August 16, 2016

Toxic Medication Overdose at Hospital Led to Patient’s Death

by Levin & Perconti

When we enter the hospital for treatment we trust that the doctors and other medical professionals will provide us with the best care possible. Unfortunately that is not always the case. A medication mistake proved deadly for one woman. A lawsuit was filed against the doctors and Gottlieb Memorial Hospital alleging that they administered a lethal dose of Fentanyl which caused the woman’s death the next day. The lawsuit was filed by the woman’s estate administrator and seeks damages of more than $50,000.

Medication Mistakes

Medical mistakes, including medication errors, are the third highest cause of death in the United States. This is a chilling fact that is very sobering. Medication mistakes impact hundreds of thousands of people every year and are responsible for about 1,000 deaths every day. The problem seems to be getting worse before it gets better. Medication mistakes include various things such as:

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January 25, 2016

Pharmacist Sued For Causing Bad Drug Interaction

by Levin & Perconti

A lawsuit was filed in Cook County alleging a pharmacist gave a customer incorrect information that caused a severe drug incompatibility. The woman visited a Walgreen pharmacy in Markham looking for sinus medication. According to the lawsuit, she asked the pharmacist which medication could be taken safely along with the anti-epilepsy medication Kepra that she was already prescribed. The pharmacist told her that she could safely take Sudafed with it. However, after taking the over-the-counter medication, the woman lapsed into a coma. She now suffers from memory loss due to the incompatibility of the drugs.

Medication Errors
According to the FDA, medical errors injure more than a million people per year in the U.S. and account for at least one death per day. This includes a variety of medical mistakes, including pharmaceutical errors. Incorrect dosage, incorrect prescriptions, and drug interactions generally account for the most common medication mistakes. Sometimes the doctor prescribes medication without checking to see if there is a potential for negative interaction with other medications the patient is taking. In this instance, the woman specifically asked the pharmacist for a medication that would be safe to take with her prescription. The lawsuit alleges that the pharmacist and drugstore were negligent and were responsible for providing proper medical advice.

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May 13, 2015

Prescription Error Nearly Kills Child

by Levin & Perconti

Pharmacy errors are a serious problem in the United States. While some of these errors are caught before serious damage is done, others result in serious personal injury or wrongful death. The most tragic of these cases are those that involve children, whose small bodies are even less likely to be able to cope with receiving an overdose or improper medication. Unfortunately problems in our pharmacy system lead to these errors happening all too often.

Young Boy Nearly Killed by Pharmacy Error

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March 22, 2015

Illinois Doctor Pleads Guilty After Over-Prescribing Clozapine

by Levin & Perconti

We rely on doctors, including psychiatrists, to keep us healthy. When one prescribes us a medication we trust them and take it. This is particularly true of vulnerable people like nursing home residents and other individuals who have to rely on health care providers for their day-to-day needs. Sometimes health care providers make errors, so we have a medical malpractice system to help right those wrongs. But in some much rarer cases doctors are much more malicious than that, and they actually intentionally act against their patients' interests for their own financial benefit. These cases can result in doctors losing their licenses or even facing criminal charges.

Suspended Illinois Psychiatrist Pleads Guilty to Criminal Charges

Way back in 2009 the Chicago Tribune and Pro Publica reported that Dr. Michael Reinstein was over prescribing the psychiatric drug clozapine and that it appeared that he was receiving kickbacks for doing so. Previously, in the early 1990s, Reinstein was actually suspended from the Medicaid program after being accused of failing to keep proper records. His Medicaid bills from 1991 showed that he had cared for 70 patients a day on 44 different days and that on 12 days he had seen over 100 patients. If a doctor were to see 100 patients even in a 16 hour shift he or she would have a little less than ten minutes with each patient and that presumes that the doctor would take no breaks to eat, get a glass of water, or use the restroom.

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February 6, 2015

FDA Shortens Experimental Drug Access Process

by Levin & Perconti

When you or a loved one is facing what appears to be a terminal illness treatment decisions can be difficult. Not only do you often have to learn a lot to truly give informed consent to the available treatments, but in the case of experimental treatments even more issues arise. The experimental nature of these treatments means that there is no guarantee that they will work and no guarantee that they will not make your situation even worse than it already is, but on the other hand such a treatment may present the only chance there is of recovery.

Some patients are pushed into these treatments and medications without truly understanding the consequences while others who know what they are getting into are denied access to potentially life saving or lengthening treatment. The red tape patients and their doctors have to go through to get access to these treatments can be prohibitive. This conflict is real and difficult to resolve. In light of it, the Food and Drug Administration (FDA) has now announced that it will make access to these treatments easier for patients.

