Product Liability Attorney Blog

It has been proven that many people who suffer through a traumatic experience seek to be in the company of people who have a higher chance of understanding what they have been through. With so many Paxil patients suffering from various adverse side effects, it's no wonder why some of them are turning to Internet forums for comfort.

Support groups are everywhere, and there are groups in every city across America that can help people with just about every situation there is, to find other like-minded people to talk to. While you can always find a support group for health conditions like cancer, Multiple Sclerosis and even Stevens Johnson syndrome; there aren’t any support groups for Paxil patients.

While Paxil has caused various health problems for patients including mania and aggression, it also causes some patients to attempt suicide and even murder. Paxil patients didn’t really have a forum for sharing their experiences of addiction and adverse side effects until now. The Internet offers all sorts of forums for Paxil patients to get together and talk about their experiences with the drug. Right now, the Paxil Information and Support Center is an online resource that former Paxil patients can use to get in touch with and talk to each other.

This support group is also there to help families that have to cope with birth defects after mothers were prescribed Paxil during pregnancy. These Paxil birth defects pose major health problems for the babies that can be long-term and it is very stressful for these families. These families turn to the Paxil Information and Support Center so that they can learn more about the side effects of the controversial drug and how to handle them.

Even former Paxil patients who are considering filing a lawsuit against the makers of Paxil come to the Paxil Information and Support Center because they can get a free consultation with an experienced Paxil attorney. Others who have succeeded in fighting these cases offer a lot of good help and advice. It just proves that if you are suffering from Paxil side effects or have in the past, Internet forums like those at the Paxil Information and Support Center can be helpful and offer you a bit of privacy as well.

Back in June 2009, the U.S. Judicial Panel on Multidistrict Litigation (MDL) decided that the multitude of Reglan lawsuits wasn’t going to be consolidated into one court. This decision has many people wondering just how this decision might affect the plaintiffs in those lawsuits.

Recently, Reglan lawsuits in New Jersey were to be consolidated in State court, which will consist of over 1,000 cases, but wasn’t granted MDL status. Multidistrict litigation (MDL) is what it’s called when a certain number of lawsuits are consolidated into one court for the purposes of pre-trial motions. This occurs when all of the cases share things in common such as the defendant, or specific injury.

Consolidating the Reglan lawsuit can be beneficial because consolidating can speed up the pre-trial process. Witnesses for the defense can give depositions once rather than multiple times for individual lawsuits. Consolidation also lowers the likelihood of witnesses giving inconsistent testimony which can be damaging over time since many people can forget facts as time passes. Furthermore, consolidation keeps court costs down and lowers the chances of inconsistent rulings being handed down.

The lawsuits stemmed from various patients suffering from tardive dyskinesia after taking Reglan for longer time periods than the recommended 12 weeks. The main reason plaintiffs say that this happened is because the makers of Reglan hid the dangers associated with the drug until the FDA finally issued a black box warning against Reglan in 2009. This move alone caused numerous Reglan lawsuits to be filed across the country. Consolidating the cases seemed like the right way to handle the cases, but the petition was turned down.

There are many reasons why the consolidation to MDL may have been refused. First, some of these lawsuits had already been happening for years, making the main questions in the cases answered already, which meant that moving to another court served no purpose. Secondly, there are too many different defendants involved in the cases. Thirdly, tardive dyskinesia isn’t the only injury suffered in those cases. Some other injuries include restless leg syndrome, secondary Parkinson’s disease and neuroleptic malignant syndrome. Lastly, the effects that these injuries have on the individual plaintiffs are different, too.

A patent infringement lawsuit that Wyeth, the makers of Effexor, filed against Intellipharmaceutics International Inc. has been settled.

The suit, which was filed in the United States District Court for the Southern District of New York, focused on Intellipharmaceutics' generic version of Effexor XR in capsule form. As per the terms and conditions of this new settlement agreement between the two drug companies, Intellipharmaceutics is now allowed to hold a non-exclusive license to the patents so that they can now launch their own generic version of Effexor XR in the U.S. as long as the company gets approval from the FDA. Right now, there are no real assurances of any product that Intellipharmaceutics makes but the current success of Effexor in brand name and generic forms is certainly worth the effort.

