Drug Injury Attorney Blog

A recent study has brought up a new concern in the ongoing litigation against makers of antidepressants such as the SSRI Paxil and the SNRI Effexor. Having just come through a series of suits alleging increased risk of suicidal behavior and links to birth defects, makers of these drugs now have to content with a new allegation from a major study: Antidepressants in these classes may cause damage to patients' eyes.

Specifically, the study was conducted in Canada on patients aged 65 and up. 19,000 such patients who had been prescribed antidepressants were compared against a 190,000-strong control group of similarly-aged patients who had not been prescribed the medicine. Such a large sample gives the study a strong statistical basis compared to the typically much smaller studies done in clinical trials.

The results of the study certainly are something to consider. Overall, the risk of developing cataracts is 15 percent higher in patients who were prescribed antidepressants than in the control patients. If extrapolated to the current portion of the U.S. population on these medicines, this would mean more than 20,000 cases of cataracts per year. When considering specific medicines, the results become even more precise. Paxil, which caused an increase of 23 percent in cataracts, was seen as less damaging than Effexor, which was linked to a 33 percent increase.

The doctors conducting the study say that this likely can be linked to the direct mechanism of SSRIs and SNRIs, which force serotonin to remain in the bloodstream. The eyes have a number of serotonin receptors, and excess levels of this chemical can cause opacity in the eyes related to cataracts, they explain.

As always, patients are urged to remain on medicines they have been prescribed until they can talk to their doctor. Stopping medication on one's own initiative is risky and inadvisable — take the time to go to a physician if you have concerns.

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As a dangerous prescription medication lawyer, I often see reports of drug makers seeking the U.S. Food and Drug Administration's approval to sell their medications for different illnesses than the ones the drugs were developed to treat. Recently, drug maker Eli Lilly asked the FDA to allow it to sell its antidepressant Cymbalta (duloxetine) as a treatment for chronic pain. Since I spend a lot of time helping patients who have been hurt by dangerous prescription medications, as a pharmaceutical liability attorney, I'm concerned about Cymbalta's use by more patients, since the drug has been connected with serious risks like liver damage and skin disease.

Lilly wants to market Cymbalta for use by patients with chronic pain related to arthritis and lower back pain -- a large number of Americans, as noted in the article by Dr. Bob Rappaport, the FDA's director of the Division of Anesthesia and Analgesia Products. This would clearly be a boon for Lilly's profits because it would expand the pool of potential customers. And for drugs that don't have any serious side effects, expanding their use for patients who have different illnesses can be an efficient way to help more people feel better and get well. Cymbalta's reach has already expanded to encompass not only depression but also fibromyalgia, anxiety and pain associated with diabetic neuropathy. Most Cymbalta users are being treated for depression, but 14% are being treated for pain. Prescriptions for Cymbalta nearly tripled from 2005 to 2009, from 5 million to over 14 million.

While Cymbalta is already being prescribed to treat pain, FDA reviewers are not completely convinced by Lilly's evidence that the drug is effective for that purpose. They have pointed out flaws in the design of Lilly's studies that found the drug to be effective. Further, the FDA recently scolded Lilly for making false and misleading claims about Cymbalta's effectiveness against pain, and understating the drug's risks in its marketing materials. The drug carries a number of minor side effects, but among its serious ones are Stevens-Johnson syndrome and toxic epidermal necrolysis, two forms of life-threatening skin disease that develop as a drug reaction and usually require hospitalization. The FDA is also worried about other risks that are already included in Cymbalta's labeling, such as serious liver toxicity, and suicidality in children, adolescents and young adults taking Cymbalta for depression or other psychiatric disorders.

