Patient Safety

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.

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.

FDA Weighs in on Marketing Pharmaceuticals via Social Media

January 5, 2012 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) released a memorandum in late December laying out guidelines for the use of social media, such as Facebook and Twitter, by pharmaceutical companies in marketing their products. The memo’s release came more than two years after the FDA held hearings on the matter in November 2009. Although the memo provides useful guidance, it is not nearly as comprehensive as industry insiders expected. The guidelines only deal with online discussions of off-label drug uses, those which lack explicit FDA approval.

Social media, the FDA felt, poses different challenges and risks than previous technological advances in marketing, such as television advertising, because social media allows much faster access to information and more direct contact between manufacturers and consumers. It convened hearings in November 2009 to examine these concerns. According to the New England Journal of Medicine, the FDA issued warnings to fourteen drug companies in April 2009 after it found sponsored ads for prescription drugs in search engines that lacked a clear statement of risks.

A major question for the FDA was that of “balance,” making sure consumers had access to all relevant information about a particular drug. This includes not only information about known side effects, but also, when claims are made about a drug, about the financial interests of the person or company making the claim. Among social media services, it is also increasingly difficult to determine whether a pharmaceutical company is responsible for a claim about a medication. Google and sites like Wikipedia make it increasingly easy for the general public to make claims about prescription drugs. The FDA has a responsibility to police the accuracy of claims made by the manufacturers. A major challenge for the FDA is therefore how to deal with inaccurate information widely disseminated by people other than the manufacturers.

The FDA’s guidelines address unsolicited requests from consumers for information about “off-label” uses. Generally, companies should not directly answer questions posted online about off-label uses, but should refer people to their websites or hotlines for more information. Answering such questions, the FDA says, is not unlawful per se, but could count as “evidence of a new intended use.”
Major pharmaceutical companies, or “Big Pharma,” spent $1 billion on online marketing in 2011, according to Ad Age. This number is expected to keep increasing, but it still represents a small percentage of pharmaceutical marketing. The industry expected clear, definitive guidelines on social media use, but got something more vague. The FDA has stated that, because of the ever-evolving nature of social media, it will not issue platform-specific guidelines for each social media service. It says it plans to issue further guidelines in the future.

State Revokes Three Professionals’ Licenses to Prescribe Medication

December 20, 2011 | Lebowitz & Mzhen

The Delaware Secretary of State’s Office has suspended the Controlled Substance Registrations of two medical doctors and a nurse practitioner because of allegations that they overprescribed a number of controlled substances in unreasonable and excessive amounts. Complaints filed against the the three, who all worked in the pain management field, further allege that they disregarded evidence that some of the prescribed medications were being abused or even diverted. The suspension immediately halted their legal authority to write prescriptions. One physician and the nurse practitioner reportedly also surrendered their Drug Enforcement Agency (DEA) registrations to federal authorities. The doctors may face further disciplinary action beyond the Secretary of State’s investigation.

One of the physicians, Dr. Mohammed Niaz, worked with the nurse practitioner, Jean Binkley, as her supervisor. The Secretary of State alleges that Dr. Niaz wrote prescriptions for over 57,000 tablets of various controlled substances during the first seven months of 2011. This amount included 42,000 tablets of the Schedule II narcotic Oxycodone. Binkley is alleged to have separately written prescriptions for over 89,000 Oxycodone tablets.

The state further alleges that one patient, using prescriptions obtained from Niaz and Binkley, obtained 360 Oxycodone tablets and 90 tablets of Alprazolam within a two-week period earlier this year. This is considered an unreasonable amount for one person for such a brief period of time. Alprazolam is the generic name for the drug Xanax, a Schedule IV controlled substance used to treat anxiety, but also highly prone to abuse. Both types of drug can be highly addictive and dangerous if abused, and their distribution is strictly controlled. The state alleges that many of the drugs obtained through prescriptions written by Niaz and Binkley ended up in the hands of people who did not have a prescription and did not have guidance on how to use the drugs safely.

Dr. Patrick Titus allegedly wrote an even greater number of irregular prescriptions. One pharmacy’s records reportedly showed 3,941 prescriptions written by Dr. Titus between January and November 2011, accounting for almost 750,000 pills of seventeen Schedule II narcotic pain medications such as Oxycodone, Oxycontin, and Morphine.

The Secretary of State launched an investigation with the assistance of the Delaware Attorney General’s office and the Division of Professional Regulation. Delaware law empowers the Secretary of State to revoke a medical professional’s license to prescribe medicine if “continued registration would be inconsistent with the public interest.” The Secretary of State’s reasoning in this case seems to be that these three medical professionals have established a sufficiently questionable prescription history, and that they would constitute a threat to the public interest if allowed to continue writing prescriptions.

