Mass Torts: Drug & Medical Device Injury
Millions of Americans rely on medications or medical devices to treat serious health conditions. Unfortunately, in some cases, severe adverse side effects can lead to a host of new problems for the patient.
While it is impossible to guarantee absolute safety when it comes to drug effects and medical devices, in some cases the drug or device maker may have known about certain adverse side effects but failed to disclose the risk to medical professionals or the public.
If you suffered adverse side effects from a drug or medical device, you may be eligible to file a drug injury lawsuit to seek compensation for your injuries.
Types of Drug Injuries
Drugs are designed to treat a wide variety of health conditions. Therefore, drug side effects vary widely based on the type of drug and an individual’s reaction to that drug. Some common side effects of drugs include nausea, gastrointestinal issues, skin reactions, drowsiness, and antibiotic rash.
The manufacturers of drugs and medical devices are required to list the common medication side effects associated with the product on the product’s label. This information allows a consumer to know if the drug side effects he or she is experiencing are normal or if medical attention is necessary. Failure to seek medical attention for dangerous prescription side effects may lead a person to suffer a catastrophic drug injury, which may have lifelong effects and diminish a person’s quality of life.
Who Is Responsible for Drug Safety?
The U.S. Food and Drug Administration (FDA) regulates drugs and medical devices. The federal agency is responsible for evaluating medications and medical devices for their safety and efficacy. The FDA also may choose to approve a drug or medical device only to treat specific conditions. The approved conditions and safety risks are listed in the safety information that accompanies the drug or medical device.
Physicians who opt to use the drug to treat any unspecified condition are prescribing the drug for “off-label” use. While physicians are permitted to prescribe drugs for an off-label use, drug makers are not allowed to promote the drug for an off-label use. Drug manufacturers are only allowed to promote their drugs to treat illnesses that the FDA approved the drugs for.
Drug and medical device manufacturers have a duty to ensure that their products are safe and that they comply with FDA regulations before they put the products on the market. Medical devices and drugs must be thoroughly and reliably tested to ensure their safety and efficacy before they can be approved to enter the market, and they must disclose all test results with the FDA. If they fail to do so, drug and medical device makers may be subject to legal liability.
Types of Product Liability Claims
Plaintiffs who have been injured by a medical device defect or a dangerous drug may be eligible to file a product liability or personal injury lawsuit. There are three types of product liability cases: design defects, marketing defects, and manufacturing defects.
Design Defects: A design defect is a product liability claim that refers to cases in which it is foreseeable that a drug or medical device will cause injury because of its design. If the drug maker is aware that the drug could be dangerous, it has a responsibility to conduct extra studies or reconfigure the product to avoid or reduce the risk of injury.
Marketing Defects: In some cases, the manufacturer or other affiliated company provides consumers with inadequate warnings or inadequate instructions about how to use the product. Some manufacturers fail to warn consumers and medical professionals about the foreseeable risks a product poses. In these cases, the manufacturer or another negligent party could be held liable if a person suffers a drug side effect that was foreseeable.
Manufacturing Defects: Sometimes mistakes occur during the manufacturing process that can cause a product to be defective and potentially cause harm to a consumer. Once the manufacturer becomes aware that a manufacturing defect has occurred, it has a responsibility to notify consumers and may decide to recall the product over safety concerns.
If you or a loved one has experienced an adverse reaction from a drug or medical device, you may have a legal claim.
Drugs & Medical Devices Under Investigation
Below are a list of drugs and medical devices facing allegations for defects that have seriously injured patients:
- Xarelto: Xarelto is a new generation blood thinner that has been linked to serious and life-threatening bleeding incidents without an antidote to limit bleeding damage.
- IVC Filter: Inferior Vena Cava Filters, or IVC Filters, are small web-like devices implanted in the in the main vein of patients at risk of blood clots which may lead to damage such as a pulmonary embolism. However, these devices have been linked to migration, vein penetration, and fracture, leading to serious complications.
- Physiomesh (hernia mesh): Physiomesh is a hernia mesh product made by Ethicon, a Johnson & Johnson company. These hernia mesh products are allegedly linked to adhesions, obstructions, migration, infections, and hernia recurrence.
- Talc Powder (baby powder): Talc powder is used in common products such as baby powder and cosmetics, but this common product has also been linked to ovarian cancer.
- Essure: Essure is a non-surgical permanent birth control option that is less invasive than tubal ligation, but several Essure patients report that they have suffered serious pain, bleeding, organ perforation, miscarriage, ectopic pregnancies, and unwanted pregnancies.
- Fluoroquinolone Antibiotics: Several common antibiotics have been linked to aortic aneurysms and aortic dissections. The antibiotics linked to these side effects include Avelox, Levaquin, and Cipro.
- Hip Implants: Several metal-on-metal hip implants have been linked to serious side effects including hip implant failure, hip dislocation, metal poisoning, cancer, and tissue death.
- Shoulder Implants: Shoulder implants have been linked to a high fracture rate, metal toxicity, bone and tissue damage, erosion, and dislocation.
- Invokana: The diabetes drug Invokana has been linked to serious side effects such as kidney failure and ketoacidosis.
- Heartburn Drugs: A class of heartburn medications known as proton pump inhibitors (PPIs) allegedly increase the chance of developing chronic kidney disease and an increased risk of a heart attack or heart failure. PPI heartburn drugs include Nexium, Prilosec, Prevacid, Dexilant, Protonix, and Aciphex.
Find Out How to File a Defective Drug Lawsuit
If you or a loved one has suffered a medical device injury or dangerous drug side effect, you may qualify to file a drug injury lawsuit. You may be entitled to compensation for your medical bills, pain and suffering, lost wages and other damages you experienced as a result of the drug or medical device problems.
Contact the attorneys at Bradley/Grombacher LLP to discuss your legal options. If you have a potential case, your defective drug lawyer will work tirelessly on your behalf to put together a compelling case and help you get the compensation you deserve.