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Diabetes Drugs Linked to Thousands of Deaths, No Clinical Improvements

April 14, 2015

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.

Continue reading "Diabetes Drugs Linked to Thousands of Deaths, No Clinical Improvements" »

Diabetes Drug Makers Face Penalties for Weight-Loss Ads

April 3, 2015

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.

Continue reading "Diabetes Drug Makers Face Penalties for Weight-Loss Ads" »

Iowa Supreme Court Opens Liability for Generic Drug Injuries

March 31, 2015

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.

Continue reading "Iowa Supreme Court Opens Liability for Generic Drug Injuries" »

Zofran Birth Defect Lawsuits

March 27, 2015

4153339947_35cb8debb9_o.jpgThe birth injury lawyers at Pintas & Mullins have written extensively on the risks of birth defects in children born to mothers who took certain drugs. It has recently come to light that Zofran, a drug marketed to pregnant women to treat nausea, may also be causing birth injuries.

Zofran was approved by the FDA to treat nausea in cancer patients undergoing chemotherapy or surgery. In recent years, doctors have also prescribed the drug to expectant mothers who suffer nausea and vomiting during pregnancy, although the FDA never approved it for this use.

Prescribing a drug "off-label," or for uses not approved by the FDA, is not illegal for doctors to do; it is illegal, however, for drug companies to market their drugs for off-label uses, or to recommend doctors prescribe drugs for off-label treatments. Big Pharma by and large ignores these laws through various channels, spending large sums of money and time marketing drugs to doctors, so they will prescribe them for all kinds of treatments that have not been proven safe or effective.

Zofran's manufacturer, GlaxoSmithKline (GSK), saw the potential market for expectant mothers suffering from morning sickness. Getting a drug approved by the FDA for a specific treatment is a very long, very expensive process. Years of studies must be done in patients to prove the drug is safe and effective for long-term use, before it can be an official treatment for that purpose.

Big Pharma companies like GSK do not adhere to these guidelines, preferring to merely pay the million-dollar federal fines for illegal marketing. This is because drugs profit in the billions of dollars - a few million dollars in fines is a drop in the bucket compared to how much money they can and do make from off-label marketing.

In 2012, GSK plead guilty to federal charges of illegally marketing several drugs, including Zofran. It was the largest health care fraud settlement in U.S. history, ending in a $3 billion payment by GSK to the Department of Justice. The case was unprecedented in size and scope, and involved claims that GSK paid doctors to promote and prescribe Zofran to pregnant women. GSK ultimately pled guilty to three charges of criminal behavior.

The public is taking particular notice of the birth injury lawsuits because GSK knew there was a risk to infants from the beginning. Court documents prove that GSK knew that Zofran posed an unreasonable risk of harm to developing babies in the womb as early as 1992. The company continued to market it to expecting mothers and their physicians anyway.

About one million pregnant women take Zofran or its generic every year. Birth injuries named in Zofran lawsuits include:

• Club foot
• Cleft lip or palate
• Heart defects, such as holes in the heart
• Skull deformities, such as craniosynostosis

One of the most recent suits was filed in February 2015 by a mother who was told Zofran was safe to take while pregnant. Unfortunately, her daughter was born with various birth defects, including facial dysmorphia, hearing loss, ingueno hernia, and several heart deformities. The child endured ten surgeries in her first 12 years of life to correct the defects.

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No FDA Action after Zyprexa Deaths

March 24, 2015

1998368137_54ad6332d7_o.jpgThe long-acting form of the popular drug Zyprexa - Zyprexa RelPrevv - recently caused the death of two patients. Despite the clear link between injection of the drug and their deaths, the FDA decided not to change the drug's label warnings. Zyprexa lawyers at Pintas & Mullins warn patients of the dangers of this powerful antipsychotic.

Zyprexa RelPrevv is the long-acting version of the top-selling drug Zyprexa, which is prescribed to treat schizophrenia. Zyprexa RelPrevv must be injected by a certified health care facility with access to ER services, and patients must be continuously monitored by the facility for several hours after injection.

The patients injected with fatal doses of this drug died three to four days after receiving the drug. Both patients had extremely high levels of Zyprexa RelPrevv in their blood at time of death. The FDA launched an investigation into the issue to determine the cause of the high blood levels. Unfortunately, the FDA concluded its study with "inconclusive" results.

