Pharmacy Error Injury Lawyer Blog

Colorado Man Recovers Over $10 Million in Pharmaceutical Error Case

May 7, 2014 | Lebowitz & Mzhen

Physicians and nurses owe a duty to all of their patients to administer the proper medication and provide a certain basic level of medical care. Most of the time, physicians do the best job they can making sure that the sick are well cared for, but on occasion a lapse in judgment can result in serious consequences.

Bethel v. United States of America

In a recent case from Colorado, a man was granted a verdict in excess of $10 million after he suffered severe brain damage as a result of medication error. The facts of the case were as follows:

Bethel, the plaintiff in the lawsuit, was under the care of the Veterans Affairs Medical Center when he underwent general anesthesia. He was to be cared for by a doctor as well as by a first-year resident. The resident prepared Bethel for surgery, but in so doing administered a paralytic drug instead of a sedative drug. At this time, the doctor was away attending to another patient.

Pharmaceutical Company’s Failure to Warn Did Not Cause Plaintiff’s Injury, Court Rules

April 29, 2014 | Lebowitz & Mzhen

A federal district court dismissed a lawsuit against a pharmaceutical company for alleged failure to warn, holding that any defect in the drug’s label did not influence the prescribing doctor’s decision regarding the drug. Parkinson v. Novartis Pharmaceuticals Corp., No. 3:12-cv-02089, opinion (D. Ore., Mar. 20, 2014). In a claim for damages caused by a manufacturer’s failure to warn of a hazardous condition or risk, a plaintiff must prove that the failure to warn was a proximate cause of their injuries. The “learned intermediary doctrine” often applies in cases involving pharmaceutical drugs, meaning that the question is whether the failure to warn influenced the prescribing physician, not the plaintiff. The plaintiff must prove that the physician would not have prescribed the drug, or would have done so in a different manner, had the manufacturer provided adequate warnings.

The plaintiff was diagnosed with stage IIIB breast cancer in January 2003. She underwent chemotherapy for about six months and then voluntarily stopped receiving treatment. In May 2005, she underwent radiation therapy on her pelvis to treat pain caused by the cancer, which by then had spread. She also had surgery on her legs because of bone damage. Her physician began administering monthly infusions of Aredia, a bisphosphonate used to treat bone damage in cancer patients, in June of that year. Bisphosphonates have been associated with an increase risk of osteonecrosis of the jaw (ONJ), a condition in which the jaw bone weakens and, in some cases, dies. Dental surgery may aggravate the condition in cancer patients receiving bisphosphonates.

The plaintiff’s physician testified in his deposition that he was aware of the risks associated with ONJ, but felt that they were outweighed by the benefits of the drug for the plaintiff. He also testified that he continues to prescribe Aredia and other bisphosphonate drugs. After the plaintiff had been receiving monthly Aredia infusions for over a year, the doctor switched her to Zometa, another bisphosphonate, in September 2006. The plaintiff saw a dentist in December 2006, reportedly the first time in five years. She then began experiencing tooth and jaw aches, and was eventually diagnosed with bisphosphonate-related ONJ in January 2008.

Nationwide Lipitor Lawsuits Consolidated in One Court for Pretrial Proceedings

April 22, 2014 | Lebowitz & Mzhen

The Judicial Panel on Multidistrict Litigation (JPML) has consolidated lawsuits filed around the country against the pharmaceutical company Pfizer under the style In Re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation (No. II), No. MDL-2502. The cases involve allegations that the plaintiffs developed type 2 diabetes after taking the cholesterol-lowering drug marketed by Pfizer as Lipitor. As of April 15, 2014, the JPML has consolidated 464 claims in the U.S. District Court for the District of South Carolina. Consolidation is appropriate, according to federal statute, when multiple lawsuits involving common questions of fact are pending in multiple federal courts around the country, and a single court could efficiently handle various pretrial proceedings. 28 U.S.C. § 1407.

