Judicial Decisions

Understanding Failure to Warn Drug Disputes in Maryland

December 10, 2021 | Lebowitz & Mzhen

When you take a prescription drug, there are often numerous warnings and disclaimers that are included with the medication you are taking. Pharmaceutical drug manufacturers are often subject to labeling requirements and regulations that ensure consumers and their physicians are adequately warned about the potential risks of a medication. Thus, when a warning label fails to account for a risk that and it results in a patient injury, consumers often bring lawsuits against the company alleging a failure to warn and seeking compensation.

In a recent circuit court opinion, the court considered details surrounding warning labels on drugs. In the case at hand, the plaintiff was diagnosed with advanced-stage kidney disease after taking a drug manufactured by the defendant. According to the plaintiff, the defendant pharmaceutical manufacturing company should have more explicitly warned his doctor to regularly monitor his kidney function after prescribing the drug. If the drug’s warning label had been better, the plaintiff contended, then the physician would have monitored him differently after prescribing the drug, discovered the impact on his kidneys sooner, and prevented his injury. The lower court granted summary judgment in favor of the defendant manufacturing company.

On appeal, the court considered whether summary judgment was proper in dismissing the plaintiff’s failure to warn claim. The plaintiff argued that the lower court erred in concluding that his doctor, as a matter of undisputed fact, would have pursued the same course of treatment no matter what the warning label stated. The circuit court agreed, holding that the lower court erred in granting summary judgment to the defendants.

Maryland Product Liability Claims Involving Medical Devices

October 28, 2019 | Lebowitz & Mzhen

Many people’s lives are saved by state-of-the-art medical devices. Those that suffer from health conditions requiring medical devices often rely not only on their doctor’s advice, but also on the manufacturers that design and construct these devices. However, too many patients suffer injuries as a result of defects in these medical devices. When a defective product causes an injury, the manufacturer may be liable through a Maryland product liability lawsuit.

Medical devices include any accessory that medical practitioners use to diagnose and treat a disease, illness, or injury. Some common examples of medical devices are defibrillators, artificial hips, pacemakers, implants, intrauterine devices, vaginal mesh, and stents. Although many of these devices are designed to help patients who are suffering from severe medical conditions, they often present many dangerous side effects themselves. Maryland patients injured by these devices may hold the manufactures or other parties associated with the distribution and marketing of the mechanism responsible for their injuries.

For example, a plaintiff recently filed a product liability lawsuit against a medical device manufacturer. In this case, the manufacturer designed the sling that was implanted to treat her urinary incontinence. After the implantation, the woman suffered thinning of her urethral wall and cystitis. She argued that her injuries were because of design defects in the device and filed a lawsuit based on negligence, defective design, and failure to warn. She presented expert testimony to support her claim that the device caused her injuries. Both the trial and the appellate court held that the manufacturer could be held liable to the woman for her injuries.

Maryland Pharmacies’ Failure to Warn Patients of Side Effects Can Result in Serious Injuries

October 22, 2019 | Lebowitz & Mzhen

When a patient picks up prescription medication from a pharmacy, they assume that the instructions given to them on the medication are correct, and that the medication won’t harm them. But unfortunately, far too many Maryland patients are harmed each year as a result of a pharmacy error. One common type of error is failing to warn the patient about potential side effects that may occur, and when the patient should stop taking the medication because of those side effects.

Pharmacies have a duty to warn their patients about the common side effects of drugs and can be held liable in some instances for injuries sustained if they fail to warn. For instance, if a drug causes drowsiness and patients taking the drug are advised not to drive while on it, the pharmacy must warn patients of this. If not, they could be held liable for injuries resulting from a motor vehicle accident if it was caused by the side-effect of the drug. Plaintiffs bringing a negligence suit in these cases can recover monetary damages if they can prove the elements of a negligence suit: that the pharmacy had a duty to warn their patients, that they breached this duty, that the breach was the proximate cause of the injury, and that real damages were suffered as a result of the injury.

Recently, a state appellate court considered a case arising from this very type of accident. According to the court’s written opinion, the patient had purchased a prescription drug product at her local pharmacy. The bottle given to her with the product had instructions to “Finish All Of This Medicine Unless Otherwise Directed By Your Doctor.” The bottle did not include any warning to stop using the product if the patient developed a skin rash or other adverse reaction.

Statutes of Limitations in Maryland Medical Malpractice Claims

October 14, 2019 | Lebowitz & Mzhen

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.

Maryland Pharmacy Errors Occurring at the Drive-Up Window

April 11, 2019 | Lebowitz & Mzhen

As pharmacies have become busier and busier over the past few decades, many suburban pharmacies have begun to offer drive-up service. For many busy patients, drive-up windows are a convenient way to drop off or pick up prescriptions, voiding the need to park and get out of the car. However, conducting such important business through a drive-up window may increase the risks of a Maryland pharmacy error.

