Product Liability Attorney Blog

President Barack Obama’s birth control pill "compromise" on providing free birth control pills to workers for religious institutions is turning heads and sparking debates left and right lately. For starters, it has many activists expressing alarm that no one is thinking of the dangers linked to pills like Yaz and Yasmin.

This all got drudged up when Obama said that workers at religious institutions will get free birth control pills directly from their health insurance companies instead of through their employers, who largely disagree with providing contraception for religious reasons. His free birth control order has been met with a good deal of criticism from religious people, who have said that forcing employers to include contraceptives in their health insurance plans is “un-American.” One such statement came from Sen. Joe Manchin (D-W.Va), who is a Catholic.

“This is not only unacceptable, it is un-American. Correct this decision which will erode the conscience rights," he said.

Un-American or not, there's plenty to be worried about. When Obama made his speech concerning the addition of birth control pills to health insurance coverage, he neglected to mention the dangers linked to the pills. That is what has activists up in arms. Pills like Bayer’s Yaz, Yasmin and Beyaz have been the subject of much controversy after studies showed that the pills’ main ingredient, drospirenone, is linked to various life-threatening conditions. Some of those conditions include gallbladder disease, heart attacks, strokes and blood clots that can lead to pulmonary embolisms and deep vein thrombosis — even death.

For many activists, this omission of the pills’ dangers is irresponsible and dangerous. After studies showed the threat the pills represent, the FDA held panel advisory meetings to discuss blood clots risks. Unfortunately, these very meetings were also controversial once it was discovered that panel members had financial ties to Bayer. Regardless, the FDA has upgraded the blood clot risks on the pills’ labels. This recommendation by the FDA is viewed many to be too little, too late, and why as many as 10,000 Yaz lawsuits have already been filed by women who have suffered because of serious side effects.

The first Effexor birth defects lawsuit has been filed in Philadelphia Court of Common Pleas on February 9, after a baby died in Ohio. The lawsuit is alleging that the mother’s use of the controversial antidepressant medication Effexor is directly to blame for the death.

Glen and Lauren Boyer had a baby girl named Adelaide, who was born on February 11, 2010. Shortly after her birth she was diagnosed with lethal cardiac anomalies that included severe left hypoplastic heart, a malformed aorta, no aortic value, and a malformed mitral valve. These conditions, the Boyers believe, were caused by Lauren’s use of Effexor during her pregnancy.

In their lawsuit, the Boyer’s are alleging that the manufacturers of Effexor didn’t properly warn Lauren of the birth defects dangers linked to taking Effexor. The Boyer’s attorney has stated, “The information that patients – especially women who are pregnant – receive about the medication that is prescribed to them is crucial. This SNRI drug was approved by the FDA in 1993, but the parties involved neglected to disclose the birth defect risks to physicians treating women of child-bearing age.”

The Boyer’s are also claiming negligence, fraud and misrepresentation in causing the baby’s death. This lawsuit is the first lawsuit that will be based on birth defects caused by Effexor. Studies have shown that drugs like Effexor, Paxil and various other antidepressants cause birth defects including: PPHN, cleft palate, and heart, lung and brain defects. It is expected that many lawsuits will be filed on behalf of the families whose babies were born with these conditions. Most of the expected lawsuits will likely be based on similar claims as the Boyer’s since drug companies are known to keep dangerous side effects hidden from the general public or bury the serious side effects deep inside the package insert where they are likely to be overlooked.

While antidepressants are used to a treat a variety of conditions (including anxiety, depression and obsessive compulsive disorders), it may surprise some people to know that it is also commonly being used to treat sexual addiction.

While sexual addiction is also treated with psychotherapy, SSRI medications like Paxil and Prozac are being used in conjunction with therapy. This SSRI treatment is viewed by many different psychiatrists as a condition that is dependent on the patient’s mood. This is why some of them are prescribing antidepressants like Paxil, which they believe can help treat the patient’s mood disorder as well as help to control their sexual urges or cravings. These doctors also believe that drugs like Paxil can help to control impulsiveness which can lead to addictive behaviors.

