Presently, our law firm is working on many different types of product liability cases. Listed below are 4-types of lawsuits we are actively pursuing. If you, a family member or a friend have been affected by any of these drugs or products please feel free to contact Billie-Marie Morrison at 702-405-3476, or firstname.lastname@example.org for a free case evaluation.
On June 11, 2014, the NHTSA opened a formal defect investigation (Preliminary Evaluation, P# 14-016) into Takata air bag inflators that may become over-pressurized and puncture during air bag deployment, resulting in injury to the driver and/or passenger. On February 24, 2015, the NHTSA upgraded and expanded its investigation to include various model year 2001-2011 motor vehicles, which contain air bag inflators manufactured by Takata. During the course of the NHTSA’s investigation and its review of documents produced by Takata, the agency discovered facts and circumstances indicating that Takata may have violated the Safety Act and its regulations. Takata failed to comply fully with the NHTSA instructions and thus were ordered to pay a $200 million dollar civil penalty over the course of five years to the federal government. The air bag recall is now a full-blown crisis with nearly 70 million vehicles in the US and 100 million worldwide recalled. The recall includes vehicles from Honda, Toyota, Mazda, BMW and Audi just to name a few. The see a complete list of vehicles with air bag recalls visit https://www.nhtsa.gov/recall-spotlight/takata-airbags.
GM Ignition Switches
Recently the US Supreme Court denied review of a lower-court ruling allowing personal injury claims prior to GM filing for bankruptcy protection in 2009, leaving the door wide open for hundreds of previously barred ignition switch claims. In 2014, GM recalled more than 2 million vehicles with defective ignition switches, which can slip from the run position and cause vehicles to stall and disable safety features including air bags. Any accident involving a GM vehicle should be screened for a GM ignition switch claim.
An IVC filter is a small strainer type of device used to filter out blood clots and assist in preventing them from forming and becoming pulmonary embolisms (a blood clot that travels to the lungs). IVC stands for Inferior Vena Cava, which is the large vein that enters the upper right chamber of the heart and delivers oxygen-depleted blood from the legs, pelvis and abdomen back to the heart. The filters were designed for people who cannot take anticoagulants (blood thinners) and are at risk for pulmonary embolisms. Injuries can be in the form of: chest pain, confusion, heart rhythm irregularities, hypotension, lightheadedness, nausea, neck pain, shortness of breath, hemorrhaging, internal bleeding, pulmonary embolism, stroke and even death.
Abilify is an anti-psychotic drug developed and prescribed for schizophrenia, bipolar disorder, depression, Autism disorders and Parkinson’s disease. Despite knowing of the risks linked to pathological gambling, hypersexuality, binge eating and compulsive shopping, the manufacturers chose not to warn users in the US of these possible side-effects. Despite this knowledge, the manufactures continued to aggressively promote Abilify until April 2015 when the FDA found Abilify promotional materials to be “…false or misleading because it makes claims and representations….and implies that Abilify offers advantages over other currently approved treatments….which have not been demonstrated”.
Women suffering from pelvic organ prolapse (“POP”) and/or stress urinary incontinence (SUI) who sought help from a TransVaginal Mesh (“TVM”) implant or pelvic/bladder support system may have been victims of a defective medical device. After the shocking results of a clinical study, victims are filing suit against the TVM manufacturers. Some of the side effects with TVM include: pain radiating into lower back or extremities, and/or during urination and intercourse, infection, migration, erosion and the need for corrective surgeries. These problems can develop shortly after implantation, but may also take years to develop.
