Pharmacy Error Injury Lawyer Blog

Pharmacist Can Give Expert Testimony About Physician’s Duty to Obtain Informed Consent, Maryland Appellate Court Rules

January 22, 2014 | Lebowitz & Mzhen

A pharmacist may offer expert testimony in a wrongful death lawsuit regarding a physician’s alleged failure to obtain a patient’s informed consent, according to a ruling by the Maryland Court of Special Appeals. Fusco v. Shannon, 63 A.3d 145 (Md. Spec. App. 2013). The trial court excluded testimony from the plaintiffs’ expert witness, a pharmacist, holding that he was not qualified to offer an opinion on a physician’s professional duties. The case went to trial without the pharmacist’s testimony, and the jury found in favor of the defendants. The appellate court reversed the judgment and remanded the case to the trial court.

The decedent, Anthony Fusco, Sr., was eighty-two years old when he received a diagnosis of “low-risk” prostate cancer in 2001. By early 2003, he and his doctor decided to begin a course of treatment that included radiotherapy. He met with a doctor who explained the nature and risks of radiation treatments, including possible inflammation of surrounding organs. The doctor referred him to Dr. Shannon to prescribe a protectant medication to reduce the risk of radiation damage. Dr. Shannon prescribed Amifostine, and would later claim that he explained the risks associated with the drug, such as nausea, skin reactions, and blood pressure issues.

The Amifostine treatments began in April 2003 and continued for about a month. He received twenty-three injections, seemingly without incident, but on May 17, 2003, the day after receiving his twenty-fourth dose, Mr. Fusco was hospitalized with a severe skin reaction. He was diagnosed with Stevens-Johnson syndrome, a rare but serious skin condition, which Dr. Shannon suggested was a reaction to the Amifosine. After several hospitalizations, Mr. Fusco died of a stroke allegedly resulting from Stevens-Johnson on December 4, 2003.

Similar Drug Names Can Cause Confusion, Catastrophe if Pharmacy Makes an Error

January 15, 2014 | Lebowitz & Mzhen

Confusion between two similarly-named drugs can be harmful or even fatal if the error is not detected quickly. An error could result from any number of circumstances, such as a pharmacist who misreads a doctor’s handwriting or a nurse who accidentally administers the wrong drug. The U.S. Food and Drug Administration has procedures for comparing new drug applications to existing drugs, but this does not guard against confusion regarding drugs that are already on the market. A pharmacy journal published an account last year of one such medication error at an oncology clinic, which fortunately did not result in any complications for the patient who received the wrong medication. A version of the drug she received, however, has been implicated in numerous injuries and lawsuits.

The journal Hospital Pharmacy included an account in its June 2013 issue of a fourteen year-old girl diagnosed with acute promyelotic leukemia (APL) who received the wrong medication for about four months. APL, according to the authors, can quickly turn fatal and requires immediate treatment. Her doctors prescribed an oral dose of trentinoin, a vitamin A derivative commonly prescribed in a topical form under the name Retin-A to treat and prevent acne. It is administered orally in 10-miligram capsules to treat APL. The same basic effect that treats acne can also fight cancer cells.

After completing a course of treatment, the patient returned to the hospital about a month later. Her doctors decided to do several rounds of outpatient intravenous chemotherapy and continue the oral trentinoin. A nurse in the oncology clinic, possibly unfamiliar with the drug, instead called in a prescription for isotrentinoin under the brand name Claravis. While similar to trentinoin, isotrentinoin is primarily used to treat severe acne. It was formerly marketed as Accutane, but the manufacturer discontinued the brand in 2009, allegedly in part because of lawsuits claiming harmful side effects.

Court Finds Failure to Warn and Design Defect Claims Preempted in Lawsuit Against Generic Antibiotic Manufacturer

January 8, 2014 | Lebowitz & Mzhen

A federal court dismissed most of the causes of action in a lawsuit alleging that a generic antibiotic caused a dangerous, potentially-fatal reaction. Wilson v. Amneal Pharmaceuticals, LLC, No. 1:13-cv-00333, order (D. Id., Dec. 31, 2013). The lawsuit asserted claims under Idaho state law, but the decision is similar to federal court decisions in other states involving generic drug manufacturers. Federal laws and regulations make recovery of damages difficult for injuries caused by generic drugs.

