Articles Posted in High Alert Drugs

Earlier this month, a federal appellate court issued a written opinion in a product liability case brought against the manufacturer of Zoloft, alleging that the medication causes birth defects. The court’s decision reviewed a lower court’s decision to prevent the plaintiffs’ expert witness from testifying. Ultimately, the court concluded that the lower court was proper to not allow the expert’s testimony.

GavelThe Facts of the Case

The plaintiffs were a class of people who collectively claimed that the medication Zoloft caused birth defects when taken early in a pregnancy. In order to establish their claim, the plaintiffs planned on presenting several witnesses to show that the ingestion of Zoloft actually caused the birth defects in their children. However, the court prevented one of the key witnesses from testifying, based on the novel method the expert used in arriving at her conclusion.

The plaintiffs then tried calling another witness in place of the one who was prevented from testifying. The drug manufacturer objected to this witness as well, and the court conducted a hearing to determine whether the expert’s testimony would be admissible.

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Earlier last month, an appellate court in Tennessee issued a written opinion in a case involving the death of a man who had overdosed on prescription medication. The court ultimately determined that the patient’s death was attributable to his own actions. The case was presented to the court as a workers’ compensation case, but the issue the court decided was relevant to personal injury cases involving allegations of pharmacy error and medical malpractice.

PainkillersThe Facts of the Case

The petitioner was the surviving wife of a carpenter who involved in an accident while on the job. As a result of the accident, the man’s doctor prescribed oxycodone, a powerful and addictive pain medication. The man took the medication as directed at first but then began abusing it. According to the court’s opinion, he would skip doses of the medication in fear that he would run out when he needed it. He eventually started to take the medication with alcohol to increase the medication’s effectiveness.

About two years after his accident, the man’s wife discovered her husband’s lifeless body in bed. The woman, through her deceased husband, filed for workers’ compensation benefits based on the fact that the original injury her husband sustained occurred while he was on the job. An autopsy reported the man’s cause of death as opioid toxicity, with contributing causes of hypertension, alcohol use, and tobacco use.

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The Institute for Safe Medication Practices (ISMP) has released a report that discusses the most common pharmacy errors of 2016 and strategies to prevent these errors from harming patients in the future. The ISMP is an industry trade association containing pharmaceutical companies, doctors, pharmacists, and other medical professionals that regularly conducts observations and releases data related to prescription errors and the dangers these errors present to patients. According to the report, the most common type of pharmacy error committed in 2016 was dispensing the wrong medication to a patient, although other dangerous errors, including dosage and patient mix-ups, also ranked high on the list.

Assorted PillsThe Classes of Drugs Most Affected by Medication Errors

The ISMP study concluded that certain classes of drugs are more commonly associated with medication errors than others. According to a recent report discussing the results of the study, medication errors are most commonly associated with opioid narcotics, antibiotics, antipsychotics, and insulins.

More errors are committed in dispensing the correct dosage of opioid narcotic medicines than any other type of medicine. This is in large part due to the significant variance in tolerance and dosage from patient to patient. For example, a dose that is appropriate for one patient could cause an overdose in another, and pharmacists must ensure that they have the correct prescription information when filling these prescriptions. If something looks wrong, the pharmacist should contact the patient’s doctor directly rather than fill the prescription and provide it to the patient.

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The Institute for Safe Medication Practices (ISMP) creates an evolving list of high-alert medications that, while they are not necessarily more likely to be involved in an error, are especially dangerous if they are accidentally given to a patient. However, according to one industry news report, despite the availability of this list, many hospitals across the country do not have a readily accessible high-alert drug list or fail to take appropriate measures to ensure hospital staff is aware of the list.

Hospital CorridorThe report notes that some medications are more commonly associated with pharmacy errors. For example, medications with sound-alike names or medications that physically resemble other medications are more likely to be involved in an error. Thus, the report suggests that hospitals create hospital-specific lists of medications that may be at a higher risk of being involved in an error, due to specific factors in play at a particular hospital. For example, if the physical location of two drugs near each other has resulted in numerous errors, hospitals should add both medications to a high-alert drug list and take additional precautions so that these medications are not inadvertently mixed up in the future.

The report also explains that remedial measures taken by some hospitals are not effective in reducing pharmacy errors. For example, relying on staff training without further follow-up does not have a significant impact on error rates. Similarly ineffective measures are high-alert lists placed on pharmacy bins, since these are often overlooked by busy staff members.

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Prescription drugs are controlled by the government for a reason. Often, prescription drugs are dangerous if they are taken in conjunction with other medications, can more easily lead to an inadvertent overdose, and may easily lead to abuse because of their addictive qualities. Over the past few years, the court system has seen a number of lawsuits brought against various manufacturers and distributors of addictive prescription pain killers, claiming that the manufacturer or distributor too loosely controls the dangerous medication. In the most recent case of this type, a court held that the insurance company that covered a prescription drug distributor was required to defend against a case filed against the distributor, alleging that the distributor was negligent in continuing to provide large amounts of prescription medication to local pharmacies.

Assorted PillsThe Facts of the Case

The State of West Virginia has long been suffering from an epidemic of prescription drug abuse. The government of West Virginia filed a lawsuit against a drug distributor, claiming that the distributor was continually providing dangerous medication to “pill mills” across the state. A “pill mill” is a pejorative term used to refer to a pharmacy where loose regulation of prescription drugs results in many drug-addicted patients filling fraudulently obtained prescriptions.

