July 23, 2015

Type 2 Diabetes Medications Could Lead to Pancreatic Cancer

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by Levin & Perconti

The latest multidistrict litigation (MDL) over products liability lawsuits alleging pancreatic cancer from taking incretin mimetics makes it clear that these medications – namely Januvia, Janumet, Byetta, and VIctoza – were marketed to patients suffering from type 2 diabetes too soon. Januvia, Federal Drug Administration (FDA) approved in 2006, is one of the more popular, top-selling Type 2 diabetes drugs.

What are Incretin Mimetics?

Incretin mimetics work by prompting your pancreas to release insulin when blood sugar levels are rising, and prevents it from giving out too much glucagon. This problem is… not only can they cause pancreatitis, but evidence is emerging that they could cause pancreatic cancer (as pancreatitis can be a precursor to pancreatic cancer). Some medical journals are publishing articles stating that, while these incretin mimetics are fine for the short-term use of lowering or stabilizing glucose levels, their chemical properties prohibit long-term use for the treatment of a chronic condition like type 2 diabetes.

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July 21, 2015

New Benicar Lawsuits Filed for 2015; Litigation Moves Forward

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by Levin & Perconti

With the New Year came another lawsuit filed over Benicar (generic “olmersartan”). As the 2012 Mayo Clinic’s case study linking Benicar to severe sprue-like enteropathy continues to be discussed, patients are coming forward to report the negative side effects they have suffered from taking the drug. A lawsuit filed in the Northern District of California in January 2015 alleges that the makers of Benicar did not properly warn patients about the risks associated with the drug. See Verduzco v. Daiichi Sankyo, Inc., Case No. 3:15-cv-159, in US District Court, Northern District of California.

Plaintiffs are specifically concerned about the link between Benicar and sprue-like enteropathy. According to the complaint, two plaintiffs, Louis Verduzco and Michael Ewald, developed personal injuries including “sprue-like enteropathy, villous atrophy, lymphocytic colitis, microscopic colitis, collagenous colitis, and/or intestinal malabsorption.” Symptoms of sprue-like enteropathy include severe, chronic diarrhea, intestinal problems and substantial weight loss. These symptoms mimic that of Celiac disease, but they are not the same thing.

For these plaintiffs, exposure to the drug resulted in chronic diarrhea, rapid weight loss, dehydration and/or acute renal failure. The plaintiffs allege they had to be hospitalized for their conditions and now require ongoing medical monitoring. They also allege that they were unaware of any adverse side effects associated with Benicar, and that the maker of the drug, Daiichi Sankyo, did not properly test it to prove that it was actually effective for treating hypertension.

Litigation Moves Forward

Back in June 2013, the FDA issued a drug safety communication regarding Benicar, and requested that the drug company go through a label change to reflect this. There has been a plethora of lawsuits filed since then, most originally arising from the Mayo Clinic Study. In fact, a motion to consolidate lawsuits was filed with the US Judicial Panel on Multidistrict Litigation in late 2014. These 2014 lawsuits alleged that Benicar was defective and dangerous, and that clinical trials for the drug lasted only three months (while the drug is typically prescribed for six months to a year). See e.g., Dirksen v. Daiichi Sankyo.

It is important to note that the individuals represented in these lawsuits took Benicar and were severely injured. Their claims are that the manufacturer of Benicar, Daiichi Sankyo, knew of the link between Benicar and the rare gastro disease caused by their drug, but did not properly warn the public of the associated risks. Instead, the manufacturer put profits ahead of the public safety, resulting in a slew of mass tort litigation.

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July 10, 2015

Certain Antibiotics Linked to Peripheral Neuropathy

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by Levin & Perconti

Medical malpractice caused by a doctor or nurse’s mistake accounts for many avoidable patient injuries. However, some patients are not injured so much by the individuals who administer treatments as they are injured by the treatments themselves. Sometimes the drugs that doctors prescribe turn out to be the culprit behind a patient’s suffering. In these situations the patient may not be best served by a medical malpractice claim, but instead may have a product liability claim against the drug manufacturer. Of course, if the doctor was aware of the problems with the drug and prescribed it anyway, he or she may have committed malpractice on top of the product liability issue. This is why it is so important to speak with an attorney whenever you have been injured by the medical treatment you have received. Any type of drug can turn out to be dangerous. Currently it appears that certain antibacterials may actually be harming patients.

