Pharmacy Error Injury Lawyer Blog

Jury Awards $12.6 Million to Teenager Who Lost Her Limbs Due to Vaccination Error

January 26, 2012 | Lebowitz & Mzhen

A jury in Miami awarded $12.6 million to Shaniah Rolle, a teenager who had to have all four limbs amputated because of a vaccination error thirteen years ago. After a five-week trial, the jury deliberated for three days before reaching a verdict. Rolle will not recover the full amount of the award, however, as the jury also found that her mother was forty percent negligent in the events that led to Rolle’s injuries. The defendant, the University of Miami’s Miller School of Medicine, will probably appeal the verdict.

As a young child, Rolle suffered from intestinal problems. Doctors concluded that they would have to remove her spleen and other organs. Since the spleen ordinarily protects the body from illness by filtering bacteria and other intruders, she would need medication to guard against infection. Her mother took her to the medical school’s pediatric unit in October 1998 for a checkup. A medical assistant gave Rolle an injection of a vaccine formulated for people without spleens. The assistant did not realize that the vaccine had expired five months earlier.

Because the vaccine failed to provide her protection against certain types of infection, Rolle became extremely ill about eight months later. At another hospital in Miami, doctors learned that she had a bacterial infection through her entire body that led to blood clots in her limbs. All four limbs had developed gangrene and had to be amputated above the joints.

Since then, Rolle has reportedly led a normal life. She attends Miramar High School in Miramar, Florida, and with the help of prosthetic limbs, she is on the school’s cheerleading squad.

Rolle’s mother filed suit against the medical school and the doctors who treated Rolle. Defense attorneys argued that Rolle would have become ill with or without the vaccine. A defense expert testified at the trial that the mother did not give Rolle enough medication to allow her to avoid infection. This was the basis of the jury’s conclusion that the mother was forty percent negligent. This means that the total award will be reduced by the amount of the mother’s negligence, so instead of $12.6 million she can recover around $7.56 million. This could be delayed even further, of course, if the hospital appeals.

Online Pharmacies Offer Savings, but Also Present Risks

January 19, 2012 | Lebowitz & Mzhen

Online pharmacies have become increasingly common as an alternative to brick and mortar drugstores, offering possible cost savings and saving consumers one or more errands. Many major drugstore chains now offer online ordering in addition to their in-store services. A number of companies have set up exclusively web-based services as well. Some misconceptions exist regarding businesses that sell prescription medications online. Reputable and legitimate online pharmacies invariably require valid prescriptions, and they operate under the same rules as any pharmacy with a physical location.

A minimum amount of diligence can assist a consumer in finding a good online pharmacy. They will either need to receive a paper prescription slip from the consumer by mail, or they may call the doctor to confirm the prescription. Generally speaking, reputable online pharmacies do not solicit business through e-mail marketing. Most people by now have received more than one piece of “spam” e-mail offering discounted medications over the internet. These are not part of the legitimate online pharmacy business, but some scam services mimic legitimate services very effectively.

State pharmacy boards sometimes have information pertaining to illegitimate online operations. When in doubt, the Maryland Board of Pharmacy or the National Association of Boards of Pharmacy may have helpful information. The federal Department of Justice also investigates and prosecutes illegitimate and illegal websites. In September 2011, it reached an agreement with Google in which Google agreed to forfeit $500 million for taking advertisements from and offering support to online pharmacies based in Canada. These Canadian pharmacies target U.S. consumers, although importation of prescription medications violates federal drug laws.

Congress is also weighing in on the safety of online pharmacies. Senators Dianne Feinstein (D-CA) and Jeff Sessions (R-AL) introduced a bill in December called the Online Pharmacy Consumer Protection Act. The bill would enable the government to crack down on online services that dispense medications without a valid prescription. The bill, which the two senators have previously introduced, was originally inspired by a California teen who died of an overdose of Vicodin he purchased online.

Even legitimate online pharmacies can still present risks for consumers. CBS Sacramento reports the case of a woman who repeatedly received the wrong medication from an online service. Instead of Lipitor, the company kept sending her Zocor. Her only means of addressing the problem with the pharmacy was through an 800 telephone number. They finally determined that the woman’s doctor had phoned in the wrong prescription. The virtual nature of the pharmacy proved to be a disadvantage in this situation, since the woman had only a limited ability to address the issue with an actual person by telephone.

Drug Confusion Causes Eye Injury, $1 Million Lawsuit

January 12, 2012 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) issued an alert to pharmacists nationwide on December 28, 2011 regarding two drugs with similar-sounding names but very different uses, warning them of the risk of serious injury if one drug is accidentally substituted for the other. Durezol is an FDA-approved eye medicine that consists of a 0.05% solution of ophthalmic chemicals. Durasal, meanwhile, is a topical wart remover. It is not formally approved by the FDA, and it consists of a 26% solution of salicylic acid. Both drugs are available with a doctor’s prescription.

Ordinarily the FDA would screen trade names to see if they were substantially similar to an existing name in a way that might confuse consumers, but it never subjected Durasal to is formal approval process. Durasal reportedly went on the market shortly after the FDA approved Durezol.

