November 21, 2014

Deadly Pharmacy Errors Likely Caused by Corporate Greed?

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

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

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

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

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.

Continue reading "Lifesaving Hepatitis Treatment Sparks Debate" »

June 18, 2014

FDA Drug Event Data Now More Easily Available

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

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.

Continue reading "$650 Million Settlement Reached Over Risky Blood Thinner" »

January 25, 2014

Be Mindful Medical Malpractice Statutes of Limitations

by Levin & Perconti

When making the decision of whether or not to bring a medical malpractice lawsuit, it is vital that parties understand their state’s statute of limitations for doing so. A statute of limitations is a specific duration of time imposed by state law in which a party may file a lawsuit. Such statutes vary from states to state as malpractice claims are governed by state law and precedent. Many statutes of limitations in these cases provide a relatively significant amount of time to file suit, but potential litigants must be cognizant of these rules. It may take time to truly come to terms with an injury or death that occurs as a result of medical malpractice, and injured parties or their families may not be ready to move forward so quickly. The time to sue will pass faster than people realize, so it is important to be aware.

Med Mal Time Limits in Illinois
In Illinois, the general statute of limitations to bring a medical malpractice lawsuit is two (2) years. However, as with all such statutes, there are specific rules as to when this clock begins to run. Generally speaking, and as is in the case in Illinois, the two year period begins to run from the date that the victim knows or should reasonably have known that they were in fact injured as a result of a medical provider’s negligent acts or omissions. This is known as “The Discovery Rule,” aptly named because the basis for measuring the statute of limitations starting point relates to the discovery of the malady or injury. The rule was most recently clarified in an Illinois appellate decision.

Anyone believing they were injured by a medical provider’s negligence must be aware of the date that this occurred, and must be prepared to litigate the issue of when that person should have known. This can often complicate the case, because a plaintiff may sue for an injury years after it occurred but only because they discovered it at that time. Attorneys defending the medical provider will undoubtedly argue that the plaintiff should have been aware of the injury much earlier, thus jeopardizing the plaintiff’s lawsuit by arguing it is untimely. It is also important to keep in mind possibilities of tolling, or pausing, the statute of limitations in the event that a second injury exists but could not have been discovered until later, or that there is a second source of an injury that may not have been discoverable by the victim until much later.

In Illinois, like other states, there are exceptions and wrinkles to statutes of limitations. For example, while an individual has two years to file from the time they discover or should have discovered the injury, they can nevertheless file more than four (4) years from the time of the negligent act or omission by the medical provider. This is known as a “Statute of Repose” and it effectively a cap that all litigants must be aware of. Discovering an injury five years after the malpractice that may have caused it unfortunately means it is too late.

Furthermore, for babies injured as a result of doctor or hospital negligence during birth, there is an eight (8) year statute of limitations for the child’s parents to sue for malpractice. In malpractice cases involving minors, a lawsuit may be filed at any time up until two (2) years after the victim’s 18th birthday, but this is capped at eight (8) years from the date of the actual act or omission leading to the injury. The statute of limitations is also generally extended in other cases involving minors.

There are other such examples as well, and it is important for potential litigants to know their deadline for filing a claim to meet the statute of limitations. Contacting an attorney even just to be sure of this deadline may be a worthwhile consultation.

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October 17, 2013

Drug Recalls Due to Sterility Concerns

by Levin & Perconti

As confirmed by the U.S. Food and Drug Administration, in September alone five manufactures issued nationwide recalls for lots of pharmaceuticals due to sterility concerns.

Very often drug recalls are due to sterility concerns meaning that the manufacturer cannot ensure that the drug is free from contaminants such as bacteria or viruses which can put patients at risk of serious infections which may be life threatening. For instance Leiter’s Compounding Pharmacy recalled several lots of Bevacizumab, which is used to treat several types of cancers. Avella Specialty Pharmacy also recalled Bevacizumab. University Compounding Pharmacy recalled lots from the following three drugs, Testosterone Cyplonate, PG E-1 NS; and Testosterone CYP. Park Compounding Pharmacy also recalled Testosterone Cyplonate. Medaus Pharmacy recalled a whopping ten products because the sterility could not be confirmed.