Some Antibacterials Linked to Peripheral Neuropathy

Antibacterials called Levaquin and Avelox have been linked to peripheral neuropathy according to the U.S. Food and Drug Administration (FDA). The FDA started requiring labels for all “fluoroquinolone antibacterial drugs” back in 2013 to inform patients that the drugs can cause peripheral neuropathy and explain in more detail what that condition is. Peripheral neuropathy is serious nerve damage that can be permanent. In can result in pain, burning, tingling, numbness, weakness, or change in sensation to light touch, pain, or temperature. This class of drugs includes Levaquin and Avelox. These drugs have been approved by the FDA to treat or prevent certain types of bacterial infections.

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July 1, 2015

Benicar Linked to Gastrointestinal Problems

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by Levin & Perconti

Medical malpractice lawsuits provide a remedy when a patient is hurt by the negligence of a hospital, doctor, or other healthcare provider. Sometimes the problem is not the person providing the care, however. Sometime the treatment itself is the problem. This can be particularly true when it comes to problems with prescription drugs. While many drugs have save countless lives, other drugs are dangerous and have caused real injuries to the patients who take them. One potentially dangerous drug is called Benicar.

FDA Issued Warning About Benicar

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June 15, 2015

Soft Tissue Dermal Fillers a Risk

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by Levin & Perconti

The costs of using unsafe pharmaceuticals can be life altering. These dangerous drugs can cause serious injury or even wrongful death. The federal agency tasked with making sure our drugs are safe is the United States Food and Drug Administration (FDA). This agency is responsible for approving safe drugs and removing the dangerous ones from the market. The FDA has now announced that certain drugs used as soft tissue dermal fillers, usually for cosmetic purposes, are riskier than many initially thought. Any patient considering these products needs to fully understand the risks.

What Are Cosmetic Soft Tissue Dermal Fillers?

Soft tissue dermal fillers are injectable products that have been approved to treat wrinkles or to ënhance"a person's cheeks or lips. These products are injected directly into the area to be treated, According to the FDA they should only be injected by health care providers who have appropriate training and experience and who have an in-depth understanding of the anatomy around the treatment area.

Cosmetic Soft Tissue Dermal Fillers Pose a Risk According to FDA

Forbes reports that the FDA Office for Women's Health is warning both practitioners and patients that some soft tissue dermal fillers might accidentally be injected into facial blood vessels. This can cause blockages that restrict blood flow to tissue, and fillers that have been injected into the blood vessels can travel to other areas of the body. If this happens it can cause rare but serious side effects like stroke, visual impairment, blindness, and death of skin tissue.

The most at risk areas of the face include the skin between the eyebrows and nose, the skin in and around the nose, and the area under the eyes. As a result of the discovery of this problem the FDA is working with drug manufacturers to update their labeling to provide more warnings regarding the risks of these products. The FDA is not taking any steps, so far at least, to remove these products from the market.

How Patients Can Protect Themselves

While the FDA does not appear to be doing much to solve the problem, it had provided some advice for potential users of these products. They make the following recommendations for anyone considering using one of these dermal fillers:

*Before using the dermal fillers, talk with your healthcare provider about what the best injection sites are and what the risks associated with those sites may be.

*Understand that certain products have been approved by the FDA for certain areas of the face, and not others.

*Question your provider about any training and experience they have received in this area before undergoing any treatments.

*Read the warnings specific to the fillers that will be used on you and discuss those warnings with your provider.

If you experience any side effects after treatment like unusual pain, vision changes, a white appearance of the skin, or any symptoms of a stroke, seek immediate medical attention.

