Drug Injury Attorney Blog

As a defective drug attorney, I’ve kept an eye on the problems plaguing St. Louis-area drug maker KV Pharmaceutical. The company’s Ethex subsidiary was permanently shut down in 2010 after officers pleaded guilty to knowingly allowing oversized, defective drugs to be sold, including drugs for which an accidental overdose could prove fatal. This grew out of a series of reported managerial problems at KV, which resulted in a series of drug recalls, a shutdown by the FDA, drastic management changes and lawsuits over both drug safety and corporate management. Now, the St. Louis Post-Dispatch reported Dec. 6, KV has agreed to pay $17 million to settle allegations of defrauding the federal government by lying about its eligibility for Medicare and Medicaid reimbursements.

The allegations are against the now-defunct Ethex subsidiary. That company is accused of exaggerating the regulatory status of two drugs: nitroglycerin extended-release capsules and hyoscyamine sulfate extended-release capsules. The FDA decided in the 1990s that both were ineligible for reimbursement from federal health care programs, and they never received full FDA approval. A whistleblower lawsuit in Boston federal court alerted the government to the deception, which was in false statements in quarterly reports submitted to the government. The $17 million settlement includes $10.2 million to the federal government and $6.8 million to the states. Of the federal money, $1.5 million will be paid to the whistleblower. The money will be paid out over five years. It comes nearly two years after Ethex was hit with $27.6 million in fines and restitution for failing to report the oversized drugs problem to the FDA.

As a dangerous drug lawyer, I’m pleased to see that the penalties are so steep for placing profit above patient safety. FDA approval is not just a technical hurdle. In order to be FDA-approved, drugs must pass several trials showing safety and efficacy in human patients. Even with approval, drug makers don’t always end up with a product free of defects. That’s one reason why the approval is mandatory for Medicare and Medicaid eligibility — because taxpayers should not be asked to subsidize risky, unproven drugs. The question is whether the $17 million, and the $26.7 million before it, are more money than Ethex and KV made from sales of their unsafe and deceptive products. Only if the penalty outweighs the profits can unethical drug makers be expected to change.

At Carey, Danis & Lowe, we focus our practice on defective and unsafe pharmaceuticals. Patients trust that their doctors wouldn’t prescribe drugs that are unsafe — but when doctors and the FDA aren’t aware of the safety problem, they can’t protect patients. That’s why Missouri and Illinois state laws give drug manufacturers a legal responsibility to ensure that their products are safe and free of obvious defects. When pharmaceutical companies fail in this duty, they can and should be held legally responsible for any injuries or illness to the people who placed their trust in the products. In a lawsuit, our pharmaceutical injury attorneys can help you claim compensation for your injuries, any permanent disability or wrongful death, all medical costs and any pain, suffering or other damages.

Continue reading "KV Pharmaceutical Will Pay $17 Million to Settle Claims of Fraud on Federal Health Care Programs " »

Expert testimony at trial is very important to my work as a defective drug attorney. Because individual jurors rarely have a background in the medical field, an expert is not only a good idea but sometimes even required, in order to explain the issues the jury is being asked to decide. But in hotly contested pharmaceutical cases, disputes sometimes arise over the standards for which evidence is admissible — who is qualified to testify. That was the issue in Williams et al. v. Baxter Healthcare Corp. et al., a Nevada Supreme Court decision filed by two families with members infected by hepatitis C. The Williams, Allen, Bilger and Pagan plaintiffs allege that the infections were caused by contaminated doses of the anesthetic propofol, and claim that the four pharmaceutical defendants were partly at fault for marketing it in sizes big enough to reuse and thus contaminate.

The four plaintiffs brought two separate actions against the drug makers in response to an outbreak of hepatitis C at an endoscopy clinic in Las Vegas. The medical personnel allegedly spread the disease by inserting contaminated needles into containers of propofol, then reusing the containers with new needles and patients. They alleged defendants’ 50 mL containers were so big that they encouraged this type of unsafe reuse, and their claims alleged design defects, failure to warn and breach of implied warrantly of fitness. Defendant pharmaceutical companies sought to rebut these claims with expert testimony from David Hambrick, a registered nurse, and Dr. Jonathan Cohen, a professor of medicine. Both sets of plaintiffs moved to exclude the testimony, with the Williams plaintiffs arguing that nurses cannot give testimony, and both sets arguing that the experts could not pinpoint a cause with a reasonable degree of medical probability. The Pagan plaintiffs’ motion to exclude was granted. Both cases were appealed to the Nevada Supreme Court, where they were consolidated.

The high court first ruled that a nurse is qualified under Nevada law to give expert testimony, though only within his or her field of expertise. The court said caselaw sets forth the standards for who may give expert testimony, and those standards look for relevant skills, experience and knowledge. Under some circumstances, the Supreme Court said a nurse could meet those guidelines; it called on courts to evaluate each nurse’s qualifications on a case-by-case basis. However, it said Hambrick does not meet the guidelines because he has no experience diagnosing the cause of hepatitis C, which was the subject of his testimony. The court turned next to whether Cohen, the medical professor, can testify with a reasonable degree of medical probability as to the cause of the infection. It found that this standard should be applied when the defense is offering an independent alternative theory of causation, but not when the defense is rebutting the plaintiffs. In this case, the court found, the defense does not need to show that its theory is more likely than not, as long as it’s competent and supported by relevant research or evidence. Thus, it ordered the lower courts to exclude Hambrick’s testimony on causation but allow Cohen’s testimony.

