Drug Injury Attorney Blog

When it comes to understanding the potential risks of antidepressants such as Effexor and Effexor XR, large studies are the most important. Many initial drug safety studies only include a few hundred participants, which can in some cases be dismissed or belittled as statistically insignificant. However, a recent Canadian study involving 5,000 expectant mothers will be significantly harder to ignore on these grounds. This study found that Effexor might have a link to one of the most common and devastating birth conditions — the miscarriage.

The 5,000 women were a section of a larger group of nearly 70,000 pregnant women, and were those out of the group who had suffered a miscarriage. The study looked at the women who had unfortunately suffered this condition, and analyzed trends that may have affected their pregnancies. Specifically, the study found that women who were on antidepressants had an approximately 68 percent increase in likelihood of having a miscarriage versus those who were not. Effexor and Paxil were specifically named as antidepressants that came up in the study.

Doctors involved in the study had several comments to make about the matter. The first was to caution people against jumping immediately to conclusions; the study does not prove or conclusively state that antidepressants cause miscarriage. For example, it might be that depression itself is the cause, and depressed women are more likely to take antidepressants. However, the study did not rule a causal relationship out, either. They elaborated that even if such a link was not conclusively established, it did raise certain questions about the methods of treating female patients for depression when they were likely to become pregnant.

One potential explanation is that antidepressants cause an excess of pressure on the uterus during the pregnancy, leading to a spontaneous miscarriage. Further study will be necessary before this hypothesis can be affirmed, but it is an attempt to start the process of understanding this frustrating situation.

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Another Johnson & Johnson drug manufacturing plant operated by McNeil has received notice of problems with its manufacturing practices from the FDA. The Lancaster, Pennsylvania plant makes the heartburn and gas relief drugs Pepcid, Imodium and Mylanta. These problems, similar to those found in the company's now closed plant that made Tylenol, come after waves of recalls for defective medications and a congressional investigation into whether the company attempted to hide information from the FDA. As a defective medication lawyer, I believe this news underscores questions about how much consumers should trust medications produced by Johnson & Johnson and its McNeil division. These repeated problems could prompt concerns about any of the company’s many over-the-counter medications.

In July, the FDA issued a Form 483 to Johnson & Johnson about the Lancaster plant. A Form 483 notifies a company that the FDA has found lapses in its manufacturing practices. Of the 12 violations of good manufacturing practices that the FDA found in Lancaster -- including faulty lab work, lax hygiene and recordkeeping, and failure to follow up on consumer complaints -- five overlapped with those cited at the Tylenol plant in nearby Fort Washington, Pennsylvania. The medications from the Lancaster plant were the subject of several kinds of complaints from consumers, including "mint-flavored Pepcid tablets mixed inside the same bottle as berry-flavored tablets" and "lack of effect" in one lot of products. In addition, the FDA report cited "unlabeled test tubes filled with product sitting out on a counter" and failure to "properly clean utensils used in the drug making process," suggesting that medications could become contaminated with foreign substances or with other medications. Staff at the manufacturing plant did not follow up to investigate and correct any of these problems, the FDA report said.

Since they did not follow up on the problems, staff at the plant would have been unable to find out whether there were serious safety concerns that consumers needed to know about. In my view as adangerous medication attorney, this is troubling from a consumer safety standpoint as well as legally, since drug manufacturers are responsible for warning consumers about any safety concerns related to their products. Consumers should continue to be wary of medications produced by Johnson & Johnson. If only one plant had these problems, we might be able to dismiss them as isolated to bad management at one site, but the problem appears to be much more widespread. Even though the medications manufactured at the Lancaster plant have not been recalled, a recall may still be coming. After all, the recalls involving the Fort Washington plant's medications were delayed in similar ways and have only gotten bigger as time has gone on.

These issues raise the question of what Johnson & Johnson has been doing instead of paying attention to its manufacturing practices. Have efforts to create new products or expand existing products' reach edged out the basic safety concerns that should be at the forefront of any medical manufacturing business's operations? Or, worse, could the company have intentionally ignored problems in order to avoid bad publicity? Ignoring safety for any reason would be dangerous, legally and morally. Consumers can be hurt by lax manufacturing practices, as KV Pharmaceutical here in St. Louis found out. And those who were hurt have the right to recover financial compensation from the defective product's manufacturer. Drug manufacturers who fail to warn consumers of risks that they know about can be liable in lawsuits filed by those consumers. This allows a consumer who incurs medical costs, misses work or is unable to work, or whose quality of life suffers because of harm caused by an over-the-counter or prescription drug to require the drug manufacturer to pay these costs.