The SSRI medications like Paxil are said to work by causing chemical changes in the brain that stimulate sexual arousal. Sexual arousal actually occurs when the body releases a combination of adrenaline, serotonin, dopamine and endorphins. This chemical release is what the sexual addict is addicted to and it contributes to the addicts’ “high” which they feel before they even have sex. This state of mind in the sex addict is called the “erotic haze.” In fact, according to an article on southgrowth.com, “addicts try to stay in the 'erotic haze' as long as they can, putting off any actual sexual release. The 'erotic haze' is a somewhat euphoric state, not dissimilar to the inner state of an opiate user.”

Even if drugs like Paxil can help with some of the compulsiveness that sexual addicts display, the drug is also quite dangerous —especially when taken by pregnant women. SSRIs like Paxil have been proven to cause birth defects in babies whose mothers take the drugs while pregnant. Some of those birth defects include cleft palate, PPHN and neural tube defects. Paxil has also been linked to aggressive thoughts and behavior as well as suicidal thoughts and behavior.

If your doctor prescribes SSRI medications like Paxil to you as a treatment for sexual addiction, you may want to think twice before agreeing to it.

According to a recent study published in the British Journal of Clinical Pharmacology, senior patients taking SSRIs like Effexor and Paxil are more prone to falling down.

While many studies have been conducted on the effects of SSRI medications like Effexor and Paxil on the elderly, this most recent one has discovered that nursing home patients who suffer from dementia are as much as three times more likely to experience a serious fall than those patients who are not taking the drugs. This study also found that the larger the SSRI dosage is, the more serious the injury is after the fall. However, it should be noted that even in small doses, the results were similar.

SSRIs are a common treatment for seniors with dementia since so many of them are also suffering from depression. For this study, the researchers monitored 248 nursing home residents’ (who were diagnosed with dementia) daily SSRI drug regimen from 2006 to 2009. What they learned was that of the 248 residents, 152 of them had suffered through 683 falls. What this means is that there were an average of 2.9 falls for each person every year. They also found that 38 of the patients only fell once, but 114 patients fell on a regular basis. For all of these falls, 220 of them caused patients to suffer from various injuries, including hip and other fractures.

The lead author of the study, Carolyn Shanty Sterke of the Section of Geriatric Medicine at Erasmus University Medical Center, Rotterdam, Netherlands says, “Staff in residential homes are always concerned about reducing the chance of people falling and I think we should consider developing new treatment protocols that take into account the increased risk of falling that occurs when you give people SSRIs. Our study also discovered that the risk of an injurious fall increased even more if the residents were also given hypnotic or sedative drugs as sleeping pills.”

What this study shows is that senior patients should not be given SSRI medication like Effexor and Paxil due to the potential dangers that are linked to the drugs.

Drug giant Bayer is suing generic drug manufacturer Watson Pharmaceuticals amid claims that Watson has violated the patent for its birth control pills Beyaz, which is a reformulated version of the drospirenone-based oral contraceptive Yaz/Yasmin.

Watson has been trying to make a generic version of Beyaz that is said to be in violation of the patent... at least that is according to Bayer and its partner Merck & Cie. In court documents that were filed in U.S. District Court in Wilmington, Delaware on January 14, the two companies (Bayer and Merck) stated that they “are entitled to an award of damages and treble damages for any commercial sale or use” of the generic version of Beyaz made by Watson.

Watson is under the belief that they are the first makers of the generic version of Beyaz and are the first to request approval for any type of generic Beyaz product. It is for this reason that Watson believes that they are entitled to six months' exclusivity if they are approved. Bayer and Merck want their piece of the pie in terms of any profits that arise from the sale of generic Beyaz product sales.

Beyaz was created as a “safer” version of the controversial Yaz and Yasmin oral contraceptives. The pills are said to be safer because they added folate to the mixture that is primarily created with drospirenone and ethinyl estradiol. This effort by Bayer to add folate was meant to help reduce the chances of any unplanned babies chances of suffering from neural tube defects, but many people see it as an empty effort for the company to take the heat off of the real dangers linked to Yaz and Yasmin. Blood clots and gallbladder disease have been highly linked to the drospirenone-based pills, which makes this effort mute since Beyaz is also largely comprised of the dangerous ingredient.

A man who recently was arrested for allegedly robbing the Bank of America in Augusta is claiming that he was suffering from “involuntary intoxication” during the time, noting that he had recently started taking Paxil, a controversial antidepressant medication.