The agency did confirm, however, that it was unable to exclude the possibility that the deaths were caused by entry of Zyprexa RelPrevv into the bloodstream. The agency suggests that the drug level increase could have occurred after death, though it is not certain.

Zyprexa RelPrevv already comes with the FDA's most serious warning - a Black Box Warning - informing patients that the drug can cause post-injection delirium sedation (PDSS). This syndrome is suggestive of drug overdose, and is likely caused by unintended injection of the drug into veins or blood vessels, instead of into muscle tissue as it is intended.

If the drug is accidentally injected, even partially, into blood vessels, higher than intended drug concentrations are produced, causing potential overdose. These accidental injections can occur even with proper injection technique by a trained professional.

Zyprexa Lawsuit Largest Criminal Fine in U.S. History


Zyprexa belongs to a class of drugs known as atypical antipsychotics, which are approved to treat schizophrenia and bipolar disorder. Other drugs in this class include: Abilify, Geodon, Risperdal, Seroquel, and Symbyax.

These drugs make billions of dollars per year for their manufacturers, primarily due to their "off-label" marketing tactics. Prescribing a drug off-label, meaning for uses not approved by the FDA, is not illegal for doctors. It is illegal for drug companies to market the drugs for any uses not approved by the FDA, because they have not been proven to be safe nor effective.

For this reason, a large number of criminal lawsuits have been filed against atypical antipsychotic manufacturers for unlawful marketing. In 2009, Zyprexa's manufacturer agreed to pay $1.4 billion to resolve criminal allegations that it marketed the drug for off-label uses. The settlement included a $515 million criminal fine, the largest ever in a health care case and the largest criminal fine for a single company ever imposed in an American criminal prosecution of any kind. More on this case can be found here.

In this lawsuit Zyprexa's manufacturer was accused of promoting the drug for patients with dementia, including elderly patients in nursing homes with Alzheimer's disease. The company expended significant resources to promote Zyprexa in nursing homes. This is not only illegal but is unconscionable, as Zyprexa carries a serious warning of premature death if used in elderly patients with dementia.

Despite this fatal warning, Zyprexa was given to nursing home patients suffering from dementia to treat behavioral problems such as aggression, agitation, and hostility. Nursing homes in the United States are chronically understaffed, and employees are often tempted to dose uncooperative residents with powerful drugs, like Zyprexa, to subdue them. This is a practice known as chemical restraints, which is a severe form of nursing home abuse. More information on chemical restraints in nursing homes can be found here, on our Nursing Home website.

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$10 Million to Children's Motrin Injury Victim

March 20, 2015

2868098175_e328bf88a3_o.jpgA young girl and her family recently won a $10 million verdict against Johnson & Johnson for the severe injuries caused by Children's Motrin. The girl developed Stevens - Johnson syndrome (SJS), a rare but fatal skin reaction, to the medication, when she was just three years old. SJS lawyers at Pintas & Mullins applaud the Pennsylvania Supreme Court for upholding this verdict.

According to the Mayo Clinic, SJS is a disorder of the skin and mucus membranes and is usually an allergic reaction to a prescription or over-the-counter medication. Anyone can develop SJS at any time, and about 200 drugs have been known to cause it. Some of the most common drugs that can cause SJS include: Tylenol, ibuprofen (Advil, Motrin, etc), penicillin, Aleve, some antibiotics, and antipsychotic and epilepsy drugs.

The little girl at the center of this Children's Motrin case is now 17-years-old and permanently blind from SJS. Her mother gave her Children's Motrin for about four days because of a fever. After a few days she developed a rash that turned into blisters so severe that she was admitted to a nearby hospital.

Once SJS was diagnosed she was transferred to a burn unit in Texas. More than 84% of her body was burned from SJS, which causes the skin to shed off and is often described as "burning the body from the inside out." The disorder often leads to eye inflammation, causing extensive tissue damage and scarring that can result in blindness.