Continue reading " Another Johnson & Johnson Drug Manufacturing Plant Cited for Safety Failures " »

“My daddy used to chase me up the stairs, but he can’t do it anymore because he took quinolones,” says the 5-year-old child of professor Alan Redd.

Redd was once a very healthy, active individual. He would play with his child, ride his bike to and from work, eat well and was generally in good shape for his 45 years. Then his doctor prescribed Cipro and Levaquin for his ailments. Now he describes himself as feeling as tired as an old man, with weakness in his legs and muscles. He can't muster the energy to ride his bike any longer. Further, he said the symptoms started almost immediately upon taking the two quinolone medications.

"I feel like my tendons are becoming unglued," Redd says in one interview. He reports that the symptoms also go beyond those commonly reported. In addition to joint pain and muscle weakness, he is fatigued and suffers from insomnia.

Stories like Redd's are becoming increasingly common. Several years ago, the FDA finally acknowledged the growing number of cases of people devastatingly affected by quinolone medicines, and required the packaging of these pills to carry black box warnings clearly stating the dangers and risks.

Symptoms such as those experienced by Redd are not easy to live with, as seen above. They also vary in duration. Some patients report that the side effects subside over time, allowing them to resume their lives. Redd is hopeful that this will be the case for him, though he adds that his doctors are not sure. However, other patients are unlucky in the matter. Tendon ruptures and separations are painful, long-term injuries; unfortunately, this sometimes leads to permanently-crippled patients who end up being injured simply because they trusted their doctor's judgment about a risky medication. The matter is not one that can be left quietly alone.

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Ideally, medications are used in strict accordance with their labeling. Children are not part of the prescription group Reglan is authorized to include, so in most cases it seems irrelevant to consider them when evaluating the potential harm this medication can do — and is doing. However, factors present in childhood can contribute to other events later in life, and the current obesity epidemic among American youth could lead to an unexpected explosion of Reglan-related side effects.

Obesity is seen as a key indicator in the development of Gastro Enterological Reflux Disease (GERD). Characterized by symptoms of frequent, persistent and often intense heartburn and acid indigestion, GERD is one of the conditions Reglan was developed to treat.

While Reglan might not be directly prescribed to children in most circumstances, GERD developed in childhood can and does persist into adulthood, leading to later necessity of prescriptions to bring it under control. Further, the longer someone has GERD, the less likely it becomes that the condition will respond entirely to treatment and go away. This means doctors are more likely to bend the guidelines on length of treatment, since GERD is a painful and disruptive condition. One of the key indicators in the later development of Tardive Dyskinesia from Reglan prescription is just this sort of overprescription past the limiting time.

Further, if an obese child patient doesn't respond to other medications to bring GERD under control, doctors may resort to Reglan as a last resort in an effort to provide some relief. This, too, exposes a younger population to a risk of Tardive Dyskinesia, albeit with good intentions in mind.

The obesity epidemic is just one example of this sort of mindset limiting the process of medicine. Issues must be looked at holistically, rather than in separated and isolated incidents that aren't looked at in relation to each other.

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The legal relationship between the original designers and manufacturers of medications and the companies that produce generic formulations of the drugs remains tenuous. In some cases, patients have been able to sue the original companies for the effects of generics, while in others judges have ruled that the case only warrants a claim against the makers of the off-brand. In the most recent Reglan case, the latter seems to be the approach taken by plaintiff Susan Swicegood.

Swicegood has filed suit against the makers of a generic version of Reglan, Pliva. She argues that Pliva's generic version of the anti-heartburn medicine did not include warnings that the medicine is causally linked to Tardive Dyskinesia. The FDA has a long-standing requirement that Reglan and its derivatives carry black-box warnings on the packaging explaining this risk. Black box warnings are meant to convey specific instructions in no uncertain terms, so failing to provide them on packaging is a serious breach of ethical practices.

Part of the problem complicating matters is that Reglan and its derivatives are intended to be prescribed for short periods — usually no more than a few weeks. However, in a significant number of cases, the conditions it is intended to correct are persistent. GERD or acid reflux disease are notoriously chronic conditions, often returning very shortly after medication is discontinued. Thus, in about 20 percent of cases, doctors end up prescribing the medication for longer periods. This could potentially raise the question of improper use as a tool by the defense. The key to this argument will be whether Tardive Dyskinesia can be demonstrated to occur even in patients taking the medicine for the recommended period of time.

