Drug Injury Attorney Blog

Babies are at an increased risk of being born with congenital heart problems if their mothers had taken Effexor while pregnant. Lawsuits accuse Pfizer of failing to properly warn the public and healthcare professionals of the heart risks and other birth defects commonly linked to Effexor. It was last month that the group of lawsuits were removed from California state court to the federal court system. The complaints specifically state that “the effects of Effexor use during pregnancy caused children to develop septal heart defects and other severe health problems, resulting in life-long disabilities that may ultimately prove life-threatening for some of the children,” according to an article posted on aboutlawsuits.com.

“Defendants knew through animal and post-marketing reports that Effexor was associated with a significant increased risk of cardiac defects in babies whose mothers ingested Effexor during pregnancy," the article continues. "Other studies showed increased levels of serotonin, the primary human substance affected by Effexor, had profound effects on the pre-natal development of study animals.”

The plaintiffs are also accusing Pfizer of using an aggressive and fraudulent marketing practice when they promoted Effexor as a safe drug to take during pregnancy. Effexor can also cause other serious side effects including violent and suicidal thoughts and behavior. As for the other birth defects linked to Effexor, those include PPHN, oral clefts, neural tube defects and spina bifida. In general, SSRIs like Effexor can often worsen a person’s condition rather than help them, and the price of these medications can be very high when used for long periods of time.

Because generic prescription drugs are so much less expensive than name-brand drugs, they are often chosen by money-conscious consumers. In fact, some insurance companies refuse to pay for name-brand drugs when a generic version is available, essentially forcing their customers to use the generic. Generic drugs are supposed to be the same as their name-brand counterparts in every important respect—but as a pharmaceutical liability lawyer, I believe they have very important legal differences. And according to Bloomberg News and the AP, generics from manufacturer Ranbaxy Laboratories differed in a very important area: the company has admitted to selling impure drugs and lying to the U.S. Food and Drug Administration about it. Now, Ranbaxy has agreed to pay $500 million in criminal and civil penalties to the federal government, all 50 states and the District of Columbia. The settlement will end a years-long investigation into Ranbaxy by federal authorities.

The wrongdoing by Ranbaxy—which it admitted to in the criminal settlement but not the civil whistle-blower lawsuit—goes back many years. The federal government alleged that Ranbaxy sold several kinds of generic drugs with unspecified purity problems. No one has come forth with allegations that the tainted drugs harmed them, but Ranbaxy also admitted to intentionally continuing to sell one drug that failed a purity test. It also delayed a recall of a drug that it knew would not last as long as its expected shelf life. Regarding drug purity tests, Ranbaxy admitted to improperly storing its samples before testing, doing tests well after it told the FDA they had been done and not sticking to the testing schedule laid out by law, then lying to the FDA about it. In November, a Ranbaxy subsidiary stopped sales of generic Lipitor because shards of glass were found in the drug.

A federal investigation into some of these problems led the FDA in 2008 to ban imports of 30 Ranbaxy drugs from Indian factories. In 2011, it agreed to improve its procedures and undergo extra oversight of manufacturing processes. In 2012, it agreed to stop making drugs for the U.S. market at two plants with suspect manufacturing processes. And this week, a court unsealed a whistle-blower lawsuit filed in 2007 by former executive Dinesh Thakur of New Jersey. Thakur published a statement this week saying he took his concerns to his supervisors originally, but when they did nothing, he went to federal authorities. The $500 million Ranbaxy agreed to pay includes $350 million to settle the lawsuit, which claims Ranbaxy knowingly defrauded federally funded health care programs. The other $150 million is to pay criminal fines and forfeitures.

As a dangerous drug attorney, I’m pleased to see such a large payment for such serious wrongdoing. It may just be good luck, or poor communication, that there are no known cases of people injured by Ranbaxy’s sloppy quality control procedures and deceit. Adulterated drugs have serious consequences; an impurity can sicken people who may be taking medicines because they already feel unwell. And an overdose or underdose, both of which can be caused by sloppy manufacturing, actually threatens the lives of people who rely on the drug to be correctly manufactured. As a defective drug lawyer, I want drug safety fines to be so expensive that it more than negates any extra profits made by breaking the law.

