Product Liability Attorney Blog

A panel convening on April 9th of this year will be open to the public as well as medical professionals to discuss the subject of "Psychiatric Drug Tragedies: Personal, Legal and Medical Perspectives."

The main focus of this two-hour presentation will be centered on suicide and murder that may be caused by patients using various antidepressants like Paxil and Effexor, among others. The panel is being put together as a part of the international Empathic Therapy Conference put on by the Center for the Study of Empathic Therapy, Education & Living. It will run on April 8-10 in Syracuse, New York.

The panel is going to test suicides that are suspected as being related to antidepressants like Paxil and Effexor from three different points of view. For example, they will be discussing the case of Mathy Downing, whose 12-year-old daughter killed herself. The attorney Karl Protil settled that case without admitting negligence. There will be other families that will be discussing more kids that took their own lives; a father that killed himself; and a father who murdered two of his kids while taking antidepressants.

Antidepressants like Paxil and Effexor have been the subject of many lawsuits because of the violence and suicidal behavior that occur in a small minority of patients taking the drugs. The panel will also be talking about taking various empathetic approaches toward friends and family members that are suffering from depression before jumping to antidepressants.

This panel may be long overdue to the families and victims. The FDA took steps to prevent these kinds of calamities when it issued black box warnings on these drugs as well as suggesting label changes. The new labels now alert patients to the medications’ potential to cause serious side effects like aggression, hostility and mania. They also ensured that the labels now express these warnings toward patients of all age groups.

Antidepressant medications have gotten a bad reputation because of all of the harmful side effects that they cause. With all of the lawsuits that have been filed against the makers of antidepressants like Effexor and Paxil, would most patients be better off using natural remedies?

Anxiety and depression usually go hand in hand. When people are looking to cure their anxiety and depression symptoms, most of them will turn to prescription medication. In fact, one study that was published in the Archives of General Psychiatry says that 10 percent of the American population is on antidepressant medications like Paxil or Effexor. That means roughly 31 million people in the U.S. alone are taking these drugs — and they may not even be helping. The Journal of the American Medical Association published a study that showed that while antidepressants have been shown to work, they do not work any better than placebos (sugar pills).

One study that was conducted by the U.S. government 2006 showed that less than half of the people who took antidepressants like Paxil or Effexor experienced a drop in their depression symptoms. What's even worse, George Washington University health analyst Thomas Moore, who looked at the unpublished studies that drug companies did, says that 40 percent of the studies that focused on the potency of antidepressants presented data that they don't work.

These study results and more have caused many doctors to believe that simple life changes may be more heartening against the struggle with depression.

"Doctors are now medicating unhappiness," says Dr. Ronald Dworkin. "Too many people take drugs when they really need to be making changes in their lives."

Especially if the pills aren't working, a simple change in lifestyles may be the solution. The best part about taking advantage of a more natural form of relieving depression is that you can also avoid the dangerous side effects that the drugs pose.

If lawyers get their way, the Yaz Bellwether trial dates may be pushed back, after a motion was filed requesting more time for plaintiffs to sift through information and gather evidence.

The lawyers asking for an extension say it will benefit both sides of the cases because there are so many documents and deposition transcripts to go through before either side is ready to go to trial. It’s not just the need to sift through all of the information; it is searching for information that is relevant to the case. Right now, both sides are in agreement with wanting the discovery timeline extended. They are requesting that the trial dates be moved from March 14 up to April 14. They also want the trial that is supposed to begin on September 12, 2011, moved up to January 9, 2012.

The Bellwether trials are against Bayer, the makers of Yaz and Yasmin, and are centered around accusations that the company falsely marketed the drugs’ off-label uses. They are also claiming that Bayer hid the life-threatening conditions the pills can cause. Some of the side effects that will be the focus in these first trials include blood clots, heart attacks, pulmonary embolisms, gallbladder disease, strokes and deep vein thrombosis.

“Despite the herculean efforts of counsel for both sides, the scope of what stands before them under the current trial schedule poses an unrealistic burden," an attorney said in the motion.

