Articles Posted in Dangerous Side Effects

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sad womanDespite litigation and safety concerns, Mirena and other IUDs are experiencing a rapid rise in popularity. This rise is most notable among young women, who are choosing IUDs because they believe them to be long-acting, reversible, and safe. Our team of Mirena lawyers details the side effects of Mirena and the lawsuits stemming from these complications.

First, a little background: IUDs first became popular in the 1970s but were quickly recalled amid safety concerns. The FDA did not oversee devices then like it does now, and a particular IUD called the Dalkon Shield caused severe problems in women. More than 400,000 lawsuits were filed against the Shield’s manufacturer (including 18 wrongful death claims) causing the company to go bankrupt and the IUD market to collapse. Ultimately, $3 billion was paid to Dalkon Shield victims.

Decades later, one company chose to reintroduce a hormonal IUD into the American market.  Mirena enjoyed massive success in European countries and in 2000 the FDA approved the device. There was one caveat: it was approved only for women who already had children, which was an important but sneaky marketing move. Submitting Mirena for FDA approval only for women who had children rendered any concerns about infertility irrelevant. In other words, Bayer never had to prove that Mirena was safe for young, childless women.

In 2006, Bayer bought out the company that developed Mirena and continued aggressively marketing the product. One year later, the American College of Obstetricians and Gynecologists urged physicians to consider IUDs as a first-choice contraceptive for teens. By 2010, Bayer generated $714 million in Mirena sales.

So here is a hormonal contraceptive device that is federally approved for a specific subset of women, but is recommended by doctors to all women, including teenagers. What could go wrong?

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syringes-and-vialIn American culture, facial injections and reconstructions are commonplace. The prevalence of these procedures offers the illusion that they are completely safe, or at least have minimal risks. Unfortunately, there are very serious side effects resulting from dermal fillers. Our team of dangerous drug lawyers warns the public of these risks.

Dermal fillers – also called wrinkle fillers, injectable facial implants, or wrinkle fillers – are approved to smooth and plump the lips or cheeks. Patients receive injections directly into the treatment area from dermatologists, dentists, cosmetic or plastic surgeons, and other medical providers with appropriate training. More than one injection may be needed to achieve the desired result.

The FDA recently warned that these fillers can cause severe side effects if accidentally injected into facial blood vessels. Accidental injection can block facial veins, restricting the blood supply and potentially causing the filler to travel to other parts of the body. Other side effects include:

  • Blindness or vision impairment
  • Death of the skin (necrosis) and facial structure
  • Stroke

Accidental injection into blood vessels is more likely to occur on the skin between the eyebrows and nose, in the nose, the forehead, and around the nose and eyes. This can cause severe, permanent damage to patients. Blindness is most likely to occur from autologous fat filler, and is almost always irreversible.

Signs and symptoms of blood vessel injection include: vision changes, white-appearing skin near the injection site, unusual pain, and signs of stroke (difficulty walking, severe headache, dumbness, confusion, face drooping, dizziness).

Dermal fillers are the second-most popular facial procedure (second only to Botox). In 2013, more than 2.2 million soft tissue filler procedures were done, according to the American Society of Plastic Surgeons (ASPC). This is an alarming 243% increase from the numbers in 2010, when just over 650,000 soft tissue procedures were conducted.

The ASPC’s data also reveals that significantly more people in the Mountain / Pacific West and New England / Mid-Atlantic receive dermal fillers than in other parts of the country; and most patients are over the age of 55, Caucasian females.

An estimated 1 out of every 10,000 patients will suffer severe dermal filler complications. That’s hundreds of patients every year. The surge in dermal filler popularity means more patients will suffer from accidental blood vessel injection. The FDA will continue to monitor reports of adverse side effects.   Continue reading →

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injectionRecent studies show a strong link between the Depo-Provera birth control shot and the chances of being infected with HIV. Now, medical experts are asking the FDA to add the risk of HIV as a warning to the birth control’s labels. Dangerous drug lawyers at Pintas & Mullins explain this risk and the recent studies confirming it.

There are currently nearly 30 studies published on the Depro-Provera birth control shot. Researchers at the School of Public Health at the University of California at Berkeley examined all Depo studies in a meta-analysis, publishing the results in the medical journal Lancet Infectious Diseases.

Researchers found that Depo-Provera increased the risk of HIV infection by about 40%. It is important to note that this study was based on past data of women using different types of birth controls and HIV rates. This was not a new study based on new patients.