Atorvastatin, marketed under the brand name Lipitor, is part of the family of drugs known as statins, commonly used to reduce a patient’s cholesterol levels. Statins work by inhibiting an enzyme used by the liver to produce cholesterol. High cholesterol levels have been associated with an increased risk of heart disease, and statins have demonstrated the ability to prevent heart disease in high-risk patients. A paper published in the Lancet in February 2010 identified a slight risk of diabetes associated with statins, while a paper published in the January 2012 Archives of Internal Medicine found an increased risk of diabetes among postmenopausal women who take statins. These and other studies led to a series of lawsuits alleging that Lipitor caused plaintiffs to develop type 2 diabetes.

The U.S. Food and Drug Administration requested in August 2011 that Pfizer change the Lipitor label to include warnings about the risk of type 2 diabetes. The company changed the label in February 2012, but allegedly did not include specific warnings about the diabetes risk. The plaintiff in Jennings v. Pfizer, No. 1:14-cv-00096, complaint at 2 (D. Md., Jan. 13, 2014), describes the revised Lipitor label as “extremely vague.” The complaint in Gaines v. Pfizer, No. 1:14-cv-00170, complaint (D. Md., Jan. 22, 2014), alleges that Pfizer did not issue any warnings about the possible connection between Lipitor and type 2 diabetes before making the requested changes to the drug label. It further claims that, while the new label “warns in the most obtuse terms” about the risk of elevated blood sugar, it makes no direct warning about diabetes risk. Id. at 5.

FDA Approves Prescription-Based Antidote for Overdose of Heroin, Other Opioids

April 15, 2014 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) approved a “hand-held auto-injector” device for use with known or suspected opioid overdoses. Abuse of opioids, a group of drugs that includes many prescription painkillers, is becoming a serious problem in the U.S., and the FDA claims that opioid overdose has surpassed automobile accidents as the nation’s leading cause of injury deaths. The device, marketed under the brand name Evzio, delivers an injection of naloxone hydrochloride to counter or reverse the effects of opioid overdose. The FDA has stated that it hopes the availability of the device with a prescription will help prevent overdose deaths in emergency situations.

Opioid analgesics are a family of opiate-based drugs commonly used in prescription painkillers. They are derived from the same source as heroin and several other illegal narcotics. Common opioids include codeine, hydrocodone, morphine, and oxycodone. Opioids can be very addictive, so they are tightly controlled by the government. According to the Centers for Disease Control and Prevention (CDC), 16,651 people died of drug overdoses involving opioids in 2010, the most recent year for which statistics are available. This number accounts for about seventy-five percent of all drug overdose deaths that year. Many overdoses involve legally-obtained prescription painkillers. The total number presumably includes intentional and accidental overdoses, as well as dosage errors by a physician or pharmacist.

Evzio, as approved by the FDA, is a handheld device that injects naloxone hydrochloride, an “opioid antagonist” that is a common treatment for opioid overdose. Emergency responders often carry naloxone-containing products for use with suspected overdose victims. Since Evzio is only available with a prescription, it must be obtained in advance of any emergency situation. It is recommended for family members and caregivers of people using opioid painkillers in case of overdose. The device provides verbal instructions for use once it is turned on. A single dose of naloxone, according to the FDA, does not last as long as a typical opioid, so it cautions that the device is not a substitute for medical attention. What the device can do is delay further injury or death due to an overdose until medical attention is available.

FDA Proposes New Guidelines Regarding Off-Label Promotion of Drugs

April 8, 2014 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) recently issued draft revisions of pharmaceutical industry guidelines regarding “off-label” promotion of drugs. “Off-label” refers to information about uses of a drug that have not been formally approved by the FDA and are not included in its approved labeling. The agency has treated off-label promotion as “misbranding,” which can carry both civil and criminal penalties under the Food, Drug, and Cosmetics Act (FDCA). The Second Circuit Court of Appeals struck down the conviction of a pharmaceutical sales representative for conspiring to introduce a misbranded drug into interstate commerce, finding that the off-label promotion rule violated his First Amendment right to free speech. United States v. Caronia, 703 F.3d 149 (2nd Cir. 2012). The FDA’s proposed revisions, published in the Federal Register at 79 FR 11793 (Mar. 3, 2014), seek to apply a narrower set of restrictions on off-label promotion.