As to whether the motion will pass, that is unclear. Since the Case Management Order that was given in October 2010 specifically set the dates as a means of speeding things up, asking for yet another extension may just be denied. The trial dates were set to make the settlements come sooner rather than later and to help each side quickly understand what the strengths of their cases are as well as their weaknesses. Since there are thousands and thousands of Yaz/Yasmin lawsuits being filed, this extension just prolongs the inevitable.

Previous research tried to explain how SSRI antidepressants like Paxil and Effexor work, but up until now, no one really understood how. New research is being conducted by neuroscientists at Vanderbilt University now seeks to fully understand how SSRIs really interact with the brain’s neurotransmitters.

For the most part, the study is using a genetically-altered mouse that was changed so that it wouldn’t respond to SSRI’s like Paxil or Effexor — not even cocaine. When the scientists were creating the altered version of the mouse, senior author of the research paper Randy Blakely and his colleagues had to figure out the right parts of the serotonin transporter protein to interact with SSRIs. For that they used a fruit fly which has serotonin transporters that are not particularly sensitive to the drugs.

They changed the protein’s basic structure of amino acids and then converted parts of the human serotonin transporter into its fruit fly equal. When they did that, they were able to choose the right single amino acid they needed for potent binding to various types of SSRIs and cocaine.

Blakely claimed that other than trying to figure out how the SSRIs worked, the new version of the mouse made them realize that they might be able to build a completely new class of antidepressant drugs.

“Many antidepressants have been shown to target other proteins besides the serotonin transporter and … their efficacy in treating depression takes many weeks to develop," he adds. "There is likely a lot that we don’t know about how these drugs act.”

Just as Blakely and his colleagues thought, the modified mice showed normal levels of the serotonin transporter, and it displayed normal activity when it came time to clear out the serotonin from the synapses between nerve cells. Since it didn’t work with the Prozac or Lexapro, they were left with the thought that transporter is the real target of the SSRI medications like Paxil and Effexor.

In short, Blakely and his colleagues want to do more research to find out just how big a role the transporter plays in delaying the effects of SSRIs. They also want to know how these drugs change people’s moods. As for the cocaine, the researchers are hoping to figure out how cocaine really affects the brain.

Yaz and Yasmin once were seen as the cure-all miracle pill that could prevent everything from acne and PMS to unwanted pregnancies. While those benefits are still true, these pills also come with a risk that just don't justify those benefits for all of the patients that have filed lawsuits against Bayer.

The most common side effects that are listed with Yaz and Yasmin are blood clots that cause pulmonary embolisms and deep vein thrombosis. Those side effects have caused as many as 7,000 lawsuits so far by plaintiffs who claim that Bayer didn't properly warn them of the side effects of taking Yaz. Lawsuits filed also accuse Bayer of false advertising and misleading the public with all of the wonderful things that the popular contraceptives can do.

Gallbladder disease is another side effect that is now the cause of 2,700 separate lawsuits against Bayer. Gallbladder disease causes the liver to have a hard time producing the bile that is needed in order for the system to process the fats from food as well as the hormones found in Yaz. These hormones (drosperinone, which is a progestin, and ethinyl, which is an estrogen) from the pill eventually change the bile that the liver produces and travels into the gallbladder where it inevitably gets stuck. This is what causes the patients to suffer from gallstones that sometimes require surgery to remove.

Thousands of women have suffered from gallstones that required surgery after taking Yaz or Yasmin. This is alarming since 30 percent of the female population in the U.S. was using Yaz as their contraceptive of choice. Total lawsuits filed are expected to reach as many as 20,000 or more. If you have suffered from gallstones while taking Yaz, you should contact an attorney immediately. You may have cause for filing a lawsuit of your own.

With three new Reglan lawsuits being filed in Texas recently, one of those cases seems to stand out as it alleges that Reglan gave the patient what is being called secondary Parkinson's disease.

Teva, the makers of Reglan, has been defending itself from plaintiffs alleging that Reglan didn’t properly warn them of the negative side effects associated with the drug in thousands of lawsuits. Reglan is popularly prescribed as a treatment for gestational acid reflux disease (GERD), but it has become more widely-known for its negative side effects, which include tardive dyskinesia, neuroleptic malignant syndrome, akathisia, ocular deviation and, most recently, secondary Parkinson's disease.