A recent case illustrates a common pharmacy error that occurred through a drive-up window. According to an industry news source that analyzed the court’s opinion, a woman intended on picking up two prescriptions for her husband through the defendant pharmacy’s drive-up window. The woman’s husband had Alzheimer’s Disease and high blood pressure. Rather than providing the woman with her husband’s prescribed medication, the pharmacist at the drive-up window gave her alprazolam and sertraline. Both drugs were intended for a patient with the same last name as the woman’s husband.

The woman took the medication home and administered it to her husband. Within a few hours, she woke up to her husband calling her name. She found him lying on the floor, and he could not get up. There were no tripping hazards nearby. It was later determined that he sustained a broken hip in the fall.

Statutes of Limitations in Maryland Pharmacy Error Cases

January 23, 2019 | Lebowitz & Mzhen

Maryland personal injury plaintiffs risk having their cases dismissed if they fail to file their claims within the applicable statute of limitations. In a recent case before a state appellate court, the court dismissed the pharmaceutical claim for failing to timely file a claim.

The plaintiff had filed a lawsuit against pharmaceutical companies, alleging that they were liable for his gambling and other losses because he suffered from obsessive-compulsive disorder as a result of taking Mirapex. Mirapex is an FDA-approved medication used to treat Parkinson’s disease, which the plaintiff began taking in 2006 to treat his Parkinson’s disease. After taking it for two years, he told his doctor that he was experiencing increased compulsive behaviors, including gambling. His doctor told him there was a possible association between Mirapex and compulsive behaviors. The plaintiff raised the issue with his doctor several months later. The plaintiff’s family eventually learned of substantial debts resulting from his gambling, at which point the doctor told the plaintiff not to take Mirapex anymore, advising him to use other therapeutic options instead.

When the plaintiff filed the lawsuit against the drug’s manufacturers, the companies claimed that the lawsuit was time-barred, arguing that the plaintiff filed the case after the two-year statute of limitations for personal injury claims under state law. The plaintiff did not dispute that he knew or should have known that he had been wronged by the defendant by April 23, 2008, after discussing the effects of Mirapex with his doctor on more than one occasion. However, he did not file the claim until December 2010. The plaintiff argued that the statute of limitations was tolled until July 2010, because he continued taking Mirapex until that time, and because “continuing violations” are not time-barred. Under that state’s law, a personal injury claim must be filed within two years. However, under what it calls the “continuing accrual” principle, in continuing or recurring liability cases, “a cause of action accrues each time a wrongful act occurs,” which means that the statute of limitations begins again for that act.

Court Rejects Defendant’s Claim that Plaintiff’s Case Was Filed Too Late

November 30, 2018 | Lebowitz & Mzhen

After any Maryland pharmacy error, one of the first things to consider is when a claim must be filed. A plaintiff’s failure to file a lawsuit within the allowable time will likely result in the dismissal of the claim. In a recent decision in a pharmacy error case, the judge considered whether the plaintiff’s lawsuit was filed on time.

The Facts

According to a local news report discussing the recent decision, the 90-year-old patient had a prescription filled at a pharmacy and suffered an overdose. The woman’s son alleged that she was given an excessive amount of her prescription. A pharmacy assistant allegedly prepared the medicine to be taken once a day instead of once a week as prescribed.

Evidently, the pharmacist noticed the error before the prescription was dispensed and told the assistant to remove the extra tablets. However, the assistant left excessive tablets in the blister packages, and the pharmacist did not check the packages. The patient was admitted to the hospital a few weeks later, and subsequently died from an “acute overdose of medication,” according to the medical examiner’s report.

$3 Million Judgement Against Pharmaceutical Company Reversed in Recent Failure-to-Warn Case

September 10, 2018 | Lebowitz & Mzhen

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.

Court Dismisses Claim Against Drug Manufacturer for Failure to Provide Medication Guide with Prescription

August 7, 2018 | Lebowitz & Mzhen

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.”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.

Pharmacy Required to Inform Physician When a Prescription Requires Pre-Authorization

July 23, 2018 | Lebowitz & Mzhen

Recently, a state appellate court issued a very interesting and important opinion in a pharmacy error case discussing a pharmacist’s duty to inform a prescribing physician when a patient attempts to fill a prescription that required pre-authorization from the patient’s insurance company. Ultimately, the court held that pharmacies have a limited duty to notify both the patient as well as the prescribing physician each time a patient attempts to fill a prescription requiring pre-authorization.

The Facts of the Case

When the plaintiff was 18 years old, she suffered her first seizure. She was taken to the hospital and given a dose of Topamax, an antiepileptic medication. After discharge, the plaintiff saw a neurologist who recommended she continue taking Topamax and wrote her a prescription.

The plaintiff filled the prescription without incident until her 19th birthday. However, when she went to fill the prescription after turning 19, the pharmacist informed her that her insurance company required pre-authorization for Topamax prescriptions for patients over 18 years of age. The pharmacist told the plaintiff that they would follow up with her physician in order to obtain the required pre-authorization. Although not required to do so by law, the pharmacy routinely sent a fax to prescribing physicians offices when a patient tried to fill a medication that required a pre-authorization.