Pharmacy Error Injury Lawyer Blog

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 The court granted the defendant’s motion to transfer venue to Ohio, finding that certain public and private interests superseded the plaintiffs’ choice of venue.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.

Johns Hopkins Study Recommends Training of Nurse-Pharmacist Teams to Review Patient Drug Regimens, as a Way to Prevent Medication Errors

August 8, 2012 | Lebowitz & Mzhen

Serious complications and injuries can result from discrepancies between the medications patients take at home, the medications they receive in the hospital, and the medications they take home with them. To prevent such medication errors, a recent study out of Johns Hopkins recommends that hospitals train teams of nurses and pharmacists to reconcile patients’ medication lists. Such teams could better ensure that patients receive consistent medications and dosages, at a lower cost to both the hospital and the patient, thus improving overall health and safety for hospital patients.

The Journal of Hospital Medicine published the study, entitled “Nurse-pharmacist collaboration on medication reconciliation prevents potential harm,” in its May/June 2012 issue. The purpose of the study was to test how “medication reconciliation” could help prevent “adverse drug effects” (ADEs). The study involved over five hundred patients at a “1000 bed urban, tertiary care hospital” from January 2008 through March 2009. Nurses would conduct an interview with patients to obtain a home medication list (HML), outlining all medications regularly taken by the patients. Patients often forgot or otherwise omitted some medications during this process, or were unable to remember the name or dosage of a drug. Some patients could only provide a description of the drug’s appearance, and many were not certain what condition a particular drug treated. Discrepancies between the medications a patient was actually taking and those they received during treatment and upon discharge occurred in forty percent of hospital visits, according to the researchers.

Hospital Uses RFID Tags to Keep Track of Emergency Room Drugs

July 26, 2012 | Lebowitz & Mzhen

Hospitals must regularly contend with medical emergencies, such as heart attacks or allergic drug reactions, that require an immediate response. Hospitals maintain supplies for such emergencies, known as “crash carts,” that contain equipment and medications for diagnosing and, if necessary, reviving patients. Monitoring and maintaining the crash carts requires the careful attention of hospital staff. New technologies, however, allow hospitals to track crash cart inventories more efficiently. One Baltimore hospital is using radio-frequency identification (RFID) tags to ensure that crash carts are fully stocked with necessary drugs, and that all of the drugs are up-to-date.

A typical crash cart includes multiple shelves and trays, all of which must be carefully and consistently organized. Each crash cart has a cardiac monitor and defibrillator, equipment for intubating a patient, and other associated materials. The nine trays in each cart at the University of Maryland Medical Center in Baltimore contain a variety of drugs for emergency use. One tray could have anywhere between twenty-five and seventy-five items. Maintaining a supply of available equipment and drugs, and making sure the drugs are not expired, is critically important for patient safety.

Pharmaceutical Company Pleads Guilty to Health Care Fraud, Agrees to Pay Record $3 Billion Penalty

July 19, 2012 | Lebowitz & Mzhen

GlaxoSmithKline (GSK), one of the world’s largest pharmaceutical companies, has entered into a plea agreement with the U.S. Department of Justice (DOJ) over allegations of fraud in marketing certain drugs and of failure to report safety data, according to a DOJ press release. The DOJ had filed a three-count criminal information against GSK for alleged violations of the federal Food, Drug and Cosmetic Act, including alleged promotion of certain drugs for uses not approved by the U.S. Food and Drug Administration (FDA). This is commonly known as “off-label promotion.” As part of its guilty plea, GSK has reportedly agreed to pay a total of $3 billion in penalties and civil settlements, the largest settlement by a pharmaceutical company in history.

According to the DOJ, GSK promoted off-label uses for at least five of its drugs: Advair, Lamictal, Paxil, Wellbutrin, and Zofran. In the case of the antidepressant Paxil, GSK allegedly promoted its use to treat depression in pediatric patients despite a lack of FDA approval for such a use. GSK also allegedly paid kickbacks to doctors for prescribing these five drugs and at least four more: Flovent, Imitrex, Lotroniex, and Valtrex. In regards to the diabetes drug Avandia, the DOJ accused GSK of making false or misleading statements to doctors and the FDA, in part by omitting mention of studies investigating concerns from European officials regarding possible complications certain cardiovascular patients. The DOJ further claimed that GSK reported false “best drug prices,” the lowest price charged to customers. As a result, the company allegedly underpaid rebates that it was required to pay to state Medicaid programs.

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.