A judge has ruled that the assorted pieces of Reglan litigation cannot proceed as a single, consolidated suit for pretrial matters earlier this year. This means Swicegood and other plaintiffs must go through the system individually, which means that progress in these matters could ultimately take years.

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Doctors and patients are worried about whether the diabetes drug Avandia (rosiglitazone) is safe, as I've discussed on several occasions this year from my perspective as a dangerous prescription medication lawyer. Avandia has been associated in several studies with a marked increase in heart problems, including life-threatening heart failure. But a recent report from MedPage Today suggests that FDA seems determined not to take this drug off the market, despite those studies. An FDA advisory committee voted 20-12 in favor of keeping Avandia on the market, but 17 of the supporters wanted the drug to carry tougher warning labels. Avandia already has a black box warning, the FDA's strongest warning of a drug's risks, advising patients that it increases the risk of heart failure. So it's not clear how much good another warning label about risks of heart problems would do to prevent patients from being harmed by Avandia. As Joel Zonszein, MD, of Albert Einstein College of Medicine said, "The physician is left in limbo" by this decision.

Speaking as a href="http://www.jefflowepc.com/lawyer-attorney-1176136.html">pharmaceutical liability attorney, I believe it's good that FDA staff members and advisors are debating Avandia's risks, because that makes it more likely that they'll consider all relevant viewpoints. However, Thomas Marciniak, MD, an FDA staff reviewer, said that the debate over Avandia has turned into a turf battle between the drug's supporters and detractors, with some newcomers to the agency in the middle. Marciniak said higher-ups at the FDA reward positive assessments of drugs, while negative assessments lead to "endless meetings." Another FDA staff reviewer, David Graham, MD, pointed out that the members of the FDA advisory panel voting on Avandia's fate seemed to have been chosen to ensure a favorable outcome for Avandia. In addition, Graham alleged that higher-ups at the FDA leaked information to a popular medical blog about an Avandia study he had conducted in order to delay or prevent the study's publication.

It's unclear why the FDA wants to keep Avandia on the market, but it’s clear why GlaxoSmithKline, Avandia's maker, might be interested in doing so. We’ve already seen that the company is deeply invested in protecting Avandia. It's a profitable drug, and type 2 diabetes rates have been drastically increasing along with obesity rates. Obesity is considered a leading cause of type 2 diabetes. This means that GlaxoSmithKline stands to rake in increasing profits from Avandia as an increasing number of people need treatment for type 2 diabetes. From my perspective as a defective drug lawyer, this only adds to the questions about why the FDA seems to be protecting Avandia's place on the market.

Continue reading " FDA Dysfunction Leaves Avandia-Taking Patients to Watch Out for Their Own Safety " »

Further emphasizing the damaging and widespread effects of Levaquin, Illinois resident John Sprehe has sued the makers and a distributor of the drug, alleging that the medicine directly caused him damage and suffering in the form of tendon injuries.

Sprehe argues that the potential side effects of Levaquin use were not made clear when he began taking the medicine. He attributes his permanent and debilitating tendon injuries to taking the medication, citing its long-standing association with degradation of joint tissues.

The suit names the usual slate of defendants as seem to regularly come up in these cases. First, the suit names the manufacturers and developers of Levaquin, Johnson & Johnson, Ortho-McNeil Pharmaceutical and Johnson & Johnson Pharmaceutical Research and Development. On the distribution end, Sprehe has named Walgreens as a defendant, as well.

Sprehe's case argues that when Levaquin was first introduced, the warnings of side effects relating to tendon degradation were deeply buried in long lists of potential side effects. Furthermore, he claims that these warnings did nothing to stress that the risks were nearly tripled for patients over the age of 60, arguably one of the most common groups prescribed the medication. Going even further, he alleges that even though the companies did adhere eventually to black-box warning demands put in place by the FDA, these warnings don't elaborate on the fact that Levaquin is more toxic to tendons than similar medications.

The 10-count suit specifically alleges strict liability, negligence, breach of implied warranties, breach of express warranty, common law fraud, violation of the Illinois Consumer Fraud Act, unjust enrichment, breach of warranty and failure to warn. The plaintiff is seeking actual and compensatory damages, plus costs, pre- and post-judgment interest and other relief the court deems just. There is currently no word as to if or when the case will proceed to trial or settlement hearings.

