Posted On: March 30, 2011

What Causes Reglan-induced Blepharospasm?

With Reglan side effects lawsuits popping up all over the place, many people are wondering how Reglan causes some of the side effects, including the lesser known side effect called blepharospasm (uncontrollable blinking).

The most popular side effect that is known to occur with prolonged use of Reglan is tardive dyskinesia, which is characterized by involuntary facial movements such as lip smacking, gum smacking, excessive blinking and involuntary movements in the appendages. While most of these conditions will discontinue after a patient stops taking Reglan, some of them are permanent. Some of the conditions caused by Reglan are untreatable, and blepharospasm is one of them.

Reglan can cause blepharospasm because it contains the gastrokinetic chemical most commonly called metoclopramide. The metoclopramide directly affects the pathways of the neurotransmitter dopamine. Information posted on http://emedicine.medscape.com says, “Dysfunction of the dopamine transporter has been hypothesized to play a role in the development of TD. However, Lafuente and colleagues did not find evidence of involvement of a polymorphism with a variable number of tandem repeats (VNTD) in the DAT gene (SLC6A3) in dyskinesias induced by antipsychotics. Thus, further research is needed to investigate the role of the dopamine transporter in the development and maintenance of TD.”

Blepharospasms are characterized by involuntary blinking (which is also a symptom of tardive dyskinesia, or TD). While most people suffering from blepharospasms do not find the condition serious in itself, it can worsen to the point where the blinking evolves into full-blown spasms that are uncomfortable and can force the eye to completely close. The eye can stay closed for hours at a time, making the patient blind until the spasm stops.

The FDA eventually issued a black box warning against Reglan for causing conditions like TD and blepharospasm among other in February 2009. The warning forced all makers of drugs containing metoclopramide to include warnings about the potential side effects. Reglan is a pill used to treat gastrointestinal disorders (acid reflux). It is not approved to be used for a period longer than 12 weeks.

Posted On: March 28, 2011

Bellwether Update: Yaz Plaintiffs Seeking More Time to Gather and Review Evidence

On March 14, 2011, lawyers on behalf of plaintiffs in a federal Yaz lawsuit against Bayer filed a motion to give them more time to gather and review evidence. The extension for discovery deadline will end up prolonging the trial start date.

The extension request is likely caused by the size and difficulty of the issues in the case, as it can take a long time for lawyers to be able to sift through all of the documentation in search of relevant and usable information. Both sides can agree that they want the core case-specific discovery timeline to be extended. They basically want the bellwether trial dates to be pushed back from March 14 to April 14. They also want the trial that is set to start on September 12, 2011, moved back to January 9, 2012.

“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," says one legal team's arguments in the motion.

The plaintiff’s lawyers are claiming that they have to sift through as many as 50 million documents that they got from Bayer. They have to go through them all try to guess how many more pages — potentially millions — they will need before they are going to be ready to go to trial.

The minutes taken from a status conference that was held recently with Judge Herndon, the judge overseeing the Bellwether trials, showed that there are as many as 51 depositions that have already been taken so far. There have been 23 depositions taken from defense witnesses, with another 36 to go. Since Bayer is based in Europe, the depositions will likely be taken there.

The Bellwether trials will be focused on the side effects that patients suffer from while taking Yaz and Yasmin amid claims that Bayer willfully hid the life-threatening risks from the public. The side effects that will be the focus of these trials include pulmonary embolisms, gallbladder disease, strokes and deep vein thrombosis.

Posted On: March 25, 2011

New Black Box Warning Issued to Levaquin Amid Claims it Worsens Myasthenia Gravis

As the trial dates for the Levaquin trials finally have been announced, news hits that the FDA announced that fluoroquinolone antibiotic drugs like Levaquin now have to carry a new black box warning.

The new black box warning was enforced because the FDA says this class of drug worsens a condition known as myasthenia gravis. The black box warning is the strongest warning the FDA can impose on a drug that is already approved for public use. Fluoroquinolones like Levaquin already had a black box warning against them because they have been found to cause tendon damage and ruptures to patients, as well as other tendon problems. Many lawsuits have been filed against the makers of Levaquin, Johnson & Johnson, because of it.

