Drug Recalls: Understanding Your Rights
In the United States, the companies that manufacture, advertise, distribute, and sell pharmaceuticals are expected to adhere to certain standards of product quality and safety. Unfortunately, companies sometimes fail to successfully meet these standards.
Even when companies do their best to comply with regulations and protect consumers, concerns may come to light after the product has already entered the market and the use of the drug has become widespread. When recalls are issued for such products, it’s important for you to know what your rights are and how you should respond.
What Are Drug Recalls?
A drug recall is an official call to pull a certain pharmaceutical product from the market due to concerns that it may be defective or harmful. When issued, pharmacies and retailers are expected to take the recalled product off the shelves and stop selling it to the public.
A recall may be issued by the Food and Drug Administration (FDA) or voluntarily by the manufacturer of the drug. When the FDA issues a recall for a product (or a partial recall for a specific strength or lot number), it’s not uncommon for a manufacturer to then voluntarily issue further recalls as an additional precaution.
There are several reasons why a drug might be recalled, such as the following:¹
- Risk of health hazards: Reports from consumers and/or other evidence suggest that the use of the drug may pose unexpected health risks.
- Possible contamination: There is evidence that one or more lots of the drug may have been contaminated with another substance.
- Incorrect labeling: The product inside the container is not what it is supposed to be.
- Poor manufacturing quality: The product is impure, has an insufficient potency, is inconsistent in quality, etc.
- Failure to comply with regulations: The drug is in some way non-compliant with FDA requirements. This could be an issue with manufacturing practices, claims, labeling, etc.
Different Levels of FDA Drug Recalls
Because there are so many different reasons why a pharmaceutical product might be recalled, the FDA categorizes their recalls into three levels—Class I, Class II and Class III—based on the severity of the concern.
Class I recalls are the most serious kind of drug recall. Class I recalls are issued for products that could be seriously dangerous to human health. At this level, the issue is one that may even pose a risk of death.
For example, the FDA issued a recall in 2016 for two defective lots of hyoscyamine tablets. The lots in question were found to be inconsistent in strength, with some tablets containing very little active ingredient and others containing too much active ingredient. The low-potency tablets would likely have been ineffective, while the excessively potent tablets may have created serious health problems.²
Class II is the most commonly issued type of drug recall and is not as severe as Class I. These are used in cases where health risks are temporary or there is only a minor possibility of serious problems.
In 2019, the FDA issued a recall for one lot of Children’s Advil because the cup included with the product was marked using a different unit of measure than the directions on the label. The dosage directions were written using milliliters, while the cup was marked in teaspoons. There was, therefore, a risk that caregivers could overlook the units and accidentally give children a much higher dose than intended.²
This is the least serious type of recall the FDA issues. A Class III recall is one in which the product in question is not likely to be hazardous to human health, but it is not compliant with FDA manufacturing or labeling requirements.
For example, a Class III recall was issued in 2017 for one lot of glipizide extended-release tablets after testing showed it did not comply with water content limits. There was no reason to suspect any risks to consumers’ health.²
Your Rights as a Consumer
As someone who pays for and ingests a medication, you have inherent consumer and patient rights. The following are just a few of the rights that regulators and personal injury lawyers work hard to protect.
The Right to a Reasonably Safe, Sufficiently Potent Product
When a company introduces a drug to treat a medical condition, you trust that they have done their due diligence to ensure that it will be safe and live up to its claims. As a consumer, you have the inherent right to be protected from harm and receive medication with an effective potency.
The Right to be Informed of Known Risks and Side Effects
It is the duty of the drug manufacturer, its marketers, and its distributors to ensure that patients like yourself are given clear warnings about any known health risks or serious side effects related to the use of the medication. If a company fails to identify or disclose a risk that they should reasonably have known about, they have violated your right to this information.
The Right to Be Compensated for Losses Caused by an Unsafe Drug
If deceptive advertising, undisclosed health risks, contamination, or other issues lead you to be harmed by an unsafe drug, you have a right to be compensated for your losses. If you’ve developed new health problems or faced other issues after taking a recalled drug, you may be owed compensation for medical bills, lost wages, pain and suffering, and more.
What to Do (and What Not to Do) if a Recall Is Issued for a Drug You’re Taking
If you hear that a prescription or over-the-counter drug you’ve been taking has been recalled by the FDA or the manufacturer, do the following:
- Double-check the details of the recall first. It’s possible that it might only apply to a particular lot or dosage, or it may be a Class III recall that does not involve any risk to your health.
- If the recalled drug is an over-the-counter medication that is safe to stop taking, discontinue using it. Depending on the details of the recall, you may want to avoid other versions of the product or similar medications temporarily.
- If your medication is included in the recall and you suspect your health issues are linked to it, get in touch with a personal injury attorney as soon as possible.
- No matter what, never stop taking a prescription medication without first consulting with your prescribing doctor. In some cases, suddenly stopping or changing your dosage could have serious, even life-threatening, repercussions.
How a Personal Injury Lawyer from Schechter, McElwee, Shaffer & Harris Can Help
If a drug that you were taking was recalled and you suspect that it might have had negative effects on your health, it may be time to talk to an attorney. At our personal injury law firm, we help clients harmed by unsafe drugs recover the damages they need to cover medical costs, lost wages, and other related losses.
During your free initial case evaluation, your attorney will help you determine whether or not your situation is appropriate for an individual or class-action lawsuit. If it is, they’ll work closely with you to build up a thorough body of evidence and craft a strong case against those at fault.
Learn more or schedule a consultation today by calling our 24-hour hotline at (713) 893-0971.