Continue reading "Ranbaxy Pharmaceuticals to Pay $500 Million for Selling Adulterated Generic Drugs" »

According to information found during an SSRI study, taking antidepressant medications like Paxil or Effexor during the perioperative period can increase a patient’s chances of suffering from harmful adverse side effects.

The study was conducted by Dr. Andrew D. Auerbach, M.D., M.P.H., of the University of California-San Francisco. Researchers analyzed data collected from 530,416 patients 18 years of age and older who had undergone major surgery from January 2006 through December 2008 at 375 U.S. hospitals. What they found was that 10 percent of the patients in receipt of SSRI medications like Paxil and Effexor were more likely to require readmission into the hospital and suffer from major bleeding events that may require blood transfusions. The results of this study were published on April 29 in JAMA.

Experts believe that “the antidepressant drugs may affect blood platelet functioning, which may prevent the platelets from clotting correctly. If the blood is unable to effectively clot, excessive bleeding can occur resulting in other complications.” These risks have Auerbach recommending that patients who are taking SSRIs should stop taking the drugs before having surgery.

"Receiving SSRIs in the perioperative period is associated with a higher risk for adverse events. Determining whether patient factors or SSRIs themselves are responsible for elevated risks requires prospective study," the study concludes.

SSRIs are often given to patients suffering from major depression and anxiety disorders. Both Paxil and Effexor can cause serious side effects including violent and suicidal thoughts and behavior. The pills have also been proven to cause birth defects (PPHN, spinabifida, neural tube defects, oral clefts) in babies whose mothers take the pills while pregnant.

According to information found during an SSRI study, taking antidepressant medications like Paxil or Effexor during the perioperative period can increase a patient’s chances of suffering from harmful adverse side effects.

The study was conducted by Dr. Andrew D. Auerbach, M.D., M.P.H., of the University of California-San Francisco. Researchers analyzed data collected from 530,416 patients 18 years of age and older who had undergone major surgery from January 2006 through December 2008 at 375 U.S. hospitals. What they found was that 10 percent of the patients in receipt of SSRI medications like Paxil and Effexor were more likely to require readmission into the hospital and suffer from major bleeding events that may require blood transfusions. The results of this study were published on April 29 in JAMA.

Experts believe that “the antidepressant drugs may affect blood platelet functioning, which may prevent the platelets from clotting correctly. If the blood is unable to effectively clot, excessive bleeding can occur resulting in other complications.” These risks have Auerbach recommending that patients who are taking SSRIs should stop taking the drugs before having surgery.

Receiving SSRIs in the perioperative period is associated with a higher risk for adverse events. Determining whether patient factors or SSRIs themselves are responsible for elevated risks requires prospective study," the study concludes.

SSRIs are often given to patients suffering from major depression and anxiety disorders. Both Paxil and Effexor can cause serious side effects including violent and suicidal thoughts and behavior. The pills have also been proven to cause birth defects (PPHN, spinabifida, neural tube defects, oral clefts) in babies whose mothers take the pills while pregnant.

Recently Cook Medical, the makers of Surgisis Biodesign transvaginal mesh device implants was faced with a lawsuit over the complications linked to the implant. Now Cook Medical is in opposition of having the many lawsuits that have been filed against be consolidated in the federal courts.

On May 30, the arguments will be made to the panel of federal judges as to whether or not the Cook Surgisis mesh litigation is going to be centralized for coordinated pretrial proceedings in front of the judge who is currently presiding over numerous other lawsuits. The response was filed at the end of April and had Cook and their subsidiaries explaining that they were against the creation of an MDL as a means of handling all of the lawsuits filed against them. As part of the company’s argument, they cited that many of the claims against them were dismissed and that there just aren’t enough cases remaining to justify the move to making the proceedings into an MDL. The company is also arguing that their vaginal mesh products are different from the other devices that are involved other cases.