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For medications inarguably linked to serious medical complications, the FDA issues what is known as a black box warning label. This regulation requires the manufacturer to publish a warning on all packaging which clearly states the risks and side effects most prominently associated with the drug in question. The FDA does not often exercise this option, preferring to respect the free market in the majority of cases, since the general procedures for the review and production of medicine usually are sufficient. However, when it does require the warning, the matter must certainly be paid very strict attention.

In the case of Reglan, the FDA required a black box warning for the medicine in February of 2009. This warning reads as follows, in its complete form:

WARNING: TARDIVE DYSKINESIA Chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. The elderly, especially elderly women, are most likely to develop this condition.

Metoclopramide therapy should routinely be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia; however, in some patients symptoms may lessen or resolve after metoclopramide treatment is stopped.

Prolonged treatment (greater than 12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks to the patient of developing tardive dyskinesia.

(Metoclopramide is the chemical name for Reglan.)

This kind of warning is very valuable for patients of Reglan because it doesn't allow any serious argument about the matter. It clearly states that the drug is causally linked to the development of Tardive Dyskinesia, and that patients should not take the medicine for periods longer than recommended, as this is suspected to aggravate the risk. Warnings such as these are some of the most important tools in the defense of patients who have unfortunately contracted complications from their prescriptions.

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In the last few months I've kept tabs on medications recalled for quality control problems by McNeil Pharmaceuticals, as well as McNeil's parent company Johnson & Johnson's recalls of medications that were "musty-smelling." Unfortunately for consumers who thought their medicine cabinets were finally safe, the musty medications have apparently still been in production. Johnson & Johnson recalled 500,000 bottles of potentially contaminated Benadryl and Extra Strength Tylenol on June 15, and on July 9 it recalled another 2.5 million bottles of medications, including Tylenol for children and adults, Benadryl allergy tablets and Motrin (ibuprofen). As a defective medication lawyer, I'm concerned about what this growing list of recalled medicines could mean for consumers, who need to know which medications are safe for them to depend on and which ones could injure or kill them.

The latest recall involves medications that smell moldy or musty because they have been in contact with 2,4,6-tribromoanisole, or TBA, a pesticide and flame retardant chemical used in pallets for shipping and storing the medicines. According to Consumer Reports, people have reported "experiencing nausea, stomach pain, vomiting or diarrhea after taking the contaminated medications." Beyond those symptoms, the longer-term health ramifications of exposure to TBA are unclear. The medications recalled in July actually represent an expansion of the late 2009 recall; they were belatedly discovered to have been part of the same group of medications. Consumer Reports did not mention a reason for the months-long delay.

It's important to point out, from my point of view as pharmaceutical liability attorney, that there are two different kinds of problems being addressed by these recalls. That means that there's not just one thing going wrong in Johnson & Johnson's manufacturing plants, but a whole series of problems. While the November-January, June and July recalls relate to TBA contamination, the April and May recalls by McNeil relate to metal particles present in medications. There's also the serious issue of McNeil's having delayed informing the FDA of the problems until a year after the company knew about them.

The U.S. House Oversight and Government Reform Committee launched an investigation after the McNeil recalls were issued on April 30 to look into what Representative Edolphus Towns, D-NY, chairman of the oversight committee, called "wide-ranging problems at Johnson & Johnson.” This investigation might help protect consumers and get to the bottom of what caused 775 instances of "serious side effects" related to recalled McNeil drugs, including 30 deaths.

Consumers should not have to wonder whether they're better off suffering through a headache or allergies or taking an over-the-counter medication that could make them feel even worse. That's why the law requires drug manufacturers to warn consumers when their products aren't safe to use as intended. As we've seen, McNeil and Johnson & Johnson have a spotty record of complying with that requirement. But consumers don't have to just rely on the FDA to send warning letters and fix the problem from the top down. If a defective over-the-counter medication hurts someone who took it -- expecting that it would be safe -- that person can fight back against the drug manufacturer who failed to warn consumers of the drug's potential danger. The victim can sue the manufacturer for financial compensation for their injuries.

Continue reading " Johnson & Johnson, McNeil Drugs Continue to Be Investigated and Recalled for Safety " »

One of the most difficult concepts in medical lawsuits such as those surrounding the medicine Reglan is that the statute of limitations — a concept that says cases must be filed within a certain window of time or be dismissed for being too old — still applies as it does in criminal cases.

