Articles Posted in High Alert Drugs

According to a national news report, several retailers and pharmacy chains are suspending the sale of Zantac, a popular heartburn medication. The decision was made after concerns arose that the drug may contain a substance that can cause cancer. The makers of the drug face a potential class-action lawsuit, and other Maryland pharmacy error lawsuits may arise from those suffering the adverse effects of the drug.

According to the United States Food and Drug Administration (FDA), doctors routinely prescribe Zantac to treat heartburn and stomach acidity issues. Potential issues with the medication arose shortly after approval for mass distribution in the 1980s. However, the FDA did not provide medical professionals with the warning until they discovered that the carcinogenic agent ranged from 3,000 to over 25,000 times the approved limit. The agent has been linked to cancers of the lung, kidneys, bladder, and stomach. Additionally, the toxic agent is related to liver scarring, fibrosis and tumors. The FDA has not issued a formal recall notice, nor did they tell patients to stop taking the product, however, many national retailers have pulled the medication and replaced it with generic versions that lack the specific impurity. This, however, has brought up concerns regarding the safety and efficacy of prescription drugs whose generic equivalents are manufactured in foreign counties where the FDA typically lacks adequate oversight.

Although the FDA has not recalled Zantac, several drugstores voluntarily removed the product, likely in an attempt to avoid liability if the product eventually gets recalled. Those injured after taking a dangerous drug may seek damages for injuries in instances where a product has been recalled but a retailer or hospital does not abide by the notice. Patients and consumers may suffer serious injuries such as permanent organ damage, cancer, and even death when a party fails to comply with a recall notice. Moreover, manufacturers cannot escape liability just because they issue a recall. Manufacturers, distributors, and retailers may still face liability if they did not adequately issue the recall, provide appropriate warnings and remedies, or abide by the recall notice. Patients should heed the warnings from the FDA and their doctors about specific medications. If they do not abide by the warnings and suffer injuries, they may face difficulties holding the responsible parties liable for their damages.

When someone is injured because of someone else’s negligent actions, Maryland law allows the victim to seek monetary compensation from the responsible party. Victims of car or truck accidents, slip and fall cases, or medical malpractice, for example, can bring a Maryland personal injury claim. However, these personal injury cases are all subject to a certain statute of limitations, which is the period of time within which you must bring the case. For example, if the statute of limitations is two years, a plaintiff must file the case within two years after the accident occurs. A failure to do so will result in the claim being barred, and the victim will not be able to receive the compensation they deserve from the responsible party.

In Maryland, the statute of limitations for medical malpractice cases can be complicated, because sometimes the injury can occur long before the victim realizes. Maryland law accounts for this under Maryland Courts and Judicial Proceedings Code section 5-109, which states that a medical malpractice lawsuit must be filed within five years of when the injury occurred, or within three years of when the injury was discovered by the victim, whichever comes first. The discrepancy between the two dates can cause confusion and complicate lawsuits, making it difficult for plaintiffs to receive compensation for their injuries.

In a recent opinion, a state appellate court considered a situation like this, in which the plaintiff was not aware of the injury at the time it occurred. According to the court’s written opinion, the plaintiff, suffering from psoriatic arthritis, was prescribed Remicade by his doctor, which he continued to take for over two years. However, just over two years after he began taking the medicine, the plaintiff developed severe neuropathy. This neuropathy caused weakness, and the plaintiff lost the ability to walk and use his hands and arms. The plaintiff stopped taking Remicade but alleged that he was not aware that the medication was responsible for his injuries. According to the plaintiff, it was over a year before a different doctor told him that Remicade was the likely cause of his injuries. By that point, it had been over a year since the injury occurred, but the plaintiff only just found out about it. Thus, medical malpractice rules that account for this potential discrepancy are incredibly important for preserving a plaintiff’s right to bring a personal injury claim.

Recently, an appellate court issued an opinion addressing issues that frequently occur in Maryland pharmacy error lawsuits. The lawsuit stemmed from the tragic death of a woman who received the wrong medication from her pharmacy. Evidently, the woman was treated at a hospital for fluid buildup in her lungs. At discharge, a nurse called the woman’s pharmacy, spoke to a pharmacy technician, and ordered a prescription for a diuretic. However, the technician made several errors when inputting the patient’s information, including wrong identifying information, incorrect spelling of the nurse’s name, and misspelling of several medications. However, the most egregious error was misreporting a medication and dosage. This error had severe consequences, as the patient died as a result of the incorrect medication.