As a pharmaceutical liability lawyer, I would have preferred not to split the standard of evidence for expert testimony. Though the Nevada court took pains to emphasize that the stricter standard still applies to alternative theories of causation, it’s not hard to imagine this ruling muddying the waters. One might argue that it’s also unwise to split the standard of evidence between rebuttals and new theories because both are evidence submitted to the jury — and thus, both should be required to be relevant enough to be useful to the jury. The split allows rebuttals to be introduced regardless of whether they are more likely than not, and relies on juries to sort out probability. As a dangerous drug attorney, I believe juries are usually made of reasonably intelligent people who do their best to decide cases fairly — but they aren’t composed entirely of medical experts.

Continue reading "Court Rules Nurse May Testify Within Medical Specialty in Pharmaceutical Liability Cases – Williams v. Baxter Healthcare Corp. et al." »

As a dangerous prescription drug attorney, part of my job revolves around the effectiveness of warning labels on pharmaceutical products. So I was interested to see a recent article about a push by the U.S. Food and Drug Administration to make prescription warning labels easier to understand. The Wall Street Journal reported April 25 on a pilot program from the FDA that would replace the several-page inserts that come with prescription drugs with a simple one-page sheet. And an FDA-affiliated organization, the U.S. Pharmacopeial Convention, is developing a proposed national standard for the warning labels on the bottles themselves, which would state the purpose of the drug clearly and include simple instructions. Doctors and pharmacists are also encouraged to counsel patients more effectively, as part of a national campaign for awareness of the need to use drugs as directed.

Research shows that some patients really do need help with this. Three out of four Americans told the National Community Pharmacists Association that they don’t always use drugs as directed. One Northwestern University professor told the Journal that more than half of adults in several recent studies misunderstood packaging directions. Those mistakes can come at a price: the federal Agency for Healthcare Research and Quality found that 1.9 million Americans were hospitalized for medication mistakes between 2004 and 2008, a with 52 percent jump in hospitalizations over those four years. The professor said some instructions on prescription labels are contradictory or genuinely confusing. Trouble also arises for patients with multiple chronic conditions, which makes medication errors more likely, and people with low literacy.

Prescription and over-the-counter warning labels are an important part of drug safety. And as a pharmaceutical liability lawyer, I know they’re an important part of recovering financial compensation when you’re hurt by a dangerous prescription drug. That’s because showing that you followed the directions on the warning label is a necessary part of showing the drug caused your injuries. Under the law, you often cannot recover financial compensation if the drug company can show that you disregarded the warning label. By contrast, the pharmaceutical company has legal obligations to warn you about the potential dangers of using the drug — and failure to warn is the basis for most pharmaceutical lawsuits. Most importantly of all, easily understood warning labels have the potential to stop millions of people from becoming ill because of medication mistakes.

Continue reading "FDA Testing Proposed Simpler Prescription Drug Labels to Fight Overdoses and Misuse" »

A recent New York Times article about the drug company GlaxoSmithKline's agreement to pay a $750 million settlement to the FDA caught my eye, as a defective prescription drugs attorney. The settlement resulted from a whistleblower's suit concerning problems with contaminated and ineffective products, which she said GlaxoSmithKline chose to ignore. Whistleblowers help protect us all by holding drug companies accountable for making profit-hungry decisions that put innocent people at risk.

Cheryl D. Eckard was a quality manager for GlaxoSmithKline. In that role, she warned senior managers, including top executives, repeatedly about serious problems with their Puerto Rico plant. She recommended recalls of defective products and warned that she would call the Food and Drug Administration. Instead of carrying out the recalls and protecting patients' health and safety, the company terminated her as a “redundancy” -- British for layoff -- in 2003. The Puerto Rico plant, which produced $5.5 billion of worth drugs each year, had contaminated air and water, products that were stored in rented vans, intravenous cancer drugs of uncertain sterility, and bottles that incorrectly mixed different types of drugs. FDA inspectors failed to catch all of these problems, and the company did not live up to its promises to fix the ones that the FDA did find. The plant was closed in 2009, seven years after Eckard found the problems.

As a result, GlaxoSmithKline sold tablets of the antidepressant Paxil CR that did not contain the drug’s active ingredient, even after Eckard’s warning. Other defective drugs made in the factory included the ointment Bactroban, the diabetes drug Avandia, the heart drug Coreg, and the acid reflux drug Tagamet. When Eckard notified the FDA and sued under the whistleblower law, the FDA launched a criminal investigation, and armed federal marshals seized nearly $2 billion worth of drugs in 2005. The $750 million settlement includes $150 million to settle criminal charges for knowingly selling adulterated drugs—the first successful case of this kind. It also involves $600 million in civil penalties. Of that $96 million will go to the Eckard for blowing the whistle, under the federal False Claims Act.

As a defective prescription medication attorney, I am glad that Eckard's whistleblower suit was successful. Her story shows yet again that we cannot rely on the FDA's inspections to keep us safe, even if the FDA is trying its best. Drug companies will not always correct their mistakes, especially when profits are at stake. That means public safety depends to some extent on drug company employees who have inside knowledge and honest consciences to hold their employers, or former employers, accountable. As the federal prosecutor quoted in the article noted, the public expects drugs to be safe and perform as expected. When drug manufacturers intentionally ignore safety warnings, they undermine public health as well as public confidence in the regulatory system.

After a defective drug makes patients sick, those who were harmed don’t have to rely on the FDA or individual whistleblowers to hold drug makers accountable. Civil as well as criminal laws allow individual patients who were injured, and their families, to hold manufacturers legally liable for their actions. Drug manufacturers are legally required to warn the public if they know about potential negative effects of their products. If they sell dangerous or defective drugs without warning the public, any patient who gets hurt by these drugs can sue the drug manufacturer for the costs and injuries they suffered because of its negligence. This can include damages for medical costs, past and future lost wages, lost quality of life, damage to personal relationships, and pain and suffering. It is simply unfair and immoral to trick patients into taking a dangerous drug by withholding information about it. Companies who do this have to pay the consequences.