The FDA and doctors need to be vigilant about expanding the reach of drugs that aren't as safe as we might hope. Users of Cymbalta face serious risks, which will inevitably become more widespread as more people take this medication, and new serious risks may be discovered as well. Earlier this summer, I wrote about the potential for Cymbalta to cause terrible birth defects, premature delivery, and miscarriage. If Cymbalta is to be approved for marketing to more patients for more conditions, I hope the FDA carefully considers how to make sure patients are properly warned of all the risks they face. At the same time, the FDA isn't the only one responsible for making sure patients know what they're getting into. Drug manufacturers like Lilly have a legal duty to warn consumers and the FDA about risks that their products might pose. If Lilly knows that its studies of Cymbalta's efficacy for pain are faulty and is trying to expand its markets while putting patients at risk for serious side effects, patients could be hurt. Those patients could sue Lilly to recover the costs of their medical treatment, along with compensation for pain and suffering, loss of quality of life and past and future wages.

Continue reading " Eli Lilly Seeks to Expand Cymbalta Market Despite Serious Risks to Life and Health " »

Every use of a prescription medication is a matter of exchanging one factor for another. Chemotherapy in particular is a race between how fast the medicine debilitates the cancer and how fast it debilitates the patient. The same is true of every medicine — each pill or shot has a side effect that does undesirable things to the body, and doctors and patients must decide if the tradeoff is worth it.

Levaquin has come to represent the severity that this tradeoff can entail. It's considered a highly effective medicine that can beat down some of the toughest possible infections, but it has increasingly been demonstrated to have catastrophic, life-altering effects on prescribed patients' joints and connective tissues. Patients have been crippled by the medicine, and filed numerous high-stakes lawsuits in order to reclaim damages lost as a result of taking the pill for their infections.

Now there is new information coming out that suggests there may be even less reason to rely on such a high-risk medicine. Superbugs have been in the news for a few years now, being various strains of bacteria that are highly resistant to antibiotics that are commonly prescribed or overprescribed. These strains result from patients being treated with a medicine that takes out the majority of a certain group of bacteria, but leaves behind those that can ignore the medicine. Since these resistant strains can now grow unchecked, future doses don't accomplish anything.

This is tough news for the makers of Levaquin in particular. If Levaquin is prescribed to a patient who has a resistant strain of bacteria, then the antibiotic effect of the medicine will not work, but the damaging side effects on the body's connective tissue will remain. In short, Levaquin's efficacy has begun losing the race versus its debilitating effects on patient health.

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The effects of Paxil on the young are not limited to the potential role the drug has in the development of birth defects. Recently an article expressed incredulity that children as young as 7 were still being prescribed Paxil despite the known tendency of the drug to aggravate or even prompt suicidal thoughts in youth taking the medicine. And now a new vindication has come for the parents of children affected by this antidepressant. Dr. Maria Palazzo, a doctor who performed certain studies for Glaxo Smith Kline 10 years ago, recently pled guilty to falsifying the information in those studies.

This is not a shades-of-gray case, either; it deals with the outright manipulation and falsification of clinical trials. Palazzo previously was convicted of other offenses, predominantly Medicare fraud, though the charges of clinical falsification initially were thrown out. However, prosecutors appealed this ruling and the charges were reinstated successfully, so there can be no doubt about the nature of this case.

Glaxo Smith Kline hired Palazzo in 2000 to conduct the trials in question. Additionally, there is evidence that Glaxo knew about the potential for aggravated suicidal thoughts in young people prescribed Paxil 15 years before they announced the findings in 2006.

There were quite a few charges levied against Palazzo specifically pertaining to the Paxil case. She claims to have studied patients when allegedly she had not. She reports patients as manifesting conditions, such as obsessive-compulsive disorder, that they allegedly did not actually have. She also allegedly fudged results and reports on patients' psychiatric histories to attain more favorable results in her publications.

In addition to the 87-month prison sentence she received for the cases of Medicare fraud, Palazzo has been given a term of 13 months for the falsification of the Paxil studies. In addition, she has been ordered to pay GSK nearly $100,000 in restitution and special assessments for her role in defrauding the company.

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Plaintiffs in the assorted lawsuits pertaining to the potential birth defects caused by the antidepressant Effexor shouldn't rush to assume that the recent settlements in the Paxil lawsuits will result in similar settlements for their own cases.

