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This Week in Recalls

December 1, 2014

1672705495_5e562d2ac7_b.jpgLast week, an infant died from a dietary supplement that was contaminated with mold, and ABC aired a segment on recalled products that are still being sold on Craigslist. Product recall lawyers at Pintas & Mullins remind the public of the importance of keeping up-to-date on drug, product, and food recalls.

According to national reports, 95% of all recalled items remain in Americans homes five years after it was recalled. The ABC report called out Craigslist, the popular classifieds website, for perpetuating this problem and continuing to allow the sale of recalled items on its site.

2014 was the worst year in history for automobile recalls, with more than one in five cars and trucks on the road at risk of deadly defects. From automobiles to dietary supplements, children's products to medical devices, the U.S. recall system is broken, leaving millions of dangerous products in the hands of unknowing citizens.

Toward the end of November 2014, a dietary supplement called Solgar ABC Dophilus Powder was recalled due to mold contamination. The recall was only initiated after an infant died from the powder, suffering a fatal gastrointestinal infection. The infant received the powder for four days and quickly developed symptoms of necrotizing entercolitis (NEC), or a bowel showing signs of tissue death from fungus. The infant died shortly after surgery.

The Craigslist Dilemma

The ABC profile revealed several products that have been recalled for safety defects that are still available on Craigslist. The chairman of the Consumer Products Safety Comission (CPSC), which manages all product recalls, said Craigslists' refusal to remove such products was morally irresponsible, illegal and devastating to families.

The CPSC is often blamed for not doing enough to get the word out on recalled items. It is illegal to sell recalled items, however, very few recalls are widely publicized. Even the most well-known recalls can cause serious harm if families are never personally informed.

A six-month-old girl in Utah suffered a fractured skull and serious brain injury after falling out of the Bumbo Booster Chair while eating her breakfast. Only later did they learn the Bumbo had been recalled and "fixed" by providing a small warning label stating that children could fall out of the chairs. The family was never notified of the recall, and never noticed the small label on the back of the chair. The family sued Bumbo, which has consequently added a safety belt to the seat.

Unfortunately, it is largely up to parents and consumers to stay in-the-know on dangerous products. The American recall system is entirely voluntary for product manufacturers. They are not required that companies advertise safety defects or get any percentage of sold products back.

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Change to Come for Generic Drug Laws

November 21, 2014

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

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

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

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

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

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

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

Concerns on Capitol Hill

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

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

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

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Actos Bladder Cancer Lawsuit Begins Today

October 20, 2014

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

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

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

Proof of Bladder Cancer Destroyed

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

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

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

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

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Court Rules Pfizer Can Be Sued for Generic Drugs

August 18, 2014

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

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

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

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

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

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

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

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

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

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Actos Manufacturer Guilty of Destroying Evidence

June 23, 2014

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

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

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

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

Causation and Liability

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

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

What is a Bellwether?

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

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

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

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Urgent Recall for Patients on Blood Thinners

May 13, 2014

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

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

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

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

Pradaxa Patients Suffer Similar Fate

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

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

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

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Actos Plaintiff Receives $9 Billion Jury Award

April 9, 2014

952313_gavel.jpgThe jury is out, and the manufacturers of Actos, the once-popular type 2 diabetes medication, are now ordered to pay $9 billion (yes, with a 'b') to a man who developed bladder cancer from the medication. The award is the seventh-largest in U.S. history, and there thousands more Actos cases still to be heard. Actos attorneys at Pintas & Mullins take a closer look at Actos' first U.S. trial and what it could mean for other Actos plaintiffs.

The defendants in this case, Eli Lilly and Takeda Pharmaceuticals, are accused of many things in this Actos litigation, ranging from designing a defective drug to intentionally covering up its true side effects. The jury decided on such a large amount in part because of the seriousness of the drugs' side effects, and in part due to the poor conduct of Lilly and Takeda during the trial.

The plaintiff in this case, Terrence Allen, like too many others, developed bladder cancer from taking Actos, which was prescribed to help him manage his type 2 diabetes. The drug was introduced in 1999 and quickly became one of the hottest medications on the market; sales peaked in 2011, at $4.5 billion.

Allen and other Actos plaintiffs argue that the drugmakers knew the medication could cause cancer and chose not to adequately warn doctors and patients in efforts to boost drug sales. Pharmaceutical executives are accused on intentionally downplaying the risk of bladder cancer and misled the FDA about its true safety.

