Product Liability Attorney Blog

A new study that was recently published in JAMA Internal Medicine is suggesting that patients taking SSRI antidepressants like Paxil may be at an increased risk of complications during surgery. The risks include bleeding and death.

During their research, scientists found that patients were more likely to suffer from surgical complications after taking drugs like Paxil. In fact, the researchers found that patients receiving SSRI medications are 10 percent more likely to bleed excessively and require blood transfusions as well as being more likely to require readmission to the hospital within a month. The results of this study were published on April 29.

For now, it remains unclear why SSRIs like Paxil are linked to the complications, but there is at least one running theory. One expert has been quoted as saying that “the antidepressant drugs may affect blood platelet functioning, which may prevent the platelets from clotting correctly. If the blood is unable to effectively clot, excessive bleeding can occur resulting in other complications.”

These risks have the study’s lead researcher, Dr. Andrew Auerbach, recommending that patients taking SSRIs should stop taking the drugs before having surgery. Doctors already recommend that patients not take NSAID drugs like ibuprofen because of the bleeding risks, but more research will need to be conducted before SSRIs are formally added to that list.

Paxil is an antidepressant medication that is used by millions of people worldwide, but it can cause serious side effects, including violent and suicidal thoughts and behavior. The pills have also been proven to cause birth defects in babies whose mothers take the pills while pregnant. Some of the birth control pills linked to Paxil and Effexor include PPHN, oral clefts, neural tube defects and spina bifida. In general, SSRIs like Paxil can often worsen a person’s condition rather than help them, and the price of these medications can be very high when used for long periods of time. The drugs have also been found to be habit forming, which makes them even more dangerous.

According to information from a new study that was published in the journal Current Biology, animals (including humans), “often hunker down as they develop sleep or eating disorders, ulcers, and other physical manifestations of depression.” The study was able to show that this behavior also occurs in flies.

This study was conducted by researchers hoping to better understand the biology of depression so that they could find a new way to test antidepressant medications that are used to treat depression. The researchers that conducted the study have decided that finding symptoms of depression in insects as well as people can prove that the roots of depression are very deep.

"Depressions are so devastating because they go back to such a basic property of behavior," says Martin Heisenberg of the Rudolf Virchow Center in Würzburg, Germany.

According to Heisenberg, he and a colleague talked about whether a fly could feel fear. In a related study, this study’s coauthor, Franco Bertolucci, learned that flies quickly suppress some of their innate behaviors, which is what happens when a being feels helpless. In the end, the study showed that when flies are exposed to extreme heat, they try to get away from it like every other animal. However, when the fly realizes that they can’t get away from the heat, they simply stop doing anything and react slowly, which would indicate that they were acting depressed.

The study also showed that the female flies slow down more than the male flies in stressful situations. While the meaning of that isn’t clear yet, Heisenberg explains, "if we realize that the fly trapped in a strange, dark box, unable to get rid of the dangerous heat pulses, has to find a compromise between saving energy and not missing any chance of escape, we can understand that such a compromise may come out differently for males and females, as their resources and goals in life are different."

As to whether this study will end up helping scientists better test antidepressant medications used to treat the condition (such as Paxil or Effexor), that is still to be determined. Antidepressants are generally used to treat depression and anxiety. However, the drugs have proven dangerous for most people to use. Paxil and Effexor are also known to cause serious side effects, which can include violent and suicidal thoughts and behaviors as well as birth defects in babies whose mothers take the drug while pregnant. Some of those defects include PPHN, spina bifida, neural tube defects and oral clefts. A study like this may go a long toward helping depressed patients find alternative treatments to these dangerous prescription medications.

With over 40 lawsuits already filed against Cook Medical over vaginal mesh complications because of the company's Surgisis and Stratasis products, the case filed on April 2, 2013 by a Georgia resident did not come as much of a surprise.

The complaint accuses the company’s vaginal slings of causing her “nerve damage, chronic infection, and other pelvic mesh complications.” This newest lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania, and may join the MDL currently underway in West Virginia. Back in February, a group of plaintiffs filed a petition to request that all federal Cook Surgisis vaginal mesh litigation be coordinated as multidistrict litigation (MDL). The petition asked to let the cases be consolidated West Virginia district court.

Cook Medical isn’t the only company to be sued over vaginal mesh complications. Other companies being sued in different lawsuits include devices made by Boston Scientific, Coloplast, American Medical Systems, C.R. Bard and Johnson & Johnson's subsidiary Ethicon. The vaginal mesh devices are used to treat pelvic organ prolapse and stress urinary incontinence — both conditions caused by childbirth and menopause. Complications linked to vaginal mesh devices include erosion, infections, vaginal scarring and painful intercourse.