Myasthenia gravis is a neuromuscular disorder that makes your voluntary muscles weak. What causes the weakness in the muscles is that the nerve which is supposed to get a muscle to work doesn’t properly do its job. It's supposed to stimulate the muscle because immune cells that are supposed to fight off bacteria or viruses end up fighting the body’s own healthy cells instead. This reaction is what is known as an autoimmune response. This autoimmune disorder causes the neurotransmitters to not be able to get the messages that the nerves try to give it.

The FDA is now using its website to encourage doctors to stop prescribing fluoroquinolones like Levaquin to any patients that already have myasthenia gravis. This new addition to the warnings against Levaquin may be helpful for patients that have had their myasthenia gravis symptoms worsen after taking the controversial antibiotic.

If you have been taking Levaquin and think that it has worsened your myasthenia gravis, contact your doctor right away to see if you are right in your guess. After that you should contact a lawyer. You may be entitled to compensation for your injuries, pain and suffering.

Posted On: March 24, 2011

Supreme Court Allows Lawsuit to Continue Over Failure to Disclose Zicam Problems

As a pharmaceutical liability attorney, I’ve written in this space before about the serious side effects of the now-defunct cold medicine Zicam. Versions of Zicam containing zinc were taken off the market in 2009 after regulators confirmed that using it could cause permanent loss of the sense of smell, also called anosima. Its manufacturer, Matrixx Initiatives, has already paid $12 million to settle lawsuits from patients, and reports say many more have been filed. But on March 23, NPR reported that the U.S. Supreme Court has allowed another class-action lawsuit to continue, this one from investors in the company. Those investors allege that Matrixx intentionally withheld information about the problems to keep its stock price high, ultimately defrauding investors when prices sank.

Under FDA regulations, Zicam was not a drug, but an “unapproved homeopathic product” with active ingredients including zinc gluconate. Zinc is believed by some to help shorten the common cold, but Zicam also constricted blood vessels in the nose, ultimately killing users’ senses of smell. After receiving reports of more than 130 people who permanently lost their ability to smell, the FDA told Matrixx to stop selling the implicated products. However, the shareholders say in their lawsuit that Matrixx executives knew about the risk as early as 1999. The stock fell dramatically in 2004, after news reports about the problem were released, and shareholders filed a class-action lawsuit.

The Supreme Court was asked to rule on whether the shareholders had standing — that is, the legal right — to sue Matrixx. In a 9-0 decision, it said they did. Writing for the majority, Justice Sotomayor said the facts suggest that Matrixx likely didn’t disclose the problems because it knew they would affect its stock prices — not because, as the company claims, it didn’t believe they were significant. Among other things, the court said, Matrixx apparently hired an outside consultant and a panel of scientists to look into the smell allegations. However, Sotomayor noted, shareholders would still be required to prove their claims in court.

I look forward to seeing them do so, because — as a dangerous drug lawyer — I know many of the shareholders’ allegations could help patients involved in highly related lawsuits against Matrixx. If the company hid negative information about its products, it broke the law in at least two ways: once by misleading shareholders, and again by deceiving patients. In the case of the patients, however, the result is permanent loss of their ability to smell, and by implication taste. Money can be repaid, but losing your sense of smell is unfortunately permanent. I suspect Matrixx settled the earlier patient lawsuits because it understands how inexcusable this will look to a jury — and how much it could pay in a jury verdict as a result

Continue reading " Supreme Court Allows Lawsuit to Continue Over Failure to Disclose Zicam Problems " »

Posted On: March 23, 2011

Paxil- and Effexor-induced Tragedies the Subject of Panel Discussion in New York

Medical professionals are meeting with the public on April 9 for a panel discussion that will tackle the devastating effects that antidepressants like Paxil and Effexor have on families. The panel, titled "Psychiatric Drug Tragedies: Personal, Legal and Medical Perspectives," is a part of international Empathic Therapy Conference put on by the Center for the Study of Empathic Therapy, Education & Living. It will run April 8-10 in Syracuse, New York.

