Product Liability Attorney Blog

With recent research showing a 400 percent rise in antidepressant prescriptions, it stands to reason that some patients may believe that they will eventually be cured of their depression by using the various antidepressants on the market. At least, one would hope that's the case, as the dangers of these drugs are also well known.

However, much research has been conducted on the efficacy-to-risk ratio of antidepressant medications like Paxil and Effexor, and one thing that stands out is that neither of those medications can actually cure people of the condition. While antidepressants do help to control some of the symptoms of depression and anxiety, it often only works if the patient stays on the drugs indefinitely. The moment a patient stops taking the drug, the repressed symptoms of depression return full-force.

Another thing that stands out with drugs like Paxil and Effexor is how highly addictive they are. Most patients can’t just stop taking the drugs without suffering from horrible withdrawal symptoms. Those withdrawal symptoms will cause the initial depression symptoms to worsen, making the patient feel twice as bad as they did when getting started on the antidepressants in the first place.

Finally, recent research points out that there may not even be a real benefit to taking antidepressants like Paxil and Effexor at all. Studies have shown that Paxil and Effexor don’t work any better than placebos at combating depression symptoms. Considering that there is a huge trial and error factor in even finding the right antidepressant for each individual, it hardly seems worth suffering the serious adverse side effects during the search. All of this trial and error in finding the right antidepressant to take can even kill a patient since SNRIs and SSRIs like Paxil and Effexor have long been linked to homicidal and suicidal behavior.

To make matters worse, patients have to stay on antidepressants to benefit from the drugs, which means that the pills do not cure them of the condition. In fact, many doctors agree that talk therapy and exercise work better at curing depression than pills do. For all of that, it is simply “insane” to take antidepressants and suffer their side effects when lifestyle changes do more to get you cured from your condition.

The Reglan mass tort litigation taking place in Philadelphia got the support of the presiding judge when she denied a motion filed by the defendants to have the lawsuit dismissed. The mass tort litigation consists of about 2,000 lawsuits that were filed against the makers of Reglan, Wyeth, and the motion to dismiss was refused on the grounds of a Supreme Court ruling earlier this year.

Judge Sandra Mazer Moss of the Philadelphia Common Pleas Court decided to overrule (without prejudice) a motion that was filed by generic drug companies asking her to dismiss the Reglan lawsuits against them. In the motion, the drug companies argued that under the Supreme Court's decision in Pliva v. Mensing, the state lawsuits that were filed against them were pre-empted by federal regulations. Needless to say, when Moss ruled in favor of the plaintiffs, it was considered a huge win. In fact, one of the plaintiff’s lawyers said, "It's a recognition that Mensing does not equal immunity."

Judge Moss also denied one of Wyeth’s preliminary objections in which the company's attorneys had said that by the time it sold the brand-name version of Reglan to another company, it couldn’t change the label. According to one article on Law.com, “The orders came in one of the biggest challenges yet by generic drug companies nationally to state court lawsuits in the wake of the 5-4 ruling by the Supreme Court in June. Under federal law, generic manufacturers are required to use the same labels as their brand name counterparts.”

When the Supreme Court made its Mensing ruling earlier this year, many plaintiffs feared that they had lost the ability to lay claims against generic drug companies and hold them liable for their injuries. This recent ruling went a long way toward easing those fears.

When the average person thinks to treat his or her chronic pain with medications, generally they look for pain medications like Tylenol, Aleve or Advil. However, it is getting more and more common for some patients who are suffering from chronic pain to be given antidepressant medications.

While treating pain with antidepressants is not an approved use for the drugs, it happens all of the time anyway. Various different antidepressants are used to chronic pain, but tricyclic antidepressants like Tofranil or Anafranil appear to work better than SNRIs like Effexor or Prozac. SSRI medications like Paxil and Zoloft have shown no real benefit as a pain treatment. According to information from The Mayo Clinic, the chronic pains that antidepressants are said to help with include "arthritis, diabetic nerve damage, nerve damage from shingles, tension headache, migraine, fibromyalgia, low back pain and pelvic pain."

So far, it is not exactly know just how the antidepressants work at treating pain, but some believe that the drugs might help to increase neurotransmitters in the spinal cord that reduce pain signals.

Still, these drugs don't work immediately — in fact, it often takes a week or so before a patient begins to feel some relief.

