Pharmacy Error Injury Lawyer Blog

Former Healthcare Workers Denied Public Benefits Because of Medication Errors

October 18, 2012 | Lebowitz & Mzhen

Courts in two recent cases affirmed denials of unemployment benefits to healthcare workers, finding that their terminations resulted from employment misconduct. Both workers lost their jobs because of medication errors. In Steffey v. Unemployment Compensation Board of Review, a Pennsylvania court ruled that a nurse intentionally failed to follow protocols for reporting and treating patient complaints. A Minnesota court found that a series of errors constituted employment misconduct in Matoke v. Restart, Inc.

Wanda G. Steffey, the claimant, appealed a denial of unemployment benefits after she was terminated from her position as a licensed practical nurse (LPN) in March 2011. She testified that she had been a LPN since 1978, and had worked at the Berkshire Center since 2005. She allegedly learned, during a shift on March 11, 2011, of a patient complaining of chest pain who had a history of high blood pressure. The employer alleged that she gave the patient medicine for indigestion without authorization, and that she did not report the patient’s condition for up to three hours. This violated the employer’s protocols, which required her to check vital signs and report immediately to the charge nurse.

The claimant testified that she attempted to report to the charge nurse when she realized her medication error, but that the charge nurse was not at the station. She said she decided to monitor the patient’s condition herself, and reported the matter to the charge nurse about ninety minutes later. According to the court, the claimant admitted on cross-examination that she could usually find the charge nurse elsewhere in the facility. The court concluded, based on the claimant’s own testimony, that she intentionally did not follow protocol by providing medication to a patient without orders and by not reporting the matter to the charge nurse right away.

Appellate Court Denies State Access to Pharmacy’s Medication Error Data, Citing Federal Privacy Laws: Department of Financial and Professional Regulation v. Walgreen Company

October 9, 2012 | Lebowitz & Mzhen

A pharmacy resisted a subpoena from Illinois regulators seeking information on medication errors, citing a federal law that encourages pharmacies to track medication errors, but protects the confidentiality of those records. The trial court agreed with the pharmacy’s position in Department of Financial and Professional Regulation v. Walgreen Company, 970 N.E.2d 552 (Ill. App. 2nd Dist. 2012), and granted its motion to dismiss the subpoenas. The Illinois Court of Appeals affirmed the ruling, finding that federal law privileged the medication error records from disclosure to the state government. Although federal law encourages pharmacies to track medication errors, it limits the uses to which the government may put the resulting records.

The Illinois Department of Financial and Professional Regulation (DFPR) issued three subpoenas to Walgreens in July 2010, seeking reports of medication errors involving three specific pharmacists in Walgreens’ employ. It petitioned the circuit court to enforce the subpoenas in October 2010. Walgreens quickly moved to dismiss the petition, claiming that the records sought by the DFPR were privileged under the Patient Safety and Quality Improvement Act of 2005 (PSQIA).

The PSQIA provides mechanisms for reporting and analyzing a wide array of medication error data. The law provided for the establishment of Patient Safety Organizations (PSOs) under the Agency for Healthcare Research and Quality (AHRQ). PSOs are independent organizations that gather and analyze medication error reports from doctors, pharmacies, hospitals, and other health care facilities within a designated geographic area. They cooperate and collaborate with the AHRQ and other PSOs with the goal of developing improvements in patient safety and reductions in the number of medication errors. The PSQIA provides that all reports made by pharmacies and other organizations to their local PSO are “patient work product,” and therefore are privileged from disclosure.

Punitive Damages in Maryland Medication Error Litigation: Marsh v. Arnot Ogden Medical Center

October 4, 2012 | Lebowitz & Mzhen

In a lawsuit alleging a fatal medication error against a physician, a nurse, and the hospital that employed them, the Appellate Division of New York, Third Department reversed the trial court’s dismissal of the plaintiff’s claims for punitive damages. The court ruled in Marsh v. Arnot Ogden Medical Center, 91 A.D.3d 1070 (2012), that the plaintiff had pleaded sufficient facts to defeat a motion to dismiss and two motions for partial summary judgment on the question of punitive damages. The legal standards for punitive damages in New York differ greatly from those in Maryland, where they may be far more difficult to obtain.