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April 7, 2015

Drug Maker Fighting FDA Efforts to Approve Generic Abilify

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by Levin & Perconti

Prescription drug safety is already a complex issue. There are legitimate questions about the Food and Drug Administration's (FDA) reliance on manufacturer funded studies in making approval. There is a serious real world problem of prescription and pharmacy error, particularly as large scale pharmacies pressure pharmacists to work faster and faster. In this complex framework the FDA sometimes takes steps that actually help consumers, like approving substantially cheaper generic counterparts to extremely expensive prescription drugs. However, name-brand drug manufacturers are now fighting back, and they are going to court to do it over a generic version of Abilify.

What is Abilify?

Abilify is an antipsychotic medication that changes the actions of chemicals in the brain. It is used to treat mental health conditions like schizophrenia and bipolar disorder. It is also used in children who are often too young to be accurately diagnosed with specific mental health conditions for symptoms like aggression and self-injury associated with autism spectrum disorder.

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January 20, 2015

A Risky Situation: FDA Drug Approvals at 18-Year High

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by Levin & Perconti

The United States Food and Drug Administration (FDA) is the agency responsible for determining whether drugs are safe enough to be used in the United States. On one hand, a speedy approval process is good in that it can provide people who may otherwise die or suffer with life-changing treatments. On the other hand, speedy approval can mean approval for medications that are not actually safe which can cause serious injuries or even deaths. This dichotomy is extremely important to consider in light of the news that FDA drug approvals are at an 18-year high.

FDA Drug Approvals Reach 18-Year High

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January 9, 2015

FDA First: Panel Approves Generic Copy of Expensive Biologic Drug

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by Levin & Perconti

Most people who either take prescription drugs or care for someone who does are familiar with generic drugs. These medications are supposed to be the same as the name brand medications but they are made by a different manufacturer who did not have to front all of the costs for marketing and research and development, so they are substantially cheaper. Most drugs eventually wind up with a generic equivalent when the name brand drug maker's patent expires. But one class of drugs has, up until now, been isolated from the generic market. That era, however, appears to be at an end.

FDA Panel Approves Generic Version of Biologic Drug

The Food and Drug Administration (FDA) is the agency responsible for approving generic drugs. CNBC reports that a panel of the agency has unanimously voted to support the approval of Novartis AG's copy of Amgen's cancer drug Neupogen. Neupogen is an injectable biologic that prevents infections in breast cancer patients who are undergoing chemotherapy. Biologics are drugs made from living cells rather than being made from chemicals. A biosimilar is a biopharmaceutical drug designed to have active properties similar to one that has previously been licensed. While the panel's recommendation is not binding on the ultimate agency decision, it is rare for the agency to not follow the panel's recommendations.

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January 4, 2015

Understanding Possible Victoza Litigation

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by Levin & Perconti

When we are sick or injured we go to the doctor in hopes of getting better. Unfortunately sometimes the treatment winds up being worse than the original problem. Particularly dangerous treatments can result in personal injury or even wrongful death. It appears this may be the case with a drug called Victoza. This means that if you are taking or have taken Victoza and the medicine caused serious side effects, you should contact us as soon as possible.

What is Victoza?

According to the Food and Drug Administration (FDA), Victoza is an injectable prescription drug that might improve blood sugar in adults with type 2 diabetes. It is manufactured by Novo Nordisk and was approved back in 2010. When the FDA approved the drug, it claimed that “the benefits of this drug to patients with [type 2 diabetes] outweigh potential risks associated with its use.” As it turns out, this decision may have been wrong.

What are the Problems with Victoza?

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December 15, 2014

Recovering Cancer Patient Killed by Pharmacy Errors

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by Levin & Perconti

When we are sick we find ourselves in a position where we are completely dependent on medical professionals. When those healthcare providers make errors the results can be catastrophic. Pharmacy errors are particularly problematic because, when the wrong drug or dose is administered the cure becomes the cause of a new host of problems in an already ill person. Unfortunately, that is exactly what happened to one cancer patient in Oregon.