Understanding Medication Recalls
Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by the Food and Drug Administration request, or by FDA order under statutory authority. The FDA uses three levels to classify the severity of a drug recall. Class I recalls are where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recalls involve a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 
 Finally, Class III recalls are where the use of or exposure to a violative product is not likely to cause adverse health consequences. 

According to the FDA, many of the September recalls were Class I meaning consumers are at risk for serious adverse health consequences or death if the products are consumed. As consumers, we seek out medications and medical products to help cure or alleviate our ailments. Unfortunately, despite the best efforts of the FDA, consumers are all too often exposed to medications that can contain harmful bacteria or viruses and can cause major harm or even death if they are consumed. For instance, according to the Institute for Safe Medication Practices, in 2012 200 patients nationwide contracted fungal meningitis after receiving a steroid injection that had been contaminated.

Attorneys Who Can Help
These types of cases involving product liability as a result of a recalled pharmaceutical drug are often extremely complex and may require experienced legal counsel. Our Illinois injury lawyers at Levin & Perconti have skillfully handled a wide variety of product liability cases including those that touch on medical issues, like these medication recalls.

If you or a loved one has sustained harm or even death as a direct result of defective pharmaceuticals, please contact our attorneys for a free consultation to see what legal rights may be available to you.

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August 26, 2013

How Many Doctors will History of Malpractice are Still Treating Patients?

by Levin & Perconti

It goes without saying: All medical patients assume that the doctor treating them is capable of providing the care they need free of error. Most of us assume that the medical professionals that are working in hospitals and clinics are vetted by those making hiring decisions at these facilities. Just like we expect trucking companies to only hire safe truckers and tax providers to only hire competent accountants, it is obvious that hospitals should only hire those who will do their job appropriately.

In fact, considering the literal life and death potential outcomes of medical work, its reasonable to assume that due diligence is even more pronounced in these settings. There is simply little room for error. Those medical professionals who are shown to pose an unacceptable risk of harm to patients can not be allowed to keep treating unsuspecting community members.

Slipping Through the Cracks
Amazingly, time and again doctors with a history of committing medical errors continue to practice--often bouncing from one location to another, simply moving somewhere else after botching a job. This problem was recently highlighted in a USA Today story. The piece explores how doctors who are disciplined in one state and loss their clinical privileges are often still working on patients somewhere else.

But the problem is not isolated to doctors moving to new jurisdictions. Some state medical review boards are under fire for their relatively lax standards that allow error after error to be committed without significant punishment.

For example, the USA Today article shares information on one doctor who committed a string of mistakes over a decade. The doctor had a particular problem with medication errors, up to and including personal drug abuse. In one case, a patient of his died as a result of the doctor’s prescribing a deadly mix of painkillers and psychiatric drugs. Less than a year later a second patient died from another painkiller dosage mistake. Amazingly, it wasn’t until several years after that, that the doctor actually lost his ability to practice in the state.

This is not an isolated problem. Thousands of doctors commit a string of errors and face little penalty. The story notes, “ Many of the doctors have been barred by hospitals or other medical facilities; hundreds have paid millions of dollars to resolve malpractice claims. Yet their medical licenses — and their ability to inflict harm — remain intact.”

Interestingly, a review of the medical error data shows that malpractice is relatively concentrated--not all doctors make mistakes. Over the past ten years about 100,000 doctors had to make some form of payment for medical errors (most relatively small). Yet, a tiny fraction of that number, 800 doctors, were actually responsible for 10% of all payouts. But of that group of error-riddled professionals, less than 20% faced any state sanction at all.

We can do better than this. No matter what, it is unacceptable for dangerous doctors to continue to treat (and harm) patients. Review boards need to act swiftly to ensure every patient life is spared by getting the worst doctors out of the hospitals.

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July 17, 2013

Legislative & Administrative Response to Supreme Court Generic Drug Decision

by Levin & Perconti

Late last month the U.S. Supreme Court returned a decision in a hotly followed case known as Mutual Pharmaceutical v. Bartlett. The case was important for all medical patients, as it related to the potential liability of generic drug manufacturers following defect claims. In short, it interpreted federal statute to decide if those manufacturers could be sued when defects caused harm to patients who took the drug.

