The Goldberg Law Firm Co., LPA

The Goldberg Law Firm Co., LPA

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Dangerous Drugs and Defective Devices

You rely on prescribed drugs for your health.
You have rights if they fail you. We can help.

You rely on over-the-counter drugs, doctor’s prescriptions and medical devices to improve your quality of life,  to relieve your pain and suffering. But, sometimes the products intended to help you can actually harm you. Serious side effects of dangerous drugs and injury from defective devices can be more debilitating than the condition that led to the prescription or treatment in the first place.

Each year, dangerous medical products cause thousands of injuries and deaths in the U.S. Often, drug makers and device manufacturers recall their products – take them off the market – long after they have become aware of their potential risk for injury. As a result, unsuspecting consumers needlessly suffer illnesses and injury, undergo multiple corrective surgeries, and even lose their lives.

The law gives injured consumers the right to file a lawsuit to get compensation for a manufacturer’s negligence. Prescription drug lawsuits and medical device lawsuits involve a special area of the law known as product liability.

If you have suffered adverse effects from a medication or implanted medical device and are facing physical, emotional, and financial problems, talk to Steven M. Goldberg. He is a nationally recognized leader in the representation of victims of dangerous drugs and defective medical devices with more than 23 years experience representing clients who have suffered life-changing injuries, damages and losses as a result of unsafe products.

The number of new drugs and medical devices on the market increases each year, and so do the recalls and safety alerts. The Food and Drug Administration (FDA) has seen an unprecedented surge in the number of recalls reported to the government agency. While the reasons for recalling products vary, some of the biggest culprits are inferior raw materials, faulty labeling and packaging, contamination, improper testing, and safety problems which could cause a patient harm.

If you need more information and additional resources, keep reading.

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Why drugs are recalled

A drug recall occurs when a prescription or over-the-counter medicine is removed from the market because it is found to be either defective or potentially harmful. Pharmaceutical products are tested for safety and effectiveness before they become available to consumers. Drug makers and medical device manufacturers have a responsibility to make and market safe products and a duty to recall dangerous or defective products. But even with manufacturer testing and FDA evaluation, some safety problems surface only after a drug has been on the market and has been used by a lot of consumers. Should a problem develop, or a safety issue come into question, the manufacturer has a duty to recall dangerous or defective products in a timely manner.

A drug may be recalled due to factors including:

Health hazard. Some health risks or dangerous side effects are not always realized until after they have been on the market for a while or widely used. Too often, in their efforts to rush new drugs onto the market, manufacturers ignore safe practices and fail to conduct adequate testing that could have revealed the dangers of their products. In some cases, drug manufacturers and medical device makers are aware of dangers associated with their products before ever placing them on the market.

Mislabeled or defective packaging. Defective warnings and labels may fail to adequately warn of drug interactions, adverse reactions and serious side effects, provide instructions for safe use, or provide information regarding preexisting conditions which increases the risk of injury.  There could be problems with container design or tools – such as the dosing equipment – provided with the product.

Contamination. A product can potentially become contaminated with a harmful or non-harmful substance during the manufacturing process.

Wrong product. The package material may not describe or match the actual contents inside the package. For example, you may think you are taking a pain reliever based on the package material, when in fact what is inside the box is something else.

Poor manufacturing. Defects in manufacturing related to a product’s quality, purity and potency may cause a product recall.

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Role of the FDA

The Federal Drug Administration (FDA) is the federal agency charged with overseeing the safety of drugs, medical devices, food, cosmetics and many other health-related products. Among its responsibilities is protecting the public health by assuring the safety, effectiveness, quality, and security of drugs, vaccines and  medical devices. The FDA maintains a list of recalled drugs and medical devices.

Ultimately, FDA faces a balancing act in evaluating a new drug. If it’s good for one person or a small group, will it be good for the whole population? Which safety risks are likely to be acceptable to patients who might take a drug and physicians who might prescribe it?  Once a drug is marketed and new information about its safety becomes available, FDA must revisit these questions continually over the drug’s lifecycle.

In the end, no matter how much data are available, it’s a judgment call, weighing the known benefits against known risks and the potential – and possibly unknown – risks.

In the 1990s, the agency was widely criticized as taking too long to approve new drugs, so Congress passed legislation speeding up drug reviews. In 1992, the FDA created expedited approval programs under the Prescription Drug User Fee Act (PDUFA) – referred to as fast-track programs ­­– to give doctors and patients quicker access to new drugs and devices that are needed to treat a number of serious and unmet health issues.

Another FDA program was created in 1976. Under the 510(k) Premarket Notification program, some medical devices that the FDA determines to be low risk are allowed to go to market without comprehensive testing. If a device is already on the market and is “substantially equivalent” to the new product, it can potentially gain faster approval.

Fast-track programs and the 510(k) program draw criticism because of the concern that they put speed before safety.

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How drugs are recalled

Drug makers are expected to take responsibility for product recalls. When it is discovered that a product poses a safety risk or is defective, drug makers or distributors will often take products off the market voluntarily.

In other instances, the FDA may inform a company of findings that one of its products is defective and suggest or request a recall. If the firm refuses, the FDA may seek legal action under the Federal Food, Drug, and Cosmetic Act. Such legal action may include seizure of available product, and/or injunction of the company, including a court request for recall of the product.

When a medical device is discovered to be defective, it is the manufacturer’s responsibility to inform the FDA and the public about the flaws and any potential risks that may arise. If the manufacturer does not adequately inform the FDA and the public of these problems in a timely manner, it can be considered an “act of negligence,” which can make the company liable for injuries, illnesses or deaths that may occur as a result of the faulty device.

FDA guidelines for categories of recalls, according to the level of hazard involved:

Class I: Significant and immediate danger of death or other serious injury can result from the use of the product. Examples: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

Class II: No immediate danger of death or other serious injury. The product product may cause temporary or medically reversible health consequences, but the probability of serious injury is remote. Example: a drug that is under-strength but that is not used to treat life-threatening situations.

Class III: No immediate or perceived danger of any health issues, but the products are in violation of FDA regulations. Example: 2010 recall of children’s medicines that were potentially contaminated with small pieces of plastic during the manufacturing process.

Market withdrawal: Product has a minor violation that would not be subject to FDA legal action. The company removes the product from the market or corrects the violation. Example: a product removed from the market due to tampering, without evidence of manufacturing or distribution problems.

Medical device safety alert: A medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.

 

For an evaluation of your case, contact the Goldberg Law Firm today.