Cook is referring to the five vaginal mesh MDLs that are currently taking place against numerous manufacturers of vaginal mesh devices including CR Bard, Coloplast, Ethicon, American Medical Systems, and Boston Scientific. Judge Joseph Goodwin currently presides over the other MDLs and it was requested that Goodwin also preside over the Cook Proceedings if they are centralized as well. Complications linked to the devices include: erosion, infections, painful intercourse, vaginal scarring and more. Most of the time, these complications can’t be corrected without surgical removal of the implant. Only two of the vaginal mesh cases that have actually gone to trial resulted in an award for the plaintiff. The case against Ethicon (over the Gynecare Prolift vaginal mesh) resulted in an $11.1 million award for the plaintiff, and the case against Bard Avaulta, resulted in a $5.5 million award.

Injuries from defective drugs don’t just take place in the United States. As a pharmaceutical liability attorney, I handle claims from across the U.S.—but most of these highly profitable “blockbuster” medications are sold across the world. Next door in Canada, a lawsuit by a class of Canadian women has been approved as a class action, according to GlobalNews.ca. The women allege that Bayer, the manufacturer of Yasmin and Yaz, intentionally did not disclose the increased risk of blood clots, stroke and heart attack from taking the pills, as well as increased risks of gallbladder disease and other medical problems. All of the class members are represented by a London, Ontario law firm, which says it has heard from 2,000 women. The merits of the case are yet to be heard.

The problems with Yaz and Yasmin are known in the United States, where the Food and Drug Administration ordered a warning added to their labels last year that they increased the risk of blood clots. In fact, the drugs increase the risk of a blood clot over older kinds of birth control pills, which in turn have a slight risk over taking no pill at all. The active ingredient in Yaz and Yasmin, drospirenone, is a newer synthetic progestin—the active ingredient in hormonal birth control pills. The FDA’s label change notes that some studies have shown as much as three times the risk for Yaz and Yasmin patients. As a result, Bayer has been sued by thousands of American women who claim they suffered life-threatening blood clots, strokes or heart attacks, and families who lost young women. Thousands of other lawsuits allege that Yasmin and Yaz triggered patients’ gallbladder problems.

One patient described in the Canadian article was Carrie Gibson, age 25, who began feeling a cramp in her leg last August. The next day, while grocery shopping, she began to feel the symptoms of what she thought was a panic attack—short breathing, sweating and vomiting. It turned out that Gibson was having a pulmonary embolism, a life-threatening medical condition in which a blood clot blocks blood flow to the heart. In fact, testing showed that Gibson had blood clots in multiple places on her lungs. As a result, she now takes blood thinners and gets tested once a week; at 25, she suffers from fatigue and irregular breath. Doctors attributed these health problems to her use of Yaz over the preceding four years. An attorney in the Canadian class action told Global News that trying it as a class action allows many people to pursue compensation when they would otherwise be unable to afford an attorney.

I am pleased to see that Canadians who have suffered life-threatening medical complications from taking Yaz and Yasmin will be able to go to court. As a dangerous drug lawyer, I know how serious blood clots can be. Several lawsuits against Bayer in the United States were filed by families of young women who died of blood clot-related problems, despite otherwise being healthy. Blood clots that travel to the lungs, as Gibson’s did, can be fatal quickly and are considered medical emergencies. As a result, victims may need to take blood thinners and be monitored for the rest of their lives. As a defective drug attorney, I think that’s too high a price to pay for birth control pills—especially when a safer (but less profitable) alternative exists.

Continue reading "Canadian Judge Approves Class Action of Women Claiming Injuries From Yaz and Yasmin" »

According to the results of a new study, the symptoms of depression and anxiety can be relieved with patients being forced to exercise in the same way that voluntary exercise benefits them. The study was conducted by researchers at the University of Colorado-Boulder. The study results will be published in the European Journal of Neuroscience in February.

