Product Liability Attorney Blog

According to information that was provided by a paper first published by The Lancet, researchers are now watching how melatonin and its analogues can change the body’s internal clock (the circadian system) while treating major depression. This may cause more patients to forgo using current SSRI treatments like Effexor and Paxil.

This new treatment is called Agomelatine, which is an analogue that is currently showing some promise in this area of treatment. Basically it offers the same levels of antidepressant activity as current medications like Paxil and Effexor, but with an added bonus: Agomelatine also helps to improve the sleep patterns in the people who are being treated. This research paper was written by professors Ian B. Hickie and Naomi L. Rogers.

Both of the authors of this paper have stated that major depression is one of the biggest causes of early death and disability. Although the drugs that are currently available to treat depression work, they are also limited with what they can do and cause patients to suffer from severe side effects.

The Authors say, “Recent advances in our understanding of the fundamental links between chronobiology and major mood disorders, as well as the development of new drugs that target the circadian system, have led to a renewed focus on this area."

The paper points out that there is evidence that supports strong links between circadian problems and the most common symptoms of depression. Those symptoms include: trouble falling asleep, restless sleep, waking up early, daytime tiredness and blunting or complete reversal of the normal peaks in mood, alertness and energy in the morning. This is why it seemed natural to start investigating melatonin and drugs related to it as a means of treating depression.

The authors decided to compare melatonin, ramelteon, tasimelteon, PD-6735 and agomelatine until the agomelatine was determined to have the highest chance of working on patients. It is believed that the agomelatine’s antidepressant effects were caused by its unique combination of “binding to melatonin receptors and blocking serotonin receptors in the brain.”

To this end, the authors have stated, "In the short-term, agomelatine has similar antidepressant efficacy to venlafaxine, fluoxetine, and sertraline and, in the longer term, fewer patients on agomelatine relapse (24 percent) than do those receiving placebo (50 percent). Patients with depression treated with agomelatine report improved sleep quality and reduced waking after sleep onset."

Agomelatine is currently approved in the EU, U.S. and Australia and is seen as a huge step forward in treating depression.

The lawyer for a man who is said to have threatened to conduct a killing spree across West Virginia has said recently that his client, Nathan Jackson Fuller Jr., was mixing alcohol with Paxil and Klonopin, and lied to police after crashing his car.

Fuller’s lawyer says that he hopes the charges against his client will be dropped once he proves that there is "no truth to his [Fuller’s] statements whatsoever." Fuller chose to waive his right to a preliminary hearing on Monday May 16, of this year in Marion County Magistrate Court. Fuller’s alleged accomplice, John David Moore, has been listed as Fuller’s codefendant by a magistrate who believes that he has probable cause to bind the case against Moore. Moore’s lawyer claims his client is innocent.

Both men are being charged with conspiracy to commit murder and conspiracy to commit robbery. After Fuller crashed his car in Rivesville on May 3, and injured Moore, its alleged that he started saying a bunch of odd things to the arresting officer, who was about to arrest Fuller for driving under the influence. It was then that Fuller claimed that he was planning the killing spree.

Fuller allegedly stated that he was planning on "going through West Virginia and killing people at random, stopping at a rest area, locating a few girls, and cutting them, stealing their wallets, and then stealing their vehicle, and continue that process, flipping cars." Fuller also claimed that he had been trying to find someone to murder at Penn State and on High Street in Morgantown earlier the same day, but didn’t get the chance. Fuller then said that he met up with Moore in Morgantown.

According to the attorney, Fuller was taking the prescription medications Paxil and Klonopin. Paxil is an SSRI antidepressant that has been linked to aggressive behavior and suicidal thoughts and behaviors, while Klonopin is used to treat seizures and relieve panic attacks. Moore’s lawyer claims that his client never had any intentions of killing anyone with Fuller or even helping Fuller at all. Fuller tried to have his bail reduced, but was denied. He returned to the North Central Regional Jail on Monday after the preliminary hearing.

When it comes to lawsuits in New Jersey, it turns out that Johnson & Johnson holds the current record for claims made against it. Johnson & Johnson can credit its new lawsuit record to its popular antibiotic drug Levaquin.

