High Alert Drugs

$3 Million Verdict Upheld in Topamax Birth Injury Lawsuit

June 8, 2016 | Lebowitz & Mzhen

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.

The 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.

Hospital Discharge Is a Crucial Point When Medication Errors Are Often Overlooked

May 20, 2016 | Lebowitz & Mzhen

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.

The 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.”

FDA Implements “Black Box” Warning for Essure, Eschewing a Total Recall

March 8, 2016 | Lebowitz & Mzhen

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.

Despite 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.

Lawsuits Against Manufacturers of Dangerous Medications

January 25, 2016 | Lebowitz & Mzhen

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.

Ultimately, 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.

The Ease of Obtaining an Opioid Prescription, Even After an Overdose

January 18, 2016 | Lebowitz & Mzhen

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.

Physician 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.

Pharmaceutical Company Named in Lawsuit After Drug Linked to Birth Defects

September 8, 2015 | Lebowitz & Mzhen

Earlier last month, the major pharmaceutical company GlaxoSmithKline was named as a defendant in a lawsuit brought by the parents of a child who was born with a birth defect after his mother took medication produced by the drug manufacturer during pregnancy. According to one national news source, the drug, called Zofran, was initially approved for treating nausea in cancer patients after they received chemotherapy. However, over the years, the drug started to be prescribed to pregnant women looking to lessen the effects of “morning sickness.”

Evidently, the couple filed suit in federal court in Ohio. They allege that the manufacturer marketed the drug for “off label” use to pregnant women back in the 1990s. Shortly after this time, the company allegedly started to get complaints from mothers who took the drug during pregnancy. They were reporting that their babies were being born with heart defects and kidney malformations. In fact, subsequent research has shown that mothers who take Zofran have twice the chance of giving birth to a child with a severe birth defect.

This lawsuit is not unique. In fact, there have been several dozen similar lawsuits brought by parents of children who have been born with severe birth defects after their mothers took Zofran.

Five Dangerous Drug Combinations That Can Cause More Harm Than Good

June 1, 2015 | Lebowitz & Mzhen

Over-the-counter and prescription medications are used by almost everyone to treat medical conditions from time to time. Often, these medications are powerful drugs that if used properly can have miraculous effects, curing or minimizing the symptoms or causes of a disease. However, they can also do great harm if abused or if taken with other medications.

A recent study by the Center for Disease Control claimed that 28% of adults have two or more prescriptions during any given month. These prescription drugs—and even over-the-counter medications—can have nasty effects if taken together. Earlier last month, an online news source posted an article about some of the most dangerous, yet common, prescription and over-the-counter drug combinations that can result in serious negative long-term effects.

Drug Combinations To Avoid

The following is a list of medication combinations that should be avoided:

British Columbia Woman Dies When Pharmacists Fail to Catch Dangerous Drug Combination

October 16, 2014 | Lebowitz & Mzhen

In a frightening case out of British Columbia, a 76-year-old, otherwise healthy woman died when she was prescribed two drugs that were known to have dangerous interactions. According to a report by one local news source, the error slipped past the physician, two pharmacists, and the computer system that tracks drug interactions.

Evidently, the woman was on maintenance therapy for her colitis with a drug called mercaptopurine, an immunosuppressant. When the woman developed a case of gout, her prescribing doctor sent her to the pharmacy with a prescription for another drug. The two drugs were prescribed by the same doctor.

When she went to the pharmacy to fill her prescription for the new medication, no one at the pharmacy told her that the two drugs could be dangerous if taken together. The woman went home, continued taking her mercaptopurine, and started with the new drug as well.

Drug Manufacturers Consent to Oversight by Federal Agency Following Increased Scrutiny

June 4, 2014 | Lebowitz & Mzhen

Following a meningitis outbreak that was linked to a faulty drug, several custom drug manufacturers have recently consented to voluntary oversight by the FDA. According to a report by AZ Central, the manufacturers of custom drugs exist in a bit of a legal loophole. These manufacturers often create specific drug “cocktails” designed to treat very specific conditions.

These “shadow” drug makers, as the article refers to them, came under scrutiny after an outbreak of meningitis was linked to 64 deaths and over 700 illnesses. Under current law, these manufacturers are not regulated by the federal government. However, in 2012, there were two citations issued for unsanitary conditions and a faulty injection.

These specialty drugs, which are prescribed by doctors and filled at regular pharmacies like CVS or Walgreens, are often combinations of other approved drugs. However, since the manufactures operated somewhere between the smaller state-regulated compounding manufacturers and the large-scale drug manufacturers regulated by the FDA, it is unclear who is in charge of making sure these facilities are up to par with the governing safety standards in place.

Pharmaceutical Company’s Failure to Warn Did Not Cause Plaintiff’s Injury, Court Rules

April 29, 2014 | Lebowitz & Mzhen

A federal district court dismissed a lawsuit against a pharmaceutical company for alleged failure to warn, holding that any defect in the drug’s label did not influence the prescribing doctor’s decision regarding the drug. Parkinson v. Novartis Pharmaceuticals Corp., No. 3:12-cv-02089, opinion (D. Ore., Mar. 20, 2014). In a claim for damages caused by a manufacturer’s failure to warn of a hazardous condition or risk, a plaintiff must prove that the failure to warn was a proximate cause of their injuries. The “learned intermediary doctrine” often applies in cases involving pharmaceutical drugs, meaning that the question is whether the failure to warn influenced the prescribing physician, not the plaintiff. The plaintiff must prove that the physician would not have prescribed the drug, or would have done so in a different manner, had the manufacturer provided adequate warnings.

The plaintiff was diagnosed with stage IIIB breast cancer in January 2003. She underwent chemotherapy for about six months and then voluntarily stopped receiving treatment. In May 2005, she underwent radiation therapy on her pelvis to treat pain caused by the cancer, which by then had spread. She also had surgery on her legs because of bone damage. Her physician began administering monthly infusions of Aredia, a bisphosphonate used to treat bone damage in cancer patients, in June of that year. Bisphosphonates have been associated with an increase risk of osteonecrosis of the jaw (ONJ), a condition in which the jaw bone weakens and, in some cases, dies. Dental surgery may aggravate the condition in cancer patients receiving bisphosphonates.

The plaintiff’s physician testified in his deposition that he was aware of the risks associated with ONJ, but felt that they were outweighed by the benefits of the drug for the plaintiff. He also testified that he continues to prescribe Aredia and other bisphosphonate drugs. After the plaintiff had been receiving monthly Aredia infusions for over a year, the doctor switched her to Zometa, another bisphosphonate, in September 2006. The plaintiff saw a dentist in December 2006, reportedly the first time in five years. She then began experiencing tooth and jaw aches, and was eventually diagnosed with bisphosphonate-related ONJ in January 2008.