The main issue was whether state law regarding potential liability were “preempted’ by federal statutes which seemed to give immunity to the manufacturers. In a ruling that we discussed a few weeks ago, the court sided with the drug maker and against the medical patient.

The Court was closely divided, but a 5-4 majority stated that the generic drug company could not comply with both the state and federal law at the same time, and so the federal law must trump. A dissent argued otherwise, noting that the drug company did not have to sell its products in the state where liability was allowed. Therefore, they actually were able to abide by both laws, but simply had to decide on their own which states to sell their products and which ones not to sell them.

In any event, the majority’s ruling stands, which seems to act as a significant roadblock to all those harmed by potential design or labeling defects built into generic drugs. It is a dangerous situation, because it means that patients may be severely hurt, or killed, without any legal recourse options at all. It also acts as a barrier preventing any incentive for the generic drug company from doing anything to improve labeling or other safety features.

Fixing the Problem
Recently, the American Association for Justice (AAJ) sent out a mailer discussing possible next steps that patient safety advocates can pursue in response to the court decision. Essentially, those of us who care about dangerous generic drugs and medical errors must work through the legislative and administrative channels to change rules and/or the federal law to better protect patients.

We are already seeing some progress. The AAJ letter notes that the U.S. Food and Drug Administration (FDA) is set to issue new rules that will allow generic drug makers to edit safety labels from those used on the original product. This change comes following the urging of various members of Congress--and the lobbying efforts of the AAJ.

Those members wrote to the FDA and explained that “changes are critically important to ensure that the public is adequately informed of the risks and benefits of prescription drugs, and that consumers who are injured by generic drugs have the same legal rights as those who are injured by the brand-name versions of the same drugs.”

Dangerous Drugs
Most patients are understandably confused about when they can or cannot seek legal accountability after being hurt by a dangerous drug. As a result of various court rulings, laws, and administrative rules, there is no easy answer. At the end of the day, it is prudent always to speak with an experienced injury attorney, share your experience, and receive tailored feedback to determine what the best step is in your particular case.

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April 24, 2013

From Psychiatrists to Psychologists: New Questions About Psychiatric Malpractice and Medication Errors

by Levin & Perconti

Medical malpractice does not always occur in hospital emergency rooms or surgical facilities. Psychiatrists, psychologists, and other mental health providers can also be liable for medical malpractice – this is often called psychiatric malpractice. As we discussed earlier this week, a pending Senate bill in Illinois has brought psychiatric malpractice, particularly medication errors , into sharper focus in this state.

The Power to Prescribe
The State Journal-Register recently ran a story about Illinois Senate Bill 2187, which would allow psychologists who are licensed in Illinois to prescribe medications. Psychologists, unlike psychiatrists, are not medical doctors. Psychologists currently have prescribing authority in just two states – New Mexico and Louisiana.

If the bill passes, psychologists who earn a master’s degree in psychopharmacology and undergo additional training will be able to lawfully prescribe medications to patients in Illinois. The bill’s proponents, including the American Psychological Association, argue that it will increase access to mental health care for people who live far from good psychiatric facilities or who do not want to see multiple health providers for the same mental condition. The bill’s opponents, including many psychiatrists, argue that psychologists lack the medical training needed to safely prescribe medicine to patients.

Prescriptions and Medical Malpractice
In Illinois, medical malpractice includes negligent medical care by any health care provider. This includes physicians (like a psychiatrist), hospitals, nurses, and dentists. It also includes psychologists. Medical malpractice by psychiatrists, psychologists, and mental health care providers is often grouped under the term “psychiatric malpractice.”

Since psychiatric malpractice is a type of medical malpractice, claims against psychologists and psychiatrists for improper medical care must follow the same rules and procedures as traditional medical malpractice claims. This means that evidentiary rules, rules regarding expert witnesses, statutes of limitation, and other laws that apply to traditional medical malpractice claims also apply to psychiatric malpractice claims.

If psychologists obtain the power to prescribe medications, this opens the door for more malpractice claims against psychologists. With the power to prescribe medications comes great responsibility. Drug errors are possible when it comes to the decision or failure to place the patient on medication, the type of medication prescribed, the dosage prescribed, and ongoing monitoring of how medication affects a patient. Medication errors impact approximately 1.5 million Americans every year. If psychologists are added to the pool of providers who can prescribe medication, we can expect that number to rise.