The drug distributor had an insurance policy through Cincinnati Insurance Company. When the distributor got notice of the lawsuit, it asked the insurance company to help defend against the suit, based on the contractual obligations in the policy. Specifically, the insurance company was obligated to cover any lawsuit arising from a “bodily injury” caused by the distributor. However, the insurance company refused to defend the lawsuit, claiming that the compensation sought was for West Virginia, rather than anyone who suffered a true bodily injury. The court declined to make this distinction and found that the case was based on a claim of bodily injury. Thus, the insurance company will be required to assist the drug distributor in defending the lawsuit brought by the State of West Virginia.

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Earlier this month, a federal appellate court issued an opinion upholding a lower court’s verdict in favor of a mother whose child was born with a cleft palate and lip. According to one news source covering the case, the young girl suffers from hearing loss and speech problems, and she has undergone approximately 14 surgeries to correct the condition. The plaintiffs claim that the girl has also been subject to teasing and bullying as a result of her appearance and speech.

White PillsThe case was brought against a subsidiary of a drug manufacturing giant, Johnson & Johnson, and it alleged that the company failed to warn doctors that pregnant patients may experience a heightened chance of birth defects if they take Topamax during the first trimester of pregnancy.

A Drug Manufacturer’s Duty to the Public

In general, manufacturers of over-the-counter and prescription drugs have a duty to warn people who may take a drug of any potential serious side effects. Of course, not every side effect of a medication is known at the time of manufacture, so only those potential complications that are known about must be disclosed. However, if a company fails to warn patients or prescribing physicians of potential dangers associated with the medication, the manufacturer may be held liable for injuries caused as a result.

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When someone is admitted to the hospital, they generally have a dedicated team of doctors and nurses attending to their every need. Hospital staff is in charge of writing prescriptions, filling them, and then administering the medication to the patient. However, the transitional period following a patient’s discharge from the hospital is another matter, when patients are often left on their own to ensure that the care and medications they receive outside the hospital are congruent to those that are received while under the hospital’s care.

Pills in HandThe transition period between hospital care and outpatient care is a critical time during which medication errors often occur, according to one recent news article. In fact, this is seen as one of the most dangerous times for patients, who will likely be treated by a new team of doctors, nurses, and pharmacists.

The Sad Story of One Patient’s Experience with Hospital Discharge

Mrs. Oyler was admitted to the hospital after she was experiencing congestive heart failure. She was treated at the hospital, where she was prescribed eight new prescriptions. Upon her discharge from the hospital, the pharmacist overseeing the transition failed to accurately document all eight of the new prescriptions, leaving one off the list. The medication was called “metolazone.”

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Earlier last month, the Food and Drug Administration (FDA) issued a “black box” warning for a birth control medication, Essure. According to one local news source reporting on the newly released warnings, there have been over 5,000 women who have reported negative side effects while using Essure. These side effects include unplanned pregnancy, miscarriages, still births, and severe pain and bleeding. There are also some reports of women developing auto-immune disorders after taking the medication.

warning-1191935Despite the negative side effects, the FDA will continue to allow Essure to be marketed and sold in the United States. The FDA decided against a pharmaceutical recall and implemented a high-alert warning instead. The warning, known as a “black box” warning, is the most serious type of warning issued by the FDA. It requires that physicians provide patients with a written waiver prior to prescribing the medication. The waiver outlines the harms that the drug may cause.

According to another news source, the general response to the FDA’s action among women who had used Essure was that it fell far short of doing what needed to be done:  issue a total recall. Support groups of women who have been harmed by Essure claim that the warning will not be taken seriously enough by prospective patients, and also that it fails to include all the potential side effects of using the product.

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When a patient goes to the doctor and is given a prescription, one of the first things the patient is likely to ask is “what are the potential side effects?” Indeed, most pharmaceutical drugs have side effects of some kind, ranging from the mild to the more severe. In some cases, there is even the risk of serious injury or death.

pills-1189537Ultimately, the choice is left up to the patient to weigh the risks of taking the medication against continuing to suffer from their current ailment. However, when a drug company markets its drug in a misleading fashion, the patient cannot make an educated decision about the pros and cons of taking the prescription mediation.

In these types of cases, it is possible that a patient who is hurt after taking a medication can sue the drug manufacturer, alleging one of several available theories. In essence, many personal injury claims based on dangerous pharmaceuticals allege that, had the patient known the real dangers of taking the medication at the time, they would not have taken it. Of course, these cases are quite complex and often rely on medical and scientific expert testimony to prove the necessary causation element.

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The use of prescription opioid painkillers has soared over the past few years. In fact, according to one recent news article, the number of prescriptions for opioid painkillers has increased more than 300 percent over the past 15 years. While the medication may be helpful to those suffering from severe pain, this increase in the prevalence of addictive and dangerous medication has led to an increase in the number of addictions and overdoses. Additionally, the prevalence and ease of obtaining prescription painkillers can also act as a “gateway” to heroin, which is a cheaper and more effective drug for those addicted to opioid painkillers.

pills-1540566Physician Liability for Painkiller Overdoses

While it is legally possible for a physician to be held accountable in a court of law for negligently prescribing addictive painkillers to a patient, it is not exceedingly common. This is for a number of reasons. First, there must be some “harm” suffered by the patient. This generally requires more than an addiction to a prescription drug. However, if a patient overdoses and is seriously injured or dies as a result of the overdose, that may satisfy the damages requirement.

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