Recently in Dangerous Side Effects Category

Drugs Causing Life-Threatening Skin Reactions

December 12, 2014

n-a-10266.jpgA 19-year-old in California was recently admitted to an intensive care unit after taking a friend's antibiotic and suffering a rare, potentially fatal side effect known as Stevens-Johnson Syndrome. In related news, the FDA just updated the labelling for the drug Geodon, which can cause similar skin reactions.

The SJS and TEN lawyers at Pintas & Mullins report in depth on these rare but fatal side effects and the injury lawsuits surrounding them.

The skin reaction associated with Geodon (ziprasidone) is slightly different than Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrosis (TEN), but the early symptoms are often similar. Geodon is an antipsychotic drug prescribed to treat bipolar I and schizophrenia disorder. The drug can cause Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which is a rare but serious skin reaction that can spread throughout the body.

DRESS begins to manifest in the body as a rash with swollen lymph glands, typically accompanied by a fever, inflammation of internal organs, and high white blood cell count. If not treated quickly, DRESS can lead to death. The FDA released a safety update for Geodon after several patients alerted the agency to their skin reactions.

In these patients DRESS symptoms began 11 to 30 days after starting on Geodon, and fortunately, all survived. Geodon is administered as a capsule pill, oral suspension and injection, and the FDA has notified the manufacturer to update the drugs' labels.

California Teen 'Burning From Inside Out'


Yaasmeen Castanada is currently recovering in the University of California-Irvine Medical Center, where doctors predict that she will survive. Her incident started on Thanksgiving Day when Castanada had cold symptoms and a sore throat. One of her friends gave her an antibiotic, Bactrim, which is often prescribed to treat urinary tract infections, bronchitis, and ear infections.

That same night, Castanada's eyes and throat started burning and her lips and eyes turned red. She went to the hospital, where she has remained. On the fourth day of her hospital stay her entire back had blistered. She has undergone surgery and about 65% of her body has been affected. She is on a ventilator, under sedation, and on painkillers.

Bactrim is a sulfa-based antibiotic, which carry warnings of SJS and TEN reactions like Castanada's. About a quarter of patients who suffer the side effect die. SJS causes the top lawyer of skin to die and shed off, creating blisters and open wounds throughout the entire body. It can also affect the lungs, genitals and other organs, causing blindness, infertility, and decreased lung capacity.

We have written extensively about SJS and TEN, as it is associated with hundreds of drugs, including many over-the-counter and children's medications. It begins with flu-like symptoms, but quickly attacks the entire body. Many medical officials refer to it like burning from the inside out, and victims are often treated in hospital burn units.

Continue reading "Drugs Causing Life-Threatening Skin Reactions" »

Change to Come for Generic Drug Laws

November 21, 2014

daily-dose.jpgToday, eight in ten prescriptions are for generic drugs rather than brand names. Just thirty years ago, that number was three in ten. Generic drugs have been the topic of much debate lately, as courts and agencies throughout the country try to decide whether they should be able to update their own drug labels apart from the labels of their brand-name counterparts. Dangerous drug lawyers look further into this issue and how this decision will affect patients.

This issue was brought to the Supreme Court in 2011, in PLIVA v. Mensing. The argument in this case, made my Mensing, was that generic drug manufacturers should have the same opportunity and requirement to change drug labels as their brand-name equivalents. So, if a generic company like PLIVA knew that one of its drugs caused a serious side effect, Mensing argued, it should be required to notify the FDA and lobby for a label change.

PLIVA argued that this kind of federal regulation would directly conflict with state laws, opening the companies up to drug injury. Currently, all generic drug makers are required to have the same labels as their generic counterparts (so the branded Abilify will have the exact same ingredients and labels as the generic form, aripiprazole).

In a 5-4 decision, the Supreme Court ruled that states could not hold generic drug companies liable for failing to include additional safety information, since it was not required by federal law. This was partially based on a 30-year old law known as the Hatch-Waxman Act, which streamlined the approval process for generic drugs.

The FDA may change the federal regulations relating to generic drugs soon, however. On or before September 30, 2015, the FDA will propose a final rule on labeling changes for generic drugs. This new rule will likely reverse the 2011 PLIVA v. Mensing decision, and trigger immediate legal fights over the liability of generic drugs.

This is important for many reasons. As stated, generic drugs are currently protected from injury lawsuits filed by patients who were injured by their drugs. If they are allowed to update their labels, it will open them up to liability for failing to warn about any possible side effects patients may suffer while taking their drugs. Since the vast majority of prescriptions are for generics, the potential for drug injury claims is enormous.

Most patients do not realize that if they are seriously injured by a generic drug, they would not be able to sue the company for failing to warn about its risks. Yet these patients are often forced to take generic drugs because the brand-names are utterly unaffordable. It's a no-win situation, and the FDA is headed in the right direction to help the sick and vulnerable.

Concerns on Capitol Hill


There are other repercussions to such a rule change beyond the scope of plaintiffs' rights. A recent article in Slate goes into more depth on the Hatch-Waxman Act, describing a different conversation in Washington over generic drugs.

In recent years, generic drug prices have increased dramatically - critical drugs, like antibiotics, that used to cost pennies now cost hundreds of dollars per bottle. The current state of drug pricing in the U.S. is based off the belief that the monopolies of Big Pharma, which manufacture brand names, can be offset by so-called little pharma, which make generics.

