Recently in Dangerous Side Effects Category

$3.6 Million Verdict for Actos Bladder Cancer

February 13, 2015

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for 1409595_gavel_5.jpgA Philadelphia jury recently awarded $2.3 million to a man who developed bladder cancer and had to have his bladder removed from taking the drug Actos. Actos is prescribed to type 2 diabetics and has been subject to massive litigation and billion-dollar verdicts. Actos attorneys at Pintas & Mullins detail this most recent case.

The man, John Kristufek, was diagnosed with bladder cancer in 2008 after taking Actos for three years. In 2011, he had to have his entire bladder removed. That same year Actos finally updated its labels to include the risk of cancer. Kristufek filed suit in 2012.

In his case, Kristufek alleged that Actos' manufacturer, Takeda Pharmaceuticals, hid its association with bladder cancer from physicians. Ultimately, the jury awarded Kristufek $2.3 million in total damages, with $318,000 to compensate for past medical expenses. The jury concluded that Takeda acted in reckless disregard for patients in developing and marketing Actos.

In addition to the $2.3 million awarded to Kristufek, Takeda was also hit with $1.3 million in punitive damages. Punitive damages are considered punishment for defendants and are awarded only when the defendant's behavior has caused severe harm. That brings the total award against to Takeda to $3.6 million.

Throughout trial the jury was shown evidence that Takeda's sales representatives were told not to bring up the drug's link to bladder cancer to physicians. Punitive damages are determined to prevent drug makers from engaging in this behavior again.

Multi-Billion Dollar Awards

In April 2014, Takeda was hit with $6 billion in punitive damages for its conduct concerning Actos. This amount was likely due to the billions of dollars Takeda has reaped in profits between 2000 and 2012 - more than $24 billion.

This case and Kristufek's are the only two cases against Actos that have resulted in punitive damages. Many plaintiffs have won their injury cases against Takeda, some of which in Philadelphia. In October 2014, for example, a jury awarded a woman with bladder cancer $2 million in damages.

Despite the known risk of an extremely debilitating and life-threatening disease, neither Takeda nor the FDA ever pulled Actos from the market. Actos - which is linked to an 83% increased risk of bladder cancer - has been recalled from Germany, India, and France, however.

Continue reading "$3.6 Million Verdict for Actos Bladder Cancer" »

Drug Safety and Clinical Trial Fraud

February 11, 2015

prescription-prices-ver3.jpgWe recently reported on how and why drug companies hide the negative studies linked to their drugs and medical devices. It has recently come to light that the FDA, too, has a hand in concealing evidence of fraud in medical studies. Our team of dangerous drug lawyers details this new report and how the practice is harming the public.

The Food and Drug Administration (FDA) is responsible for regulating, approving, and overseeing the incredible amount of prescription drugs in this country. A recent report published in Slate found that the FDA habitually hides scientific fraud and misconduct from the medical community and the public. The agency actually has a long-term record of burying the details of scientific misconduct.

Because of this concealment, no one - even doctors, nutritionists and scientists - know which studies, drugs and data is of quality or simply bogus. When drug companies submit a drug to the FDA for approval, they must provide long-term, in-depth data on its side effects, efficacy, and safety. The FDA is then tasked with going through every page of this data to determine whether or not it is safe for the public.

The problem is that this data is not available to anyone else except the FDA and the drug companies - even congressional panels are unable to get the data they need when investigating dangerous drugs. In the Slate report, authored by a professor at New York University, researchers looked into FDA documents relating to about 600 clinical trials.

These 600 trials were chosen because they all were run by researchers who failed an FDA inspection. Although there was a plethora of documents available from these trials, much of the most important parts were blacked out or redacted. So much so, that only in about 1 out of every 6 trials were the NYU researchers able to figure out which study, which drug, and which drug maker were involved.

As mentioned earlier, the problem here is not that the FDA is concealing some information from public knowledge; the problem is that the agency conceals so much critically important data from doctors and other researchers.

The FDA is aware of countless scientific papers that includes questionable or unproven data and does nothing about it. No wonder unsuspecting doctors are prescribing dangerous medications, using defective medical devices, and patients do not understand how to handle their own health.