So far, only two of the cases that have actually gone to trial resulted in an award for the plaintiff. The case against Ethicon (over the Gynecare Prolift vaginal mesh) resulted in an $11.1 million award for the plaintiff, and the case against Bard Avaulta resulted in a $5.5 million award. This helps to give pending plaintiffs hope in receiving awards of their own. Should that be the case, the manufacturers may decide to follow Bayer’s lead and start negotiating settlements just to keep payouts a little bit lower in the long term. That sounds great on the surface, but generally manufacturers use the settlements to get out of paying what is truly owed to the plaintiffs. Of course, something is always better than nothing in the long run.

Another Yaz lawsuit was filed on April 2, 2013, against drug giant Bayer over the side effects linked with the company's controversial birth control pill. Other defendants named in the lawsuit include Berlex Laboratories and McKesson Corporation. The side effect highlighted in the complaint is deep vein thrombosis, which is caused by blood clots in the legs.

This complaint was filed on behalf of Tara McLaney Stanley and Jessica Carlton in the Superior Court of California in San Francisco. Both women claim that after they started taking either Yaz, Yasmin or Ocella, they developed deep vein thrombosis. Deep vein thrombosis isn’t the only blood clot-related injury caused by the fourth generation pills. The pills have also been linked to strokes and pulmonary embolisms, along with heart attacks, gallbladder disease and kidney stones.

While Bayer is in the process of negotiating various settlement agreements over blood clot-related side effects caused by Yaz use, the company still isn’t willing to completely admit liability. Bayer has been sued by thousands of women and their families for failure to warn the public and healthcare professionals of the dangers linked to Yaz. It also has been accused of knowingly hiding the dangers linked to the pills in earlier ad campaigns that promoted the drugs' off-label uses and for lying outright about the pills’ safety. With so many studies verifying the pills' dangerous side effects, Bayer’s decision to negotiate settlements appears more like a way to save the company money on award payouts rather than an admission of guilt.

With more and more women filing lawsuits every week, Bayer is likely to be in settlement negotiations throughout 2013, and possibly well beyond that. New plaintiffs and potential plaintiffs may want to hurry up with filing their lawsuits before the statute runs out.

Recently, a vaginal mesh lawsuit was filed against Caldera Medical. The suit was filed by a Kentucky woman who suffered from complications after receiving a surgical implant of the company’s transvaginal mesh device as a treatment for her stress urinary incontinence.

The complaint was filed in the Superior Court of the State of California, Los Angeles County on April 8, 2013. In the complaint, the plaintiff stated that after she received the Caldera T-Sling, she began suffering from complications which included “pain, discomfort, reoccurring infections, erosion of bodily tissues and dyspareunia.” As a result of those complications, the plaintiff’s complaint states that she has had to undergo subsequent surgeries and treatment.

Numerous side effects have been linked to vaginal mesh implants. Other complications linked to the devices include “erosion, mesh contraction, fistula, infection, inflammation, scar tissue, organ perforation, blood loss, neuropathic and other acute and chronic nerve damage and pain, nerve damage, pelvic floor damage, chronic pelvic pain, urinary and fecal incontinence and prolapse of organs.”

Caldera Medical isn’t the only company to be sued over vaginal mesh complications. Other companies being sued in different lawsuits include Boston Scientific, Coloplast, American Medical Systems, C.R. Bard and Johnson & Johnson subsidiary Ethicon. The vaginal mesh devices are used to treat pelvic organ prolapse and stress urinary incontinence. Both conditions are caused by childbirth and menopause. At least two of those lawsuits over vaginal mesh devices have resulted in awards for the plaintiffs. The case against Ethicon (over the Gynecare Prolift vaginal mesh) resulted in an $11.1 million award for the plaintiff, and the case against Bard Avaulta resulted in a $5.5 million award.

With thousands of lawsuits pending over vaginal mesh complications, many people are left wondering why the devices continue to be reported as safe. It is also a wonder why so many doctors keep performing the surgeries when the dangers linked to the devices are so evident.

According to the U.S. Preventative Services Task Force (USPSTF), there just isn’t enough proof to justify having teens and adults regularly screened for suicide risks. The task force posted its recommendation statement after it examined information from various research conducted on the subject and determined that there just isn’t enough information for the task force to recommend that everyone be screened.

However, while the USPSTF panel isn’t recommending the screening, it did state that there also wasn’t enough information NOT to recommend the screening. The purpose of this statement by the USPSTF was to address the concerns of those who currently do not have a mental health disorder. The panel does note, though, that it is critical to be able to help prevent suicide attempts and the suffering that accompanies it.