Previous other studies have already linked exercise to decreased symptoms of anxiety and depression when coupled with the sense of control patients get when volunteering to exercise or make positive life changes. Now this study is showing that the benefits exists even if the patient loses that sense of control when being forced to make the positive lifestyle changes like exercising. Examples of forced exercise include: gym classes in high school, professional athletes, military personnel and patients told to exercise by their doctors, according to Benjamin Greenwood, an assistant research professor in CU-Boulder's Department of Integrative Physiology.

"If exercise is forced, will it still produce mental health benefits?" Greenwood asked. "It's obvious that forced exercise will still produce peripheral physiological benefits. But will it produce benefits to anxiety and depression?"

The study was conducted on rats, who were divided into groups and some were forced to exercise, while others just exercised because they wanted to as they were naturally active. The results showed that both groups of rats benefitted from the exercise.

"Regardless of whether the rats chose to run or were forced to run, they were protected against stress and anxiety," said Greenwood, lead author of the study. "The implications are that humans who perceive exercise as being forced — perhaps including those who feel like they have to exercise for health reasons — are maybe still going to get the benefits in terms of reducing anxiety and depression."

This study may help doctors to start prescribing exercise to their depressed patients and those with mental illnesses before they start running to dangerous antidepressant medications like Paxil. Paxil has long been used to treat depression symptoms, but is very dangerous and addictive. Paxil has also been linked to serious side effects, including violent and suicidal thoughts and behavior as well as birth defects in babies born to mothers who take Paxil during pregnancy.

According to a recent study that was published in Clinical Psychological Science, a journal of the Association for Psychological Science, people who think a specific way may make them more susceptible to depression within six months after being exposed to others with the condition. The study was conducted by psychological scientists Gerald Haeffel and Jennifer Hames of the University of Notre Dame.

Previous studies have attempted to prove that the people who don’t respond well to negative happenings in their lives and who also view the negative events in their lives as somehow caused by their own insufficiencies are more likely to become depressed. This “cognitive vulnerability” is viewed by some experts as a way to be able to predict depressive episodes in a person’s future. These cognitive vulnerabilities are also believed to become more solid in individuals during their teen years. Based on this knowledge, the researchers in this study sought to figure out if this behavior was contagious by observing the attitudes and behaviors of college roommates and conducting a survey afterward.

The results of their study showed that the “freshmen who were randomly assigned to a roommate with high levels of cognitive vulnerability were likely to 'catch' their roommate’s cognitive style and develop higher levels of cognitive vulnerability; those assigned to roommates who had low initial levels of cognitive vulnerability experienced decreases in their own levels. The contagion effect was evident at both the 3-month and 6-month assessments.”

If this study is proven true, it could help doctors better be able to provide better treatments for those newly-developed cases that may be safer. For example, should a patient’s depression be found to be caused by “contagion,” talk therapy and a change of environment will likely work better than antidepressant medications like Paxil or Effexor. The dangers linked to antidepressants like Paxil and Effexor include violent and suicidal thoughts and behaviors as well as birth defects in babies whose mothers take the drug while pregnant. Some of those defects include PPHN, spina bifida, neural tube defects and oral clefts. With this study in mind, newly diagnosed cases may be able to avoid the dangerous drugs and relieve their depression in a far safer way.

An interesting clinical trial that was looking into the use of magic mushrooms as a possible treatment for depression has been halted due to current regulations regarding the use of illegal drugs in research.

The study’s lead researcher, professor David Nutt, once fired in 2009 from a position as the British government’s chief drug advisor, believes this regulation is “archaic” and blocks scientific progress. Nutt and his team at Imperial College London believe that they have found proof that the hallucinogen psilocybin might be able to combat the effects of severe depression in cases where the patient was resistant to previous treatments. However, psilocybin is the psychoactive ingredient in "magic mushrooms" and has been banned in the UK as a Class A drug.