Continue reading "GlaxoSmithKline Pays $750 Million for Selling Tainted and Ineffective Products" »

Though my work as a dangerous drugs attorney focuses on helping people who were victimized by defective medications, I believe strongly that scientists and regulators have an important role in keeping us safe from dangerous drugs. In a recent New York Times article, I read about one such person, Dr. Frances Oldham Kelsey, who will be honored by the U.S. Food and Drug Administration for her lifetime of work on the behalf of patients and consumers. Kelsey, now age 96, was one of the first FDA scientists to insist that drug manufacturers demonstrate that their products are safe and effective, rather than allowing them to push through their applications for approval without rigorous review.

Fifty years ago, Kelsey reviewed the William S. Merrell Company's application for approval to sell Kevadon (thalidomide), a drug that was being prescribed to many European women to alleviate morning sickness during pregnancy. Thalidomide is now famous for causing severe birth defects: "thalidomide babies" were born without limbs, or with flipper-like limbs. When it applied for approval to sell the drug in the U.S., Merrell already had a bad relationship with the FDA. Kelsey sensed that the company was holding back important information, so she insisted that the company provide test results that showed that thalidomide was safe. Merrell complained to her superiors, insisting that she was "depriving" people of the medication's benefits, but her bosses backed her up. It soon became clear that she was right to be suspicious. She found reports that the drug caused nerve damage, which Merrell had withheld. The company backed away.

Kelsey might have recognized that something was amiss with thalidomide because of her earlier pharmacological work at the University of Chicago. There, she had helped a professor establish that a widely used medicine, elixir of sulfanilamide, contained a poisonous industrial solvent. The drug had been marketed without any restrictions even though it was linked to scores of deaths, and in the aftermath, Congress passed the 1938 Food, Drug, and Cosmetic Act to force drug companies to test the safety of their products.

But by 1960, Congress had not yet given the FDA the authority to force companies to show that their drugs were safe and effective. Drug manufacturers could simply file information with the FDA and begin selling their drugs 60 days later, as long as the FDA didn't object. Drug manufacturers sent their new concoctions to doctors and simply asked them to try them out in patients, rather than performing the controlled tests that are now required. After the Washington Post ran a front-page article about Kelsey's refusal to approve thalidomide for sale in the U.S., Congress finally gave the FDA power to require the drug industry to show their products' safety and effectiveness. President John F. Kennedy awarded Kelsey the Distinguished Civilian Service Medal. Kelsey and her colleagues then created the rules that are still in effect today for how medical testing must be performed, with three separate phases for clinical trials in humans, and protections for human subjects and against conflicts of interests.

On Sept. 15, 2010, Kelsey received the first Kelsey Award from the FDA, an honor to be bestowed on an FDA staffer each year. For the last two decades, the FDA has leaned more toward drug manufacturers' desire to get their drugs approved swiftly, even without detailed data about the drugs' safety and effectiveness. But now that the Kelsey award has been established, as a dangerous medication lawyer, I hope that more FDA staffers will follow in her footsteps and focus on patient and consumer safety over drug companies' interests. Kelsey's experiences show clearly that drug companies do not assume that it's their job to keep patients safe. Drug companies have been trying to fast-track the approval of their drugs for decades, regardless of the drugs' safety and effectiveness, because there are profits to be made in doing so. The case of thalidomide demonstrates that the public should not trust drug manufacturers to look out for public interests, nor even the FDA in all cases, since FDA scientists before Kelsey had not necessarily insisted on proof of drugs' safety either.

The law gives patients and consumers their own weapons to fight back against drug companies when necessary. Drug companies are legally required to warn consumers of risks that may come with taking their drugs. If they don't, and patients suffer because they took a drug that they wouldn't have if they'd known the risks, drug manufacturers can be held responsible for the harm that their drugs caused. Patients who suffer injuries can require the drug manufacturers to pay for medical expenses, lost wages, permanent injuries, and pain and suffering related to the injuries that these drugs caused.

Continue reading "FDA Doctor to Be Honored for Fighting Against Manufacturers of Dangerous Drugs" »

The FDA is requiring changes in label for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction. NSF has not been reported in patients with normal kidney function. Patients at greatest risk for developing NSF after receiving GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury or chronic, severe kidney disease.

The gadolinium constrast agents are sold under the brand names: (1) Ablavar (gadofosveset trisodium), (2) Eovist (gadoxetate disodium), (3) Magnevist (gadopentetate dimeglumine), (4) Multihance (gadobenate dimeglumine), (5) Omniscan (gadodiamide), (6) Optimark (gadoversetamide injection), and (7) Prohance (gadoteridol).

BACKGROUND: GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging or magnetic resonance angiography.
RECOMMENDATION: Healthcare professionals should screen patients prior to administration of a GBCA to identify those with acute kidney injury or chronic, severe, kidney disease.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse

One of the most difficult Effexor-related birth defects is the condition known as Persistent Pulmonary Hypertension of the Newborn (PPHN). Described briefly, PPHN results in the infant being unable to breathe properly due to a defect in the way blood interacts with the lungs.

It is not a minor matter, but rather a very serious condition requiring extensive treatments that can be difficult and expensive for a family to bear. The fact that it can result from a medicine intended to treat the mother makes this birth defect heartbreaking.