Thus, patients are given two options for the drugs they need: the brand-name, which is monopolized by one company, or, when the patent runs out, the generic, which is supposed to be made by multiple companies at more affordable prices. The problem with this is that "little pharma" is a competitive industry just like Big Pharma. Generic companies often ditch smaller, less profitable drugs (like antibiotics) to sell newer, more profitable drugs.

Continue reading "Change to Come for Generic Drug Laws" »

Actos Bladder Cancer Lawsuit Begins Today

October 20, 2014

court-room-detail.jpgA plaintiff diagnosed with bladder cancer after taking the drug Actos will have his chance in court beginning today, Monday October 20th. This will be the first Actos trial in West Virginia over allegations that the diabetes drug causes bladder cancer. Actos attorneys at Pintas & Mullins detail this case and others like it around the country.

Actos is a drug to treat type 2 diabetes, and was widely referred to as a 'blockbuster drug' when it was introduced in 1999. So-called blockbuster drugs are extremely popular medications that generate at least $1 billion in sales each year (some examples are Lipitor and Vioxx). Actos was launched in the U.S. by two pharmaceutical companies, Eli Lily and Takeda Pharmaceutical.

Due to massive litigation, many internal documents have been released that expose how much was known about Actos before it was introduced to American markets. The West Virginia plaintiff, for example, claims that the companies knew Actos could cause tumors. He bases this claim on preclinical studies Takeda conducted before 1999, involving tumors in male rats who took Actos.

Proof of Bladder Cancer Destroyed


The West Virginia plaintiff, Richard Myers, was diagnosed with bladder cancer less than two years after starting on Actos. In his trial, the jury will hear arguments from both sides and decide whether to award Myers punitive (intended to punish Takeda and Eli Lily for their actions) and compensatory damages (meant as recovery for actual costs from his bladder cancer).

The jury will also hear about Takeda and Eli Lily's efforts to destroy documents related to Actos. We have written about this before, after a jury awarded a man injured by Actos $9 billion. It was during this trial that it became clear the companies had intentionally destroyed evidence relating to its knowledge of Actos and its effects in the human body.

This $9 billion award is the seventh-largest in U.S. history; the judge decided on this massive award to punish Takeda and Eli for destroying evidence and to deter other pharmaceutical companies from engaging in such actions. Among the evidence destroyed before trial included internal communications about Actos, such as emails from over 45 employees. These documents, which had been under legal protection since 2002, could have irrefutably proven that Takeda knew about the risk of bladder cancer in Actos users.

The West Virginia jury will be told of Takeda's destruction of documents that proved the company wa aware of Actos' cancer risks. Despite this evidence, it took the FDA over a decade to warn the public about the possibility of bladder cancer from Actos. The agency finally issued a warning in 2011 that discouraged doctors from prescribing Actos to diabetic patients with active bladder cancer - and that any patient taking Actos for over on year could develop the cancer.

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Asthma Drug Xolair Causing Heart, Brain Problems

October 1, 2014

asthma-3.jpgThe FDA recently issued a warning on the popular asthma drug Xolair (omalizumab) after numerous studies found safety problems with the drug. After reviewing these studies, the FDA released an alert on the increased risk of heart and brain issues in patients. Dangerous drug attorneys at Pintas & Mullins detail these studies and what they mean for patients.

Xoliar is an injectable drug for asthma patients over the age of 12, whose symptoms cannot be controlled with inhaled drugs. According to the FDA's safety alert (here), the drug can narrow blood vessels that supply blood to the brain and heart, potentially causing heart attacks and strokes. Xolar's labels were recently updated to reflect this particular risk.

Cancer Risks and Allergic Reactions


Experts are also concerned about the possibility of cancer development in Xolair patients, however these risks have not been fully studied. The FDA did note that it could not rule out a potential cancer risk for this drug. The drug was approved in 2003, leaving the long-term effects unknown. The cancers most associated with Xolair are of the prostate, skin, and breasts.

The possibility of cancer was raised because of Xolair's reaction with the antibody human immunoglobin E (IgE). Xolair works by blocking IgE from causing an allergic reaction, however, IgE also plays an important role in the body's ability to recognize cancer cells. This suggests that, by blocking IgE, Xolair may also be blocking the immune system from attacking cancer cells.

Xolair's packaging contains what is known as a "black box warning," which is the most severe warning from the FDA. Drugs with black box warnings can reasonably cause permanent or fatal injuries in patients. Among the side effects listed on Xolair's black box labelling is the possibility of anaphylaxis, or severe allergic reaction.

Some experts estimated that nearly one in five patients taking Xolair will suffer an allergic reaction, which would occur two to 24 hours after a Xolair dose. Signs and symptoms of anaphylaxis include:

• Trouble breathing caused by narrowed airways
• Dizziness or fainting
• Swelling of the tongue or throat
• Chest tightness
• Hives or rash
• Drop in blood pressure
• Itching

It is important to note that an allergic reaction can occur even in patients who have taken Xolair in the past without side effects.

The FDA recommends that doctors who prescribe Xolair should observe their patients for at least two hours following a dose. Doctors, patients and families should be prepared to manage life-threatening reactions after taking the drug. The federal agency started investigating Xolair's safety in 2009, after several studies linked the drug to cardiovascular and cerebrovascular problems.

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Pregnancy, Anti-Depressants, and an Impossible Choice

September 12, 2014

playing-with-light-1.jpgIt is a decision that too many women face, and that has no easy answer: to remain on antidepressants during pregnancy despite risks of abnormal development or birth problems, or to stop taking the medication, placing yourself and your child at risk of the dire effects of major depression. SSRI attorneys at Pintas & Mullins take a fresh look at this issue and the complexities involved.