The three new lawsuits filed in Texas were filed on February 23, 2011. It has been requested that the cases be heard by a jury. The symptoms of secondary Parkinson's disease include shaking or tremors in extremities, limited movement, weaknesses in the face and/or throat that can make it difficult to eat or swallow, stiff and aching muscles, vacant facial expression and difficulty walking.

One of the plaintiffs in the new Reglan lawsuit is Ronald Cherry, who developed tardive dyskinesia after having taken Reglan for 10 years. Cherry says that he didn't know about the possibility of developing tardive dyskinesia when taken for more than 12 weeks. In actuality, Reglan is not supposed to be taken for more than 90 days in a row and is not recommended for long-term use as in Cherry’s case. Donnie Collins took Reglan for treating GERD. He took it from February 2002 to September 2003 and claims that he was diagnosed with Reglan-induced Parkinson's disease, as well as orobuccolingual dyskinesia and tardive dyskinesia. He also took the drug for more than the 90 days recommended. J.E. Godwin developed tardive dyskinesia after taking Reglan from September 2008 until March 2010.

All three Texas residents file their lawsuits at the same time. The judge that is said to preside over the cases is U.S. District Judge T. John Ward.

Bayer Inc. is planning to sell its controversial birth control pills Yaz and Yasmin in Brazil in an attempt to recuperate some of the company's lost profits due to lawsuits and negative press the pills are receiving in the United States.

The drug company is planning on doubling its profits from $15 billion to $27 billion by 2015 with the sales of Yaz in the Latin American country. In fact, the chairman of Bayer, Andreas Fibig, was bragging that the company currently holds a strong market position in Brazil. If you couple that with the blockbuster birth control pills and the new products that Bayer plans to launch in the country in the next few months and years, it is expected that lawsuits filed against the company won't cause as big a dent in its bottom line as was expected. In fact, Fibig stated as much during a press conference in Sao Paolo. The company is actually planning on launching no fewer than five new drugs in Brazil this year in addition to the birth control pills Yaz and Yasmin.

When Yaz and Yasmin first hit the scene, they were marketed as the best drug to hit the world since aspirin. These pills were touted as being able to cure everything from acne to PMS. This carefully-structured marketing campaign helped make the pills the No. 1-selling birth control pill in the United States. Yaz was so popular, women were requesting the drug by name.

However clever this marketing campaign was, the FDA eventually caught up with Bayer and forced the company to change its advertising techniques when the company was accused of downplaying the negative side effects of the drugs and of encouraging uses of the pills that aren't approved by the FDA. However, this did little to help the young women who were already suffering from some of those adverse side effects, such as heart attacks, strokes, pulmonary embolisms, deep vein thrombosis and blood clots.

Thousands of lawsuits have been filed against Bayer for failing to properly warn the public of the pills' side effects — and more are expected as a result... perhaps even in Brazil.

Now that the statute of limitations has come and gone for people wanting to file Reglan side effects lawsuits, many are wondering just how long it will take before settlements start being announced.

The statute of limitations for filing Reglan lawsuits was up on February 26, 2011. This is a full two years after the FDA issued a black box warning against the pill amid claims that it caused tardive dyskinesia and various other harmful side effects. It was approved as a short term (12 weeks or less) treatment for gastroesophogeal reflux disease (GERD) in 1995.

Despite it being recommended for short term treatment, many doctors were prescribing it for as long as years at a time. As a result of such long term treatments, patients were developing serious side effects such as Neuroleptic Malignant syndrome, Akathisia, ocular deviation and, of course, tardive dyskinesia.The makers of Reglan, Wyeth, has been sued by countless patients, all claiming that the company didn't properly warn them of the harmful side effects and that it purposely omitted information about long term treatment on the label.

As to how the Reglan settlements will be decided, that will likely depend on the severity of the conditions suffered by patients because of the pill and whether it prevents sufferers from being able to work. For example, with TD, a patient may not be able to work properly as the disorder causes them suffer from involuntary movements in the face and extremities and the condition can be permanent for some people. However, most side effects suffered from Reglan often can be stopped after the patient stops taking Reglan.