Treatment of PPHN focuses on getting more oxygen into the infant's blood. There are a number of methods used to do this, each of which create its own unique problems.

The first option is to deliver 100 percent oxygen directly to the child, using either a hood or a mask. This is a temporary solution at best, of course, because the body wasn't designed to process pure oxygen.

Sometimes assisted ventilation is the preferred technique. In this case, a tube is inserted into the child's throat to allow a machine to take over for her breathing. This procedure can be enhanced with the addition of nitric oxide, a gas that helps relax the constricted blood vessels in the lungs, allowing better blood flow and easier breathing.

A treatment of last resort is Extracorporeal Membrane Oxygenation. This treatment is a terrifying one, as it involves putting the child on a lung-bypass machine. In essence, when the child's lungs and heart prove unable to handle the problem, the infant is placed on the machine that draws their blood, cleans and oxygenates it, and then resupplies it back to the child.

Each of these options can be difficult for a parent. Worse, they aren't always guaranteed to work. The idea is to give the infant's body time to adapt to the world and heal while being given assistance, but in some cases the damage is too extensive.

PPHN is a serious condition, and needs to be discussed critically with mothers who are on Effexor while pregnant.

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A recent $81 million settlehttp://www.jefflowepc.com/lawyer-attorney-1176136.htmlment between the Department of Justice and Johnson & Johnson's Ortho-McNeil Janssen Pharmaceuticals Inc. means sales reps for the company will be monitored with compliance officers who will observe and report on the representatives' behavior on the job.

The measure, part of a Corporate Integrity Agreement, calls for randomly-timed, full-day observational ride alongs, encompassing all therapeutic products and programs for the company. The compliance officials will observe all meetings the sales representative conducts during their work day.

Observations will end in a formal report, including the identities of the sales representative and the compliance professional, the date and time of the observation, any products promoted during the event, an assessment of the degree of the representative's compliance with Ortho-McNeil's policies and identification of any off-label promotional activity.

Specifically, any cases of improper promotion must be rigorously reported to relevant officials on an annual basis. Johnson & Johnson stated that ride along observations were already part of policy, but were simply not reported prior to the current agreement.

Other regulations will apply to sales representatives as well. They will require three hours of training on regulatory law and its penalties, as well as signing statements describing the scope of the work they are permitted to perform. The agreement also mandates a centralized system that tracks all presentation engagements by Ortho-McNeil personnel.

This agreement has been scheduled to remain in place for a five-year period. Violations and failures to comply will range from $1,000 to $5,000 dollars per day, depending on the severity of the infraction.

The primary aim of the agreement is to protect consumers from gross misrepresentation of products such as the controversial antibiotic Levaquin, a specific Johnson & Johnson brand. Promotional officials will not be permitted to downplay the serious potential risks in J&J products under this agreement.

As a defective medication lawyer, I have closely watched the continuing reports of problems with drugs manufactured by McNeil Pharmaceuticals. In January, I wrote about the unsettling recall of products made by McNeil Pharmaceuticals, a unit of Johnson & Johnson. That recall involved over-the-counter medications that many of us know well, such as Tylenol, Rolaids, Motrin and St. Joseph Aspirin. Now, the FDA has issued a new recall for commonly used infants' and children's medications that McNeil produces, such as Tylenol, Motrin, Zyrtec and Benadryl.

Initially, the FDA said that the products involved in the current recall could have stronger concentrations than they were supposed to, or they could contain inappropriate inactive ingredients or tiny particles. Just a few days later, we began to see more damning reports, alleging quality and security lapses at McNeil’s Fort Washington, PA, manufacturing plant. A routine FDA inspection of the plant found that raw materials for the infants' and children's medications were contaminated with Burkholderia cepacia bacteria, which is often resistant to common antibiotics. The Center for Disease Control says that the bacteria can be harmful to people with weakened immune systems or chronic lung disease. The FDA was concerned that the contaminated materials could have been used in the products that were recalled, although McNeil says that its tests of those products did not show contamination. The FDA and McNeil both say that the chance of harm from using these products is remote, but they advise customers to stop using the recalled drugs immediately.

Unfortunately, McNeil has not given consumers a lot of reasons to trust its word. The earlier McNeil recall involved medications that had a "musty" smell and that gave consumers stomach pain, nausea, vomiting and diarrhea. It was suspected that the drugs were tainted with 2,4,6-tribromoanisole (TBA), a flame retardant and pesticide used in shipping pallets. The most disturbing part was that McNeil waited at least a year, rather than the legally required three days, after receiving complaints about the medicines before it fulfilled its duty to report the problem to the FDA. In the current case, McNeil appears to be equally unable or unwilling to meet its reporting duties; the FDA has faulted it for failing to report the contamination or recall lots of tainted medicines. And infants and children have less-developed immune systems than adults, so contaminated drugs could put them at serious risk of illness. We still don't know what those "tiny particles" are that McNeil initially cited as the reason for the recall, but there have been over 40 consumer reports to the FDA about dark flecks in the medications.

Now, the House Committee on Oversight and Government Reform plans to hold hearings to investigate McNeil and the FDA. As a pharmaceutical liability attorney, I would recommend that consumers who have been harmed by these contaminated drugs ask questions too, including ones about their legal rights in situations like this. Drug manufacturers have a legal duty to warn consumers and the FDA about risks that their products might pose, such as the risk of bacterial contamination that could cause infection. If McNeil knew about problems and kept them quiet, and consumers took their contaminated medications and became sick, those consumers could sue McNeil to recover all of the costs their illnesses.

