Pharmacy Error Injury Lawyer Blog

Second Circuit Court of Appeals Holds “Off-Label” Promotion is Protected Free Speech – United States v. Caronia

December 11, 2012 | Lebowitz & Mzhen

Alfred Caronia, a pharmaceutical sales consultant for Orphan Medical, Inc., was convicted of conspiracy to introduce a misbranded drug into interstate commerce in violation of the Federal Drug and Cosmetic Act (“FDCA”). Caronia appealed the conviction and argued that the conviction rested solely on his speech in violation of the First Amendment. In a 2-1 split decision, the Second Circuit Court of Appeals agreed with Caronia and vacated the conviction.

Caronia promoted the drug Xyrem for “off-label” use. An off-label use is generally defined as using a drug for a purpose other than what has been approved for by the U.S. Food and Drug Administration (“FDA”). In this case, Xyrem is a powerful central nervous system depressant whose primary active ingredient is “GHB,” which is federally classified as the “date rape drug.” The FDA has approved Xyrem for only two medical indications.

Caronia was unknowingly recorded while promoting Xyrem for medical indications not approved for by the FDA, as well as subpopulations that had not been approved. The government alleged that Caronia was marketing Xyrem for medical indications he knew were not approved for by the FDA and that he knew Xyrem’s labeling lacked adequate directions and warnings for such uses. Thus, the government argued, Caronia conspired to introduce a misbranded drug into interstate commerce in violation of the FDCA.

On appeal, Caronia’s primary argument focused on the constitutionality of the misbranding provisions of the FDCA as interpreted by the government at trial. In addressing Caronia’s arguments, the court found that the FDCA provisions effectively regulate content, favoring one type of speech over another – “on-label” speech versus “off-label” speech. The court also found the provisions discriminated amongst speakers, penalizing only certain individuals — namely pharmaceutical manufacturers. These findings led the three-judge panel to examine the FDCA provision in question under the “strict scrutiny” standard of review.

Pharmaceutical Company Allegedly Knew of Harmful Fosamax Side Effects as Far Back as 2004, According to Review of Internal Documents: In Re: Fosamax Products Liability Litigation

December 5, 2012 | Lebowitz & Mzhen

Fosamax, a drug marketed as a treatment for osteoporosis by the pharmaceutical company Merck, is the subject of a massive amount of nationwide litigation. Many pending lawsuits allege that the drug caused osteonecrosis of the jaw (ONJ), a rare degenerative bone condition that can cause severe pain and disfigurement. Federal courts began grouping Fosamax lawsuits together for pre-trial proceedings in 2006, under the title In Re: Fosamax Products Liability Litigation. The consolidated case has included more than one thousand individual lawsuits. According to a report by Martha Rosenberg in OpEd News, newly-available internal documents from Merck suggest that scientists employed by the company knew about possible harmful side effects of the drug several years prior to the beginning of litigation over the drug.

The U.S. Food and Drug Administration (FDA) approved Alendronate, marketed under the brand name Fosamax, in 1995 for the treatment of osteoporosis resulting from menopause and other conditions. The drug is part of the bisphosphonate family of drugs. The current nationwide litigation largely alleges ONJ resulting from Fosamax use. ONJ is a rare condition in which the jaw bone begins to die from lack of blood. It can be severely painful for those afflicted, as the bone is literally dying. It is associated with certain cancer treatments, infections, and, according to the American College of Rheumatology (ACR), bisphosphonate use. The ACR estimates that ONJ occurs in somewhere between 1 in 1,000 to 100,000 cases, depending on the length of exposure to the drug.

The Judicial Panel on Multidistrict Litigation (JPML) began grouping Fosamax lawsuits together in 2006, creating a single matter in the U.S. District Court for the Southern District of New York on August 18 of that year. Federal district judges around the country may transfer pending lawsuits related to Fosamax to this court for pre-trial proceedings, in an effort to use court resources as efficiently as possible. According to the JPML, as of November 14, 2012, a total of 1,109 Fosamax lawsuits had been transferred to the Southern District of New York, and 968 were still active on that date. A handful of lawsuits against Merck have gone to trial at the state and federal level, and Merck claims that it won five of the first six trials.

Medical Malpractice Lawsuit Alleges that VA Doctors Overprescribed Antipsychotic Medications, Causing Woman’s Suicide: Grese v. United States of America

November 30, 2012 | Lebowitz & Mzhen

A woman’s lawsuit against the federal government alleges that incorrect diagnoses and incorrect dosages certain medications caused her sister’s suicide in 2010. The plaintiff in Grese v. United States is demanding $5 million in damages, claiming that doctors and other medical professionals with the U.S. Department of Veterans Affairs (VA) breached various professional standards of care by continuing to prescribe medications known to have harmful side effects after the decedent had already attempted suicide, and then by dispensing an excessive amount of a particular antipsychotic drug.

The decedent, Kelli Grese, committed suicide on November 12, 2010 by swallowing a large amount of the antipsychotic medication Seroquel. A few weeks before her death, according to the plaintiff’s complaint, doctors had increased her supply of the medication from thirty days to sixty days, and she almost immediately obtained a sixty-day supply. This gave her enough Seroquel to last 120 days under the earlier prescription, and it allegedly enabled her to commit suicide.

According to the Hampton Roads Daily Press, Grese was discharged from the U.S. Navy in 1997, and she began receiving treatment at the Hampton VA Medical Center during the 1990’s, with treatment for mental health issues beginning in 2008. She had diagnoses for post-traumatic stress disorder, depression, substance abuse, and attention-deficit disorder (ADD). The VA hospital treated her with counseling and medication. She received a diagnosis of severe depression in March 2009 after admission to a psychiatric hospital, with a designation as a suicide risk. She reportedly also suffered from paranoid delusions, recurrent psychosis, and major depressive disorder. After her discharge from the psychiatric hospital, the complaint alleges, the VA continued her existing treatment plan despite “obvious and clear deterioration in her psychological functioning.” Complaint at 4.

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.