A hernia occurs when organs, intestines or connective tissue, breach a weak point or a hole in a muscle. This is often caused by some type of pressure such as heavy lifting or pulling. In order to repair a hernia, doctors often recommend a mesh patch to reinforce the muscle, close the hole and to reduce the likelihood of a reoccurring hernia. Hernia repair surgery is among the most common medical procedure done annually. Common complications after a mesh implant include: ongoing chronic pain, infections or abscesses, adhesive scar tissue, intestinal blockage/obstruction, organ perforation, allergic reaction, rejection of implant, foreign body reaction, mesh migration or erosion mesh shrinkage/contraction, dental problems, joint aches and pains, severe headaches, liver abnormalities and rashes. In May of 2016, Ethicon (a division of Johnson & Johnson) issued a voluntary recall of its Physiomesh Flexible Composite Mesh for laparoscopic use from the global market. The recall was initiated after two (2) studies revealed higher rates of hernias reopening and the need for more operations with the Ethicon mesh compared to similar hernia mesh. Other hernia mesh products named as defective include: Atrium C-Qur Mesh, Kugel Hernia Mesh, 3D Max Hernia Mesh, Perfix Plug Mesh, Ventralex ST Mesh patch, Sepramesh Patch, Surgipro Hernia Mesh and Paritex Plug and Patch System.
Xarelto is an anti-clotting, blood thinning medication similar to Coumadin (warfain) and Lovenox (enoxaparin). Xarelto is prescribed to reduce the risk of stroke and blood clots, as well as to treat deep vein thrombosis (“DVT”) and pulmonary embolisms (“PE”); especially after knee or hip replacement surgery. Possible side effects from Xarelto are: uncontrollable or unusual bleeding, discolored urine (blood in the urine), red or black-colored stools, vomiting or coughing blood, retinal hemorrhage, stroke and even death.
Invokana, Invokamet, Invokamet XR
According to the FDA, the diabetes drug Invokana, Invokamet and Invokamet XR increases the risk of foot and leg amputations. Anyone taking any of these medications should notify their healthcare professional/medical provider of any pain or tenderness, sores, ulcers or infections of the feet or legs. Never stop taking any medication without approval from the prescribing physician or healthcare professional/medical provider.
Risperdal is the brand name for the drug Risperidone to treat schizophrenia in teenagers and adults, Bipolar I Disorder in those ages 10 and older, and irritability associated with autistic disorder in children age 5-16 years. According to FDA, elderly dementia patients who took Risperdal are 1.6 – 1.7 times more likely to die of various ailments, including heart disease and pneumonia. Medical research has also found a connection between Risperdal and adolescent male breast enlargement (Gynecomastia) and production of milk from breasts (Galacomastia). It is also believed that Risperdal may cause heart disease, diabetes, Neuroleptic Malignant Syndrome (“NMS”), Tardive Dyskinesia (“TD”) and a decreased white blood cell count.
Zofran is manufactured by GlaxoSmithKline (“GSK”) and was approved by the FDA for preventing nausea and vomiting due to chemotherapy and surgery. Although Zofran is not approved for any other indication, it is often prescribed “off-label” by physicians to treat morning sickness in pregnant women. Studies published in 2013 and 2014 found that Zofran is associated with an increased risk of heart defects and oral clefts in newborns if taken by women during the first trimester. In 2012, the U.S. Department of Justice reached a $3 billion settlement with GSK after the government alleged it illegally promoted the off-label uses of several drugs, including promoting Zofran for use by pregnant women to treat morning sickness.
Asbestos fibers are microscopic and durable and were therefore used in a variety of industries for many years. Workplace exposure to asbestos materials was extremely common in naval shipyards, power plants, railroad infrastructure and other industrial jobsites including many of the construction trades. Asbestos-related diseases can lay latent or dormant for many years and has been diagnosed in family members of those exposed to asbestos because these dangerous fibers were transported on the clothing, hair or the body, exposing others with to the same dangerous asbestos fibers. Asbestos exposure can be deadly.
DePuy hip and knees, Stryker hip, Wright hip and Zimmer hip.
The law of product liability deals with the liability of the manufacturer, wholesaler, or retailer of a product for injuries resulting from that product. This includes the manufacturer of component parts of the product, an assembling manufacturer, the wholesaler, the retail store or other ultimate sellers of the product, and any other party in the distributive chain, regardless of whether you actually purchased the item yourself.