Continue reading "FDA and Congress Investigate Contamination and Other Problems at Johnson & Johnson " »

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" »

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" »

The U.S. Food and Drug Administration announced Aug. 24 that it is looking into safety problems with a popular weight-loss drug. According to the Los Angeles Times, the agency has received at least 32 reports of liver problems with orlistat, sold over the counter as Alli and as the prescription drug Xenical. The FDA is analyzing data included in those reports, as well as data from manufacturers, and said it would announce results as soon as the study is complete. The agency is not taking any enforcement action yet and did not tell patients to stop taking the drugs, but it did tell them to talk to their doctors if they see signs of liver problems.

The FDA’s press release said the agency received the 32 reports of problems with orlistat between 1999 and October of 2008. Of those patients, 27 had to be hospitalized, and six suffered liver failure. The most common liver problems reported to the FDA as side effects of orlistat were weakness, abdominal pain and jaundice, which is a yellowing of the eyes and skin. Other signs of liver problems include fatigue, fever, brown urine, pale stools, nausea and vomiting, itching and loss of appetite.

Orlistat helps patients lose weight by stopping the digestive tract from absorbing about 25% of the fat they eat. The 2007 approval of the over-the-counter version, Alli, was widely anticipated by the weight-loss community because of its apparent effectiveness. However, Alli was not without side effects even before the recent reports of liver problems. In fact, the drug is somewhat famous for having an embarrassing, though minor, side effect -- fecal incontinence, or loss of control over the bowels, especially in people who eat too much fat. Alli’s manufacturer, GlaxoSmithKline, went so far as to tell users to carry a change of clothes for the first few days they use the drug, in case of an “accident.” Long-term studies have also linked orlistat to cancer, although not definitively.

As a dangerous drug lawyer, I am much more concerned about these new reports of possible liver damage than I am about fecal incontinence. Liver problems can lead to liver failure, and liver failure is a serious, life-changing health problem with a high chance of death. People with liver failure require hospitalization, close monitoring, special diets and, in cases where the organ cannot recover, liver transplants. This is an unacceptable risk to exchange for the opportunity to lose a few pounds. Orlistat is very popular, with more than 22 million users worldwide. That means that even if only a fraction of those users develop serious liver problems, thousands of people could still develop life-threatening illnesses or lifelong, disabling organ damage -- all to lose a few pounds.

Continue reading "FDA Announces Investigation Into Reports That Weight-Loss Drug Caused Liver Failure" »

As a St. Louis drug liability lawyer, I was scandalized but not surprised by a recent revelation that Merck & Co. and Schering-Plough Corp. actively suppressed evidence about their drugs’ efficacy in order to prtect their bottom lines. The two New Jersey companies last week stated they would pay $5.4 million to settle civil claims that they had buried test results suggesting two of their new cholesterol drugs were less of a breakthrough than they were purported to be. The 5.4 million sum only represents only the costs of the investigations, which came from 35 states plus the District of Columbia. The two companies need not make any other payments, or admit to any sort of wrongdoing -- despite some pretty damning evidence.

In January of 2008, Merck and Schering-Plough released studies showing that Vytorin and Zetia were no more effective at reducing plaque buildup in neck blood vessels than Zocor, an older drug that is now available in a vastly cheaper generic form. The trouble is, these studies were completed in 2006 -- two years prior to the results' release. In other words, plenty of time was allowed for consumers and their doctors to be misled into spending more money than they really needed to. With sales of Vytorin at $2.78 billion and Zetia at $2.41 billion in 2007, that means thousands or even millions of people were misled by these companies’ failure to warn them. They may also have assumed unnecessary risks of serious side effects, including muscle disease and even cancer.

In fact, a 2007 piece in the New York Times suggested that Merck and Schering-Plough may have also suppressed evidence from clinical trials that found a connection between the drugs and liver problems. But even if there were no evidence of safety problems, it’s disturbing that drug companies would choose to bury negative information about their products in order to protect their profits. If they are willing to hide information about comparative efficacy and liver disease, what else might they be hiding? This deception alone is enough to form the basis of a strong St. Louis defective medication lawsuit claiming damages for the drug companies’ failure to warn consumers.

Continue reading "Merck and Schering-Plough Pay $5.4 Million to Settle Drug Cover-Up Suits" »

A panel of experts convened by the U.S. Food and Drug Administration has voted to lower the maximum dosage of pain reliever acetaminophen, HealthDay reported June 30. The vote made big news because acetaminophen is an extremely common ingredient in over-the-counter cold and flu medicines taken by millions of Americans each year, including Tylenol and Excedrin. The panel acted out of concerns about liver damage, a known side effect of acetaminophen overdose. The FDA is not required to follow its panel’s recommendations, but it typically does.

Doctors have known for years that an acetaminophen overdose can cause liver damage. In fact, the FDA says acetaminophen is the leading cause of liver failure in the U.S., contributing to 200 deaths a year and sending 56,000 to emergency rooms. Acetaminophen is safe for most people at recommended doses, but an FDA report issued in May says many consumers don’t realize they’re endangered when they go over the recommended dosage, or combine multiple medications containing acetaminophen. That concern drove the vote to lower the recommended dosage, which is currently 4 grams daily and 1,000 milligrams in any individual pill. The panel did not set a daily maximum, but reduced the per-pill maximum to 650 milligrams for over-the-counter medicines.