An article published by the New York Times last week has sparked controversy in the medical field over whether antidepressants - specifically, a class known as SSRIs - are safe to take during pregnancy. Some applauded the article, believing that too many women are unaware of the risks of certain medications; others pushed back against it, arguing it would spread unnecessary fear based on conflicting research. Mental health organizations were largely on the nay-saying side, stating that the author trivialized depression instead of treating the women facing this issue with compassion.

Some medications, such as the acne drug Accutane, are irrefutably linked with birth defects when used in pregnant women and relatively easy for women to stop taking. Depression is not like acne; it is a serious, life-changing mental disorder with complex and largely unknown causes. The Times author states that pregnant women "rarely" stop taking SSRI antidepressants even though they have been linked in numerous studies to a host of birth disorders. The FDA has issued clear statements on the risks of Paxil in particular, so why are so many pregnant women still taking them?

Navigating the Unknown


Doctors generally believe that depression is more dangerous for mother and child than an SSRI medication. Statistically, women with depression who stop taking medication are three times more likely to relapse than those who continue taking an antidepressant. On the other hand, the medications cross the placental barrier during pregnancy, and blood samples taken at birth indicate that the drugs do indeed enter the fetus' bloodstream and amniotic fluid.

There have been numerous studies on this topic with conflicting results. Some studies found a link between SSRIs and infant cardiac deaths, others with miscarriage, lung conditions, autism, ADHD, and clubfoot. Still others have found no correlation or even suggested SSRIs cause lower cardiac defects. For example, since 2011 five studies have been published on the link between SSRI use and autism, three of which found some type of association.

Conversely, animal studies show that pregnant women who show stress, depression or anxiety are more likely to have children with inadequate neurological development or suffer miscarriages or preterm birth. Other studies found that children whose mothers were depressed during pregnancy were more likely to suffer from future mental illness, such as schizophrenia or depression.

In other words, for many women, it is a no-win situation. For pregnant women suffering from depression, all factors need to be taken into account. Do you think your depression could be managed without medication, supplemented by talk therapy or behavioral counseling, consistent and regular exercise, and other interventions? Or, would tapering off the medication cause too much stress and anxiety, ultimately causing more harm than good? For some, the depression may be so severe that medication is undoubtedly the best bed; for others, major changes in lifestyle are within reach and preferable to the risks of SSRI use. We urge anyone facing this type of situation to consult psychiatrists, family and doctors to come to the final decision.

Despite the dearth of factual knowledge there are efforts being made to fund studies and research. It is an important and serious issue that affects more women than we could ever know. There is a wide array of information on this topic available online (some more reputable than others). The New York Times recently published a series on mental illness in new and expectant mothers, available here.

Continue reading "Pregnancy, Anti-Depressants, and an Impossible Choice" »

Court Rules Pfizer Can Be Sued for Generic Drugs

August 18, 2014

56444937_564e2c24b0_o.jpgIn a controversial ruling, the Alabama Supreme Court allowed a man injured by a generic version of Reglan to sue the drug's brand-name manufacturer, Pfizer. Although this is not the first time a high court has taken this type of stand, it is still significant as courts face similar lawsuits across the country. Dangerous drug lawyers at Pintas & Mullins unpack this ruling and how the plaintiff won his case.

Reglan is a heartburn medication originally developed by Pfizer to treat gastric esophageal reflux disease (GERD) along with nausea, gastroparesis, and other heartburn-related issues. Among the listed side effects of Reglan include tardive dyskinesia, which is an irreversible disorder involving abnormal or delayed movement.

One heartburn patient in Alabama, Danny Weeks, developed tardive dyskinesia after taking the generic version of Reglan, called metoclopramide. Weeks sued Pfizer for failing to inform him and his doctor of the serious risks of long-term Reglan use. As the named defendant, Pfizer argued that it had no direct relationship with Weeks or his doctor since he was prescribed the generic version of the drug.

Big Pharma has been using this argument to protect itself from liability for decades, often with much success. The tides started turning in 2011, however, when the U.S. Supreme Court ruled that generic drug makers had to produce drugs with the exact same ingredients and labels as their generic equivalents. This shielded generic drug makers from injury liability, as they could not be held accountable for any failures to warn against risks. Thus, the generic version of Reglan that Week's was prescribed was, in accordance with federal law, the exact same drug as Reglan in every way.

Regarding Pfizer's argument denying direct relationships with its consumers, the Alabama high court noted that the company completely ignored the nature of its medications. The court stated that consumers (obviously) cannot buy prescriptions directly from drug makers - the only way to obtain medications is to be prescribed by a medical professional.

Further, the court stated that brand-name drug makers are indeed responsible for patient's injuries, if the patient was not adequately warned of the risks. In essence, Pfizer was told that since it failed to properly list tardive dyskinesia as a side effect on its labels, it should be held responsible for the damage done to unsuspecting patients.

This is a controversial ruling because of how prevalent these types of cases are in U.S.
courts. To date, nearly 30 other courts have made opposing rulings in favor of Big Pharma. Pfizer and other similar companies claim that being held responsible for injuries from generic drugs would "stifle innovation." Other courts can see right through this argument, such as the appeals court that recently allowed a drug claim against GlaxoSmithKline over the generic version of its drug Paxil. This case was filed by the widow of a man who took the generic Paxil antidepressant and later committed suicide.