On the surface, the cases do look very similar. Both cases involve mothers being prescribed an antidepressant during pregnancy, and the children being born with birth defects. The mothers in these cases believe that the pharmaceutical companies bear a responsibility for the defects and should pay a settlement to help with the burden of caring for a disabled child.

The problem is, there is an equal reason to realize that the cases might not be as perfectly related as it sounds.

Paxil is an SSRI, a Selective Serotonin Reuptake Inhibitor. It focuses solely on preventing the brain from reabsorbing serotonin, leading to an elevated mood. By contrast, Effexor is an SNRI, a serotonin-norepinephrine reuptake inhibitor. It focuses on preventing the brain from absorbing serotonin and norepinephrine, to achieve a similar effect.

This isn't to say the two drugs aren't related — they are. SSRIs and SNRIs are very similar and fundamentally the same principle governs their mechanism of action: Let the body keep “feel good” chemicals in its system.

However, legal cases are often decided on fine distinctions. A blood-alcohol content variation of .o1% can be the difference between a DUI and an official warning, depending on the jurisdiction.

This isn't to say that plaintiffs affected by Effexor prescribed during a pregnancy should give up hope. Far from it. It simply means that rather than assuming the Paxil case means their own case is likely to be victorious, they should focus on presenting the most solid case of their own that they can, and expound heavily on its own unique merits. Each case is its own entity, and should be weighed in that regard.

The Food and Drug Administration has issued a worrisome new warning about Lamictal, a drug used to treat seizures in children and bipolar disorder in adults. According to the FDA, Lamictal (lamotrigine) can cause aseptic meningitis, an inflammation of the brain and spinal cord that is not caused by bacterial infection, like other types of meningitis. GlaxoSmithKline, Lamictal's maker, says the risk of contracting aseptic meningitis from taking the drug is very rare, but the company agreed to change the drug's label to include a warning about it. Russell Katz, MD, director of the Division of Neurology Productsof the FDA's Center for Drug Evaluation and Research, said, "Aseptic meningitis is a rare but serious side effect of Lamictal use." As a defective medication lawyer, I think it's very important that doctors and patients be made fully aware of the risks associated with this drug so that they can make an informed decision about using it.

Patients taking Lamictal should be alert for signs of aseptic meningitis, which include headache, fever, stiff neck, nausea, vomiting, rash, and photophobia, or sensitivity to light. If they experience any of these symptoms, they should contact their health care professional right away. To diagnose the condition, doctors have to perform a spinal tap on the patient and examine a sample of spinal fluid.

Between Lamictal's FDA approval in December 1994 and the FDA's review of adverse event reports undertaken after November 2009, the FDA had received 40 reports of aseptic meningitis in both adult and pediatric patients taking Lamictal. The symptoms started within 1 to 42 days of starting the drug. Thirty-five patients had to be hospitalized, and one died, though the death was not thought to have been caused by meningitis. The 35 patients who were hospitalized recovered when they stopped taking Lamictal. Fifteen of them saw even worse symptoms return within just a few hours when they started taking the drug again. Forty-six million prescriptions for Lamictal had been dispensed during this period.

Aseptic meningitis is not the only significant but rare risk associated with this drug. A few months ago, I wrote about Lamictal users' increased risks of suicidal thoughts and suicide attempts. The drug also carries a black box warning about the drug's association with Stevens-Johnson syndrome, an often-fatal kind of rash. As GlaxoSmithKline works to increase its sales despite Lamictal going generic in 2009, pharmaceutical liability attorneys like me worry that the company and others like it will stop paying as much attention as they should to patients' safety. Drug companies are well aware that they have a responsibility to warn patients, doctors, and the FDA about risks associated with their products. But unfortunately, we regularly see drug companies fail to do so when they are more focused on money than medicine. Because the law requires them to warn the public, if they fail to do so and an unsuspecting patient is harmed by a defective drug, the drug maker can be held legally and financially accountable.