So far, Wolters Kluwer Health is saying that Effexor XR, as well as the generic versions of it, have had sales of $2.8 billion in the United States alone in the last 12 months. That is an astounding record considering the host of lawsuits being filed against Wyeth, now a division of Pfizer, over the drug's adverse side effects. Regardless of the potential for lawsuits on the drug, Intellipharmaceutics stands to make enough money from sales to cover that expense and still make a hefty profit.

Dr. Isa Odidi, CEO of Intellipharmaceutics, showed just how excited the company is when the doctor said, "We are very pleased with the settlement of the litigation relating to our generic version of Effexor XR, as this removes a significant barrier to the commercial launch of our generic product upon FDA approval. With five products awaiting FDA approval, we continue to work aggressively to both advance and expand the number of products in our portfolio."

An article written by Dr. Stuart Bramhall has made a very interesting point concerning the many copycat drugs that are on the market today, sold by what he classifies as “disease-mongering pharmaceutical companies.” In the article, Bramhall questions pharmaceutical companies marketing so many drugs that are what he refers to as “me-too” drugs. He calls them that because they are basically copycat drugs that have small variations of drugs that are already on the market.

The article makes special mention of SSRI medications like Paxil and Effexor.

“The main downside of me-too drugs is that they are a primary factor in skyrocketing health care costs, which in turn are the main reason hundreds of thousands of Americans can't afford to see a doctor when they are ill," Bramhall says.

In the cases of Paxil and Effexor, both of which are known to cause serious side effects, patients can find themselves stuck in a Catch-22 situation in that they get sick and then take a prescription that makes them worse, causing them to need more medication. It’s a vicious cycle.

He mentions that Big Pharma's obsession with copycat drugs ignores the many illnesses and early deaths that are caused by these drugs when marketing and selling them. He talks about how copycat drugs are presumed safe because their approved counterparts are on the market already and selling well.

Bramhall has a point. Oftentimes, doctors will prescribe Paxil for depression and if the patient doesn’t respond to it, they will simply move on to another one just like it, like Effexor. SSRI’s have already had study results claiming that they don’t work any better than placebos, so the many variants of SSRI medications seem almost pointless.

“I, like most of my colleagues, have never found a differential response to different brands," Bramhall says of this issue. "My own clinical experience coincides very closely to recent meta-analyses of three decades of SSRI efficacy studies: about 35-40 percent of patients (only slightly higher than the placebo response) get a positive response to any SSRI, while 60 percent [of them] fail to improve or experience horrible side effects.”

It makes sense to put two and two together by saying that pharmaceutical companies keep pushing these meds by turning every foible into a disorder that requires treatments. With so many drugs on the market that do the same thing, they have a lot of drugs to sell. But do they really have to make and sell the same drugs over and over again, where the only real difference is the non-medicinal fluff? I ask this especially when some studies show that they don’t work any better than a sugar pill.

Dr. Reddy's Labs launched three drugs in the American market on June 6 after receiving FDA approval for those drugs, which include generic Effexor XR.

The announcement came on June 6 that the drug maker was approved by the FDA in selling donepezil hydrochloride (generic Aricept) which is used to treat Alzheimer’s Disease, venlafaxine hydrochloride extended-release (generic version of Effexor XR) and a generic version of Femara, which is used to treat breast cancer. The company also stated that it had actually received FDA approval for selling the Aricept and Effexor XR in May, even though the letrozole pills were only given approval last week.

The patents for Effexor won’t expire until 2017, but generic drug companies have been trying to get their hands on the rights to sell their own copies of the controversial, but still hugely popular antidepressant. With only 5 years on the clock before it becomes open season for the generic Effexor makers, Dr. Reddy’s was eager to reach a settlement with Wyeth so that they could get as much money off of selling the drugs as possible before the stampede starts. The thousands of lawsuits that have been filed against the makers of Effexor don’t matter very much when there is so much money to be made.

A senior official for an Indian pharmaceutical company summed it all up best when he said, “Given the large number of generic firms that had challenged the patents of Wyeth over Effexor and the series of settlements Wyeth had entered into, the average settlement amount is insignificant, mostly slightly over the litigation charges incurred by the drug firms.” This statement makes sense when you think that drug companies lose millions in settlements and litigation fees, but they also rake in billions in sales.