The appeals court in that case ruled that since Glaxo was singularly responsible for the drugs' design and labelling, it was largely irrelevant that it not directly produce its generic version. There are some efforts being made to clarify this issue - the FDA, for its part, recently proposed a new rule that would allow generic manufacturers to add their own labels and warnings. This would be an important step forward, as most of the drugs consumed in the U.S. are generic, putting patients at risk of inadequate or out-of-date warnings.

Unsurprisingly, generic drug makers are less than thrilled about this proposal. They claim that it would add $4 billion to national health care costs. Where exactly this $4 billion would come from, however, remains unclear.

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Drug Companies Prey on Poor, Homeless, For Drug Research

July 30, 2014

homeless-and-hungry-1.jpgIn American urban centers, where homelessness is abundant and the working class slips into poverty, it is not difficult to find people willing to test experimental drugs in exchange for a little cash. Here in Chicago, ads for pharmaceutical studies can be found on CTA trains and buses; in Philadelphia, they are advertised in local newspapers, and recruiters often visit shelters. Dangerous drug lawyers at Pintas & Mullins take a closer look into how Big Pharma is testing medications on the homeless, and getting away with it.

Carl Elliott, writing for Medium, recently published an extremely troubling but illuminating article on this topic. The studies discussed in his piece can be for pharmaceutical companies, medical schools, or drug testing companies, who pay volunteers to take new, experimental drugs, and monitor their reactions.

Many programs request volunteers who are already addicts, or depressed, but most are to test the risks and side effects of psychiatric drugs, such as stimulants (Adderall, Vyvanse), anxiety drugs (Valium, Xanax), antipsychotics (Risperdal, Seroquel), and antidepressants (Paxil, Zoloft). Aside from homeless shelters, research organizations often recruit subjects from facilities where mentally ill residents are provided shelter and meals.

Most people simply do not think about how pharmaceuticals are approved for market - or they think the research is highly controlled in medical centers. In reality, Big Pharma contracts the research out to private research organizations, which can run clinical trials quicker and cheaper than medical schools. Today, the contract research industry generates annual income of more than $100 billion.

Is This Legal?


Not too long ago, when clinical trials were run by government programs, this type of payment-for-treatment was considered unethical. Experts believed that paying a subject placed vulnerable, uninsured people to serious health risks. As mentioned above, clinical trials moved into the private sector, and ethics were sidestepped.

In the federal guidelines for drug research are instructions to avoid coercion and undue influence in recruiting volunteers. The problems with this language are obvious: Elliott compares using addicts and the homeless for drug trials with children working in sweatshops. No one is coercing or threatening these people to do this (that would make it illegal), but it is an ethically wrong to exploit desperate people and take advantage of them by offering money.

The more dangerous and lengthy the program, the more it pays; many trials offer more than $6,000 for inpatient drug studies, and subjects no longer have to be in good health. Volunteers are accepted with wide ranges of ailments, from liver disease to schizophrenia. Researchers freely admit that 85 to 90 percent of subjects volunteer for the money.

The drug trial business is just that: a business. Currently, there are about ten different types of atypical antispychotics on market, and many more that were tested but never approved for market. When the patent on these drugs expire, rival companies will need to test their own versions to sell. This a business like any other - drug companies need mentally ill people to test their drugs on, and there is a steady supply of this demographic in halfway houses and homeless shelters.

Homeless subjects that take part in in-patient studies told Medium reporters that they are treated well - meals are ordered in several days a week, access to TV, DVDs, XBOX, birthday parties - comforts that we take for granted. Many feel that the side effects are worth it, most of the time, and take volunteer for dozens of trials.

Another Medium profile of drug trials, written by Peter Aldous, details how the doctors running these trials are often themselves abusing drugs. In fact, it is not uncommon for disgraced doctors to find high-profile jobs in the drug industry. Aldous found dozens of doctors working on clinical trials who have had disciplinary action taken against them by state medical boards. Making matters worse, the FDA rarely inspects trial sites.

Many argue that doctors should be held to higher standards for clinical research than for regular practice. These doctors are responsible for the welfare of dozens, if not hundreds of patients who rely on them for advice. They should be at the top of their game, not bottoming out.

Side Effects, Deaths, and Lawsuits


Antipsychotics are booming in the U.S., often prescribed in nursing homes, prisons, and to children, however, they cause dangerous and permanent side effects. Among the most popular antipsychotic drugs include Abilify, Seroquel, Risperdal, and Zyprexa.
Side note: Prescribing these drugs to elderly residents of nursing homes can be considered nursing home abuse, as the FDA has added warnings to antipsychotic labels regarding the risk of early death in patients with dementia.

Medical malpractice lawsuits can also result from negligently performed or poorly monitored drug trials. The children of Walter Jordan recently sued the research firm CRI Lifetree for his wrongful death. Jordan was a veteran, widower with three children, and paranoid schizophrenic surviving on disability benefits. He was offered around $2,000 to take part in an antipsychotic drug trial, where he would spend about two months in-patient.

It was a Phase I trial, so he would remain on the drug and monitored for new and changing side effects as doctors steadily increased his doses. Staff would monitor his heart rate, rhythm and blood pressure, as antipsychotics can cause dangerous heart conditions. Eight days into the trial, Jordan felt discomfort in his chest and was short of breath. Doctors told Jordan he was having a panic attack and prescribed an anxiety drug; by noon, he had been given a second dose of the anxiety drug, started shaking, the fell unconscious. At 12:35, he was pronounced dead. His autopsy lists heart attack as his cause of death.