Continue reading " FDA Issues Warning for Users of Seizure Drug About Risk of Brain Inflammation Meningitis " »

Part of why so many lawsuits regarding medical injuries and complications from prescription medicines take so long to resolve is that it is very difficult to get hard data on the matter quickly enough to help conclusively decide a case. It is in pharma companies' interests to promote the benefits of their medications over the risks, and they naturally are inclined to look at the positive results when weighing their decisions.

Then there's the fact that different people react in different ways to medicines. Certain side effects are very rare, or restricted to only a portion of the population at large. As an analogy, not everyone is allergic to seafood or shellfish, but those who are adamantly cannot take certain treatments in which shellfish play a part. The fact that these patients aren't in the majority does not change the fact that they're still harmed if a doctor prescribes them such treatments.

Whether Yasmin and Yaz fall into this category is still a matter of heated contention, both legally and scientifically. Several recent studies illustrate this point, as highlighted in an article published by the FDA this April.

The first studies mentioned seem to suggest that Yasmin at the very least has a comparable effect to other COC contraceptives. The researchers looked specifically at the risk for venous Thromboembolism, a potentially fatal pulmonary condition that has been linked in some cases to COC medicines.

However, another set of studies suggested that the women who experience increased heart and embolism complications when taking Yaz or Yasmin may have preexisting conditions. Specifically, the studies suggest that those suffering complications made up only a very small portion of the study, in such small numbers that they can be dismissed as statistically insignificant.

These difficulties aren't meant to imply that there is no risk when taking Yasmin, but they do demonstrate just how hard it is to get solid information out of scientific examinations. It isn't a matter of television science where the DNA evidence is ready in an hour — these cases take time, and a great deal of expertise is required to successfully navigate the maze of issues.

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Patients in different conditions are at different risk levels for developing side effects from medications like Reglan. When trying to evaluate the risks versus benefits of going on Reglan, it's important to consider your own physical condition entirely before starting treatment.

First, consider what Reglan is meant to treat. It can be used to control chronic nausea and GERD, also known as acid reflux disease. These conditions are not necessarily minor — chronic nausea isn't just queasiness, and GERD can't be dismissed as heartburn, and both can be debilitating.

For example, chronic nausea can lead to disorientation and vomiting. It can make it difficult to eat, which combined with a pattern of vomiting can mean severely-reduced caloric intake. GERD means that acid is frequently getting into the patients' throats. This is not something that can be ignored either: Stomach acid is powerful stuff, and it can leave severe, painful blisters on the throat. These scars can turn cancerous over time, and even if they don’t, they can rob people of sleep and comfort, degrading their general health. It is important to consider the severity of the conditions before making any decisions.

But Reglan has been demonstrated to be a primary cause of Tardive Dyskinesia. This condition also is serious, and potentially permanent. It can lead to constant facial tics that have been described as painful, exhausting and disfiguring, as well as motions in the extremities, all uncontrollable. The risk of this condition must be weighed against the severity of the conditions being treated.

Furthermore, the age and condition of the patients in question have a significant impact on the potential to develop Tardive Dyskinesia. TD manifests most commonly in older patients who were prescribed Reglan, and not as frequently as in younger patients. The longer a patient is on the medicine, particularly when going past the recommended 12-week cutoff, the more likely TD will result.

The conditions Reglan is intended to treat are indeed serious, but so is TD. Patients are advised to think carefully and exhaust all other options if they can before risking a neurological condition.

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Our society is growing by leaps and bounds. Thus, the number of people who require treatment for various conditions, including depression, has increased as well.

In 2007, CNN released a report that antidepressants were the most prescribed medications in the United States. Antidepressant prescriptions outweighed painkillers, mood stabilizers, digestive medications and every other category of medicine prescribed in the United States. That's simply staggering to think about. According to the CNN report, 118 million prescriptions were for antidepressants in 2005. The next closest category was high blood pressure meds, with 113 million scrips written.

According to the National Institutes for Mental Health, major depressive disorder alone accounts for 14.8 million adults each year, and is one of the leading causes (if not the leading cause) of disability in the U.S. Bipolar disorder accounts for a further 5.7 million adults. Neither of these statistics deals with the numerous children who are also diagnosed with depression, and require medication, often in the form of an SSRI or SNRI.