Oregon Cancer Patient Given Wrong Drug to Treat Anxiety

Central Oregon’s KTVZ reports that sixty-five year old Loretta Macpherson died as a result of being given the wrong medication. Ms. Macpherson went to the hospital to be treated for anxiety. One month before she went to the hospital she had undergone surgery to remove a cancerous brain tumor. She had been making a speedy recovery, and before her trip to the hospital was expected to recover fully. Then tragedy struck.

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December 9, 2014

FDA Takes Action to Provide More Information Regarding Safety of Prescription Drugs for Pregnant Women

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by Levin & Perconti

Time and time again we see the same thing—a complete lack of information regarding prescription drug safety for pregnant women and their fetuses. And when this information is not provided, women find themselves either harmed themselves or dealing with harm done to their children that sometimes is not recognized until birth or even after. Fortunately, it appears that the Food and Drug Administration (FDA) is finally taking steps to provide expectant mothers with more desperately needed information so they can make the right choices for their family regarding their health care. The changes will also help breastfeeding mothers.

FDA Changed How Pharmaceutical Companies Present Medication Risks During Pregnancy
The New York Times reports that the FDA changed how pharmaceutical companies will present the risks of taking medications during pregnancy and breast-feeding. The system up to now was created in the 1970s and is vague and ultimately not terribly useful. A key problem is that most drugs were classified in the category that meant “animal studies have shown potential risks to the fetus, but … no adequate studies exist for humans.” In other words, most drugs were categorized as “we don't know the risk” and the guess work was completely pushed off onto the expectant mother.

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December 6, 2014

California Delayed Action on Translating Drug Labels

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by Levin & Perconti

America is a melting pot, and it always has been. Throughout our nation's entire history there have been members of our community who have spoken languages other than English as their primary language. As medical science advanced and our medical system became more complicated, we have had to take steps to ensure that both international guests and new immigrant residents can obtain medical care when necessary. Some doctors have taken it upon themselves to learn second or even third languages, and hospitals work to bring in translators when necessary. However, a big hole in this system exists on the pharmacy side of things. When the instructions that come with prescription drugs are either not translated or are improperly translated for a non-English speaking patient, the result can be injury or even wrongful death.

California Delayed Action on Translating Prescription Drug Labels

The Sacramento Bee reported earlier this year that the California State Board of Pharmacy opted not to decide yet whether pharmacies should be required to translate prescription drug labels for patients with limited or no English-language skills. Most people at a meeting of the Board agreed that change is necessary in part because of the relatively high rate of adverse medical reactions amongst patients with limited English. However, a host of complicating issues also arose at the meeting relating to how many different translations would be necessary, how accuracy would be insured, and who would be held responsible for inaccurate translations and their consequences.

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November 29, 2014

FDA Panel Recommends Against Strictest Warning for Steroid Shots

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by Levin & Perconti

The United States Food and Drug Administration (FDA) is responsible for determining what warnings drug manufacturers are required to put on the drugs they produce. After the serious pharmaceutical error involving the meningitis outbreak caused by contaminated steroid injections, the FDA is considering requiring more stringent warning labels for the drugs. Such warnings could possibly prevent future injuries and deaths. However, it looks like the FDA will probably not opt for harsher labels, leaving essentially what was the status quo at the time of the meningitis outbreak in place for the foreseeable future.

Panel Rejects Strict Warnings

The New York Times reports that an FDA advisory panel decided Tuesday not to recommend using the sternest federal warning label on steroid injections intended to treat neck and back pain. These panels are typically made up of groups of medical experts. The group makes recommendations to the FDA about what actions it should or should not take on issues like labeling. The recommendations are in no way binding. However, the agency usually follows these recommendations.

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November 21, 2014

Deadly Pharmacy Errors Likely Caused by Corporate Greed?

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by Levin & Perconti

Another patient has lost her life to a tragic pharmacy error. A new report out of Texas shows what may be the cause of some of these totally preventable wrongful deaths: corporate greed.

Pharmacy Accused of Causing Deadly Drug Overdose

Katheryn Barton, a California woman, claims that her mother Ruth Eller died because of a pharmacy error, reports CBS Los Angeles. Ms. Eller was in generally good health, but she experienced an arrhythmia of the heart. Her doctor prescribed a generic version of the drug diltiazem to treat the condition. She had that prescription filled by the Kenneth Road Pharmacy in Glendale, California. That is where the problem occurred.