His family sued CRI for failing to properly monitor Jordan and refusing to medically intervene to save his life. There was an emergency department right around the corner from the CRI clinic he was staying in, and doctors were well aware of the drugs' cardiac risks. The case ended in a sealed settlement.

Continue reading "Drug Companies Prey on Poor, Homeless, For Drug Research" »

New Evidence Further Discredits Pradaxa

July 28, 2014

pradaxa.jpgThe controversy over the popular blood-thinning drug Pradaxa is reaching new heights after a slew of negative articles and editorials. The highly-esteemed British Medical Journal (BMJ) recently published reports criticizing the data used to support the safety and efficacy of the drug, along with the suspect behavior of those who were apart of the approval process. Pradaxa attorneys at Pintas & Mullins are happy to see critics finally speaking out.

Pradaxa is an oral tablet commonly prescribed to patients at risk of heart attack and stroke, and is manufactured by Boehringer-Ingelheim. It is intended to thin the blood to reduce the risk of blood clots, which is known as anticoagulation. Pradaxa is a new type of anticoagulant (in the same class as drugs like Eliquis and Xarelto), and was thought to eventually replace warfarin, the original anticoagulant that has been used for more than 60 years.

The problem with warfarin is how strictly patients must be monitored while on it; patients prescribed to Pradaxa, on the other hand, do not need to be monitored as closely, making it seem like a simpler treatment. It is becoming increasingly clear, however, that the "simpler treatment" strategy is actually a red herring.

As the investigative editor for the BMJ points out, Boehringer-Ingelheim failed to disclose all of the information it had on Pradaxa and its risks to the FDA. Among the undisclosed finding included the actual amount of life-threatening bleeding situations, and the dose that could prevent such an accident from occurring.

Other information not previously released by the drugmaker related to the amount of monitoring that would be necessary to achieve the right doses in patients. The main reason doctors would prescribe Pradaxa over warfarin is because the company promised that the same anticoagulating effects could be safely achieved in patients without routine monitoring. As it is turning out, this does not seem to be the case.

No Antidote for Pradaxa


Despite all of this, the worst and most dangerous side effect of Pradaxa is the likelihood of suffering a major bleeding event, as there is no reversing agent for the drug's blood-thinning effects. For patients on warfarin, a dose of vitamin K can quickly and safely reverse the drug, giving blood the ability to clot and stop bleeding. If a patient on Pradaxa starts to bleed, even if they are immediately hospitalized, there is no way for doctors to stop the bleeding. Too many patients have died on hospital beds while doctors and nurses stood helplessly by.

Pradaxa is also a brand-name drug, and much more expensive than warfarin. The evidence against the drug continues to pile on, and doctors throughout the country are beginning to see this. Particularly doctors in emergency and trauma departments, who have been opposed and skeptical of the drug from the start after seeing many bad bleeds in Pradaxa patients. As information against Pradaxa slowly leaks out, it becomes increasingly clear that Boehringer-Ingelheim knew about the risks and simply hid them to gain approval.

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How Big Data is Helping the FDA Track Drug Complications

July 22, 2014

rosy-glasses-crimson-pills.jpgThe FDA is tasked with the immense responsibility of tracking adverse events, both major and minor, from over-the-counter and prescription medications. Recognizing the seeming impossibility of spotting serious side effects before they become a national problem, the agency is now looking toward big data for help. Dangerous drug attorneys at Pintas & Mullins detail this new effort, and how it could involve your own personal medical records.

This new government project, called Mini-Sentinel, costs around $116 million, and will mine national databases of medical records for adverse events from medications (this does not include supplements, as they are not regulated by the FDA). The current system used by the FDA to track adverse events is notoriously sub-par - it relies on voluntary reports from patients, doctors and pharmacists. The information received in this outlet, then, is random and cannot reflect true patient outcomes.

The director of the FDA's Center for Drug Evaluation and Research stated that the agency desperately needs a faster way to monitor drug safety. In its effort to do so, the FDA contracted with Mini-Sentinel, which manages the health records of nearly 180 million Americans. Almost all data used by the FDA is from billing records, meaning the agency is not looking at the actual doctor charts and notes, just codes from tests and procedures done for patients.

It took five years to build the pilot program and the team notes that it is impossible to mine the data based on individual doctors or patients, so privacy is kept intact. Mini-Sentinel is now a routine part of the FDA's safety monitoring, conducting hundreds of queries per year.

Real Problems, Real Solutions


If the FDA notices a trend of side effects from a certain drug, they call on Mini-Sentinel to conduct a data search into it. For example, a high blood pressure medication sold as Benicar was recently linked to serious intestinal problems in patients. Although initial reports denied a link between the two, a second investigation by Mini-Sentinel found a definitive link - but only in patients who had been taking Benicar for longer periods of time.

As a result of this comprehensive search, the FDA released label updates for Benicar warning patients of the risk of serious intestinal side effects. Officials state that such a quick and definitive answer would have otherwise been unavailable.

The ability to sift through huge mines of patient data seems like the most obvious opportunity for the FDA to track, monitor, and release information on drug safety information. What is at issue now, is how to properly do the sifting. Some experts believe that billing data was not meant to be used in this way, and are concerned that patients may get a false sense of security about the safety of medications.

The FDA's contract with Mini-Sentinel is up in September 2014; however, the agency is still trying to discern the best way to conduct its data searches. The agency is acutely aware that how you phrase questions about a drug's safety will greatly impact what the answer is.