The presentation is expected to last for 2 hours and will focus mostly on the negative effects of antidepressants that cause patients to kill themselves and even commit murders. The panel will make special mention of specific cases of aggression and suicidal behavior and how the cases are related to antidepressants like Paxil and Effexor, among others.

After numerous tragedies, the FDA issued a black box warning against antidepressants like Paxil and Effexor; this included adding more information to the drugs’ labels that made it a point to let patients understand that all negative side effects applied to users of all ages. The added label warnings included the drug’s abilities to cause serious adverse side effects including aggression, hostility and mania. The new labels also contained a medication guide that provided more details to the side effects from the antidepressants.

Antidepressants like Paxil and Effexor have caused a firestorm of lawsuits and will likely be the subject of thousands more before it is all over. Drug companies that make these drugs have also gone under fire for hiding the dangerous effects of their drugs from the public. GlaxoSmithKline, the makers of Paxil, even has been investigated for manufacturing and packaging adulterated drugs at its Cidra, Puerto Rico, plant that has since been closed down. The panel discussions should help victims of these drugs and medical professionals better understand each other, which may help to prevent more tragedies in the future.

Posted On: March 21, 2011

Study Shows Depression Can Worsen Arthritis Pain in the Knee

According to a new study, arthritis in the knee can get worsened when patients are going through depression regardless of how mild or bad the condition is in the X-ray.

The study was conducted by assessing arthritis pain in patients that had depression as well as arthritis. It also seemed to show that the patients with depression experienced more pain than those that didn't have symptoms of depression. What that means is that the depressed patients simply experienced the arthritis pain differently. So even if the X-ray showed that the arthritis wasn't severe, the depressed patients reported extreme pain. This information was conducted by interviewing 660 men and women that were 65 yeas old or older.

It stands to reason that a depressed person is more likely to focus on the pain of arthritis, but would an antidepressant like Paxil or Effexor help? In cases where the actual arthritis X-ray shows a mild case, Paxil or Effexor may well help relieve the depressive symptoms that could cause a patient to experience more pain than they should be feeling.

"The relationship between pain and depression suggests that both should be considered by physicians when treating patients with knee osteoarthritis, particularly in those with X-rays not indicating severe damage to the joint," Tae Kyun Kim, author of the study, says.

Since pain and depression seem to be joined when dealing with arthritis pain levels, Paxil or Effexor may help the patient relieve some pain — but at what cost to them? Both Paxil and Effexor have been linked to severe side effects that can be fatal to some patients, specifically the elderly. The damage could get even worse if taken in conjunction with arthritis medications. If you or someone you love is experiencing depression while suffering from arthritis pain, talk to a doctor before agreeing to take SSRI antidepressants like Paxil or Effexor. It could just save your life.

Posted On: March 18, 2011

Study Says Paxil and Effexor Among Top Ten Meds To Cause Violent Behavior

In a study that was recently released by the Institute for Safe Medication Practices (ISMP) in the Journal of PLoS, the top 10 medications that help to induce violence in users on the market are mostly comprised of antidepressants.

According to both the ISMP report and the FDA's Adverse Event Reporting System, it appears as if these medications have also been linked to homicides and other violent crimes as well. It stands to reason when you look at these reports that sometimes the drug is worse than the disease it is prescribed to treat. Paxil and Effexor are a part of that list of drugs that can harm not only the user, but the rest of the community as well. Some of the other medications include a malaria drug and a drug that helps people quit smoking. The drugs specifically named in the report include:

  • Pristiq
  • Effexor
  • Luvox
  • Halcion
  • Strattera
  • Lariam
  • Amphetamines
  • Paxil
  • Prozac
  • Chantix

Each of the drugs mentioned in this study have the potential to cause users to suffer various harmful side effects. Some of those side effects may even be life threatening. In fact, thousands of lawsuits have been filed against the makers of Paxil and Effexor with the plaintiffs claiming the drug companies hid the dangers from the public and even medical practitioners just to ensure higher sales.