Lawsuits against Levaquin side effects such as tendon ruptures have piled up to the thousands amid claims that the drug giant didn’t properly warn the public or doctors before allowing the drug to be prescribed. So far, it is not clear if the FDA’s forced label changes are responsible for the higher rate of lawsuits.

Earlier this year, the FDA forced Johnson & Johnson to change the labels on Levaquin because of the high risk of tendon damage involved in taking the drugs. Part of that label change was to issue a black box warning against the drug. Black box warnings are the highest warnings the FDA can impose.

The label changes also stated that the drug can worsen muscle weakness in patients that have myasthenia gravis. Myasthenia gravis is an autoimmune disease, meaning it prevents the immune system from creating antibodies to normal body tissue. Ortho McNeil (a subsidiary of Johnson & Johnson), the makers of Levaquin, responded to the black box warning by writing a “Dear Health Care Professional” letter in March.

In the letter, the company told doctors about the label changes and urged the doctors to tell their patients about the potential adverse reactions that have been linked to Levaquin and other types of fluoroquinolones. The letter also encouraged doctors to report any history of myasthenia gravis or breathing problems to them. This may be so that Johnson & Johnson can conduct its own research in hopes of debunking information that already proves how dangerous Levaquin can be for some patients.

With a record for the most lawsuits, it looks like the "Family Company" has little to be proud of.

Researchers at the University of Texas Southwestern Medical Center have stated that when it comes to taking antidepressants like Effexor, two might not be any better than taking one.

It is common for doctors to prescribe more than one type of antidepressant to depressed patients when they find that one treatment isn’t working on its own. However, new research suggests this combination of medications may not work either.

“Clinicians should not rush to prescribe combinations of antidepressant medications as first-line treatment for patients with major depressive disorder," lead researcher Dr. Madhukar H. Trivedi, professor of psychiatry and chief of the division of mood disorders at UT Southwestern, said. "The clinical implications are very clear — the extra cost and burden of two medications is not worthwhile as a first treatment step.”

The study, “Combining Medication to Enhance Depression Outcomes (CO-MED),” was conducted nationwide and required researchers at 15 different sites across the country to keep tabs on 665 patients aged 18 to 75 that had a severe depressive disorder. The researchers formed three groups that were set up in accordance with their treatment types and each of them was given FDA-approved antidepressants.

The first group took Lexapro and a placebo; the second group was given Lexapro and Wellbutrin; and the third group took Effexor and Remeron. After 12 weeks, every group showed the same amount of response to their depression. However, the third group (to which Effexor was given) suffered from more side effects of the drugs than the first two did. After seven months, remission and response rates remained similar in all three groups, but side effects were more frequent in the third group.

It should be noted that a third of patients treated for depression experience remission of their symptoms after 12 weeks when taking medications.

In the consolidated Levaquin lawsuit that is to take place in a Minnesota federal court, it has been decided that Clinton-nominated federal Judge John R. Tunheim will have the honor of presiding over the litigation. Tunheim once oversaw the collection of millions of pages of information in the 1990s that had to do with the assassination of John F. Kennedy. He will now supervise the 2,500-plus plaintiff claims against the makers of the popular antibiotic Levaquin.

Right now there are almost 1,000 Levaquin lawsuits that have been consolidated in a multidistrict litigation (MDL).This is a lot like a class action lawsuit. There are at least 1,500 more lawsuits that are still pending in New Jersey state court, which is where the drug’s makers, Johnson & Johnson, is headquartered.

As for the case, on April 27, Tunheim was the moderator in a status conference for the MDL. It was here that it was announced that a post-trial motion schedule was being done for the Schedin v. Johnson & Johnson case. This case saw the plaintiff awarded $1.8 million in punitive and compensatory damages when the court decided that the defendant didn’t properly warn the public about the side effects associated with Levaquin, such as tendon ruptures. Schedin ruptured both his Achilles tendons after taking Levaquin for an infection.

It is expected that the next federal Levaquin lawsuit trial will start at the end of May. The final pretrial conference for this case, which was brought by Calvin Christensen, should take place on May 26. The next state lawsuit is expected to go to trial at the end of August or the beginning of September. The trial is going to combine these two cases.

Levaquin was once at the top of the heap when it came to prescribed antibiotics, but many people are wondering if the onset of generic versions of the drug coupled with the many lawsuits will finally result in an end to Johnson & Johnson’s antibiotic profit domination.

