Pharmacy Error Injury Lawyer Blog

CEO of Fitness Website Pleads Guilty to Labeling “Drugs” as “Nutritional Supplements”

April 27, 2012 | Lebowitz & Mzhen

The founder and chief executive officer of a popular fitness website, Bodybuilding.com, has pleaded guilty in a federal court in Idaho to five misdemeanor counts arising from products sold through the website that the government alleged were “misbranded drugs.” The products allegedly contained various forms of steroids classified as “drugs” under federal law. Prosecutors sought to hold him liable for allegedly misleading the public about the products’ components.

Ryan DeLuca served as the CEO of Bodybuilder.com between 2007 and 2009. During that time, according to federal prosecutors, the company sold at least five products labeled and marketed as “dietary supplements” that the federal Food, Drug and Cosmetic Act classified as “drugs.” The products, which had names like “I Force Methadrol” and “Rage RV5,” allegedly contained synthetic anabolic steroids or synthetic steroid “clones.” The U.S. Food and Drug Administration (FDA) began investigating the company as early as 2002. It executed a search warrant in September 2009 on the company’s headquarters in Idaho. In November 2009, the company issued a voluntary recall of sixty-five “dietary supplement” products the FDA said should be classified as steroid-containing drugs.

Federal prosecutors charged DeLuca with at least five misdemeanor counts of “introduction of misbranded drugs into interstate commerce.” They alleged that Bodybuilding.com had gross receipts of nearly $1.8 million from the sale of mislabeled product between January and July of 2009. They further alleged that the company’s FDA compliance officer told DeLuca and others in 2009 that certain products violated FDA labeling regulations. Each misdemeanor charge could result in a one-year prison sentence.

DeLuca pleaded guilty to the five counts on April 9, 2012 in a federal court in Boise. He agreed to pay a fine of $500,000, and the government recommended that he receive probation, but no jail time.

Pharmacy Errors and Injuries Can Result From Similar-Sounding Drug Names

April 19, 2012 | Lebowitz & Mzhen

Three medications with similar-sounding names have caused some confusion, and almost caused some serious injuries, in recent months, according to the Philadelphia Inquirer. Two heart medications, Pradaxa and Ranexa, have names that resemble each other and PreNexa, a prenatal vitamin available only by prescription. Medication errors with heart patients or people who are pregnant can have serious short- and long-term consequences, so caution and vigilance are crucial to help patients avoid mix-ups.

Since two of these medications treat heart conditions, mix-ups in pharmacies could be common. Fortunately, that does not currently appear to be the case, but the potential remains for dangerous errors. Any mix-up of these three drugs has the potential for catastrophe, but patients can take a few simple steps to protect themselves. The U.S. Food and Drug Administration generally does not allow drugs used to treat the same or related conditions to have substantially similar or confusing names, but it does happen on occasion. A patient could ask the doctor to include a notation explaining the purpose of the prescription, in order to guide a pharmacist in dispensing the proper medication.

A person filling a prescription also has the ability to discuss the medication with the pharmacist on duty, which is an excellent way to get additional information on the medication and possibly correct errors. If the pharmacist has more information from the patient, the pharmacists can better understand and assist the patient’s needs. A quick conversation with a pharmacist can even reveal, and give an opportunity to correct, errors made in filling the prescription.

A quick review of these three medications can illuminate the risks patients face from drug mix-ups. Pradaxa is an anticoagulant used in patients suffering from atrial fibrillation, a heartbeat irregularity that increases the risk of blood clots. Blood clots can cause stroke and other serious, even life-threatening conditions. Taking the wrong medication leaves the patient at an elevated risk for blood clots. Giving Pradaxa to a patient who does not have atrial fibrillation puts that patient at risk for excessive bleeding and other complications, particularly in people who are pregnant.

Ranexa is an anti-anginal medication that treats chest pain occurring when the heart is not getting sufficient oxygen. Angina sufferers must take the drug on a regular basis for it to have effect, although it cannot cure angina. A person who should be taking Ranexa faces a higher risk of hemorrhaging and bruising if they take Pradexa by mistake.