In defense of the panel’s decision, task force member Dr. David Grossman said, "Unfortunately, at this time we don't know if asking everyone who visits their doctor or nurse about their risk factors for suicide leads to fewer suicides and suicide attempts."

More studies need to be done in order to provide the right type of evidence to support the screening and provide better assistance to those people at risk, he added.

"The task force calls on the research community to prioritize studies to develop screening tools that can better identify people without symptoms who are at risk for suicide and to create effective support and treatment programs for people with risk factors for suicide," Grossman added. "We know that many people who attempt suicide have visited a health care professional within a month before their attempt. This means that we have a real opportunity to help if we find better tools."

Antidepressants like Paxil and Effexor are generally used to treat the major depression and anxiety that can often be the underlying cause of a person’s suicidal tendencies. However, both Paxil and Effexor have proven to be more dangerous than the condition for most people. Paxil and Effexor are also known to cause serious side effects, which can include violent and suicidal thoughts and behaviors as well as birth defects in babies whose mothers take the drug while pregnant. Some of those defects include PPHN, spina bifida, neural tube defects and oral clefts.

It turns out that sales of generic versions of Yaz and Yasmin birth control pills has not decreased at all, despite the thousands of lawsuits filed by women who have suffered from potentially life-threatening side effects. In fact, drug manufacturer Actavis Inc. is planning to start selling generic versions of Yaz again following a recent ruling made by the U.S. Court of Appeals for the Federal Circuit Court.

The appeals court decided to reverse a previous decision that was handed down in Nevada federal court. This ruling had stated that Bayer’s (the makers of brand name Yaz and its sister pills Yasmin) patent on the pills was invalid. This particular patent for the drug is set to expire on June 14, 2014. A spokesperson for Bayer, Astrid Kranz, said of the verdict, “We disagree with the court’s ruling and are evaluating our options.”

It seems as if the dangers of the pills are completely ignored by drug makers like Actavis. The most dangerous side effects linked to Yaz use are blood clots that can lead to strokes, deep vein thrombosis and pulmonary embolisms. Blood clots have been the subject of thousands of lawsuits and complaints against Bayer. Other side effects linked to Yaz use include heart attacks, gallbladder disease, kidney stones and irritable bowel syndrome. The cause of all of the side effects is the fourth generation pills’ main active ingredient, drospirenone, which is a synthetic progestin.

And now, with the ruling against Bayer’s ownership of the patent on Yaz, companies like Actavis are more than happy to make money off of the billion dollar seller — once again proving that money is far more important to companies than consumer health. Bayer has been settling lawsuits all over the country as a way to save the company from larger payouts after it became clear that the company was losing ground in failure-to-warn cases filed against it.

A couple from Kentucky filed a vaginal mesh lawsuit against Boston Scientific on March 2, 2013. The lawsuit was filed in federal court in the Western District of Kentucky (Bowling Green) amid claims that the company’s Obtryx Transobturator sling device caused the patient to suffer from complications.

The court documents filed by the plaintiffs claim that the vaginal mesh was defective and caused her to suffer from “significant physical and mental pain.” She originally had the vaginal mesh implant procedure performed as a treatment for both urinary stress incontinence and pelvic organ prolapse. The conditions are caused by childbirth and/or menopause. The plaintiff is accusing Boston Scientific of “consistently underreporting and concealing information concerning the tendency of its mesh products to fail and cause severe injuries and complications.”

Boston Scientific is also being accused of “failing to research and establish proper protocol for safe and effective procedures used to remove its vaginal mesh products, thereby making it virtually impossible to do so in the event of complications.”

Despite the complications linked to various vaginal mesh devices, devices like the Obtryx Transobturator Sling System continue to be marketed as a safe, reliable devices. Boston Scientific in particular uses an aggressive marketing strategy that goes directly to the consumer. This company isn’t the only one being sued over complications with their vaginal mesh device implants. Manufacturers like American Medical Systems, C.R. Bard, Johnson & Johnson subsidiary Ethicon and Coloplast are also being sued over similar vaginal mesh complications.

To date, only two of those cases have gone to trial and both resulted in an award for the plaintiff. The case against Ethicon (over the Gynecare Prolift vaginal mesh) resulted in an $11.1 million award for the plaintiff, and the case against Bard Avaulta resulted in a $5.5 million award. Many plaintiffs are hoping that those cases will set a precedent in future claims.

Continue reading "Despite Growing Number of Yaz Settlements, Many Women Still Haven’t Filed Claims" »

A couple from Kentucky filed a vaginal mesh lawsuit against Boston Scientific on March 2, 2013. The lawsuit was filed in federal court in the Western District of Kentucky (Bowling Green) amid claims that the company’s Obtryx Transobturator sling device caused the patient to suffer from complications.

