Researchers and drug manufacturers continually strive to produce medications that are effective in treating health conditions while minimizing the risks of dangerous side effects. Pharmaceutical companies must conduct extensive research and clinical trials to be reasonably sure that the drug or medical device works as intended without unnecessary or dangerous complications. The companies must document any risks or adverse side effects as they submit a drug for approval by the United States Food and Drug Administration (FDA). Sometimes, however, the dangerous effects of a drug are not apparent until widespread post-market use of the medication. In these cases, the drug may be subject to a recall, or the FDA may require additional warnings about the risks of taking a particular medication or using a specific medical device.
Still, not all drug injuries from defective or dangerous pharmaceuticals are the result of unforeseen side effects. Patient illness or injury may occur after an unethical company hides evidence of risk or fails to disclose side effects attributed to the drug.
Some pharmaceutical companies make false or misleading claims about their drugs and the efficacy of those drugs, encouraging doctors and patients to use a medication that will not effectively treat a medical condition. This can lead to unnecessary risk of adverse side effects as well as a delay in getting treatment that actually works to cure the disease or alleviate the symptoms of a chronic illness. In preventative medicine, it can cause a person to experience the unwanted medical condition he or she attempted to avoid.
Another consideration is off-label use of a drug. The FDA does not prohibit off-label use, or using a drug or device in the treatment of a condition other than the one for which it was developed. However, it does prohibit drug manufacturers and pharmaceutical companies from marketing the drug for off-label use.
In any of the above conditions, a patient harmed by the use of a dangerous drug or defective medical device may be able to obtain financial compensation for medical expenses, pain and suffering, and other costs associated with drug injury. Whether filing an individual claim or joining a class action against a negligent drug company, a person can hold pharmaceutical companies liable when medications bring harm rather than healing.
According to a Mayo Clinic Study, approximately 70 percent of Americans are taking at least one prescription drug; more than half are taking two. The National Center for Health Statistics, and agency of the Centers for Disease Control and Prevention (CDC) reports that more than 75 percent of patient visits to doctors' offices, emergency rooms, and hospital outpatient facilities result in drug therapy or prescription medications. The IMS Institute for Healthcare Informatics reports that Americans spent $325.8 billion on prescription drugs in 2012, indicating that "Big Pharma" is indeed a big business.
Some of the major players in the pharmaceutical industry have been forced to pay out billions of dollars in settlements through pharmaceutical lawsuits brought by individuals, class action, or the United States Department of Justice. A large number of DOJ lawsuits involved violation of the False Claims Act, including marketing a drug for off-label use.
Among some of the top pharmaceutical companies who have paid settlements for off-label promotion and for providing kickbacks are GlaxoSmithKline, Eli Lilly, Pfizer, Bristol-Myers Squibb, and Merck.
When the risks associated with taking a medication outweigh the benefits, a dangerous drug is likely to be recalled. Still, many drugs which have been the subject of numerous pharmaceutical lawsuits are approved by the FDA and still allowed to be prescribed to patients. In some cases, the FDA may issue additional warnings or require manufacturers to create additional warnings on drug labels, but often, patients are unaware of the risks a medication poses until it is too late.
Anti-anxiety drugs, contraceptives, cholesterol medications, diabetes drugs, and others are among some of the medications currently embroiled in dangerous drugs litigation:
These drugs often carry potentially deadly side effects and chronic medical conditions. Many increase the risk of stroke, heart attack, or pulmonary dysfunction. Some result in organ damage such as liver damage or kidney failure.
If you have lost a loved one to a fatal medical condition caused by a dangerous drug, or if you have suffered illness or injury as a result of taking a dangerous prescription drug, you may be entitled to financial compensation.
Dangerous drugs are not the only medical treatment options affected by recalls and litigation. The medical devices used in surgeries - whether surgical robots or implants - are intended to facilitate surgery, ease recovery, and effectively repair injury. Unfortunately, surgical robots can cause significant harm when they are not functioning properly or when the surgeons who use them do not have adequate training in their use. Surgical tools have caused perforation, laceration, and burn injuries in patients.
Medical implants such as hip implants, knee implants, and vaginal mesh can break down and corrode, causing illness or injury. The results of a defective medical device can lead to illness from toxic materials or injury from displacement, puncture wounds, and laceration. Patients may suffer intense pain, disfigurement, and life-threatening injuries or illnesses.
Among the medical devices currently under litigation are the following:
Sometimes, a patient may not know of the risks or side effects associated with a dangerous medical device until the surgery has already been performed and the implant is already inside the patient's body.
Bleeding, corrosion, burns, scarring, and other serious complications can occur as a result of a defective medical device or one that fails sooner than expected. These complications can result in illness, disability, and further surgery to repair not only the underlying condition, but also any new injuries sustained from use of the defective device.
If you or a loved one has been harmed by a dangerous drug or defective medical device, contact an experienced product liability lawyer with the Law Firm of Oklahoma. During a free consultation, we can evaluate your claim to determine what compensation may be available to you through a personal injury lawsuit or class action. Call (405) 608-4990 to learn more.