law. If a state law conflicts with a federal law, the state law cannot be enforced. Federal preemption is a principle of constitutional law that attempts to organize and reconcile the powers of federal, state, and local governments. Preemption is derived from the Supremacy Clause in the United States Constitution. Preemption defense arise often in medical device and drug cases.
Punitive Damages. Separate money damages awarded by a jury and which are intended to punish, reform, and/or deter a bad-acting defendant and others from engaging in similar conduct. Typically punitive damages are awarded when a defendant had prior knowledge of a serious issue or problem and ignored this knowledge to the injury or detriment of other people.
Statute of Limitations. Every state has statutes which limit the amount of time a person is permitted to bring a lawsuit after an injury (including a physical injury from a medical device or drug). In North Carolina, a medical device or drug failure is typically a product liability/negligence action, and the statute of limitations in those cases is typically three years. N.C. Gen. Stat. § 1-52.
MANUFACTURERS AND PRODUCT SELLERS
Bayer, Inc. A corporation which manufactures and sells many medications, including Xarelto.
Cook Medical, Inc. A corporation which has manufactured a large number of the IVC filters on the market. On July 21, 2014, the Cook Medical IVC Filter MDL was situated in the Southern District of Indiana.
C.R. Bard, Inc. A company which develops and manufactures medical device products, including transvaginal mesh and IVC Filters.
Depuy. A collection of companies which develops and manufactures medical products, including artificial hips and knees. Depuy, Inc. and Depuy Orthopaedics is owned by parent company, Johnson & Johnson.
Glaxo Smith Kline. A multinational medical company and the makers of Zofran.
Janssen Pharmaceuticals. The makers of prescription medication, including Invokana, Risperdal, Xarelto.
Pfizer, Inc. A corporation that manufactures and sells the erectile dysfunction drug Viagra.
Stryker. A company which develops and manufactures medical products, including artificial hips.
Zimmer-Biomet. A company which develops and manufactures medical products, including artificial hips and knees.
acetabular cup. A cup made of metal or ceramic or other material manufactured to sit in the body’s hip cavity (acetabulum) and into which is secured the femoral ball at the top of the femoral stem. An acetabular shell sits inside the acetabular cup.
acetabulum. The hip cavity on the hip bone, where the head of the femur sits.
ASR. The acronym which stands for “Articular Surface Replacement,” a surgical procedure where only the articular surface of the hip (the cup and the ball) is replaced. This metal-on-metal hip replacement system was developed and manufactured by Depuy Orthopaedics.
chromium. One of the metal materials used in the construction of the metal-on-metal hip components. Evidence of chromium in the blood of patients who received the metal-on-metal hip components created a red flag for the safety of the metal-on-metal design.
cobalt. One of the metal materials used in the construction of the metal-on-metal hip components. Evidence of chromium in the blood of patients who received the metal-on-metal hip components created a red flag for the safety of the metal-on-metal design.
Depuy ASR Cup. The metal cup manufactured by Depuy Orthopaedics which is part of the ASR XL Acetabular System.
Depuy ASR Settlement(s). So far, there have been three Settlement Agreements in the U.S. Depuy ASR Hip Litigation, one dated November 19, 2013, the second dated March 2, 2015, and a third extension dated March 3, 2017, each of which covers a different time period for the date when a person underwent revision surgery following implant of the Depuy ASR hip.
Depuy Pinnacle. A metal-on-metal hip replacement system manufactured by Depuy Orthopaedics. Like the Depuy ASR XL Acetabular System, the Pinnacle has failed an alarming number of times and required thousands of revision surgeries.
femoral ball. Also called the femoral head, it is a metal ball that is fixed on a stem inserted into a femur as part of a hip replacement surgery.
femoral stem. The rod-like component part of an artificial hip that slips down inside the femur bone.
implantation surgery. This is the original hip replacement surgery, where the surgeon implants the artificial hip components into a patient.
metallosis. The build up of metal levels in the blood and in body tissue. When a metal-on-metal artificial hip cup and ball grind together, it is believed that tiny shavings are released into the body, elevating metal levels. This is a substantial health concerns for individuals who received metal-on-metal hip replacement components.
metal-on-metal (“MoM”). The construction of artificial hip components using metal materials, such as cobalt and chrome. The hip component manufacturers developed this hip replacement system with the hope that it would last much longer than hip components made with other materials, such as ceramic. However, the failure rate proved much higher.
revision surgery. A surgery required when a hip replacement surgery has failed. The surgeon must re-enter the hip area, secure the loose or failed components, or remove and replace the failed components.
rerevision surgery. A surgery required when a revision surgery fails. Yes, sadly this means that the person has had to undergo three surgeries to the same hip (the implantation surgery, the revision, and the rerevision). There are cases where patients have had to undergo three, four, and even five surgeries to stabilize and repair a hip. Obviously, these are among the very worst results.
THA. Total Hip Arthroplasty, the medical term for a total hip replacement surgery.
total hip replacement. A total hip replacement replaces the body’s hip joint with an artificial one, and these artificial hips are usually made out of metal or plastics. A total hip replacement typically consists of four separate parts: (1) a stem, (2) a head, (3) a liner, and (4) a cup (called an “acetabular cup” or shell). After the surgeon hollows out the patient’s femur bone, the stem is implanted. The head is a metal ball that is fixed on top of the stem. The femoral head forms the hip joint when it is placed inside the liner and the cup (the “acetabular shell”).