The FDCA generally prohibits “misbranding” of an approved drug. In a “Guidance for Industry” document published in January 2009, the FDA addressed the distribution of medical literature and other scientific publications regarding off-label uses of approved drugs. The FDA has strict labeling requirements for all approved drugs, including risks of side effects and complications and instructions for use. Off-label marketing of a drug, the FDA stated in the guidance document, constitutes unlawful misbranding of a drug because the drug’s label does not include “adequate directions for use,” as required by the FDCA. 21 U.S.C. § 352(f), 21 C.F.R. § 201.100(c)(1).

The defendant in Caronia was charged with conspiracy to introduce a misbranded drug, and introducing a misbranded drug, into interstate commerce. 21 U.S.C. § 331(a). If a defendant had the “intent to defraud or mislead,” the offense carries a maximum penalty of three years in prison, a $10,000 fine, or both. 21 U.S.C. § 333(a)(2). The case involved Xyrem, a central nervous system depressant with only two FDA-approved uses. The drug contains GHB, a powerful depressant commonly known as the “date rape drug,” making it one that the FDA closely watches.

Public University Collaborates with Private Drugstore Chain on New Model of Patient Care

March 26, 2014 | Lebowitz & Mzhen

A national pharmacy chain has partnered with a medical school and a pharmacy school to open a store that will explore a new model for patient care. The “Walgreens at UCSF” store, located on the University of California, San Francisco campus, is reportedly designed to enable extensive communication between pharmacists and patients. Substantial numbers of people in the U.S. take prescription and over-the-counter medications on a daily basis, and medication errors are a significant cause of injuries and deaths. Various hospitals and other medical facilities are trying out different models of care in an effort to reduce the number of medication errors, and the severity of the injuries they may cause, as much as possible.

The central idea behind Walgreens at UCSF, like many other experimental programs, is the importance of communication between patients, physicians, and pharmacists. Few pharmacies are designed with one-on-one pharmaceutical counseling in mind, and pharmacists tend to remain in the back of the store. The store includes a 1,200-square-foot area with numerous private consultation areas, which pharmacists can use to meet with patients. UCSF describes a concierge desk where patients can check prescriptions and set up pharmacist consultations. Pharmacists employed by both the university and Walgreens will work side-by-side. Rather than simply dispensing medications, pharmacists would work with patients to help them understand how to take medications properly, and provide them with a better overall picture of their health.

According to UCSF, citing the Centers for Disease Control and Prevention (CDC), eighty-two percent of people in the U.S. take medication on a daily basis. Twenty-nine percent take at least five medications per day. Medication errors can occur at any stage of the treatment process, with doctors making a prescription error, pharmacies dispensing the wrong medication or wrong dosage, and patients not following the directions for their medication. UCSF cites statistics from the National Consumers League stating that three-fourths of Americans do not always follow medication instructions, while about one-third do not always take prescribed medications at all. Medication errors cause as many as 1.5 million injuries, 700,000 emergency room visits, and 7,000 deaths every year, at a cost of around $3.5 billion.

Study of “Collaborative Pharmaceutical Care” Finds 3/4 Reduction in Hospital Medication Errors

March 19, 2014 | Lebowitz & Mzhen

A new study, conducted in Irish hospitals and published in a British journal, reviewed the effectiveness of a “collaborative” model of managing hospital patients’ medications. The model, known as the Collaborative Pharmaceutical Care in Tallaght Hospital (PACT), involves close involvement of clinical pharmacists in all stages of patient care during their stay in the hospital. The study, which was uncontrolled, found that PACT resulted in a reduction in the rate of medication errors by more than three-fourths.

The study was published in the online edition of the British Medical Journal Quality & Safety on February 6, 2014. The researchers compared the benefits of PACT to “standard ward-based clinical pharmacy,” with a focus on adult hospital patients receiving acute care, who were prescribed at least three medications in the hospital, and who left the hospital alive. The study included 112 patients receiving care based on PACT, and 121 patients receiving standard care. They measured the rates of medication errors and of potentially severe errors per patient.

