Pharmacy Error Injury Lawyer Blog

Study Examines the Use of Antipsychotic Medications to Treat Children with ADHD

January 30, 2013 | Lebowitz & Mzhen

A study published last year examined the rate at which doctors prescribe antipsychotic medications for children diagnosed with attention deficit hyperactivity disorder, commonly known as ADHD or ADD. The researchers found a significant increase in the rate of prescriptions in recent years, and psychiatrists may now prescribe antipsychotics for children or adolescents with ADHD in one-third of all visits. The U.S. Food and Drug Administration (FDA) has not approved antipsychotic medications for ADHD in children, making it an “off-label” use. While this is not illegal per se, it raises concerns about known and unknown side effects and the risks of dangerous medication errors.

ADHD is a mental health condition that affects both children and adults, and can severely impact a child’s functioning in school and other activities. Symptoms include easy distraction, difficulty focusing, irritability, and difficulty remaining still. The most common pharmaceutical treatment for ADHD consists of stimulant drugs like Adderall and Ritalin. According to the Centers for Disease Control and Prevention (CDC), ADHD affects about 5.2 million children between the ages of three and seventeen, just over eight percent of all children in the U.S. in that age range. About twelve percent of boys and nearly five percent of girls in that age range have been diagnosed with ADHD.

Lawmakers Attempt to Strengthen Regulation of Compounding Pharmacies

January 26, 2013 | Lebowitz & Mzhen

A bill introduced late in the most recent session of the U.S. Congress would have enhanced federal regulation of compounding pharmacies. The bill never made it out of its committee, but the representative who introduced it says he plans to try again in the new session. At least one state governor has also proposed a state-level bill, and a nationwide organization is conducting its own pharmacy inspections. The nationwide outbreak of fungal meningitis in late 2012, traced to a compounding pharmacy in Massachusetts, was a major factor in bringing about these actions.

Congressman Edward J. Markie, the Democratic representative for Massachusetts’ Fifth District, introduced H.R. 6584, The Verifying Authority and Legality in Drug (VALID) Compounding Act on November 2, 2012, not long before the end of the Congressional session and only a few days before the 2012 Presidential Election. It gained eight cosponsors, and was referred to the House Subcommittee on Health, where it remained, and died, at the end of the 112th Congressional Session. Given the turbulent political atmosphere in Washington DC at the time, it is perhaps not surprising that the bill gained little support or attention. Markey has stated that he intends to reintroduce the bill in the 113th Congress.

The VALID Compounding Act would give the U.S. Food and Drug Administration (FDA) authority over large compounding pharmacies, particularly those that act as drug manufacturers. Smaller “traditional” compounding pharmacies would be exempt from FDA regulation, provided that only licensed pharmacists or physicians personally compound drugs for individual patients with valid prescriptions, the pharmacy uses best manufacturing practices and approved ingredients, and it does not copy commercial drugs. Compounding pharmacies could request waivers of the three restrictions from the FDA in cases of drug shortages or if it is deemed necessary for public health. The law would also create a public list of drugs that should not be compounded, and would require labeling of compounded drugs to indicate that the FDA has not tested or approved the drug.

Study Shows Impact of Hospital Medication Errors Involving Injectable Drugs

January 22, 2013 | Lebowitz & Mzhen

A recent study examined the impact of injectable medication errors in hospitals, noting the impact of such errors on both patient health and hospital finances. Costs associated with adverse drug events (ADEs) associated with injectable medications can exceed $5 billion per year, the study found, and can affect over 1 million hospitalizations annually. The study identifies some of the drugs most likely to be involved in medication errors, and has some suggestions for improving patient safety.

A medical device company, Becton, Dickinson and Company, commissioned the study in collaboration with an actuarial consulting firm, Milliman, Inc. The study, entitled “National Burden of Preventable Adverse Drug Events Associated with Inpatient Injectable Medications: Healthcare and Medical Professional Liability Costs,” was published in the online edition of the journal American Health & Drug Benefits on December 10, 2012. It involved the actuarial review of data from the years 2009 to 2011 obtained from MEDMARX, an online system for anonymously reporting medical errors, along with hospital data on medications administered via injection, and data on insurance claims through private health plans and Medicare. The goal was to determine the incremental cost, defined as including all costs from the time of a patient’s admission to the hospital and continuing for a period of four months.

Biotech Company Pleads Guilty to Illegal Marketing of Anemia Drug

January 10, 2013 | Lebowitz & Mzhen

A giant biotechnology company pleaded guilty in December 2012 to a single charge of illegally marketing a drug for uses expressly denied by the U.S. Food and Drug Administration (FDA), thus increasing the risk to patients of medication errors. A years-long investigation by the federal government, reportedly assisted by some company employees, led to a single misdemeanor charge. The guilty plea includes a sizeable criminal fine and civil settlement. The judge presiding over the case has delayed his decision on approving the settlement agreement, although he denied a whistleblower’s challenge to the settlement.

