Judicial Decisions

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.

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.

Third Circuit Addresses Issue of Standing in “Off-Label” Pharmaceutical Marketing Litigation

July 12, 2012 | Lebowitz & Mzhen

The Third Circuit Court of Appeals affirmed the dismissal of a consolidated putative class action lawsuit against pharmaceutical company and its affiliated marketing companies. A trial court had ruled that plaintiffs lacked standing to sue the defendants over alleged off-label marketing of certain drugs. The plaintiffs were consumers, whose doctors allegedly prescribed the medications for off-label uses; and third-party payors (TPPs), including an insurance company and several unions. In In re: Schering Plough Corp. Intron/Temodar Consumer Class Action, the Court of Appeals ruled that the plaintiffs had not shown a sufficient connection between the defendants’ marketing and the actual prescriptions or the alleged injuries. The case demonstrates not only an aggressive posture by the defendant, but also the difficulty of asserting a class action in drug-related injury cases.

The U.S. Food and Drug Administration (FDA) regulates prescription medications, approving drugs for certain uses and prohibiting advertising for unapproved, or “off-label,” uses. It does not, however, regulate doctors, and therefore has no jurisdiction over how doctors prescribe approved drugs. The defendant, Schering-Plough Corporation (Schering) manufactured several oncology and hepatitis drugs approved by the FDA. A 2001 FDA investigation found that Schering had promoted off-label uses of these drugs. Schering eventually pleaded guilty to one count of conspiracy to make false statements to the government and entered into a settlement agreement, paying a $180 million fine in 2007. It also paid $255 million to settle civil fraud claims with Medicare, Medicaid, and the Veteran’s Administration.

Lawsuits against Schering by consumers and TPPs soon appeared all over the country, claiming that Schering’s misconduct caused doctors to prescribe their drug for off-label, and therefore ineffective, uses. The Judicial Panel on Multi-District Litigation consolidated the cases and moved them to the District of New Jersey. The named plaintiffs filed a consolidated class action in December 2007 alleging violations of federal and state Racketeer Influenced and Corrupt Organizations (RICO) acts, state consumer fraud laws, and various common law claims. The TPPs claimed that they had to pay for both the ineffective prescription and a subsequent effective one, while the consumers claimed injuries and medical expenses. The District Court dismissed the entire suit in July 2009 for lack of standing and failure to state a claim, holding that the complaint did not include enough facts connecting the alleged injuries to the alleged misconduct.

Court Rejects State Effort to Obtain Patient Data In Pharmacy Error Investigation

June 14, 2012 | Lebowitz & Mzhen

An appellate court in Illinois has rejected an effort by the state’s Department of Financial and Professional Regulation (DFPR) to obtain quality control reports from a pharmacy. Walgreens Pharmacy refused to comply with a subpoena from DFPR seeking information on several pharmacists under investigation. Walgreens argued that producing the reports would violate patient privacy rules. Under 2005’s federal Patient Safety and Quality Improvement Act (PSQIA), pharmacies are encouraged to report information on prescription misfills and other medication errors to groups known as patient safety organizations (PSO). The law provides that these reports, intended for use in promoting patient safety, are protected from discovery or disclosure. The court ruled that Walgreens’ quality control reports fall under the PSQIA’s protection.

DFPR was conducting an investigation of three pharmacists employed by Walgreens. On July 1, 2010, it served a subpoena on the company, requesting “incident reports of medication error involving” the three pharmacists. Walgreens objected in writing and refused to comply with the subpoena. DFPR filed a petition in circuit court seeking judicial enforcement of its subpoena on October 8, 2010.

Glaxo Pays $750M in Settlement for Violations in Pharmaceutical Drug Manufacturing

November 23, 2010 | Lebowitz & Mzhen

Our Washington D.C. pharmacy error injury attorneys have been following the recent announcement by the U.S. Department of Justice (DOJ) that GlaxoSmithKline (GSK), a research-based pharmaceutical and healthcare company, has agreed to pay the government $750 million in an effort to settle criminal and civil charges alleging that the company sold adulterated drug products to Medicaid and other government health plans, risking the health and safety of consumers.

Cheryl Eckard, a former Quality Assurance Manager for GSK, was reportedly assigned to visit the company’s Cidra, Puerto Rico plant in 2002 with a group of 100 experts and scientists to survey violations cited by the FDA in drug manufacturing. Eckard reportedly discovered major manufacturing and quality testing issues that went beyond the FDA violations, and that could have caused medication error or patient harm.

Deficiencies found in the plant include the release of a topical antibiotic Bacrtoban ointment used to treat skin infections on babies that contained microorganisms, and the production of the Kytril injection, used by cancer patients for nausea that was reportedly not sterile. Deficiencies were also found in the manufacturing of the antidepressant Paxil CR tablets, causing the drug to have the incorrect amounts of active ingredients. Another manufactured drug, Avandamet, a derivative of the drug Avandia, used to treat diabetes, were reportedly found to be superpotent and subpotent.

As the Cidra plant was reportedly GSK’s top manufacturing facility in the world at that time, bringing in $5.5 billion every year, Eckard found that GSK could not assure that they produced contamination-free products that were made in accordance to the drug formula registered with the FDA. She reportedly advised GSK managers to close the plant, and submitted an extensive report to the compliance department at GSK, who claimed her report was unsubstantiated.

Preventing Prescription Errors: Consumer Reports Health Poll Finds Patients Want More Drug Information

August 30, 2010 | Lebowitz & Mzhen

Our Baltimore, Maryland pharmacy error injury lawyers have been following the results of a recent Consumer Reports Health Poll, that found that 65 percent of most Americans feel that drug makers have too much influence on doctors, and that doctors are too quick to prescribe drugs instead of exploring other non-drug options to manage health conditions. The poll also found that as patients, many Americans have a strong desire to acquire more drug information and safety details to prevent prescription errors in the future.

The Consumer Reports Health Poll found that:

• 45 percent of Americans take at least one prescription drug per day on a regular basis, and on average, they take around four prescription drugs.
• 39 percent of American consumers cut costs on personal healthcare in ways that might be dangerous and could lead to personal injury, with 27 percent failing to comply with drug prescriptions. In an effort to save money, 38 percent of individuals under the age of 65 who don’t have prescription drug coverage, failed to even fill the prescription.
• 87 percent of Americans stated that understanding the safety of a prescription drug was very important, and 79 percent of individuals were concerned about dangerous drug interactions. 78 percent worried about drug side effects.

• 47 percent of Americans said they think that pharmaceutical companies sway doctors’ choice of drug administration for patients based on gifts, and 41 percent of people stated that they think doctors tend to prescribe newer drugs that are more expensive.

According to the Institute of Medicine, at least 1.5 million drug errors occur every year in this country—errors that are preventable. John Santa, M.D. M.P.H., and Consumer Reports Health Ratings Center director, claimed in the study that Americans who are taking multiple drugs considered drug safety and side effects to be a high priority. The poll found that safety information provided in the pharmacy, doctor’s office or hospitals is not always comprehensive enough to prevent medication mistakes or drug error, and needs to be addressed.