When you receive a prescription from your doctor or undergo a drug-based treatment at a clinic or hospital, you expect your medication to work as intended. You expect it to help you get better—not worse—and while you might expect some side effects, you hope they will eventually subside.
Unfortunately, severe complications from dangerous drugs are a genuine concern. Each year, patients across Florida experience life-altering and life-threatening complications after taking medications recommended by their doctors. If you have been harmed (or if a loved one has been harmed or tragically killed) by a dangerous drug, here’s what you need to know:
Common Issues that Can Make Prescription Drugs Dangerous for Patients
Medically speaking, numerous issues can make prescription drugs dangerous for patients. Hazardous drugs can present a wide range of health risks, and these health risks can have a wide range of potential consequences. But, more generally, the risks associated with dangerous prescription medications fall into three broad categories:
- Unanticipated Health Risks—Sometimes, prescription drugs present unanticipated risks. Despite the laboratory testing and clinical trials required before pharmaceutical companies are allowed to bring new drugs to market, unanticipated risks can still come to light during the “post-market” phase. While these risks will come to light fairly quickly in some cases, in others, the risks for patients may not become clear until several years down the line.
- Undisclosed Health Risks—Sadly, undisclosed health risks are also a genuine concern. Numerous investigations have revealed that pharmaceutical companies either ignored or covered up known risks when seeking FDA approval.
- Contamination—Contamination is another issue that can make prescription drugs dangerous. When medications become contaminated with harmful bacteria or viruses during manufacturing, storage, or preparation, this can present life-altering (if not life-threatening) risks for patients.
As discussed below, these issues can provide grounds for patients and their families to seek just compensation. Pharmaceutical companies and healthcare providers must avoid manufacturing and prescribing dangerous drugs, and when they fail to meet this duty, they can—and should—be held accountable.
When Are Pharmaceutical Companies Liable for Selling Dangerous Drugs?
So, when are pharmaceutical companies liable for selling dangerous drugs? The short answer is that pharmaceutical companies can be held liable whenever they put dangerous drugs on healthcare providers’ or pharmacies’ shelves. This is true whether a drug is dangerous due to an unknown health risk, an undisclosed health risk, or contamination.
Under Florida’s product liability laws, pharmaceutical companies are subject to “strict liability” when they sell dangerous drugs. This means that proof of negligence or intentional misconduct is not required. Dangerous drug lawsuits against pharmaceutical companies involve claims based on “defects,” and these can also take three primary forms:
Defective Design
Sometimes, drugs are dangerous because of their chemical composition. This is referred to as having a “defective design.” When a drug suffers from a defective design, all batches and doses of the drug will present potential health risks for patients.
Defective Manufacture
Some issues—such as contamination—can arise during the manufacturing process. Even if a prescription drug would be safe under normal circumstances, the pharmaceutical company can still be held fully accountable if a problem with its manufacture puts patients at risk.
Failure to Warn
Pharmaceutical companies can also be held fully accountable for their failure to warn. This applies to both known and unknown risks. If patients need information about a drug to make informed decisions about their healthcare, then failing to provide this information can provide clear grounds for liability.
When Are Healthcare Providers Liable for Prescribing or Administering Dangerous Drugs?
Healthcare providers can also be held liable for prescribing and administering dangerous drugs in some cases. Not only can healthcare providers be held liable for knowingly prescribing and administering dangerous drugs, but they can also be held liable when they should know that a drug presents unreasonable risks to their patients. Doctors and other healthcare providers’ duty of care extends to all areas of the practice of medicine, and when they fail to meet this duty, they can—and should—be held liable for medical malpractice.
For example, let’s say a pharmaceutical company recalls a drug due to concerns that it can cause heart attacks in patients with certain medical conditions. If a healthcare provider fails to remove the drug from its inventory and subsequently administers it to a patient who suffers a heart attack, the provider could potentially be liable.
Prescription and Non-Prescription Medications That Have Recently Come Under Scrutiny
Just how common are dangerous drugs? The short answer is that they are far more common than most people realize. Pharmaceutical companies frequently issue recalls, and in many cases, they also decline to issue recalls despite clear evidence of severe health and safety concerns.