These days, many people who have committed violent crimes have claimed that they did so because of the prescription medications they were taking. One bipolar Canadian woman, Michelle Francoeur, successfully used Effexor as her defense when she was accused of having sex with a 15-year-old boy. She was misdiagnosed with depression and given Effexor as a treatment, but was later found to be bipolar instead. The jury believed that her excessive behavior such as drinking, coupled with the dosage of Effexor she was given for a misdiagnosed condition, may have been a contributing factor in the impairment of the woman's overall judgment.

This new study that cites antidepressants like Effexor and Paxil as inducers of violent behavior may mean that many more people might commit violent crimes just because they are taking these medications. It is for reasons like this that people should consider very closely whether they will take a medication. It's not just your own life that you may be saving.

Posted On: March 16, 2011

FDA Wins Consent Decree With McNeil Over Unsolved Tainted Drug Problems

I’ve written here many times before about the ongoing manufacturing problems at plants owned by McNeil Pharmaceuticals and Johnson & Johnson, which has led to 19 recalls of major over-the-counter drugs such as Tylenol, Motrin and Benadryl. As a dangerous drug lawyer, I was therefore disappointed but not surprised to read that McNeil has agreed to a consent decree with the U.S. Food and Drug Administration, preventing it from making and selling drugs at certain plants until it complies with the law. The consent decree also includes two McNeil executives personally, as the FDA noted. It applies to the plants in Fort Washington and Lancaster, Penn.; and Las Piedras, Puerto Rico that were the sources of the recalled drugs.

The drugs were recalled for a variety of reasons, including too-high concentrations of active ingredients in children’s medications; particles of wood and metal in the drugs; and a “musty” smell determined to come from packaging chemicals, which triggered reports of vomiting and diarrhea. FDA inspections found that the three plants had serious safety problems, including dirty equipment and poor quality control. Executives are also accused of attempting to cover the problems up, including a “secret recall” in which the company sent people to stores to buy up products. As a result, sales are down and the Fort Washington plant is closed.

Under the five-year consent decree, that plant must remain closed; the two others can stay open but must comply with good manufacturing practices or face fines of $15,000 a day. McNeil must also hire an independent expert to inspect the plants and certify them as compliant, which the FDA will follow with its own inspection. And the drug maker is required to destroy all drugs returned since December of 2009. The consent decree must be approved by a federal judge before it goes into effect.

As a dangerous medication attorney, I’m very pleased that the FDA is taking stricter regulatory action against these blatant failures by McNeil to protect its own customers. All tainted drugs pose a potential threat, but the children’s drugs were particularly worrisome because they had higher concentrations of active ingredients than they should have, making it very easy to accidentally overdose a small or slight child. In extreme cases, this could cause serious health consequences. The consent decree comes after more than two years of failed inspections at McNeil plants, so it’s clear that the company has been given plenty of chances to clean up its act independently. And a criminal investigation is reportedly ongoing, though the FDA release doesn’t mention it, suggesting that we may not have heard the last about this.

Continue reading " FDA Wins Consent Decree With McNeil Over Unsolved Tainted Drug Problems " »

Posted On: March 16, 2011

Reglan: Parkinson's Disease May Not Be So Wrong A Diagnosis After All

Reglan has gotten a lot of attention and bad press for causing harmful side effects. However, one of those side effects is known as Secondary Parkinson's disease.

What makes this information interesting is that Reglan is most known for causing Tardive Dyskinesia (TD), neoleptic malignant syndrome (NMS), akathisia and ocular deviation. However, the pill that is most commonly used to treat GERD (gastroesophogeal reflux disease) often has some of the TD symptoms misdiagnosed as Parkinson's disease. That may have caused many TD sufferers to miss the deadline for filing Reglan side effects lawsuits.

