Articles Posted in Dangerous Drugs

The drug Pradaxa was the first in a new class of anticoagulant drugs called thrombin inhibitors. Pradaxa was an immediate hit with atrial fibrillation patients as an alternative to the high-maintenance Warfarin. The industry standard of anticoagulant treatments up until recently, warfarin requires constant blood monitoring to check for hemorrhaging. However, this new class of thrombin inhibitors claimed to have less side-effects and no need for blood monitoring. This claim was met with great enthusiasm by patients and physicians alike, to the tune of $1 billion in annual sales. Unfortunately, in all of the excitement, some major details got overlooked. Contact a Boston Injury Lawyer.

Pradaxa Manufacturer Settles $650 Million Lawsuit

All anticoagulants come with a risk of increased bleeding. It’s what can be done once the hemorrhaging begins that determines the safety of the drug. With Warfarin, despite the inconvenience of constant blood monitoring and the very increased risk of hemorrhaging, there is an approved reversal agent (antidote) if hemorrhaging does occur. Physicians can administer a dose of vitamin K and fresh frozen plasma to quickly halt the bleeding. Unfortunately, no such antidote exists with Pradaxa or any thrombin inhibitor currently on the market. Boehringer Ingelheim’s failure to warn of this very important detail is at the core of many of the 4,000 lawsuits recently settled by the manufacturer for a total of $650 million. The settlement comes out to more than $150,000  per person. Continue reading

The state’s highest court has just upheld the $63 million Massachusetts drug defect ruling against Children’s Motrin and Johnson & Johnson’s McNeil Consumer Healthcare unit. The family of Samantha Reckis was awarded the verdict in Plymouth County in 2013.

They had sued the manufacturer after she became legally blind and sustained toxic epidermal necrolysis from taking the over-the-counter medication. Reckis, now 16, was just 7 when she took the med to combat a fever. J & J had sought to appeal the verdict, saying the award was too high.

The Supreme Judicial Court, however, disagreed with the company. It pointed to the long injuries sustained by Samantha including the loss of 95% of her skin’s top layer, heart failure, liver damage, seizures, stroke, and cranial hemorrhage. Reckis also continues to struggle with other disabilities and will likely continue to endure hospitalizations and other health issues for life, including more pain and suffering.

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The family of Abbie Harper is suing Walgreens and Abbott Laboratories for wrongful death. The 23-year-old law school student had been using the FreeStyle-brand test strips made by Abbott to monitor her diabetes.

The products liability case contends that the strips, along with a blood glucose meter and Omnibod insulin pump, which were made by defendant Insulet, gave Abbott the wrong glucose readouts, causing her to take less insulin than she needed. Abbott died in November 2013.

Four days after her passing, Abbott recalled the test strips, noting in certain instances that the product had provided the wrong low blood glucose findings. The plaintiffs believe that aside from the product defect, there were also issues of compatibility involving certain devices. Their legal team believes that a manufacturing error caused the test strips to become defective.

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A jury says that Johnson & Johnson must pay the family of an autistic boy $2.5 million for failing to warn that its antipsychotic medication, Risperdal, could cause abnormal breast development in males. The plaintiffs claim that Austin Pledger, then 7, took the drug in 2002 and developed size 46 DD breasts. Gynecomastia is the medical term for this condition.

Risperdal’s generic name is risperidone. While there have been numerous Risperdal lawsuits settled, this is the first one involving gynecomastia that accuses J & J of hiding the risks to go to trial. Among those that gave testimony was former Food and Drug Administration commissioner David Kessler, who was a paid expert witness for the family of Pledger. He said that J & J knew about the risks but did not disclose the data that demonstrated to what extent young males could experience abnormal breast growth.

Despite the verdict, J & J’s Janssen unit, which marketed Risperdal, maintains that the drug’s FDA-approved label did in fact properly warn of possibly side effects. They also maintain that Pledger was not hurt by taking the drug but instead his quality of life improved “significantly” while on the medication.

A jury has ordered Takeda Pharmaceutical Company to pay $2.3M in compensatory damages and $1.3 million in punitive damages to a man who claims that the diabetes drug caused him to develop bladder cancer. John Kristufek said that the drug maker hid the dangerous risks involved with taking the medication.

Actos is a pill that is designed to regulate blood sugar levels. It is typically prescribed to people with type 2 diabetes.

In his drug defect lawsuit, Kristufek argued that although drug representatives don’t deliver the medication or information to doctors offices and pharmacies, they come up with strategies to get doctors to prescribe Actos as safer than other diabetes medications. The incentive for the salespersons, Kristufek claims, is commissions, bonuses, and other rewards.

With the school year only a few weeks away, we can’t help but think about the myriad of cases on schools and school-aged children that we have defended these 50 years at our family-serving legal office. Being parents, we would like to offer some safety advice, with the hope that this new academic year turns out to be an enjoyable and enriching experience.