Notice the disparity in the numbers: More than 100 million prescriptions, but not even 50 million patients in the adult category. This isn't to make the case that we're overprescribing, but rather to illustrate the sheer scale of antidepressant prescription in America versus the number of patients dealing with the conditions.

Further, this is a year in which the makers of Paxil have been brought repeatedly to court over the potential birth defects and suicide prompting effects caused by this medication. They have settled the cases in amounts ranging into the billions of dollars. New lawsuits continue to be filed despite GlaxoSmithKline's attempts to settle, and they lost their first bellwether case.

The issue is not, and will never be, a small one. Each story is important on its own merit, and people should not be afraid that they are the lone voice that will be raised in the matter.

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The makers of Levaquin, the antibiotic increasingly associated with tendon and joint damage, have a new problem to contend with in the ongoing legal struggles associated with the medicine. A collection of 96 plaintiffs from multiple states filed a joint lawsuit against Ortho-McNeil in St. Clair County, Ill.

This lawsuit has the potential to show the widespread risk that Levaquin poses to patients. Unlike other medicines prescribed very narrowly, such as the controversial GERD medication Reglan, Levaquin is prescribed for numerous bacterial infections ranging from respiratory illness to urinary tract conditions. The patients filing the suit claim to have been prescribed Levaquin for just such a variety of cases, meaning if this case goes forward, it will have a bearing on many such situations.

The claims made in the case follow a similar pattern to those that have been filed previously. The plaintiffs argue that they were not provided adequate warning about the potential risks that Levaquin posed. Further, they claim that the warnings, which did exist, were only part of a very long list of potential side effects and had no specifying information. For example, multiple plaintiffs in the case allege that they were not given warning that the risk was higher for patients of a certain age, or those undergoing specific courses of other treatment.

The specific charges made include liability concerns, as well as allegations that Ortho-McNeil violated specific Illinois fraud regulations. The plaintiffs are seeking a variety of compensations, including damages done, costs for pre- and post-trial affairs and any other judgments and relief that the court sees fit to provide.

The specific defendants named are Ortho-McNeil, parent company Johnson and Johnson and the drugstore Walgreens. The pharmaceutical companies are named for their roles in the manufacture and testing of Levaquin, whereas Walgreens is named because it is alleged they sold the product while knowing full well of the effects it might cause.

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As a pharmaceutical liability attorney, I was interested in a report that Astra Zeneca has settled 17,500 lawsuits at a cost of $198 million over complaints that it failed to warn patients that its drug Seroquel (quetiapine) could cause diabetes in some users. Astra Zeneca faces 26,000 lawsuits over this issue, and agreed to pay $520 million after federal investigations into its illegal marketing of Seroquel. Seroquel is the company's second-highest-selling drug, after Nexium (esomeprazole), a treatment for gastroesophageal reflux disease. When a drug is used by as many patients as Seroquel is, a large number of patients will experience the many side effects that the drug can cause, so it's especially important for drug companies to properly communicate the drug's risks to the public, the FDA, and medical professionals.

Yet Astra Zeneca seems to have been eager to push sales of Seroquel higher and higher, perhaps recklessly. Seroquel is approved by the FDA for the treatment of schizophrenia and bipolar disorder, and is prescribed off-label for other conditions like obsessive-compulsive disorder, post-traumatic stress disorder, restless legs syndrome, autism, alcoholism, depression, Tourette’s syndrome, sleep disorders and anxiety disorders. In April, government officials said that Astra Zeneca had paid illegal kickbacks to doctors to promote unapproved uses of the drug by children, the elderly, veterans and prisoners. Antipsychotics like Seroquel account for a big portion of Medicaid drug costs, and Seroquel is the fifth-best-selling drug in the world -- it brought in $4.9 billion in sales in 2009.

