Product Liability Attorney Blog

The controversial birth control pills Yaz and Yasmin have come under fire from people claiming that the drugs have caused such side effects as strokes, heart attacks and blood clots to its users who were not properly warned about these potential complications by the drug's makers, Bayer.

Yaz/Yazmin is also popular for use as an acne controller, even though it is not approved for that use. Many teens have chosen Yaz as a birth control method specifically for its alleged "benefits for the skin". However, regardless of its uses, the drug may be the reason why an 18 year old girl from Independence Township in North Carolina is no longer living. According to a report in the Eastern Express Times, Michelle A. Pfleger was on her way to a morning class at Elon University on September 14 when she collapsed on the ground. The girl was pronounced dead shortly thereafter at the hospital.

While the official cause of death has been recorded as a pulmonary thromboemboli (obstruction of the blood vessel of the lungs) by the North Carolina Office of the Chief Medical Examiner, the girl's mother believes that it was Yaz that killed her daughter. Pulmonary thromboemboli is basically a blood clot, which is a well known side effect of Yaz. While it should be noted that the girl was treated with an analgesic (painkiller) because of a knee injury just the day before she died, the mother goes on to say "there's just really no reason that a healthy young woman who has a knee injury would have developed this."

While the medical examiner did know about the girl's knee injury he does state that he doesn't believe that it contributed to her death. In a statement to the Eastern Express Times, Dr. Alberto Estrada, the director of the vascular lab in Phillipsburg's Warren Hospital, said that it is rare for an 18 year old to die from pulmonary thromboemboli. He goes on to say that birth control pills such as Yaz may not be the direct cause of a death however there is the possibility that it could be a contributing factor if the conditions were right.

Patients take Reglan as part of their treatment for gastro-esophegal reflux disorder (GERD) and other gastrointestinal problems. Women also have used Reglan to help them produce breast milk. The drug even has been prescribed to premature babies that are experiencing GERD and other reflux problems. But many of these patients are starting to find that the adverse side effects of the drug may be worse than the disorders that it’s treating.

Some of the side effects associated with Reglan also are commonly reported with a multitude of drugs, such as headaches, vomiting, diarrhea and more. However, one major side effect that patients are getting from taking Reglan is tardive dyskinesia (TD), which is a movement disorder that causes symptoms including:

• feeling restless
• having a constant need to move around
• lip smacking
• continuous chewing or sucking movements
• grimacing (making faces)
• puckering or pursing the lips
• facial jitters or twitching
• tongue protrusion
• rapid eye blinking

The problem with these side effects is that it can take a while for a patient to notice them. When they do, the symptoms can be easily misdiagnosed as other things long before TD is identified. The symptoms listed above generally are misdiagnosed at first as restless leg syndrome or even Parkinson's disease. The movements associated with TD can occur in the arms, legs, torso and fingers, which is likely why Parkinson's often is diagnosed. Generally it is only after continued prescribing of Reglan that doctors notice that the symptoms may be related to the drug.

If you are experiencing any of the symptoms listed above and have been taking Reglan for a period of 3 months or more, you should tell your doctor immediately. You might be suffering from TD and may be eligible for compensation. You should not take yourself off of Reglan without a doctor's supervision.

According to the St. Clair Record, lawyers on behalf of the plaintiffs in a Yaz/Yasmin lawsuit have asked U.S. District Judge David Herndon to force Bayer, the makers of Yaz, to produce production documents from all over the world. Herndon currently is assigned to preside over all the Yaz lawsuits in the country.

Back in November, plaintiffs’ lawyers had made the request for all of the production documents from as many as 100 different countries as part of their lawsuit, which claims that Bayer purposely downplayed some of the adverse side effects associated with the popular birth control drug in their advertising campaign. These side effects allegedly include maladies such as injured kidneys and disorders of the bloodstream.

In response to the request, Bayer's attorney filed a motion to protect the company’s documents on December 3, 2010, claiming that the plaintiffs only wanted to use the documents as leverage in the case and not for actual evidence.