The link between Actos and bladder cancer was scientifically proven in 2004, but the manufacturers refused to acknowledge the association until 2011, when it finally placed warning labels on the drug at the request of federal regulators.

Allen was prescribed the drug in 2006 - meaning after the medical and pharmaceutical community knew of the link between Actos and bladder cancer, but before Lilly and Takeda decided to properly warn patients on the drug. He developed bladder cancer five years after he started taking the drug.

Evidence and Documents Destroyed

One of the most egregious aspects of this case, apart from the seriousness of the injury itself, was how Takeda and Lilly handled its events. Going back to 2004, when the bladder cancer risk was associated, Takeda executives sent internal emails stating that Actos was vital to the company's financial survival and to drag out placing a cancer risk on warning labels as long as possible.

These emails were produced in court because both Takeda and Lilly were under court orders to preserve all documents regarding Actos as evidence. Despite this order, Takeda failed to preserve much of its internal Actos documents - whether this was done intentionally or not is a point of debate, but after lawsuits started being filed the company destroyed the files of over 45 former and current employees, including top executives and sales representatives, so you be the judge.

Regardless, the evidence about how much Takeda knew and when was largely lost, so the judge penalized Takeda by telling jurors that the files may have strengthened and supported Allen's arguments about the company's wrongful information withholding.

Many believe that this document destruction bolstered the jury's award decision, to punish a drug company acting with such malice and disregard for not only patient safety but legal proceedings as well. This was the first bellwether trial in the Actos multi-district litigation (MDL), which consolidates thousands of Actos cases before a single judge in Louisiana.

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Medical Device Recall Rates Double

March 21, 2014

5205198800_afbc523eb7.jpgOver the past decade, recalls of defective and dangerous medical devices have nearly doubled in the United States. There has also been a substantial increase in defects that could cause very serious injury or death, rather than minor faults. Medical device recall lawyers at Pintas & Mullins examine how and why the recall rates are increasing.

In 2003, just over 600 medical devices were nationally recalled; by 2012, that number jumped to 1,190. A few years ago, the Government Accountability Office wrote a report noting that device recalls often were not announced until it was far too late to prevent injuries in patients. One example of this type of negligence occurred in 2007, when Medtronic recalled its Sprint Fidelis defibrillator wires, which are implanted in patients with irregular heartbeats.

These defibrillator wires were recalled because they could fracture while inside patients, causing death or very serious injury. Some patients did die, because by the time Medtronic decided to recall the wires they had already been implanted in thousands of people, many of whom had no idea there was a recall at all.

A Class I recall is the most serious type of recall, reserved for devices that have reasonable potential to cause devastating injury and death. One of the most recent Class I recalls was initiated in August 2013 by Medline Industries. The company recalled its ACME Monaco Guidewires, similar to the Medtronic defibrillator wires, because the coating could flake off the wires.

Recalls with Real Consequences

An executive at AdvaMed, a medical industry trade group, stated that the spike in recalls can be attributed to device manufacturers being more conscientious and pro-active approach to FDA compliance. Other experts wonder if the recalls are reflective of a more serious problem - the lack of rigorous federal oversight during the premarket approval process.

Some officials note that, had the FDA required more testing on these medical devices before they were approved for sale, some recalls could be avoided completely. However, it is a significant step forward that the federal government is making attempt to analyze this information at all.

When a recall occurs, patients can request repair kits or go to the hospital to receive a replacement device, free of charge. If the recalled medical device is implanted inside the patient, however, the remedial options are often detrimental to the patients.

Take for example, the recent massive recalls of metal-on-metal hip implants due to high rates of premature failure, dislocation and metal poisoning. Patients who require hip implants are already vulnerable to injury, and forcing them to undergo painful and often risky revision surgeries to remove and replace the recalled hip is incredibly negligent and certainly not in the best interest of the patient.

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New Cholesterol Drugs Linked to Brain Disorders

March 10, 2014

lipitor-bottle_l.jpgThe FDA recently announced that it was aware that patients taking new, experimental drugs to treat high cholesterol were suffering adverse cognitive events. The new drugs, developed by Sanofi and Regeneron, are known as PCSK9 inhibitors. Cholesterol drug lawyers at Pintas & Mullins explain the potential side effects among these and other cholesterol-lowering drugs.