Clearly, Seroquel generates a lot of money for Astra Zeneca. It's unfortunate that it has done so at the expense of some patients, who allege that they developed diabetes because they were taking this medication. Diabetes isn't a side effect that goes away when a patient stops taking a drug that causes it -- it's a lifelong condition that requires constant attention and can have serious consequences if it's not treated. Diabetics must watch their diet and exercise, and take medications to control their blood sugar, or risk complications such as blindness, heart disease, kidney failure and limb amputations. This means that patients who became diabetic after taking Seroquel had to add all these concerns to their existing medical issues. And since Seroquel has been used heavily among Medicaid patients, problems with Seroquel affect many who have the fewest financial resources to deal with them.

This is why, as a defective medication lawyer, I am glad to see that patients who became diabetic from taking Seroquel have stood up for themselves and gotten financial compensation from the company that allegedly caused their illness. Patients who have been harmed by dangerous or defective medications can and should recover compensation from the drug manufacturer whose product harmed them. Drug manufacturers are required to warn consumers of their products' risks, and if they fail to do so, the law allows consumers harmed by the defective drugs to sue. The patient can require the manufacturer to pay for their medical costs, lost wages from missing work or being unable to work, and diminished quality of life, which the manufacturer ultimately caused. Consumers who trust that a medication is safe and that it will help them should not have to bear all the consequences alone if they find out that they were wrong -- and that the manufacturer knew about it.

Continue reading " Patients Receive $198 Million Settlement in Case Alleging Seroquel Led to Diabetes " »

Sometimes there are no adequate words one can use to explain something. Indeed, there are some revelations that baffle people and should cause them to raise a great many questions. One such revelation is the recent story that a great portion of clinical trials of pharmaceutical drugs are never published or are buried where they cannot be readily accessed.

According to the Annals of Internal Medicine, nearly one-third of all studies are left completely unpublished and inaccessible to anyone but the group that performed the study. This analysis included medicines such as antidepressants, antipsychotics and blood pressure medication — medicines that society at large has a bit of a vested interest in knowing about.

All clinical trials are required to be registered at clinicaltrials.gov, but this is not the same as publishing. The material is not present in the public database of medicine studies, PubMed. Thus, it creates a situation where groups can claim they performed a study without having to demonstrate evidence. Fortunately, the industry at large operates on an assumption that a study not put through PubMed isn't relevant, but it still raises uncomfortable questions about why they aren't going public in the first place.

This creates a situation known as publication bias. By observing the requirement that they publish to the less public site, pharma companies then can pick and choose which articles see the light of day. Thus more positive articles and studies are shown to the public at large, creating a more positive perception of drugs such as antidepressants than the medical studies might perhaps warrant.

Doctors need to very seriously consider this. They often learn about a drug long after the trials are finished, and at a time when trials may not be being currently performed. If this kind of publication bias is genuinely the norm, do doctors want to risk prescribing these potentially-compromised medicines to their patients?

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Between February — when all existing Yaz suits were consolidated — and now, the number of cases on the docket in new Jersey has grown by a factor of ten. Where before there were just 39 suits pending, now there are in excess of 400 on record.

Litigation in the New Jersey Yaz cases was consolidated at the request of Judge Donald Volkert Jr. Judge Volkert made the proposal because he was concerned that the rapidly-growing case would overwhelm the court system and crowd out other litigation that required due attention. Given the fast growth since this decision, it would seem his suspicion has been borne out.

Judge Brian R. Martinotti currently is overseeing the cases. He has directed the defense and the plaintiffs on the manner in which they may communicate, and has ordered both sides to brief each other with fact sheets during the discovery phase in which information is gathered. The next phase of the trials is expected to begin in September, which is when the first hearings will be held.

The New Jersey consolidation and growth is also only part of the larger, grander picture. In Illinois, all the Yaz litigation occurring at the federal level also was consolidated recently. This process is estimated at encompassing approximately 2,000 cases. In Pennsylvania, a similar state-level consolidation has occurred for cases pending there.