"The discovery demands in this litigation no longer bear any relationship to the truth-seeking function of litigation," Bayer's attorney wrote.

Bayer’s counsel also claims that the request is impossible based on the size of the documents alone. The Bayer legal team is arguing that there are 7,000 documents in total that easily weigh an astonishing 200 tons.

While that argument is a plausible one, word hasn't come out about what Herndon is going to do about the plaintiffs’ request. Bayer has come under fire a lot against Yaz's adverse side effects — effects which can be fatal in some cases. Yaz has been linked with heart attacks, strokes and blood clots since it has been released and there are many lawsuits being filed against the company. Whatever Herndon's decision is regarding the production documents, his decision likely will affect other cases against the drug giant.

According to the Yale Daily News Report, one of the professors at the Yale School of Medicine recently signed her name to a ghostwritten study on the side effects of Paxil.

In a claim originally made by the Project on Government Oversight (POGO), associate professor Kimberly Yonkers signed her name to a report that was written about the popular antidepressant in 2003. Trouble is, she didn't actually write it.

POGO has claimed that the ghostwritten study (supposedly authored by Yonkers) was not even an actual study but rather a part of a promotional scheme that the makers of Paxil, GlaxoSmithKline, created as a means of increasing sales for the popular drug. Yonkers insists, however, that she was very involved in the writing and editing of the report. The reports of the study that were written were meant to show that Paxil was safe and perhaps to downplay the negative side effects.

Also, a former spokesperson for Wyeth Pharmaceuticals named Daniel Carlat says that Glaxo seemed to take advantage of Yonkers by using her as a "mouthpiece" so that they could further promote Paxil. According to the National Center for Biotechnology Information, the negative side effects of Paxil may include headaches and vomiting. But it also may cause even more serious problems such as skin rashes and blurred vision.

As to Yonkers' claims that she had written the report, there could be some legal issues ahead for her because often times writers have to sign non-disclosure agreements that usually include clauses that allow the hirer to pursue legal action if the writer in any discloses their involvement in the document production. Clauses often require writers to give up any claims to writing, editing or proofing the document as well as disclosing any information that is written in it.

When it comes to the lawsuits that have been filed against GlaxoSmithKline, the makers of the popular antidepressant Paxil, there is really no way of knowing how any specific case will turn out since some cases have been settled while others have been dismissed.

While it is common for many cases to be won on the merits of other cases when product or company liability is concerned, it seems that this is not the case for Glaxo's popular drug. In July 2010, for example, Glaxo ended up settling a little more than 800 lawsuits under the allegations that the drug caused birth defects. Those settlements cost the company more than $1 billion. The Wall Street Journal quoted an e-mail that the paper received from Glaxo that stated that the company "has reached an agreement to settle certain cases involving the use of Paxil during pregnancy. The details of those settlements are confidential. Other cases remain pending."

One of the cases that was pending at the time concerned a 14-year-old girl named Anna Blyth whose mother took Paxil while she was pregnant. Anna was born with cardiac problems. The lawsuit claimed that Glaxo failed to properly warn the public about Paxil's side effects like birth defects. Halfway through the trial, the judge in that case dismissed it because Glaxo denied any wrongdoing with regard to its marketing and Anna didn't suffer any long-term effects.

In another case, the family of a boy that died when he was 6 weeks old because he was born with persistent pulmonary hypertension of the newborn (PPHN) received an undisclosed settlement from Glaxo. It is hard to tell which cases will be settled, which ones will win and which ones will be awarded nothing or dismissed. If the cases that have gone to trial so far tell you anything, it is that you simply never know.

On Friday, the Supreme Court agreed to take on an appeals case that will decide whether generic drug makers can be sued for failure to properly label their drugs' side effects the same way that name brand manufacturers can. This will apply even if they follow the federal rules that only make the generic makers use the same information that the brand name companies do.