Xarelto As Prime Example

The NYU researchers offer a perfect example of how seriously this is harming us. The blood thinner Xarelto was approved for market based on a study called RECORD 4, which involved thousands of patients. The FDA inspected or audited 16 of the clinical sites used in RECORD 4, finding falsified data, systemic discarding of medical records, misconduct fraud, and other suspect behavior.

The RECORD 4 practices were so bad that the FDA declared it unreliable and its data worthless. Yet, still even today, the results of RECORD 4 remain in established medical journals (such as The Lancet) without any mention of its fraud. In researching what blood thinners to prescribe to patients, then, doctors are basing their decisions on a study that was dangerous and falsified.

Consequently, just a few years after its release, reports started emerging on Xarelto's extraordinary danger. The drug can cause fatal internal bleeding, strokes, heart attacks, and other life-threatening side effects. Xarelto has and continues to kill masses of patients, who were as unaware of the drug's dangers as their doctors.

Continue reading "Drug Safety and Clinical Trial Fraud " »

IV Fluids Cause One Death, Many Illnesses

February 3, 2015

At least one patient has died after being injected with an IV saline solution and dozens more have been sickened. The IV solution, made by Wallcur LLC, is intended for training purposes only. Dangerous drug lawyers at Pintas & Mullins warn patients receiving saline injections to keep this alert in mind.

15643200_67a5c33596_b.jpg Wallcur is a medical training product company based in San Diego. Its medical-grade versions of 0.9% sodium chloride (also called normal saline) were shipped to health clinics, surgical centers and urgent cares in seven states. These states are Colorado, Florida, Georgia, Idaho, Louisiana, New York, and North Carolina.

The solutions are labeled as Practi IV Solution Bags. Medical personnel were unaware that the products were for simulation only, and have been using the mock-solution for serious cases of dehydration and other medical conditions.

Because the IV solution is intended for training only, the seriously ill patients did not receive the treatment they desperately needed. Some patients have been hospitalized, and one has died. Patients are displaying symptoms such as:

• Fever
• Chills
• Tremors
• Headaches

The FDA released a Safety Alert on January 10, 2014 warning medical centers not to inject patients with Wallcur's training solution. Before administering any IV solution to patients, the FDA advises medical personnel to carefully check the labels to confirm they are not intended for training. Wallcur's products often include the language "for clinical simulation."

The FDA and CDC are currently working with Wallcur and its distributors to determine how many products entered the supply chain. According to Reuters, medical-grade versions of this normal saline solution have been in short supply. For this reason medical clinics have likely brought out older stocks to keep up with demand, not realizing Wallcur's solution were for simulation only.

FDA's Adverse Event Reporting System

Anyone suspecting that any Wallcur training IV products may have been injected into patients should report the incident to the FDA's MedWatch Adverse Event Reporting program, located here. This should be done whether or not there was an injury suffered.

This system allows the government to gather information on the side effects of prescription drugs and devices. The system is voluntary and can be used by anyone, from the public to drug companies to doctors. Drug makers file the highest number of side effect reports - close to 97% of all reports in the system. Not surprisingly, the drug companies often file with incomplete information in efforts to underplay the seriousness of some drug side effects.

In reports involving the death of a patient, for example, many filed by drug makers do not include the cause of death or the possible role of a medicine. This is a serious problem because the FDA Reporting system is the most important tool we have to keep track of medicine safety. Virtually every prescription has its own set of side effects; it is literally a matter of life and death that we know how many people are harmed and by what drugs.

Continue reading "IV Fluids Cause One Death, Many Illnesses" »

FDA Considering Generic Drug Labelling Changes

January 21, 2015

3446691811_d541bfc6dd_b.jpgThe U.S. Supreme Court recently refused to hear an appeal by generic drug manufacturers, allowing a Fosamax failure-to-warn lawsuit to move forward. This could have far-reaching effects for patients injured by generic drugs throughout the country. Dangerous drug lawyers at Pintas & Mullins explain what is at stake in this lawsuit and how the FDA plans to react.

