Many people associate lawsuits relating to medications with direct claims against drug manufacturers. In those cases, typically the ingredients themselves of a drug are alleged to be harmful. For example, in 2020, the U.S. Food and Drug Administration (FDA) reported that Zantac, an over-the-counter heartburn and ulcer medication, contained ingredients that could be cancer-causing, prompting the drug’s removal from the market, and lawsuits across the country. However, even where drugs are approved by the FDA, physicians may be liable for errors in prescribing them.
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What is a Medication Error?
The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as, “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer.” Medication errors are a prominent and serious threat to patient safety. In fact, the FDA reported that it receives more than 100,000 reports each year associated with suspected medication errors.
Medications are necessary to ease the afflictions of those who suffer from minor to severe medical problems. However, many drugs contain ingredients that drastically affect a person’s body and/or brain function. The human body is complex, and healthcare providers are required to consider a variety of factors in deciding how to prescribe medications. Failure to do so can result in serious and irreparable harm. Therefore, physicians must be especially careful when prescribing since, although the margin of error is small, the consequences can be both monumental and catastrophic.
Serious harmful results of medication errors may include:
- Life-threatening medical problems
- Birth defects
Medical Errors are a Leading Cause of Death in the U.S.
A 2018 Johns Hopkins study found that medical errors kill more than a quarter of a million people annually. Patients who place their trust in their doctors, nurses, and hospitals can find these statistics more than frightening. Obviously, mistakes can happen anywhere, at any time; however, the three most common types of preventable medical errors include misdiagnosis, delayed diagnosis, and medication errors.
Why Medication Errors Occur
Medication errors occur for a variety of reasons, including:
- Errors made in the ordering process of the drug.
- Caregiver miscommunication.
- Mistakes made when inputting the information electronically.
- Misreading labels due to packaging similarities.
- Misreading labels due to medication name similarities.
- Improperly dispensing of prescription drugs.
An article by the National Law Review outlined three primary reasons why medication errors occur:
- “Distractions: Physicians have many duties and calls for their attention. Unfortunately, that means that sometimes they will incorrectly write a medication type or dosage. It is thought that 75 percent of all medication errors happen because of such distractions.
- Illegible Writing: Physicians are practically infamous for their indecipherable handwriting on prescriptions. If a pharmacist then tries to guess at the dosage or medication type, that miscue could have serious consequences for the patient. Of course, nowadays, many prescriptions are transmitted electronically, which helps to lessen the risk of errors.
- Poor Communication: This can happen between the doctor and the patient, between two different physicians, and between the physician and the pharmacy. Drug names often sound alike, and drug abbreviations can create even more confusion that leads to error and injury for the patient.”
The FDA has provided specific guidance for drug manufacturers in an attempt to prevent errors once a drug is ultimately prescribed by a physician. In 2016, the FDA issued a final guidance entitled “Safety Considerations for Product Design to Minimize Medication Errors.” The FDA’s website notes a few of the guidelines contained therein:
- Tablets and other oral dosage forms should have distinct and legible imprint codes so healthcare providers and consumers can verify the drug product and strength.
- The package design should protect the consumer against incorrect use. Medications applied to the skin (topical) should not be packaged in containers that look like the containers usually associated with eye, ear, nasal, or oral products. Similar looking containers have resulted in people putting a topical product in the eye, ear, nose, and mouth.
- Oral syringes and other dosing devices co-packaged with a liquid oral dosage form should be appropriate for the doses to be measured.
Standard of Care for Physicians
Nonetheless, even with guidance by the FDA, errors are inevitable. When a physician prescribes a medication in error, the physician may be found liable for medical malpractice.
In Pennsylvania, to succeed in a medical malpractice case against a physician, a Plaintiff must prove: (1) the physician owed a duty to the Plaintiff; (2) the physician breached that duty; (3) the breach of duty was the proximate cause, or a substantial factor, in bringing about the harm suffered by the Plaintiff; and (4) the damages suffered by the Plaintiff were a direct result of the harm.
The duty owed to a patient by a physician partly depends on whether the physician is specialized. A non-specialist physician has a duty to use the skill and knowledge usually possessed by physicians in the same or similar locality. A specialist, on the other hand, is held to a higher standard. A specialist physician is expected to exercise the degree of skill, learning, and care normally possessed by the average physician within that particular specialty. For example, a psychiatrist prescribing medications for mental illness should be held to a standard of how an average psychiatrist would prescribe under the circumstances, rather than how a general practitioner or oncologist would prescribe.
Additionally, physicians have specific duties in relation to the prescribing of medications. In Makripodis v. Merrill-Dow, the Superior Court of Pennsylvania held that physicians must be fully aware of: (1) the characteristics of the drugs they prescribe, (2) the amount of the drug which can be safely administered, and (3) the various medications the patient is taking. Furthermore, physicians must advise patients of any dangers or side effects associated with the use of a drug, as well as how and when to take the drug. Failure to do any of these things can result in physician liability.
Prathyusha Chowdri, the author of an article entitled: “My Doctor Prescribed the Wrong Medication. Is It Medical Malpractice?” lays out circumstances where physicians may be liable for prescribing medications. A physician may be liable where s/he:
- Prescribes the wrong dosage;
- Provides incorrect instructions for taking the medication;
- Prescribes the medication for the wrong amount of time;
- Prescribes a medication which contains an ingredient to which the patient is allergic;
- Prescribes a medication that has a dangerous interaction with one of the other medications the patient is taking;
- Prescribes a medication that will harm the patient because of the patient’s other underlying medical conditions;
- Prescribes a medication that is ineffective and causes the patient’s underlying and/or untreated condition to worsen; or
- Fails to relay a drug manufacturer’s warning of risks and side effects to the patient, which is needed in order for the patient to make an informed decision.
Medical Malpractice Cases are Complex
Proving that a physician prescribed the wrong medication is no easy task. In order to establish that a physician was negligent (i.e., committed malpractice) usually requires the opinion of an expert in the field of expertise that the Defendant Physician practices. In fact, to file a lawsuit where professional negligence is alleged, an expert must certify that: “There exists a reasonable probability that the care, skill, or knowledge exercised or exhibited by the physician in this case fell outside acceptable professional standards and such conduct was a cause in bringing about the harm sustained by the patient.”
For these and other reasons, medical malpractice cases can often be complex and difficult undertakings. To succeed requires the assistance of attorneys who understand the issues and have the experience necessary to litigate medical malpractice cases.
Victims of Medical Malpractice May Get Help
Slade McLaughlin and Paul Lauricella have been practicing law for decades with a combined legal experience of nearly eighty years. Since the 1980s, they have focused their practices on medical negligence, and have secured for their clients numerous multi-million-dollar verdicts in medical malpractice cases. They have successfully litigated cases against doctors in a wide variety of specialties. They understand the medical concepts and the medical jargon. They have the resources to enlist highly qualified experts who can explain complex medical concepts to Judges and juries. If you think you have been the victim of medical negligence, contact McLaughlin & Lauricella by email for a free consultation or call us at 1-855-633-6251.