Pharmacy Error Injury Lawyer Blog

FDA Announces Nationwide Recall of Antibacterial Drug Following Diluent Mix-Up

September 23, 2021 | Lebowitz & Mzhen

The FDA recently announced that Azurity Pharmaceuticals (Azurity) is voluntarily recalling some batches of its medications related to a diluent mix-up. The recall may affect Maryland patients who have consumed the antibacterial medication. According to the statement, the company is recalling Firvanq and Vancomycin as certain lots of their products contain incorrect diluents.

Healthcare providers typically prescribe Vancomycin to treat clostridium difficile, commonly known as C-Diff. C-Diff is a bacterium that can cause severe diarrhea and inflammation of the colon. The bacterium causes about half a million infections every year in the United States. The medication specifically targets the bacteria responsible for enterocolitis and diarrhea. The medication package includes a bottle of the medication, a USP powder, and a flavored diluent. However, nearly 3,000 kits contained a diluent that goes with a different gastric medication. The company stated that the incorrect diluent might not completely solubilize the c-diff medication. As such, the mistake may lead to persistent diarrhea, resulting in electrolyte imbalances, dehydration, and colitis. In some severe cases, patients may suffer colon perforation that may require colectomy or lead to death. The company is urging retailers and patients to review their medications and return the medication.

Drug manufacturers, pharmacies, and healthcare providers have the duty to warn users of the risks associated with a medication or medical device. Each provider’s duties vary depending on the type of error and the relationship between them and the consumer. However, those who fail to warn a patient or consumer may be liable for related injuries or illnesses.

Lack of Medication Instructions Presents Serious Risks for Maryland Patients

September 16, 2021 | Lebowitz & Mzhen

Medications not only have to be safe but also must contain sufficient warnings and instructions so that patients will know how to use them safely. A medication’s lack of clear instructions and warnings puts patients at risk. A plaintiff may bring a Maryland pharmacy claim against a drug manufacturer for failing to warn of the dangers of taking a medication.

Do Drug Manufacturers Need to Put Warnings on Dangerous Drugs?

Unless a danger is obvious and widely known, a medication must provide adequate warnings concerning the medication’s risks, such as known side effects. Warnings must also be clear and easy to understand. The medication also must include adequate instructions on how to take the medication safely. Courts will consider the knowledge and expertise of the average consumer that uses the medication. If a medication’s instructions are not clear enough or do not contain sufficient information so that consumers will know how to safely use the medication, the instructions are not sufficient, and the manufacturer may be liable for injuries that occur as a result.

Recent Drug Recalls May Impact Maryland Patients

September 9, 2021 | Lebowitz & Mzhen

Pharmaceutical drugs are intended to treat serious illnesses and conditions. As a result, these drugs are often very powerful and carry the potential to cause severe injuries in the event of even a minor error. One common type of Maryland medication error involves recalled medication.

While most pharmaceutical drugs are manufactured according to very specific criteria, sometimes something goes wrong during the manufacturing process. It could be that a base ingredient was contaminated or the factory where the drug was created suffered some type of equipment malfunction. When a medication is not made according to the precise specifications, it can cause the medication not to work—or worse—it can cause other very serious side effects.

Recently, an industry news source reported on several drug recalls. For example, one manufacturer recalled 267 million prefilled saline syringes after finding that the plunger may pull back and introduce air into the syringe, which can cause serious adverse outcomes. Another recall, issued by the manufacturing giant, Pfizer, involved the company pulling several batches of its smoking cessation drug Chantix off the shelves after finding some pills contain elevated levels of a likely carcinogen.

Changing the Health Care System to Prevent Maryland Medication Errors

August 31, 2021 | Lebowitz & Mzhen

Medication errors are an unfortunate yet avoidable part of the healthcare system in the United States. While technology, training, and oversight aimed at reducing medication errors have improved over the years, these instances continue to occur. According to the Academy of Managed Care Pharmacy (AMCP), Maryland medication errors cost patients, consumers, and the healthcare system millions of dollars. Further, data indicate that medication errors harm over 1.5 million people each year.

Medication errors are preventable events that result in inappropriate medication use and patient harm. The events may stem from a healthcare professional’s conduct, a specific product, or a system. For instance, errors may stem from communicating prescriptions, dispensing or administration, marketing or labeling, or monitoring. Many errors stem from illegible handwritten prescriptions, missing information, incorrect drugs or dosage, orally transmitted prescriptions, or medication samples.