The risk of HIV infection was strongest among women who engage in commercial sex, injectable drug users, and those with known HIV-positive partners.

Depo-Provera is a shot that provides protection against pregnancy for three months at a time using the hormone progestin. In many parts of the world, this type of birth control is critically important as the only long-acting and discreet options available to women.

Thus, medical experts are calling on the FDA to add the risk of HIV to Depo’s labels, so women are aware and take precautions. Women need to have informed conversations with their healthcare providers about the known and unknown risks of contraceptives and all the options available to them.

Decades of Research

In 2012 the CDC acknowledged that several studies suggested the link between progestin-only birth control shots and increased HIV risk. These studies are not meant to guide individuals, but to help women make the best practical decisions for their health and wellbeing. Frankly, this information is most relevant for women where Depo is one of very few contraceptive options and where HIV rates are high – namely, East and South Africa.

American women using Depo should know that there is data suggesting this shot increases HIV acquisition risk. Women who do not know their partners’ health status, have many partners, or have an HIV-positive partner should consider switching their contraceptive method, preferably to condoms. There are many contraceptive options in the U.S. that do not have the increased risk of HIV; Depo-Provera should be the last-resort choice for at-risk populations.

The link between Depo and HIV has been a topic of research for over 20 years by agencies like the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Some animal studies have shown that progestin can cause vaginal inflation and the suppression of T-Cell activation, which protect the body’s immune system. T-Cells are also the same cells that are infected and attacked by HIV.

Nearly two dozen American doctors and scientists have petitioned the FDA to add language to Depo’s labelling that warns of the risk of HIV. Depo’s labels currently say that the shot does not prevent HIV, without any further warning. The petitioners highlighted one particular study which found that women using a different form of birth control shots, Noristerat, did not have similar HIV infection increases. This rules out the possibility that women who receive contraceptive shots were less likely to take measures to prevent HIV.

Our team of dangerous drug attorneys is currently investigating cases of serious illness from contraceptives like Depo-Provera and Mirena. We provide free legal consultations to concerned individuals and their families nationwide. We have been fighting against drug companies for 30 years and have won millions for our injured clients.

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file00053336815-thumb-250x187-94324The FDA recently announced that six diabetes drugs are causing serious blood problems in patients. The drugs, including Farxiga and Invokana, can cause a disorder known as diabetic ketoacidosis. Our team of diabetes drug lawyers warns the public that medications to treat Type 2 diabetes can cause severe, life-threatening side effects.

Diabetic ketoacidosis occurs when the body produces high levels of ketones, which are types of blood acids. This complication is normally seen in patients with Type 1 diabetes, which makes these recent reports all the more disturbing. All patients suffering this side effect had to be hospitalized or go to the ER, and some continue to experience complications.

Signs and symptoms of diabetic ketoacidosis develop quite quickly, and can include:

• Nausea and vomiting
• Fruity-scented breath
• High blood sugar levels
• Excessive thirst and frequent urination
• Abdominal pain
• Confusion
• Unusual fatigue

Normally, when sugar enters the body it is used as energy for muscles and other tissue with the help of insulin. If there is not enough insulin in the body, cells cannot convert sugar to energy, prompting the release of hormones that break down fat as an alternate energy source. This process then produces toxic acids – ketones – and any excess acids spill over into the urine.

Diabetic ketoacidosis is usually triggered by an infection or illness, such as pneumonia or a UTI. Missed insulin treatments or improper insulin therapy can also trigger the condition, along with alcohol or drug abuse, physical or emotional trauma, or high fever.
If left untreated, diabetic ketoacidosis can be fatal. Those at highest risk of fatal complications are patients younger than 19 and patients who frequently miss insulin doses.

Six Drugs Named in FDA Reports

The six drugs causing this condition make up the class of Type 2 diabetes drugs called sodium-glucose contransporter-2 inhibitors, or SGLT2 inhibitors. These include Farxiga, Xigduo XR, Invokana, Invokamet, Jardiance, and Glyxambi.

At least one of the manufacturers (Janssen, which makes Invokana and Invokamet) did report that there were cases of diabetic ketoacidosis during clinical trials.