Both Pfizer and Amgen are also currently developing PCSK9 inhibitor medications, which investors are watching very closely and with high expectations. An estimated one in six adults, or about 17% of the population, has high cholesterol according to the CDC. This condition is a major factor in the development of heart disease and diabetes, and many patients need medications to maintain normal cholesterol levels in addition to diet and lifestyle changes.

The most popular class of cholesterol-lowering drugs is known as statins, and includes drugs like Crestor, Lipitor, and Zocor (UPDATE: generic Lipitor was recently recalled, read more here). These medications block the liver's ability to produce LDL, or "bad" cholesterol and are prescribed to about 20 million Americans.

Similarly, PCSK9 drugs block the protein that maintains the presence of LDL cholesterol in the blood. In the most recent clinical trials, the FDA observed adverse neurocognitive side effects, such as memory loss and confusion, in patients. As a result, the agency has requested that Sanofi and Regeneron consider including neurocognitive tests in at least one group of patients.

Statins are also linked to adverse neurological side effects, including Lou Gehrig's disease, though for statin patients memory loss may be the least of their worries. Statins, particularly in high doses, are associated with extensive liver damage, muscle damage (rhabdomyolysis) and type 2 diabetes.

The FDA recently required all statin drugs to include the risk of increased blood sugar and type 2 diabetes, specifically among women. The side effects associated with cholesterol drugs have become increasingly serious, with patients losing their jobs due to memory loss and confusion, and being diagnosed with diabetes despite lifestyle changes.

It is important for patients to realize that once you decide to begin a medication to help lower your cholesterol, you will likely have to stay on it indefinitely. The only exception is in patients taking significant measures to change their diet and lifestyle. Factors that contribute to high cholesterol and can be changed through will alone include:

• Smoking
• A diet high in fat, salt and of course, LDL cholesterol
• Lack of exercising (about 30 minutes per day)
• Heavy alcohol use
• Stress and anger management
• Being overweight or obese

The FDA has been criticized in the past for failing to warn patients and physicians early enough about the risks of drugs. It seems that they are increasing the effort to be as transparent as possible and make the public aware of possible side effects. The warnings regarding PCSK9 drugs are part of the FDA's oversight of new drug development.

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High Court Rules Pharma Companies are Liable for Drug Design and Marketing

January 27, 2014

12151375045_6985691b46.jpgPennsylvania's Supreme Court recently ruled that pharmaceutical companies may be held liable for negligently designing and marketing drugs. The case specifically centers on the now-discontinued drug Redux, which was created by Pfizer. Our team of dangerous drug lawyers explains what this Pennsylvania ruling means for future plaintiffs injured by pharmaceuticals.

Redux (dexfenfluramine) was a diet drug approved by the FDA in 1996 and pulled from the market just over a year later, in 1997. The drug was recalled along with fenfluramine in the infamous "fen-phen" heart valve disease debacle. There has been extensive litigation over fen-phen and Redux injuries, which is currently ongoing in Pennsylvania.

Pfizer attempted to argue that it was immune from most claims of negligence and particularly from negligent marketing. The plaintiff in this case, Patsy Lance, had a daughter who took Redux and ultimately died from pulmonary hypertension. Lance is now arguing that Redux was an excessively dangerous drug that should have never been sold in the first place.

Pharmaceutical plaintiffs in Pennsylvania typically sue drug companies under failure-to-warn claims, however, Lance is arguing much broader claims of negligence, including defective design and fraudulent marketing. She also claims Pfizer knew of the drugs' severe health risks and that they far outweighed the supposed benefits.

The 4-2 Pennsylvania Supreme Court ruling for Lance is significant because it could open up a plethora of opportunities for injured patients. It is important to note, however, that this ruling likely only extends to drugs that have been withdrawn from the market by the FDA.

It is also worth noting that the majority opinion for this ruling was penned by Justice Saylor, who is a Republican and who does not usually err on the side of plaintiffs. He wrote that pharmaceutical companies violate standards of care if it chooses to market a drug it knows to be harmful. He further asserted that Pfizer did not present a reasonable argument as to why it should be immune from responsibility in the death of Lance's daughter.

FDA Approval Process Widely Criticized

Much of Pfizer's argument relies on the notion that if the FDA approves a drug as safe and effective, patients must defer to that authority. The FDA's approval process, however, has come under immense fire in recent years, and is subject to extensive scientific criticism.