For its part, Congress recently established a foundation called the Reagan-Udall Foundation for the FDA, which is researching how to use large databases to study drug safety. Needless to say, there is a lot of work that needs to be done to get a handle on this new science and to create set guidelines and methodology. One of the problems with the Reagan-Udall Foundation, however, is that nearly all of its funds come from Big Pharma: Johnson & Johnson, GlaxoSmithKline, Merck, Pfizer, etc.

Continue reading "How Big Data is Helping the FDA Track Drug Complications" »

Januvia Linked To Heart Failure and ER Visits

July 7, 2014

3447520846_68739029a0_b.jpgJanuvia, a popular type 2 diabetes drug, has been linked to many controversial and dangerous side effects in recent years. In the latest newsbreak, experts are taking a closer look into the risk of heart failure in patients taking Januvia. Our team of Januvia lawyers report on recent studies and reports linking the drug to life-threatening heart conditions.

An observational study on Januvia was recently published in the journal JACC Heart Failure. Medical researchers involved in the study analyzed insurance claims from more than 7,600 patients who suffered from both diabetes and heart failure. Researchers found that patients taking Januvia were much more likely to be hospitalized for heart failure than those not on the drug.

Fortunately, the study did not find that Januvia patients were more likely than non-users to pass away from cardiac events. This study adds to the growing body of evidence that Januvia and other drugs in its class (and perhaps even type 2 diabetes drugs overall) increase the risk of heart failure.

Januvia is part of a class of diabetes drugs known as DPP-4 inhibitors. Among the other drugs in this class include:

• Janumet
• Victoza
• Byetta
• Onglyza
• Juvisync
• Bydureon

Among many others (a full list of DPP-4 inhibitors can be found on our website, here). Onglyza was also recently investigated for heart failure risks. In February 2014, the FDA announced that it was requesting clinical trial data from Onglyza's manufacturer. This investigation was launched in response to a study that found Onglyza patients had substantially high rates of hospitalization from heart failure.

Pancreatic Cancer Risks


Januvia, Onglyza and the like initially received national attention after the risk of pancreatic cancer became evident. Pancreatic cancer is one of the deadliest forms of cancer, as it spreads incredibly rapidly and is extremely difficult to diagnose in its early stages.

Patients who suffered pancreatic cancer after taking these drugs are now filing lawsuits against drug manufacturers by the thousands. The issue at the center of this litigation is whether the drug makers knew about the risk of pancreatic injury and deaths before the drugs were put on market.

It has been reported and confirmed that Januvia's manufacturer, Merck, failed to conduct safety studies in patients with a history of pancreatic issues, even though it was a known risk factor. Merck's failure to conduct safety studies for something as serious and fatal as pancreatic cancer is inexcusable, and why so many patients are choosing to file suit against the drugmaker.

One plaintiff was in her mid-70s when she died from pancreatic cancer. Although she had diabetes, she lived an otherwise healthy lifestyle for someone her age, and was prescribed Januvia in 2006 to help her manage her illness. Just over one year after starting on the drug, she was diagnosed with pancreatic cancer. She died within a month of diagnosis. Her daughter recently filed a lawsuit against Merck, claiming the company designed and misrepresented a defective drug, which directly caused her mother's death.

Continue reading "Januvia Linked To Heart Failure and ER Visits " »

Actos Manufacturer Guilty of Destroying Evidence

June 23, 2014

364748005_c10f9bbd46_b.jpgActos attorneys at Pintas & Mullins recently reported that the jury in the first bellwether lawsuit decided to award plaintiffs injured by the diabetes drug Actos $9 billion. In addition to this immense award, the judge in the case also found that Takeda Pharmaceuticals (which marketed Actos along with Eli Lilly) was guilty of intentionally destroying evidence.

Throughout the trial, which was filed by a man named Terrence Allen who developed bladder cancer from taking Actos, it became clear that Takeda had knowingly destroyed millions of documents relating to the drug. This, despite being under court orders to preserve such documents since 2002.

The Louisiana federal judge presiding over this case, Judge Doherty, informed the jury that Takeda destroyed much of its internal communications regarding the drug, including emails from more than 45 current and former employees. The judge then allowed the jury to infer, if it wanted to, that the missing documents could have proved that Takeda executives knew about the causal link between Actos and bladder cancer.

Surprisingly, Actos is still legally prescribed and sold in the United States and has not been recalled by the FDA. The agency did, however, issue a Safety Announcement regarding Actos in September 2010, in which it stated that it was reviewing data from a decade-long study to determine whether there was a strong link between bladder cancer and Actos use.

Causation and Liability


The reason this document destruction is such a big deal is because it could, if more information were available, prove liability. Pharmaceutical companies are typically not held legally responsible for significant side effects of their prescription drugs unless they were aware of these effects and failed to warn doctors about them. If it becomes clear the company willingly chose to fail to warn patients and physicians of the dangers, lawsuits may be filed.

In this Louisiana case, the judge stated that the destroyed documents were in fact relevant to the case, intentionally erased, and that their erasure negatively affected the plaintiff's case. The plaintiffs, Terrence Allen and his wife Susan, alleged that Takeda knew of the bladder cancer risk even before it applied for Actos approval in 1999.

What is a Bellwether?


Thousands of lawsuits have been filed on behalf of those diagnosed with cancer after taking Actos, with more than 6,000 currently pending in the Louisiana MDL. As stated, this $9 billion jury award was the first bellwhether case in this MDL. Bellwether trials are used as tools to help resolve mass tort.