Diabetes Drugs Marketed as Weight-Loss Aids

We recently wrote a post involving three of these drugs (Farxiga, Jardiance, and Invokana) and how they are marketed. The FDA has been asked to penalize makers of these drugs for advertising them as weight-loss products. A public advocacy group stated these direct-to-consumer ads are misleading, overstating the benefits of these drugs while undermining the very real and severe risks. The FDA has never reviewed the validity of weight loss from diabetes drugs, and the recent diabetic ketoacidosis developments are further proof that these drugs are causing much more harm than good.

Farxiga has also been linked to bladder cancer and Invokana has been linked to cardiovascular and bone risks. Despite these known serious risks, millions of prescriptions continue to be written and filled.

Nearly 26 million Americans have diabetes, and the vast majority suffers from Type 2. Unfortunately, drugs have become the first line of treatment to help lower blood sugar levels, even though study after study shows drugs increase the risk of death, heart attack, cancer, and other complications. The problem with these drugs is that they do not treat the underlying cause of diabetes and do not prevent the long-term damage caused by Type 2 diabetes. They merely mask the symptoms short-term, so patients believe they have a handle on a disease that is ravaging their body.

The hard truth: Type 2 diabetes is directly caused by lifestyle, and the only way to successfully treat and eventually reverse it is by implementing lifestyle changes. It is best to speak with your doctor, but some of the lifestyle changes with the most far-reaching and irrefutable effects are also the most obvious: cutting out added sugar and processed foods, exercising, following a nutrition plan, and addressing any underlying emotional issues.
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file1201295296054.jpgThousands of men have filed lawsuits against makers of testosterone treatments for injuries ranging from stroke to heart attack. Our team of t-therapy lawyers is constantly working to provide our clients the latest updates on these claims.

Seven manufacturers have been named in t-therapy litigation, which was recently centralized in the Northern District of Illinois. The first case is expected to begin in the fall of 2016. Some legal experts believe these claims will set a precedent in pharmaceutical litigation because t-therapy drugs were heavily marketed to men suffering from so-called “Low T,” which is not an FDA-approved use for these drugs, nor is it a valid medical condition.

Low T is not a recognized disease in any sense of the word – men’s testosterone levels naturally decrease with age, just as women’s estrogen levels naturally decrease. It is simply a part of getting older. Despite this, drug companies spend millions of dollars on direct-to-consumer ads every year that tell men they should consult their doctor about the possibility of Low T. “Borderline Low T,” was a term invented by Big Pharma to profit off the insecurities of aging men.

Over the past decade, t-therapy prescriptions have increased 10-fold in the United States. It is worth noting that the U.S. is one of only three countries in the world (along with Canada and New Zealand) that allows direct-to-consumer advertising for prescription drugs.

In response to this disease mongering, the FDA issued several warnings to t-therapy manufacturers demanding labels be revised so patients and doctors know that these drugs are approved only to treat serious medical conditions such as hypogonadism. The labels, updated in March 2015, also must warn that these drugs carry extreme, life-threatening cardiovascular risks.

Gels, Patches and Shots, Oh My!

The most well-known product at the center of these claims is AndroGel, however, recent studies have shown that short-acting injections carry the greatest risks. One study examined data from half-million new users of t-therapy. Of these, 7% used patches, 37% received injections, and 55% used gels.

The men who received injections had the greatest risk of cardiovascular side effects (stroke and heart attack), hospitalization, and death. There was no marked difference between patches and gels. This study did not include long-acting forms of t-therapy, which was just recently approved in the U.S.

The shorter-acting forms of injectable t-therapy, which were studied, caused testosterone levels to spike more severely. Researchers suggested that it may be wise for patients to take lower doses of the injections at more frequent office visits. Injections are typically much less expensive than gels or patches, making these findings all the more worrisome.

As mentioned, these drugs should only be prescribed to patients with hypogonadism or other medical conditions that cause dangerously low hormone levels. These drugs are not safe or at all necessary for men experiencing normal testosterone decline.

It’s this kind of sensationalism that has endangered healthy men and led to thousands of life-threatening injuries. The major complaint in the t-therapy litigation regards how heavily Big Pharma marketed these drugs to men who did not suffer from an FDA-approved medical condition. By doing this, drug companies purposefully put men’s lives in danger in order to reap larger profits.

Reports from the manufacturer of AndroGel illuminates how far Big Pharma was willing to go in its marketing to healthy men. Before AndroGel was approved, the company estimated hypogonadism (again, the only condition approved for t-therapy) affected about one million men. After the gel was approved, the company announced the market grew to about four million. Three years later, in 2003, the company estimated approximately 20 million men were eligible to receive AndroGel.

