Over-the-counter (OTC) drugs and medications are widely used these days for common ailments. OTC drugs are popular and convenient because consumers can buy them without any input from a doctor or other medical professional. Ready access to OTC drugs presents some risks, however. On this page, our product liability lawyers will look at potential lawsuits involving OTC drug injuries.
OTC Lawsuits – News and Updates:
July 2024: Healthy Living Migraine Relief acetaminophen pills have been voluntarily recalled at the request of the FDA. The recall comes after the FDA found that the product label contained inaccurate or misleading information. The Health Living brand products are manufactured by Aurobindo Pharma USA, Inc.
June 2024: An over-the-counter “male enhancement” dietary supplement product called Ram It To the Moon has been recalled by the manufacturer, Integrity Products, in response to an FDA request. The supplement was recalled after is was found to be “tainted” with sildenafil. Sildenafil happens to be the active drug in Viagra – which suggest that this contamination may have been intentional.
January 2024: Several batches of the widely popular cough syrup Robitussin were recalled by the manufacturer, Haleon. The recall came after it was discovered that the products may have been contaminated with bacteria during the manufacturing process.
December 2023: The Tylenol autism lawsuits in the federal court MDL essentially over now after the MDL judge ruled that the plaintiffs’ scientific evidence on causation was not reliable and, therefore, inadmissible. The judge found that the evidence and expert findings linking Tylenol use during pregnancy to autism and other issue was not based on reliable scientific methods. This ruling effectively ends all of the Tylenol autism cases in federal courts.
October 2023: Ion and Restore brand nasal sprays, manufactured by Biomic Sciences, were recalled this month. The nasal sprays were recalled due to a potential microbacterial contamination in the sprays.
March 2023: Several brand of hand sanitizer including Clean Pro Supply, Midwest Cleaning Solutions, and Soft Hands, were recalled because they were contaminated with methanol during the manufacturing process. The hand sanitizers were made by Jarman’s Midwest Cleaning Systems, Inc.
January 2023: In 2019, independent lab testing found that the popular antacid drug Zantac contained high levels of NDMA – a known human carcinogen. This prompted a widespread Zantac recall and led to thousands of product liability lawsuits by individuals claiming they developed cancer from using Zantac. The Zantac lawsuits in federal courts were consolidated into an MDL, but after 2 years of discovery the Zantac cases in federal courts will now be dismissed because the MDL judge ruled that the plaintiffs’ causation evidence was not admissible.
OTC vs Prescription Drugs
The obvious distinction between prescription medications and OTC drugs is that you don’t need a prescription from a doctor to get OTC medications. Whether a drug is classified as OTC or prescription is determined by the U.S. Food and Drug Administration (FDA) based on certain established criteria.
In recent years, the rules for classifying a drug as OTC have been loosened allowing a larger number of products to be sold over-the-counter. According to the FDA, there are now over 700 medications and medical products available over-the-counter that were only available by prescription in the 1990s.
The FDA relies heavily on drug warning label requirements to ensure that medications are reasonably safe for OTC status. The drug warning labels are supposed to provide consumers with critical information such as:
- Potential adverse medications
- When and how to use the medication
- When to stop using the medication
- When you should consult a doctor
- Potential side effects from the medication
Labels also provide instructions, including the directions for use, active ingredients, and the purpose of the drug. Reading OTC medication labels is important to avoid interactions with your prescription medications. If you’re unsure, ask your doctor or pharmacist whether an OTC medication is safe given your underlying health condition.
OTC medications come with tamper-evident packaging (TEP) to protect against criminal tampering. Never use an OTC product if the package is damaged, the safety seal is broken, or the medication appears discolored. Report any signs of tampering to the store or pharmacy where you purchased the product.
Misuse of OTC Drugs
Consumers regularly misuse OTC medications. Common forms of misuse of OTC drugs include taking the medication for something OTHER than its intended use, and mixing it with something to create a different drug.