To back up a little, mass tort litigation involves many lawsuits filed by plaintiffs who suffered similar injuries from the same drug, product or device. The Actos lawsuits are considered a mass tort because most plaintiffs are all suing the drug manufacturer for causing a similar injury - bladder cancer, and withholding the information it had about this injury.

So, one of the tools federal courts have in mass torts is known as a bellwether trial, which judges decide to use. During bellwether trials, the plaintiffs, defendants and judge all decide on 5-10 specific cases that will represent the larger class as samples. These cases are then prepared and tried to a jury, to give all interested parties a good idea of what will likely occur in the future trials. For example, if more Actos plaintiffs win their bellwether trials, Takeda will become more and more willing to settle for a large amount.

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Pradaxa Lawsuits Settle for $650 Million

May 29, 2014

Thumbnail image for 7866565462_241dea3e9e_c.jpgOur team of dangerous drug lawyers confirm that patients seriously injured by the blood-thinning drug Pradaxa recently got a dose of good news: Pradaxa manufacturer Boehringer Ingelheim just agreed to end most of the injury cases in a $650 million settlement. The popular blood thinner is associated with at least 500 patient deaths.

Boehringer was scheduled to defend itself in the first Pradaxa injury case in September 2014 - the first of over 4,000. The majority of these lawsuits were filed on behalf of family members who died from bleed-outs caused by the drug, which has no antidote.

Pradaxa is a blockbuster drug initially touted as a replacement for warfarin, which was close to the only option for blood thinners for about 60 years. Warfarin, unlike Pradaxa, requires close medical monitoring, however, which gave Pradaxa a leg-up on its competition.

As mentioned, there is no antidote for Pradaxa. This means that if a patient taking the drug starts to bleed - even from a minor contusion like falling on a sidewalk or a cut to the hand - they could suffer fatal bleed-outs. Many doctors have come forward saying they were forced to helplessly watch Pradaxa patients bleed to death on their tables. Patients are now claiming that Boehringer marketed Pradaxa as superior to warfarin without sufficient evidence, and without fully disclosing its devastating lack of reversing agent.

The average payout per plaintiff is estimated at around $163,000 - many contend that Boehringer wanted to settle these lawsuits en masse because the problems with Pradaxa are clear and tragic. Patients argue that the company knew about Pradaxa's fatal risks even before it was released onto market in 2010.

By 2011, over 540 deaths had been reported in associated with the drug, along with nearly 4,000 serious side effects. As patients started filing lawsuits, it became clear that Boehringer hid key data about Pradaxa from federal regulators, including dozens of reports of fatal bleeding. The company failed to disclose this data in order to win approval.

Then, earlier this year, a judge ordered Boehringer to pay nearly $1 billion in fines for failing to preserve evidence - internal documents, files, emails, etc - concerning the maketing and development of Pradaxa. More on that scandal can be found here.

Similarly, the manufacturers of Actos were recently charged for destroying documents in the Actos bladder cancer litigation, and leading to a $9 billion punitive award for the plaintiffs.

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Urgent Recall for Patients on Blood Thinners

May 13, 2014

7866565462_241dea3e9e_c.jpgOur team of product recall lawyers announce that a Class I recall was recently initiated for Alere PT/INR Professional Test Strips, which are used to monitor anticoagulant drugs status at home. Patients taking oral anticoagulant drugs like warfarim, Coumadin, Pradaxa or heparin, should check their brand of PT/INR test strips immediately. Three patients have died due to the defective strips.

The specific product being recalled is the Alere INRatio 2 PT/INR Professional Test Strips (PN 99008G2). Patients using these strips are experiencing false reads on them, meaning that patients with dangerously high INR readings are seeing inaccurate results on their strips. These defective products are telling patients that their INR readings are normal when they are in reality dangerously, even fatally high.

Alere has received several reports of patient injury, including three deaths from false INR readings. The company reports that the strips can read anywhere between 3.1 and 12.2 units lower than the actual INR. This can cause patients to suffer spontaneous bleeding episodes, which can ultimately result in fatal bleed-outs. All three deaths were associated with uncontrollable bleeding.

The manufacturer has not yet stated how or why the products are defective, and stated that all patients using these strips should have received a letter around April 16, 2014 informing them of the problems. Anticoagulant and blood-thinning therapy is prescribed to patients who have recently undergone heart valve surgery, have a history of heart attacks, or suffer from an irregular heartbeat (atrial fibrillation). Drugs like warfarin, heparin, Coumadin, and Pradaxa help prevent blood clots that could cause strokes and heart attacks in these vulnerable patients.

Pradaxa Patients Suffer Similar Fate

This month, the Journal of Neurosurgery reported that the side effects of popular blood thinner Pradaxa are just as fatal and irreversible as from defective testing products. The authors of that report focused on one Pradaxa patient, an elderly man, who had been on the drug for just one month. The man suffered a seemingly minor fall at his home, and despite immediate medical care, doctors were unable to stop his intracranial bleeding, taking his life.

Pradaxa is commonly prescribed to elderly patients, and far too many fatal bleeding episodes are triggered by falls at home or in nursing homes. Patients over the age of 75 with pre-existing kidney conditions should be extremely cautious when considering taking a blood thinner, particularly Pradaxa.