Secondary Parkinson's Disease is also called Secondary Parkinsonism. The disease is characterized by symptoms that are similar to those experienced with Parkinson's. Some of those symptoms include the following:

  • shaking or tremors in extremities,
  • limited movement,
  • weaknesses in the face and/or throat that can make it difficult to eat and swallow,
  • stiff and aching muscles,
  • vacant facial expression,
  • and difficulty walking

Parkinson's was the diagnosis for patients complaining of these symptoms but it took some time before the symptoms were linked to Reglan use. But even now that it is known that Reglan can cause the disease, the chances of a patient using Reglan has increased from 15 percent to 61 percent. That is an astounding number even if you consider that most of the patients that took Reglan had taken it longer than the 90 days maximum that is recommended... and some for periods of months to years longer.

Secondary Parkinson's caused by Reglan is not incurable like the regular disease is, and generally the symptoms stop once the Reglan is discontinued. Some patients, particularly the elderly or very young, can experience these symptoms for months or years before symptoms start to subside.

Parkinson's occurs when the dopamine production in your body diminishes as time goes by because of cell damage that occurs when the Parkinson’s progresses. It is this dopamine reduction that happens in the brain that makes it hard to tell the difference between regular Parkinson's disease and Reglan-induced Parkinson's. Reglan-induced Parkinson's is now the subject of a lawsuit that was filed in Texas on February 23, 2011.

Posted On: March 14, 2011

The Effexor Defense: Gary Michael Hilton is Convicted of Homicide

Gary Michael Hilton’s efforts to claim that the antidepressant Effexor was responsible for the murder of Cheryl Dunlap didn't work when the jury took one hour to declare Hilton guilty and recommend the death penalty as punishment.

Hilton is a drifter who was convicted of murdering two women — one of which was a nurse, Cheryl Dunlap, who was killed in 2007. The pharmacist that testified at his trial said that it was a combination of drugs that may have made him do it. The drugs mentioned were Ritalin (commonly used to treat ADD in children) and Effexor, a controversial antidepressant. The other additive to this deadly mixture was caffeine. The pharmacist claimed that these drugs, in conjunction, cause the type of manic behavior that could prompt Hilton to kill the woman. It was stated that Hilton had a habit of consuming large quantities of caffeine which may have contributed to the problem.

The defense experts talked about a traumatic brain injury that Hilton experienced as a kid as well as emotional abuse he received from his mother and stepfather his entire life. When you combine that with the drugs and the caffeine, Hilton’s lawyer stated during closing, it was a "perfect storm that was like putting gasoline on a fire.”

The prosecuting State Attorney Willie Meggs debunked the defense closing by breaking down the testimony when he said Hilton suffered a "bump on the head at 9, had a bad childhood, and then began abusing Ritalin – and that made him what he is." The prosecutor also made a reference to what Hilton said to police about kidnapping victims: "If you take them, you have to kill them – or else you'll get caught."

In the end, the jury didn’t buy the Effexor defense. The sentencing hearing is expected to take place on April 21, 2011.

Posted On: March 11, 2011

Bellwether Update: Herndon Attends Status Conference in Illinois

On February 14, 2011, Judge David Herndon held a status conference in Illinois. The multi-district litigation process that is known as the bellwether trials is nearing its start as lawyers for both sides of the lawsuit against Bayer, the makers of Yaz and Yasmin, talked about the progress of the pretrial efforts. Some of those mentioned during the conference included witness depositions, the production of evidence and trial selection.

Conference reports show that the witness depositions from the defense have already started, and that more of them are going to happen throughout April. The defense did not formally list the witnesses names, though it is assumed that most of them are either technical and medical experts that will be able to offer Bayer support in their claims that Yaz and Yasmin are not any more dangerous than any other birth control that is out there today.

Lawyers for both sides also pointed out that one of the bellwether Yaz cases might get dismissed. Should that happen, it will be up to the defense to pick another case to replace it. However, so far, no one knows just how much participation in that process the defense is supposed to have. In October of last year, Herndon created a trial schedule for 3 of the bellwether Yaz cases. The first one, about pulmonary embolism, was to reach court by September 12, 2011. The second gallbladder case was to reach trial by January 12, 2012, and the third blood clot case was to reach trial April 2, 2012. While Herndon will preside over pretrial proceedings, he may even preside over some of bellwether cases during trial.