The fact is that antidepressants like Paxil, Effexor and Prozac have been proven to be very dangerous. Studies have shown that the drugs can cause serious adverse side effects that have the potential to make the patient suicidal. Aggressive behavior has been noted in many patients taking antidepressants — even that patients have been driven to act out with homicidal behavior.

To make matters worse, other studies have shown that antidepressants work no better than placebos at curing depression symptoms, which is causing many doctors to balk at prescribing the drugs at all. Instead, doctors are prescribing lifestyle changes, better nutrition and talk therapy. With all of the potentially deadly side effects linked to taking antidepressants, it seems unnecessarily dangerous to prescribe it for pain. If you want to know about the benefits to taking antidepressants for treating pain, contact your doctor and be sure that you fully understand the risk-to-benefits ratio before taking the drugs.

Wyeth, the makers of Effexor, is being sued by a health fund for municipal workers in New Jersey's Bergen County. The manufacturers are being sued amid claims that the generic version of the drug has not been on the shelves in Bergen for the past two years, which allowed Wyeth to overcharge for the brand name drug instead.

The antitrust lawsuit was filed by the Bergen Municipal Employee Benefits Fund last Thursday. Plaintiffs' lawyers are seeking class action status with the U.S. District Court in Trenton. The full complaint is saying that Wyeth used “sham litigation to delay marketing of a generic version of Effexor XR, also known by its generic name, venlafaxine hydrochloride, by 13 other drug companies.”

The complaint also states that Wyeth holds the patent on Effexor, which is FDA-approved, and only was supposed to have the exclusive marketing rights to the drug through June 13, 2008. In filing multiple lawsuits against all of the companies that wanted to start introducing the generic version of Effexor to the market, Wyeth essentially “tagged another two years onto its period of exclusive use.”

On Tuesday, a spokesman for Wyeth, said that while the company knows about the Bergen complaint, it hadn’t yet been given a copy of the document. However, Wyeth officials are still going to dispute the accusations made against the company.

“We categorically deny the claims asserted in the complaint relating to the Effexor XR patents," a company spokesman said. "The company stands behind its Effexor XR portfolio, which represents an important innovation in the treatment of depression and anxiety and has benefited millions of patients across the country. Pfizer intends to defend itself vigorously against the plaintiff’s claims.”

The fund’s lawsuit further claims that the drug company lengthened its monopoly on Effexor by saying that it had a new extended release formula that didn’t have any side effects like the regular version did. Most of the previous lawsuits Wyeth filed against generic manufacturers were settled by the generic companies before the courts could decide whether Wyeth’s new patent claims were merited.

According to new study results conducted by the FDA, patients taking Yaz and Yasmin have a 75 percent higher risk of suffering from blood clots than people taking non-drospirinone-based birth control pills.

Recently, the FDA released a new drug safety report focused on the controversial oral contraceptives Yaz and Yasmin. While the study also looked at other pills whose primary ingredient is drospirenone (which is a synthetic progestin), Yaz and Yasmin were a primary focus of the study. What they learned during that study was that drospirenone-based pills represent a definite increase in risk for blood clots that can lead to potentially fatal conditions including heart attacks, strokes and pulmonary embolisms.

This particular FDA study analyzed data collected from 800,000 women between the years 2001 and 2007. The study included researchers from the FDA, Kaiser Permanente, Vanderbilt University and the University of Washington, who together discovered the 75 percent increased risk over the other birth control pills that use levonorgestrel instead. The study also found out that drospirenone doubled the risk of arterial thrombotic events (ATE) in new patients. More significantly, the study showed that those side effects occurred within the first three months of taking Yaz or Yasmin.

This will certainly help boost the claims from thousands of Yaz lawsuit plaintiffs who claim that they developed blood clots after taking Yaz or Yasmin. Most of those women are claiming that the makers of Yaz and Yasmin didn’t properly warn them that they could develop these life-threatening conditions associated with the pills. Bayer has stubbornly stood by the pills, claiming that its own study reveals that drospiranone-based pills are no more dangerous than other birth control pills. This new FDA study may finally put the matter to rest and provide the information necessary to get the pills recalled.

A recent Levaquin lawsuit has been transferred into federal multidistrict litigation (MDL) in the U.S. District Court for the District of Minnesota after being filed by Walter Adamushko. He is claiming that the controversial antibiotic Levaquin caused him to suffer from painful tendon ruptures.