Health Canada has made it known that the agency is conducting a safety review of birth control pills that contain drosperinone. At the top of that list are Yaz and Yasmin, which have been linked to severe side effects like venous thromboembolism (VTE). VTE is a form of blood clot, and like another form of blood clot (pulmonary embolism) it has been linked to oral contraceptives that contain drosperinone.

Right now Yaz and Yasmin are the two birth control pills that are being marketed in Canada. Drospirenone is a type of synthetic progestin that is linked to various other harmful side effects, such as heart attacks and strokes. Those side effects have been the source of many harmful conditions in women — even death for some. Most recently, the British Medical Journal published results from two studies that show that drosperinone-containing birth oral contraceptives were more likely to cause blood clots than the older generation pills that use levonorgestrel.

Even the group Drug Watchdog has urged women to contact it if they experienced blood clots after taking Yaz or Yasmin. While the FDA is reviewing the pills, they still advise women to take them — with proper monitoring by their doctors. They are also urging patients taking Yaz or Yasmin to contact the doctor immediately if they experience of the symptoms of blood clots while taking them. The symptoms include persistent leg swelling, leg pain or tenderness, chest pain or sudden shortness of breath.

The FDA advising women to take the pills while reviewing how dangerous they are may seem like a contradiction, but until the review is finished, there is little else that the agency can say. However, with the long list of lawsuits against the makers of Yaz and Yasmin, it is hoped by many that FDA will recall the pills after the reviews.

On May 18, the lawyers on both sides of the first Yaz bellwether trials convened and finally agreed to the new trial schedule for the Yaz lawsuits that will go through the American judicial system.

The first Yaz lawsuit that will see the inside of a courtroom will be representing plaintiffs that suffered from pulmonary embolisms caused by the controversial birth control pills. According to materials that were released from the status conference, this first case has been set to begin on January 12, 2012, in the federal courts. Two other state pulmonary embolism trials will follow soon afterward.

The second trial is set to begin in April 2012, and will be the first Yaz gallbladder disease bellwether trial to reach the courtroom. Again, there will be two different state trials that will go to court shortly after the federal bellwether cases begin. The state gallbladder disease trials will likely happen within 2 months following the federal cases.

Finally, it was decided that the deep vein thrombosis trials will start in late June 2012. Another two state cases will go to court within 2 months of the bellwether cases. Altogether, that will make it a total of 9 Yaz trials that are set to begin with a 9 month period. The trials are expected to set precedents in how future Yaz cases will be judged.

The first trial was supposed to begin in September of this year, but a delay was ordered when lawyers on both sides of trial asked for more time to go through expert testimony and evidence. According to the minutes that were released from the status conference, Judge Herndon (who will be presiding over the first of the bellwether trials) said, “something drastic would have to happen” if they were to decide to delay the trial schedule that has been established at the conference.

There is a great deal of evidence that supports the fact that Reglan side effects for children are harder to detect, but that they are also more severe than in adults.

Reglan (metoclopramide) is a popular drug that is used to treat gastroesophageal reflux disease (GERD). While it is meant to be used for periods of no longer than 12 weeks, it is often prescribed for longer terms. The drug is also commonly prescribed to children and babies when they haven’t responded well to other treatments. The downside to taking this medication is that it also causes patients to suffer from various side effects.

One of the more severe side effects from taking Reglan is tardive dyskinesia, to which there is no known treatment or cure. This condition causes patients to suffer from involuntary facial ticks and spasms of the lower limbs. These symptoms are also very hard to detect in babies and small kids. However, there are symptoms that you should watch out for if you have given your baby or young child Reglan that can let you know if they are having adverse effects from the drug. Some of the symptoms to watch out for include:

• agitation
• confusion
• diarrhea
• dizziness
• drowsiness
• fast heartbeat
• fever
• headache
• increased sweating
• rigid muscles
• tiredness
• trouble sleeping

Due to unrecognized TD symptoms in children, many kids aren’t diagnosed with the condition quickly because the parents simply don’t know what they are looking for. Because of tardive dyskinesia in their children, thousands of parents have filed Reglan lawsuits claiming that they weren’t properly warned of the serious risks the drug posed to their kids.