Further compounding the issue is that these statutes vary from area to area, and from state to state. There is no national standard for the statute of limitations. The limitations can vary based on the type of damage done, such as the difference between property damage or personal damage.

What makes the issue especially difficult in the Reglan lawsuits specifically is the fact that the damage associated, the condition Tardive Dyskinesia, is a delayed-onset condition. It doesn't start immediately when taking the medicine, often taking weeks to manifest. This means that the issue of when the statute of limitations begins is anything but clear.

Some jurisdictions have ruled that the statute of limitations began when the FDA made the first announcements that Reglan was associated with a risk of Tardive Dyskinesia. Other cases have stressed the lack of clear knowledge that some patients have as to why they developed the conditions they're dealing with. Many do not know that their prescription of Reglan is related to the sudden twitches and jerks their extremities are making. To this end, some jurisdictions have defined the statute as beginning when the patient first is informed of the potential association between the medicine and the condition.

It's hard to give precise information about these time limits, because as said they vary from state to state. If you have taken Reglan and subsequently developed the condition of Tardive Dyskinesia, get in touch with officials as soon as possible to see what the relevant information about the statute of limitations is.

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Four plaintiffs have filed two new lawsuits against the manufacturers of Levaquin, claiming that the antibiotic caused them a number of tendon difficulties.

Lovie Armstrong, Cecil Brown, Darrell Griggs and Bessie Smith filed their cases in the Madison County circuit court in Illinois. These two new lawsuits name parent company Johnson and Johnson, manufacturer Ortho McNeill and distributor Walgreens as defendants in this latest case against the popular antibiotic. The suits claim that the medicines were marketed directly toward elderly patients, a category already at risk for tendon damage, even though the effects of Levaquin were by that point already well known.

Tendon ruptures are the most commonly-cited reason for Levaquin lawsuits. Such ruptures are very painful, and can be potentially crippling. The patients most frequently prescribed Levaquin, the elderly, are already at risk for such ruptures, and may be poor candidates for rehabilitation and surgical procedures necessary to correct the damage caused by a burst.

Particular threats for tendon ruptures exist in the Achilles tendon. This tendon is under more pressure than any other tendon in the body, supporting as it does the entire weight and balance of the person. Correcting a rupture to it can require being laid up for months at a time, something that the aged are advised to avoid because of risks of infection, pneumonia and peripheral artery disease. Levaquin simply ends up compounding their problems, and yet it is marketed most consistently to them for serious infections in the first place.

The effects of Levaquin are not a new discovery. The drug was accepted for prescription in 1996 — 14 years ago. These side effects have been known about since at least 2000, and possibly earlier. The lawsuits are simply the newest, as many others are still pending, including some that have been consolidated into one class action suit at the federal level.

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The process of getting a pharmaceutical manufacturer to acknowledge the potential dangers of its medicine is long, slow and tedious.

After all, the company itself cannot be relied upon to be completely unbiased in the reporting of the medicine it produces. In the case of Yaz, the story is incredibly one-sided. Media reports have focused heavily on how the medicine is simple, effective and almost trendy to take. Similarly, there are reports that it can help reduce or even cure young adult acne, as well as help manage weight. At the risk of sounding cliché, these are concerns that appeal directly to many young women, so the appeal of the drug immediately is apparent.

Any mention of its side effects, on the other hand, is few and far between. Recently a certain Broadway star sued because her experiences with Yaz led her to have a stroke at a very young age. This brought a great deal of publicity to the matter, but what about the young women who were exposed to these conditions before a star was? Why wasn't their story enough to warrant at least a warning label?

The issue is a difficult one. The studies that have been done aren't ironclad conclusive; more tests are required to make sure the science is accurate and inarguable, and these matters take time. However, it is increasingly clear that taking contraceptives such as Yaz can raise blood potassium levels. This, in turn, can create complications when other medicines, such as commonly prescribed NSAID painkillers, are introduced into a compromised system.

What's worse is that the symptoms are so quiet, and nothing can be done about them in some cases. The strain on the heart might not be noticed until a heart attack. In the meantime, patients are urged to talk to their doctors and see what their options might be.

The FDA has just given approval for the extended release (XR) version of the antidepressant Effexor to be produced in a generic formulation. As with all such cases of named medications going generic, this carries benefits and risks. Indeed, the very language contained in the FDA press release should be cause for careful consideration and expanded vigilance.