The highly-esteemed Journal of the American Medical Association recently released a series of reports and studies centering on FDA dysfunction, the results of which are very alarming. The report receiving the most public attention examined nearly 200 new drugs approved between 2005 and 2012, and found that one-third of them were approved based on one, short-term clinical trial (more on that study here). Researchers wrote that the flexibility of approval standards leads to differing, inconsistent levels of certainty over the actual risks and benefits of new drugs.

The FDA responded by citing its "extensive" post-market surveillance programs. These reporting systems, however, are notoriously lax, and fail to accurately reflect the actual harm done to patients by drugs and medical devices.

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One-Third of Drugs Approved Using Single Study

January 22, 2014

pills-7_l.jpgA study recently published in the esteemed Journal of the American Medical Association (JAMA) found that one-third of all drugs were approved by the FDA based on one clinical trial. This is incredibly important, as Americans are seriously injured and killed every day from unknown effects of pharmaceuticals and medical devices, while medical companies reap the profits. Dangerous drug attorneys at Pintas & Mullins take a closer look at the JAMA study.

Researchers identified 188 new drugs approved by the FDA between 2005 and 2012, ranging from cancer treatments to drugs for cardiovascular diseases. About 37% of these drugs were approved based on a single clinical trial, despite clear federal rules that require at least two pivotal trials before approval.

So what is the difference between drugs that are studied in-depth and those that only require preliminary evidence of efficacy and safety? In the case of medical devices, many cardiovascular products, such as defibrillators, are approved without ever being tested in humans. This is possible through a specific FDA program that allows devices that are similar to other, older devices to be quickly approved.

Surveillance Programs not Enough

In a statement, the FDA asserted that it tailors approval requirements for each individual drug and disease area, and that it has a strict surveillance program in place to monitor new drugs and devices after market release. This practice is backwards and dangerous, placing American lives at risk.

Nowhere is this more evident than in the recent recalls of two cardiac defibrillators, the Riata from St. Jude Medical and the Medtronic Sprint Fidelis. These devices are implanted in patients with irregular heartbeats and shock the heart with electrical wires if an irregularity occurs. They were approved through the accelerated FDA process because they were similar in design to previously-approved devices. These defibrillators have caused dozens of deaths due to bad wiring and other defective parts.

Having a "strong" surveillance program does nothing to protect innocent patients who are being used as little more than guinea pigs for Big Pharma's latest development. In fact, most follow-up studies requested by the FDA are never even conducted. Of all the follow-up studies requested in 2008, only 31% had been carried out by 2013.

In effort to remedy this, JAMA researchers urged the FDA to place statements on drugs' labels that clearly define what type - and how much - evidence went into the approval of the drug. A novel and admirable concept, but not one I see happening anytime soon.

The goal of rushing drugs onto the market, for some ailments, makes sense. Patients fighting cancer do not have time to wait for three clinical trials to be completed before they can start taking a promising new drug. That makes sense. But for ailments like type 2 diabetes or osteoporosis, for which there are already dozens of drugs on market, accelerated approval does not make sense and is causing great harm.

Further compounding the problem, only about 34% of all new drug approvals are based on studies that last longer than six months. This is unacceptable for many reasons, most importantly because patients blindly trust the FDA to approve drugs that are extremely effective and do not carry any serious side effects. It is impossible for medical researchers to determine the true risks of a prescription drug after only six months of use. For most drugs, the actual long-term risks are not known until years, even decades after initial approval.

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Accutane Manufacturer Loses another Legal Battle

January 17, 2014

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for 1409595_gavel_5.jpgHoffman-La Roche, the manufacturer of acne drug Accutane, recently tried to remove the judge presiding over its consolidated injury cases. The New Jersey Supreme Court rejected the drug maker's request, making for what we can assume will be a very awkward court proceeding. Our Accutane attorneys take a closer look at this massive acne drug litigation.

There are over 7,700 lawsuits currently consolidated in the Accutane multidistrict litigation (MDL), which is presided over by Judge Carol Higbee. Hoffman-La Roche (Roche) attempted to expel Judge Higbee because of comments she made during a conference about the Accutane MDL. Higbee apparently criticized Roche for refusing to settle the injury cases and how it treated plaintiffs.

Accutane Recalls, Million-Dollar Verdicts

The Accutane plaintiffs all suffered serious injuries and health complications after taking the acne drug, including inflammatory bowel disease (Crohn's Disease and colitis), suicidal thoughts, bone growth issues, and birth defects. Thus far, Roche has paid about $53 million to Accutane plaintiffs nationwide, all of whom suffered from inflammatory bowel disorder from taking the acne medication.