Zimmer Durom Cup. The metal cup manufactured by Zimmer. The Durom Cup failed often and has been the subject of many lawsuits.
INTRAUTERINE DEVICE (IUD)
levonorgesterel is a hormone released into a woman’s body from an IUD (like the Mirena IUD) which serves as a contraceptive and prevents pregnancy.
Mirena IUD is an intrauterine birth control device sold by Bayer. It has been shown to cause fluid buildup in the brain, which can be a serious health issue.
IVC. The acronym for “inferior vena cava,” which is the primary vein running from your lower body to your heart and which carries deoxygenated blood. The vena cava veins move this deoxygenated blood into the right atrium of the heart, where it can be oxygenated and sent back out into the body. Obviously the IVC is a vitally important vein inside the body, and when problems occur they can become serious and even life-threatening.
Deep Vein Thrombosis. Deep Vein Thrombosis (DVT) is a blood clot that forms in a vein. Often these blood clots originate in the leg or thigh. If the blood clot becomes loose it can travel through the inferior vena cava and settle in the lung, a condition called pulmonary embolism. Blood clots can form during lengthy surgeries (where your body remains still for a long period), or on a long plane ride, or while driving a car for a great distance. Cancer patients can also develop DVT.
Pulmonary Embolism. Pulmonary embolism (PE) occurs when the blood clot (DVT) travels to the lung and creates a blockage in one of the arteries in the lung. This condition is very serious. It can cause permanent damage to your lung, reduce the oxygen levels in your blood, which can damage other organs (suddenly starved of oxygenated blood), and if the clot is large, it can even cause death.
IVC Filter. A small metal cone-shaped device which is implanted in the inferior vena cava, usually by inserting it surgically through a vein in the neck. The filter allows blood to flow freely, but is intended to capture a blood clot moving through the inferior vena cava. When the IVC filter catches these blood clots, it has effectively prevented the clot from traveling to the lungs and has thus prevented the onset of pulmonary embolism. It is estimated that 250,000 people have an IVC filter implanted each year, and that well over a million people have received the IVC filter in the last ten years.
gynecomastia is the growth of female breasts in men and boys. Studies of Risperdal have shown that young people using the drug had elevated levels of prolactin, a hormone which allows women to produce breast milk. Elevated prolactin levels in young boys can cause them to grow female breasts.
Risperdal (risperidone) is an antipsychotic drug developed by Janssen Pharmaceuticals to treat schizophrenia and bipolar disorder. It has been shown to cause gynecomastia in boys.
dyspareunia. Difficult or painful sexual intercourse. Dyspareunia can be a complication from transvaginal mesh implantation.
polypropylene. A type of plastic used to make some transvaginal mesh products. It is defined as a “thermoplastic polymer resin.” Many experts contend that it is an inappropriate material to implant in women.
POP. Acronym for Pelvic Organ Prolapse, which occurs when an organ (like the bladder) drops (“prolapses”) from its normal position in the body and presses against the walls of the vagina. Physicians have used transvaginal mesh products to treat this condition (with often terrible results).
SUI. Stress Urinary Incontinence, a kind of urinary incontinence that occurs when a woman places a stress on her body, as when she is lifting a heavy object, exercising, or even coughing; these “stresses” put pressure on a woman’s bladder, sometimes causing involuntary loss of urine.
TVM. Acronym for transvaginal mesh.
Xarelto. Xarelto (or rivaroxaban) is a blood thinning (anti-coagulant) medication. It was developed to prevent serious conditions that sometimes arise after surgeries (such as artificial hip and knee surgeries). As an anti-coagulant, it was intended to prevent pulmonary embolism (PE) and deep vein thrombosis (DVT) and strokes. The patients Xarelto was intended to help were those with atrial fibrillation (or irregular heartbeat), who were a group of people more vulnerable to PE, DVT, and stroke after surgery. Xarelto was approved for sale by the FDA in July 2011. Eventually, the FDA expanded approval of Xarelto to treat all patients with PE and DVT and atrial fibrillation.
Atrial Fibrillation. Irregular heartbeat. A condition Xarelto is intended to treat.
Warfarin. Warfarin, or Coumadin, is an anti-coagulant drug that has been on the market for more than fifty years. Warfarin has certain side effects, and patients on warfarin required restrictions on their diets and needed routine blood tests. Xarelto was marketed as superior to warfarin.
Vitamin K. An antidote to internal bleeding for patients taking warfarin. There is no vitamin K “parallel” for people taking Xarelto. For Xarelto, it can take 24 hours for a dose to get out of the body.
Zofran. Zofran (or ondansetron hydrochloride) is a prescription medication that helps prevent nausea and vomiting by blocking the effects of serotonin, a chemical in the body that can trigger nausea and vomiting. It was originally designed to help cancer patients dealing with the side effects of chemotherapy but is also approved by the Food and Drug Administration (FDA) for those suffering nausea due to radiation therapy, anesthesia and surgery.