Keith Webber, Ph.D., is the deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research. This is the body that makes determinations on drugs' safety and warning labeling concerns. Webber was quoted on the FDA website as saying, “The approval of this widely-used antidepressant is another example of the FDA’s efforts to increase access to safe and effective generic drugs."

This is obviously the case. There is nothing inherently wrong with generic medications. Generic labels of acetaminophen, ibuprofen, lansoprazole, omeprazole and other drugs that are available over the counter indisputably have improved the quality of human life.

However, this blog has kept track of the many continuing problems that are present in SSRIs and SNRIs like Effexor and Paxil. These problems have included the on-the-label acknowledged risk of increased suicidal thoughts and ideation, as well as a host of alleged links between pregnant mothers prescribed the medication and the formation of birth defects in their children.

Indeed, in the same press release where Webber cites the decision as part of the FDA's desire to make safe drugs available, more sobering information follows: Generic venlafaxine hydrochloride will have the same safety warnings as Effexor XR.

Considering this medication still has cases pending against it pertaining to both the current acknowledged problem of increased suicidal thoughts among young patients and the potential of birth defects caused by the medicine, it gives one pause to think that the FDA is promoting it as “safe and effective” when giving permission for generic use.

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Diabetics should take note of two newly published studies that confirm existing evidence that the diabetes drug Avandia (rosiglitazone) increases the risk of heart attacks as well as heart failure. As a defective drug injury attorney, I've been closely following the news about Avandia this year. In February, the disturbing findings of the Senate Finance Committee that GlaxoSmithKline, Avandia's manufacturer, made claims it knew were misleading about the drug's safety. In April, the FDA considered ending a study of Avandia early because it was unethical to expose patients to a 64% greater chance that they could have a heart attack associated with the drug. Now, the Consumer Reports Insights column in the Washington Post is advising diabetics to opt for the older diabetes medicine metformin over Avandia, because two more studies have just shown that Avandia increases the risk of heart attack, stroke, heart failure and death.

Avandia already carries a black box warning, the FDA's strongest warning, that lets patients know the drug has been associated with heart failure. But in light of the two newly published studies, FDA regulators are questioning whether Avandia should be pulled off the market entirely because of its association with heart attacks. In one of the studies, published in the Archives of Internal Medicine, Dr. Steven Nissen of the Cleveland Clinic added 14 more studies to the 42 on which he performed a meta-analysis. This expanded and updated analysis confirmed his 2007 finding that taking Avandia increases the risk of heart attack. The Journal of the American Medical Association published another study, by the FDA's David Graham and others, that found that taking Avandia increased the risk of stroke, heart failure and death. Graham and his colleagues' study was based on their analysis of more than 227,000 Medicare records for patients taking Avandia or Actos (another diabetes drug).

From my perspective as a dangerous prescription drug injury lawyer, it's worrisome that so many patients' lives and health remain at risk while GlaxoSmithKline continues to deny what many studies have found. The FDA plans to consider Avandia's safety in a mid-July advisory committee meeting, and the agency has noted its concerns about the drug for several years now. It's unclear why FDA officials have not taken action against Avandia already. Internal FDA reports released by the Senate Finance Committee suggest that 500 heart attacks and 300 cases of heart failure could be prevented every month if Avandia patients took Actos instead, and some observers suspect that GlaxoSmithKline had declined to inform the public of these risks, even though the company had known of them for years.

Knowing how many things diabetics have to manage in their lives to stay alive and healthy, it's hard to imagine that a drug manufacturer would choose to put patients' lives at greater risk by withholding or denying information about a drug's safety. But that may be what is happening here -- and if so, it’s illegal as well as bad ethics. 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 they thought they could trust, drug manufacturers can be held responsible for the physical, emotional and financial harm that results. Diabetes already carries an increased risk of heart and blood vessel disease, so it seems unlikely that patients and their medical caregivers would knowingly choose a drug that seriously increases their risks of heart attack and heart failure.

Continue reading " More Evidence Emerges of Increased Risk of Death and Disability From Avandia " »

While there are plenty of reasons to celebrate the recent sweeping settlements between Paxil manufacturer Glaxo Smith Kline (GSK) and plaintiffs alleging birth defects caused by the medication, not everything has been entirely put to rest.

