Pharmaceutical Injury: What You Should Know￼
August 17, 2022 @ 4:58 pm
According to the IQVIA Institute for Human Data Science, Big Pharma is flourishing in the U.S.
- “Prescription drug use reached a record 194Bn [194 billion] daily doses in 2021,” representing a 9.6-percent growth increase in the last five years.
- Wholesaler “spending at list prices . . . has increased from $581Bn to $776BN” over the past five years.
- Payer net spending has increased from $463Bn to $586Bn over five years.
The statistic that’s often much harder to find is how many of those medications caused harm—an injury, an illness or even death. They’re labeled pharmaceutical injuries or called a drug injury, and they may happen more often than we’d like to think.
Likelihood of Pharmaceutical Injuries
Many of us take medication without considering whether the unthinkable might happen. We swallow the pill or capsule, apply the cream or ointment, or use the inhaler, for example, and trust that it will do what it’s supposed to do and nothing more. Sometimes, however, it does something else instead of or in addition to what we were anticipating. In some cases, the adverse reaction is immediate while in others, problems can develop over time, making a regular medication no longer a viable or safe option.
According to the Food and Drug Administration, “Estimates suggest that FDA receives reports of about 1 to 10 percent of the adverse events that occur.” Meanwhile, some studies “estimate that 6.7% of hospitalized patients have a serious adverse drug reaction with a fatality rate of 0.32%.” These figures translate to more than 2.2 million serious adverse drug reactions that cause more than 106,000 deaths annually, making drug injury potentially the fourth leading cause of death—”ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents and automobile deaths.” This is a figure for hospitalized patients alone.
Adverse Drug Reactions
Adverse drug reactions occur when your body has a negative response to a medication. The reaction may be a response to starting a medication, stopping a medication, or even increasing or decreasing the dosage or frequency of a medication.
Many of the responses that a drug might cause are known, documented through testing and considered side effects—secondary responses that your body may have. While most side effects are undesirable but somewhat acceptable, they may cross a threshold where they become harmful or even life-threatening.
For example, nausea, dry mouth, dizziness and drowsiness are all commonly cited side effects for any number of drugs. They’re undesirable reactions that are often considered manageable trade-offs for the benefits of the drug causing them. However, adverse reactions like liver damage, for example, stroke, heart attack or chronic conditions like diabetes are examples of adverse reactions that are serious enough to be life-threatening.
What Legally Qualifies as a Pharmaceutical Drug Injury?
The critical issue for establishing pharmaceutical injuries is not just that an adverse reaction occurred but in particular why it occurred. A clear connection must exist between the drug and the drug injury, with some degree of negligence at fault.
During clinical trials, manufacturers test drugs to determine whether they work, how well they work, how various dosages might affect efficacy, how administering the drug affects efficacy, what side effects come into play and even how the drug interacts with other medications. Human trials often begin with small groups of individuals being treated for a single condition and expand to include varied individuals with additional conditions.
Manufacturers then use that data to determine dosages, schedules, and criteria and requirements for using and administering the drug properly as well as possible side effects. As a drug is approved, prescribed and used for the general population over time, recommended dosages and label use may change as more long-term data become available.
Therefore, several factors become important in proving pharmaceutical injury cases.
1. Patient Compliance—A patient must have taken or used medication exactly as it was prescribed. Failing to take medication as directed, splitting dosages or doubling up missed dosages, for example, can make proving patient compliance difficult. Patient diet and use of herbal supplements or over-the-counter medications, for example, can also add complexity due to interactions.
2. Unanticipated Side Effects—Doctors often fail to discuss possible side effects with patients, and multiple specialists may be prescribing. They may overlook critical drug interactions or even fail to consider how a prescription might affect pre-existing conditions. Sometimes, pharmaceutical manufacturers resist full disclosure of the number of side effects a drug may have or downplay the strength of potential adverse reactions. Add into all of this the responsibilities of a pharmacist to ensure that the prescribed drug is a good choice for the patient and that it’s dispensed with accurate instructions and warnings.