In addition to prescribing errors, malpractice by mental health providers can take on other forms as well. Other medical errors can be intertwined with the use of medications, so they may also rise if psychologists get prescribing authority. According to an article from Psychiatric Times, here are a few common types of malpractice claims brought against mental health providers that can be affected by medication:

· Failure to obtain informed consent to therapy, given the patient’s mental state. The patient’s mental state could be affected by the use of medications.

· Inaccurate assessment and treatment (with medication or other forms of therapy) of suicide risk.

· Failure to protect third parties from a mental health patient’s violent tendencies, which might have been controlled with medication.

A national study found that 1 in 5 Americans suffer from a mental illness. With the number of people affected by mental illness, it seems like expanding prescribing authority to psychologists is just one attempt to make mental health treatment more available and accessible. However, it is important to explore the medical and legal effects of any such potential solution.

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April 22, 2013

Would a Proposed Law Increase Medication Errors in Illinois?

by Levin & Perconti

Medication is so pervasive in society that it is easy to forget about the delicate nature in which drugs must be used. Just because someone has bottles of pills lying around or receive prescriptions on a routine basis does not mean that drugs do not pose incredible risks that need to be balanced properly. There is a reason that strict rules are in place which dictate who can provide drugs, when, how, and in what quantity. The possibility of addiction, over-medication, adverse reactions are severe.

Even when properly regulated, errors occur. The medical malpractice lawyers at our firm work with many local families whose loved ones suffer injury (or death) because of medication errors. Even nurses and doctors make mistakes when it comes to the prescription and administration of powerful medications.

These risks are leading many advocates to stand in opposition to a proposed bill in Illinois that would expand the scope of people who are allowed to prescribe medications. The legislation (SB 2187, HB 3074) would allow psychologists to prescribe drugs. This drive to provide drug-use power to non-medical doctors is part of a movement often referred to as “RxP.”

Those supporting the drive have adequate motivations at their core: expanding access to patients in lower-served communities. Psychiatrists are sometimes hard to find. Therefore, residents in certain areas may need to wait months before having an appointment and potentially receiving medication for mental health challenges. Some argue that expanding the prescribing power to psychologists will fix the problem, ensuring that all residents have access to the beneficial tools they need to live better lives.

Fears of Increased Medication Errors
Expanding access to care is a worthy goal. But a chorus of Illinois groups are waving red flags in opposition to this proposal. They worry about a groundswell of medication abuse and drug errors which may cause more harm than good.

The Illinois State Medical Society voiced concern over the legislation. The President of the group said, “To have that hands-on experience, to have that interaction with patients is so important. The concern is that psychologists have not had that clinical experience. You need years of experience in terms of knowing how these drugs will work in the body, how they're eliminated from the body and how they interact with other medications."

Proponents of the law counter that the legislation calls for expanded training before psychologists would obtain prescribing powers. Most notably, the professionals would need to obtain a Master’s degree in psychopharmacology (on top of their actual Psychology doctorate). This is added to additional internships, training, and experience requirements.

Illinois Drug Law Change - Unlikely
The bill passed out of a Senate committee unanimously earlier this year. Despite that, most do not expect this measure to make it much farther. The opposition from powerful state interest groups is likely too much to overcome. In fact, similar bills have been proposed in the state at least 14 times in the past years; all were defeated. Nationwide only two states have expanded prescription power to psychologists since 1995, even though dozens have tried.

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January 20, 2013

President Clinton Speaks on Patient Harm

by Levin & Perconti

Former President Bill Clinton spoke this week in harsh terms about the many changes that still need to be made in the U.S. healthcare industry to control costs and keep patients safe. Since leaving office, Clinton has worked on many different initiatives, with much of it focused on health care worldwide. His latest statements on our own health care system are an important reminder of the complexities involved and the need to increase focus on making real changes to save lives.

Too Much Confusion
Clinton discussed these issues when speaking at the first ever Masimo Patient Safety Science and Technology Summit. The purpose of the conference was mostly to share information about health monitoring devices which may be able to collect important data to prevent future patient deaths. These devices have the potential to offer significant benefit to individual patients while provided comprehensive information about common safety problems.