The plaintiff’s doctor prescribed Bactrim, a generic antibiotic manufactured by the defendant, Amneal Pharmaceuticals. After taking the medication for one week, the plaintiff reportedly developed Stevens-Johnson syndrome, a reaction to a medication or infection that causes painful rashes and blisters. It can be very difficult to treat, and in severe cases, can cause permanent injury or death. The plaintiff sued Amneal in state court, asserting seven causes of action including defective design, negligent manufacture, and failure to warn. Amneal removed the case to federal district court based on diversity jurisdiction. It attached various FDA documents to its answer, including formal approvals of changes to the drug label.

Amneal moved the court to take judicial notice of the documents it produced with its answer, and to dismiss the plaintiff’s complaint for failure to state a claim on which the court could grant relief. The plaintiff opposed the motion for judicial notice and moved the court to allow discovery to proceed. The court denied the plaintiff’s motion and granted the motion to take judicial notice. Judicial notice is proper, it held, when the evidence in question is widely available or a matter of public record. It found that all of the documents in question were easily obtainable online, and that no one disputed their authenticity. The court proceeded to decide the motion to dismiss without the introduction of any further evidence besides the pleadings.

Employment Lawsuit Reveals Potential Illegal Pharmacy Operation

December 26, 2013 | Lebowitz & Mzhen

A federal employment termination lawsuit against a major corporation had the unintended consequence of revealing a potentially unlawful scheme of illegally operated pharmacies. Please note, however, that just because a former employee made allegations in his complaint doesn’t necessarily mean that they are true. Individuals can allege anything they want in a complaint, and may have a greater incentive following termination.

The case, Weidman v. EXXON MOBIL CORPORATION, Dist. Ct., ED Va. (2013), was filed in federal court following the plaintiff’s termination after nearly four years of employment.

The plaintiff was employed as a senior physician in a Virginia office, and claims that, after working for the company for two years, he discovered that it had been operating illegal pharmacies. Plaintiff claimed that large quantities of medication were being illegally stockpiled in the clinic in which he was working, as well as in other locations. Plaintiff did not state for what reason the medication was being collected. He further alleged that many of the senior managers were aware of the illegal activities, and that they requested he participate in a purported scheme involving a pharmacy which was allegedly distributing the stockpiled medications to ExxonMobil employees.

Settlement in Hospital Pharmacy Case Demonstrates Weaknesses in Systematic Checks

December 19, 2013 | Lebowitz & Mzhen

Hospital pharmacies, as opposed to retail pharmacies, present unique challenges that can lead to mistakes being made. Those include a much larger amount of patients being served at any given time, more complicated health issues or treatments, different doctors providing coordinated care, and the different medical professionals’ habits in writing prescriptions and delegating tasks to others.

In one case (login required), which eventually prompted a malpractice lawsuit, there was some confusion when a doctor initially wrote a prescription for 10 units, and after deciding to increase the dosage, rather than writing a fresh prescription, he wrote a 2 over the 1, in an attempt to indicate 20.

What happened next, however, demonstrates what can, and does, happen in practice. The nurse practitioner who had walked in as the doctor was writing the prescription, did not know what dosage the doctor had intended, and when she found it in the patient’s file, had difficulty discerning what the doctor had intended. After conferring with the pharmacist for several minutes, and stating that they both saw a 1 and a 2, they concluded that the prescription must have been for 120 units. The prescription for 120 millimoles was filled for the patient, and the prescription was filled and administered to the patient. The nurse practitioner left, since her shift had ended, and when she returned the next day, the patient had died.

Compounding Pharmacy and Drug Maker at Center of Contamination Lawsuit

December 12, 2013 | Lebowitz & Mzhen

A California man and his wife recently filed a lawsuit against the drug maker Genentech, a compounding pharmacy, and the doctors responsible for injecting contaminated medicine into his eye that caused him to become blind.