Furthermore, all the cases have presented similar claims. Namely, they argue across the board that Bayer Healthcare Pharmaceuticals, the maker of Yaz, is directly responsible for an increase in blood potassium, a thickening of the blood and coronary conditions such as pulmonary embolisms and strokes.

This presents a picture that should be sobering to Bayer. This is not a handful of isolated claims that can be quieted down with private, no-fault-incurred settlements. Rather, it is a widespread outcry of public indignation at what is perceived as a dangerous and misleadingly-advertised product.

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A heartbreaking new story has emerged in the ongoing case against the makers of the oral contraceptive Yaz. Rebecca Anderson-Hull has joined those filing lawsuits against Bayer Pharmaceuticals, claiming that it was the contraceptive that ultimately led to the thickening of her blood and the pulmonary embolism that caused her to suffer extensive brain damage from oxygen deprivation.

Rebecca now requires the full-time supervision of her family. She has trouble walking, and finds it difficult to speak or think clearly. But when asked her opinion on the matter, she unequivocally states that she believes Bayer knew the risks of the medicine she was prescribed, and that the company is to blame for not just her current plight, but also for the burden it has placed on her beloved family.

Rebecca was on Yaz for two years before the incident took place. Many patients in the lawsuits that have followed have confirmed similar stories. The illness and results take a long time to build up, not occurring as an immediate side effect, which has obscured the extent of the danger and limited the understanding of those seeking to respond to it.

Part of the case rests on the fact that the FDA had repeatedly warned Bayer about the misleading nature of their advertisements for Yaz and its sister drug, Yasmin. Two letters have been sent to Bayer about its promotional materials. The first cited Bayer for misleading advertising practices directly, as in their “balloons” commercial that claimed Yaz was effective for uses that it had not been approved for. The second letter addressed Bayer's release of information on studies, which the FDA says had improperly presented the data involved. Most studies explain each individual batch of cases, but the Bayer study averaged out the results so as to disguise certain study results, FDA says.

The case has not been scheduled for any specific date, but is likely to be considered along with the many others currently in process.

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The rheumatoid arthritis drug Arava (leflunomide) will now carry a black box warning, the Food and Drug Administration's most serious warning, to alert patients to the danger of fatal liver damage associated with taking the drug. The FDA received 49 adverse effect reports, including 14 deaths, between 2002 and 2009. This warning comes after the nonprofit consumer advocacy group Public Citizen asked the FDA to remove leflunomide from the market because it was too dangerous. As a dangerous drug attorney, I hope that in the future, patients will have enough information about the risks of this medication to make informed decisions about whether to take it.

Leflunomide has carried a boldface warning since 2003, explaining the risk of severe liver injury and warning women who are pregnant or may become pregnant not to use the drug. This year's review of more recent adverse effects prompted the FDA to issue a stronger warning. Besides the 14 deaths associated with taking leflunomide, adverse effects reported to the FDA included jaundice, bleeding and clotting disorders, and encephalopathy, or injury to the brain. Thirty-six of the patients reporting adverse events were hospitalized. For most of those who were harmed, the injuries occurred within the first six to 12 months of treatment, although in some cases the injuries happened after six years. Itching, yellow eyes or skin, dark urine, loss of appetite and light-colored stool are warning signs that should prompt a patient taking leflunomide to contact a health care professional.

The new black box warning states that patients with preexisting liver disease or elevated liver enzymes should not take leflunomide, and that health care professionals should use caution when prescribing it to patients who are taking other drugs that can injure the liver, such as Tylenol, Motrin, Advil, and Aleve. These categories of patients are at the greatest risk of injury from the drug. Patients who do take lefunomide should have their liver enzyme levels monitored at least once a month for three months at first, and then at least quarterly after that.

Most people suffering from rheumatoid arthritis must take medications for the illness for the rest of their lives, so the potential for injury by this medication may be great. Rheumatoid arthritis is an autoimmune disorder in which the body's immune system mistakenly attacks the body's own tissues, causing joint problems, fever, and fatigue. It affected 1.3 million people in the United States in 2005. Leflunomide was approved by the FDA in 1998 for treatment of rheumatoid arthritis under the brand name Arava, and went generic in 2005, most likely broadening its appeal because patients could get it for a lower price. That means hundreds of thousands of patients could be taking this risky medication.