Doctors Offer Five Steps to Help Seniors Reduce Their Risk of Drug Side Effects

December 14, 2011 | Lebowitz & Mzhen

For people over the age of 65, two-thirds of emergency room visits result from side effects of medications in two broad categories, according to the Boston Globe and the New England Journal of Medicine. The categories are medications used to treat heart disease and those taken for diabetes. The study specifically lists blood thinners and anti-platelet drugs in the heart disease category, and blood-sugar-lowering drugs and insulin in the other. Numerous emergency room visits happen because of dangerous, and preventable, interactions between these drugs and other common medications.

The Globe goes on to list a series of tips to help seniors educate themselves about their medical conditions, their treatments, and the most common dangers inherent in their prescribed medications. Many medications require frequent, often constant, adjustments in dosage, so close communication with your doctor is essential. Long-term use of some medications can often cause their own medical complications and side effects, such as hypoglycemia with blood-sugar-lowering medications. The author quotes five tips from the American Association of Family Practitioners:

1. Obtain both written and verbal instructions from your doctor about the proper use of your medication. Ask your doctor to repeat the instructions as many times as it takes until you understand them. Understanding exactly how and when to take your medication is perhaps the most important step in avoiding injury.

2. Read your prescription, then read the label of the drug once you get it from the pharmacy. Read both the label on the bag and on the bottle itself. Make sure your name appears on all labels, and make sure the name and dosage of the drug match the prescription. Incorrectly-filled prescriptions are a frequent cause of medication-related injuries.

3. Talk to the pharmacist about possible side effects. You have an opportunity to do this whenever you pick up a prescription. The pharmacist can explain possible side effects and common drug interactions to you. That is part of why the pharmacist is there.

4. Stay in contact with your doctor and show up when requested for further testing. Notify the doctor of any side effects you are experiencing, no matter how minor they may seem to you. Failure to follow up once a medication is prescribed can lead to negative side effects down the road if the doctor cannot make adjustments to your treatment based on new information or changing circumstances. The doctor may also need to adjust medication based on unforeseen side effects, drug allergies, or other drug interactions.

Hospitals and Pharmacies Hit by Nationwide Drug Shortages

November 3, 2011 | Lebowitz & Mzhen

A shortage of commonly-used drugs is impacting care in hospitals nationwide. Reports released by the American Hospital Association and the American Journal of Health-System Pharmacists indicate a chronic shortage of crucial medications, with over 800 AHA-member hospitals reporting shortages. Shortages can appear quite suddenly in a hospital environment, with the need for a specific drug suddenly spiking to an amount greater than the supply. Hospitals and pharmacies struggle to compensate for these shortages, sometimes by prescribing alternative drugs, and sometimes by turning to less-than-scrupulous vendors with uncertain records of quality. The possibility for errors, both in prescribing and dispensing medications, is great in such situations.

In a report published by the Patriot-News, one Pennsylvania hospital stated that, out of around three thousand prescription medications commonly used, it experienced shortages of 211 drugs in 2010, up from 70 in 2006. This mirrors conditions in hospitals all over the country. Healthcare administrators around Pennsylvania have reported shortages of fifty or more medications in their facilities, often stating that the shortages are the worst in at least twenty years. This puts significant pressure on doctors, nurses, and pharmacists to identify and locate acceptable substitute medications, often with very little time to spare.

The Food and Drug Administration reported shortages of 178 drugs in 2010. The majority of the shortages are of older drugs administered in hospitals by injection or intravenously. Shortages can result from problems with raw materials and problems arising in the process of producing and distributing drugs. Some drugs may be held up by new regulations, but many drugs fall by the wayside if manufacturers find them not to be profitable.

When a particular drug is unavailable due to a shortage, medical professionals must locate another treatment. This often involves an alternative medication that may not be as effective, that may not be recommended for a particular use, or that may not have equally good quality control. Nine patients died at Alabama hospitals earlier this year, allegedly due to a substitute drug contaminated with bacteria commonly found in tap water and bathrooms.

Reducing Medication Error Injury by Keeping Health Record Journals

August 30, 2011 | Lebowitz & Mzhen

Our Prince George’s County, Maryland pharmacy error lawyer blog recently reported on the important role communication plays between patients and their healthcare providers—in order to reduce the risk of medication errors or pharmacy misfills, and to promote the safe and effective use of drug therapy.