Pharmaceutical Company Fined $1.1 Billion Over Deceptive Drug Marketing

April 12, 2012 | Lebowitz & Mzhen

An Arkansas judge imposed a $1.1 billion fine on Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, after a jury found the companies liable for deceptive trade practices and false claims. The state of Arkansas sued the companies, alleging that they presented false and misleading information to doctors and patients about the antipsychotic drug Risperdal. The state attorney general’s office accused the companies of downplaying, hiding, or omitting mention of the risk of certain side effects in off-label uses of the drug. This is one of several verdicts against Janssen and Johnson & Johnson in suits brought by state governments, and more lawsuits are pending in other states.

This case is important to advocates for victims of pharmacy and medication errors because doctors and pharmacists rely on accurate information to perform their professional duties. Incorrect or misleading information endangers patients’ health, and even their lives, particularly when such information may have been deliberately put forth by a drug’s manufacturer.

Risperdal first entered the market in 1994 as a “second-generation” antipsychotic. Johnson & Johnson has earned billions of dollars from sales of the drug, which became available in generic form under the name Risperidone in 2004. The U.S. Food and Drug Administration (FDA) first approved Risperdal for the treatment of schizophrenia in adults. It later approved the drug for use in schizophrenia patients ages 13 to 17, and for bipolar disorder. The drug is sometimes used “off-label” for anxiety disorders and other mental health conditions.

The controversy in the Arkansas lawsuit began in 2003, when Janssen sent a letter to over 6,000 doctors in the state regarding use of Risperdal in elderly dementia patients. The letter allegedly minimized or concealed information regarding the elevated risk of stroke and diabetes for elderly dementia patients using the drug.

The state of Arkansas sued Johnson & Johnson and Janssen in 2007 for violations of state deceptive trade practice laws. It asked the judge to impose the statutory fine of $5,000 for each prescription issued under the marketing campaign, estimating the total number of prescriptions to be more than 250,000.

The judge penalized the companies for almost 239,000 prescriptions that violated the state’s False Claims Act, and for 4,600 letters to doctors violating the Deceptive Trade Practices Act. He imposed fines of $5,000 and $2,500, respectively, for these violations, totalling $1.1 billion.

Drug Manufacturer Recalls Vaccine Due to Expired Ingredients

April 6, 2012 | Lebowitz & Mzhen

Lebowitz & Mzhen

April 6, 2012

Updated: August 26, 2016 3:28 pm

Two Families Sue Pharmacy, Alleging Their Children Received Incorrect Dosages

March 30, 2012 | Lebowitz & Mzhen

Two mothers are suing a pharmacy in Gig Harbor, Washington, claiming that their sons received incorrect dosages of prescription seizure medications. In both cases, the parents claim that the dosages dispensed by Olympic Pharmacy were big enough to be almost fatal for the children. The Washington state Board of Pharmacy has reportedly begun an investigation of the pharmacy based on the claims made in the lawsuits.

Laura Carlson says that Olympic dispensed the wrong dosage of medication for her son Chad twice in a period of about two years. In 2009, 11 year-old Chad received a prescription for 8 mls of Lorazepam, a powerful medication used to treat seizures and anxiety. The pharmacy allegedly dispensed the medication in a single pre-filled syringe. Chad reportedly became dizzy after taking the medication, eventually becoming unresponsive. He ended up hospitalized for four days while enduring hallucinations. Carlson looked at the packaging and saw that the prescription was for eight syringes, each containing a 1 ml. dose. Chad had significantly overdosed.

In 2011, Chad’s prescription had changed to pills rather than injections. Carlson filled a prescription at Olympic for 300 mg pills of Lorazepam. When Chad took them, he reportedly began vomiting repeatedly and violently. The pharmacy, it turned out, had given him 600 mg pills, doubling his dosage.

