Articles Posted in Product Liability

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newbornThe Depakote lawyers at Pintas & Mullins are currently accepting cases involving spina bifida in children born to mothers who took the anti-seizure drug Depakote during pregnancy. Here, we report on a Depakote injury lawsuit filed by an Ohio woman and her daughter, who was born in 2004 with numerous birth defects.

The mother, Pamela Rheinfrank, filed suit against Depakote’s manufacturers, Abbott Laboratories and AbbVie Inc, under claims of: defective design, negligent misrepresentation, failure to warn, fraud, breach of warranty, and unjust enrichment. The federal judge assigned to her case, U.S. District Judge Susan Dlott, preserved only her warranty and failure to warn claims.

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weighing-788291-m.jpgFor more than a decade, the FDA refused to approve pharmaceutical obesity treatments based on a long history of ineffective, unsafe “weight-loss” drugs. Within the last three years the FDA has approved five obesity drugs onto market, due in large part to the $50 million Big Pharma lobby. Dangerous drug lawyers at Pintas & Mullins highlight the severe dangers of these new diet drugs.

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

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

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

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

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

Victoza and Pancreatic Cancer

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

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

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

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

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

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

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

Diabetes Drugs do not Reduce Heart Conditions

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

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

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

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

Conquering Obesity

Patients battling obesity and type 2 diabetes must read all labels carefully and thoroughly before taking any type of medication. Patients also need to be aware that excessive sugar acts as a poison in the body, contributing to obesity and other chronic and fatal diseases. Losing weight is difficult, but it should not focus on counting calories or excessively exercising. It is necessary to make a holistic, overall lifestyle change to beat obesity.
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2737354030_604ffba77b_b.jpgThe Iowa Supreme Court recently ruled that a patient injured by a generic drug could successfully sue the drug maker, Pliva Pharmaceuticals, under state law. This is a landmark decision that may have ripple effects across the country. Dangerous drug lawyers at Pintas & Mullins tackle this issue below.

Generic vs. Brand Name Drugs

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

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

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

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

How they Differ

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

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

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

Legal Disputes

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

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

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

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

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

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

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

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

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

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

New FDA Rule Proposal Fuels Battle

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

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

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

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

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