Recently in Product Liability Category

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" »

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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$2.5 Million Verdict for Risperdal Victim

February 25, 2015

3447564554_dc04a547bb_b.jpgOur team of Risperdal attorneys recently reported on the Risperdal injury case ongoing in Alabama court. We are happy to announce that the jury just awarded the victim and his family with $2.5 million in damages.

This case was brought by an autistic man, Austin Pledger, who was prescribed Risperdal when he was seven years old. At the time, in the early 2000s, Risperdal was approved only for use in adults. Throughout his five years taking the drug, Pledger developed large breasts from a hormonal imbalance caused by Risperdal.

His trial against Risperdal's manufacturer Johnson & Johnson lasted one month, during which the jury saw definitive proof that J&J hid evidence that Risperdal was linked to breast tissue growth in adolescent boys. This is a serious medical condition known as gynecomastia. Of the 12 jurors assigned to the case, only one disagreed with the verdict.

Pledger was prescribed Risperdal to help the behavioral issues caused by his autism. His physician was visited several times by J&J representatives, who gave out samples of the drug and downplayed the risk of gynecomastia in children. Because of this marketing specifically to pediatric doctors, about 20% of Risperdal's sales in the early 2000s were for children even though it was not approved for adolescent use.

J&J Admits to Criminal Misconduct


The former FDA commissioner David Kessler testified in this case, stating that he believed J&J knowingly manipulated scientific data to undermine the link between Risperdal and gynecomastia. This unconscionable behavior was confirmed in 2013, when J&J admitted to criminal misconduct and agreed to a $2.2 billion fine. It remains one of the largest health care fraud cases in United States history.

This 2013 case involved federal fraud and allegations that J&J paid doctors to illegally promote three drugs, one of which is Risperdal, for off-label uses. In addition to prescribing children this powerful, dangerous drug, J&J also encouraged doctors to prescribe it to elderly patients with dementia.

Antipsychotic drugs like Risperdal are extraordinarily dangerous in dementia patients. There is an array of scientific evidence proving that these types of drugs can cause strokes and premature death in dementia patients. The FDA explicitly refused to approve Risperdal for dementia treatment for this very reason.

Between children and the elderly, J&J knowing put some of the most vulnerable members of society at risk and showed blatant disregard for doing so. Aside from these federal lawsuits, there are thousands of others pending nationwide regarding gynecomastia. This $2.5 million verdict is actually the first gynecomastia case to go to trial.

Prescribing powerful medications to people with behavioral problems - whether they are elderly people with dementia or autistic children - is a serious problem known as chemical restraint. In fact, in 2000, when J&J met with the FDA to discuss Risperdal, an FDA official explicitly expressed his concern that Risperdal would be used "as a chemical straitjacket."

Continue reading "$2.5 Million Verdict for Risperdal Victim" »

Risperdal Breast Growth Case Begins in Alabama

January 26, 2015

3506647818_ff9cb1a2e3_b.jpgThe popular antipsychotic Risperdal has been named in thousands of lawsuits throughout the country for a troubling side effect in young men. The drug, commonly prescribed to treat bipolar disorder, carries the risk of abnormal breast growth. Risperdal lawyers at Pintas & Mullins explain these lawsuits and who may be eligible for compensation.

One of the most recent cases is being argued in Philadelphia court against Risperdal's manufacturer, Janssen Pharmaceuticals, which is a unit of Johnson & Johnson. The victim in this case is a 20-year-old man with autism from Alabama, who took Risperdal to help the irritability caused by his autism. He began taking the drug as an eight-year-old boy, despite it only being approved for adults.

He and his family accuse Janssen of purposefully obscuring evidence that Risperdal caused certain hormones to spike - specifically, the growth hormone prolactin, which is responsible for the development of female breast tissue. They claim that Janssen failed to adequately warn both patients and physicians about the risks of abnormal breast growth (a condition medically referred to as gynecomastia).

At the time the eight-year-old boy was prescribed Risperdal, in 2002, it was approved only to treat adult psychotic conditions. In 2006, the FDA approved the drug to treat irritability in autistic children and adolescents. The company attempted to have Risperdal approved for children several times before this, but was rejected by the FDA over safety concerns.

To address this issue, the former FDA commissioner David Kessler is expected to take the stand in this case. Kessler is expected to testify about Janssen's efforts to hide the risks of Risperdal from the public.

Young Lives Altered


There are more than 1,250 Risperdal lawsuits pending in courts throughout the country, most of which related to abnormal breast growth in young men. Six of these cases have been selected as bellwether trials in 2012, however, Janssen agreed to settle these cases before they went before juries. Janssen agreed to settle another 80 cases in early 2013.

In November 2013, Janssen agreed to a $2.2 billion settlement with the federal government over false claims over Risperdal. The company pled guilty to illegally promoting Risperdal for off-label use in the elderly, such as those with dementia or Alzheimer's in nursing homes. The illegal marketing took place over a decade, between 1993 and 2004, and led to regulation concerns in 36 states.

Janssen is accused not only of illegally marketing Risperdal, but also of paying doctors to speak favorably of the drug. The company paid for gold outings and other flashy incentives to get doctors to prescribe the drug to patients just like the eight-year-old in Alabama. Many of those boys taking Risperdal grew breasts and had to undergo mastectomies.

Janssen claims that Risperdal's labels always included the risk of gynecomastia in adults, and notified physicians that it was not proven safe and effective for use in children. The company believes the doctor who prescribed Risperdal should be held at fault. The trial is expected to ask about three weeks.

Continue reading "Risperdal Breast Growth Case Begins in Alabama" »

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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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.

Continue reading "Court Rules Pfizer Can Be Sued for Generic Drugs" »

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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