The lawsuit makes several different sorts of arguments regarding culpability of the various defendants for the resulting injury and damage suffered by the plaintiff.

The complaint states that he became blind in one eye when an eye doctor injected Genentech’s drug Avastin, which was contaminated with streptococcus, in order to treat his macular degeneration. The drug is primarily intended for use in the treatment of cancer, but it can be used to treat eye conditions, in so-called off label use.

Court Sides with Plaintiff in Expert Testimony Prescription Medication Injury Case

December 5, 2013 | Lebowitz & Mzhen

The U.S. District Court for the District of Columbia reached an instructive decision regarding conflicting expert testimony in prescription medication injury cases where causation is at issue.

In the case, Patteson v. Maloney, Dist. Court, Dist. Col. (2013), the plaintiff was suing her prior psychiatrist for prescribing her Seroquel, which was an antipsychotic drug, in order to treat her insomnia.

After taking the medication, the plaintiff developed tardive dyskinesia, a movement disorder characterized by repetitive, involuntary movements and uncontrollable muscular tics. Her lawsuit thus claimed that the condition was caused by the Seroquel, on the basis of expert testimony. The defendant psychiatrist motioned to exclude all testimony linking Seroquel to tardive dyskinesia.

District Court Denies Pharmacy’s Motion in Fertility Medication Error Case

November 27, 2013 | Lebowitz & Mzhen

The U.S. District Court for the District of South Carolina recently handed ruled on a motion to dismiss, filed by Walgreens in a negligence lawsuit regarding improperly dispensed fertility medication.

In the case,

Caesar v. Walgreen Co., Dist. Court, D. South Carolina (2013), the plaintiffs allege that Walgreens improperly filled her prescription at three times the proper dosage. The couple was in the process of attempting to conceive a child through the process of in vitro fertilization (“IVF”). Following some testing regarding her levels of thyroid stimulating hormone (“TSH”), she was prescribed 50 mcg of levothyroxine in order to lower her TSH levels to an optimum number for conception.

However, instead of being given the 50 mcg, Walgreens provided her with a dosage of 150 mcg, which caused her TSH levels to drop dramatically to 0.006, far below the optimal levels of 1 and 2 for conception and implantation. She had filled her initial prescription and subsequent refills at the same Walgreens for a period of three months.

Supreme Court Affirms FDA Approved Drug Labels Do Not Shield Brand Name Drug Makers from Liability

November 20, 2013 | Lebowitz & Mzhen

In 2009, the United States Supreme Court handed down a seminal decision regarding the liability of drug manufacturers for failure to adequately warn of the risks associated with using a particular drug. The Court examined the argument of a drug manufacturer that it could not be held liable for a failure to warn, eventhough it would have been possible to issue a more updated warning label, because the FDA had already approved the drug, and its manner of uses, as safe.

The case, Wyeth v. Levine, 129 S. Ct. 1187 (2009), arose out of an incident whereby the injection of a drug caused a woman to suffer gangrene from a known side effect, which ultimately resulted in the amputation of her arm.

The drug at issue, Phenergan, is an antihistamine used to treat nausea. The injectible form of the drug can be administered two different ways. One way is through a traditional IV, and the other is more akin to a shot. If the drug accidentally enters an artery, it causes immediate and irrevercible gangrene. When the patient was given the drug, she was given it in the shot manner, and it somehow entered an artery, causing gangrene, which ultimately resulted in the amputation of her forearm.

Massachusetts Senate Passes Bill Regulating Compounding Pharmacies

November 13, 2013 | Lebowitz & Mzhen

The Massachusetts Senate voted late last month unanimously to increase regulatory oversight within the state of drug compounding pharmacies, in order to help protect patient safety.

The potential issues regarding the largely unregulated compounding pharmacies such as the one in Massachusetts, which was believed to be the source of a deadly fungal meningitis outbreak, have been discussed at length on this blog.

Following the contamination of compound medications affecting hundreds of patients, which was eventually traced back to a Massachusetts lab, one of the most important regulations of the bill is that it establishes sterile compounding and complex non-sterile compounding specialty licenses, which will be issued by the Board of Registration of Pharmacy.