Back in 2006, the annual sales of Levaquin (levofloxacin) passed $1.4 billion in the United States alone. For a while, it was the most-prescribed antibiotic on the market. Sales of the popular drug rose in 2007 a mere 1.7 percent once news of the tendon ruptures started to circulate. By 2009, sales of Levaquin in the U.S. had dropped by 6 percent, and that is just the beginning. It isn’t just the side effects that caused the major drop in sales. Competing antibiotics also played a role in it.

Negative attention on Levaquin and Johnson & Johnson will continue throughout 2011 as some of the lawsuits are likely to reach a courtroom by the end of the year. However, that is not the only problem facing Johnson & Johnson when it comes to Levaquin: In June, the patent will expire on the drug and many generic versions will be made available to the public. The FDA has approved an oral solution of generic Levaquin that is being made by Hi-Tech Pharmacal Co. Inc. This generic competition is expected to take a big cut out of Johnson & Johnson’s Levaquin sales.

Levaquin trials are set to begin this summer. They follow a verdict previously awarded to one plaintiff, John Schedin, of $1.8 million in punitive and compensatory damages after he suffered two torn Achilles tendons as a result of taking Levaquin. In 2009, Levaquin was issued a black box warning by the FDA due to the drug’s increased risks of causing tendon ruptures.

With all of this competition for sales and the lawsuits, it makes many wonder if the brand-name version of Levaquin’s market dominance has come to an end. Only time will tell, but for the many patients that have suffered from tendon ruptures, it didn’t come soon enough.

Despite the thousands of lawsuits against the makers of Levaquin due to the serious side effects including tendon ruptures, the FDA has approved the release of a generic Levaquin oral solution.

This generic Levaquin oral solution is made by Hi-Tech Pharmacal Co. Inc., and was approved by the FDA in April. While it won’t hit the market until June of this year (once Levaquin’s patent runs out), it has many people wondering if that is a good idea considering the many side effects already associated with the original version of the drug.

The original version of Levaquin is manufactured by Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals Inc. It is a wildly popular antibiotic that is used as a treatment for many conditions such as mild to severe bacterial infections. Back in July of 2008, the FDA enforced a “black box” warning on the label of the drug because of the tendon ruptures. To date, there are more than 2,600 lawsuits waiting to reach a courtroom, and almost all of them are because of patients suffering from tendon ruptures.

The representatives for the plaintiffs as well as the defense got together in a multidistrict litigation status conference so that they could talk about how to proceed with the Levaquin trials. One lawsuit has already been ruled in favor of plaintiff John Schedin, who had suffered from both of his both Achilles tendons being ruptured after taking Levaquin. Schedin was awarded with $1.8 million in punitive damages as well as compensatory damages.

It is hoped that the Levaquin lawsuits that reach trial first will help to set a precedent for the cases that follow. Most of the plaintiffs are alleging that they were not properly warned of the risks of taking Levaquin before taking the drug. It is a wonder that the FDA would approve yet another version of the antibiotic after all of these complaints from patients, but if the past offers any insight, there will be many more Levaquin lawsuits filed in the future with the generic oral solution.

Bayer has responded via press release to the studies that have recently been published in the British Medical Journal. The studies basically said that women taking Yaz and Yasmin have a higher chance of developing blood clots than those taking other oral contraceptives.

The press release issued by Bayer in response to the BMJ publication states that the information in the BMJ studies is unreliable because of the methods the researchers used to gather their data. Bayer put the focus on various earlier studies that they paid for instead of giving credit to the BMJ study. The previous studies basically showed that Yaz birth control pills weren’t any more dangerous than any other oral contraceptive on the market.

The BMJ study's data showed that women taking Bayer’s Yaz and Yasmin, which are drosperinone-based drugs, have twice as high of a chance of developing blood clots than if they took older contraceptives that are based on levonorgestrel (another synthetic progestin). When Bayer dismissed the BMJ study, it also said that the studies the company funded have repeatedly proven that the chances of women developing thromboembolism are no higher than in taking other birth control pills. However, in 2010, Bayer was forced to update its warning labels on Yaz and Yasmin to include the increased risks involved in taking the pills.

