Drug Injury Attorney Blog

As a dangerous drug attorney, I was very interested to see a series of warnings from the U.S. Food and Drug Administration about the drug Tamiflu. Tamiflu (oseltamivir) is an antiviral drug that fights the flu; it has been in the news recently because of its use to fight the H1N1 virus, also known as the swine flu. The FDA warning is not about the efficacy of the drug, but about its dosage in liquid form, which is intended for children. The prescription labeling information for Tamiflu is generally given in teaspoons or milliliters (by volume), the FDA said, but the dosing dispenser that comes with the drug is marked in milligrams (by weight). This can confuse parents and may lead to a toxic overdose or an underdose that can’t protect the child.

The discrepancy was first revealed in a letter published in the New England Journal of Medicine Sept. 23, WebMD reported Sept. 25. One of the authors of that letter was Kara Jacobson, a health researcher at Emory University. Jacobson’s six-year-old daughter was prescribed Tamiflu for H1N1, but her prescription was for three-fourths of a teaspoon twice a day. Because the dispenser was measured in milligrams, Jacobson and her husband, a doctor, had to track down and solve the equations to translate their daughter’s dosage, a process that took thirty minutes. Many other families wouldn’t have the awareness to identify that problem or the time and resources to solve it, Jacobson and her co-authors warned in their letter.

Both the FDA and Tamiflu’s manufacturer, Roche, have asked doctors to write their prescriptions in milligrams. They also asked parents and caregivers to be aware of the problem and if necessary, replace the included dosing dispenser with a syringe or other measuring device that uses milliliters. The FDA’s public health alert includes a chart giving the recommended dosage in both milligrams and milliliters according to the child’s weight.

The consequences of an incorrect dose can be serious. An overdose of Tamiflu is literally toxic; parents are advised to call a poison control center if they believe their children have been overdosed. Rare but serious adverse effects of Tamiflu can include liver problems, cardiac arrhythmia, seizure, aggravation of diabetes and a life-threatening skin condition called Stevens-Johnson syndrome. Meanwhile, an underdose of Tamiflu can make the drug ineffective, which puts the patient at risk for the worst symptoms of H1N1, including acute respiratory distress that leads to death in about half of those affected. While scientists still don’t fully understand the disease, children may be at special risk from the flu because studies show they don’t have the antibodies older people have.

As a defective prescription drug lawyer, I am happy to see that this problem was addressed before any reported cases of serious side effects from Tamiflu. Busy working parents with no special scientific or math training may not even notice the problem (especially since it uses the metric system), and if they do, it doesn’t seem likely that they’d come up with the equation Jacobson used. Thanks to worries about H1N1 spreading among children, the drug has sold so well that pharmacies briefly ran out of it, so there’s a lot around. With millions of parents stockpiling Tamiflu for use as a prophylactic, it’s not hard to imagine that a few might make mistakes that could seriously harm their children -- with the best of intentions.

Continue reading " FDA Warns Doctors and Parents About Dosage Discrepancy for Liquid Form of Tamiflu " »

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Nearly seven months after the drug Phenergan was the center of a controversial U.S. Supreme Court ruling, the Food and Drug Administration has required a black box warning for the label of its generic version, promethazine. According to the Associated Press, the agency made the labeling change to warn patients about the possibility of gangrene if the drug is administered improperly -- the same issue at the center of the Supreme Court case.

Promethazine, an anti-nausea, anti-vomiting and sedative drug, is administered as an injection deep into muscle tissue. However, if it’s administered to an artery or under the skin instead, it can damage tissues so badly that the cells die, sometimes causing gangrene and amputation of the affected area. According to the FDA’s press release, the new label moves the warning about the possibility of gangrene from the package insert onto the outside of the package itself. It will also caution health care professionals to inject the drug deep into the patient’s muscle, and to give the injection slowly and at low concentrations to prevent promethazine from leaking from the veins into the surrounding tissue, where it can do damage.

The lack of strong warnings on the drug was the center of the Supreme Court case, Wyeth v. Levine. Patient Janet Levine sued drug company Wyeth after an injection of Phenergan caused the amputation of her right arm. She alleged that Wyeth failed to provide sufficient warning about the risk of gangrene. Wyeth argued that its labeling was sufficient because it had been approved by the FDA. The federal law allowing the FDA to regulate drug labeling preempts state law, the drug manufacturer argued, meaning that state juries like the one in Levine’s case should not be able to find that its labels are insufficient. This would have effectively ended nearly all lawsuits against drug manufacturers over this issue. However, the Supreme Court ruled 6-3 for Levine, saying Congress did not intend to preempt state juries when it established the FDA.