The former President’s speech touched on many different issues related to patient safety. For example, according The Patch, he spoke about the “Byzantine” rules affecting the industry and the half-measures related to hospital efficiency which ultimately lead to serious problems in patient safety. He noted that all of this leads to nearly 200,000 patients who die each and every year in preventable ways. These problems are unacceptable, as the consequences of not changing are far too high.

In placing the blame squarely on human errors, he noted: “There’s no devil here. We have an encrusted system that's killing people, not because there's somebody lurking behind the curtain.”

The former president was clear that tackling the costs of health care go hand-in-hand with improving outcomes. Preventing deaths and the subsequent expensive complications from medical errors would go a long way to cutting our total healthcare spending.

At the summit various speakers discussed different ways to address the problem. For one thing, drug administration errors need to be tackled and the use of older blood in transfusions need to be limited. Older blood can break down and then cause problems for recipients.

On top of this, the often-mentioned use of checklists was touted as a simple way to cut down on errors. It might seem silly to suggest that a checklist might prevent a significant number of errors, but researchers continue to find that these reminders cut down on oversights. Yet, many physicians continue to eschew these sorts of protocol changes. Many consider them overly simplistic and not useful in their own practice. This is unfortunate. While most doctors get it right every time without a checklist to help them, all it takes is a single slip-up or mental lapse to cause serious harm. Obviously doctors get it right most of the time, but the safety protocols are needed for those exceptions.

Clinton ended his speech with a call to action, noting that, “I know that none of you want to be a part of a system that leaves us sicker and broke, or you wouldn’t be sitting here. I think our future belongs to creative networks of cooperation. We’ve got to share data, not hoard it. It’s not unrealistic to think that by 2020, you can get rid of unnecessary deaths in the American healthcare system."

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December 21, 2012

The Dangers of Negligent Opioid Prescriptions

by Levin & Perconti

A new article from the Journal of the American Medical Association delves into an issue which is at the intersection of many complex ideas about patient safety, negligent doctor conduct, and potential malpractice: opioid overprescription. As reported in a recent story on the topic at Science Daily, the practice of doctors when it comes to prescribing various painkillers to treat chronic problems may actually be causing significant harm. The main concern is that overuse of the drugs may be creating dependency which results in abuse, overdose, and a burgeoning illegal market for the drugs.

The Prescription Drug Problem
The article places the scope of the problem into perspective, explaining that “More people in the U.S. die from a drug overdose than they do from motor vehicle accidents and more of those deaths are caused by prescription opioids than those attributable to cocaine and heroin combined."

Of course, recognizing the scope of the problem is not akin to admitting that medical professionals are contributing to the harm. However, a closer look at the spread of prescription drug addictions and overdose danger suggests that there is much more that medical professionals can do to limit the harm. Most notably, the opinion piece suggests that too many medical professionals use these drug prescriptions as a crutch for a wide swath of ailments. The overuse of these prescriptions lead to underuse of safer, alternatives. It may be easiest to automatically write a prescription for chronic pain, but other options need to be explored.

This is not a new problem. For example, several years ago an opinion piece from the Journal of the American Medical Association also suggests that practitioners need to be incredibly vigilant about use of these opioid medications. The article discussed research from years prior which found a clear link between the prescriptions from medical providers and increased overdoses. There are regional distinctions, with doctors in some parts of the country giving patients these drugs in much higher proportions than in other locations. The high-prescription spots come with significant increases in overdoses. Can more be done by doctors to fix the problem?

Legal Liability
Actually holding a medical provider accountable for prescription drug overdoses is very fact-dependent. As a general rule, an intentional overdose or abuse of these medication is not an example of malpractice--after all, it is an intentional act by an individual. However, in certain cases medical providers may have acted negligently which caused harm. Unclear instructions on the use of the drug, reckless prescriptions to those with obvious addictions, and the running of “pill mills” where doses are given out at will, all may raise unique issues which could result in some sort of legal action.

No matter what the case, however, it is reasonable for medical providers to be prudent about their use of these medications. The problem is well-known and many ways to limit harm exist. Hopefully, more doctors heed the warning signs and act prudently to stop the spread of the problem.