TD is often misdiagnosed as Parkinson’s Disease because of the similar symptoms of each condition. It is advised that if your child has been diagnosed with Parkinson’s after taking Reglan, you should seek another diagnosis.

Mary “Arlene” Baymiller just received probation for the murder of her husband, Charles “Skip” Baymiller, after a request from her children in a “Paxil Defense” case.

According to details from the case, Charles was suffering from dementia, which caused Mary to start taking Paxil for anxiety and Ativan and Ambien for sleep. When Mary started to complain about suffering from bad side effects of the drugs, her doctor increased her dosage. Her lawyer stated that on Friday, May 20, she was sentenced to 5 years of probation for the murder. The reason the murder happened, says her lawyer, is that her drug cocktail caused her to suffer from a “catatonic drug-induced state.” He says that this is what caused Mary to kill Charles by stabbing him hundreds of times in the throat in October of 2009.

After the stabbing, Mary stabbed herself and tried to overdose on the Paxil and sleeping pills. Mary says that she doesn’t remember stabbing her husband because of the drugs’ affects. Her attorney also said that “because there was no blood spatter on the walls that the stabbing was not in a violent frenzy because the blood would have flown off the blade and into the wall.” Her adult children came to her defense during sentencing.

Deputy District Attorney Eliott Sattler disagreed with the probation order and stated that he thought it was sending a bad message to the public. He asked the judge, “What does it say to the next person in a difficult situation with a loved one? We are living in an aging society. What does that say to them? To condone what she did?”

Judge Perry did warn Mary that if she violated the terms of her probation, he would give her a large sentence. As part of her probation, Mary must keep getting treatment for her mental health problems, and take her drugs as they are prescribed to her. Judge Perry defended his position by saying that there was no reasonable explanation for why Mary killed her husband “other than the medications involved,” and said she had suffered enough by losing "her best friend of 43 years."

The Drug Enforcement Administration (DEA) decided to host a one-day event last September that gave people the chance to return their unused prescription medications like Paxil in an effort to help combat prescription drug abuse. The first one was so successful, they did it again in April of this year with similar success.

According to information provided by the DEA, the reports say that they were able to collect 376,593 pounds (188 tons) of pills, some of which included antidepressants like Paxil — more than what it collected last year. The pills that are being brought in are those that nobody wants and are willing to give back to the government. Naturally, this amount is not the number of pills that are actually out there. The DEA says of the reasons behind this "drug day:" "More Americans currently abuse prescription drugs than the number of those using cocaine, hallucinogens and heroin combined. . . . [I]ndividuals that abuse prescription drugs often obtained them from family and friends, including from the home medicine cabinet."

A study that was released two years ago found that "the number of Americans taking antidepressants doubled to 10.1 percent of the population in 2005 compared with 1996, increasing across income and age groups." Author and clinical psychologist Bruce Levine talks about drugs like Adderall (addies), an amphetamine, being taken by teens and college kids. He says that the drugs act the same way on the brain as cocaine does, "and if one takes the antidepressant Effexor at the same time one is taking the antidepressant Wellbutrin, one can sense the hypocrisy in labeling certain psychotropics as 'antidepressants' and other psychotropics as 'ADHD psychostimulants.'”

Since popular drugs like Paxil and Effexor are addictive and dangerous when taken correctly, they can be even more dangerous when taken for recreational purposes. That is why the DEA hosted such an event — in the hopes of helping to make some of the drugs less available to the public. While many people still keep their medications and often hand them to friends and family members, it is recommended that you don’t. Doing that can cause more harm than good since each dosage given in prescription form is specific to each individual’s needs and can have deadly consequences.

The second Levaquin trial has finally begun in Minnesota as of Tuesday, May 31, 2011. The case in the courts now is the second of the Bellwether trials that has been brought to court. It will be important in setting the precedent for future lawsuits.

Calvin Christensen is an elderly man from Minnesota who experienced a tendon rupture after taking Levaquin roughly 6 times between 2001-2006. His lawsuit was first filed in September of 2007. Christensen’s lawsuit is against Johnson & Johnson, the makers of Levaquin, and alleges that the drug giant failed to properly warn the public of the drug’s increased risks of causing tendon damage.