This video from the Associated Press explains the issue:
Video from the Associated Press:

Of course, the pharmaceutical industry resisted the panel’s efforts to further regulate acetaminophen, arguing that the high doses currently allowed are necessary for patients treating chronic pain. According to the AP, acetaminophen-containing drugs saw $2.6 billion in sales last year, with over-the-counter medicines representing 80% of those sales. However, as a dangerous drug lawyer, I’m pleased that the panel took steps to keep American consumers safe. Many millions of Americans keep these medications in their homes as medicine-cabinet staples, and some use acetaminophen every single day. That means millions of people are exposed to injuries from acetaminophen overdose. Even if only a fraction of these end up accidentally overdosing, they could still represent thousands of unnecessary and preventable deaths.

When most people think of dangerous drugs, they think of medications that are defective by design or manufacture, like Vioxx -- that is, the medicine is dangerous no matter how it’s used. But manufacturers of drugs (and other consumer products) can also be legally liable if they fail to give consumers sufficient warning of a serious safety problem with their products. Consumers need clear information to make informed decisions about what medications are safe for them. If manufacturers fail to warn patients about the dangers of their products in a way that meets FDA standards, and patients are hurt as a result, those patients have the right to hold the manufacturer legally responsible with a defective drug lawsuit.

Continue reading "FDA Calls for Reduced Maximum Dosage of Common Pain Reliever Acetaminophen" »

Upset with the U.S. Food and Drug Administration, Zicam maker Matrixx Initiatives Inc. has withdrawn two of its cold remedy nasal products even though company officials maintain the products are safe.

The FDA said it received more than 130 complaints from consumers saying they have lost their sense of smell after using the products.

Jennifer Warren, a former school teacher who lives in Huntsville, Ala., said she lost her sense of smell after using Zicam to prevent the duration of a cold a few years ago, but had never complained to the FDA or the company because she figured there was no way to prove Zicam caused her anosmia.

She said she doesn’t want to sue Scottsdale-based Matrixx (Nasdaq:MTXX) even after learning others have had the same experiences.

“I don’t think Zicam was created to hurt anyone,” she said. “We sit here and we rip and we rave about all these drugs not being allowed on the market. The first time anything goes wrong, everybody wants to go sue, sue, sue. That drives me nuts. I honestly believe the people were trying to do something to help people not get sick.”

William Hemelt, acting president and chief operating officer of Matrixx, said the FDA action was taken without reviewing research he would have been more than willing to provide.

“We think the science does not support this allegation at all,” he said. “Quite honestly, we would not be selling the product if we thought it was unsafe.”

Zicam products use a homeopathic remedy called Zincum Gluconicum 2x, which means they require FDA approval.

Dr. Sam Benjamin, a medical doctor with a homeopathic license, said he can’t figure out why the FDA has taken so long to deal with the issue.

“I can think of no part of alternative medicine that summons up more worry to conventional physicians than homeopathy,” said Benjamin, who has a medical talk show on KTAR 92.3 FM on Saturdays at 2 p.m. and 1,000 followers on Twitter. “There are so many drugs around that cause problems, why would one event want to expose people to any danger.”

Brett Berty, a senior recall strategist at Stericycle Inc. in Lake Forest, Ill., is coming to Phoenix this week to meet with Matrixx officials to see if he can help the company with damage control.

Usually, he said, companies will voluntarily recall a product before the FDA gets involved. That’s not how it happened with Matrixx. The FDA stepped in and warned Matrixx that it had received more than 130 consumer complaints and that the company needed to stop marketing the product until it can put a warning label on its packaging that it could cause anosmia.

Over the past 10 years, Berty has worked with manufacturers to conduct about 1,300 recalls, including Vioxx.

“Typically, hopefully, the manufacturer will work with me prior to approaching the regulatory agency,” he said. “The most important thing for Matrixx is you can turn a seemingly awful situation into an opportunity if you’re judged by the public as being part of the solution. How swiftly do they execute that will demonstrate their concern for the public’s safety.”

When the FDA sent the warning letter to Matrixx and advised consumers not to use certain Zicam cold remedies, on June 16, Matrixx’s stock plummeted 70 percent to $5.78 a share. It bounced up a bit to $6.13 a day later, but nowhere near its 52-week high of $19.74, near its trading point before the FDA sent the warning letter.

For the fiscal year ended March 31, Matrixx reported $13.8 million in net income on $112 million in net sales, up from $10.4 million in net income on $101 million in net sales a year ago.

Hemelt said he will be meeting with FDA regulators to discuss the issue. He also scheduled a conference call with investors.

The FDA advises against using:

Consumer advocacy group Public Citizen has asked federal regulators to require a black box warning on the label of a drug it says may induce miscarriage or premature labor, the Associated Press reported May 6. Amitiza (lubiprostone) is prescribed to people who suffer from chronic constipation, but it is chemically similar to misoprostol, which can induce labor and miscarriage in pregnant women. Amitiza’s label currently warns that the drug has not been tested in pregnant women and that they should use it only if the benefits outweigh the risk to the fetus, but Public Citizen wants a stronger label. Neither the FDA nor the drug’s maker, Sucampo Pharmaceuticals, commented for the story.

Amitzia, which is considered less addictive and easier to tolerate than older laxatives, was prescribed more than a million times in 2008. Its chemical cousin, misoprostol, is approved for treatment of gastric ulcers in the United States. However, misoprostol also causes uterine contractions and thins the cervix, which is why it is widely used off-label, and approved in other countries, to induce labor and end pregnancies. In fact, it may be prescribed with the abortion drug RU-486. It is also used when a natural miscarriage or other obstetric problem leaves tissues in the uterus.

It is unclear whether Amitzia has similar effects. No studies have been done examining the drug’s effect on human pregnancies, but studies with Guinea pigs have shown a 4% miscarriage rate. For that reason, it is still available to pregnant women, although its label suggests that they weigh the risks of using Amitzia against its benefits. A spokesman for Public Citizen called that label “grossly inadequate” and lacking in useful information.