The instructions on the bottle said to take one tablet four times daily, instructions which Ms. Eller followed. After three days, she was unresponsive to her daughter. So her daughter started to dig into the more detailed instructions provided by the drug's manufacturer. And those instructions indicated that the drug Ms. Eller was actually provided with was an extended release drug, and that it should only be administered once a day. Ultimately Ms. Barton discovered that the dosage the pharmacist had instructed Ms. Eller to take was ten times the amount of the medication that Ms. Eller's doctor had prescribed. Ultimately, as a result, Ms. Eller died and the coroner listed the cause of death as diltiazem intoxication due to pharmacy error. Ms. Barton immediately reported the incident to the California Board of Pharmacy, but that agency only fined the pharmacy's owner $1000 for the error. So Ms. Eller will have to file a civil action against the pharmacy to see any justice done for her mother.

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October 18, 2014

FDA Allows Drugmaker to Test Experimental Drug on Ebola Patients

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by Levin & Perconti

Prescription drugs are regulated by the Food and Drug Administration (FDA) in the United States. There is a lengthy process that drugs must go through before being approved for use on human patients. The usual process takes years. And even when drug makers go through that process, sometimes drugs are unsafe and can wind up causing serious injuries or death. However, the FDA is going to allow a North Carolina drug manufacturer to test its experimental drug in Ebola patients.

Pharmaceutical Company's Plans to Test Drugs on Ebola Patients

U.S. News & World Report reports that a drug company called Chimerix Inc. received FDA approval to proceed with a trial involving their drug called brincidofovir. The drug, an antiviral tablet, will be tested on patients who are currently infected with the Ebola virus. The FDA already allowed the drug to be administered to the first Ebola patient diagnosed in the United States, who passed away last week.This drug is not only being developed to fight Ebola. It could also eventually be used to treat a virus that infects patients who are undergoing bone marrow transplants. The Department of Defense has been working with Chimerix to determine whether this drug could be an effective treatment for the small pox virus as well.

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September 20, 2014

FDA Panel Wants to Limit Testosterone Drugs

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by Levin & Perconti

Anyone who watches television has seen the commercials advertising prescription drugs designed for men suffering from “low T,” or low testosterone. The picture these commercials paint is that any of the discomforts of aging can be magically cured with a pill or cream. However, that may be about to change.

Panel Recommends New Labels

The New York Times reports that a panel of twenty medical experts voted this week for the Food and Drug Administration (FDA) to impose new limitations on the testosterone drug industry. The panel recommended that the agency tighten the labeling of these drugs so they are not prescribed to men who are only experiencing the effects of getting older, such as decreased energy and libido. Decreased testosterone is a perfectly normal part of aging. Most men start to see their testosterone levels gradual drop at some point in their thirties. Of course, there are some men who suffer from dramatic drops in testosterone due to a medical problem. Those men are exactly the men who the panel would say should be treated with these drugs.

While the FDA is not required to do what the panel tells it to do, the agency usually follows the advise of such expert panels. If the FDA does follow the recommendation, it could affect both the advertising of these drugs and whether insurance companies cover them.

It used to be that testosterone drugs were only taken for serious medical conditions. However, now over two million men in America are on the drugs. And most of them are taking the drugs to treat aging. According to the FDA, the benefits of testosterone treatments for men who are perfectly healthy and are just aging are unproven. Meanwhile the drugs carry side effects and some studies indicate they could lead to heart problems.

Of course, even if the FDA follows the panel's recommendations, the practice of using these drugs to treat normal aging will not be snuffed out. Doctors will still have the ability to prescribe the medication “off-label,” that is, for reasons other than the specifically approved reasons. However, at least if the labeling on the product explains that it is not to be used to treat aging, patients may be better informed and might ask more questions about the risks and rewards of the treatment.

