Your Rights if Injured by a Prescription Drug or Medical Device
Technological advancements in the fields of chemistry, medicine and biology have allowed for the creation of prescription drugs, over-the-counter medications and medical devices that can alleviate pain, eliminate infection and save lives. These products have already enhanced and saved countless lives, but there are some situations where a drug or device may be defective, inadequately tested or simply dangerous. When this occurs, patients can experience serious injuries or may even lose their lives. Even if the drug or device was approved by the Food and Drug Administration (FDA) and is legally on the market, the injured patient may have the right to move forward with a lawsuit against the drug company or device manufacturer.
Prescription and over-the-counter medications are approved by the FDA if they are properly tested and manufactured and offer benefits that outweigh their known risks. Medical devices may be approved on the basis that they are “substantially equivalent” to devices already approved and on the market for the same use or, for new devices, that they are reasonably effective and safe. In spite of approval requirements, products sometimes still make it to the shelves and into the hands of healthcare professionals when they can cause serious harm. They may also be improperly marketed or mislabeled. Accordingly, there are certain circumstances where the drug company or manufacturer of the medical device may be held liable.
An injured patient may have grounds for a lawsuit if a drug was improperly marketed or labeled, manufactured incorrectly or inadequately tested. The following are basic examples of when a manufacturer may be held liable for injuries caused by one of their drugs or devices:
- The manufacturer gained FDA approval based off falsified test results.
- The manufacturer’s application for approval to the FDA was missing relevant test results that showed adverse reactions.
- The drug was part of a batch manufactured at a specific facility where the wrong formula was used or the dosage was mislabeled.
- The medical device had a manufacturing defect that rendered it dangerous or ineffective.
- The medical device had a design defect that impacted its efficacy.
- The manufacturer gained approval from the FDA based off a 510(k) application for a medical device that was not actually substantially equivalent to an already approved device.
- The manufacturer marketed a device or drug for a use other than what it was approved for.
- The manufacturer’s advertisements for the drug were misleading or provided incomplete information to potential patients.
Whether it is the product itself or the manner in which it is labeled or marketed, it is important to establish how the manufacturer should be held accountable. There are some circumstances where the manufacturer may be held strictly liable for a patient’s injuries, meaning the patient need not prove fault or wrongdoing on the part of the manufacturer, only that the device or drug was defective and that the patient used it and was injured. This may apply in cases where the drug or device had an inherent design or manufacturing defect. If the warning label or instructions for use were inadequate or false, this may also provide grounds for pharmaceutical litigation based on strict liability.
The injuries caused by a dangerous drug or defective medical device may have a profound impact on a patient’s life. Recovering financial compensation can help the patient work to rebuild and recover what was lost. Compensation may be awarded for medical care, future medical expenses, lost wages, loss of potential earnings, emotional trauma, pain and suffering and possibly punitive damages. Because every case is different, we recommend talking to an attorney who is skilled in handling these lawsuits in your area. Contact Napoli Shkolnik PLLC today.