Complaints about confusion between the two drugs began as early as 2009, with ophthalmic patients accidentally receiving the wart remover Durasal. Obviously a solution of more than a quarter acid is not ideal to place into one’s eye, and several patients have allegedly suffered severe eye injuries as a result. Durasal’s manufacturer, Elorac, Inc., has reportedly not responded to the FDA’s request to discuss a possible recall of the drug. The Philadelphia Inquirer reported that a company spokesperson at one time said the company planned to introduce a new product, also containing salicylic acid but with a different name. As of early January 2012, however, Durasal remains on the market.

A New York City patient filed a lawsuit against pharmacy chain Walgreens in early 2011 for mixing up the two medications. The man had just undergone minor eye surgery and went to fill a prescription for Durezol, the eye medicine. The pharmacy allegedly gave him Durasal instead, causing what he described as “grievous personal injury.”
The Consumerist reports that, despite packaging and warning labels, medicine mix-ups are a fairly common occurrence. They reference the story of an Arizona woman who mistook superglue for eyedrops in 2010 and needed emergency medical intervention. Eye drops may present a particular problem, since some patients may not able to immediately review the label and instructions due to impaired vision. The packaging for Durasal includes a clear warning that the product is “NOT FOR USE IN EYES,” but media reports do not indicate if pharmacies ordinarily dispense the medication in its original packaging, or if the warning was visible to the particular injured individuals.

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.

FDA Wants More Warning Label Information for Yaz

December 27, 2011 | Lebowitz & Mzhen

A panel at the U.S. Food and Drug Administration (FDA) recommended that the labels for certain popular birth control pills, including the pill marketed as Yaz, should be updated to include new data that suggest an elevated risk of blood clots. The affected drugs are manufactured by Bayer. A panel of experts met for over nine hours on Thursday, December 8, to discuss data regarding blood clot risks with contraceptives containing the synthetic hormone drospirenone. It ultimately voted 21-5 to urge Bayer to update its labels. The panel had earlier voted 15-11 in support of keeping drospirenone-containing drugs on the market, a vote of confidence that the drugs still offer a benefit to patients. A full third of the panel voted against that recommendation. The FDA did not set a timetable for Bayer to change its labeling.

Bayer first released Yaz in 2006, and within a year its annual sales had reached $2 billion. This was boosted by an aggressive advertising campaign targeting women in their 20’s and touting the overall health benefits of the drug. In addition to its contraceptive benefits, ads claimed that Yaz could provide relief from PMS and acne. Millions of women started taking the drug, but by 2008 the possible health risks were becoming clear. Five studies conducted since 2009 have suggested a higher risk of potentially fatal blood clots, with one finding a 75 percent higher chance of developing blood clots as compared to patients taking older contraceptive drugs.

ABC News reports on a 24 year-old woman in Madison, Wisconsin who started taking Yaz in 2007 after seeing its ads on television. Within three months, she began to feel pain in her legs, which she attributed to time spent on her feet in her job as a nurse. The pain quickly turned out to be blood clots that traveled to her lungs, where they caused a pulmonary embolism. She spent almost two weeks in a coma, and when she woke up she had lost her sight. Whether her blindness is in anyway related to the drug is not known, but her blood clots are consistent with the findings of numerous studies of drugs containing drospirenone.

The Associated Press has a report on a 20 year-old California woman who died on Christmas Eve 2008 of a blood clot that had traveled to her lung. She had started taking Yaz two months earlier.

In 2008, the FDA sent a letter to Bayer regarding their advertisements for Yaz. FDA studies had shown that Yaz was not an effective treatment for PMS, and that it was not very effective at treating acne. State health authorities also made allegations of false advertising regarding Yaz’s supposed health benefits. Bayer reached a settlement in which it agreed to launch an expensive series of “corrective” television ads. These ads stated that Yaz could treat premenstrual dysphonic disorder (PMDD), a severe form of PMS, but was not indicated for the treatment of regular PMS.

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.

Hospital Patient Mistakenly Given Drug Used in Executions

December 7, 2011 | Lebowitz & Mzhen

The family of a south Florida man has filed a lawsuit against North Shore Medical Center in Miami. The man, 79 year-old Richard Smith, died in July 2010 when he went to the hospital complaining of shortness of breath and received the wrong medication. The nurse who administered the allegedly fatal dosage received disciplinary sanctions and paid a fine, which the family does not find satisfactory.

Smith told doctors he had shortness of breath and an upset stomach. His treating physician ordered Pepcid, an antacid available over the counter. The ICU nurse instead took a vial of Pancuronium from a locked cart and put it in Smith’s IV. Pancuronium is a muscle relaxant used by the ICU when intubating a patient. In larger doses, it is used by the Florida prison system in executions as part of a three-drug cocktail. The drug does not affect consciousness, but does significantly impair motor functions. At high enough doses, a person would not be able to breathe.