The FDA approved the drug in question, Aranesp, in 2001 to treat anemia in patients undergoing kidney dialysis and for cancer patients undergoing chemotherapy. The drug’s manufacturer, Amgen, is reportedly the world’s largest biotechnology company. Sales representatives employed by Amgen began reporting concerns about the company’s marketing of Aranesp and other drugs to the Department of Health and Human Services, which launched an investigation as early as 2004. Employees wore recording devices during meetings with Amgen managers, which provided evidence that the company was offering doctors financial incentives to prescribe Aranesp over other drugs, and promoting the drug for off-label uses.

Amgen allegedly promoted the use of Aranesp in cancer patients who were not undergoing chemotherapy. At least one study, reportedly sponsored by Amgen, showed an increased risk of mortality for non-chemo cancer patients. The company also allegedly promoted administering Aranesp less frequently but in larger doses, after the FDA refused to approve the drug for such a use. This was supposedly to encourage doctors to use Aranesp over a competing drug. The company allegedly profited $85 million from the misbranded drug.

Pharmacy and Surgical Errors Lead to Hefty Fines for Hospitals

December 26, 2012 | Lebowitz & Mzhen

The California Department of Public Health recently issued fines for ten hospitals in that state, totaling $785,00 in penalties for medical errors that occurred between 2010 and 2011. Under California state law, hospitals are required to report errors to the state. The state decides the appropriate penalties and announces both the errors and the penalties in an effort to reduce surgical and medication mistakes, according to a recent article in the L.A. Times.

The article describes one of the errors as involving a patient who died after mistakenly being given a blood thinner instead of a procoagulate (having the opposite effect from what the desired medicine would have done). Another of the errors involved a nurse practitioner prescribing a medicine to which the patient was allergic, resulting in the patient’s spending time in the hospital’s intensive care unit.

Many of the hospitals have described measures they have taken to reduce the risk of error. In the case of patient allergies to specific medicines, the hospital apparently re-trained staff on procedures regarding allergies and implemented a new electronic health records system that makes patient information easier to access.

No system can prevent all errors, but publicly fining hospitals for medical and pharmacy errors is absolutely a step in the right direction for preventing these types injuries in the future. With greater awareness of the issues pervasive in medicine and surgery, we can hope that errors will become fewer and fewer. However, as long as there are similarly named medications, or drastically different pills that resemble each other in size, color, or shape, we will still face the risk of pharmacy errors.

Maryland and many other states impose requirements on hospitals similar to those in California. Under Maryland law, hospitals must report any serious errors that affect patients during treatment. In addition to reporting the errors, hospitals must also analyze how and why the error occurred. Unlike California, however, Maryland has traditionally not identified by name the hospitals that report errors.

This difference may have both positive and negative effects. On the one hand, it may encourage higher levels of reporting by allowing for some degree of anonymity. However, hospitals who fail to report may be subject to even harsher sanctions than mere monetary fines, so the costs of being caught failing to report may outweigh any potential benefits. On the other hand, it creates less accountability and allows hospitals with broken systems to remain quietly broken.

In an Effort to Reduce Medication Errors, San Diego Hospital Implements High Tech Program

December 19, 2012 | Lebowitz & Mzhen

There are approximately 1.3 million people in the United States injured by medication errors every year. Since 2000, the U.S. Food and Drug Administration (“FDA”) have received more than 95,000 reports of medication errors. These reports are voluntary, however, and it is believed that the rate of error is actually much higher. Medication errors occur for a number of reasons, including miscommunication of drug orders, poor handwriting, drugs with similar names are confused or packaging is poorly designed, and even confusion of dosing units.

The FDA takes a number of measures to help reduce medication errors, including reviewing drug names, labels, and packaging, as well as analyzing reports of error and creating guidance for the industry. The FDA reviews around 1,400 reports of error per month, analyzing the cause and type of error that in turn helps the agency develop guidance for health care professionals.

In a remarkable effort to reduce these types of error, San Diego’s newest hospital, Palomar Medical Center, located in Escondido, CA, has taken substantial steps to ensure the prescription drug process is as safe as possible. The hospital has implemented a program that requires doctors to place medication orders via a sophisticated computerized system. Often times, an error may begin with the doctor’s initial prescription being incorrect or misunderstood. The system is designed to require doctors to confirm the order and the dosage as well as being for the correct patient — the computerized process is key to ensuring there are no mistakes made in the first crucial step of the doctor ordering the medication.

All of the medications are bar coded. When the nurse is at the point of giving medication to the patient, the bar code helps to once again confirm it is the correct medication, dosage and patient. The nurse will scan the bar code on the medication, the nurse’s own badge is scanned, the patient’s bar code is scanned and the system then confirms “this is the correct medication, patient and dosage that should be given at this time,” essentially giving the nurse a green light to proceed.

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.