The news certainly has been good for plaintiffs in the Paxil birth defects cases so far. Just eight months ago, a jury awarded a $2.5 million settlement to the plaintiff in the first major test case, the Kilker trial. Now, GSK has elected to cease pursuing litigation in nearly 200 of the current cases, including nearly 100 that haven't yet formally gone to court. While the terms of the settlements are confidential, they clearly were satisfying to the plaintiffs involved in the matter.

However, cases remain pending that are due resolution in the fall. Additionally, there are complicated matters involving certain parts of the case, as minors are involved. This requires the intervention of the Orphan's Court, which is sure to make proceedings move cautiously.

There are, of course, plenty of reasons to be optimistic. According to representation for both sides, the plaintiffs and defendants have shown a willingness to work together, and GSK has avoided the stereotypical “not a penny” behavior one might expect from a pharmaceutical giant.

Companies like GSK operate on budgets of billions of dollars. Amounts that seem like a lifesaving surplus to many plaintiffs are fairly small amounts to big pharma producers. More important to such companies is their reputation with the public and with agencies such as the FDA. Decades ago, the makers of Tylenol recalled their entire on-the-shelf product line because it became clear someone had tampered with the medicine and it was harming peoples' lives. They put client safety and their reputation first over profits, which is clearly the strategy that GSK has elected to pursue for the moment.

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The modern mass media is a complicated phenomenon, and what predominates is rarely representative of everything going on. For example, right now the news is dominated by events at the G20 summit and the massive oil spill in the Gulf. News about the intensely disruptive side effects of Reglan seems to be in short supply. However, this does not mean that there is no news at all, nor does it mean that no one is looking into the problem on behalf of the plaintiffs affected by Reglan and its side effect, Tardive Dyskinesia (TD).

Fourteen trials have been set to see review between now and January of 2011, all pertaining to Reglan and its side effects. Beginning April 19th, the first of the Reglan trials began in Birmingham, Alabama. Other states considering cases include Oklahoma, Arkansas, Colorado, Pennsylvania, North Carolina, West Virginia, South Carolina, Texas and California, according to the Jere Beasley Report.

Further, the signs are good for those patients involved in the lawsuits. The evidence is certainly on their side. TD has manifested in two fashions in Reglan patients, both of which can provide strong evidence for the plaintiffs in their pursuit of justice.

In the first case, the disorder presents temporarily. Some patients who are on the medication eventually develop TD, and after they stop taking the medicine it fades away. This shows a causal or at least correlated link — when taking the meds, patients display symptoms. In other cases, the disorder presents permanently or semi-permanently, as indicated in the black-box label warning ordered by the FDA. This demonstrates the potentially serious nature of what Reglan can do to patients, and is very likely to sway a jury through personal testimony from patients still demonstrating the symptoms of the illness.

So if you're considering getting legal help for a case related to Reglan, but feel that it's an issue no one is talking about, be assured that there are steps being taken and efforts being made.

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Sometimes a look back is the best way to gain perspective. Often the most difficult time when attempting to gain recognition for harm done by a prescription medication is after trouble becomes known, but before that knowledge is widespread. Pharmaceutical companies often play a role in the confusion of information as they take steps to protect their products and reputations.

In the case of Reglan, warnings about the potential link between the medicine and Tardive Dyskinesia (TD) go back to 2004. However, most of the cases have only been set for trial in the last year or so. This leads to a discrepancy of perception: Weren't these people warned about it, and didn't they choose to take it?

However, consider that up until fairly recently, Reglan was only indicated by its parent company as linking to TD in .2% of cases. This is technically true, if you accept that the company is talking about doses taken in the short, no-more-than-12-week time span indicated on the label. However, in as many as 30 percent of cases, doctors had been prescribing Reglan for much longer periods. Correspondingly, the rate of those affected by TD was significantly increased.

Now, a great deal can be said about the doctors who prescribed Reglan for longer periods than indicated. However, the parent company was representing the information in a skewed way, giving the impression that the absolute numbers of patients was much lower than it actually ended up being. This raises doubts about the “weren't they warned?” argument.

The matter came to a head recently, with the FDA ordering a black-box warning put on all packaging for Reglan, stressing the potential effects of TD and mentioning that the ailment could be permanent. This occurred in 2009, four years after the initial warnings appeared. Thus, it is on good ground that most of the Reglan cases are going forward: There has been a disconnect in the matter, and it must be resolved.

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