From my perspective as a defective drug lawyer, it's good that the FDA is adding a more serious warning to this drug, and I hope that no more patients will be harmed by it. I've worked with many patients who have been hurt by medications that they thought would help them, and what they have to go through is heartbreaking. They incur sometimes vast medical costs as doctors try to figure out why they're sick and how to help them get better. Sometimes their injuries are permanent and cause intense pain. They miss work because they don't feel well and have to attend so many medical appointments, and their quality of life and their relationships with family and friends suffer. All of those are injuries directly caused by the harmful prescription drugs they took, and patients have the right to hold the drugs’ manufacturers legally liable for causing them, if the manufacturers failed to warn about a risk they knew or should have known about. That means patients can recover compensation for all of those costs directly from the drug manufacturer.

Continue reading " Rheumatoid Arthritis Drug Arava Blamed for 14 Patient Deaths From Liver Failure " »

The drugs Yaz and Yasmin continue to be associated with a thickening of the blood, a raise in blood potassium and the increased potential for stroke. A stroke is a debilitating event that can lead to extensive, long-term consequences if not outright death in patients afflicted. It can be terrifying to experience, and can take an extensive amount of time to recover from. The therapy required for rehabilitation after a stroke is both mental and physical in nature, and can pile up costs very quickly for patients who aren't prepared for such an eventuality.

One of the more common results of a stroke is paralysis or at least a reduction in function in the limbs. This can take the form of delayed responses, limb shaking or displaying weakness in picking up objects, as well as a complete lack of sensation or ability to raise the affected extremity. Depending on the severity of the condition, this can sometimes be treated with physical therapy and strength-building exercises.

Another condition that isn't quite as well understood, and thus is no less difficult to treat, is aphasia. Aphasia is the inability to comprehend words. There are two broad types of the condition, spoken and written. Spoken aphasia indicates the inability to understand what you or others may be saying. Written aphasia is the inability to read or write coherently because the words “just look wrong.” Either one can be a terrifying experience, because they entail having to learn how to use language all over again in some cases. The physical effects of a stroke are bad enough, but to throw in an inability to communicate is an exceptional burden.

Physical and mental therapy takes a lot of time. There are no quick answers or easy solutions for people whose bodies have been debilitated by a stroke or hemorrhage in the brain. With this in mind, the risks of Yaz and Yasmin can quickly be seen as being somewhat unbearable.

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Recent news has focused extensively on Glaxo Smith Kline's extensive, $2.4 billion settlement of numerous ongoing lawsuits pertaining to several of its flagship drugs. Part of this series of settlements is intended to go toward cases involving the company's flagship antidepressant, Paxil. The exact amount? A cool $1 billion. Very nearly half of Glaxo's entire legal defense budget for such matters is being allotted toward settling cases pertaining to just one of its drugs.

The settlement touches on 800 cases and closes the book on them, which is an average of approximately $1.25 million per case. This isn't to say this is the amount awarded to each plaintiff, of course — much of it likely will go to clearing up legal fees and the like. Regardless, it is an incredible sum of money to be paying, especially as Glaxo insists that the decision does not acknowledge the culpability of their medicine in the cases. The decision, they insist, is merely to settle the matter and move forward with reputation untarnished.

Regardless of such wrangling, the first case in the Paxil birth defect trials that went to court was an unequivocal loss for the corporation, with the jury overwhelmingly deciding that the company had been negligent in failure to warn. Furthermore, another 100 cases or so still are pending against the company. The details of ongoing litigation are always limited, and terms of the settlement are confidential despite the release of the sum involved in this one aspect of the cases.

Of these remaining unsettled cases, three are scheduled to go to trial as soon as the end of this year. Lawyers on both sides of the lawsuit acknowledge that Glaxo's loss in the test case is a strong indicator of how future cases may go as the matter continues to unfold.

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