Adamushko and the other plaintiffs in the MDL are hoping to get a settlement that will give them fair compensation for all of the pain and suffering that they went through after taking Levaquin. Adamushko and the other plaintiffs are all alleging that “Levaquin is defectively designed, inadequately tested, dangerous to human health and lacks proper warnings as to the dangers associated with its use.”

Adamushko is also claiming that the manufacturers of Levaquin knew that Levaquin was dangerous and debilitating but didn’t properly warn him of that fact before he started taking the drug. According to Adamushko, Ortho-McNeil “knowingly and recklessly omitted and concealed … the dangers of Levaquin” from both patients and healthcare professionals. His complaint states that the drug company acted in a wanton and deliberate manner when hiding the dangerous side effects of Levaquin.

Levaquin lawsuits have been filed by the thousands amid similar claims after patients started suffering from ruptured tendons while taking the drug. The drug is mostly used a means of treating sinus infections and other infections. It is most dangerous for senior patients and those who are taking corticosteroids. So far, three Levaquin cases have gone to trial, and one plaintiff, John Schedin, was awarded nearly $2 million. The other two cases went in favor of the defendants. However, one thing that is clear is that new plaintiffs each have their own histories with their own circumstances in taking Levaquin. Sometimes it is even the smallest difference that can mean the difference in winning or losing a lawsuit.

Benjamin Wachs, writer for the Messenger Post Media and editor of Fiction365.com, has a lot to say about the American over-drugging issue. As one of his recent articles points out, "according to the Atlantic Monthly (using data compiled by the World Health Organization), 47 to 55 percent of Americans are diagnosed with a mental disorder at some point in their lives. From depression to psychosis, no other nation comes close to the incidents of mental illness we have.”

A recent study backs up his statement. The study shows that antidepressants like Paxil are the second-most-prescribed medication in the United States. Wachs’ column states that Americans are twice as often diagnosed with a mental illness than the Ukraine, which was second on the list. While it is not completely understood why this is, Wachs believes that Americans are being over-diagnosed in that every personality trait now has become associated with a “syndrome.”

Wachs isn’t the first columnist to write about the over-drugging of Americans; however, his methods of explaining his views are very to the point. For example, Wachs states that “We (Americans) love the idea that we can pop a pill to change our personalities. Much in the same way Americans are always looking for a quick fix way to lose weight without the work, we’re looking for a quick fix to make us happy without really trying.”

Whether or not you completely agree with Wachs, we all can admit he has a point — and pharmaceutical companies are capitalizing off of it. There is a great deal of money in over-diagnosis. With every new condition that is developed, there is a pill created to cure it. Depression and anxiety seem to be the most popular mental disorder diagnoses these days, and antidepressant medication like Paxil and Effexor are being used on all age groups. Even children are being given Paxil to help them combat obsessive compulsive disorder. With this over-medicating, many patients are suffering from the adverse side effects linked with the drugs, including aggressive behavior and suicidal thoughts and behavior.

Considering that studies have also shown that antidepressant medications like Paxil are no better at curing depression than placebos anyway, it may be time for Americans to try something new. After all, people keep taking these medications and they are still depressed. When it comes to the risks-to-benefits ratio, it seems as if no one is really winning but the drug companies, and the lawsuits patients file don't seem to be enough to get the companies to shape up. As Wachs says, “as long as we think that slapping a label on something is the same as understanding it, it won’t get better."

Health Canada has issued a warning that people who have myasthenia gravis should avoid using Levaquin and other similar antibiotics because they are believed to make the condition much worse.

While Health Canada does admit that the chances of worsening myasthenia gravis are rare in Levaquin patients, it is serious and has the potential to cause patients to suffer from breathing difficulties and weakness in the muscles. Fluoroquinolones like Levaquin are generally used as a treatment for various infections including sinusitis, but the drugs are also linked to severe adverse side effects, including tendon ruptures.

Back in 2008, the FDA issued a black box warning, the strongest warning available, against Levaquin and other fluoroquinolone antibiotics because of the risks involved in taking the drugs. Myasthenia gravis is a rare condition that weakens the muscles in places like the eyes, face, throat and neck. Health Canada announced earlier in the week that the makers of fluoroquinolone antibiotics like Levaquin should update the labels on the drugs to reflect the new warnings against patients with myasthenia gravis.