As a dangerous prescription drug attorney, I am pleased that the FDA took the next logical step after the Wyeth ruling -- confirming the need for a labeling change by ordering the strongest warning available. Tissue death, gangrene and resulting amputation are not common reactions to promethazine -- but when they happen, they change the lives of the victims forever. Losing an arm requires victims to relearn how to do nearly everything in life, from eating to dressing to driving. It also takes away careers and livelihoods; Levine, the plaintiff in the Supreme Court case, was a guitarist and pianist before she lost her arm. If it can prevent others from suffering from an irreversible, lifelong disability, this labeling change is worthwhile.

Continue reading " FDA Orders Black Box Warning for Injected Sedative at Center of Supreme Court Case " »

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Pharmaceutical company GlaxoSmithKline discussed burying studies linking antidepressant Paxil (paroxetine) to birth defects, Bloomberg News reported Sept. 15. The revelation came in the opening phases of a lawsuit against GlaxoSmithKline by Michelle David and her three-year-old son, Lyam Kilker, who claim Paxil is responsible for Kilker’s life-threatening heart defects. The plaintiffs and their dangerous prescription drug attorney claim GlaxoSmithKline knew Paxil could cause birth defects and intentionally withheld that information in order to protect the drug’s sales, estimated at $942 million in 2008. According to Bloomberg, the case is the first of more than 600 claiming that GlaxoSmithKline knew Paxil causes birth defects, but continued selling it anyway without notifying consumers, doctors or regulators.

The memo in question was written in 1997 by GlaxoSmithKline executive Bonnie Rossello, about the possibility of doing animal studies on the drug. “If neg[ative], results can bury,” Rossello wrote. The plaintiffs also claim the manufacturer knew when it bought the drug’s patent in 1980 that the previous owner had found evidence that Paxil caused birth defects in rats. Nonetheless, they said, GlaxoSmithKline resisted doing a study on its drug for almost 20 years to see why the young rats in that study died. In 1998, the plaintiffs said, GlaxoSmithKline reviewed its reports of Paxil side effects and found a high number of birth defects -- then deleted the relevant parts of the report and never notified the U.S. Food and Drug Administration. And in 2001, an internal report said birth defects in a patient’s fetus were “almost certainly” caused by Paxil use.

After a 2003 order from the FDA for more safety tests, the company acknowledged that Paxil increased the risk of birth defects. Nonetheless, a lawyer for the drug maker said at trial that it had not received reports of the specific defect Kilker has before he was born in 2005. Since 2003, several studies have shown that Paxil use during pregnancy increases the risk of heart defects in babies by 1.5 to 1.7 times. A study in the British medical journal The Lancet also found that babies born to mothers using Paxil had withdrawal symptoms, including convulsions. The drug’s labeling now warns of this risk, and the American College of Obstetricians and Gynecologists has recommended that pregnant women and women trying to become pregnant avoid Paxil.

As a defective prescription drug attorney, I will watch this and other Paxil cases closely. Heart defects in newborn infants are frightening and potentially life-threatening. Children with severe defects may need surgery or multiple-drug regimens to be well enough to live normal lives. This is a terrible challenge for any family to face -- and juries will likely sympathize with children who are ill through no fault of their own. That may be particularly true if plaintiffs can prove that GlaxoSmithKline knew or should reasonably have known about the link between Paxil and infant heart defects earlier. If these plaintiffs can prove the claims outlined in the article, I think they have a strong chance.

Continue reading " Memo Introduced at Paxil Trial Suggests Drug Company May Have Buried Negative Studies " »

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Pharmaceutical company Pfizer Inc. will pay $2.3 billion to the federal and state governments over allegations that it illegally marketed several drugs for off-label uses, the New York Times reported Sept. 2. The fine settles both criminal and civil allegations against the giant manufacturer for illegal off-label marketing of Bextra (gabapintin), a painkiller that is now discontinued, as well as Zyvox, an antibiotic; Lyrica, a nerve pain medication; and and Geodon, an antipsychotic. Whistle-blowing former employees and government regulators accused Pfizer of pushing doctors to prescribe Bextra for levels of pain beyond its FDA approval and at higher doses than approved, even though risks of the drug increased with the dosage. Bextra was withdrawn in 2005 because of reports that it increased risk of heart attacks and potentially fatal skin disorders.

This is actually the fourth off-label marketing fine for Pfizer. Most recently, the company was accused of pushing Neurontin, a drug approved for treating epileptic seizures and nerve pain, for off-label use to treat psychiatric disorders from the depression and anxiety spectrums. One of the six whistle-blowers in the current case was a sales representative for Pfizer while it was settling the Neurontin allegations. He said managers told him and his colleagues to ignore the controversy and the companywide integrity agreement Pfizer signed, and continue to market Bextra for illegal uses. “The whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player,” he told the newspaper.