The case brought before the Supreme Court was based on Teva Pharmaceuticals USA et al v. Olga Pikerie, which was filed by a woman seriously injured by the generic form of the drug Fosamax. Olga Pikerie was prescribed Fosamax and its generic equivalent (alendronate sodium) to help treat and prevent osteoporosis. She took the drug from 2006 to 2011.

Fosamax Femur Fractures

Within those four years, Pikerie suffered a left femur fracture, a serious side effect that thousands of other patients have experienced. Although Fosamax was developed and intended to be a bone-strengthening drug, it can actually have the opposite effect in some patients, causing thigh bones to break while engaging in normal activities like walking or standing. The risk is highest in women taking the drug for about five years or longer. More information on Fosamax and its risks can be found here on the New York Times wellness blog.

Fosamax was released in 1995 and heavily marketed to women at risk of osteoporosis - by 2008, medical researchers found a clear association between Fosamax and low-impact femur fractures. Two years later the FDA began its own investigation into the drug and its side effects, ultimately concluding that there was indeed a link between Fosamax use and unusual but serious thigh bone fractures. The FDA further stated that there was little if any benefit from the drug after three to five years of use.

Despite these known risks, when Fosamax's brand patent expired in 2008 generic drug makers started selling the drug. Like millions of others, Pikerie took both the brand name and its generic equivalents, ultimately suing all companies that sold her the drug.

Her claims against all companies are the same: that they manufactured and sold a drug they knew to be unreasonably dangerous, that they failed to produce a safe product, failed to adequately warn patents about the side effects, and failed to take other available steps within their control to protect patients from injury.

SCOTUS Decision Points to Federal Drug Law Changes

The generic drug manufacturers attempted to appeal the case, arguing that Pikerie's claims were preempted by federal law; specifically, the U.S. Supreme Court's (SCOTUS) decision in PLIVA v. Mensing. We have written extensively about the PLIVA case, in which SCOTUS held that generic drug companies must exactly match the warning labels of its brand name equivalents.

Thus, even if generic drug makers knew that a drug was excessively dangerous, it would be impossible for the company to add additional information or warnings to its labels. Generic drug labels must exactly match the labels provided by the brand name company.

Pikerie is arguing, however, that Fosamax's brand name labels had been updated to reflect the risk of serious bone fracture, but the generic companies did not update their products accordingly. In other words, the generic labels did not match the brand name's. This is why her case is allowed to move forward.

For its part, the FDA recently revealed its plan to finally allow generic drug makers to update their own labels as they see fit, which would change the landscape of these types of lawsuits completely. Under the new federal law, generic drug makers will be required to update their labels according to the latest safety information, ultimately exposing them from drug injury claims like Pikerie's. Currently, generic drug companies are completely protected from injury lawsuits.

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How Drug Companies Hide Negative Studies

January 15, 2015

clinical-trial-capsules.jpgAnyone who has been injured by a medication or medical device - or knows someone who has - is well aware that these products are not always as safe as they seem. Big Pharma purposefully and consistently keeps the American public in the dark regarding its drugs and medical devices, hiding negative studies that could discredit their products. Dangerous drug lawyers reveal this practice of so-called "publication bias."

Half of all clinical trials, studies that measure the safety and efficacy of drugs and medical devices, are never published. Furthermore, the studies that result in negative or unpromising results are significantly more likely to remain hidden. This is the practice known as publication bias, and it is exponentially affecting what we know about the drugs we are prescribed.

These studies are not just hidden from public view; they are hidden from doctors and other researchers as well. Without full safety and efficacy data, doctors are forced to merely guess at which drugs and devices are best for their patients. These blind decisions often have devastating consequences for the patient, who suffer life-threatening or fatal complications from a drug they should not have been prescribed.

In effort to make all clinical trials public knowledge, the Institute of Medicine recently published a report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks. In this report, the IOM concludes that sharing data is in the best interest of the public and the current practices are unacceptable. To compile the report IOM assembled a committee to develop principles and framework to improve how we share trial data.

It should be normal practice to share data at the end of each clinical trial, researchers need to plan and document how their data will be usable to others who need it. This is literally a matter of life and death for so many people, data sharing needs to become an essential step in running a clinical trial.