The decedent, Leslie E. Marshall, was a patient at defendant Arnot Ogden Medical Center (AOMC) in April 2009. According to the plaintiff’s complaint, a nurse gave him an injection of an insulin-reducing medication by mistake. The plaintiff, who is Marshall’s daughter and the executor of his estate, alleges that she warned the nurse prior to the injection that Marshall was not diabetic and was not prescribed insulin, but that the nurse injected the drug anyway. The nurse contacted the attending physician by telephone to inform her of the error. The doctor instructed the nurse to check Marshall’s glucose level every two hours, and to contact her if it dropped below 120. At 8:15 p.m., Marshall’s level was reportedly 132, but by 10:15 it had dropped to 107. The doctor then allegedly told the nurse to stop testing Marshall’s glucose until morning. The next test, at 6:15 a.m., showed a glucose level of 15. Marshall died later that morning, reportedly due to insulin overdose caused by the nurse’s medication error.

The plaintiff sued the doctor, the nurse, and AOMC in New York Supreme Court. The doctor moved to dismiss the claim for punitive damages, and the nurse and AOMC each moved for partial summary judgment as to punitive damages. The trial court granted all three motions, and the plaintiff appealed. The appellate division reversed the three orders, finding that the plaintiff had established issues of fact that could lead to punitive damages. The standard for punitive damages, it said, was proof of a defendant’s “reckless indifference equivalent to willful or intentional misdoing,” id. at 1071, which could be shown by the nurse’s alleged failure to heed the plaintiff’s warning or the doctor’s alleged instruction to stop the glucose tests.

Insurance Company Denies Accidental Death Benefits, Arguing that Man’s Death from Medication Error Was Not an “Accident”: Estate of Paul v. New York Life Insurance Company

September 27, 2012 | Lebowitz & Mzhen

After a nurse’s medication error allegedly caused a man’s death, his executor claimed compensation under the Accidental Death Benefit (ADB) clause of his life insurance policy. The insurance company refused, arguing that the man’s death was not “accidental,” as defined by the policy. The executor sued, claiming in Estate of Paul v. New York Life Insurance Company that the insurer breached its contract with the estate. The trial court granted summary judgment for the defendant, and the New Jersey Appellate Division affirmed its ruling. The case offers a useful glimpse at how insurance companies view injuries caused by medication errors.

Richard Paul, the decedent, resided in a nursing home when he died. He was receiving treatment for multiple chronic illnesses, including chronic obstructive lung disease and chronic heart failure. A nurse at the nursing home accidentally administered another patient’s medication to him on December 27, 2007. The nursing home transferred him to an intensive care unit at a local hospital upon discovering the error, but his condition worsened. He died in the hospital on January 5, 2008.

Jeffrey Paul, Richard Paul’s son and the executor of his estate, retained a board-certified internal medicine specialist, Donald J. Corey, M.D., to review reports relating to Richard Paul. Although the death certificate identified lymphoma as the cause of death, Dr. Corey prepared two reports that challenged this conclusion. The first report said that the medication error had “a direct causative role” in Richard Paul’s death. The second report, completed a few months later, attributed his death to the nurse’s error and noted that Dr. Corey found no evidence of lymphoma recurrence.

Federal Court Transfers Lawsuit Against Pharmaceutical Company from Washington DC to Ohio

September 20, 2012 | Lebowitz & Mzhen

A woman must pursue her lawsuit against a pharmaceutical company in the Southern District of Ohio rather than the District of Columbia, according to a ruling in Sheffer v. Novartis Pharmaceuticals Corporation. The plaintiff and her husband brought suit alleging claims including strict liability and failure to warn of potentially harmful side effects for cancer patients using the drug Aredia. The court granted the defendant’s motion to transfer venue to Ohio, finding that certain public and private interests superseded the plaintiffs’ choice of venue.