Bayer was also forced to pull its major advertising campaign that downplayed the risks associated with taking Yaz and touted the pills as a cure for acne and major PMS symptoms. All of these warnings against the pills have done little to dissuade young women from taking them. In fact, another study showed that Yaz was the most popular oral contraceptive used by teens today. Yaz side effects have been the subject of much controversy as the Bellwether trials are almost underway. While the trials could very well set the precedent for future decisions, they are not expected to reach a courtroom until later on this year.

While conducting research on mice, scientists from Rockefeller University have shown that patients who are taking anti-inflammatory medications minimize the effectiveness of various antidepressants, including Paxil.

Paul Greengard, Ph.D., and Jennifer Warner-Schmidt, Ph.D., has found that over-the-counter medications like ibuprofen, naproxen and aspirin actually lower the benefits patients receive from taking serotonin reuptake inhibitors (SSRIs), including Paxil. The actual findings were recently published in the journal Proceedings of the National Academy of Sciences. So far, experts believe the study might be of the most importance to Alzheimer’s patients. The reason for this is because Alzheimer’s patients are more likely to suffer from depression and they believe that in treating that depression better the disease may be less harsh or severe in its progression. But that’s not all; the researchers also believe that successfully treating the depression may also help reduce the elderly’s chances of getting Alzheimer’s in the first place.

During the study, the researchers basically gave the mice antidepressants like Paxil while the mice were taking anti-inflammatory drugs to see how the mice started to act while doing things that are considered sensitive to antidepressant treatment. The mice that were taking antidepressants showed behaviors that were inhibited by the anti-inflammatory treatments. After that phase was complete, they did the same tests on human patients and the people who were depressed and taking anti-inflammatory meds as well were not as likely to get relief from their symptoms than those depressed people who didn’t take the anti-inflammatory.

Warner-Schmidt summed the study up best by stating, “The mechanism underlying these effects is not yet clear. Nevertheless, our results may have profound implications for patients, given the very high treatment resistance rates for depressed individuals taking SSRIs.”

“Many elderly individuals suffering from depression also have arthritic or related diseases and as a consequence are taking both antidepressant and anti-inflammatory medications,"Greengard added. "Our results suggest that physicians should carefully balance the advantages and disadvantages of continuing anti-inflammatory therapy in patients being treated with antidepressant medications.”

With all of the Reglan lawsuits happening because of the drug’s increased risk of causing such severe side effects as tardive dyskinesia, many are wondering why patients don’t insist on other medications to treat their acid reflux.

Reglan isn’t the only treatment used to fight off acid reflux, but it is certainly one of the most dangerous. Thousands of patients are filing Reglan lawsuits because of the severe side effects that they have suffered as a result of using the medication. Side effects of using Reglan include: tardive dyskinesia, Secondary Parkinson’s disease, neuroleptic malignant syndrome, akathasia and cervical dystonia (torticollis).

If you are concerned about the various side effects that you can develop because of Reglan use, you should talk to your doctor about using an alternative. Some of the popular alternatives to Reglan include:

• Tums
• Rolaids
• Zantac (Ranitidine)
• Pepcid (famotidine)

Another dangerous alternative that was recalled voluntarily was called Propulsid (cisapride). It was recalled because of the risks it posed to the heart. People who suffer from GERD or heartburn can utilize the alternatives to Reglan mentioned above which all help to neutralize and/or temporarily prevent your stomach from creating stomach acid.

There are, of course, other prescription drugs that serve as an alternative to Reglan. These include proton pump inhibitors (PPIs) such as Prilosec (omeprazole), Prevacid (iansoprazole) or Nexium (esomeprazole). These prescription medications work by blocking an enzyme in the stomach wall that is necessary for producing stomach acid.

If you are suffering from chronic acid reflux disease or heartburn, you should seriously consider using alternatives to Reglan if you want to avoid the harsh side effects. Those mentioned above may be safer if not with the same effectiveness as Reglan. However, if you have taken Reglan for longer than the approved use of 12 weeks, and are suffering from severe side effects, you may want to contact a doctor right away to discuss an alternative medication.

Earlier this month, the British Medical Journal (BMJ) published two studies that seem to prove what Bayer has been denying since Yaz came out on the market… that the popular oral contraceptive may be more risky than any other form of birth control. The results also back up a previously-released U.S. study.