3. Acute or Permanent Harm—The patient must have suffered permanent harm or injury that can be documented. Allergic reactions can range from mild rashes to anaphylactic shock. Since kidneys filter toxins from the body, they can suffer damage from some types and dosages of medications, for example. Other frequently cited serious injuries include strokes, heart attacks, heart damage, chronic conditions like diabetes, degenerative bone syndromes, brain infections, cancer, debilitating physical or psychological conditions, or even death.
4. Negligence—Determining who is at fault for a drug injury can be complex. If the fault lies with the drug itself, the manufacturer is typically at fault. If a doctor prescribes it in error or for an off-label use or fails to counsel a patient properly, the fault might be the doctor’s. If a pharmacist dispenses the wrong drug or wrong strength of drug or mislabels warnings or instructions, the pharmacist may be at fault. Ultimately, you trusted people who had a duty to protect you, and someone let you down.
How To File a Pharmaceutical Injury Claim
If you or someone you care about has suffered a serious drug injury, the best thing you can do is to start gathering the documentation and information needed for a successful pharmaceutical injury claim.
1. Alert Your Doctor—If you are taking a medication and you experience side effects, you need to alert your doctor. This gives you an official record that you had certain adverse reactions and that you communicated concern to your care provider.
2. Record Medication Use and Side Effects—Track and document the medicine you take, when you take it and how much you take as well as any side effects you experience. A simple notebook or daily planner with enough space for notes can be critical in establishing a cause-effect relationship between the drug and debilitating symptoms.
3. Keep Copies of All Medical Records—Request copies of all medical visits, tests and diagnostics, scans and other assessments. These records are useful for establishing dates and objective medical data.
4. Educate Yourself—Read the warning inserts that come with your prescriptions. All medication should come with accompanying information explaining the drug, its uses and its potential side effects. Black box or boxed medications carry warnings of potentially serious adverse events. Many black box drugs began as regular pharmaceuticals, but the number and seriousness of the resulting side effects after the drug was prescribed to the general population warranted the addition of a box warning. That warning, however, does not relieve drug makers, doctors or pharmacists from the responsibilities associated with manufacturing or prescribing the medication. Often, drugs that are causing medical injuries find their way into the news. They may also be listed through the FDA’s searchable MedWatch Safety Information and Adverse Event Reporting Program database. Many black box medications have eventually been removed from the market entirely, but it took time—and injury claims—to make that happen.
5. Contact a Personal Injury Attorney—Because pharmaceutical injury claims can be so complex, you’re going to need a knowledgeable personal injury attorney to establish what happened, determine who is at fault, and sue for the damages you need and deserve. Your case may merit multiple claims of various types.
Damages From a Pharmaceutical Injury Claim
If you’ve suffered serious harm from a medication, filing a pharmaceutical injury claim is often the only way you can gain access to the financial resources you need.
- You probably have medical bills for everything from the prescription that made you sick to hospital stays and rehabilitation.
- You may be worried about how you’ll be able to afford continuing and future treatment, rehabilitative therapies, medical equipment or living assistance.
- Your entire lifestyle may have changed due to your injury, and you may need costly changes or renovations to your home to accommodate your new requirements.
- You may have lost your job or your ability to work and earn wages at former financial levels.
- You may have significant pain and distress that result in damages and merit psychological assistance.
- If the victim of the drug injury was your spouse, for example, you may be suffering from the loss of your companion in life and all that a loss like that entails.
Pharmaceutical injury claims address all of these expenses, losses, needs and more. Compensation can give you the funds you need to take care of your past expenses, your current costs and the needs you are likely to have in the future. In some cases, victims are able to collect punitive damages as well.
Statute of Limitations on Pharmaceutical Injury Claims
If you or someone you care about has suffered a drug injury, you need to reach out to a firm of experienced personal injury attorneys like Morrow, Morrow, Ryan, Bassett & Haik now. In Louisiana, you typically have just one year to file a claim. However, while that year may begin on the day you first noticed symptoms or an adverse reaction occurred, in some cases, the statute of limitations deadline may be adjustable to a date when the issue was “reasonably discoverable.”
Let us help you help yourself—and ensure that what happened to you doesn’t have to happen to anyone else. Reach out online or call 800-655-483 for a free consultation. Yes, pharmaceutical injury claims can be complex, but that’s why we’re here to help.