Every year, 1.5 million Americans experience medication-related injuries, according to a study by the Institute of Medicine. In order to prevent medication errors, the American Pharmacists Association (APhA) reports that it is important for patients to keep accurate health records with them when visiting the doctor and pharmacist, including current prescription medication lists detailing the dosage information along with all health conditions that the medication is treating.

Patient medication lists can reduce the risk of pharmacy misfills, incorrect dosages, medication duplication, allergy interaction, and any harmful side effects from potential dangerous drug interactions. The APhA also states that by keeping drug lists with them at all times, patients can prevent medical error by providing emergency staff and hospital pharmacists with important information that could saves lives in an emergency.

According to a recent Chicago Tribune article, doctors are now recommending that individuals turn the medication lists into a comprehensive health journal, to keep healthcare providers informed and to prevent medication error injury.

Report Finds Medication Errors in Chronic Drug Therapy After Seniors Leave Hospitals

August 29, 2011 | Lebowitz & Mzhen

According to a recent study discussed in the Journal of the American Medical Association (JAMA), that our Baltimore medication error lawyers have been following, hospitalized patients are more likely to have medication errors than non-hospitalized patients—when drugs used to treat chronic conditions are unintentionally discontinued in hospitals, especially if the patients are in a hospital’s intensive care unit.

The study reportedly showed that transitions in healthcare can increase a patient’s chances for medical errors that stem from inaccurate or incomplete communication between the hospital staff, the primary care physician, and the patient—causing an interruption or discontinuation of medications that aim to help treat patients’ chronic diseases on a long term basis.

According to the authors, the problem of medication errors and the unintentional discontinuation of drugs can happen during hospital stays, transfers and discharge. Treatment in intensive care units can also increase the risk of medication errors of omission as the healthcare providers are focused on emergency care and may engage in the practice of discontinuing a medication used for chronic illnesses during a time of critical illness.

The medication error study followed nearly 400,000 patients who were older than 65, and who had over one year of experience continuously taking one of the following five drug classes: respiratory inhalers, gastric acid suppressors, statins, anticoagulant or antiplatelet agents, and levothyroxine, used to treat the thyroid gland.

Medical Error Leaves Judge with Surgical Sponge in Body

August 25, 2011 | Lebowitz & Mzhen

Our Baltimore medication error injury blog recently reported that according to the Institute of Medicine, 1.5 million medication error injuries occur every year around the country that are preventable, and as many as 98,000 deaths due to medical errors.

When Nelson Bailey decided to have elective surgery for diverticulitis, a condition causing him abdominal discomfort, he was told that he would be out of the Good Samaritan Medical Center in around four days. What Bailey didn’t expect, according to a recent article in the Sun Sentinel, was that he would suffer from two different and equally serious medical errors at the hospital that would change his live completely.

Bailey, a Palm Beach County judge, underwent the intestinal surgery in October 2009, where the surgeon made a medical error by mistakenly leaving a surgical sponge inside Bailey’s body—that was reportedly as big as a washcloth, and was left to fester for five months.

When Bailey was recovering from surgery he then experienced a hospital pharmacy error, after the pharmacy prepared the incorrect medication. The doctor had reportedly ordered blood pressure lowering medication, but when the wrong medication was sent from the pharmacy, the nurse gave him the drug without double checking the drug label.

New Palm-Vein Scanning Technology Introduced to Reduce Medical Errors in Hospitals

August 22, 2011 | Lebowitz & Mzhen

Our Hartford County, Maryland pharmacy error injury attorneys have been following the latest healthcare technology introduced by New York University’s Langone Medical Center, in an effort to reduce the amount of time it takes to check patients in to the hospital, and to eliminate medical errors.

As our lawyers have discussed in a previous Maryland medication error injury blog, according the Institute of Medicine, there are 1.5 million medication error injuries every year that are preventable, and as many as 98,000 deaths due to medical errors.

The new biometric technology aimed to improve patient safety is made by Fujitsu, the technology services company, and works with the concept that like fingerprints, every patient has an individual and unique palm-vein configuration. The technology uses near-infrared waves to take an image of a patient’s palm veins, which the software then links to that patient’s medical records in about a minute. Other reported benefits of the technology is that a patient does not have to be conscious during the check-in process, and the system eliminates the need for a patient to fill out any forms, unless the patient’s insurance has changed since the last palm scan.

The hospital reportedly experiences around 1.7 million patient visits per year, and is in the process of converting as many patients as possible to the new palm scanning system, to prevent medical errors and patient injury. Since 250 scanners were installed in June, over 25,000 patients have received palm-vein scans that have been registered in the system. The palm scan does not appear in the patient’s medical records, and it is not stored as an image. After the palm is scanned, the image is converted into special numeric code.