Here are five examples of prescription and non-prescription medications that are currently the subject of lawsuits filed in Florida and across the country:
GLP-1 (Semaglutide) Weight Loss Drugs
GLP-1 weight loss drugs have become extremely popular in recent years—so popular that doctors’ offices and pharmacies often face shortages. However, there are also serious concerns about the safety of these drugs, as patients have reported—and studies have confirmed—that they can cause a variety of severe medical conditions. These include gastroparesis, pulmonary embolisms, and non-arteritic anterior ischemic optic neuropathy (NAION), among others. As a result, numerous lawsuits have been filed against the makers of:
- Ozempic
- Wegovy
- Rybelsus
- Mounjaro
The long-term effects of these drugs are still not well understood. But this has not stopped drug companies from making them or healthcare providers from prescribing them. Many more lawsuits will be filed, and through these lawsuits, patients and their families will be able to uncover what the drug companies know (and have known) about the risks these drugs present.
Contaminated Eye Drops
Contaminated eye drops have been the subject of litigation for years. While this litigation initially focused on eye drops sold by the pharmaceutical companies Global Pharma and Delsam Pharma, it has expanded to include several other defendants. Notably, since these are not prescription drugs, some plaintiffs have also filed lawsuits against retailers like Amazon and Walmart—which can also be held liable for selling dangerous and defective products (including dangerous drugs).
Suboxone (Buprenorphine and Naloxone)
Suboxone, a medication for treating opioid addiction and chronic pain manufactured by Indivior, Inc., is the subject of ongoing litigation involving claims that the drug can cause severe tooth decay, among other issues. While the litigation with individual plaintiffs remains ongoing, Indivior, Inc., recently entered into an $86 million settlement with the State of New York to resolve lawsuits filed by Attorneys General in more than a dozen states.
Tepezza (Teprotumumab)
Tepezza, a medication for treating thyroid eye disease (TED) manufactured by Horizon Therapeutics, is also the subject of multiple lawsuits filed across the United States. These lawsuits allege that Tepezza causes hearing loss and other hearing impairments. Many of the lawsuits against Horizon Therapeutics were filed after a Stanford University School of Medicine study found that 65% of patients taking Tepezza experienced hearing-related complications.
Valsartan
Valsartan is a medication used to treat hypertension and other medical conditions that Novartis and other drug companies manufacture. It has also been found to contain N-nitroso dimethylamine (NDMA) in some cases. NDMA is classified as a probable human carcinogen. Ongoing lawsuits against Novartis and other drug companies allege that these companies failed to do enough to ensure patients’ safety, and they are seeking just compensation for bladder cancer, colorectal cancer, leukemia, non-Hodgkin’s lymphoma, and other cancers.
The FDA’s Role in Ensuring Drug Safety
At this point, you might be wondering about the FDA’s role in ensuring drug safety. After all, drugs sold in the United States are subject to FDA approval, and the FDA is the primary federal agency responsible for ensuring that dangerous drugs do not end up in the hands of healthcare providers or patients.
But, there is only so much that the FDA can do. The volume of drugs, medical devices, and other items that the FDA needs to review each year is substantial, and the number of drugs subject to its “post-market” oversight continues to grow annually. Thus, while the FDA can proactively identify drug-related risks in some cases, more often than not, it only takes action after learning of concerns from drug companies, healthcare providers, or patients.
The FDA’s List of Recalled Medications
In addition to conducting pre- and post-market drug safety assessments, the FDA maintains a list of recalled medications. As we mentioned above, however, not all dangerous drugs are subject to recalls. As a result, while this list is an excellent place to start if you have concerns, you should not dismiss your concerns if your (or your loved one’s) medication isn’t on this list. Instead, you should consult with a healthcare provider promptly and with a lawyer if you have questions about your legal rights.
Do You Have a Lawsuit for a Defective Medication?
This brings us back to our initial question: When can (and should) patients and families in Florida seek compensation for dangerous drugs?
Understanding your legal rights in this situation can be complicated. Do you have a claim? If so, should you sue the drug company or your healthcare provider (or both)? What evidence do you need to prove your legal rights? How much financial compensation should you seek in your lawsuit, and how can you ensure you can recover the full compensation you deserve?
But, while understanding your legal rights can be complicated, the first step is easy. If you have any drug-related concerns, you should schedule a free consultation with a lawyer who can help you. At Silva & Silva, we have significant experience handling dangerous drug cases—including product liability cases against pharmaceutical companies and medical malpractice cases against healthcare providers. Our lawyers can help you understand your situation and make informed decisions about your next steps, and if you are entitled to just compensation, we can handle your lawsuit at no out-of-pocket cost.
Contact Silva & Silva for a Free, No-Obligation Consultation
Do you have questions about seeking financial compensation for serious or fatal complications from a dangerous prescription or non-prescription drug? If so, we encourage you to contact us for a free, no-obligation consultation. To speak with an experienced lawyer at Silva & Silva in confidence as soon as possible, please call 305-445-0011 or tell us how we can reach you online today.