Pharmacy Error Injury Lawyer Blog

Marketing of Drugs that Deviates from Voluntary Industry Standards Does Not Violate False Claims Act, Court Rules: United States of America et al v. Pfizer, Inc.

November 23, 2012 | Lebowitz & Mzhen

A federal court recently dismissed a lawsuit by the federal government alleging that a pharmaceutical company’s marketing activities violated the False Claims Act (FCA). The government claimed in U.S. ex rel Polansky v. Pfizer, Inc. that the company’s marketing of one of its drugs, which deviated from industry guidelines, constituted “off-label” marketing in violation of federal law. The court held that the industry guidelines were not legally-enforceable restrictions, and it further concluded that the government was trying to use the FCA to restrict marketing in a way that the regulatory agencies had chosen not to do. Since doctors often rely on pharmaceutical companies’ marketing to determine what drugs to prescribe and in what amounts, this decision could have a substantial impact on patient safety.

The pharmaceutical company Pfizer manufactures and markets the drug Lipitor as a treatment for high cholesterol. The company allegedly encouraged doctors, through its marketing materials and sale representatives, to prescribe the drug for patients whose cholesterol levels and heart disease risk factors were less than the guidelines established by the National Cholesterol Education Program (NCEP). The NCEP is a program of the National Institutes of Health, which works with a large number of organizations to raise awareness of the dangers of high blood cholesterol. The label produced by Pfizer in 2005 for Lipitor included the NCIP’s guidelines for drug intervention, but a new label introduced by Pfizer in 2009 did not include the guidelines.

VA Hospital Ruled Not Liable for Medication Error of Contract Anesthesiologist: Bethel v. US, Court of Appeals

November 18, 2012 | Lebowitz & Mzhen

A lawsuit, Bethel v. United States, sought to hold the federal government liable for a medication error at a Veterans’ Affairs (VA) hospital that allegedly caused a man severe and permanent brain damage. The anesthesiologist directly accused of the error was an employee of a state hospital who, pursuant to a contract between the two institutions, was working at the VA hospital that day. A federal district judge held that the VA was vicariously liable for the anesthesiologist’s negligence even without a direct employer-employee relationship, and ruled for the plaintiffs after a bench trial. The Tenth Circuit Court of Appeals reversed the finding of vicarious liability and remanded the case to the trial court to apportion liability among the other defendants.

David Bethel was admitted to the Veterans Affairs Medical Center (VAMC) in Denver, Colorado on September 10, 2003 for surgery. The anesthesiologist, Dr. Robin Slover, was an employee of the University of Colorado School of Medicine (UCSM) assigned to work at VAMC. A VAMC employee, first-year resident Dr. Nicole McDermott, assisted Slover during the procedure.

Prior to the procedure, Bethel began to complain of difficulty breathing. The court states that it is not clear what drugs, if any, he had received at this point. McDermott and another resident had to restrain him while Slover returned from another room. Slover administered a paralytic drug called Rocuronium and several other drugs in order to render Bethel unconscious. Bethel eventually needed a tracheotomy to allow breathing. He remained in the hospital until January 2004. Cardiac arrest and a lack of oxygen caused a hypoxic-ischemic brain injury, which has rendered him unable to provide for his own needs or care for himself. The trial court eventually concluded that the drug Rocuronium caused Bethel’s operating room symptoms, and that someone gave it to him by mistake after Slover prescribed a different drug.

Appeals Court Affirms Seemingly Low Damage Award in Medication Error Case, Amends Judgment to Add Loss of Consortium Damages: Langley v. American Legion Hospital

November 9, 2012 | Lebowitz & Mzhen

A woman seeking treatment for an allergic reaction to a bee sting alleged in a lawsuit that she suffered severe and ongoing injuries when hospital staff incorrectly administered her medication. After a trial in Langley v. American Legion Hospital, the court awarded her $25,000 in damages, but awarded nothing to her husband for his loss of consortium claim. The plaintiffs appealed, and the appellate court, while affirming the amount of damages awarded to the wife, reversed the trial court’s denial of damages to the husband.

Shirley Langley went to the emergency room at American Legion Hospital in Crowley, Louisiana on December 5, 2007 with a bee sting causing an allergic reaction. After an initial subcutaneous injection of epinephrine seemed successful, she developed a rebound reaction. The ER doctor ordered another subcutaneous dose of epinephrine, but Langley received the dose intravenously. As an expert would later testify, drugs administered intravenously have a much faster and more pronounced effect. Epinephrine is a very powerful stimulant that can cause a significantly increased heart rate and other complications. After receiving the intravenous dose, Langley reportedly complained of a headache, and her blood pressure quickly shot up from 136/55 to 205/129. Her heart rate increased from 101 beats per minute to nearly 190. She spent about eight hours in the Intensive Care Unit receiving treatment for supraventricular tachycardia.

After the incident, Langley allegedly began to experience multiple health complications, including possible heart and nerve damage, and both pain and numbness in her extremities. She claims she experienced recurring nightmares, anxiety, weight loss, and mood swings. She and her husband, Gregory Langley, sued the hospital, claiming damages for her pain and suffering and medical costs, and for his loss of consortium. The parties stipulated that the hospital breached its standard of care, so causation and damages were the only issues at trial. The court awarded the plaintiffs $25,000 in general damages, but nothing for the loss of consortium.

Contaminated Medicine Believed to Be Source of Nationwide Fungal Meningitis Outbreak

October 27, 2012 | Lebowitz & Mzhen

Lebowitz & Mzhen

October 27, 2012

Updated: October 27, 2012 1:49 pm

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.