Each of these cases was meant to help set an expected precedent for further Yaz trials so as to avoid clogging up the courts with multiple lawsuits, and gives Bayer the chance to settle some cases out of court should the company choose to. There are thousands of lawsuits filed against Bayer amid claims that the company didn't properly warn the public of the negative side effects of Yaz and Yasmin. Some lawsuits accuse the company of misleading the public through its advertising as well. Bayer stands to lose millions in potential settlements.

Posted On: March 9, 2011

FDA Resumed Triad Inspections Only After Colorado Hospital Found Contamination

Last month, I wrote a blog post about allegations that contaminated alcohol wipes were to blame for the death of two-year-old Harrison Kothari in Texas. As a dangerous medical device attorney, I’m disappointed, but not surprised, to see the wipes popping up again in news reports that the same infection triggered an investigation by a Colorado children’s hospital. As MSNBC reported March 7, The Children’s Hospital in Aurora, Colo. began an internal investigation after several children were infected with Bacillus cereus. It eventually found that the problem was contamination in Triad brand alcohol wipes. The discovery was credited with triggering the recall of the wipes, but critics wonder why the agency didn’t take action when it originally discovered problems with the plant in July of 2009.

Bacillus cereus is best known for causing food poisoning; it’s not an infection that typically gets passed around a hospital. So doctors at The Children’s Hospital were alarmed when they diagnosed it as a blood infection in several patients in late November. Those included Peyton Armstrong, 10, who was there for a medical port to start chemotherapy for leukemia, but developed an infection that nearly killed him and delayed his treatment. The wipes were used to sterilize children’s skin, and Triad was the only supplier; a spokeswoman said the hospital used about 2,500 a day.

After the hospital reported the problem, the FDA sent an inspector to the plant on the next business day, which eventually led to a Jan. 6 recall. But the FDA’s own documents show that it found problems in the plant as early as July of 2009, more than a year before the Colorado outbreak, and didn’t launch a recall or penalties because it did not believe the problems posed an imminent health hazard.

Clearly, that has turned out not to be true — certainly not for the Armstrong and Kothari families, and as many as 100 others who have contacted the Kothari family’s attorney. As a defective medical device lawyer, I know this could be extremely widespread and extremely serious. Alcohol prep pads, swabs and swabsticks are used as disinfectants before an injection or surgery, which is important because bacteria can cause an infection when the skin is cut. These contaminated pads don’t just fail to protect patients — they actually introduce the infection into some of the most vulnerable populations. Hundreds of millions of pads and swabs have been recalled, many of them packaged with injectable prescription medications or sold under a store brand name. We may only be seeing the beginning of a flood of complaints and lawsuits from people who were seriously hurt by contaminated Triad products.

Continue reading " FDA Resumed Triad Inspections Only After Colorado Hospital Found Contamination " »

Posted On: March 9, 2011

Yaz Lawsuits Expected to Reach 25,000

It is expected that more than 25,000 Yaz side effects lawsuits may be filed against Bayer before the smoke starts to clear for the drug giant.

More and more women are coming forward with lawsuits alleging that the company purposely downplayed the negative side effects of its controversial birth control pills Yaz and Yasmin — and that Bayer illegally marketed the pills to treat conditions it wasn't approved for by the FDA. This huge number of litigants has the potential to have a devastating effect on the future of the pills' sales in the U.S. In fact, many are expecting that the pills will be recalled as a result of the immense number of lawsuits.

However, Bayer has a contingency plan in the works that it hopes will help take the sting out of the lawsuit settlements they may be paying in the U.S. The drug company is planning on selling the controversial pills in Brazil, along with at least five other drugs that are expected to hit the market by 2015.