Christensen’s Levaquin lawsuit is the second one to go to trial. The first case was filed by John Schedin after he suffered from tendon ruptures. Schedin's $1.8 million verdict is currently being appealed. It is likely that Christensen’s case will use some examples that Schedin’s case had. Although it is also likely that defense lawyers will be allowed to make objections that they couldn’t make during the first trial, they also will likely be allowed to object to evidence from Schedin’s case being used.

The first New Jersey Levaquin trial is set to begin in August or September, 2011, and the third Bellwether trial (after Christensen's) is set to take place in September. The next case management conference in New Jersey is set to take place on June 13.

Levaquin has had thousands of lawsuits filed against Johnson & Johnson because of tendon ruptures. Since most of the cases allege that the drug company didn’t warn the public properly of the side effects, the outcome of Christensen’s case will play a large roll in how the other cases will be tried and settled. If Schedin’s case gives any idea as to how that will work out for the plaintiffs, there may at least be some monetary relief, if not total release from the pain of their injuries.

As the Yaz Bellwether trials are commencing, Bayer, the makers of the popular and controversial birth control pills, is about to have its product reviewed by regulators following the many studies that allege that the pills increase users’ chances of getting blood clots more than other medications do.

All of this comes on the heels of a recent report was published by the British Medical Journal that discovered that the risks were increased as much as two times to three times simply from taking Yaz and Yasmin. As a result of the study, the FDA announced that they will be looking into those risks. Tuesday’s statement explained that all drugs containing the synthetic progestin drosperinone will be investigated.

European regulators announced last week that they changing the prescription information of Yaz and Yazmin so that they will include the new research findings. While it is known that all birth control pills are linked to an increased risk of blood clots, the FDA review is going to focus specifically on the drospirenone that is most often found in Bayer’s Yaz, Yasmin, Beyaz and Safyral. The FDA expects to give its results ready as early as this summer. The investigation will consist of studying 800,000 people it will commission to examine the risks.

For now, the regulators have advised doctors and patients to keep an eye out for any symptoms that can signify that a person may have a blood clot. Some of those symptoms can include leg or chest pain.

With all of the negative information being given about the pills, Bayer still stands behind the use of the drosperinone publicly. The pills are still top earners for them and make up at least 3.3 percent of the company's revenue.

“Patient safety is Bayer’s top priority," a statement from the company says. "Bayer’s analysis of the overall body of available scientific evidence continues to support its current assessment about the safety of its oral contraceptives.”

According to an article by Dr. Keith Ablow on Foxnews.com, patients suffering from dementia should be treated with antidepressants like Paxil before they are given dementia medications.

Dr. Ablow’s reason for saying that is because he thinks that at least 1 million Americans that are diagnosed with dementia (even Alzheimer’s dementia) are not suffering from dementia at all, but depression. While there is no cure for dementia right now, there is a cure for depression. Dr. Ablow believes that depression patients are being misdiagnosed with dementia because the symptoms of both are virtually the same. The symptoms of both conditions include: memory loss, profound changes in energy, difficulty concentrating and a hard time making decisions, and even changes in motor functions that can cause patients to stumble, wander and even get lost.

Ablow says in his article “because major depression can so perfectly mimic dementia, I believe that every individual diagnosed with dementia should be treated for major depression, just in case that condition is actually to blame.” Ablow goes on to say, “That may seem like a very bold therapeutic strategy, but there simply is no way to know for sure what percentage of the millions of Americans diagnosed with dementia might have actually been misdiagnosed and might well be completely curable.”

Ablow believes that starting with a low dose antidepressant like Paxil for treating people who have been diagnosed with major depression, and then upping the dose if nothing happens is the way to go. He believes that it is then that doctors can begin to add repetitive transcranial magnetic stimulation (rTMS), which is a new technology that treats the symptoms of major depression without any serious side effects attached to it that drugs like Paxil can cause.

The treatment delivers magnetic waves to the part of the brain that is believed to be underactive in depressed people. rTMS, when taken with an antidepressant, could be a better treatment for older Americans that are diagnosed with dementia. Ablow’s article states, “The idea of ‘empirically’ (without clear evidence) treating dementia as depression would be no different than empirically treating lung cancer with antibiotics were it impossible to know with absolute certainty whether pneumonia might be the real diagnosis.”