High Alert Drugs

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.

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.

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.

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.

DEA Suspends Licenses of Drug Distributor and Two Pharmacies for Selling Excessive Amounts of Painkillers

May 22, 2012 | Lebowitz & Mzhen

The U.S. Drug Enforcement Agency (DEA) has suspended a major pharmaceutical distributor from shipping or selling certain painkillers and other medications from a Florida facility as part of a settlement with the company. Two Florida pharmacies have also had their controlled substance licenses suspended. The DEA’s investigation centered on large shipments of painkillers from the distributor to the pharmacies. The painkillers were then sold to the public.

The DEA pursued these companies as part of a broader crackdown on prescription drug abuse, particularly the abuse of painkillers. The issue is of particular concern because of the risk of medication errors in pharmacies that might illicitly distribute prescription drugs.

Two CVS pharmacies were the focus of the DEA’s investigation. The two stores, both located in Sanford, Florida, reportedly ranked 23rd and 37th in the nation for highest number of oxycodone pills sold.

Oxycodone, also known as ‘Oxy,’ is an opiate painkiller with a high potential for addiction and abuse, and therefore it is strictly regulated by the DEA. A pharmacist employed at one of the stores allegedly told DEA investigators last year that they would sometimes run out of oxycodone less than an hour after the store opened, and that they nearly always ran out before noon. The DEA suspected both stores of inappropriately dispensing oxycodone and other controlled substances, alleging that the pharmacies’ sales of the drugs were unusually high.

Pain Patches Pose a Serious Risk to Children, FDA Warns

May 15, 2012 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) has issued a reminder to the public of the danger posed to young children by patches containing the painkiller fentanyl. Young children, largely because of their curiosity, are at high risk of exposure to fentanyl if patches are within their reach. The patches contain a high concentration of a powerful narcotic, and even used patches can retain as much as fifty percent of the drug’s original potency. Improper use of the patch could result in a serious medication error or injury. The FDA’s notice also contains advice for proper storage and disposal of the patches.

Doctors prescribe fentanyl patches to treat chronic pain, of a moderate to severe level, that requires a more regular application of medication than painkillers in pill form would allow. They are available under the brand name Duragesic, or as a generic. The patch, when applied directly to the skin, provides a steady dosage of fentanyl, a very potent opioid narcotic. It is only recommended for patients who have already taken another narcotic pain medication, and therefore have a tolerance to its effects. Patients should only use the patches on their skin, and they are specifically cautioned not to chew on or swallow any part of a patch. Fentanyl patches pose such a great danger to young children in part because children are more likely to put them in their mouths, and because they have not built up any tolerance to narcotic medications.

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.