What Are the Causes of Medication Errors?

While advanced technology, reporting technology, and monitoring address some of the common causes of medication errors, there are fundamental issues with addressing systematic attitudes of blame and liability. Medication errors can result in serious formal punishment against the healthcare provider. These punishments can include fines, license suspension, or revocation. As a result, many healthcare providers focus on shifting blame rather than addressing the system issues that caused the error.

Ibuprofen Formulations May Pose a Risk to Maryland Children

August 25, 2021 | Lebowitz & Mzhen

The Pharmacy Times recently reported an issue that many parents are facing when administering ibuprofen oral medication to their children. Maryland medication errors can result in serious adverse side effects to infants and children taking cold and flu medication or pain relievers. In some cases, these errors result from a caretaker’s failure to read the packaging instructions. However, marketing errors increase the likelihood of a dosing error.

The report focuses on the two different concentrations of children’s and infant’s ibuprofen. The infant’s formulation is intended for babies aged 6-23 months, weighing between 12-23 pounds. The infant’s formation is 40 mg/mL, whereas the children’s formulation contains 20 mg/mL. The childrens’ formulation is intended for children aged 2-11 years or weighing 24-95 pounds. While companies rely on the consumer carefully reading the dosing and administration instructions, confusion often arises because of the similarities in packaging and labeling.

Pediatric hospitals and medical providers are becoming more aware of the confusion, and as such, parents are receiving education regarding dosage upon discharge. However, the Institute for Safe Medication (ISM) reported that medical providers had received several reports about medication mix-ups occurring after a child was discharged.

Maryland Personal Injury Claims Stemming from Medication Dispensing Errors

August 18, 2021 | Lebowitz & Mzhen

Pharmacies and pharmacists play a critical role in the stream of efficient healthcare in the United States. While advances in clinical therapies have resulted in life-saving measures for many people, pharmacies have become inundated with patients. As a result, Maryland pharmacies are more prone to engaging in medication errors. Medication errors are any error that occurs at any step along a patient’s healthcare treatment plan. These errors can occur when a clinician prescribes a medication to when the patient receives a refill. If a patient experiences an adverse drug event because of a medication error, they may recover damages from any negligent healthcare providers responsible for the error.

Adverse drugs events are a common yet preventable healthcare event. The Patient Safety Network (PSN) reports that healthcare providers have access to over 10,000 prescription medications, and almost one-third of American adults take five or more medications. Moreover, every year, adverse drug events make up approximately 700,000 emergency room visits. These errors occur to every type of patient, including those receiving care and treatment in the hospital.

Some groups of people are more vulnerable to medication errors. These groups include older adults, especially those who take several medications. Further, pediatric patients often experience medication errors because clinicians may fail to account for the patient’s stature before dispensing medications. Moreover, another notable factor is a patient’s socioeconomic status and literacy.

Labeling and Packaging of Medications May Contribute to Maryland Pharmacy Errors

August 11, 2021 | Lebowitz & Mzhen

Pharmacy errors can occur at different stages of the process of prescribing and dispensing a medication. And although some pharmacy errors may be caught quickly or may have a short-time effect, others can be devastating for Maryland pharmacy error victims. To decrease the prevalence of pharmacy errors, many researchers have looked to documented cases to determine where and how changes can be made.

According to a recent article, the labeling and packaging of medication contributed to two recent pharmacy errors. In one case, the prescriber of a mediation had prescribed sacubitril-valsartan (Entresto), a multi-ingredient medication that combined two drugs. The prescriber listed the strength of the medication prescribed as 100 mg, which was to be taken twice a day. When the pharmacist was filling the prescription, the pharmacist saw that the medication did not include a 100-mg strength, so the pharmacist chose the closest choice—97/103 mg strength (97 mg of one drug and 103 mg of another). However, the prescriber had intended that the patient take the total amount of the 2 drug ingredients (49/51) with 100 mg total.