In 2008, the first Accutane trial was won by a plaintiff who was awarded $10.5 million by a jury. One year after this case Accutane was permanently recalled from the market, though it still sells the drug under the name Roaccutane in other countries.

In 2010, a year after the official recall, Roche was forced to pay over $25 million to a single patient who developed severe inflammatory bowel disease from Accutane. The man had to undergo five surgeries and have his colon completely removed as a result. This case was presided over by none other than Judge Higbee, who ordered the court to pay another $18 million in 2012 to two Accutane patients who developed ulcerative colitis.

What won the case for these plaintiffs were internal Roche documents dating from 1994 which outlined a series of Accutane patient reports experiencing IBD. Accutane was approved in 1982, and by 1997 the FDA began receiving its own reports of IBD in Accutane patients, along with cases of severe depression, suicidal thoughts and actions, and psychosis. By 2005, there were nearly 200 suicides associated to Accutane use.

An End in Sight

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Lipitor Maker Slammed with Whistleblower Lawsuit

January 14, 2014

lipitor-bottle_l.jpgPfizer, the world's largest research-based pharmaceutical company, was recently slapped with a federal lawsuit over its marketing of popular cholesterol drug, Lipitor (atorvastatin). The whistleblower in this suit, Health Support Awareness Inc., argues that Pfizer deceptively misbranded Lipitor to keep it in high demand and at inflated prices. Lipitor attorneys at Pintas & Mullins are anxious to see what is revealed during the course of this case.

A whistleblower, or qui tam lawsuit, can be filed by anyone who has information that a company is in anyway defrauding the federal government. If the case results in a settlement or verdict, that whistleblower is then entitled to a percentage of the money, typically between 15 and 30%.

In the Pfizer Lipitor case, Health Support accused the healthcare giant of, among other things, defrauding Medicare and Medicaid out of billions of dollars. Indeed, the rate of Lipitor's prescriptions is jarring: between 2007 and 2010, over 43% of Medicare patients were prescribed to a statin, which is a class of cholesterol-lowering drugs and for which Lipitor is a front-runner. Just in 2010, this cost the federal agency $6.7 billion.

Half of men aged 65 to 74 are prescribed a statin drug to control cholesterol levels, and the drugs are generally helping curb the rates of fatal heart disease. However, in its haste to develop and market statins to a nation plagued by heart disease, Big Pharma failed to adequately test the drugs for long-term health effects.

Knowing Fraud

Pfizer is specifically accused of fraudulently keeping Lipitor prices high and engaging in illegal promotions to keep demand up. The company's aggressive, misleading marketing campaign worked, and Pfizer enjoyed major profits from the drug at the expense of the American healthcare system.

Lipitor was developed by Warner-Lambert, which in 1997 hired Pfizer to market the drug. In its first year, the statin reaped over $1 billion in sales. Pfizer accomplished this by pouring millions into TV ads and hiring high-profile spokespeople, such as Dr. Robert Jarvik. Another major and incredibly deceptive tactic Pfizer employed to boost sales was to lower the doctor-recommended cholesterol levels for prescribing. As a result, exactly as they had hoped, this led to even more demand for the statin drug.

Pfizer also engaged in several extremely underhanded activities during the time Lipitor's patent was supposed to end, including paying a generic company to delay its release of the generic Lipitor and then pitting another generic maker against it so the two would release the drug at the same time. In turn, the other generic company agreed to give Pfizer 70% of its generic Lipitor profits.

All the while, Pfizer steadily increased the price of Lipitor and continued to bombard the public with TV ads. The FDA sent numerous warning letters to the company regarding these ads, requesting that many be discontinued due to blatant overstatement of Lipitor's benefits.

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Feds Investigate Maker of Cholesterol Drug, Juxtapid, over False Marketing

January 13, 2014

5776691316_d050fefb1b.jpgThe CEO of Aegerion Pharmaceuticals, which manufactures popular cholesterol drug Jextapid, recently went on CNBC's Fast Money to talk about the drug. During his interview, the CEO stated that Juxtapid could prevent heart attacks and lengthen life, though neither claim has been studied or approved. Dangerous drug lawyers at Pintas & Mullins see this type of fraudulent marketing all too often by Big Pharma, and remind Juxtapid patients that the drug should only be used for treatment of HoFH.