As a defective prescription drug attorney, I agree. While I am sure most patients will do what’s best for their unborn children, they must be armed with good information to do so. As things currently stand, they must rely on a doctor or their own self-directed research to find that information. History has shown over and over again that pharmaceutical companies cannot be trusted to disclose information that might hurt their drugs’ sales. Pregnant women taking Amitzia could run extremely serious risks -- inducing a miscarriage or giving birth prematurely, which can cause death and serious birth defects in the baby and is also extremely expensive. Until quality studies in humans establish that Amitzia is safe, women should at least be clearly warned of the risks.

The dangerous pharmaceutical lawyers at The Lowe Law Firm represent victims of just this kind of oversight -- people who were hurt by a drug that was supposed to help. Based in St. Louis, we handle defective medication lawsuits for victims in Missouri, the Midwest and around the United States. If you’ve been seriously harmed or lost a loved one to a defective prescription drug, we would like to help. To learn more, please contact us online today or call toll-free at 1-877-678-3400.

In a decision that affects nearly every home in the United States, the U.S. Food and Drug Administration required stronger warnings Tuesday for labels on several common over-the-counter painkillers. According to Forbes magazine, the rules require pharmaceutical companies to display the chemical name of the product prominently on its label and warn of any potential interactions with other drugs or common consumables like alcohol. Products containing acetaminophen must also warn about the risk of severe liver damage, and products containing non-steroidal anti-inflammatory drugs must warn about the risk of stomach bleeding. Manufacturers have one year to change their labeling to comply.

The labeling change affects multiple common over-the-counter pain relievers, including Advil, Tylenol, Bayer, Aleve, Excedrin and Motrin. The generic names of the affected products include aspirin, acetaminophen, ibuprofen, naproxen and ketoprofen. All of those drugs but acetaminophen are in a category of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are associated with an increased risk of bleeding in the stomach, particularly in people over 60, those who are taking blood thinners or steroids or people with ulcers or other stomach problems. Heavy use of NSAIDs also contributes. Labels will soon warn consumers about the potential for stomach problems and common risk factors.

Acetaminophen, which is in a category of drugs by itself, does not carry a risk of stomach bleeding. Rather, the new FDA rule will warn consumers of the increase risk of severe liver damage from taking acetaminophen, especially for exceeding the maximum recommended does. According to an FDA press release, research shows that some people take more acetaminophen than the label recommends, while others may take several acetaminophen-containing products at once without realizing the risk. Having three or more alcoholic drinks on the same day can also increase the risk of liver damage. In addition, taking acetaminophen with the blood thinner warfarin may increase the chances of serious bleeding problems. An FDA advisory committee plans to meet in late June to discuss

As an dangerous drug injury attorney, I am pleased at the FDA’s announcement. The problems with both kinds of medicines have been understood for decades, and in fact, acetaminophen overdose is the most common cause of acute liver failure in the United States. Unfortunately, many consumers don’t realize this, so they feel free to take another dose if the first does not work to relieve their pain. As the FDA press release notes, manufacturers have voluntarily added some amount of safety labeling to address the issues, but not as many as the agency now requires. With literally millions of Americans of all backgrounds and states of health taking these medications every day (at a cost of billions of dollars annually), we need clear safety information on their labels.

The pharmaceutical liability lawyers at The Lowe Law Firm represent people who have suffered serious illnesses or injuries because they took a dangerous over-the-counter or prescription medication. In a defective drug lawsuit you can win back the cost of the drug and all of the treatment it necessitated, as well as compensation for a serious injury, permanent disability or the loss of someone you love. If this sounds like your situation and you’re ready to take the next step, you can learn more about your rights and your options at a free, confidential consultation. To set one up, please contact our main St. Louis office or call toll-free at 1-877-678-3400.

The FDA plans to study how well consumers absorb information and respond to television advertisements for prescription drugs, American Medical News reported Feb. 2. The agency is interested in how well consumers learn about the risks and benefits of drugs they see on television, the article says, with the goal of setting standards for the ads. To study this, the FDA will produce television ads for a fictional blood pressure medication and recruit 2,400 people to watch them and tell researchers what they've learned. The study's start date was not announced, but the FDA was taking public comments until the end of January.

Television ads that market directly to consumers -- rather than to the doctors responsible for prescribing drugs -- have been controversial throughout their 12-year lifespan. The ads were not allowed on the air or in print at all until 1997, and only one other country, New Zealand, allows them on television. Since TV pharmaceutical ads were introduced in the U.S., doctors and consumer activists have repeatedly complained that the ads encourage patients to ask for drugs that they don't really need, wasting doctors' time and raising the risk of over-medication. Another concern is that direct-to-consumer ads gloss over the risks of a drug and spend more time on their benefits, presenting a biased view. And one study showed that the ads aren't very effective, raising concerns about wasted millions that are built into the cost of the drugs.

In response, the American Medical Association has called for drug makers to submit to mandatory FDA review of the ads; allow doctors to learn about a drug before advertising it to consumers; and make a more balanced presentation of drug risks and benefits. Congress is also concerned about the safety of drug ads, which is why it asked the FDA to set drug advertising standards in the FDA Amendments Act of 2007. The FDA's advertising study was launched in response to that legislation, in hope of eventually devising standards.