Unfortunately for the many women that have already suffered or lost their lives as a result of taking Yaz, the move to Brazil, as well as any potential recalls of the drugs, did not come fast enough. Women have experienced potentially life-threatening conditions such as heart attacks, strokes, deep vein thrombosis, gallbladder disease, pulmonary embolisms and blood clots after taking Yaz and Yasmin.

Bayer is stubbornly standing behind its pills, claiming that their drugs are no more dangerous than any other birth control pill on the market today. However, what may likely propel a great deal of settlements in favor of the plaintiffs is that Yaz and Yasmin boast an ingredient that does set them apart and make them different from other contraceptives. The drosperinone that was once the company's main selling point for the pills, is what studies show is causing all of these side effects. In the end, Bayer's blockbuster boast might be a blockbuster bust for their bottom line.

Posted On: March 7, 2011

Yaz is Moving To Brazil

With so many lawsuits against Bayer over the controversial birth control pills Yaz and Yasmin, sales have lagged. The drug giant has decided to respond by taking the pills to Brazil.

Both Yaz and Yasmin have gotten a bad reputation after it was discovered that the pills caused adverse side effects such as heart attacks, strokes, pulmonary embolisms, gallbladder disease, deep vein thrombosis and blood clots. Many young women and their families have filed thousands of lawsuits as a result of this. The lawsuits claim that Bayer knowingly misled the public and doctors about these side effects by implementing a clever marketing campaign that downplayed the risks, and showcased its off-label uses like curing acne and symptoms of PMS.

The company is hoping to be able to double their profits when the pills move to Brazil. Currently, Yaz and Yasmin rake in approximately $15 billion a year in sales. They are hoping to bring that number up to $27 billion by 2015. Andreas Fibig, the Chairman of Bayer, said in a press conference in Sao Paolo that the company has a strong market position in Brazil, and that once the new drugs Bayer is making hit the market, it should make up the difference in sales losses and settlements for Yaz in the U.S. The company is predicting to put out at least 5 new drugs in the coming months and years in Brazil.

Yaz and Yasmin were issued black box warnings by the FDA after the government warned Bayer in letters in 2003, 2008 and twice in 2009. The FDA accused the company of false advertising, and of unsanitary conditions in one of its manufacturing plants. With all of the bad press the company has received over its birth control medications, Bayer still stubbornly stands behind its popular pills... and now it looks like it may have found a way to recoup some its losses with the move to Brazil.

Posted On: March 4, 2011

Misdiagnosed Bipolar Disorder Leads to Sexual Assault of a Minor After Woman Takes Effexor

Michelle Francoeur of Saskatchewan, Canada, was recently found by the court to be criminally not responsible for the sexual assault of a 15-year-old boy when she was found to suffer from a misdiagnosed and mistreated mental illness.

In 2008, Michelle was 27 years old and teaching students between kindergarten and ninth grades. She was having some problems, so she went to her doctor, who diagnosed her with depression and prescribed the antidepressant Effexor. While the drug was meant to help treat her depression, it wound up ripping her life apart.

After a couple of months on Effexor, Michelle started behaving oddly. She was drinking to excess, had trouble sleeping, lost a lot of weight because she stopped eating and even talked excessively. This was deemed as a radical change in her normal personality. According to her lawyer, Michelle was even taking shortcuts in raising her two small children, who were 5 and 7 at the time. Eventually, she became sexually involved with a 15-year-old student. As a result of it, she was fired from her job and formally charged with sexual assault.

When her family started to get concerned about her increasingly erratic behavior, they sent a letter to her doctor, which eventually led him to reassess Michelle's initial diagnosis. He determined that Michelle was suffering from bipolar disorder. This is where things get interesting because Effexor, which Michelle was taking at the time, is known to exacerbate manic behavior in people suffering from the condition. This manic phase is determined by the sufferer feeling a heightened sense of emotion such as elation, euphoria, racing thoughts, inability to sleep and difficulty seeing the consequences of their actions.

Michelle's lawyer told CBC in an interview, “It was a very tragic circumstance… It was a lady who has an underlying condition which was misdiagnosed and received medication that really had a catastrophic effect on her.”