Both of the studies may serve as the smoking gun that supports Yaz lawsuit plaintiffs’ claims in court. The study conducted in the U.S. was performed by researchers from the Boston Collaborative Drug Surveillance Program at Boston University's School of Medicine. That study showed that the women that were taking Yaz had more than twice the chance of developing blood clots than the women who were taking some other form of oral birth control. The main factor in play with Yaz is its main ingredient, drosperinone, which is a synthetic progestin. Most other birth control pills use a different synthetic progestin called levonorgestrel. Up until Yaz came on the scene, levonorgestrel was the main ingredient in birth control pills.

The UK study concluded that the women who took birth control pills that consisted of drosperinone as its main ingredient were almost three times as likely to develop blood clots as those taking older birth control pills that don’t have drosperinone in them. Considering that these studies came out just a week after the Canadian Medical Association Journal (CMAJ) published a study of 2.7 million American women which showed that the women taking Yaz had a 20 percent chance of developing gallbladder problems, these new study results certainly gain attention.

The evidence is piling up against Bayer and their birth control pills, even as a third study recently showed Yaz and Yasmin are the most popular oral contraceptives among young women in America today. With so much proof regarding the drugs' side effects, their popularity should drop.

Some British scientists are claiming that they have figured out how antidepressants like Paxil and Zoloft can make new brain cells. The researchers study stem cells regularly and this new discovery could help scientists to finally figure out a better way to treat depression.

So far, studies about antidepressants and SSRI medications like Paxil have only been able to show that antidepressants can generate new brain cells, but the studies couldn’t explain how. The study that was published in the journal Molecular Psychiatry used Paxil and other antidepressants as the primary focus. Some of the researchers discovered that the medications control and help regulate the glucocorticoid receptor (GR), which is a necessary protein that controls the person’s responses to stress. It is the GR that is responsible for creating the new cells.

"Having identified the glucocorticoid receptor as a key player in making new brain cells, we will now be able to use this novel stem cell system to model psychiatric illnesses in the laboratory, test new compounds and develop much more effective, targeted antidepressant drugs," Christopher Anacker, a doctorate student who led the study, said.

Studies have already shown that depressed patients display less neurogenesis, which is new brain cell generation. Researchers think that the reduced neurogenesis might be what causes symptoms of depression like mood swings and memory loss. Anacker's research team used hippocampal stem cells from humans (which is the source new brain cells in people) to look for evidence of what antidepressants really do. They did this by treating the brain cells and adding Zoloft, Prozac and Paxil.

This new research could be revolutionary, according to Anacker.

"For the first time in a clinically-relevant model, we were able to show that antidepressants produce more stem cells and also accelerate their development into adult brain cells," he says.

GlaxoSmithKline has released a new study that goes against its own antidepressant medication, Paxil. The study shows that the drug poses a clear risk of suicidal thoughts and behavior to the patients who take it. What this means is that the company's own findings may be the very tool that can help patients win their lawsuits against it.

The study was published in the Journal of Clinical Psychiatry, and shows that people are 7 times as likely to attempt suicide than those people who were taking a placebo. In the clinical trials, 0.34 percent of the patients taking Paxil tried to kill themselves versus the 0.05 percent of the patients taking placebos. In addition, another study conducted by GSK that was published in the Journal of the American Medical Association in early 2010 also showed that Paxil didn’t work any better than the placebos at getting rid of depression, anyway.

Paxil has caused a slew of problems for GSK since it first hit the market. Years ago, the FDA issued a black box warning against the drug because of the severe side effects that were associated with it. GSK has known as early as 2006 that the drug increased the risk of suicides in its patients, and lawsuits have been filed by the thousands by plaintiffs claiming that the drug giant hid the risks associated with the drug.

None of that is more interesting than the fact that the company’s own research is now confirming the very things that other studies have been saying for years. Glaxo has tried to hide the real risks that come with taking Paxil, but perhaps the company has finally realized that it is a pointless effort. Publishing the findings of their research that basically proves everyone else right all along may appear like a gutsy move, but in the end, there really didn’t seem to be any other options. If Glaxo continued to try to claim that their own studies had results that contradicted those from the hundreds of other studies that all work against Paxil, Glaxo’s research trials would likely lose credibility and force even stricter monitoring of the company’s research practices.

In light of all of the research against Paxil, it might be best for Glaxo to cut its losses with Paxil and move on.