Familial homozygous hypercholesterolemia, or HoFH, is a rare genetic disorder causing dangerously high cholesterol. The disease renders patients unable to remove LDL, or "bad" cholesterol from the blood, significantly increasing the risk of cardiac arrest and heart disease. Symptoms of this disorder include cholesterol deposits in the eyelids, fatty skin deposits on the ankles, hands, elbows, or knees, and chest pain.

False Claims, Subpoenas, and Federal Investigations

When Aegerion's CEO, Marc Beer, appeared on Fast Money, he illegally touted Juxtapid (lomitapide) for the prevention of heart attacks and extending life in general practice. The FDA notes that clinical trials used for market approval show no such data, as the pill was only effective in lowering LDL cholesterol in HoFH patients. After his illegal promotion, the FDA sent Beer a warning letter, reminding him that Juxtapid is not approved or labelled as a treatment to prevent heart attacks and lengthening life expectancy.

Juxtapid costs HoFH patients over $250,000 per year, and Aegerion is clearly hoping to get the drug prescribed in higher numbers in 2014. Confirming this, the company increased its sales predictions for 2013 from $15-25 million to $30-35 million, though the actual sales numbers are much, much higher. The company is projecting sales of $210 million for 2014.

A few months after the warning letter, the U.S. Department of Justice sent Aegerion a subpoena requesting documents related to the marketing and sales of Juxtapid. The federal investigation will undoubtedly lead to a hefty fine for Aegerion for its misbranding.

Fast Money interviewed Beer on June 5 and October 31, 2013. Among his misleading claims, he is quoted as saying that the drug can significantly lower the risk of death in younger patients, and that HoFH patients will suffer fatal cardiac events if not prescribed to Juxtapid therapy. Federal agencies could not let these statements slide, as they were both misleading and failed to address the true risks of such therapy.

Aegerion was swiftly asked to stop misbranding and recommending Juxtapid for unapproved uses. The company was also required to submit a plan of action to the FDA by November 22, 2013, correcting any misimpressions the public may have gleaned from the interview (a copy of the FDA warning letter can be read here).

Potential Lawsuits

If a drug is prescribed to you for uses not intended on its labels and you suffer a serious adverse event, you have every right to file a lawsuit, particularly if the drug's manufacturer knowingly marketed it for unapproved uses. Similarly, if a prescription or over-the-counter drug causes a serious side effect that was not listed on its labels, patients may file a lawsuit for the manufacturer's failure to warn.

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OTC Laxatives may Lead to Death, Kidney and Heart Injuries

January 10, 2014

11825448006_e5b61d4729.jpgThe FDA recently issued a warning regarding the use of over-the-counter laxatives manufactured by C.B. Fleet Company. According to the agency, these laxatives are causing severe kidney and heart damage, and potentially death, if more than one dose is taken within one day. Drug injury lawyers at Pintas & Mullins remind consumers taking OTC laxatives to avoid this dangerous product.

Many consumers taking C.B. Fleet's laxatives products have been hospitalized for dehydration and dangerously low electrolyte levels, with at least one suffering fatal kidney and heart injuries. As stated, these products are most likely to cause severe injury if more than one dose, or a larger-than-recommended dose, is taken within 24 hours.

Negligent Warnings

Although the drugs warn consumers not to take more than one dose within 24 hours, C.B. Fleet failed to include certain age and health restrictions. The laxative labels failed to alert consumers that those over age 55 and patients with certain health conditions need to speak to a physician before taking the over-the-counter sodium phosphate drug. Consumers in those specific groups are at much higher risk of serious side effects.

Patients with the following conditions or taking the following medications need to consult a doctor before taking any type of sodium phosphate laxative:

• Colon inflammation
• Kidney dysfunction
• Patients taking aspirin
• Ibuprofen
• Other non-steroidal anti-inflammatory drugs
• Diuretics
• Angiotensin-converting enzyme inhibitors
• Angiotensin receptor blockers (such as for high blood pressure)

It is important to note that some laxatives are sold under generic and store-brand labels (opposed to labels denoting C.B. Fleet). These products are sold both as oral tablets and as enemas. It is impossible for the FDA to know the true amount of serious incidents and deaths related to these products, however, because adverse events are not required to be reported to the government.

Mining the data it does have available, however, the FDA knows of at least 54 patients who were critically injured by sodium phosphate laxatives over the past few decades, including more than a dozen deaths. The actual number, as stated, is unknown.

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