The woman’s family filed a wrongful death lawsuit against the hospital and the pharmacy, alleging damages for negligence and requesting additional damages due to aggravating circumstances. The hospital settled their claims, and the lawsuit against the pharmacy proceeded to trial. The pharmacy moved to dismiss the aggravating circumstances portion of the lawsuit. The trial court granted the motion, and the jury awarded the family two million dollars in damages; however, the amount was significantly reduced because of the applicable damage caps. The family appealed the judge’s decision to dismiss the aggravating circumstances element of their claim.

Under Maryland law, pharmacy error plaintiffs can recover damages for the injuries they sustained because of the pharmacy’s negligence. Maryland law allows plaintiffs to recover compensatory damages to make them “whole again.” There are two main types of compensatory damages, special and general. Special damages are usually tangible costs that the plaintiff incurred because of the defendant’s negligence. Whereas, general damages are those that cannot be easily quantifiable, such as pain and suffering.

It is estimated that pharmacy errors are responsible for between two to five percent of global hospital admissions. While determining the exact number of Maryland pharmacy error victims is difficult to determine due to the lax reporting requirements, experts believe that at least seven million people fall victim to medical errors each year. What’s more, the same experts believe that nearly a third of these errors are entirely preventable.

Of course, not all pharmacy errors result in patient harm. Most often, pharmacy errors that do result in harm to the patient involve at least one high-risk medication. However, the term “high-risk medication,” is somewhat controversial in that it implies that less attention needs to be paid to anything that is not a high-risk medication. Nonetheless, the term is commonly used to refer to medicines that are frequently involved in errors or present heightened risks of harm.

An industry news source recently published an article discussing what pharmacists can do to reduce the frequency of pharmacy errors. The article identifies several risk areas where pharmacists should pay extra attention.

Medical errors are consistently ranked as one of the leading causes of death in the United States, with some estimating that as many as 440,000 people die each year from preventable medical errors. One of the more common medical mistakes are pharmacy errors that occur in retail and hospital pharmacies. Pharmacy errors can be harmful not only when patients have a negative interaction with the unprescribed drug but also when a patient fails to get the necessary medication.

Pharmacists are highly educated and well-trained medical professionals, like doctors, dentists, or nurses. Because of this, pharmacists have a professional duty to ensure that their patients are provided the correct medication, in the right dose, with the appropriate instructions. When a pharmacist makes an error, and a patient suffers as a result, the patient may be able to pursue a Maryland pharmacy error lawsuit against the negligent pharmacist as well as the pharmacy where the error occurred.

Given the prevalence of pharmacy errors, significant effort has been devoted to understanding the cause of these errors. It has been determined that certain medications are more likely to be involved in a medication error. Typically, these are medications that have similarly spelled or pronounced names as other drugs. Industry professionals call these look-alike sound-alike drugs, or LASA drugs. The most dangerous LASA drugs are those that share their names with drugs that have adverse interactions with other commonly prescribed drugs. A few examples of LASA drugs are:

Pharmacists are medical professionals and – although it is not always evident to patients – a significant amount of work goes into filling each prescription. Aside from making sure that the correct drug, dose, and amount of medication is provided to a patient, pharmacists are also responsible for ensuring the quality of the medicine being provided to patients, and for making sure that prescribed medication is suitable for the patient.

The vast majority of the time, pharmacists deal with controlled substances that have not just the power to help a patient, but also the potential for danger. Some of these drugs may have serious side effects or exact dosing requirements, and many of the drugs handled by pharmacists can be habit-forming or addictive.

A recent article discussed the lack of safeguards in one hospital pharmacy that allowed a physician to overprescribe painkillers in fatal or near-fatal doses to 34 patients. Typically, the hospital required a pharmacist to approve a prescription electronically before a doctor or nurse can access the medication cabinet and obtain the drug to give to the patient. In the event of an emergency, access to the medicine cabinet was allowed through a physician override. Evidently, physicians were able to access all types of dangerous medications, including fentanyl and Versed, without having to justify the circumstances of the emergency.

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Under Maryland law, most cases must be brought within three years from when the claim “accrues.” However, when someone ingests a dangerous medication, the potential harms of the drug may not be immediately apparent. This is true in both pharmacy errors, where a pharmacist provides a patient with the wrong medication, and also in cases involving dangerous prescription drugs that are marketed as safe. This raises the question, when to these Maryland pharmacy error cases accrue?