Hypogonadism is listed as a rare disease by the Office of Rare Diseases, which is part of the National Institutes of Health. To be classified as such, it would have to affect less than 200,000 Americans. This condition is either caused by dysfunction of the gonads or of the brain’s ability to message the gonads. Patients are either born with hypogonadism or develop it from injury or infection. In other words, there is a pronounced difference between naturally declining testosterone and hypogonadism.
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weighing-788291-m.jpgFor more than a decade, the FDA refused to approve pharmaceutical obesity treatments based on a long history of ineffective, unsafe “weight-loss” drugs. Within the last three years the FDA has approved five obesity drugs onto market, due in large part to the $50 million Big Pharma lobby. Dangerous drug lawyers at Pintas & Mullins highlight the severe dangers of these new diet drugs.

Nearly one in five deaths in the U.S. is associated with obesity, according to a new study from Columbia University. As the number of overweight and obese Americans continues to grow, we are putting ourselves at risk of serious and often fatal complications, such as heart disease, diabetes, hypertension, and lipid problems. About 75% of American healthcare costs already stem from the eight obesity-related diseases.

The government is rightly taking steps to address this obesity epidemic; however, pharmaceutical intervention will do far more harm than good. First, there is no proof that drugs of any kind improve the complications of obesity, such as heart attacks and strokes. Second, the side effects of these drugs are immensely serious: suicidal thinking, cancer risk, and heart conditions just to name a few.

The FDA held fast for 13 years, refusing to approve any diet drugs after massive deaths and injuries from drugs like fen-phen. Immense pressure from Big Pharma, medical societies (funded by Big Pharma), and the U.S. Senate (lobbied by Big Pharma) pushed the FDA to approve new obesity drugs, however. Among them include Saxenda, which is merely a higher dose of the diabetes drug Victoza.

For the first time in history, in 2013, the American Medical Association declared obesity a disease. Unfortunately, this designation ignores the root causes of obesity and calls on Big Pharma to “treat” this newly-coined disease and its symptoms. Obese and overweight people will not benefit – and in fact will be seriously harmed – by new weight-loss drugs. The only sectors that will benefit are the pharmaceutical industry and medical institutions.

The diet drug industry spent $60 million in the last five years to urge the FDA to approve its products. Aside from the very real adverse effects this will have on patients, it will also drive our healthcare costs sky-high as expensive drugs are prescribed and paid for by insurance.

Victoza and Pancreatic Cancer

Victoza, along with Januvia, Janumet and Byetta are associated with a significant risk of pancreatitis and pancreatic cancer. These drugs are prescribed to treat type 2 diabetes – a complication of obesity – and have been subject to massive injury lawsuits. The FDA has issued numerous warnings about these drugs to address the risk of pancreatic diseases, including cancer, hemorrhagic pancreatitis, and necrotizing pancreatitis, all of which are often fatal.

As mentioned, Saxenda (liraglutide) was approved for weight loss in 2014 and is a higher dose form of Victoza. Already, Victoza has been labelled the primary suspect in more than 345 deaths and 3,100 hospitalizations. Saxenda and Victoza are also linked to thyroid tumors, gallbladder disease, and heart rate increase.

Saxenda’s manufacturer, Novo Nordisk, claims the drug will produce weight loss of about 5% after one year. Weight loss should be a result of improved health, however, not the endgame in itself. People suffering from obesity must lose weight as a result of better lifestyle factors. Losing weight through a pill will not improve health alone; to the contrary, it will likely worsen patient health.

Studies measuring the cardiovascular and cancer risks of Saxenda are still ongoing, with results expected in 2016. The FDA is taking the “wait and see” approach on serious heart conditions and cancer risk, all the while patients continue popping Sandexa.

Another weight loss drug recently approved, Belviq, is associated with heart valve problems. Neither the FDA nor Belviq’s manufacturer itself know if the drug changes patient risk of heart problems, stroke, or death. The study measuring the long-term cardiovascular safety of Belviq is expected to end in 2019.

That the FDA allows serious risk studies to be done after drugs go to market should concern everyone, not just those fighting obesity. That any harm is accepted at all is unacceptable, and routinely exposing patients to drugs that have not been properly studied is even more unconscionable.

It is worth repeating that losing 5% of body weight through diet and exercise is not equal to losing 5% of body weight through a drug. The beneficial improvements to cholesterol, blood pressure, heart disease and blood sugar are enacted only by lifestyle changes.

