Articles Posted in COVID-19

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.

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.

As vaccination rates for COVID-19 continue to increase throughout the country, vaccine errors—although uncommon—do continue to occur. Individuals who suffer injuries due to a Maryland vaccine error may be able to file suit against the person and entities responsible for the error. Most vaccine errors are not purposeful, but rather are the result of mistakes. These lawsuits generally are based on negligence.

A negligence claim requires that a plaintiff demonstrate that a person or entity had a duty to act a certain way towards the plaintiff, failed to meet that duty by acting or failing to act in some way, the failure caused the plaintiff damages, and the plaintiff suffered damages. Generally, negligence claims must be filed within three years of the date of the injury. A plaintiff has to show that it is more likely than not that the victim’s injuries were caused by the defendant’s conduct.

Some vaccine error cases may cause the vaccine to be ineffective, exposing the patient to harm as an unvaccinated individual. Other vaccine errors can directly result in injury and even death. Pharmacists, pharmacies, manufacturers, hospitals, doctors, nurses, and other medical providers all may be potential defendants in vaccine error cases. Filing a vaccine error lawsuit requires substantial time and diligence before and after filing the lawsuit, including investigating the claim and potential defendants, properly filing and serving the complaint, meeting deadlines, filing motions, engaging in negotiations, and trying the case. Damages may include past and future medical treatment, lost income, pain and suffering, loss of companionship, and loss of parental care.

The COVID-19 vaccine has been a welcome achievement for many. All individuals 12 and older living in Maryland are eligible to receive the COVID-19 vaccine and more than 6 million doses have been administered so far. But with the rate of vaccinations in the largest vaccination effort in U.S. history, COVID-19 vaccine-related errors do occur. According to one news source, an analysis of COVID-19-related event reports that were submitted to the Institute for Safe Medication Practices National Vaccine Errors Reporting Program from December 2020 to April 2021 reveals common COVID-19 vaccine errors:

Shoulder injury related to vaccine administration (SIRVA)

COVID-19 vaccines can be improperly injected into a patient’s shoulder joint instead of the deltoid muscle in the upper arm. This may occur due to a lack of training on the correct technique for administering intramuscular vaccines.

Maryland, along with every other state in the U.S., paused the use of Johnson & Johnson’s coronavirus vaccine last week after six recipients of the vaccine in the country experienced a rare blood-clotting disorder. Over seven million people have received Johnson & Johnson’s vaccine in the United States so far. The six people who experienced the clotting disorder were women between 18 and 48 and experienced the disorder within three weeks of receiving the vaccine. In those cases, the blood clots occurred in the brain, and the women all showed low levels of platelets. One woman died from the illness. In a step to reduce Maryland vaccine errors and adverse reactions, Maryland’s Department of Health decided to pause the use of the Johnson & Johnson vaccine in the state “out of an abundance of caution.”

The AstraZeneca vaccine, which has been distributed in Europe, also had cases of individuals with blood clotting, which were “very, very similar” to the Johnson & Johnson clotting cases, one expert noted. Both vaccines use similar technology. A government committee will meet to evaluate further use of the Johnson & Johnson vaccine. The Centers for Disease Control said that individuals who have received the Johnson & Johnson vaccine in the past month should reach out to their doctors if they have abdominal pain, shortness of breath, leg pain, or severe headaches. Health officials reported that the people who experienced the clotting disorder most commonly had a persistent, moderate to severe headache that started six days or later after receiving the shot.

Individuals who experience vaccine errors or adverse reactions may be able to recover compensation from the administrator or manufacturer of the vaccine in some cases. A Maryland vaccine error claim based on negligence requires a showing that the defendant owed the individual a duty, the defendant failed to meet the relevant standard of care, the defendant’s negligent conduct caused the individual’s injuries, and the individual suffered damages. These cases can be complicated and often must rely on the testimony of experts to explain the link between the error and the injuries the individual suffered. Victims of a vaccine or medication error may be able to receive financial compensation for past and future medical expenses, loss of wages and earning capacity, and other damages depending on their circumstances. A negligence claim in Maryland has to be filed within three years after the date of the injury.