Recently Gov. Patrick declared a public health emergency in Massachusetts for the rapidly growing opioid addiction rates. From 2000 to 2012, the number of unintentional opioid overdoses rose by 90%. In the state, a person who consumes opioids is three times more likely to die than a drunk driver. Undoubtedly, this has raised concern among parents about the availability of opioids and other drugs at schools and popular places where children come together.

The law aims to limit access to drugs by minors. According to the Controlled Substances Act, it is illegal to sell, consume or possess drugs, drug paraphernalia including tobacco rolling papers or alcohol within 300 feet of schools, whether public or private, up to secondary school. In 2011 Gov. Patrick tried to reduce this space to 100 feet, though thankfully, without success.

Based on the reported cases in Massachusetts, in 2012 marijuana and alcohol were the most popular drugs among teenagers younger than 18, and also the substances for which they most often sought treatment. Most teenagers start using these substances before reaching high school: the mean age of first alcohol use was 13.2 years, while for marijuana, it was 12.8 years.

How does the law limit access and possession of these substances by minors?
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A multi-party lawsuit against the New England Compounding Center for the drug injuries and deaths of people who received contaminated steroid injections is proceeding. Named among them are NECC owners Greg Conigliaro, Lisa Cadden, and Barry Cadden. Products liability lawyers are attempting to add more defendants, including the maintenance company that was tasked with cleaning the facility where the compounding pharmacy was located and a number of pain clinics where the tainted injection was administered.

Hundreds of patients in at last 23 states were exposed to fungal meningitis via the shots, which contained black mold, and over 60 people died from related complications. The defective drug came from NECC, which is a compounding pharmacy in Framingham, Massachusetts that has since been shut down. It also is seeking bankruptcy protection.

In one fungal meningitis lawsuit related to this particular contamination outbreak, one woman isn’t suing NECC but instead is going after its sister companies, which share ownership and other ties with it:

Following the discover of “foreign matters” in vials of drugs for injection, Pallimed Solutions, Inc., a Woburn, Massachusetts compounding pharmacy, had recalled over a dozen products. The decision comes after the state board ordered the company to stop making drugs that were supposed to have been manufactured with sterile processes.

So far, there have been no reports of related injuries or illnesses.

Among the products included in the voluntary recall are those used in eye treatments and hormone replacement therapy and for erectile dysfunction. In a press release, Pallimed Solutions said it made the decision to call back the products following an inspection by the Massachusetts Board of Registration in Pharmacy and the US Food and Drug Administration and to ensure patient safety. According to The Globe, late last year the state of Massachusetts told Pallimed to stop making sildenafil citrate, also known as Viagra, because it was manufactured using “improper components.”

At least 50 federal lawsuits have been filed in nine states seeking products liability compensation from the New England Compounding Center, the Framingham, Massachusetts pharmaceutical company that is the identified source of a tainted steroid injection that has made nearly 600 people ill with fungal meningitis, spinal infections, and/or other complications, including joint infections and stroke. At least 37 people have died. More drug injury cases against NECC are also being submitted in state court.

According to the drug defect lawsuits, the compound pharmacy made a dangerous and flawed product. Millions of dollars are being sought by the plaintiffs for their personal injuries, mental anguish, emotional trauma, lost wages, costly medical bills, and other related damages, as well as the wrongful deaths of loved ones. In Massachusetts, please contact our Boston fungal meningitis law firm to request your free case evaluation.

Because so many dangerous drug cases are in progress, attorneys are seeking to have one judge hear the pretrial and discovery portions of all the federal lawsuits via multidistrict litigation. The complaints would then go to a judge in the original district for trial.

We blogged last month about the nationwide outbreak of meningitis that originated in a Framingham, MA compounding pharmacy.

A consumer watchdog organization, Public Citizen, is now asking the Food and Drug Administration to re-inspect over a dozen specialty pharmacies with records of violations. Public Citizen sent a letter to the FDA on Thursday calling for the agency to re-examine 16 compounding pharmacies that received warnings from the FDA between 2003 and 2012.

Public Citizen decried what it says is the FDA’s recurring failure to follow up on warning letters to pharmacies. “By not fully investigating what could potentially be deadly violations of the law, the FDA is disregarding its primary purpose, which is to protect the lives of citizens,” said Dr. Michael Carome, Deputy Director of Public Citizen’s health unit.

The fungal meningitis outbreak that has killed 36 people and made ill more than 500 has been linked to contaminated pain injections from the New England Compounding Center of Framingham, MA.

The FDA inspected the New England Compounding Center three times before the outbreak and issued a warning letter in 2006, according to Congressional investigators. The letter addressed numerous violations, such as repackaging FDA-approved drugs into smaller doses and mass producing drugs without prescriptions.

Public Citizen wants the FDA to look into warning letters sent to pharmacies in 15 states for a number of violations, including: producing drugs from non-FDA approved ingredients, making copies of already approved drugs, and making compounds without a prescription from a doctor.
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