Kaeley Triller’s 3 year-old son reportedly had a similar experience in January. She says that Tristan Triller suffered insomnia, convulsions, and hallucinations after he took anti-seizure medication obtained at Olympic. Doctors at the ER determined that he had received four times the prescribed dose of medication. Once Tristan recovered, Triller did not consider the matter again until she learned of Chad Carlson’s two overdoses.

Both parents have filed lawsuits against Olympic, claiming the pharmacy negligently dispensed incorrect dosages of medications to their children at least three times in the past three years. Carlson’s suit reportedly claims that the pharmacy “poses an imminent public health danger” because of repeated medication errors and a lack of procedures and oversight to prevent future misfills.

Washington’s Board of Pharmacy also reportedly initiated an investigation of Olympic, based at least in part on the claims made by Carlson and Triller. The Board reportedly conducted fifty investigations of alleged pharmacy errors around the state in 2011. The Board has the authority to penalize licensed pharmacists, such as through fines or license suspensions, but it is limited to an administrative process. It cannot recover damages for the injured parties through litigation.

Family of Woman Who Died After Receiving the Wrong Medication Sues the Pharmacy

March 22, 2012 | Lebowitz & Mzhen

The family of a Kentucky woman who died after allegedly receiving the wrong prescription medication has sued the pharmacy that dispensed the medication. The two medications have similar-sounding names but very different purposes. The family’s lawsuit alleges negligence and violations of state law that caused or contributed to the woman’s death.

Mary Moore, an elderly Louisville resident, had just been discharged from the hospital on November 10, 2010, where she had undergone treatment for congestive heart failure, kidney failure, and high blood pressure. She went to a Walgreens pharmacy to fill a prescription from her doctor for Hydralazine, a drug used to treat high blood pressure. The pharmacy instead gave her Hydroxyzine, an antihistamine considered unsafe for people over the age of 65.

Because of the alleged error, Moore’s high blood pressure was completely untreated for two weeks. The pharmacy discovered the error and gave her the correct medication, but by then the damage was done. Moore reportedly could not tolerate the prescribed dose of the blood pressure medication. According to the lawsuit, the medication could not control her blood pressure, and the stress on the heart caused “decompensation” of her congestive heart failure. This was followed by “decompensation of her chronic kidney disease.” Within a few days of starting the Hydralazine, Moore was hospitalized again. She died on December 6, 2010.

The lawsuit names as defendants both Walgreens and the pharmacist in charge at the time the medication was dispensed to Moore. Moore’s family primarily alleges that Walgreens and the pharmacist were negligent in dispensing the wrong medication. They further allege that, by not offering Moore counseling from a pharmacists when she picked up the medication, Walgreens violated state law. The law, according to their complaint, requires a pharmacist to offer a consultation with a patient picking up a medication for the first time. Had the pharmacist offered a consultation with Moore, the plaintiffs argue, one of them would likely have noticed the error with the medication
Hydralazine is a muscle relaxant used to treat high blood pressure and other conditions. It works by relaxing the blood vessels that allow blood free flow through the body. Hydroxyzine, on the other hand, is an antihistamine used to treat allergy symptoms of allergies such as itching, and to treat nausea-related symptoms resulting from conditions like motion sickness. The National Institutes of Health specifically recommend against the use of Hydroxyzine by people over the age of 65, noting that other medications offer similar benefits at a lower risk. In this case, though, the issue was not the treatment of allergies at all.

Voluntary Recall Announced for Certain Oral Contraceptives Due to Packaging Error

March 15, 2012 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) announced on February 24 that Glenmark Generics USA, the North American division of Indian pharmaceutical company Glenmark Generics, Ltd., was voluntarily recalling seven lots of oral contraceptives at the consumer level. The recall is reportedly due to a packaging error, in which blisters were oriented incorrectly within the packaging for the tablets. This may cause the sequence of tablets to be incorrect, causing patients to take the tablets in the wrong order. This could therefore cause the overall treatment to be ineffective, leading to insufficient contraception and other health risks. The FDA recommends that anyone using oral contraceptives with the faulty packaging should immediately switch to a non-hormonal form of contraception.