It is no surprise that the COVID-19 pandemic has taken a major toll on the United States’ health care system. All areas of the system—from hospitals to local clinics and even pharmacies—are struggling, as staff are overworked, underresourced, and overly stressed one year into the pandemic. Of particular concern to Maryland residents are the potential impacts on pharmacists and pharmacy errors. When pharmacists are struggling, they are more likely to make careless errors and cause significant harm to patients, who may not realize the mistake until it’s too late. And, according to a recent NBC News article, pharmacists across the country are voicing concerns about the current state of their work, and what it might mean for patient safety. The most important part? These concerns started before COVID-19, and are likely to continue even once the virus is behind us as well.

According to the NBC News article, the past decade has led to an increase in work for pharmacists across the country, but fewer staff members to complete it. An estimated 155,000 pharmacists working at chain drugstores over the last decade have found themselves pushed to do more—work faster, fill more orders, and juggle a wider range of tasks—with fewer and fewer staff members. The pace expected from them is not only unmanageable but dangerous, as patient safety may suffer from pharmacists too exhausted or distracted to follow all safety protocols. NBC News spoke specifically to 31 pharmacists and pharmacy technicians in 15 states, who reported on 12-hour shifts so busy they didn’t have time to go to the bathroom and on rushing to complete their job but making mistakes along the way. The pandemic has made things even worse, as pharmacists now have additional duties with COVID-19 testing, deep cleaning constantly, and vaccinating patients.

Pharmacy errors can range from small, like miscounting the numbers of pills in a bottle, to potentially deadly, such as combining drugs with dangerous interactions or administering the wrong medication at too high a dosage. Maryland residents should be on the lookout for these errors to avoid any potentially harmful consequences. Specifically, those picking up prescriptions should always make sure that the medicine is the correct one, that the dosage matches the labeling in the instructions, and that they understand when and how to take the drug. But, if an accident does occur, patients should not presume it was their fault for not checking thoroughly enough or catching it themselves. Maryland state law allows patients to hold negligent pharmacies responsible for the harm they’ve caused, and patients can recover significant monetary damages through a Maryland pharmacy error lawsuit.

Medication errors occur all too frequently in the United States. They account for thousands of deaths each year throughout the country. They may be the result of negligent acts, such as failing to follow proper procedures, failing to communicate necessary information, and failing to verify the patient’s information, including any allergies. In a Maryland medication error case alleging negligence, a medication error victim must prove that the defendant owed the victim a duty by exercising a certain degree of care toward the victim, the defendant failed to meet the requisite standard of care, the victim suffered injuries, and the defendant’s conduct caused the victim’s injuries.

Medication errors can involve the improper administration of a vaccine. According to an analysis conducted by the Institute for Safe Medication Practices of reported vaccine errors in 2017, the majority of errors involved administration of the wrong vaccine. Other errors included expired vaccines, the wrong dose, the wrong age, the wrong timing, the wrong patient, the wrong route, and a component/vaccine omission. In some cases, a vaccine error may simply negate the effect of the vaccine, but other errors may cause injury and even death.

Victims of vaccine errors or other medication errors may be able to recover compensation for their injuries by filing a Maryland negligence claim. Victims often need an expert to testify to prove their case by establishing a link between the medical error and the victim’s injuries. Experts may also be able to testify concerning whether an error was made and who was at fault. Generally, a Maryland negligence claim must be filed within three years of the date of the victim’s injury. Plaintiffs in medication error cases may be entitled to recover financial compensation for medical bills, physical therapy, future medical expenses, loss of earning capacity, lost wages, and other damages.

Vaccines are life-saving substances that can provide children and adults with protection against many serious diseases and illnesses. However, in some cases, errors or unintended side-effects can occur, leaving individuals with injuries or illnesses. If an adult or child suffers an injury following medication or vaccine, they may file a Maryland pharmaceutical error lawsuit.

The United States generally maintains the most effective and safe supply of vaccines and medications. In most cases, side effects of a vaccine are temporary and mild; however, patients may develop serious side effects in some cases. Some common vaccine injuries are severe allergic reactions, drug interaction injuries, unlisted side effects, seizures, and wrongful death. Proving that the actual vaccine caused an injury can be complicated; however, there are situations where administration or dosage may cause the victim’s injuries.

For example, recently, national news reports revealed that health officials inadvertently gave 42 people the Regeneron IV Covid treatment, instead of the Covid-19 immunization. The National Guard stated that the individuals were given the treatment intravenously at a vaccination clinic. All of the individuals who received the antibody treatment instead of the immunization have been contacted. Health officials explained that they do not believe that the patients face any risk of harm from the error. However, the Health Department is working with the National Guard to review its policies and procedures.