The patient’s doctor later increased the dose to 100 mg, which was to be taken twice a day. The pharmacist dispensed the same 97/103 mg medication and gave instructions to take two tablets twice a day. The patient had severe adverse effects and the error was discovered. The insert on the medication suggested that the total amount was the basis for clinical trials, but the label listed the ingredients separately. To make matters more confusing, other combination tablets are prescribed according to the strength of each drug rather than the total, such as carbidopa-levodopa (for example 25-100).

Maryland Medication Error Lawsuits

July 31, 2021 | Lebowitz & Mzhen

Medication errors that result in serious illness or death are one of the most disturbing types of medical negligence claims. While any medical error can cause a serious or life-threatening situation, medication errors often result in immediate death. Maryland’s medication errors not only cost people their lives, but they also cost healthcare systems and taxpayers a significant amount of money every year.

When individuals seek medical treatment for a long-term condition or emergency, they understandably put their trust in the various medical providers coordinating their care. However, successful coordination requires that each provider engages in their duty of care to the patient. In many situations, one misstep can cause a deadly chain of events.

What Are the Leading Causes of Medication Errors?

Medication errors can result from a doctor’s, nurse’s, or pharmacy’s error. Many claims stem from inadequate written or oral communication, system errors, untrained medical providers, and ineffective precautions. These errors may cause patients to experience an allergic reaction, adverse side effects, or deprive them of life-sustaining medication. A medical provider or pharmacy may be liable for negligence if they

Maryland Pharmaceutical and Vaccine Error Claims

July 25, 2021 | Lebowitz & Mzhen

While more Americans are willingly taking the COVID-19 vaccine to protect themselves and the vulnerable individuals around them, it is understandable that consumers question the efficacy and safety of the vaccine. Maryland pharmaceutical errors can occur in various situations, and despite the safety of the vaccine, accidents and reactions can occur. Although there has been an overwhelming number of safe vaccinations, some people have suffered serious reactions. The common side effects of the vaccine include pain, redness, swelling, tiredness, muscle pain and fever. However, a small number of people suffered anaphylaxis, thrombosis, and heart issues. These cases are exceedingly challenging, mainly because the vaccines have not been subject to the same testing standards as other medications and vaccines.

Communicable diseases can threaten the livelihood of an entire population, and the government goes to great lengths to ensure that the public has access to critical medications and vaccines. However, in turn, the government created a safety net to protect those who do suffer an adverse reaction or injury because of a vaccine. Historically the National Vaccine Injury Compensation Program (VICP) compensates those who suffered injuries because of a childhood vaccine injury. To qualify for the program, the claimant’s injuries must meet certain thresholds, and the suit must be brought within the statute of limitations. However, injuries related to the COVID-19 vaccine would not fall under VICP’s protections.

Do Vaccine Manufacturers Have Immunity?

Yes, the Department of Health and Human Services provides immunity to companies that develop vaccines to address emergent diseases and viruses. As such, the Countermeasures Injury Compensation Program (CICP) prevents consumers from suing a COVID-19 vaccine producer unless the company engaged in willful misconduct. In these cases, affected consumers can only recover if they meet the program’s high evidentiary standards. Although compensation is available under the program, it is much less than is available under VICP.

Exceptions to the Statute of Limitations in Maryland Pharmacy Errors Cases

July 16, 2021 | Lebowitz & Mzhen

A statute of limitations, or the time period in which a claim must be filed, is generally strictly construed. In a Maryland pharmacy error case for personal injury or wrongful death generally has to be filed within the three-year statute of limitations applicable to those cases in Maryland. A medical malpractice claim generally has to be filed within five years of the date of injury or within three years of the date the injury was discovered, whichever comes first. This means that if a pharmacy error victim files after the statute of limitations has passed, the claim will be dismissed, regardless of the merits of the claim. The statutes are strictly construed because they are meant to limit the liability of defendants over an indefinite period of time to increase fairness and predictability.

Are There Exceptions to the Statute of Limitations?

Yes, there are some exceptions to the statute of limitations. As stated, if an injury was not known or discoverable until a certain date, the clock will not start running until that time (which may be a point of litigation in some cases). There is also an exception if the potential plaintiff was incapacitated and unable to file a claim while the statute of limitations was running. Similarly, a minor may not be expected to file a claim until they reach the age of majority. In any event, after any pharmacy error injury is incurred or discovered, it is essential to have the claim evaluated by an experienced attorney to determine the applicable statute of limitations.