We visit our doctors and other medical professionals to recover from injuries and manage any medical conditions. We might get prescriptions for blood pressure, pain, or undergo surgery to replace our hips or improve our hearts. However, when the companies and manufacturers of the medications and devices we need sell us defective products, our lives can be put at risk.
Dangerous prescription drugs and defective medical devices contribute to thousands of preventable illnesses, injuries and deaths each year. The Alabama medical product liability attorneys at Mezrano Law Firm are proud to help those who were injured due to the negligence of big pharmaceutical companies and medical product manufacturers. Our job is protecting your rights.
Each year, the U.S. Food and Drug Administration (FDA) approves hundreds of new pharmaceuticals and medical devices to go to market – only if these products are safe and perform effectively as intended. Unfortunately, the trend of profits over people has led to lax safety procedures and testing, cover-ups and consumer injuries and fatalities.
When a company or manufacturer develops a medical device, they must submit it, along with appropriate safety testing results, to the FDA before it can go to market. However, a section added to the Food, Drug and Cosmetic Act in 1976 has provided many manufacturers a shortcut around this lengthy process.
If a manufacturer can show that their medical device is “substantially equivalent” to an existing, approved medical device, they can apply through what’s called the 510(K) approval process. The device manufacturer submits paperwork detailing the similarities between the two products – but is not required to do any additional testing. This even includes devices that are surgically implanted in the body.
Many opponents of the 510(K) argue that the process needs to focus more on patient safety than efficiency. The FDA seems to agree there’s a need for a change, and recently proposed a change to the program – that manufacturers may only use the 510(K) process when their applications are based on medical devices approved over the past 10 years.
An article by Associated Press also found that, out of approximately 4000 medical devices listed in the FDA database, just six devices accounted for a full 25% of injury reports:
If the FDA identifies a potential health risk related to a drug, it issues a public safety announcement. It also requires the manufacturer add new warnings to the drug’s prescribing information and patient information guidelines.
However, if that drug’s risks outweigh its benefits, the manufacturer may choose to pull the drug off the market instead. The FDA can also request the manufacturer recall a drug. The FDA classifies drug recalls by the level of risk they present to the public:
Not every drug recall makes it onto the news. However, the FDA posts all recalls online in weekly updated reports, along with the reason for the recall. The FDA typically publicizes recalls for drugs that cause a serious health hazard, or drugs that are widely popular.
Just like any product, medical devices can be recalled for defects or if they present a risk of injury to consumers and patients. Manufacturers voluntarily recall defective or dangerous devices when they become aware of problems. The FDA can step in if the manufacturer fails to order its own recall.
Whenever a company recalls a product or device, they’re required to notify the FDA, who will then publicly announce the recall. Common reasons to recall a medical device include manufacturing defects, software problems, mislabeled instructions or lack of sterility.
The FDA also maintains a database of recalled medical devices.
You may be able to hold the maker of dangerous drugs or defective medical devices accountable for your injuries or medical complications. Manufacturers may be held liable when their products:
When drug and medical device companies fail to properly test their products, or withhold pertinent information on the safety of their products, and that product causes you harm, they can be held liable in a product liability action. Our Alabama attorneys can speak with you about your personal situation and guide you toward an efficient course of action.
You may hear many different terms when you’re injured by drugs or medical devices, specifically legal phrases like “mass tort,” “class action” or “multidistrict litigation.” Although many people think a mass tort is another method of litigation, it actually means a type of injury. So, a class action lawsuit or multidistrict litigation (MDL) is the avenue to compensate the victims for those injuries.
A mass tort involves hundreds or thousands of people who were all injured in the same way. For example, if defective transvaginal mesh is recalled after causing injury to many people, this mass tort would lend itself well to an MDL action.
Multidistrict litigation and class action lawsuits are similar, but they’re not the same. MDL involves multiple lawsuits and remains that way throughout the proceedings. The cases are all grouped together so the details of the case go through a single court to maximize efficiency. A class action suit, on the other hand, is one case with multiple plaintiffs.
You shouldn’t have to suffer for someone else’s negligence. You may be eligible for compensation for your injuries from a defective medical device or drugs – compensation that can help pay your medical bills and cover lost income while you take the time you need to recover.
The personal injury attorneys at Mezrano Law Firm are dedicated to protecting the rights of the people of Alabama. We’ll stand up to the pharmaceutical and medical device companies on your behalf. Contact us today for experienced representation. We have offices in Birmingham, Tuscaloosa, Florence, Mobile, Montgomery and Gadsden. For a consultation, call us at 205-206-6300 or fill out our contact form.