Diabetes Drugs do not Reduce Heart Conditions

Similarly, in December 2014, a study was published that found that none of the 30 type 2 diabetes drug approved in the last decade improved important health outcomes, like heart attacks and blindness. If they were told about the risks of cancer and heart attack from these drugs, most patients would choose to not take these drugs. Most patients, as it turns out, are not fully or even partially informed about diabetes and weight loss drug risks.

Patients are not told that studies measuring the actual, long-term risk of important adverse events are not conducted until after the drug is approved for market. They are not told that the risk of side effects increase the longer they take the drug. They are not told that the root cause of their obesity and diabetes cannot be cured by pharmaceuticals. They are not told that the largest contributor to obesity and diabetes is merely excess sugar and a sedentary lifestyle.

Patients are also unaware that drug companies are fined millions and often billions of dollars each year for falsely marketing diabetes drug treatments. More on these diabetes drug topics can be found here and here.

To date, more than 120 lawsuits have been filed against Victoza and Saxenda for pancreatic cancer development. These patients claim that if they had been properly warned about the risk of cancer they would not have chosen to take these drugs. Pancreatic cancer is extraordinarily hard to treat and is a leading cause of cancer death.

Conquering Obesity

Patients battling obesity and type 2 diabetes must read all labels carefully and thoroughly before taking any type of medication. Patients also need to be aware that excessive sugar acts as a poison in the body, contributing to obesity and other chronic and fatal diseases. Losing weight is difficult, but it should not focus on counting calories or excessively exercising. It is necessary to make a holistic, overall lifestyle change to beat obesity.
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vitamins-781607-m.jpgActos’ manufacturer, Takeda Pharmaceuticals, recently agreed to pay $2.37 billion to resolve the majority of bladder cancer lawsuits. Our team of Actos attorneys is pleased to announce this potential settlement to our Actos bladder cancer clients.

Takeda Pharmaceuticals is Asia’s largest drugmaker and will continue to sell Actos in the U.S., Japan and other countries after litigation resolves. Several countries, including France, Germany and India, have banned Actos for its extreme cancer risk.

Actos was introduced in 1999 to treat type 2 diabetes and became the world’s best-selling diabetes drug in 2007. Even before Actos was approved, animal studies showed high rates of bladder tumor development. One study found that those taking Actos had an 83% increased risk of developing bladder cancer. Others have found similar egregious risks.

Takeda is facing an estimated 10,000 bladder cancer lawsuits. The terms of the settlement would offer an average payout of more than $296,000 to each plaintiff. This is merely an average, however, as each plaintiffs’ unique circumstances will be taken into account, including history of toxic exposure, smoking, and age.

Historic Awards

This average payout is negligible considering the recent verdicts against Takeda for Actos victims. Just a few weeks prior to this settlement announcement, a jury hit Takeda with a $3.6 million verdict for a man who developed bladder cancer from Actos. The jury concluded Takeda acted with reckless indifference for the health of the public.

Another Actos award is actually the seventh-largest in U.S. history. In April 2014 a federal jury announced Takeda (and Eli Lilly, the drug’s American marketer) was liable for $9 billion in damages to a man who developed bladder cancer. The award was later reduced to $36.8 million, but the message remained the same.

There are several other examples of multi-million dollar jury awards to plaintiffs victimized by Takeda. Undoubtedly, the company calculated the risk of litigating all 10,000 Actos suits and decided to settle instead, removing the threat of more jury’s finding Takeda liable for massive awards.

Actos sales peaked in 2011 at $4.5 billion. Since its release, Actos has generated more than $16 billion in sales. Considering these numbers, the $2.4 billion settlement is likely to be opposed by some Actos victims. Former Actos users claim Takeda ignored or concealed concerns about the drug’s cancer risks before introducing it to market, misleading doctors, patients, and U.S. regulators.

This $2.37 billion settlement is among the largest targeting a drug’s side effects. The only larger settlement that comes to mind was the 2007 agreement between Merck and about 30,000 plaintiffs who were injured by the painkiller Vioxx. Merck paid $4.85 billion in that accord.

Type 2 Diabetes Cash Cow for Big Pharma

The type 2 diabetes drug industry is massive and ever-expanding. Pharmaceutical companies have convinced the public that they need drugs to control their conditions and that drugs alone will treat diabetes. Contrary to what Big Pharma is telling you, drugs cannot reduce your risk of complications from diabetes; drugs merely mask the symptoms short-term.