The appeal comes from PLIVA Inc. A woman named Gladys Mensing took the generic version of Reglan, known as metoclopramide, for four years because she had diabetic gastroparesis. Her suit claims that she got a severe neurological movement disorder called tardive dyskinesia (TD) from taking it. TD is a common side effect of taking the brand name Reglan. The woman also claims that the generic version of Reglan that she was taking didn't properly warn her of the risks on the labels like they should have.

After the woman sued, the generic drug's manufacturers and distributors requested that the suit to be thrown out. According to them, they followed the government regulations about labeling because they are required to have the same label on metoclopramide that is on the name brand Reglan and they did that. The problem with that logic is that Wyeth, the makers of Reglan, also is being sued for not properly adding warnings to its labels.

A federal judge agreed with the companies and said that the suit was pre-empted by federal laws that forced the labels to be the same. However, the 8th Circuit Court of Appeals in St. Louis said that they should have included more warnings and overruled the original judge. The judge basically said that generic versions of Reglan didn't have to be marketed and that if the companies didn't like the original labels warnings on Reglan, they could have opted not to sell the generic version rather than profit off of it. When this ruling was appealed, the Supreme Court opted to hear the case in the spring.

With all of the lawsuits and settlements that the makers of the popular drug Paxil have been forced to comply with due to the alleged birth defects the drugs causes, many women that have taken Effexor may be watching the outcomes of these lawsuits closely.

Women that were taking Effexor while they were pregnant and gave birth to children with specific birth defects that have been linked to the drug are right to pay very close attention to the outcomes of all of the lawsuits that have been filed against GlaxoSmithKline, the makers of Paxil. Some of the complications that have been linked to Effexor include persistent pulmonary hypertension of the newborn (PPHN) and congenital heart defects.

Effexor is an antidepressant that is most commonly prescribed to treat depression, obsessive-compulsive disorders and severe anxiety disorders. It is in a class of drugs called serotonin-norepinephrine reuptake inhibitors (SNRI). While Paxil is actually an SSRI, research has shown the risks of both drugs have been shown to be the same because they both effect the same level of serotonin the brain.

This is why women that have taken Effexor may want to follow what is happening with the Paxil litigations. Even though one recent case has been dismissed against Glaxo, the company has agreed to settle something like 800 of the lawsuits filed against it. At this point there haven't been any lawsuits filed against Wyeth, the makers of Effexor.

However, recent studies are showing that there is a link between Effexor and an increased risk of miscarriage. A recent study has shown that women that took Effexor are twice as likely to have a miscarriage as women that didn't take the drug. This study was published in the Canadian Medical Association Journal. While Glaxo has paid more than $1 billion toward Paxil settlements in general, this amount likely will increase before the storm clouds disappear.

Knowing that the link to birth defects and miscarriage can be sustained with published research will likely make Effexor lawsuits come out of the woodwork sooner rather than later. Perhaps the women are just biding their time so that they can use the rulings against Paxil and the settlements to further their cause. If you think that your child has suffered birth defects due to Effexor you still have time to get proper compensation.

A woman was admitted to the Valley Psychiatric Hospital in Chattanooga, Tenn., after suffering from jitters and extreme nervousness that she attributes to taking Reglan. Her doctor later confirmed this.

"It was my sister who prompted me to go back to my doctor — she said I looked wild,” the woman stated in an interview. “I felt like I was going to jump out of my skin; I couldn't sit still and kept having panic attacks. I was admitted to the psychiatric hospital because my system had reached a super-saturation point; a psychiatrist explained that I had to take other meds to counteract the Reglan, and looking back, that really makes me angry with the makers [Wyeth] of Reglan."

The woman also likens herself to Elvis when she further says, "that's what killed Elvis — taking so many drugs to counteract all the other drugs he was taking, and his body just couldn't take it. Of course I didn't abuse drugs like he did, but I can relate after Reglan did this to me."

