Articles Posted in High Alert Drugs

funeralMaryland 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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pharmacyLast 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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Plaintiffs have to be careful when it comes to filing a Maryland pharmacy error claim. A recent case shows how asserting the wrong claim in a case can result in the case’s dismissal.

In that case, the plaintiff brought a claim against a drug manufacturer for allegedly causing her husband’s death due to the manufacturer’s failure to provide a medication guide with her husband’s prescription. The manufacturer made a generic form of amiodarone hydrochloride, a drug used for certain life-threatening heartbeat irregularities. As a generic drug, it is required to have the same labeling as its approved brand-name counterpart. One of the labeling requirements is making medication guides available for distribution to each patient who is prescribed the drug. The medication guides explain the approved uses of the drug and also explain the drug’s side effects “in nontechnical, understandable language.” In amiodarone’s medication guide, it states that the drug should be used only to treat “life-threatening heartbeat problems.”Legal News Gavel

The plaintiff’s husband died after taking amiodarone to treat his non-life threatening atrial fibrillation. The plaintiff alleged that her husband died because he had been taking amiodarone, which he had been prescribed. The manufacturer allegedly failed to provide the medication guide for distribution, which her husband did not receive when he filled his prescriptions in May and June 2015. The plaintiff claimed that her husband was not aware that only those with life-threatening heartbeat irregularities should take the drug, due to its serious side effects. She argued that the manufacturer failed to warn her husband by failing to provide the medication guide, as required under federal law.

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Earlier this month, the Food and Drug Administration announced a voluntary recall of several lots of an increasingly popular drug that is designed to combat the effect of an opioid overdose. According to a recent news report discussing the voluntary recall, two specific lots of the drug Naloxone have been recalled based on the “potential presence of embedded and loose particulate matter on the syringe plunger.”

SyringeHospira, the company that manufactures the drug, moved forward with the recall after it discovered that users may experience certain side effects if they inject the affected medication. These side effects include local irritation, an allergic reaction, inflammation of a vein, restriction of blood supply to healthy tissue, pulmonary embolism, and pulmonary infarction.

The FDA explains that users should be sure to check the medication before injecting it. Specifically, users should look for discoloration or particulate matter. The drug’s manufacturer explained that the recalled medication was provided to medical professionals and law enforcement. The company has stressed that none of the recalled lots were distributed to individual patients.

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Medical errors are all too common in hospitals throughout the country. In any Maryland medical error case, a plaintiff must show that the defendant was negligent in acting or failing to act in some way. There are four elements a plaintiff must prove in order to be successful in a medical negligence claim: a legal duty, a failure to perform that duty, causation, and damages.

White PillsMedical errors cases can be hard to prove in some cases because a plaintiff must show that the defendant’s actions or failure to act were the cause of the plaintiff’s injuries. This can be tricky, especially in medical error cases, because patients are often already sick and proving causation is not always clear-cut. Additionally, the issues involved in the case are often complex and involve scientific principles beyond the understanding of most people. For that reason, such cases often rely on the testimony of experts.

In some cases, an expert is needed simply to understand whether mistakes were made and who may be at fault. As one example, a recent study revealed the problem of accidental overdoses from a drug that has been used on cancer patients for many years.

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Shingles is a viral disease characterized by a skin rash consisting of painful blisters that usually appear in a strip across a person’s face or body. While the symptoms of Shingles will usually go away within a few weeks, some experience nerve pain that can last years.

Legal News GavelThe disease is caused by a reactivation of the varicella zoster virus (VZV), the initial exposure of which causes chicken pox. The reason why the VZV virus reactivates is not widely understood by the medical community, although it is understood to occur more in the elderly and those with a compromised immune system.

There have been several vaccines created to prevent Shingles. As of 2017, a new vaccine called Shingrix was approved for patients over 50 years of age and can prevent most cases of Shingles. Once Shingrix was approved for use, it later became the preferred vaccine according to the Center for Disease Control (CDC). Unfortunately, it has been involved in Maryland pharmacy errors and errors in other states.

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Manufacturers of pharmaceutical drugs – like other products – are responsible for the products they market and release to the public. Some drugs pose a serious health risk due to potential negative interactions with other commonly taken medications, other medications are easily abused and can lead to dependence or addiction, and many pharmaceuticals can have serious side effects when taken improperly.

Legal News GavelIn general, the manufacturer of a medication is responsible to include an adequate warning, fully disclosing the risks involved with taking the medication. If a drug manufacturer fails to include an adequate warning with their product, they may be held liable for any injuries caused to those who take the medication through a Maryland product liability lawsuit.

Testosterone-Therapy Drugs

Testosterone-therapy drugs have been available for decades, and until recently, they have primarily been prescribed to younger men with low testosterone production. However, over the past few years, doctors have been prescribing testosterone-therapy drugs to older men. These medications, however, are not without their risks.

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In the pharmacy world, it is well-known that diabetic patients are among those with the highest risk of being victims of Maryland medication errors. This is due mostly to the fact that diabetic patients are often required to take several medications in a very specific dose, as well as the fact that a failure to get the medication (or too large a dose of the medication) will likely result in an adverse health event.

Legal News GavelAccording to a recent study, those patients who suffer from Type 1 diabetes are more likely than patients with Type 2 diabetes to experience a medication error. The study followed 671 diabetic adults who were admitted to the hospital. Researchers tracked the patients from admission until discharge and double-checked each administration of medication. As it turned out, about 30% of patients experience at least one error.

The most common type of error accounted for roughly 60% of all errors and was an error of omission. When this type of error occurs, a patient is not given the medication that they were prescribed by their physician. Other common error types were wrongly added medications and improperly administered medications.

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While all prescription drugs pose risks if taken in large quantities or by certain patients taking other medications, some medications have such a high likelihood of being involved in a Maryland pharmacy error that they have been labeled as “high-alert” medications. According to a recent industry news report, high-alert medications are those that have an increased probability of negative interaction when taken with another commonly prescribed drug, have serious side effects even when taken alone, or must be taken in very specific doses to ensure that the medication is effective.

Legal News GavelWhile many types of medication are high-alert, some commonly seen high-alert medications in out-patient pharmacies are chemotherapy medication, pediatric solutions, insulin, and opioids. The list of high-alert medications in hospital pharmacies is similar and includes epinephrine and hypoglycemic agents. That being said, it is understood that insulin presents the highest risk of all medications, due to the various forms and doses of the drug as well as the high-risk status of many insulin patients.

The article details certain steps that pharmacies should implement when filling prescriptions for high-alert medications. For example, using system alerts whenever a pharmacist fills a high-alert medication triggers a cue for the pharmacist to provide additional counseling to the patient regarding the high-alert medication. System alerts may also be set to alert pharmacists to patients who present an especially high risk of being a victim of an error.

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Patients have to put a great deal of faith in their doctors, nurses, and pharmacists. We put our lives in the hands of medical providers. But medical providers can make mistakes just like anyone else. Since medication errors occur all too frequently, doctors, nurses, and pharmacists have to be vigilant in making sure that every patient is getting the right medication.

Legal News GavelProving Negligence in Medication Error Cases

To recover damages in a Maryland medication error case, a plaintiff must show that the defendant acted negligently. Negligence can be shown by demonstrating that the defendant was negligent in doing or failing to do something. A plaintiff must show the following elements:  the defendant had a legal duty to use due care toward the plaintiff, the defendant failed to perform that duty, the plaintiff suffered damages, and the defendant’s failure to perform the required duty caused the plaintiff’s damages.

Examples of damages available to medication error victims include medical expenses, lost wages, physical therapy, and loss of earning capacity.

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