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December 6, 2012

Malpractice Case Settles After IV Pumped Into Girl's Hand Instead of Vein

by Levin & Perconti

Fox News 40 recently shared information on an agreement in a medical malpractice case involving a horrible medical error that has scarred a young child. This is one of those cases that acts as an important testament to the fact that medical mistakes occur far too frequently, involving basic lapses in care, and often cause permanent injury to vulnerable patients who relied on their caregivers to their own detriment.

Antibiotic IV Medical Error
According to the report, the young girl was in a local facility in September when something went terribly wrong. The story is somewhat sparse on the details, but somehow a medical caregiver accidentally missed the girl's vein when setting up for intravenous medication. As a result, when antibiotics were pumped through the IV, the drugs did not go into the girl's vein and throughout her body via the bloodstream. Instead, the drugs were pumped directly into her hand. This error had serious consequences. Before the problem was caught the girl suffered third degree burns. Unlike most burns which occur from the outside of the skin, the girl's burns in this case were internal. The girl is still recovering from her ordeal, and it is unclear what long-term consequences she might experience as a result of the medical mistake. Right now she is wearing a compression glove in hopes of limiting the permanent scarring.

The facility admitted the error. The news article quotes one representative as saying that "We are very sorry that this occurred and understand how distressing it is...A situation like this should not occur.”

Obviously the young girl's family was outraged. And they sought accountability by seeking out a medical malpractice attorney to share their story and understand how the law might apply in their case. Unfortunately, this particular hosptial requires all patients to sign a mandatory arbitration agreement when entering the facility.

However, the family pursued the case anyway. They went through the arbitration process and eventually reached a settlement with the facility for the errors. It is unclear what the settlement was for, because the agreement is private and the details of the arbitration process are not made public. However, in previous demands, the family asked that the nurses of the facility be required to receive extra training to ensure that similar errors do not occur in the future. It is unclear if that demand was followed through as part of the settlement.

Accountability Following Medical Errors
It is important for families like this one to come forward and ensure there is accountability for these mistakes. Sadly, obvious errors like this one occur far more than most suspect. The problems frequently bunch up at certain facilities which often have chronic malpractice problems. If the errors keep getting swept under the rug, then little to nothing is done to ensure changes are made to spare future victims. It is usually only when a family comes forward and says "enough" that real progress is made.

Sometimes there are roadblocks thrown in front of that progress--such as the mandatory arbitration clause included in hosptial admission papers. However, there are times when this can be worked around or when the aribitration process itself can be used to ensure there remains accountability and redress to improve care down the road.

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Propofol Is At It...Again

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December 4, 2012

Propofol Is At It… Again

by Levin & Perconti

Propofol, the anesthetic that pop star Michael Jackson fatally overdosed on in 2009, has made its way into the news once again. An orthopedic surgeon from Fargo was recently acquitted on criminal charges that he drugged his wife, pediatrician with propofol and sexually assaulted her.

During the trial, the wife testified that her husband sexually assaulted her after injecting her with propofol, an anesthetic that is normally used to sedate patients before surgery. Park Rapids Enterprise reports that only two days after a jury found the defendant not guilty of gross sexual imposition and reckless endangerment, the wife filed a civil lawsuit against her estranged husband, seeking more than $50,000 in damages, including loss of income and employment, as well as damages for mental anguish, emotional distress, and pain and suffering.

The Medical Malpractice Lawsuit
The 17-page malpractice lawsuit claims propofol isn't for home use, wasn't used on the plaintiff with proper monitoring or safety equipment and was dangerously mixed with other medications--all which are allegations that were raised in the criminal case. The lawsuit also alleges that the doctor negligently failed to obtain informed consent from his wife before giving her the drug, irrespective of the fact that she herself is a doctor.

The lawsuit further claims that the administration of propofol and other dangerous drugs caused the woman to suffer memory loss, confusion, inability to remain conscious, organ failure, and "other physical and emotional harm."

The defendant is expected to take a similar defense to his criminal trial, stating that, "[My wife] was aware of the risks, the benefits, she requested it, all the same stuff that we talked about during the [criminal] trial."

Additional defendants included in the suit are: the Plastic Surgery Institute, where the surgeon worked and obtained the propofol for home use; the PSI Surgical Center of which he was a member; one of the surgery institute's owners; and a nurse who works at the institute and testified as a defense witness in the trial.