While the county’s Assistant District Attorney Hank Syms doesn’t believe that Paxil could have made the man commit the crime, studies have shown that Paxil and other SSRIs can cause people to act in aggressive and even homicidal ways. Syms denies these claims made by the defendant, and “waved away any claim” of this or any other type of intoxication when the robbery happened back in July 2010. He defends this by stating that “about one-third of clients that (go on to) make guilty pleas say they are affected by some form of medication.” Syms does, however, admit that he hasn’t heard of the Paxil defense used in court before because he assumes that most defense lawyers would “know better than to claim it.”

“What we have with this charade about ‘Paxil made him do it’ is the opposite of taking responsibility," Syms said.

Regardless of Syms’ personal opinion, the Paxil defense has been proven to be a valid one. It is not uncommon for judges and juries alike to accept the scientific proof of how SSRI medications like Paxil can alter a person’s brain chemistry and cause patients to act in impulsive and aggressive ways. In fact, there is a black box warning against the drug’s use on the Paxil labels.

As for this particular case, it is reported that Feliz Vega Jr. went to the Bank of America through a back door and aimed a paintball gun at the four tellers who were working at the time. He then proceeded to rob the bank. He got away with $12,000 in cash after telling the tellers to put the money in a “happy birthday bag.” During the crime, Vega was wearing a ball cap, ski mask and batting gloves.

Vega was eventually caught because of a tracking device that was in the bag. He was charged with four counts of armed robbery plus fleeing and attempting to elude.

A Minneapolis jury recently handed down a verdict in favor of Johnson & Johnson, which was sued by Clifford Straka. Straka’s lawsuit accused the drug company of failing to properly warn the public and healthcare professionals about the tendon rupture dangers linked to Levaquin.

While the jury’s verdict came as a blow to the plaintiff, their determination that Johnson & Johnson did not properly warn doctors and consumers about the tendon damage risks just adds salt on the wound. It seems almost impossible that a jury could agree with the plaintiff’s claim and still rule in favor of the defendant, but that is exactly what happened in this case.

Basically, even though the jury ruled that J&J failed to give proper warnings of the side effects linked to Levaquin, they also decided that the company was not responsible for any of Straka’s injuries since his lawyers couldn’t prove that his injuries were caused by the drug. Considering that Straka developed two tendon ruptures after taking Levaquin, it is astonishing that the jury would not link the two.

Levaquin is one of the most popular antibiotics in the American market. There have been countless studies that prove that the drug causes tendon ruptures — especially in patients 65 or older (Straka is 78) and those taking corticosteroids. The dangers are so widely known that the FDA even issued a black box warning against the drug in 2008, and numerous lawsuits have been filed against the manufacturers of Levaquin. At least one of those cases resulted in a $1.8 million award for plaintiff John Schedin — a ruling that was upheld on appeal.

One thing is certain: This newest ruling should not be viewed as a precedent since all individual cases are unique and warrant their own results. Schedin’s case is a testament to that.

Back in December, the FDA had its hands full with birth control pill issues. On December 8, 2011, it convened an advisory panel to discuss the safety concerns linked to Yaz and Yasmin (which are both drospirenone-based pills). What is not as commonly known is that the regulators also issued a statement that said that “a new brand of morning after pill is safe for women of all ages to take.”

What this means is that the original age for women to get non-prescription emergency birth control has been lowered from the original age of 17. The U.S. Secretary of Health and Human Services, Kathleen Sebelius, disagrees with this ruling. The main source of this controversy is the Plan B One-Step pill, which Sebelius said has been ruled as “safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases” by the Center for Drug Evaluation and Research.

Still, Sebelius believes that there just isn’t enough information to confirm the pill’s safety for women of all ages. This new emergency birth control pill has many wondering if younger patients will suffer the same fate as many patients who once took the drospirenone-based birth control pills Yaz and Yasmin. Both of those pills have been proven to cause severe adverse side effects like blood clots to young women who take the pills. The FDA estimates that as many as 10 in 10,000 women annually have a risk of developing life-threatening blood clots in the first year that they use Yaz, Yasmin and other dropirenone-based pills.

Should the Plan B pill be found dangerous, it could cause the public to distrust the FDA's methods in testing new drugs. Giving Plan B to younger women who may be completely unaware of the risks involved in taking these pills, may just end up being fatal for them in the long term.