Another thing that might affect settlement amounts is how much liability the jury holds against Wyeth. This will all depend on how far the company went to downplay the negative side effects from the public and/or doctors. Lastly, settlement amounts will likely be different for younger patients than older ones, with the younger patients receiving more money. This is because such potentially harmful side effects are often considered more debilitating in a young person because the younger generally don't have any pre-existing conditions.

Sooner or later, all pharmaceutical drugs will have to deal with the dreaded patent expiry. One of those drugs that will face patent expiry this year is the controversial antibiotic Levaquin.

Patent protection allows the makers of pharmaceuticals possession of the sole rights to the selling and marketing of their products for a limited time. Once the patent expires, that protection goes out the window, and the makers of these drugs will inevitably lose money after generic versions of the drugs hit the market. Naturally, consumers prefer to spend less money on the generic versions, which can eventually cause the makers of the name brand to lose as much as 90 percent of its initial consumer market for that drug.

Sophia Snyder, pharmaceutical analyst for IBISWorld, says that generic drugs can be as much as 30 percent cheaper than the name brands. She also states that of the $860 billion that is raked in from blockbuster drug sales around the world, only $295 billion (35 percent) of that is from the sales of brand name drugs. However that amount is likely to decline after 2015 as fewer brand name drugs will be released in the coming years, offering generic drug makers less drugs to be able to duplicate. The drugs scheduled to expire in 2011 include: Lipitor, Zyprexa, Concerta, Protonix and Levaquin.

Levaquin has been the subject of many lawsuits because the drug can cause tendon ruptures. Most recently, a man was awarded $1.8 million dollars in damages. The suit alleged that Johnson & Johnson didn't properly warn the public or physicians about Levaquin's causing damage to the Achilles tendons. That lawsuit was the first Levaquin case to go to trial; however, many more are being prepared now. There is no news on when another Levaquin case may go to trial, but if the first settlement sets the precedent, there will likely be many more settlements reached against Johnson & Johnson.

If you were planning on filing a Reglan lawsuit, it's almost too late — your time is nearly up. Since the FDA black box warning was issued on February 26, 2009, the two-year statute of limitations is here. This means that the time for filing Reglan lawsuits soon will have passed.

Patients taking Reglan have suffered from countless harmful side effects, including tardive dyskinesia, Neuroleptic Malignant syndrome, Akathisia and ocular deviation. This caused many patients to file lawsuits against the makers of Reglan amid claims that Wyeth did not properly warn patients about the harmful side effects of the drug.

Reglan is used for the treatment of gastroesophageal reflux disease (GERD), heartburn and acid reflux. Reglan has also been used (in an off-label manner) to treat nausea and morning sickness in pregnant women as well as helping breastfeeding women to lactate. When patients are taking Reglan for prolonged periods of time, they increase their chances of contracting tardive dyskinesia and other harmful conditions. It is for this reason that the FDA has recommended that patients only take Reglan for 12 weeks or less. However, even with this recommendation, many patients were prescribed the pill for a period of a year or longer. This is how so many patients ended up with tardive dyskinesia.

Tardive dyskinesia (TD) causes sufferers to experience symptoms that are often misdiagnosed as Parkinson’s disease. Symptoms of TD include loss of muscle control, grimacing, lip smacking, lip puckering, tongue protrusion and rapid blinking. Right now there is no cure for TD.

Sufferers are encouraged to talk to their lawyers immediately. Even if you aren’t sure if you have a valid case, a lawyer can help you figure it out. There is nothing to fear in seeking compensation for your injuries. Drug companies know how dangerous Reglan is and it is their job as well as doctors' to properly warn patients of the side effects of the pills they are taking beforehand. Talk to a lawyer today because there is no tomorrow.

Now that the two year anniversary is up on the FDA black box warning against Reglan, many potential plaintiffs may be rushing to file their 11th-hour Reglan side effects lawsuits. In the wake of this, it makes sense to remember the case that may have set the precedent for the potential outcomes for new claims.