Despite the fact that the Medical Research Council was given a £550,000 grant to conduct the trial, Nutt has explained that they cannot continue. When he was talking about the subject at the British Neuroscience Association's Festival of Neuroscience in London, he said: "We're not allowed to go and pick the mushrooms anymore and finding a company to provide this illegal drug in a way that can be prepared for trial use as yet has proved impossible. We are between a rock and a hard place, and that's very unfortunate because if this is an effective treatment, as it may well be for some people, then they are obviously being denied that possibility."

With current UK laws being what they are, academic researchers cannot make their own Class A drugs and they also have to get them from an outside resource because companies that could supply the drugs have to go through "regulatory hoops" to get the right license to do so. Nutt estimates it would take as long as a year to clear these regulatory hurdles and could make the trial cost three times as much. He goes on to say that the new regulations on drugs is getting insane.

Current drug treatments being used to treat depression could use some help. For example, antidepressant medications like Paxil are known to cause serious adverse side effects like violent and suicidal thoughts. Paxil is also known to cause birth defects (PPHN, oral clefts and heart, lung and brain defects). So many side effects are caused by drugs like Paxil that researchers like Nutt and his team are always on the lookout for newer ways to treat the condition. For now, at least, it looks like the magic mushroom route may not be the next big thing in depression medications.

As a dangerous drug lawyer, I was sorry to see that the judge in an Actos injury lawsuit threw out a large verdict this week. According to Bloomberg News, a Los Angeles Superior Court judge ruled that there was not enough evidence linking Jack Cooper’s bladder cancer to his use of Actos, throwing out a $6.5 million verdict. The ruling reversed what had been a victory for the plaintiffs in the first of the many trials over whether Actos caused bladder cancer. Actos (pioglitazone) is a prescription drug intended to help control blood sugar in patients with Type 2 diabetes. After studies showed that it was associated with an increased risk of bladder cancer, it was withdrawn from the market in France and a warning was added to the label in the U.S. Drug maker Takeda Pharmaceutical is facing more than 3,000 lawsuits in the United States.

The case brought by Cooper was one of several gathered in Los Angeles. Others are pending in southern Illinois state court and consolidated in Louisiana federal court, where the first of more than 1,200 cases is scheduled to start in January. After the verdict in Los Angeles, the judge ruled that the jury should never have considered it in the first place because the doctor who testified for Cooper gave “inherently unreliable” testimony. Cooper, 79, took Actos for four years before he was diagnosed with bladder cancer. Takeda’s lawyers argued that Cooper was always at high risk for the cancer because he was elderly, male, a former smoker and a diabetic. (All Actos patients are diabetic or at risk of becoming diabetic.) Cooper’s attorney said he would appeal the ruling throwing out the verdict.

The Actos bladder cancer lawsuits typically allege that Takeda withheld information on the link between long-term use of its drug and bladder cancer. The connection was allegedly revealed as early as 2004,or even in pre-approval rodent studies. More recently, a French epidemiological study found a strong enough connection to justify banning it in that country; Germany has requested no new prescriptions. Last year, Canadian researchers found that taking Actos at all increases the risk of bladder cancer by 83 percent, and even more for those who used Actos at higher doses or for more than two years. An FDA study looking into the link is ongoing, but right now, only a warning has been added to the label.

As a defective drug attorney, I will be interested to see if this verdict is restored by an appeals court. Judges rarely throw out the entire trial after the fact, and appeals courts typically give juries great deference because juries’ job is to be finders of fact—judges rule on the law. If evidence shows that Takeda did fail to disclose evidence of a link between Actos and bladder cancer—or even actively suppressed the evidence—the company would be liable for the injuries to every patient who developed bladder tumors while the truth was not known. That could be many millions of dollars just for the 3,000 lawsuits that currently exist. But more lawsuits are likely to be filed, because at its peak, Actos was a popular drug—and very lucrative one for Takeda. As a pharmaceutical liability lawyer, I hope those profits didn’t come at the expense of adequate safety warnings to patients.