Because she was so young and her body so small, the SJS ravaged her body and left permanent skin and eye damage. Her family filed a lawsuit on her behalf in 2009, nearly a decade after the devastating injury occurred. Her mother claimed she never would have given the girl Children's Motrin if the drug's labels specifically mentioned the risk of this horrific disorder.

The trial lasted about nine weeks and the jury ultimately found Johnson & Johnson liable for negligently failing to warn of the risks associated with Children's Motrin, awarding the girl and her family $10 million. The mother argued that if the drug's labels had instructed her to stop using the product if a rash occurred, she would not have continued giving her daughter the Motrin.

The jury agreed that an adequate warning would have prevented the little girl from receiving more and more doses of Motrin, which contributed to the severity of the disease. Johnson & Johnson petitioned the Pennsylvania Supreme Court to hear the case on appeal. The Supreme Court denied the appeal, upholding the verdict for the girl and her family.

Johnson & Johnson Guilty for Recalled Children's Medicines


In an unrelated drug recall case, Johnson & Johnson recently pled guilty for selling children's Tylenol and Motrin contaminated with metal pieces. The company was fined $20 million for the recall in addition to $5 million forfeiture.

The contamination was first reported on in 2009, when a consumer complained to Johnson & Johnson about black specks in the bottom liquid of a bottle of Infant's Tylenol. The company failed to take any action to correct the problem until the FDA stepped in. The agency investigated its manufacturing plant in Pennsylvania, prompting a recall of infants' and children's over-the-counter drugs.

Continue reading "$10 Million to Children's Motrin Injury Victim " »

FDA Warns of Heart, Stroke Risk with Testosterone Products

March 9, 2015

4015453081_83b21940a5_b.jpgThe FDA just released a Safety Communication regarding products used to treat low testosterone due to aging. After months of speculation, the government has confirmed the increased risk of stroke, heart attack and other serious side effects with these "low T" drugs. Testosterone therapy lawyers at Pintas & Mullins detail this new alert and the dangers of T-Therapy.

As men age, testosterone naturally declines just as estrogen naturally declines as women age. Testosterone is a hormone associated with many functions, such as sex drive, bone density, muscle strength and mass, sperm production, fat distribution and red blood cell production.

Companies that make testosterone therapy products - like AndroGel and Axiron - have aggressively marketed these as a fountain of youth for men. More than $80 million was spent on AndroGel advertisements in 2012 alone. And it worked: the same year sales of prescription T-therapy gels topped $2 billion.

In 2014, the FDA announced its investigation into these products after numerous studies showed an increased risk of cardiovascular illness in men taking them. For the first time, the FDA is officially confirming these studies, issuing a warning (found here) to help stop the overprescribing of T-therapies. These drugs are packaged as gels, patches, injections, pellets, and materials applied to the gum or cheek.

T-therapy drugs are traditionally only prescribed to men with serious, diagnosed testosterone conditions such as hypogonadism. The actual benefits and risks of T-therapy for natural testosterone decline are not clear, however. Some of the symptoms of low-T, such as emotional or physical changes and changes in sleep patterns or sexual function, may often be caused by other factors, like depression, thyroid problems, excessive alcohol use, or medication side effects.

Risks of T-therapy Outweigh Benefits for Most


Many consider this FDA action belated; in July 2014 the Canadian government issued a very similar warning on the cardiovascular risks of these products. This was based on researched published in 2013 that found a 30% increased risk of death, heart attack and stroke among men taking testosterone drugs compared to men who did not.

Another study that was funded by the National Institutes of Health found that men over the age of 65 who were taking T-therapy had double the rate of heart attacks as men not taking it. That study analyzed medical outcomes of more than 56,000 men.

In its warnings, the FDA urged doctors to only prescribe T-therapy to men with serious medical necessity. This can include men with hypogonadism, brain or genetic conditions, and patients on chemotherapy. The agency specifically stated that testosterone is being used extensively in men who have low-T "for no apparent reason other than aging," and that the safety of this use "has not been established."

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$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.

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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.

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Drugs Causing Life-Threatening Skin Reactions

December 12, 2014

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

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

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

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

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

California Teen 'Burning From Inside Out'


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

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

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

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

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

Change to Come for Generic Drug Laws

November 21, 2014

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

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

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

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

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

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

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

Concerns on Capitol Hill


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

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

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

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