The court documents filed by the plaintiffs claim that the vaginal mesh was defective and caused her to suffer from “significant physical and mental pain.” She originally had the vaginal mesh implant procedure performed as a treatment for both urinary stress incontinence and pelvic organ prolapse. The conditions are caused by childbirth and/or menopause. The plaintiff is accusing Boston Scientific of “consistently underreporting and concealing information concerning the tendency of its mesh products to fail and cause severe injuries and complications.”

Boston Scientific is also being accused of “failing to research and establish proper protocol for safe and effective procedures used to remove its vaginal mesh products, thereby making it virtually impossible to do so in the event of complications.”

Despite the complications linked to various vaginal mesh devices, devices like the Obtryx Transobturator Sling System continue to be marketed as a safe, reliable devices. Boston Scientific in particular uses an aggressive marketing strategy that goes directly to the consumer. This company isn’t the only one being sued over complications with their vaginal mesh device implants. Manufacturers like American Medical Systems, C.R. Bard, Johnson & Johnson subsidiary Ethicon and Coloplast are also being sued over similar vaginal mesh complications.

To date, only two of those cases have gone to trial and both resulted in an award for the plaintiff. The case against Ethicon (over the Gynecare Prolift vaginal mesh) resulted in an $11.1 million award for the plaintiff, and the case against Bard Avaulta resulted in a $5.5 million award. Many plaintiffs are hoping that those cases will set a precedent in future claims.

According to a new study that was published in the journal Brain, Behavior and Immunity, depression might affect a person’s physical activity and the effects of light alcohol consumption since the mental condition also inhibits the anti-inflammatory effects.

This study was conducted by researchers at Duke Medicine and showed that when looking at the measurements of the cardio-metabolic risk marker C-reactive protein (CRP), it showed that there was a substantial depression risk.

"Our findings suggest depression not only directly affects an individual's mental and physical health, it might also diminish the health benefits of physical activities and moderate alcohol consumption," said lead author Edward C. Suarez, Ph.D., associate professor of psychiatry and behavioral sciences at Duke Medicine. "This appears to be specific to inflammation, which we know increases the risk for heart disease, so our findings suggest that depression could be a complicating risk factor."

CRP is a biomarker that helps to predict a person’s potential future chances of suffering from heart disease as well as other chronic inflammatory conditions. The researchers found that when depression is left untreated, it actually hindered the anti-inflammatory effects that goes with drinking moderate to light amounts of alcohol and exercise. The researchers found that the participants they analyzed who were active and had lower CRP levels saw no real benefits to their CRP levels unless they were depressed.

"This is a novel finding, and it seems to be specific to inflammation as measured by CRP," Suarez said, given that depression did not affect other health markers such as fasting triglyceride and cholesterol levels.

Depression is a condition that affects billions of people worldwide and is generally being treated with antidepressants like Paxil and Effexor. However, these drugs have proven dangerous for most people to use. Paxil and Effexor are also known to cause serious side effects, which can include violent and suicidal thoughts and behaviors as well as birth defects in babies whose mothers take the drug while pregnant. Some of those defects include PPHN, spina bifida, neural tube defects and oral clefts.

According to the National Institute of Mental Health's STAR*D study, only a third of patients taking antidepressants like Paxil to treat depression responded to the drug. Finding out just why that is could help researchers identify predictors on whether an antidepressant should be used at all. This new study was published in Biological Psychiatry.

The study was hoping to identify specific genes that aid in predicting a patient’s expected response to antidepressants like Paxil. The research, conducted by Dr. Katherine Tansey of Institute of Psychiatry at King's College London and colleagues, sought to figure out if specific genes really can help predict antidepressant responses in alleviating depression symptoms.

"Our study quantified, for the first time, how much is response to antidepressant medication influenced by an individual's genetic make-up," said Tansey.

To perform this work, the researchers estimated the magnitude of the influence of common genetic variants on antidepressant response using a sample of 2,799 antidepressant-treated subjects with major depressive disorder and genome-wide genotyping data.

They found that genetic variants explain 42 percent of individual differences, and therefore, significantly influence antidepressant response.

"While we know that there are no genetic markers with strong effect, this means that there are many genetic markers involved. While each specific genetic marker may have a small effect, they may add up to make a meaningful prediction," Tansey added.

"We have a very long way to go to identify genetic markers that can usefully guide the treatment of depression. There are two critical challenges to this process," said Dr. John Krystal, editor of Biological Psychiatry. "First, we need to have genomic markers that strongly predict response or non-response to available treatments. Second, markers for non-response to available treatments also need to predict response to an alternative treatment. Both of these conditions need to be present for markers of non-response to guide personalized treatments of depression."