Companies like Johnson & Johnson, Novartis, Medtronic, and GlaxoSmithKline are currently the gatekeepers of their own data. For its part, the FDA needs to release more data they have from the drug approvals processes. The FDA holds more data than anyone else in the drug industry - their European counterpart, the European Medicines Agency, already publishes its data.

Recent FDA Actions

One of the most glaring recent consequences of undisclosed data concerns transvaginal mesh medical devices. These mesh products are implanted in women suffering from pelvic organ prolapse (POP) or stress urinary incontinence (SUI), however, they carry immense risks without any evidence of benefit.

The FDA recently issued a warning that transvaginal mesh products (TVM) were associated with serious side effects including mesh erosion through vaginal tissue, infections, bleeding, organ perforation, and urinary problems. Thousands of women have had to be hospitalized and undergo additional surgeries to treat TVM complications or have it removed completely. For many patients, however, complete removal is impossible.

Continue reading "How Drug Companies Hide Negative Studies" »

Antidote Discovered for Blood Thinner Xarelto

January 9, 2015

pills-15.jpgPopular blood-thinning drug Xarelto is prescribed to patients to prevent blood clots and prevent strokes. Most patients do not know that Xarelto may also cause irreversible internal bleeding, often resulting in extended hospitalizations and death. Xarelto lawyers at Pintas & Mullins are currently accepting cases of serious bleeding events from Xarelto use.

Xarelto is a billion-dollar drug very similar to the blood-thinner Pradaxa, which is also known to cause devastating and fatal bleedouts. Both Xarelto and Pradaxa were introduced onto market to replace warfarin, which has been the first-line blood thinner for the last 60 years.

Blood thinners, also called anticoagulants, prevent the obstruction of blood flow to vital organs. Warfarin was a revolutionary drug when it was invented in the mid-1950s, and it was the most widely used anticoagulant in the world for many decades. Warfarin does require a commitment for patients, however; patients taking it must take it at the exact same time every day, change their diet and lifestyle, and go to regular checkups.

Not surprisingly, Big Pharma worked hard to develop a newer, less intensive drug to replace warfarin as the preeminent blood thinning medication. Pradaxa (made by Boehringer Ingelheim) and Xarelto (manufactured by Bayer and Johnson & Johnson) are the result of this years-long effort.

Pradaxa was the first challenger on U.S. markets, in 2010, with runaway success. It was a blockbuster for Boehringer, and by August 2012 more than 3.7 million Americans had filled prescriptions for Pradaxa, while worldwide sales neared $210 million.

Big Pharma Places Profits over Patients

Unfortunately, in order to keep the drug selling, Boehringer failed to notify patients that there was no antidote for the blood thinning effects of Pradaxa, meaning that even minor injuries could cause fatal bleed-outs, leaving doctors without any way to stop bleeding. These bleed-outs continue until the drug is flushed out of the system or the patient dies, whichever comes first.

Xarelto works in much the same way as Pradaxa, which is why the FDA fast-tracked its approval. Although both Pradaxa and Xarelto cost much (MUCH) more than warfarin and are just as effective, patients often prefer them because they do not require frequent doctor visits or changes in diet or lifestyle visits. What patients do not know that that, unlike warfarin, there is no antidote for bleeding events.

Thousands of deaths are now linked to Pradaxa and Xarelto, resulting in massive litigation against their manufacturers. Families who lost loved ones to fatal bleed-outs are filing suit against these companies, hoping to gain justice for the loss of their loved one, their extensive medical bills and other damages. In May 2014, thousands of Pradaxa lawsuits were settled for about $650 million.

Now, a pharmaceutical company claims to have a new drug that can reverse the effects of Xarelto. The experimental drug, andexanet alfa, was shown to immediately reverse the anticoagulant activity of Xarelto in patients enrolled in studies. Additional data on this study is expected in mid-2015.

Continue reading "Antidote Discovered for Blood Thinner Xarelto " »

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.

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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.

Continue reading "Actos Bladder Cancer Lawsuit Begins Today" »

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.

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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.

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