This is because, unlike warfarin, Coumadin and heparin, Pradaxa has no antidote. Meaning, if a patient on a warfarin blood thinner starts to bleed uncontrollably, the effects can be reversed with a high dose of Vitamin K. This therapy does not exist for Pradaxa, so patients who start to bleed, even minimally, may suffer fatal bleed-outs while doctors watch on, helpless.

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The Deadly Risks of Epidurals

April 24, 2014

The FDA recently issued a warning regarding injectable steroid epidurals. New warning labels on these steroid drugs will now indicate that they may cause rare but fatal complications in some patients, sometimes within just minutes. Medical malpractice attorneys at Pintas & Mullins highlight this newly-recognized risk and who may be most likely to suffer fatal complications.

labor-shortly-after-epidural.jpg Spinal injections of steroids are used for many reasons in the medical community despite lack of federal approval. It may be surprising to hear (it certainly surprised us) that corticosteroid injections into the epidural are not approved by the FDA, since the drugs have been used in this way for many decades throughout the U.S. The FDA asserts that it has not approved steroid injections in the epidural because it has not yet been proved the practice is safe and effective.

The potential side effects are largely neurological, and include:

• Blindness
• Stroke
• Paralysis
• Death

Steroids are often injected to treat neck or back pain that radiates to the arms and legs, and to reduce swelling or inflammation. The FDA launched an investigation into this practice after a large number of medical professionals started voicing concerns about the neurological side effects.

After it became clear there was a significant safety issue, the FDA started an official review of the agency's Adverse Event Reporting System database and other medical literature. After this review, the agency decided to update all the warning labels of steroid injections on the life-threatening risks of injecting patients for pain.

To further raise awareness of this issue, the FDA's Safe Use Initiative called together a panel of medical experts - including pain management experts - to help define the proper techniques for using steroid injections. This panel's recommendations on reducing harm to patients will be released once they are finalized.

Later this year, the FDA also plans to convene an Advisory Committee meeting of even more experts, who will discuss the benefits and risks of epidural steroid injections. This committee will decide whether or not the agency needs to take even further action to prevent serious harm.

The following steroid drugs are commonly injected into the epidural (bottom area of the spine) to relieve pain:

• Betamethasone
• Dexamethasone
• Hydrocortizone
• Methylpredisolone
• Triamcinolone

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The Risks of Painkillers for Pregnant Women

April 14, 2014

a-whole-galaxy-of-multi-colored-uppers-downers.jpgRecent reports show that physicians are prescribing opioid painkillers to expectant mothers in exceedingly high numbers, even though the risks and potential dangers to developing fetuses are presently unknown. Dangerous drug lawyers at Pintas & Mullins take a closer look into this report and the possible repercussions of this troubling trend.

The new research analyzed over one million pregnant women enrolled in Medicaid, which is a federal program that covers medical expenses for about 45% of U.S. births. Researchers concluded that nearly 23% of pregnant women on Medicaid filled a prescription for an opioid painkiller in 2007, which is a marked increase from 2000 and the largest percentage to date. This amounts to one in five women using opioids during pregnancy.

Other research shows that among women using private health insurance, the amount that is prescribed an opioid painkiller holds steady between 12 and 14%. These figures are disconcerting for many reasons - first, because of how many women are so uproariously concerned about the effects of minor food and drug products on their pregnancies. Doctors note that they see many, many women who are worried about the effects a cup of coffee or piece of sushi may have on their pregnancy - but then turn around and pop an oxycodone.

The top-prescribed painkillers were codeine, hydrocodone, and oxycodone, and women were typically prescribed for short periods, about a week or less. Prescription rates were highest in the mountain states (Utah, Idaho) and in the South, and lowest in the Northwest and Northeast. The difference between the regions was stark, and concerning to researchers.

It is hard to believe, one doctor noted, that the Southern pregnant women suffer from that much more pain than expectant mothers in the Northeast. Further reinforcing the concern, opioid prescribing rates varied widely not only between states and regions, but between counties as well. This suggests an overall lack of attention and diligence to potential abuses.

Learning From the Past

The risks pharmaceuticals pose to fetuses are never known until it is too late - less than 10% of all medications in the U.S. have been adequately studied for effects on fetuses. Take, for example, the recent litigation and devastating stories from women who took an SSRI antidepressant while pregnant.

Expectant mothers who took medications like Prozac, Zoloft, Paxil, Celexa and Lexapro were giving birth to children with heart defects, limb and muscle malformations, and other severe disorders. Study after study confirmed the increased risk for mothers on SSRIs, and lawsuits began to be filed in large numbers. Litigation against SSRI drug manufacturers is ongoing, and mothers concerned that their child's birth defect was caused by a prescription should consider contacting a birth injury lawyer immediately.

Doctors are now seeing an increase in neural tube defects in children born to mothers taking opioids during pregnancy, particularly in first trimester use. Researchers note that opioid use in very early pregnancy translates to about double the risk of infant neural tube defects. Prolonged use of these drugs can also result in addiction in infancies, which is clinically referred to as neonatal abstinence syndrome.

In response to these troubling reports, the CDC recently established a Treating for Two initiative (website here), which aims to help doctors and patients treat ailments during, before and after pregnancy. The initiative aims to improve the health of mothers and children and prevent birth defects overall.

Some experts note that rising obesity rates may result in an increase in chronic back pain for pregnant women, which may help explain rising prescriptions; the most common ailments pregnant women on opioids suffer from are back and abdominal pain. Doctors note that there are many other alternative therapies, such as physical therapy or acupuncture, which would better help these ailments.

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