Maryland courts employ the “discovery of harm” method when determining when a claim begins to accrue. Thus, it is only when a plaintiff becomes aware of their injuries that the clock starts ticking. A recent federal appellate decision involving a dangerous prescription drug illustrates how courts engage in this type of analysis.

The Facts of the Case

According to the court’s recitation of the facts, in 1999, the plaintiff was prescribed Vioxx by her physician to relieve pain and inflammation. The following year, the plaintiff suffered “cardiovascular injuries” while taking the medication. However, the plaintiff’s doctor continued to prescribe Vioxx, and the plaintiff continued to take the medication. In 2002, the plaintiff discontinued the use of Vioxx.

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In a Maryland “failure to warn” claim, a plaintiff may bring a claim against a defendant manufacturer for failing to warn of the risks associated with a product. A product must adequately warn consumers of the dangers and risks in using the product, unless those dangers are a matter of common knowledge or are so obvious that they do not require a warning. For example, a drug manufacturer could be liable for the side effects of a drug if it failed to adequately disclose the risks of the drug, failed to disclose an unreasonably dangerous condition, or failed to instruct consumers on the correct use of the drug.

Courts will consider the knowledge and experience of consumers in determining whether a person can reasonably be expected to understand the use and risks of a product. Warnings and disclosures must be clear, direct, and easy to understand. Instructions and disclosures can be inadequate if they are ambiguous or do not contain enough information about how to safely use the product or the risks of improper use. A plaintiff with a successful failure to warn case can potentially garner a range of compensatory damages, including medical bills, the costs of future treatment, out-of-pocket expenses, loss of income, mental anguish, and pain and suffering.

FDA Issues Safety Announcement for Medication for Leukemia Patients

The U.S. Food and Drug Administration (FDA) recently issued a safety announcement, stating that some leukemia patients receiving the medication Idhifa are showing signs and symptoms of the syndrome that are not being recognized. Idhifa’s Medication Guide already has a warning about differentiation syndrome, but despite this, the FDA has become aware of cases of the syndrome that not being recognized, with patients not obtaining the proper treatment. Idhifa is used to treat patients with acute myeloid leukemia, and works by blocking enzymes that promote an abnormal blood cell growth. However, it can cause differentiation syndrome, which can be life-threatening if not treated quickly.

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Maryland personal injury plaintiffs can bring failure-to-warn claims if a manufacturer fails to adequately warn consumers of a product’s risks. In one recent case against drug manufacturer GlaxoSmithKline, a patient alleged that the manufacturer failed to warn consumers of its association with suicide for certain patients.

The Facts of the Case

A doctor prescribed a patient Paxil, manufactured by GlaxoSmithKline (GSK) to treat the patient’s depression and anxiety. However, his prescription was filled with the generic version of Paxil, paroxetine. A few days later, the patient committed suicide and paroxetine was found in his system. The patient’s wife sued GSK, alleging that the manufacturer negligently failed to warn patients that paroxetine was associated with suicides in patients older than 24, and that her husband (who was 57) died as a result.

Generic drug manufacturers are required to use a label approved  by the brand-name manufacturer and approved by the U.S. Food and Drug Administration (FDA), and only the brand-name manufacturer can obtain FDA approval to change the label. In this case, the brand-name manufacturer of Paxil, GSK, created the its label, and the generic drug manufacturers were required to use the same label. Labels for paroxetine warned that it was associated with suicide in patients under 24, but did not warn about an association with suicide in older patients.

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Last week, the Food and Drug Administration announced that the manufacturer of a popular blood-pressure medication would be recalling thousands of bottles of the medication after what appears to have been a medication mix-up. According to one news source covering the recall, Accord Healthcare announced that it would be recalling one lot of its Hydrochlorothiazide tablets in the 12.5mg dosage.

The recall was announced after a pharmacist at a local drugstore discovered that a bottle marked as containing the 12.5mg tablets of Hydrochlorothiazide tablets actually contained another medication. None of the medication was provided to patients, and the manufacturer’s initial investigation into the error did not cause them to believe that any other lots suffered from a similar error. However, out of precaution, the manufacturer recalled the entire lot that contained the bottle with the wrong medication.

The Hydrochlorothiazide tablets are round orange pills that have the letter “H” on one side, and the number “1” on the other side.

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