The COVID-19 pandemic has disrupted millions of lives across the world, nation, and the state of Maryland, but fortunately, vaccines are currently being distributed. As of January 15th of this year, approximately 12.2 million individuals have received the first dose of the COVID-19 vaccine. While the vaccine is a good thing and a sign of hope to many, its distribution is vulnerable to errors, just like any medication or drug. Pharmacy and medication errors do happen in Maryland, and so there is potential for vaccine errors as the state rolls out the vaccine as well.

Fortunately, the Institute for Safe Medication Practices (ISMP) recently provided safe practice recommendations for administering COVID-19 vaccines, following several reports of errors. There are two main types of reported errors that affect patients: dilution errors and mix-ups with look-alike products. First, the Pfizer vaccine must be diluted with a preservative-free sodium chloride injection. Unfortunately, multiple errors have occurred in the dilution, with too little diluent added and patients having too much of the vaccine administered. These errors can potentially lead to potentially stronger adverse effects for patients. Second, Moderna’s vaccine has been confused by some with the new Regeneron monoclonal antibody casirivimab, likely due to labeling issues and the fact that they look alike. It is reported that two versions of vial and carton labels for the Regeneron antibody exist, but neither includes the name of the specific antibody or has a functioning barcode. These mix-ups could result in patients receiving the wrong drug.

To reduce the risk of errors, ISMP offered several recommendations for health care organizations. These recommendations include safely selecting vaccination sites, verifying the competency of the vaccinators, dispensing pharmacy-prepared syringes, identifying and differentiating monoclonal antibodies, separating different vaccines when storing them, and preparing for allergic reactions. Hopefully, these recommendations can prevent future vaccinations from occurring. However, recommendations have been made in the past to prevent common pharmacy errors that occur in Maryland every day, and yet they unfortunately still happen. It is important that those who may be injured as a result of those errors understand that state law may provide them a remedy through a personal injury lawsuit. If they are interested in filing one, they should begin by reaching out to a pharmacy error attorney who handles these matters.

Although the COVID-19 is generally accepted to be safe, some people may still have adverse reactions to the vaccine. Like all vaccines, the vaccine still carries some risk of a Maryland medication error. The vaccine may have adverse side effects. It also will not be 100% effective for everyone, and it is unclear how long immunity will last.

The federal government granted companies immunity from liability for the development and administration of vaccines unless there is “willful misconduct” on the part of the companies making and distributing the vaccines. Pharmacists in Maryland are allowed to administer vaccines, and the federal government has declared pharmacists as covered under the emergency preparedness act allowing them to administer the vaccine without risk of liability. Yet pharmacists must also follow the federal government’s guidance to qualify for protection. Pharmacists must complete required training, administer an FDA-approved vaccine, administer according to the vaccination schedule, and follow record-keeping and reporting requirements.

Thus, in limited circumstances, injured patients may be able to recover compensation for their injuries. Victims of medical malpractice may be able to recover compensation if they prove that a healthcare professional failed to meet the standard of care in providing care to the patient by negligently acting or failing to act in some way.

While Maryland patients often trust their pharmacies to give them the correct prescription medication and dosage, pharmacy errors, unfortunately, do occur consistently throughout the state. These errors can take various forms—such as incorrect dosage or incorrect medication—can be harmless or cause severe injuries and illness. Currently, there are three known pharmacy errors repeatedly happening across the country, reported by the Pharmacy Times. Maryland patients should be on alert for these errors that may affect themselves or their family members.

The first is an error occurring with rapid-acting insulins. According to the Pharmacy Times, errors have been reported due to searching for rapid-acting insulins by generic name, which has caused mix-ups between two insulins that pharmacists may think are the same but are not. The authorized generic version of a new type of insulin has a different onset of action after the injection, and some different ingredients. It cannot be used as an exact substitution for the brand name, although some are prescribing it that way, which may cause issues as patients use it.

The second error is a dispensing error in fentanyl. Transdermal fentanyl patches are placed on the skin. Sometimes, when writing the prescription, there can be multiple confusing numbers that lead to mix-ups. For example, one prescription read “fentanyl patch 72-hour 50 mcg/hour,” with mcg/hour being the dosage or strength of the patch. But the pharmacy employee who entered this prescription into the computer read “fentanyl patch 72,” which led him to mistakenly select a 75 mcg per hour patch instead of 50. This dispensing error can lead to stronger dosages of fentanyl being given to patients.

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