According to the description provided in the study, the primary goal of PACT is to reduce the rate of medication errors that commonly occur when a patient is transferred between doctors or departments within a hospital, or transferred from one facility or organization to another, by improving the process of “medication reconciliation” (MedRec). This involves comparing a patient’s current medication orders to the medications a patient has been taking in order to prevent omission of a necessary drug, inclusion of an unnecessary or dangerous drug, or incorrect dosages.

Over-Prescribing of Antibiotics May Be Putting Hospital Patients at Risk

March 12, 2014 | Lebowitz & Mzhen

Lebowitz & Mzhen

March 12, 2014

Updated: March 12, 2014 12:59 pm

Proposed Laws Increasing Ratio of Pharmacy Technicians to Pharmacists Could Adversely Impact Patient Safety

March 5, 2014 | Lebowitz & Mzhen

Pharmacies often rely on a team of medical professionals to meet the demands of customers. These teams consist of pharmacists, who must meet educational and licensing requirements in all U.S. states and the District of Columbia; and pharmacy technicians, who are not always subject to such strict credentialing requirements. Some states set a maximum ratio of pharmacists to pharmacy technicians, while others simply require that the pharmacist have adequate support from staff and technology to perform their professional duties. Pending legislation that would increase the number of technicians that can work under a pharmacist has raised concerns about patient safety.

To obtain a pharmacy license, an individual must obtain a degree from an accredited pharmacy school, pass several examinations, and maintain continuing education requirements. Many states do not require as many credentials to work as a pharmacy technician. Maryland requires a person to have a high school diploma or equivalent, complete a 160-hour training program or obtain certification from a national pharmacy organization, and complete annual continuing education. Supervision of pharmacy technicians by licensed pharmacists is critically important to patient safety.

According to a report by Tampa’s WFTS on pending legislation in Florida, errors occur in an estimated 0.09 percent of all prescriptions filled in the United States. While this seems like a small number, the Kaiser Family Foundation estimates, based on data from 2011, that doctors write more than 59 million prescriptions per year in Maryland alone. That means that more than 53,100 pharmacy errors may occur per year in this state. Most of these errors do not cause any harm, but injuries from pharmacy misfills can be severe.

Washington DC News Investigation Finds Multiple Medication Errors at National Pharmacy Chain

February 27, 2014 | Lebowitz & Mzhen

In a report on its investigation of the national pharmacy chain CVS/pharmacy, Washington DC’s NBC affiliate, News 4, claims to have found numerous alleged medication errors and other problems. Consumers reported receiving the wrong prescription and, in at least one case, meeting with indifference from employees. A former CVS pharmacist with more than thirty years at the company filed a whistleblower lawsuit last year, alleging in part that the company fired him in retaliation for reporting his concerns about an increasing rate of medication errors due to staff reductions. CVS has denied the allegations against it and publicly stated its commitment to protecting patients’ health and safety.

Washington’s News 4 reported a woman’s claim that CVS made a mistake when refilling her prescription for potassium citrate, which she took for her kidneys. She noticed that the pills did not look familiar, and saw that the pharmacy had given her a bottle of potassium chloride instead of citrate. The pills look similar and have similar names, but they have very different uses. Potassium chloride is used to treat hypokalemia, or low blood potassium, and can cause serious, even fatal, complications for some kidney patients. The woman claimed that when she notified the pharmacy manager of the mistake, he responded “Well, potassium is potassium.”
The report also looked at automatic refills, a service offered by CVS and other pharmacies. This allows the pharmacy to refill a prescription at regular intervals, so that the patient does not have to call and request a refill. Problems may occur, however, if the pharmacy refills prescriptions that the patient does not want or need. An elderly patient told the news team that he ended up with more Lidoderm patches, which contain an extremely strong painkiller, than he wanted, based on the auto refill system. This could lead to confusion for some patients, who might not realize that they are receiving medications they did not request.