The woman stayed in the hospital psych ward for a period of two weeks where she underwent group and individual therapy to get over her fears. She claims that she was exposed to much ridicule when other patients found out that she was a school guidance counselor.

All of this happened 15 years ago. The woman alleges that while the side effects of the drug were mentioned then, it was easy to miss something because they didn't give out printouts like they do today and everything was written in fine print. Many people today know exactly how she feels; fortunately, a lot of patients now are getting the compensation that they deserve for their trouble. If you are taking or have taken Reglan and feel like you are suffering from adverse effects, you should contact your doctor immediately. Time is running out for you to be able to file for compensation.

An Edina man won $1.8 million recently after a federal jury ruled that Johnson & Johnson failed to properly warn its patients of the adverse effects of the popular antibiotic drug Levaquin. The drug has been proven to cause tendon damage.

The Minneapolis jury ruled in favor of the 84-year-old man on Wednesday. In this case, the man will receive $1.12 million in punitive damages and $700,000 in compensatory damages for suffering from the rupture of both of his Achilles tendons after taking Levaquin in combination with a steroid 5 years ago. He was given Levaquin when he suffered from bronchitis. At the time the man and his doctor were unaware of the risks associated with taking the drug combination.

The ruling is very welcomed after three weeks of testimony. According to Ron Goldser, an attorney with Zimmerman Reed, who acted as co-council in this case, the plaintiff "is very pleased because he feels his decision to come forward has been vindicated — he came forward so this doesn't happen to others. It was never about the money for him."

Since 2008, the FDA has forced the drug manufacturers to issue black box warnings on their drugs packages so that patients and doctors easily can read the adverse side effects that taking Levaquin can have. This risk is even higher if the patient is over 60 years old and if they are also taking steroids. This ruling may be setting a precedent for the many more that will follow. It is rare for proven cases to be ruled against once a couple of claims have gone through. If these cases are a sign of what is to come, Johnson & Johnson could wind up settling many more cases just to avoid the embarrassment and excessive attorneys fees that it will take to try and keep its name clean.

The statute of limitations may be running out for people that want to file lawsuits against the makers of the popular drug Reglan. Current reports state that it is believed that the clock will run out on lawsuit filings as early as February 2011.

The reason for this is because the FDA posted the black box warning in 2009 against the drug Reglan because of the risks it posed to users getting Tardive Dyskinesia. That would make February 2011 the second anniversary of that FDA ruling. In many states, that time period of 2-year period marks the statute of limitations for filing any lawsuits against Reglan. While there likely is a large amount of people whose injuries would qualify, not many realize that there is a time limit with which to file.

Reglan mostly is prescribed for treatment of gastroesophageal reflux (GER) and gastroesophageal reflux disease (GERD). The drug also has been used to treat breastfeeding mothers who have a difficult time producing breast milk. It should be noted, however, that the chances of a mother suffering from tardive dyskinesia is most likely to occur if the mother is taking Reglan for more than three months.

Many women that agree to taking Reglan are not even told about the real risks of the drug by their doctors beforehand. That is why there are so many women that will be affected by the statute of limitations. When you add that to the more serious side effects of the drug like Neuroleptic Malignant Syndrome (NMS), which can eventually lead to death in the most serious cases, the statute of limitations can force many potential claimants to rush to get their claims filed. In the end, courthouses in many states are likely to get filled with Reglan cases in the near future.

Canadian David Carmichael easily can attest to the extremely harmful affects of taking Paxil. In fact, he claims that his son Ian died in 2004 due to the side effects that David suffered while taking Paxil.

In a story that was originally published with the London Free Press on October 13th, Carmichael's story sheds new light on some of the dangerous side effects that Paxil can have on its users. According to the story, Carmichael was put on Paxil in 2003 as a form of treatment for his severe depression.

"The doctor didn't tell me about any of the possible side effects," he stated in an interview with QMI News Agency.

At one point, Carmichael started to become extremely delusional and psychotic. During this episode, Carmichael thought that his son had suffered from brain damage after having epileptic seizures. Carmichael thought that this brain damage would make his son hurt other people. Because of this belief, Carmichael strangled his son to death in the hotel room.