FDA Rejects Oral Testosterone Replacement Drug

In a related story, an FDA advisory committee rejected a new testosterone-replacement drug called Rextoro this week, reports The Wall Street Journal. The committee decided that the benefit-risk profile of the drug was not sufficient to approve it. One member of the panel, Dr. A. Michael Lincoff, reported that members of the committee were concerned that an orally administered testosterone pill like Rextoro “might tend to be used more off-label.” In other words, the theory is that oral testosterone replacements are more likely to be used to treat normal aging than other methods of testosterone replacement.

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August 22, 2014

Judge Blocks FDA's Attempt to Make Generic Version of Sedative Precedex Available

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by Levin & Perconti

Reuters reports that a federal judge has issued a temporary restraining order against the FDA which prevents it from allowing the sale of generic versions of a sedative called Precedex. Precedex is manufactured by a drug company called Hospira Inc. However, the court's decision has nothing to do with any sort of medication or pharmaceutical error. The order that the generic drugs not be produced had nothing to do with any kind of medical malpractice. Instead it has to do with drug company profits.

FDA Rules Generic Manufacture Okay, but Court Steps in

The FDA had previously ruled that drugmakers could sell generic Precedex so long as the labeling of the generic drugs left out information about uses that are covered by Hospira's patent on the drug. The patent covers “intensive care unit sedation.” In response, Hospira filed a lawsuit the very next day requesting a restraining order preventing the FDA's ruling from going into effect.

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July 25, 2014

Lifesaving Hepatitis Treatment Sparks Debate

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by Levin & Perconti

Prescription drugs, when properly used and administered, save lives. When insurance companies fail to provide lifesaving drugs, or delay providing the drugs, people can be seriously injured or even die as a result. Unfortunately, some of these vital drugs can carry extremely hefty price tags, which gives insurance companies and public health care providers and incentive to deny requests for their use.

One such drug is Gilead Sciences' breakthrough hepatitis C treatment, Sovaldi. Those who are prescribed the drug must take it daily for twelve weeks. An extremely large percentage of people with a particular type of the disease who take Sovaldi are essentially cured with few side effects. But here's the rub. The price for twelve weeks of drugs is $84,000. This means that just in the State of Oregon, according to the Washington Post, would have to spend $360 million to provide its Medicaid beneficiaries with the drugs. To put that into perspective, Oregon only spend $377 million on all prescription drugs for all Medicaid recipients in 2013.

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June 18, 2014

FDA Drug Event Data Now More Easily Available

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by Levin & Perconti

Prescription drug errors hurt and kill people in the United States every year. Between pharmacists providing the wrong pills, doctors prescribing the wrong medications, and drug companies marketing unsafe drugs, the problem is staggering. The Food and Drug Administration (FDA) is the federal agency that has been charged with keeping track of complaints about medications. The FDA also announces voluntary recalls of medications when those recalls are initiated. However, up until now, the FDA has not provided the public with easy access to that information.

That is about to change. The FDA announced earlier this month that it is launching a “new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency.” This information will all be available at a new website titled openFDA. This new step toward transparency has been in the works for some time, but is being released just shortly after the Centers for Disease Control made their new treatment tracker website available, which is based on records of Medicare payments to doctors.

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June 4, 2014

$650 Million Settlement Reached Over Risky Blood Thinner

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by Levin & Perconti

CBS News reported last year that seventy percent of Americans take at least one prescription drug each day. Whether the drugs are for depression, high cholesterol, chronic pain, to battle infection, or for any of a host of other medical conditions, Americans rely on those medications. Americans also rely on the pharmaceutical companies who create and manufacture these medications to make them as safe as possible. And when the mediations come with risks of side effects, Americans expect to be warned about those side effects. We expect them to provide the pros and cons of the medication, so we can make an informed decision about whether to take them. Unfortunately, sometimes that does not happen, and patients are injured, or even lose their lives.

One group of such cases involves a prescription drug called Pradaxa, which is also known as dabigatran. ABC News reports that its German manufacturer, Boehringer Ingelheim, has agreed to pay $650 million to settle roughly 4,000 claims regarding the drug’s marketing and safety. The average payout per case is $162,500.

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