Glenmark has not said how many total packages are affected by the recall, only the number of lots. It has said that a sufficient amount of the product is still available on the market, so the recall should not significantly impact the total supply. The tablets were reportedly manufactured by Glenmark in India and distributed by its North American division to retail pharmacies and wholesalers.

The affected products contain a mixture of Norgestimate and Ethinyl Estradiol in varying proportions. Both are hormones used in oral contraceptives, the treatment of menopause symptoms, and other conditions. Patients are instructed to take specific tablets at specific times during a 28-day period, and an interruption of the prescribed cycle can interrupt the contraceptives’ efficacy. The specific tablets covered by the recall, according to the FDA, contain tablets with doses of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg of the two compounds.

The FDA says that the packaging error does not pose any immediate health risks to women using the product. The principal risk, it says, is that unintended pregnancy could result from a lapse in contraceptive coverage resulting from the error. It could potentially pose health risks to people using oral contraceptives for non-contraceptive reasons, but that issue is not addressed by the FDA’s announcement.

Earlier in February, pharmaceutical company Pfizer also issued a recall of twenty-eight lots of similar generic tablets and brand-name Lo/Ovral-28 tablets. The tablets, manufactured by Pfizer and labeled under its Akrimax Pharmaceuticals brand, had similar packaging errors to the Glenmark product. Packaging on the Pfizer products might indicate the wrong sequence of tablets and contain inaccurate information on ingredients. Some tablets contain active ingredients and others only inert ingredients, and the sequence is critically important. The recall affected around 1 million packages.

Pharmacy Mistakenly Gives Cancer Medication to Multiple Children

March 7, 2012 | Lebowitz & Mzhen

Children who should have received chewable fluoride tablets may instead have received Tamoxifen, a drug used to treat breast cancer, from a CVS Pharmacy in Chatham, New Jersey. Up to fifty families, according to initial reports, may have been affected by the error, in which the pharmacy dispensed the wrong medication over a period from December 1, 2011 to February 20, 2012. The fluoride pills, prescribed by dentists to prevent tooth decay, are typically flavored, while the cancer medication reportedly has a bad taste if chewed. Because of this, pharmacy representatives say that children would probably have noticed that they had received the wrong medication.

CVS issued a statement saying that children from roughly thirteen families mistakenly received Tamoxifen pills mixed in with the fluoride tablets. A spokesperson attributed the error to a “single medication restocking issue” at the one pharmacy location. The error affected the supply of 0.5mg fluoride tablets. The pharmacy reported that, according to the families they contacted, none of the children actually received any of the incorrect pills.

According to the Associated Press, Tamoxifen acts by blocking the female hormone estrogen. As such, it is not likely to cause serious harmful side effects to a child if taken for a short period of time. The New Jersey Attorney General’s office and the state’s Division of Consumer Affairs have nevertheless ordered the pharmacy to produce records for the period from December to February to account for the mixup. The pharmacy reports that it is still investigating the matter and is cooperating fully with state authorities.

The particular incident had a positive outcome because, fortunately, no one was injured, and the particular drug involved in the mixup had limited potential to cause harm. It underscores the critical importance, however, of remaining watchful for errors that can occur. In addition to checking to see that the label on the medication bottle matches the prescription, patients should also confirm that the medication itself matches the description. Many prescription bottles include a physical description of the medication itself, identifying the shape and color of the medication and stating whether it is in tablet, capsule, or another form. Not all pharmacies include this information on the bottle itself, but all prescriptions should include an insert with comprehensive information about the drug, including a physical description. This is a patient’s last line of defense against potential pharmacy errors.