Continue reading "Judge Overturns $6.5 Million Actos Injury Lawsuit Verdict, Citing Lack of Evidence" »

Information collected from a pilot study is showing that deep brain stimulation (DBS) helps six out of seven patients with their treatment-resistant depression. The results of this study are being met by experts with cautious optimism.

With severe depression being a common condition among people worldwide, doctors and researchers are constantly looking for safe ways to treat the patients that will help them avoid the dangerous drugs (like Paxil and Effexor) that are often used. Deep brain stimulation may just prove to be one of those methods. The fact is that with Paxil, Effexor and other antidepressant medications, patients are susceptible to suffer from all sorts of side effects. Some of those side effects include violent and suicidal thoughts and behavior as well as birth defects in babies born to women taking the drugs during pregnancy. The likelihood of patients suffering from these side effects increases when the patient shows a resistance to the drug treatments since doctors will often up the dosage in an effort to get the meds to work. With DBS showing such good results so far, patients with a resistance to treatments may finally get some relief.

When DBS is performed, “an electrode is attached to a pacemaker-like device which delivers small pulses of currents to areas deep within the brain in an effort to help regulate the brain’s own signals that are not functioning properly.”

DBS is approved by the FDA as a treatment for Parkinson’s Disease, but more testing will have to be done to see how it will work in treating depression.

“Treatment-resistant depression is a horrible disease. It can result in death, and people who live with it often have very difficult lives,” said researchers. “These impressive findings in the medial forebrain bundle must now be replicated in a double-blind fashion, like the study we’re doing with Brodmann Area 25 — that’s the way to prove it.”

According to a new study recently published in the current issue of Journal of Affective Disorders, religious beliefs cause a significant improvement in the outcomes of patients who are receiving short-term treatment for psychiatric illness.

The study was conducted by researchers at McLean Hospital and led by Dr. David H. Rosmarin, Ph.D., McLean Hospital clinician and instructor in the Department of Psychiatry at Harvard Medical School. They analyzed data collected from participants at the Behavioral Health Partial Hospital program at McLean. The goal of the study was to find out if a patient’s belief in God, coupled with their treatment expectations, affected their outcomes.

"Our work suggests that people with a moderate to high level of belief in a higher power do significantly better in short-term psychiatric treatment than those without, regardless of their religious affiliation. Belief was associated with not only improved psychological wellbeing, but decreases in depression and intention to self-harm," explained Rosmarin.

The results of the study showed that of the participating patients, over 30 percent of those who stated that they were not particularly religious saw the same benefits from their treatment if they still believed in God deeply. However, those patients who believed in God only a little bit or less than that were two times as likely to experience no response to their treatment. What this means is that patients who believed greatly in God showed better treatment outcomes than those who didn’t.

The study’s conclusion stated that "belief in God is associated with improved treatment outcomes in psychiatric care. More centrally, our results suggest that belief in the credibility of psychiatric treatment and increased expectations to gain from treatment might be mechanisms by which belief in God can impact treatment outcomes."

"Given the prevalence of religious belief in the United States — over 90 percent of the population — these findings are important in that they highlight the clinical implications of spiritual life," Rosmarin commented. "I hope that this work will lead to larger studies and increased funding in order to help as many people as possible."

With so many patients who have psychiatric illnesses being treated with antidepressant medications like Paxil or Effexor, this study could prove very useful. It is well documented that psychiatric patients often suffer from conditions like depression and anxiety, which are treated with dangerous drugs like Paxil or Effexor. It is also well-known that those drugs cause serious side effects like violent and suicidal thoughts and behavior. Knowing that a patient’s religious beliefs can help play a role in their treatment may help some patients avoid the fates that their “cure” can cause.