As a Missouri drug injury attorney, I am concerned about the possible over-medication effect of prescription drug advertising. Statistics show that prescription drug errors are already responsible for more deaths each year than illegal drugs, so we hardly need to create more unnecessary prescriptions. Furthermore, the drugs that are most likely to be advertised on television are the newer drugs, which means we still have relatively limited information on their safety and efficacy. Among recent heavily advertised drugs that turned out to have serious problems are Vioxx, a painkiller now withdrawn from the market after strong links to heart attacks and strokes, and Zyprexa, a psychiatric medication that may cause diabetes and was allegedly illegally marketed for off-label uses.

The Lowe Law Firm has active pharmaceutical liability practices for victims of both Vioxx and Zyprexa. If you or someone you love developed serious health problems after taking these drugs -- or other dangerous pharmaceuticals -- we would like to hear from you. Based in St. Louis, we help clients in the Midwest and throughout the United States. To schedule a free consultation, please contact us online or call us at 1-877-678-3400 as soon as possible.

An FDA panel, citing safety risks, voted Jan. 30 to remove a pair of painkillers from pharmacy shelves. According to the Associated Press, the panel of outside experts voted to end sales of Davron and Davrocet because of concerns that their safety risks outweigh their benefits. The FDA is not bound by the decision, but it frequently follows the recommendations of its outside panels.

Davron (propoxyphene) is a opioid painkiller used for mild to moderate pain. Davrocet is a combination of Davron and acetaminophen, the active ingredient in Tylenol, and is now more frequently prescribed then Davron alone. Like all opioids, both drugs carry a high potential for addiction and abuse and are not safe when combined with alcohol. They have also been linked with serious health problems, including heart problems, respiratory disorders and kidney and liver problems. And in the 1970s, studies linked the drug with suicide, prompting an unsuccessful drug recall campaign from watchdog group Public Citizen. Complaints from the same group spurred the current review.

Davron has been on the market since the 1950s and is now among the 25 most commonly prescribed drugs in America, with 20 million prescriptions written in 2007. However, because it is a relatively weak painkiller competing in a field that includes newer, stronger drugs, experts are concerned that its risks are now greater than its benefits. A limited federal study showed about 500 Davron-related deaths in 2007; 20% of these were suicides. In Florida, medical examiners found Davron in the bodies of 341 people who died of any cause and cited it as the cause of death in 85 cases (about a quarter of the total). The British version of the drug was banned outright in 2005.

The FDA may not take such a drastic step; it could choose to strengthen the warnings on Davron's label or further restrict its use. However, the controversy over this drug dates back more than 30 years -- making its risks older than some of the patients taking it. As a Missouri defective drug lawyer, I know that the FDA is currently very reluctant to recall prescription medications, sometimes even when there's strong evidence that they have serious defects. However, when the doubts about a drug have persisted for so long, it may be time for serious action. Thanks to advancements in medical science, doctors now have a variety of safer or more effective drugs to replace it with.

If it turns out that Davron has been putting patients at serious risk of suicide, heart problems and other serious side effects for decades, its manufacturers could be legally liable to thousands or even millions of families in a defective prescription drug lawsuit. If you believe you or someone you love was hurt by Davron, Davrocet or another potentially dangerous medication, The Lowe Law Firm can help. Based in St. Louis, we help clients in Missouri and throughout the nation who have lost a loved one or sustained permanent injuries because of a drug company's carelessness.

To learn more about your rights at a free consultation, please contact the Lowe Law Firm online today or call toll-free at 1-877-678-3400.

Pharmaceutical company Wyeth is the subject of a Congressional investigation for its use of ghostwriters to publish favorable articles in medical journals, the New York Times reported Dec. 12. The newspaper reported that Sen. Chuck Grassley, a Republican from Iowa, has asked With and its ghostwriting services company to disclose the roles of the doctors and the amounts of payments made for the articles.

The ghostwritten articles were on hormone replacement therapy Prempro, for women undergoing menopause. The drug’s sales dropped sharply after a federal study linked it to an increased risk of breast cancer, heart attacks and strokes. However, the ghostwritten articles were favorable to the drug. One that was published more than a year after the federal study said that there was no definitive evidence that the drug caused cancer, and that hormone users had a better chance of surviving cancer.

The senator requested the disclosures after Congress received documents from a personal injury lawyer investigating ghostwriting by Wyeth. According to those documents, Wyeth planned and commissioned at least 10 medical journal articles before those articles were even seen by the doctors who “wrote” them. Revisions by those doctors were subject to Wyeth’s final approval, the documents said. This contradicts medical journals’ ethical standards, which generally forbid ghostwriting, according to the New York Times.

As a Missouri dangerous drug attorney, I am extremely interested in this ongoing story, but not as surprised as I could be. Thanks to my pharmaceutical liability practice, I’ve known for some time that some drug makers are willing to actively mislead the public about their drugs’ safety. In fact, this isn’t the first dangerous drug that has benefited from medical ghostwriting -- articles have also been ghostwritten for Redux and Pondimin (also Wyeth products) and Vioxx (Merck). All three of these have since been withdrawn from the market after being linked to serious heart and lung problems.

Prempro is still on the market, but doctors have been advised to prescribe it only at low doses and for patients with severe symptoms. If the Congressional investigation finds that Wyeth knew about its health problems and intentionally covered them up by paying for favorable reports, the drug manufacturer may be hit with a new round of Prempro lawsuits. There is also anecdodal evidence that breast cancer rates in woman over 50 are declining because of reduced use of Hormone replacement therapy to "treat" the symptoms of menopause.The Lowe Law Firm represents clients who have been hurt by a prescription drug whose dangers were hushed up in this manner by manufacturers eager to protect their profits. If you believe you may have a defective medication case and you’d like to talk more about your options, please contact our firm online or call us at 1-877-678-3400 to set up a free initial consultation.