Shirley Sheffer, a resident of Yorkshire, Ohio, sought treatment for breast cancer. As part of her chemotherapy, she received infusions of Aredia, a drug manufactured and marketed by Novartis Pharmaceutical Corporation to treat metastasizing cancers affecting bone. Aredia is part of a family of drugs known as bisphosphonates. It reportedly works by decreasing the amount of calcium that the bones release into the bloodstream, thereby slowing the bone breakdown process and enhancing bone density. This is called “antiresorptive therapy.” According to the American College of Rheumatology (ACR), antiresorptive therapy using bisphosphonates is associated with a frequently painful condition called osteonecrosis of the jaw (ONJ), in which part of the jawbone weakens and eventually dies. The ACR notes that the specific cause of ONJ in cancer patients receiving antiresorptive therapy remains unknown.

Woman Injured by Medication Error During Eye Surgery Gets New Trial

September 13, 2012 | Lebowitz & Mzhen

A woman who lost one of her eyes after eye surgery got a new trial after her case went before the Iowa Court of Appeals. After a trial in Whitley v. C.R. Pharmacy Service, Inc., a jury originally returned a verdict in favor of the defendant pharmacy. The plaintiff appealed, arguing that the trial court erred in allowing the pharmacy to introduce never-before disclosed evidence at trial. The appeals court agreed that this prejudiced the plaintiff, and granted the new trial.

Whitley was a member of the Iowa Army National Guard who needed to improve her eyesight in order to apply for an officer commission in the armed forces. An ophthalmologist, Dr. Lee Birchansky, performed Epi-LASIK on both of her eyes in November 2005. Whitley later developed corneal scarring, a known side effect of the procedure. At Birchansky’s recommendation, she underwent a procedure called corneal scraping on March 9, 2006. A medication called mitomycin is used during this procedure. Birchansky’s office ordered a 0.02% mitomycin solution from C.R. Pharmacy.

Whitley reported a stinging sensation when Birchansky applied the mitomycin, which continued long after the procedure. After several weeks, she could only see colors and shapes, and she had persistent headaches. Birchansky referred her to a glaucoma specialist, who suspected Whitley had received the wrong concentration of Mitomycin. Birchansky sent the remaining mitomycin, which he found in a container with a C.R. Pharmacy label dated March 9, for testing at the University of Iowa. The tests revealed that the solution contained no mitomycin. Whitley’s condition deteriorated further. She underwent corneal transplant surgery in both eyes, but still lost her left eye.

Limited “Health Literacy” Can Increase Risk of Medication Errors and Other Complications

September 5, 2012 | Lebowitz & Mzhen

A significant percentage of Americans have “health literacy” ranked as “basic” or “below basic,” according to a study conducted by the federal government. The National Center for Education Statistics (NCES) defines “health literacy” as the ability to read, comprehend, and make use of everyday written medical or other health information. Low levels of health literacy can put patients at greater risk of injury due to misdiagnosis or medication errors. Patients may not communicate their medical history or other important information to their doctor, leading to an incorrect diagnosis or treatment. They may also misunderstand instructions for medications, potentially leading to injury. Numerous medical organizations have programs to promote health literacy and to facilitate communication between patients and medical professionals in order to improve treatment and prevent injury.

The NCES conducted a Highlights of Findings” target=”_blank”>National Assessment of Adult Literacy (NAAL) in 2003. The NAAL surveyed reading skills and other indicators of literacy around the country, including health literacy. It identified four levels of health literacy: proficient, intermediate, basic, and below basic. About thirty-six percent of U.S. adults, or roughly 77 million people, had “basic” and “below basic” health literacy. It is important to note that any individual person’s level of health literacy is highly dependent on that person’s circumstances. The problem affects people across society.