David Juurlink, a drug safety expert at the Sunnybrook Health Sciences Center of Toronto, has admitted that Paxil can cause suicides in some people that are taking the drug.

"It's not much of a stretch to think it might rarely trigger homicidal behavior, too," Juurlink adds.

As a result of the murder, Carmichael was charged with first-degree murder but he was not found guilty for the crime. Instead it was ruled that he was not criminally responsible because of a mental disorder.

The potential links between his behavior and having taken Paxil wasn't formally explored during the court proceedings; however, since his 2009 trial decision, research has proven that violent behavior does occur with people that are taking the drug. Carmichael's story is only one of many. It is for this reason that if you think that you may be suffering from any of the severe side effects of Paxil such as suicidal/homicidal thoughts or behavior, you should consult your doctor immediately.

While GlaxoSmithKline, the makers of the popular drug Paxil, had agreed to pay more than $1 billion as a means of quickly resolving more than 800 lawsuits against the company back in July, more cases and settlements may bring the total to twice that amount.

Lawsuits and investigations against its drugs Paxil and Avandia have plagued the company. Plaintiffs claim the company attempted to hide the risks of taking Paxil — including suicide, addiction problems, birth defects and deaths. When the FDA issued severe warnings against Avandia and restricted the marketing of that drug, as well, settlements were bound to arise — and they did.

According to people closely linked to the lawsuits, Glaxo has paid out about $1.2 million per family to those that had children that suffered from birth defects (there were 100 unsettled cases pending at the time) caused from Paxil. The company has stated that they put aside $2.4 billion to resolve cases against them that were related to both Avandia and Paxil. That amount just doesn't look like it will be enough in the end.

The settlements brought about by the cases from Paxil alone have cost the company $2 billion in settlements already. In October, it was reported that Glaxo paid $750 million for selling adulterated drugs (Paxil) after a manufacturing problem at its plant in Puerto Rico. The company was found to be in violation of good manufacturing practices.

While $2.4 billion may sound like an enormous sum, it pales in comparison to what the constant lawsuits are demanding the company pays — and this doesn't include the legal fees. All of these lawsuits have made consumers wary about trusting the drugs that they are prescribed. In the long term, Glaxo may wind up paying so much in settlements and legal fees that sales just might not be able to make the losses worth it. If this does happen, perhaps they will finally learn their lesson and change the company's practices.

According to a recent seven-week study published in the Journal of Oncology, antidepressants like Paxil and Effexor can lessen the severity of hot flashes in menopausal women.

The study looked specifically at the effect that SSRI (Selective Seretonin Reuptake Inhibitors) medications had on these women. It seemed to offer some sense of relief during the women's hot flashes. Celexa (Citalopram) seemed to work the best because it can be used while the women are taking Tamixofen, a popular drug to treat breast cancer. A common side effect of taking Tamixofen is hot flashes.

Paxil and Effexor can't be used while taking Tamixofen because paroxetine and flouxetine stop the enzymes that the body needs in order to metabolize Tamixofen. The research was conducted on 254 women whom had started menopause and whom said that they had hot flashes at least 14 times a week. For the first week of the study, the women kept track of each hot flash and how severe it was.

Next the researchers gave some of the women Citalopram and some placebos to see how their hot flashes went over the next 6 weeks. The women that were taking the antidepressant showed up to 55 percent fewer hot flashes; in the control group, just 23 percent of participants felt a decrease. The women taking the smaller does of the antidepressant didn't see a huge difference but the women taking the 20 mg dose did.

All of the women that were taking the antidepressants, however, did note that they had better sleep and moods. Since the doses of antidepressants like Paxil and Effexor are usually higher when used to treat depression or sever anxiety disorders (30 mg) than those doses used for this study, there was no evidence that patients would experience the severe side effects that often go along with taking Paxil and Effexor.