Research from the U.S. Consumer Product Safety Commission indicates that defective or unsafe products cause 29.4 million injuries and 21,400 deaths each year. Within the U.S., an estimated $700 billion is spent annually on the injuries, deaths, and property damage caused by consumer product incidents. You or your child may be injured by something seemingly harmless or something you use every day, such as a hairdryer, toaster, baby chair, toy, iron, coffee maker, air conditioner, car, hand tool or even your clothing. Product liability law gives consumers the ability to sue for and recover damages from manufacturers, distributors, and vendors for injuries resulting from accidents caused by products. Virtually all products are subject to products liability law, not just items on the store shelves – products subject to the law run the spectrum from food, drugs, appliances, automobiles, medical devices, medical implants, blood, tobacco, gases, real estate, writings, maps, and even commercial jets.
Each year hundreds of new drugs enter the $60 billion per year prescription-drug industry promising to improve our lives. But every year, 200,000 Americans die and numerous more are injured as a result of false and misleading claims by pharmaceutical companies. Despite the series of clinical trials and tests conducted on prescription drugs to protect the public, many drugs are causing serious injuries. According to the General Accounting Office, 51 percent of FDA-approved drugs have major adverse effects that aren’t detected until after the general public uses them.
Prescription drugs are regulated and approved by the Food and Drug Administration (FDA). Under current FDA regulations, new drugs are approved in half the time they were 15 years ago. This is because under the Food, Drug, and Cosmetic Act, the FDA can approve new drugs for marketing without long-term testing if it will benefit the public interest. 21 C.F.R. 310.303 (1997). Unfortunately, the current incidents of prescription drug injuries suggest that the public’s best interests are not being served. In the last 4 years, the following widely used drugs are among those that have been recalled and banned by the FDA. In many instances, these drugs were recalled within a year due to deaths or serious adverse effects by users.
A significant portion of recalled drugs were aggressively marketed by pharmaceutical companies, even when they knew use of their drugs could result in serious side effects or death. Because side effects for all medications are seriously underreported — some experts estimate that at best one in 10 are actually reported to the FDA — the real danger and number of injuries related to prescription drugs may be significantly higher.
Fortunately, the law provides you with rights. Under 402A of the Restatement (Second) of Torts, prescription drug manufacturers can be held strictly liable for selling products in a defective and unreasonably dangerous condition, even though they may have exercised the utmost care in the preparation and sale of their product. A product may be defective or unreasonably dangerous in several ways. One way is if the manufacturer failed to warn consumers of potential injury risks associated with the product. A product might also be defective or unreasonably dangerous if it was improperly designed (i.e. inappropriate chemical composition or dosage). Lastly, the product may also be defective if an error occurred during the manufacturing process. A prescription drug contains a manufacturing defect when it departs from its intended design even though it was carefully prepared and marketed. Manufacturer liability may also extend to what your physician tells you about the prescription drug.
Congress defined the term “dietary supplement” as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. Whatever their form may be, federal law places dietary supplements in a special category under the general umbrella of “foods,” not drugs, and requires that every supplement be labeled a dietary supplement.
The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify the FDA if it intends to market a dietary supplement in the U.S. that contains a “new dietary ingredient.” The manufacturer (and distributor) must demonstrate to the FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.
FDA regulations require that certain information appear on dietary supplement labels, including: a descriptive name of the product stating that it is a “supplement;” the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product. In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a “Supplement Facts” panel. This label must identify each dietary ingredient contained in the product.
Manufacturers and distributors do not need FDA approval to sell their dietary supplements. By law, the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for the FDA to “approve” dietary supplements for safety or effectiveness before they reach the consumer. The Federal Trade Commission regulates the marketing of dietary supplements. Once the product is marketed, FDA has the responsibility for showing that a dietary supplement is “unsafe,” before it can take action to restrict the product’s use or removal from the marketplace. Manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products.
If there is a medication, product or device not listed above, please feel free to call or email Billie-Marie at (702) 405-3476 or BMorrison@CpkLaw.com anytime to inquire about any potential pending lawsuits. If you have any questions or would like more information pertaining to the drugs and products listed above please call Billie-Marie.