Shortages of Important Drugs Give Rise to Concerns Over Safety of “Grey Market” Replacements

February 29, 2012 | Lebowitz & Mzhen

Shortages of certain prescription medications are nothing new to most pharmacists, hospitals, and doctors. According to the American Hospital Association, nearly 99.5 percent of U.S. hospitals reported some drug shortages in the first half of 2011, with 44 percent experiencing shortages of more than twenty drugs and 78 percent rationing drug supplies to deal with shortages. The Food and Drug Administration (FDA) reports that the number of drugs reported to be in short supply has increased from around 55 in 2006 to 178 in 2011, and the number could go as high as 350 for 2011 when statistics become available. Aside from basic problems of availability of medications to patients who might desperately need them, the situation also lends itself to unscrupulous behaviors like price gouging and hoarding. The nonprofit research and advocacy group CorpWatch recently issued a report on concern over “grey markets” that spring up for certain drugs that are in demand but also in short supply.

“Grey markets” can endanger patients not only by charging high prices for drugs, but also by removing key quality control procedures and the professional safeguards enjoyed when dealing with licensed doctors and pharmacists. The CorpWatch report describes how a New Hampshire woman found her routine appointments for cancer treatment cancelled when the hospital could no longer obtain her medication. Her particular medication, doxorubicin, trade name Doxil, is used to treat breast cancer and many other forms of cancer, and it is one of the few possible treatments for many people.

The CorpWatch report claims that Doxil’s manufacturer, Johnson & Johnson, actually subcontracts many of the stages of production, which has caused significant delays in production schedules for the drug. A single facility in Ohio manufactures Doxil, according to the Los Angeles Times, and it reportedly cannot keep up with demand. The plant closed temporarily due to concerns over product safety, which only made the shortage worse.

The FDA recently announced that it has approved the importation of shipments of substitutes for Doxil and another cancer drug, methotrexate, from foreign manufacturers. Lipodox, a drug manufactured by Indian company Sun Pharma Global, will temporarily replace Doxil. Australian company Hospira will send shipments of its version of methotrexate, a drug used to treat childhood leukemia. At best, these shipments will cover shortages for no more than a few months. Doctors interviewed by the New York Times stressed that this solution is extremely temporary.

Children’s Shelter Staff Prone to Medication Errors, Says Grand Jury

February 22, 2012 | Lebowitz & Mzhen

A grand jury in Kern County, California recently asked an emergency juvenile shelter to report on how its staff handles prescription and over-the-counter medications for children that are sheltered there. It also called on the county’s Department of Human Services to make a registered nurse available at the shelter 24 hours a day. The grand jury’s actions came after news of medication errors appeared, along with allegations that the shelter is violating state regulations by having staff members provide medications to children without oversight by medical professionals. The dispute has also sparked a debate over semantic issues of who may “dispense” medications.

The A. Miriam Jamison Children’s Center is a 24-hour emergency shelter for “abused, neglected and exploited children” operated by the Kern County Department of Human Services. It provides temporary shelter for children in the protective custody of law enforcement or social services. Over the past year, news of several errors in providing medications to children at the shelter reached the director of the Department of Human Services. Errors have included incorrect doses of medications and incorrect medications. No serious injuries have been reported, but the risk of injury is certainly present. Children have had to go to Kern Medical Center (KMC) because of medication errors at least twice.

After officials put an employee on administrative leave for a medication error, some shelter employees began to refuse to handle medications for children. The Service Employees’ International Union (SEIU) also stepped in, arguing that employees who were not registered nurses could not legally give medications to children under state nursing regulations. Additionally, the shelter reportedly has an agreement with KMC, which sends nurses to the shelter for children’s medical issues, that shelter employees will not deal with children’s medications.

The grand jury’s investigation centers around state regulations and the shelter’s agreement with KMC, but it has also sparked a debate over exactly what activities by shelter staff are prohibited. State law says that only registered nurses may “dispense” or “administer” medications. Pharmacists “dispense” medications by counting and packing pills. Nurses “administer” medications by giving doses directly to patients. The Department of Human Services argues that shelter employees do not do either of these, but rather “deliver” medications to children by taking them from a labeled container, following the container’s directions, and giving them to the children to take.