According to the complaint, the defendants "did, could, or should have foreseen the risk of the potential harm caused by the unsupervised or unmonitored release of propofol and other dangerous drugs requiring a doctor's prescription for use."

As the misuse of proporfol persists long after the unethical application that lead to the death of famed pop singer, Michael Jackson, our firm continues to diligently represent Illinois residents in medical malpractice suits.

Legal Help in Chicago
Each Chicago medical malpractice lawyer at our firm has understood that patients face significant risks if the safeguards for sedation are not correctly in place when propofol is administered. Moreover, our lawyers understand the concern regarding the role propofol should play. The worst medical disasters often occur during sedation.

If you or a loved one have been harmed by careless medical professionals--doctors, nurses, aides, and others-then you may have a personal injury or wrongful death claim. We welcome the opportunity to review the details of your case and to consult with you on the best course of action.

November 21, 2012

Latest News Regarding Contaminated Injection & Fungal Meningitis Outbreak

by Levin & Perconti

According to a recent story from NBC News, many U.S. Senators continue to ask tough questions of state and federal regulators responsible for the safety of pharmaceutical products across the country. The questioning was spurred by the widespread and high-profile fungal meningitis outbreak tied to contaminated epidural shots. Over 17,000 vials of a spinal steroid injection from a single pharmaceutical compounding center were sent to clinics in 23 differen states--those steroids were contaminated with a fungus. All told about 14,000 doses were given to patients before the problem was identified and all of the steroid were recalled.

Current Infected Counts
According to the U.S. Centers for Disease Control and Prevention website on the situation, 480 people have been identified as having contracted fungal meningitis in the latest outbreak. In addition, 33 people have died. Those deaths were essentially caused by strokes that were connected to the meningitis. Seniors and other vulnerable patients were most at risk of suffering more serious complications from the meningitis.

The Illinois Department of Public Health explains that three pain clinics in the state received doses of the contaminated steroid. Two of those facilites are in Chicago and one is in Westchester. All told about 350 Illinois residents are thought to have actually gotten the epidural injection. Of that group, at least two have been positively identified as having the fungal meningitis. However, more cases may pop up. That is because the meningitis has a long incubation period. It may not be detectable for quite some time, with patients only showing symptoms weeks or even months down the road. All of this means that it remains imperative for those who may have been affected to be incredibly care about their condition. This is not something to take lightly.

New Legislation Coming?
Considering the scope of the problem, it should come as no surprise that policymakers are scrambling to figure out what went wrong and what needs to be done to ensure no similar outbreak ever happens again. For example, reported recently by NBC News, members of Congress recently grilled various regulators involved in the situation, including state officials and those at the U.S. Food and Drug Administration (FDA).

Interestingly, FDA officials conceeded that a simlar problem might occur again, unless changes are made. That is because there remains a lack of coordination between invovled parties to properly monitor problems at these compounding facilities and to take action if those problems pose real danger to consumers. FDA representatives noted that they do not really know the details of these facilities in each state, including what they are creating, how they are regulated, or the manner they use to create products that are then sent to consumers across the country.

Some senators are already calling for federal legislation to tighten rules, coordinate efforts, and otherwise ensure a similar problem is caught before so many are harmed. However, the exact details of the possible legislation are still unknown. Most lawmakers contnue to collect information from various states to get a handle on the lay of the land before committing to a particular course of conduct.

In any event, if you or someone you know may have been harmed by this situation in Illinois, take a moment to contact the product liability attorneys at our firm to see how we can help. We are aiding those in our area affected by the meningits outbreak to ensure their legal rights are respected.

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November 2, 2012

Who Might be Accountable Following the Meningitis Outbreak?

by Levin & Perconti

Considering that the spinal steroid associated with the fungal meningitis was only recalled last month and investigations continue into the details of the incident, it is too early to know with certainty how various legal development will play out in these cases. That is made even more true by the fact that not all of those affected by the incident have actually come forward yet to explain their situation to legal professionals. In addition, as we have previously explained, the long incubation period for the fungus at issue might mean that those who develop the meningitis may actually still not know for sure. Long story short, we've got a long way to go before different details of the case are finalized and specific pronouncements can be made about how legal details will likely play out.