Health Canada says that the risks to myasthenia gravis patients seems to most apply to the patients who take the antibiotic in liquid form or extended release tablet form. Levaquin has long been linked to tendon ruptures and thousands of patients have filed lawsuits against the makers of the drug amid claims that they failed to properly warn them about the real risks involved.

Only three of the lawsuits filed have seen the inside of a courtroom so far. Two of the cases were ruled in favor of the defendants, but one man, John Schedin, won his claim. The defendants tried to have the decision reversed on appeal, but the judge upheld the original ruling.

The FDA has issued an update to the public that addresses the potentially harmful drug interactions between methylene blue and psychiatric drugs, including SSRIs like Paxil and Effexor.

The FDA's update provides even more information about adverse effects reports of a condition known as serotonin syndrome. Most of the cases of serotonin syndrome were reported to the FDA's Adverse Event Reporting System by patients who were taking both serotonergic psychiatric drugs as well as methylene blue. The patients also seemed to experience their conditions when they had parathyroid surgery, which is why they were taking methylene blue in the first place, since it can be used intravenously as a visualizing agent. The specific methylene blue was given in doses ranging from 1 mg/kg to 8 mg/kg.

Since the methylene blue isn’t currently FDA approved, there are limited data available on the drug’s uses under different conditions. So far, there is no way for healthcare professionals to fully understand the potential risks of serotonin syndrome for those patients taking serotonergic psychiatric drugs like Paxil or Effexor and methylene blue. One thing that is known is that not all serotonergic psychiatric medications are equal when it comes to serotonin syndrome and methylene blue. So far, the cases of patients that developed serotonin syndrome seemed to happen to those who took SSRIs like Paxil and Effexor, serotonin norepinephrine reuptake inhibitors (SNRI) and clomipramine.

This newest FDA update points out just how dangerous drug interactions can be. With all of the data showing the health risks associated with SSRIs like Paxil and Effexor when used on their own, it seems strange to even consider mixing those medications with any other drugs, much less those that aren’t approved yet. Perhaps that is why so many Paxil and Effexor patients have filed lawsuits after suffering from such harmful side effects. With these new data, more lawsuits will likely follow.

In the most recent FDA update, regulators have updated their statement made about the harmful effects linked with combining the antibacterial agent linezolid (Zyvox) with seretonergic psychiatric drugs like Paxil. The updated statement shows that there is the potential for serious central nervous system toxicity.

The cases of serotonin syndrome that have been reported to the FDA seem to be caused by an adverse reaction to patients taking SSRIs or SNRIs in combination with linezolid. In these reports, the drugs specifically mentioned include paroxetine (Paxil), fluvoxamine (Luvox), fluoxetine (Prozac, Symbyax), sertraline (Zoloft), citalopram (Celexa), escitalopram (Lexapro), vilazodone (Viibryd), venlafaxine (Effexor), desvenlafaxine (Pristiq) and duloxetine (Cymbalta).

So far, it is not fully understood just what it is that causes the adverse reactions when linezolid interacts with these medications. However, some believe that it is caused from inhibition of monoamine oxidase A. This is the enzyme that the body uses to help metabolize serotonin in the brain. When this is prevented or slowed, it causes a toxic buildup that can even cause death, though only one person was reported as dying from it.

In a statement, the FDA said "Healthcare professionals and patients may not realize that linezolid has monoamine oxidase inhibitor properties."

Linezolid is most commonly used to treat “vancomycin-resistant Enterococcus faecium infections, pneumonia and skin and soft-tissue infections — including those caused by methicillin-resistant Staphylococcus aureus.” Linezolid is generally not mixed with SSRIs and other psychiatric drugs unless it is an emergency where the linezolid is necessary in treating a patient. It is currently recommended that healthcare professionals fully weigh the risk-to-benefit ratio when thinking of using this harmful combination of medication. In addition, regulators are also suggesting that doctors first use something else when possible. The regulators are also advising doctors to immediately stop giving patients the serotonergic drug and keep a close watch for any adverse side effects if they decide to use the linezolid.

A new study is claiming that one out of every eight teenagers is currently suffering from some sort of social phobia that will require antidepressants (like Paxil or Effexor) as a treatment. The study was conducted by researchers at the National Institute of Mental Health (NIMH).

Published in Pediatrics, the study was conducted with researchers gathering data through surveys that were given to 10,000 teens that were between the ages of 13 and 18. The survey basically just asked the teens to explain how shy they were during face-to-face interviews. What they found out during their research was that was that half of the girls and 43 percent of the boys admitted that they were either extremely shy or somewhat shy. Of those kids, 12.4 percent have been found to have met the criteria needed for a doctor to diagnose them with a social phobia. The criteria they met are outlined in the Diagnostic and Statistical Manual of Mental Disorders.