In Kellog vs. Wyeth, a Vermont woman named Ethel Kellog sued the makers of Reglan after she developed tardive dyskineisa (TD) while taking the generic version of the pill (metaclopramide). Kellog started taking Reglan in 2000 as a treatment for gastroesophogeal reflux disease (GERD). She took the medication for four years, and all the while she was suffering from the severe side effects of TD. She finally filed a lawsuit against Wyeth and the makers of the generic version of the drug in 2007. She filed before the black box warning was issued in 2009.

Kellog's lawsuit claimed that Wyeth knowingly added misleading information about the drug on its warning label. She claimed that the company purposely acted as if the drug was less dangerous than it was. Her suit also claimed that Wyeth specifically kept the warnings limited to those that used the drugs short term, even though most patients (like herself) were prescribed the medication over the long term.

Naturally, Wyeth denied this claim and asserted that the federal regulations wouldn't let them change the warning label after it was already approved for use by the FDA. The makers of the generic versions claimed that they were not allowed by law to make any changes to the warning labels of the brand-name version of the drug.

In the end, the judge in the case ruled in Kellog's favor.

“There is no evidence that FDA has ever brought, or threatened to bring, an enforcement action against (or otherwise sanctioned) a drug manufacturer who sought to strengthen or add a warning to its label," the judge stated. "Likewise, there is no evidence that FDA has proposed to withdraw approval for a generic drug because its manufacturer sought to strengthen a label warning."

Many Yaz lawsuits have been filed by women who have experienced some of the pill's adverse side effects amid claims that Bayer, the makers of Yaz and its sister drug, Yasmin, misled the public in its advertisements. The total number of lawsuits filed against the company has now exceeded 6,000, with no clear end in sight.

Yaz side effects have also gone under fire. The drug is made with drosperinone, a type of progestin; research has shown that the drosperinone increases the risks of patients suffering from potentially life-threatening conditions such as heart attacks, strokes, pulmonary embolisms, deep vein thrombosis and blood clots.

On February 14, 2011, at the Status Conference that was convened by Judge David R. Herndon, a lot of the attention was focused on the bellwether cases that are supposed to reach trial in September. The bellwether trial are meant to be used as test cases so that a precedent may be set in settling the other Yaz lawsuits. The main aspect of the bellwether trial that was discussed during the Status Conference was the issue of discovery involving the production of documents and depositions.

So far, it is said that one bellwether case is going to be dismissed without prejudice, meaning that defendants will then be allowed to go with a different one instead and that the defendants are working with the plaintiffs to that effect, should the need arise.

While not a lot is happening in the courtroom yet, the 6,000-plus cases being filed are sure to increase to the point where Bayer may finally have to admit that Yaz is in fact more dangerous than other birth control pills that don’t contain the combination of dropserinone and ethinyl. There is no real way to know how the bellwether cases will end, but it is fair to say that at least some of the lawsuits against Bayer will be won. It’s just a matter of getting the first cases tried.

Five of the Paxil birth defects trials are finally set to begin in May of this year amid claims that the makers of Paxil, GlaxoSmithKline, didn’t properly warn the public of the pill’s potential to cause birth defects to the babies of women who take Paxil during pregnancy. While these aren’t the first Paxil cases to go to trial, there is no way to predict what will happen — especially if you look at some recent prominent cases that went to trial.

One such case, Kilker v. Glaxo, resulted in the family being awarded a $2.5 million settlement. This lawsuit claimed that the child’s birth defects were the direct result of Paxil being taken during pregnancy, and alleged that Glaxo tried to bury all of the studies that linked the drug to birth defects. The jury in this case did not give the plaintiffs any punitive damages because it did not agree that the drug giant acted with any outrageous conduct.

Another high-profile case, Blyth v. Glaxo, that is currently going through the appeals process, was thrown out of court when Glaxo motioned for a summary judgment. This case was about a 14-year-old girl with heart defects whose parents sued Glaxo amid claims that the company didn’t warn the public about the risks to pregnant women and their babies. Glaxo has responded to these claims against them by stating that the labels on Paxil did in fact have all of the risks listed on it, and that the girl didn’t suffer from any long-lasting health problems after she had the 9 surgeries to correct her heart defects after her birth.

It's anyone’s guess as to how the five cases set to begin in May will turn out, but the developments certainly have everyone’s attention. The cases will be tried in Philadelphia.