Sebelius may turn out to be correct when she said “it is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age.” These differences may just end up causing unnecessary suffering by lowering the age requirements for getting ahold of these medications. In the long run, this FDA decision may turn out to be irresponsible at the very least.

Talia K. Weiss, who filed a Yaz lawsuit on October 12, 2011, has had her case transferred to federal court. Weiss’ lawsuit claimed that she was not aware of the dangerous side effects when she started taking the pills in 2008; she since has developed gallbladder disease as a result of her Yaz use.

Weiss’ original complaint was filed in the Circuit Court in Seminole County; however, the transfer puts her case in the District Court for the Middle District of Florida. Her lawsuit was transferred because of the amount of money that she was looking to receive in damages, which is more than $75,000, and due to the diverse nature of people who were involved in the case. This particular Yaz lawsuit may, in fact, end up becoming a tag-along for the Illinois Yaz MDL.

Yaz and Yasmin are both drospirenone-based birth control pills that studies show causes serious adverse side effects. Some of those side effects include gallbladder disease (which Weiss suffers from), heart attacks, strokes and blood clots. Weiss filed her lawsuit amid claims that Bayer, the manufacturers of Yaz and Yasmin, did not properly warn her or healthcare professionals about the risks involved with taking the pills. Weiss took Yaz until 2010 and is claiming that her gallbladder disease has caused her to suffer from “severe and permanent personal injuries as a result, including gallbladder disease.” Her condition has caused her to be hospitalized and leaves her needing long-term medical care.

Weiss’ lawsuit is only one of a long stream of Yaz cases that have been filed against Bayer. While the company maintains that their pills are no more dangerous than other non-drospirenone-based pills, the lengthy number of women developing serious conditions after taking the pills would suggest otherwise. Even the FDA held an advisory panel meeting to discuss potentially taking Yaz off the shelves because of the blood clot risks. However, that meeting has been the subject of controversy after the panel voted in favor of Yaz as panel members were accused of having financial ties to Bayer. So far, there is no news as to whether another vote will be held by a panel that doesn’t include potentially biased members.

Sweden’s Karolinska Institute has reported results from a new study to WebMD.com that shows that pregnant women taking SSRI medications like Paxil double the chances of their babies being born with a potentially deadly lung condition.

The report shows that Paxil and other SSRI medications double the risk that babies will be born with a condition called neonatal pulmonary hypertension (PPHN) when mothers take the drugs while pregnant. This new research was conducted by scientists from Sweden, Norway, Iceland, Finland and Denmark, who analyzed information that they collected from birth registries in their respective countries. The records spanned from 1996-2007.

So far, this study is the largest one to check for a link between PPHN and SSRIs. For the study, 30,000 pregnant women were given various SSRI drugs to take while they were pregnant. A little more than one-third of those women were given the drugs during the third trimester of gestation. Of those women, somewhere between 3 in every 1,000 babies were born with PPHN. This amounts to double the normal rate of PPHN births to women that didn’t take SSRIs like Paxil.

According to this report, this study raises “more questions than answers.” The questions are about whether pregnant women should actually be given SSRIs. PPHN isn’t the only birth defect that has been linked to drugs like Paxil, either. Other birth defects such as oral clefts, cleft palate and heart and brain defects have been reportedly linked to SSRIs through various studies as well. However, with all of the studies showing the dangerous side effects linked to drugs like Paxil, doctors are still prescribing these medications to patients with mild to severe depression and anxiety. This is also why so many people have filed lawsuits against the manufacturers of these drugs. The manufacturers are being sued amid claims that the drug companies are failing to disclose these real birth defects dangers to doctors and patients before allowing them to be prescribed.

Some of the plaintiffs suing Bayer over Yaz birth control pills is calling for Judge David R. Herndon, the judge presiding over the Yaz bellwether trials, to take a look at the claims that there was a conflict of interest in the recent advisory panel meeting vote over Yaz blood clots risks.

