Alabama Defective Drug and Devices Lawyers

Representing victims of dangerous drugs and medical devices throughout the state

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.

The FDA’s role in medical device safety

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.

The FDA had around 2,000,000 reports in its prescription drugs adverse events database for 2018, while 2017 saw nearly 300,000 injuries from defective medical devices.

The 510(k)process

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:

  • Hip prostheses
  • Insulin pumps (sensor)
  • Spinal stimulators
  • Surgical mesh
  • Insulin pumps (implanted)
  • Defibrillators

Drug recalls & the FDA

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:

  • Class I recall. The most urgent recall, Class I applies to defective drugs than can cause serious injury or death.
  • Class II recall. A Class II recall includes situations where a drug can cause temporary health problems, or poses a slight threat of a serious nature.
  • Class III recall. The last serious category, Class III recalls are for products that violate FDA manufacturing or labeling laws, but are unlikely to cause physical harm.

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.

Device recalls & the FDA

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.

Negligence, defective drugs and 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:

  • Have a design flaw that makes the product or medication inherently dangerous
  • Reaches the market with a manufacturing error like the introduction of a hazardous or toxic substance
  • Fail to provide proper warning of potential side effects
  • Employ deceptive marketing, especially erroneous or exaggerated claims about the benefits of the product

Types of litigation for dangerous drugs and devices

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 (MDL). In an MDL, civil cases from Alabama and across the country are transferred and consolidated to a single district court for pre-trial procedures. This consolidation helps save judicial resources, eliminate redundancies in fact-finding and discovery and prevent inconsistency in rulings. One federal judge oversees all proceedings, and has the power to dismiss certain counts in a lawsuit. At the end of this process, if a case isn’t dismissed or a settlement isn’t reached, a case can be released back to its original court to go to trial.
  • Class action lawsuits. A class action lawsuit lets multiple plaintiffs group together to make the same complaint against a company or manufacturer. One plaintiff or stand-in represents the group, and any settlement or jury award is split among the entire class. It’s important to note that medical device injury cases don’t typically lend themselves well to class action suits, as different people suffer different injuries. Class action suits can be beneficial for some, as they’re less expensive, but settlements and awards tend to be smaller. The court’s decision is binding.

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.

Compassionate Alabama product liability attorneys

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 205.407.1768 or fill out our contact form.