The longer you are on any drug, the more likely you are to experience serious side effects. Diabetes drugs like Avandia, Januvia, Janumet, Byetta and Victoza are now clearly linked to pancreatic cancer, heart attacks, and premature death.
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blood-glucose-meter-1413150-m.jpgAn investigation by a medical group and news journal recently found that none of the 30 most popular type 2 diabetes drugs reduced the number of heart attack, stroke, blindness or amputation; instead, these drugs were linked to thousands of deaths and hospitalizations. Diabetes drug lawyers at Pintas & Mullins detail this important report.

The Slippery Slope is a joint investigation by MedPage Today and the Milwaukee Journal Sentinel, examining 30 diabetes drugs approved by the FDA between 2004 and 2013. The team combed through thousands of pages of FDA medical and data reviews, label histories, and pharmaceutical company records to reveal the truth about these drugs.

Millions of Americans – more than 9% of the population – have type 2 diabetes. It is reaching epidemic proportions, causing limb amputations, deaths, kidney failures, and blindness throughout the country. It is also a cash hog for Big Pharma, which keeps turning out diabetes drugs like clockwork.

All 30 drugs examined in the report were approved based on their ability to lower elevated blood sugar, called HbA1c, in patients. This is only a partial view of the disease, however, as elevated blood sugar is merely a symptom of diabetes, not the cause. None of these drugs were ever proved to reduce the incidence of heart attack, blindness or amputation.

Rather than improving patient’s quality of life, these drugs are merely masking the real cause of the disease and patients are paying the price. Researchers found at least 3,300 deaths and 20,000 hospitalizations linked to diabetes drug side effects since 2004 – and these are just the incidents reported to the FDA. FDA data is infamously incomplete, so this number is likely significantly higher in reality.

For a full list of the drugs studied (including Victoza, Janumet, Januvia, Byetta, and Tradjenta) redirect to MedPage Today’s website, here.

Big Pharma Paying Doctors to Tout Diabetes Drugs

In addition to finding no clinical improvement and dangerous drug risks, investigators found that Big Pharma pays millions of dollars to doctors on panels that make decisions on diabetes treatments – specifically, the doctors in the American Association of Clinical Endocrinologists and the American Diabetes Association.

These panel members receive millions of dollars for “speaking and consulting” activities for Big Pharma. This is entirely legal, but the conflict of interest is obvious, and patients are almost completely unaware of this relationship. Patients wrongly assume that their doctors are prescribing them life-changing medicine that will control their diabetes, putting their lives on the line for bad science.

Not only are American diabetic experts in the pockets of Big Pharma, but these associations are constantly changing the definition of the disease. Before the changes, in the mid-1990s, more than 21 million Americans were considered diabetic or pre-diabetic; now, more than 77 million American qualify. Sales of diabetes drugs have skyrocketed at the same time, reaching $23 billion in 2013 – the same year these diabetes panels issued a statement telling doctors pre-diabetes can be treated with drugs.

This would be less disturbing if the side effects of these drugs were not so catastrophic. Drugs like Januvia, Byetta and Victoza are associated with pancreatitis and pancreatic cancer. Pancreatic cancer is among the most deadly and aggressive forms of cancer. Actos is associated with bladder cancer, which has an extremely high recurrence rate. Avandia is linked to severe and fatal heart problems.

Most patients taking these drugs have no idea they can cause cancer, heart failure, and other devastating side effects. And the diabetic drug industry keeps booming, making more than the NFL, NBA, and MLB combined.
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15422447919_9f0b96ef22_c.jpgDiabetes drug companies are facing potential federal penalties for advertising these drugs as weight-loss aids. Five drugs specifically are named in the complaint: Victoza, Invokana, Jardiance, Farxiga, and Bydureon. Dangerous drug lawyers at Pintas & Mullins warn patients of the dangers of diabetes drugs.

A consumer watchdog group, Public Citizen, filed the complaint to the FDA, urging the agency to impose penalties on the drug makers. The group says that the ads are everywhere, in magazines, websites and other media, describing that these medications can help patients lose weight.

Public Citizen argues the ads substantially overstate the benefits of diabetes drugs and negligently undermine the risks. Spokespeople for the drug companies stated that weight loss was seen in clinical trial for Bydureon, Invokana and Farxiga, and that “these secondary effects are important.”