It turns out that on Jan. 17, a plaintiff steering committee went against a motion that intended to exclude David Kessler’s opinions against the FDA. Kessler is the former commissioner of the FDA. Kessler is claiming that there was a conflict of interest in the vote on Yaz and Yasmin since four of the panelists had financial ties to Bayer, the makers of the drospirenone-based pills. Those ties are suspected of being the reason why the panel voted to keep Yaz on the market and only instill stricter warnings on the labels. The questionable panelists included Paula Hillard, Anne Burke, Melissa Gilliam and Julia Johnson.

"Due to the complex dynamics that are part of the FDA advisory committee meetings, and in light of the fact that a reasonable person with knowledge of the relevant facts could question the above members' impartiality, it is my opinion that the FDA advisory committee was not independent of Bayer, and its recommendations and votes need to be viewed as such," said steering committee leader Roger Denton.

This statement will have plaintiffs and their lawyers seeing red, especially considering how it appears that Bayer purposely hid its ties to the panel members from its own experts. Either way, Bayer is under a great deal of scrutiny at the moment. Meanwhile, Judge Herndon has postponed the onset of the Yaz bellwether trials (there will be nine) pending mediation by an outside party. The trials, which were to begin on January 9, will now have to wait until April 30 if the mediation doesn’t work. The mediation is intended to give both parties a chance to settle the matter out of court.

Recently, a judge from Winnipeg, Canada ruled that SSRI medications like Paxil can cause some children to commit murder. This ruling is based on a recent trial of a 15-year-old boy who murdered his friend during an argument.

While SSRIs like Paxil, Effexor and Prozac (the latter having been specifically mentioned in the case) have been proven to cause patients to suffer from aggressive thoughts and behaviors, these side effects are often ignored when doctors write the prescriptions. The boy in this particular case is believed to have been on various drugs a long time before he stabbed his friend to death. Claims from various people are stating that the boy wasn’t violent or aggressive before this particular incident occurred. The word is that the boy was, however, taking Prozac, which his doctor claimed was a “solution” for his drug problems (the boy was experimenting with cocaine).

"He had become irritable, restless, agitated, aggressive and unclear in his thinking," said Justice Robert Heinrichs of the Manitoba Justice Department, who made the ruling in this case. "It was while in that state he overreacted in an impulsive, explosive and violent way. Now that his body and mind are free and clear of any effects of Prozac, he is simply not the same youth in behavior or character."

While the boy has pled guilty to the charges, the judge’s ruling does have some people blaming the SSRI that he was taking for the incident. SSRIs like Paxil and Prozac have long been linked to other serious side effects as well. For example, studies show that babies born to mothers who take SSRIs are sometimes born with various birth defects including cleft palate, neural tube defects, PPHN and other conditions. The main point here is that if these drugs are so harmful to adults, kids should definitely stay away from the mind altering drugs as much as possible.

The FDA has been warning women about various different prescription medications to avoid when they are pregnant or considering becoming pregnant. The list the drug regulators came up with is not particularly lengthy, but it is relatively diverse. Before the FDA named the drugs that it believes posed the most significant birth defects risks, the agency tested each one, conducted research and experiments and they did a survey on each medication. The list of medications likely to cause birth defects included SSRIs like Paxil, Effexor and Zoloft, along with Topamirate (Topamax), Depakote, Wellbutrin and Diflucan. There are so many studies and FDA warnings against the use of SSRI medications, it is a wonder that the drugs are still prescribed at all. Countless studies have shown that Paxil and Effexor not only cause birth defects (PPHN, spina bifida, neural tube defects, etc.), they also cause patients to suffer from suicidal and homicidal thoughts and behaviors. These are very dangerous pills. To make things worse, many patients also become addicted to the pills after taking them for an extended periods of time.

Current research is also showing that antidepressant medications like Paxil and Effexor do not even provide any more benefits than placebos at treating the depression symptoms. While this isn’t new information, another more recent study has been published to verify that claim. For this most recent study, researchers gave participants either a daily dose of sertraline for a period of 16 weeks, a placebo, or talk therapy. The patients taking the antidepressants had a 31 percent response rate, the talk therapy patients had a 28 percent response rate and the placebo group had a 24 percent response rate. This just adds more fuel to those who believe that SSRIs just shouldn't be prescribed as a treatment for depression.

The study’s lead researcher, Dr. Jacques P. Barber, the dean of the Institute of Advanced Psychological Studies at Adelphi University in Garden City, New York, said, "I was surprised by the results. They weren't what I'd expected."