However, one beginning question that many local community members might be asking relates to who might be held responsible for this obviously preventable tragedy. Right now there are various possibile responsible parties: the compounding company where the fungus was tracked to (New England Compounding Center), the individual medical professionals who gave out the drug, the clinics where they worked, the suppliers of the contaminated drugs, and potentially others. When first looking into the matter, legal professionals must start with a wide scope and alter the details as more information comes in regarding exactly what happened at every step of the chain which allowed certain patients to receive the dangerous drug.

Product or Service?
In any event, one basic issue that will likely determine many details of the litigiation is whether courts determine the contaminated drug to be a product or if they determine the administration of that drug to simply be an indistinguishable component of a service--providing medical care. The difference may seem academic, but it might have huge implications on the specifics of the legal case against possible defendants--particularly the clinics and doctors involved in the fiasco.

Damage caused by products generally trigger "strict liability" legal rules. That means that a plaintiff who is injured has less of a burden when arguing in court on the responsibility of various parties, from the pharmacy that made the drug to the doctor that dispensed it. Strict liability means that these parties may be held responisble (in whole or in part) regardless of whether individual acts of negligence can be identified. The key is merely that harm arose and that the defednant played a certain role in the carrying of that dangeorus product to the patient which cased the injury.

Conversely, if the administration of the drug is deemed merely a service, then medical malpractice rules will likely apply in suits against medical professionals and clinics. These standards are a higher burden for plaintiffs, because actual negligence must be shown. That means that it is not enough for a plaintiff to explain the harm and show that it was caused by a product used by the defendant. In addition to that, the plaintiff would also have to show that the professionals breached a duty of reasonablenes (acted negligently). That might be far harder to prove with the evidence available.

In any event, the legal ramifications of these cases will undoubtedly develop in the coming weeeks and months as more affected parties come forward and the first suits are filed. In Chicago or throughout Illinois, if you have been affected by this incident, please take a moment to call the injury lawyers at our firm to learn about your claim and to preserve your legal rights.

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October 13, 2012

More Details on Previous Compounding Pharmacy Allegations

by Levin & Perconti

In many injury cases, past conduct of the parties factor into the legal issues at play. That is because these cases are rooted in negligence--did the defendant act unreasonably? The determination of what is or is not reasonable is based, in part, of past conduct and experience. It is reasonable to take actions to correct risks that your know exist. You know they exist if there have been problems in the past.

However, it is important to note that product liability rules are somewhat different than traditional negligence cases. While past conduct may impact a determination of reasonableness, in some cases reasonableness is not even a factor. That includes some product liability cases where “strict liability” is applied. This refers to legal rules which requires companies to pay for the harm caused by their products regardless of whether specific act of negligence can be identified.

These issues are important to consider in the ongoing spinal steroid recall case. It is instructive to understand exactly what this company knew or should have known about the safety of its products and protocols.

As summarized in a helpful new CBS article, many new allegations were made this week about the pharmacy attached to this fungal meningitis scare. In particular, the story argues that the company may have done work outside of the scope of its state license and might even have misled state regulators.

The Governor of the state where the compounding company is located explained to reporters this week that the business had a license only to fill prescriptions for certain patients. However, they might have done more than that. He summarized that, “What they were doing instead is making big batches and selling them out of state as a manufacturer would, and that is certainly outside of their state license.

In the aftermath of the Governor’s remarks, a Congressman sent a letter to the U.S. Food and Drug Administration to determine if the company misled the federal agency as well and violated federal safety rules. The representative went on to ask if sanctions against the company were possible. There is no word yet on the FDA response.

For their part, the involved company has not made many statements since the problems started. The products were recalled and the business’s entire operation has been shut down while the mess is sorted out. In addition, a second pharmacy has also agreed to temporarily shut down. State and federal regulators are going to investigate that facility as well to determine if there is any risk of similar contamination problems which might place patients at risk. Considering the seriousness of this outbreak--twelve have already died--there is no room for error or lax responses.

Legal Help in Illinois for Fungal Meningitis
Many more complex legal details stemming from this case will no doubt unfold in the coming days, weeks, and months. Right now it is important for all local residents affected to understand that they have legal rights. If you were involved in this incident, please take a moment to call our office, share your story, and see how we can help. There is no obligation and nothing to lose from learning about your options.

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