These companies are acutely aware that at least 90% of type 2 diabetes patients are overweight or obese and the attempt to cash in on that is quite clear. There is a big difference between claims of benefits based on comprehensive, proven studies and claims based on superficial endpoints or appeals to vanity. The FDA has never reviewed the validity of weight loss with diabetes drugs.

Victoza Pancreatic Cancer

More important, however, should be disclosing the actual risks of these drugs. Victoza in particular should be noted, as it is being linked to serious pancreatic cancer development. In August 2013, a panel of federal judges decided to centralize all lawsuits naming Victoza, Janumet, Byetta and Januvia – all type 2 diabetes drugs in a class called incretin mimetics.

These cases are now known as Incretin Mimetics Products Liability Litigation. The allegations against these drugs are all similar, involving pancreatic diseases.

Patients with type 2 diabetes turn to drugs because of the advertisements by Big Pharma proclaiming the drugs will not only control their diabetes, but also help them lose weight and control their blood pressure. What the promotions fail to mention is that the drugs can actually cause the development of a far worse disease: cancer.

The pancreas aids in digestion, secretes insulin and helps regulate how sugars are metabolized; so it makes sense that a medication that alters the body’s insulin levels could negatively affect the pancreas. Unfortunately, pancreatic cancer has an extremely poor prognosis and survival rate, even when it is caught early. Pancreatic cancer typically spreads very quickly and is a leading cause of cancer death.

Victoza, Januvia, Byetta and Janumet are also associated with acute pancreatitis, necrotizing pancreatitis, and hemorrhagic pancreatitis, all of which are life-threatening. Even patients who stop taking these drugs after showing symptoms of pancreas injury may continue to suffer adverse effects.
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2737354030_604ffba77b_b.jpgThe Iowa Supreme Court recently ruled that a patient injured by a generic drug could successfully sue the drug maker, Pliva Pharmaceuticals, under state law. This is a landmark decision that may have ripple effects across the country. Dangerous drug lawyers at Pintas & Mullins tackle this issue below.

Generic vs. Brand Name Drugs

First, a little background on generic versus brand name drugs in the United States. When Big Pharma develops a new drug, it enjoys 20 years of patent protection before any generics can be made. Once the patent expires, the FDA requires that all generic drugs contain the same active ingredients as the brand name drugs, be identical in strength, dosage form, and route of administration, meet quality standards, and be manufactured under the same regulations as brand names.

There is an elaborate and comprehensive system in place to ensure the efficacy, safety, quality and purity of most generic drugs, particularly of those used in life-or-death situations, such as amoxicillin. The issue of generic drugs may never cross the minds of some people; yet in the U.S., this issue is an ideological, legal, business, economic, and regulatory battle.

Big Pharma has spent decades of time, money and resources trying to convince physicians and the public that generics are not as safe as branded drugs. This is a common phenomenon in our mass-marketed society – Kleenex vs. tissue paper, Jiffy vs. store-brand peanut butter, etc. – but it is quite different in pharmaceuticals, which must be approved and regulated.

The exorbitant costs of pharmaceuticals in the U.S. has been argued over since the 1960s, when the large price differences between branded and generic drugs prompted public outcry. Costs have only amplified over time – cancer drugs especially – and we tolerate it. We depend on drugs more over lifestyle changes to cure our ailments, which are by and large caused by our affluent lifestyle. The more we depend on drugs, the more Big Pharma can charge us for them.

How they Differ

Generic drugs are not exactly, 100% identical to brand name drugs; there is a specific matrix the FDA uses to prove they are bioequivalent in all the ways that matter (more on this can be found here, on the FDA’s Generic Drugs Q&A). Generics can be different in seemingly insignificant ways: the colors, size, price, shape, manufacturing plant, chemical binders, coatings, dyes, and filling agents.

The sciences of similarity and difference are not proven or defined as fact, however. Definitions change all the time and new forms of potential difference keep coming out. When there is so much we admittedly do not know about pharmaceuticals and how they interact in our bodies, why are we taking the risk?

Again, this comes down to drug pricing. Many, many people would not be able to afford the drugs they need to survive if they were not made by generic companies. But almost anything can cause adverse or catastrophic reactions when it comes to medications, even things that aren’t active ingredients. There are much more to those tiny little pills than what meets the eye, and decades of medical research proves that the inactive ingredients can be just as important, or just as dangerous, as the active ingredients.