One of the most notorious examples of OTC medication misuse has occurred with pseudoephedrine (the active drug in cold medicines like Sudafed). Pseudoephedrine is commonly repurposed in a lab to make the illegal drug called crystal meth. This problem became so widespread that most states have regulations requiring medications containing pseudoephedrine to be keep in a safe place and only sold with proof of identification.
Two other commonly abused OTC medications are dextromethorphan (DXM) and loperamide. DXM is a cough suppressant, while loperamide is used to treat diarrhea. DXM can be taken alone or combined with other drugs, and some users inject it to feel its effects more quickly. Loperamide is often taken in large doses by those seeking its effects. Abuse of either drug can lead to addiction and potential overdoses.
Dangerous OTC Drug Interactions
Combining certain medications can lead to serious drug reactions, even with OTC medications. Prescription medications, for example, can interact dangerously with OTC medications. Doctors refer to this as a drug-drug interaction, which occurs when two drugs with similar active ingredients are taken together, leading to over-medication and potentially creating new medical issues. For instance, combining a prescription anti-inflammatory drug with OTC ibuprofen can result in an excessive dose of similar substances.
An opposition reaction can happen when two medications have opposing effects on the body. For example, a prescription drug intended to lower blood pressure may interact with an OTC medication that raises blood pressure. Additionally, some medications can affect how the body processes or absorbs other drugs, reducing their effectiveness. Food can also impact medication effectiveness; some medications must be taken on an empty stomach, while others should be taken with food.
OTC Dangers From Uncoordinated Medical Care
The potential for prescription medications to interact with OTC medicines can become even more confusing when you have multiple healthcare providers. Uncoordinated care can lead to situations where one doctor approves an OTC medication without being aware of all the other medications you are taking. Receiving the wrong medications—both prescription and OTC—while in the hospital is not only possible but also dangerous. Studies show that more than 60 percent of hospital patients miss their regular medications during their stay.
Doctors and pharmacists often work long hours, and during a 12-hour shift, a pharmacist may fill between 300-450 prescriptions. Under these conditions, mistakes can happen, especially if a pharmacist is overworked and tired. If these errors are compounded by incorrect OTC medication advice, the consequences for your health can be severe.
If you have experienced a serious drug interaction due to a prescription mistake or incorrect OTC medication recommendation, it’s important to take action. Pharmacists and doctors have a duty to protect their patients from harm. No one should suffer serious side effects or a decline in health due to the negligence of an overworked medical professional. A personal injury lawyer can review your case for free and help determine how the error occurred and who may be liable. Personal injury lawyers specialize in protecting the rights of innocent victims, and they understand how unfair it is when a medical professional’s mistake results in a serious drug interaction that delays your recovery or causes new health issues.
OTC Medication Lawsuits
Most lawsuits involving OTC medications involve medication or prescription errors by a doctor or pharmacist. Even though OTC medications are not prescribed by your doctor or dispensed by your pharmacist, they can still have some liability for injuries related to OTC medications.
Doctors and pharmacists have a professional duty to their inform their patients about potential dangers from common OTC medications. These can be dangers from OTC medications that may arise because of the patient’s medication condition or history, or potential adverse drug interactions between OTC medications and a drug that the doctor prescribed.
For example, if a doctor prescribes you a medication that has known adverse reactions with certain OTC drugs, he or she arguably has a duty to warn you about that potential dangerous interaction. Pharmacists also have a similar duty. So if you come to pick up your prescription and your also buying an OTC medication that could adversely reaction with that prescription medication, the pharmacist would have an obligation to warn.
In addition to medical malpractice cases, OTC medications can also be at issue in product liability lawsuits. These are civil lawsuits filed against the drug manufacturer if the OTC medication causes some type of physical injury. They are usually based on failure to warn.
A good example of product liability lawsuits involving an OTC medication are the Zantac cancer lawsuits. The Zantac lawsuits allege that Zantac contained a carcinogenic chemical called NDMA. Individuals who used Zantac and developed cancer are now suing the manufacturers for product liability.
Contact Our Product Liability Attorneys
If you think you may have a product liability or medical malpractice cases involving injuries related to an OTC medication, call our national injury lawyers today for a free case evaluation. Call us at 800-553-8082 or contact us online.