Since antidepressants are commonly prescribed as treatments for adults who have anxiety, depression, OCD and phobias, it would stand to reason that antidepressants would be prescribed to teens as well. However, Kathleen R. Merikangas, the lead author of the study, disagrees with that. Rather, she and her colleagues found that teens with a diagnosed social phobia aren't more likely to take antidepressants like Paxil and Effexor as part of their treatment. This belief is based on the fact that those drugs aren’t marketed for that type of treatment.

Of course, most people know at this point that how a drug is marketed rarely has anything to do with how it is prescribed. However, Merikangas says, "Behavioral therapy and exposure therapy really work for these kinds of fears. You don't have to put them on lifelong [antidepressants]."

With that statement made, Merikangas didn’t say that antidepressants like Paxil and shouldn’t be used at all — just that they shouldn’t be used for the entirety of a teen's life. Research has already shown that they drugs cause aggressive behavior and suicidal thoughts and behavior.

A new study that focuses on children with OCD is suggesting that the condition can be treated with both talk therapy and antidepressant medications like Paxil and Effexor, which is just odd given that antidepressants are known to cause birth defects when they are taken by pregnant women. Why should we assume giving them to children is safe?

A recent study conducted at the University of Pennsylvania School of Medicine in Philadelphia states that as many as 1 in every 100 children has OCD. The study was published in the Journal of the American Medical Association. In children, OCD works the same way that it does with adults in that children will feel anxious and afraid until they repeat a certain pattern of behavior to correct it. A common habit among OCD children is hand washing.

Researchers collected information from kids separated into three groups. One group focused on kids who took nothing but antidepressants for their OCD; the next group were kids who only had therapy; and the last group focused on the kids that took antidepressants and had therapy as well. When three months went by, the researchers checked in with the kids and their parents and they learned that the kids that went to therapy did better than those that didn’t.

Knowing that the study mentions the use of antidepressants like Effexor or Paxil as part of a successful treatment, many are wondering if these potentially dangerous pills will be prescribed to kids with OCD. Research has shown that prescription medications like Paxil and Effexor have been linked with severe adverse side effects which include aggressive behavior and suicidal thoughts and behavior. It just doesn’t seem appropriate to offer drugs with these kinds of side effects to kids, but then again, with research currently suggesting that antidepressants don't work any better than placebos, many people are wondering why the drugs are still being prescribed to anyone at all.

A Chicago woman, Mindy Verson, filed a Yaz lawsuit on September 28. Verson claims that taking the controversial contraceptive caused her to develop pulmonary embolism and venous thromboembolism.

Verson’s lawsuit lists the makers of Yaz, Bayer, as the defendant in her lawsuit. The woman claims that Bayer knew (or should have known) that the pill wasn’t properly tested before reaching the marketplace. She also claims that Yaz’s design was defective and that there were no proper warnings given of the risks associated with it.

Verson began taking Yaz back in 2009 and she says that her pulmonary embolism and venous thromboembolism were directly caused by the pills. Research has proven repeatedly that Yaz and other birth control pills that contain drosperinone can cause severe and potentially life-threatening side effects, including blood clots that can lead to pulmonary embolisms and venous thromboembolism, heart attacks, strokes, gallbladder disease and even death.

Verson’s lawsuit is only one of thousands that have been filed against Bayer in the past few years. With so much damage being caused to women taking Yaz, more lawsuits will likely be filed against Bayer. Countless Yaz lawsuits have been filed with plaintiffs accusing the drug company of hiding the real risks linked to Yaz, and using misleading advertising to help promote Yaz’s off-label uses. One of Bayer’s Yaz ad campaigns practically claimed the pill was a cure for everything from acne to severe PMS, which the pills are not approved to treat.

Some of the most anticipated Yaz trials (Bellwether trials) will take place in early 2012 and will be presided over by Judge David R. Herndon. With Bayer standing stubbornly behind its oral contraceptives, the trials should prove interesting. The drug company continues to claim that its own research has proven that Yaz, which contains drosperinone, is no more dangerous than other birth control pills that do not contain drosperinone. It seems that Bayer will not accept the many studies that already prove that claim to be false.