Maryland Hospital Patients Possibly Affected by Radiology Technician Suspected in Hepatitis C Outbreak

August 30, 2012 | Lebowitz & Mzhen

The arrest of a radiologic technician in New Hampshire on charges that he allegedly infected at least thirty-one hospital patients with hepatitis C, has led to concerns about similar outbreaks in at least seven other states where he worked in recent years, including Maryland. The technician also has a history of disciplinary actions at hospitals in several states for alleged drug use and theft of medications. The case has led to some discussion about standards and regulations for radiologic technicians and the impact they may have on patient safety.

Police arrested 33 year-old David Kwiatkowski in late July on suspicion of stealing anesthetics from Exeter Hospital in New Hampshire. Furthermore, he allegedly contaminated syringes, which were subsequently used on patients, with the hepatitis C virus. Thirty-one patients at that hospital tested positive for the same strain of the virus as Kwiatkowski. New Hampshire officials have recommended that around 4,700 people in the state undergo testing for hepatitis C. As alleged details of his history have become public, it has raised concerns in multiple states about not only theft of medications, but possible exposure of patients to the disease.

From May 2008 to March 2010, Kwiatkowski reportedly worked at four different hospitals in Maryland. According to the Associated Press, those hospitals are contacting hundreds of former patients each regarding the matter, with as many as 1,750 people possibly affected. Two of the hospitals told the AP that they did not fire Kwiatkowski, nor did his behavior during his employment there raise “red flags.” Hospitals in other states have different reports.

FDA Warns of Seizure Risk Connected to Multiple Sclerosis Drug

August 23, 2012 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) recently warned doctors and consumers about a risk associated with a relatively new drug, Ampyra, used to treat multiple sclerosis (MS). Patients who are just beginning to take the drug showed an elevated risk of seizures, and patients with kidney impairments were particularly at risk. A few weeks after the FDA’s announcement, Ampyra’s manufacturer, Acorda Therapeutics, Inc., announced that the drug did not show significant improvement in MS patients over a placebo in a second study.

Ampyra is used to improve walking speed in MS patients. The FDA announced the drug’s approval on January 22, 2010, and said that Ampyra was the first prescription medication approved for this purpose. MS is a chronic disease of the central nervous system that affects about 400,000 people in the U.S. Symptoms can range from mild to debilitating, and the nature and onset of symptoms is unpredictable in any individual patient. Difficulty walking is one of the most incapacitating symptoms. Ampyra, which is a potassium channel blocker, reportedly works by improving the transmission of signals across MS-damaged nerve cells. The drug is an extended-release capsule, taken by mouth every twelve hours. In the first year of its availability, doctors prescribed it for around 46,000 patients.

Doctor Groups Advocate for Limits on the Use of Painkillers for Anything Less than Severe Pain

August 16, 2012 | Lebowitz & Mzhen

Several groups of doctors and health care officials are calling on the U.S. Food and Drug Administration (FDA) to modify its guidelines for opioid painkiller prescriptions. The proposed changes would include restrictions on “off-label” uses, meaning uses not explicitly approved by the FDA, and limits on the amount of time a doctor may prescribe a painkiller for a patient. The purpose of the changes would be to counter a growing rate of abuse and addiction to the powerful drugs, which has recently resulted in multiple adverse reactions and medication errors.

Abuse of prescription drugs is now the “fastest growing drug problem” in the U.S., according to the Centers for Disease Control and Prevention (CDC). The CDC says that about 27,000 people died from accidental drug overdoses in the U.S. in 2007, and an increased use, and abuse, of prescription opioid painkillers is responsible for much of that total. The government has already attempted crackdowns on “pill mills” and pharmacies that, they allege, sell painkillers to addicts without medical necessity. This includes widespread investigations of drug wholesalers that move large volumes of painkillers and other controlled medications. The latest recommendations would impact how pharmaceutical companies label and market their drugs, in addition to how doctors prescribe them.