While the sentiment is nice, and it saved Michelle from time in prison, it didn't help her destroyed career and reputation. Misdiagnoses and treatment like Michelle's is not uncommon, and many doctors could prevent situations like this by simply taking more time in assessing patients before making prescription decisions. While Michelle certainly has grounds for filing a lawsuit, right now she is just happy to be cleared of deliberate wrong doing and hoping to get on with her life.

Posted On: March 3, 2011

FDA Issues Safety Warning That Stomach Acid Drugs May Cause Mineral Deficiency

A recent series of articles caught my attention as a dangerous drug attorney because it affects common over-the-counter drugs for acid reflux as well as prescription versions. The FDA announced March 2 that protein pump inhibitor drugs, including Prilosec (omeprazole), Prevacid (lansoprazole) and Zegarix (omeprazole and sodium bicarbonate), have been associated with low levels of magnesium in the blood of people taking them for three months or longer. Formally known as hypomagnesemia, the condition can cause muscle weakness, confusion, hallucinations, irregular heartbeat and seizures. The FDA recommends that patients use over-the-counter PPIs only as directed, and doctors monitor magnesium levels in patients taking prescription drugs.

Proton pump inhibitors are prescribed for acid reflux (gastroesophogal reflux disease), stomach ulcers and other digestive conditions. Reuters reported that Americans filled about 21 million prescriptions for the drugs in 2009, and weaker over-the-counter versions of some are available. The FDA’s announcement said it had received about 48 reports of low magnesium levels. Of those patients, about a quarter didn’t improve after taking magnesium supplements, and the drugs were eventually discontinued. The biggest risk of hypomagnesemia may be developing a heart arrhythmia, which can lead to a stroke in some cases. But low magnesium levels can also create high blood pressure and neurological side effects including tremors and involuntary movements, seizures, hallucinations, depression and confusion.

As a defective drug lawyer, I’m pleased that the FDA is taking early action on this drug’s potential safety risks. There are no reported incidents of people dying or sustaining permanent disabilities from proton pump inhibitors, but that’s a possibility given the risk of arrhythmia-related stroke or epileptic seizure. It’s an even stronger possibility for people who are on a PPI as well as diuretics or the heart drug digoxin, which is used to treat heart failure and atrial fibrillation, a type of heart arrhythmia. Those are not uncommon drugs, and neither are PPIs, which means millions could be at risk. With such frightening and serious conditions at stake, patients should be well armed with information when they consider starting a PPI.

Continue reading " FDA Issues Safety Warning That Stomach Acid Drugs May Cause Mineral Deficiency " »

Posted On: March 2, 2011

Understanding the Statute of Limitations for Filing Yaz Lawsuits

Thousands of young women and their families have already filed lawsuits against Bayer, the makers of the popular and controversial birth control pills Yaz and Yasmin. However, for those that haven’t filed lawsuits yet there is some news about the statute of limitations that is worth listening to.

The fact is, Yasmin has been on the market in the U.S. since 2001 and its sister pill Yaz has been out since 2006. This is important to know since the statue of limitations for filing drug injury lawsuits is different in each state as well as from person to person. The clock starts ticking on the statute for filing your own lawsuit from the moment that you first start experiencing the symptoms and side effects. It is for this reason that you should keep track of the first day that you take the pill and the first day that you start to experience any side effects and know that Yaz was responsible. The date of discovery in your case will help determine how long you have for filing your Yaz or Yasmin lawsuit.

The statue is designed to protect both the patient and the drug company in a way. It helps defendants protect themselves from plaintiffs that may file claims for conditions that existed before taking the drugs and it also helps plaintiffs to establish a proper time line of proof that their injuries were caused by the drugs.

As more and more lawsuits are being filed against Bayer, the makers of Yaz and Yasmin, and the Bellwether trial on its way, there may still be time to file your Yaz lawsuit, depending on your individual case. However, depending on when you first started taking Yaz and started experiencing the negative side effects, your time may be running out fast. Contact a lawyer today to find out if you can file a Yaz lawsuit.