Legal Disputes

The highest courts in our country are grappling with this issue as well, to varying results. The most important decision came in 2011, in the U.S. Supreme Court’s (SCOTUS) Pliva v Mensing ruling. SCOTUS found that, since the FDA requires labeling on generic drugs to be identical to brand name counterparts, those injured by generic drugs cannot sue the manufacturers for failure to warn.

This decision awarded generic manufacturers immunity from liability based on failure to warn claims. Two years later, in Mutual Pharmaceuticals v Bartlett, SCOTUS again granted generic makers immunity, this time from claims based on design defects. This was a huge blow to patients and public safety. More than 80% of all drugs prescribed are generic. Since these decisions, anyone injured by these drugs have little to no legal recourse against the companies that made them.

Recently, the Iowa Supreme Court offered a bit of hope for injured patients. This landmark decision, Pliva v Theresa Huck, came from a lawsuit filed by Theresa Huck, who was injured by Pliva’s drug metoclopramide (the generic of Reglan). Huck developed a serious neurological disorder, tardive dyskinesia, from the drug and sued both Pliva and Reglan’s branded manufacturer, Wyeth Pharmaceuticals.

The Iowa Supreme Court found that Wyeth was not liable for Huck’s injuries since she took the generic form of Reglan; it also found that SCOTUS’s Mensing decision could not apply to her case, opening Pliva up to liability.

The court found that Huck’s claim was based on Iowa’s laws of insufficient warnings because Pliva did not issue stronger warnings on metoclopramide that the federal government approved in 2004. Thus, the state law had to apply rather than the federal law. Mensing applies only to federal labelling laws.

Huck claimed that Pliva failed to update its warning labels in 2004 when the FDA approved new, stronger warnings for Reglan. The Iowa Supreme Court agreed, ruling that Pliva could and should have independently updated its labels to match the new warnings, that it had a federal duty to do so, and that Huck’s claims survived the 2011 SCOTUS preemption.

The updated warnings listed the risk of tardive dyskinesia as a possible side effect and that patients should not take the drug for longer than 12 weeks. Neither Huck nor her doctor saw these new warnings, because Pliva’s metoclopramide did not include it. She consequently developed the neurological disorder, which causes uncontrollable body movement and has no cure or treatments, and continued to take the drug for two years.

Pliva attempted to have the decision appealed to SCOTUS, however the court denied its petition without elaboration. In 2009, the FDA took further action, requiring all forms of metoclopramide to include a Black Box Warning – the FDA’s most severe alert – about the risk of tardive dyskinesia and long-term use.

The lesson here is that patients injured by generic drugs need to carve out creative legal avenues in order to sue generic drug makers. Huck and her legal team succeeded because they filed a claim based on breach of state law duty to warn, rather than federal law duty to warn (known as the Hatch-Waxman Act, more on this below).

Another story on a successful tardive dyskinesia plaintiff can be found here. The plaintiff in that case took metoclopramide and developed the disorder, suing Wyeth and winning in Alabama Supreme Court.

New FDA Rule Proposal Fuels Battle

In 2013, the FDA proposed a rule that would allow generic drug makers to update their own labels without first gaining federal approval. In a public hearing on this proposal, several consumer and advocacy groups came together to voice their support.

This proposal makes sense at the most basic level: as long as a drug stays on the market, we are constantly learning new information about its risks. Currently, when new safety studies come out on a drug, brand name companies can independently update the drug’s labels to reflect this new information, while generic drug companies cannot.

This was evidenced in Huck’s lawsuit, when in 2004 Wyeth updated the labels to include the risk of tardive dyskinesia, and Pliva did not. Generic companies like Pliva are not allowed to make changes to labels unless the FDA approves them or the branded name updates labels first. Generic companies have little to no incentive to update their labels or to monitor side effects, since they are protected by the 2011 SCOTUS ruling.

As stated, generics make up about 84% of the American drug market. That means the vast majorities of people taking medications do not know the true risks of these drugs, and have no legal recourse if they suffer a severe side effect.

Advocates argue that this FDA proposal would immediately solve this problem. Generic companies counter-argue that the proposal would have disastrous ripple-effects and that it contradicts the federal Hatch-Waxman Act. This Act, enacted in the mid-1980s, requires all generics to have the same labels as generic equivalents. It is also what the majority of SCOTUS judges based their 2011 decision upon. Drug industry insiders view this proposal as a direct conflict to the Act’s guiding principle.
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