Despite the huge size of the fine, the Times said, the $2.3 billion payment represents fewer than three weeks of Pfizer’s sales. This incongruity, as well as Pfizer’s history of recidivism when it comes to illegal marketing practices, left prosecutors, drug safety advocates and pharmaceutical liability attorneys feeling cynical. Almost every major drug maker has been accused of paying kickbacks to doctors or hurting federal health programs financially -- in fact, Pfizer’s behavior in this most recent case allegedly cost Medicare and Medicaid millions of dollars. However, Pfizer general counsel Amy W. Schulman said consumers and regulators can still trust Pfizer because “the vast majority of our employees spend their lives dedicated to bringing truly important medications to patients and physicians in an appropriate manner.”

As a dangerous drug lawyer, I believe every part of that statement except the last clause -- “in an appropriate manner.” It is difficult to believe that the manufacturer is committed to appropriate drug marketing when it has now been fined four times for the same illegal marketing. Even though this fine set new records for its size, I do not believe that the company’s behavior will change until the fines get even higher -- or affect its profits in another substantial and long-term way. If the former employee is right that sales are the most important consideration at Pfizer, regulators must take actions that hurt sales and profits before this company, and others engaged in the same practices, will ever truly change. Until then, consumers trying to protect themselves have little choice but to question their doctors closely about FDA approval for the drugs they are prescribed.

Continue reading " Drug Maker Pfizer to Pay Largest Criminal Fine Ever to Settle Allegations of Off Label Marketing " »

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Researchers who study the effectiveness and safety of asthma drugs are questioning the results of a new study, Reuters reported Aug. 19. The new study examines the safety of a class of inhaled asthma drugs called long-acting beta agonists, which include Serevent (salmeterol) and Foradil (formoterol); and, in combination with inhaled corticosteroids, Advair (salmeterol and fluticasone) and Symbicort (formoterol and budesonide). The study was conducted by researchers including Dr. David Lang of the Cleveland Clinic Foundation -- but it was funded with an unrestricted grant from GlaxoSmithKline, the maker of Serevent and Advair. As a result, say independent researchers, the study’s conclusion -- that these drugs don’t increase asthma-related illnesses -- is not reliable.

For several years, scientists have suspected that long-acting beta agonists actually increase the chances of serious complications from asthma. In fact, one 2003 study showed that the chance of death was actually higher for asthma patients using the drug than it was for those taking only a placebo. Another study found that the risk is even greater for African-Americans, although it was not clear why that might be. The FDA updated the drugs’ warning labels to reflect that risk three times, in 2003, 2005 and 2006, and recommended in 2008 that long-acting beta agonists be banned as asthma medication.

The study by Lang and his colleagues examined that risk. They examined hospitalizations for asthma in Philadelphia between 1995 and 1999, then checked them against prescription rates for both short-acting and long-acting beta agonists. According to the findings, hospitalizations rose with short-acting beta agonist prescriptions, but fell with more prescriptions for the long-acting drugs. The researchers concluded that the study showed no evidence that long-acting beta agonists increase asthma-related illnesses.

Asthma drug researcher Dr. Christopher Cates of the University of London disagreed. He said the study design was unreliable, at least in part because researchers didn’t determine whether the drugs were prescribed for asthma. (As a dangerous drug attorney, I can add that correlation between two events does not necessarily mean that one caused the other, although dishonest people may try to imply otherwise.) Another independent scientist, Dr. Shelly Salpeter of Stanford University, said the association between long-acting beta agonists and asthma complications is clear from multiple studies. In fact, both doctors said, the medical community has moved on to examining whether these drugs are safe in combination with corticosteroids; recent evidence suggests that they are not.

As a pharmaceutical injury lawyer, I am not surprised that a study funded entirely by GlaxoSmithKline would draw conclusions favorable to GlaxoSmithKline’s drugs. There are 300 million people around the world who suffer from asthma, and Advair alone has $3.8 billion in annual sales. All of those profits and more would be lost to the drug maker if it is forced to remove Advair and Serevent from the market because of safety concerns. Nonetheless, evidence is growing that these drugs may actually raise the risk of a serious asthma-related illness, up to and including fatal illnesses. Under those circumstances, it is, at the least, highly irresponsible to sponsor studies that deceptively claim otherwise. If even a fraction of those 300 million people fall seriously ill because they were misled into believing long-acting beta agonists were safe, the drug maker could be responsible for thousands of deaths and catastrophic illnesses.

Continue reading " Scientists Question Findings in Study of Asthma Drugs Funded by Drug Manufacturer " »

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