According to hospital records, no one noticed Smith’s condition for thirty minutes. When hospital staff finally recognized the problem, Smith’s heart had stopped. Resuscitation efforts did not succeed in reviving him. An investigation by the state found that the nurse on duty not only failed to read the label on the medication, but failed to scan both the drug label and Smith’s patient ID bracelet. These would have alerted the nurse to the problem. Another report indicated that the nurse did not follow safeguards established for the drug cart containing the Pancuronium. The state cited the hospital for this failure. The hospital has reportedly removed Pancuronium from most nursing areas in the hospital and created a new packaging system with clearer warnings.

According to local news covering the story, the nurse still works at North Shore. He reportedly received a reprimand, paid a $2,800 fine to the state, and attended remediation courses. The hospital described this as appropriate counseling and re-training. Smith’s family disagrees, saying through their attorney that the nurse should not still be permitted to work with patients. This Pharmacy Error Injury Lawyer Blog has previously reported on cases where medication errors causing death have led to criminal convictions for involuntary manslaughter. In this instance, the consequences apparently end at professional discipline.

Government Promotes Communication Between Doctors and Patients to Reduce Pharmacy Errors

November 28, 2011 | Lebowitz & Mzhen

https://www.youtube.com/watch?v=VuGuYC80XxsThe Agency for Healthcare Research and Quality (ARHQ), an agency of the federal government, has partnered with the Ad Council to promote two-way communication between patients and their doctors as a means of improving care and reducing errors. The campaign currently focuses on public service advertisements targeting clinicians and emphasizing the idea that simple communication with patients can be one of the most powerful diagnostic tools. According to research, patients are more likely to adhere to their treatment plans if they engage in direct communication with their doctors. Communication can also help doctors understand a patient’s condition and make more informed decisions as to medications.

This Pharmacy Error Injury Lawyer Blog has previously reported on various efforts by doctors and hospitals to improve patient safety. Both Maryland and Oregon have shown signs of improvement in communication between pharmacies and state pharmacy boards, leading to successes in both reporting of errors and prevention of future errors in hospitals. The “Good Catch” program, pioneered at Baltimore’s Johns Hopkins, promotes voluntary reporting of errors through internal hospital channels in the hopes of preventing more serious errors before they occur. The program has caught on in other hospitals around the country and has produced positive results.

The ARHQ/Ad Council campaign differs from the above programs in that it is an initiative of the federal government, and therefore has potential to reach doctors, hospitals, and pharmacies nationwide. It also represents a collaboration between the public and private sectors, with the nonprofit Ad Council distributing PSA’s for the ARHQ. The ARHQ is part of the U.S. Department of Health and Human Services. Its mandate is to conduct and support research regarding issues of health care such as safety, quality, cost, and access. It publishes and disseminates this research to clinicians nationwide. The agency also regulates certified Patient Safety Organizations, groups authorized by federal statute to promote reduction of medical errors and improvement of patient safety.

Pharmacist Jailed for Fatal Medication Error

November 16, 2011 | Lebowitz & Mzhen

An Ohio pharmacist spent six months in jail for a medication error that led to the death of a two year-old child. Emily Jerry’s parents took her to a Cleveland hospital in February 2006 for the last of a series of cancer treatments. Her doctors ordered an intravenous chemotherapy solution. A pharmacy technician prepared her medication with the incorrect dosage of saline, 23 percent instead of 1 percent, and supervisor Eric Cropp signed off on the technician’s work. The saline amount proved to be lethal. Emily slipped into a coma shortly after the solution was administered, and she died several days later.

Cropp lost his pharmacist license and was charged with involuntary manslaughter for Emily’s death. The pharmacy technician who prepared the solution testified to the Ohio Board of Pharmacy that she told Cropp something was wrong with the mixture, but that he approved it anyway. Evidence presented in the criminal case depicted an overburdened pharmacy and staff, indicating that the pharmacy’s computer system was down the day of Emily’s death and the pharmacy was short-staffed, leading to a backlog of orders. Testimony suggested that the pharmacy had rushed and difficult working conditions. The specific chemotherapy solution for Emily was also evidently requested on an expedited basis. Cropp was found guilty and sentenced to six months in prison in August 2009. The pharmacy tech who actually mixed the solution apparently faced no criminal penalties.

Pharmacy representatives and advocates criticized the verdict and punishment for criminalizing a human error, albeit a tragic one. The Institute for Safe Medication Practices compared the process of investigating and criminally prosecuting a pharmacist to a game of “Whack-A-Mole,” with multiple government entities each swinging at the exposed medical professional. It also claimed that the pharmacist in this case was just one part of a larger, often-dysfunctional process. As a convicted felon, Cropp will never work in a pharmacy again.

While Cropp’s criminal case was ongoing, lawmakers were reviewing the fact that Ohio did not require pharmacy technicians to be licensed by the state. Republican state senator Ted Grendell proposed a bill that became known as “Emily’s Law” in July 2007, requiring a competency test for pharmacy technicians and imposing criminal penalties on both pharmacists and technicians for performing pharmacy work without meeting the new qualifications. Governor Ted Strickland signed the bill into law in January 2009.