FDA Announces New Policy

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December 24, 2014

Preventable Medical Errors Not Prevented Nearly Enough

by Levin & Perconti

One of the saddest things about many of the personal injuries and wrongful deaths that result from medical malpractice is that so many of these injuries are entirely preventable. Whether its a hospital's failure to use appropriate safety protocols or a medical worker's failure to comply with those protocols, far too many people suffer entirely preventable injuries.

Study Discusses Evidence-Based Estimate of Patient Harms Associated with Hospital Care
The Journal of Patient Safety published a study by Dr. John T. James, PhD that provides information about preventable hospital injuries. In the study, Dr. James reviewed data from medical records of patients treated in New York Hospitals. The original study was based on data from 1984 but it has now been updated with numbers from studies from 2008 to 2011. The studies used what is called the “Global Trigger Tool” to flag certain evidence in medical records that may point to an adverse event that harms a patient. The review of these records allowed the study's author to estimate that the true number of preventable patient deaths caused by hospital error is around 400,000 per year. Experts were also able to estimate that serious harm happens somewhere between ten and twenty times as often as lethal harm.

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October 8, 2014

FDA Approves a New Hepatitis Treatment, but it Comes With a Startling Price Tag

by Levin & Perconti

The Food and Drug Administration (FDA) announced today that it has approved a new prescription drug to treat chronic hepatitis C(genotype 1). The drug is called Harvoni and it is made by Gilead Sciences. It is the first combination pill approved to treat the disease, and is also the first approved treatment for the disease that does not also require the administration of interferon or ribavirin. The drug works by interfering with certain enzymes that the hepatitis C virus requires in order to multiply. The hope is that using this sort of one-pill treatment for the disease will simplify treatment. It is a laudable goal, as simpler treatment regimens could ultimately results in less medical malpractice and better outcomes for patients, assuming that the simpler treatment regimen is safe.

Additional Purported Benefits of the Drug

In addition to being a one-pill solution, Harvoni could also decrease the overall duration of treatment for Hepatitis C, reports The New York Times. For a large number of patients it would also make it possible for them to be treated exclusively with an oral medication for the first time. Finally, it is cheaper than an already existing treatment called Sovaldi, also made by Gilead Sciences. However, that does not mean by an stretch of the imagination that Harvoni will be cheap.

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August 13, 2014

Illinois Officials Suspend Controversial Psychiatrist’s License to Practice

by Levin & Perconti

The Chicago Tribune reports that Illinois officials have suspended a controversial psychiatrist’s license to practice. The doctor, Dr. Michael Reinstein, prescribed a dangerous antipsychotic drug called clozapine to patients in nursing homes and mental health facilities. Dr. Reinstein prescribed to drug to over half of the patients he was treating. The drug is linked to the potentially wrongful deaths of three of Dr. Reinstein’s patients, resulting in the doctor being accused of fraud. As it turns out, the accusations are substantiated.

The Illinois medical board suspended Dr. Reinstein’s license because it found that he received $350,000 in illegal payments from the maker of clozapine while he disregarded both the drug’s life-threatening effects and the fact that there were other safer treatment options for his patients. Clozapine increases the risk of death in elderly patients and can result in inflammation of the heart wall and seizures. It also has substantial side effects that are not fatal but that seriously impact quality of life, including but not limited to extreme constipation, bedwetting, night-time drooling, muscle stiffness, sedation, tremors, and weight gain. Prescribing such dangerous drugs unnecessarily is a serious type of medication error malpractice.

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June 24, 2014

Failure to Translate Drug Information is a Prescription for Deadly Errors

by Levin & Perconti

Prescription drug errors are a serious cause of death and injury in the United States. As we reported earlier this year, Portland’s KATU found that 15,000 people are killed each year by prescription pills in the United States. The Food and Drug Administration (FDA) reports that medication errors kill at least one person every day in the United States, and injury 1.3 million others each year. These drug errors often result in lawsuits over personal injury or even wrongful death.

In a recent article, California Health Report described a different type of prescription drug problem that we don’t often think about that is becoming much more serious as our country becomes more and more diverse. According to the United States Census Bureau, one in five Americans speaks a language other than English at home. However, many pharmacies only provide drug information and instructions in English. And that English, especially the English regarding side effects and drug interactions, can be difficult to understand for even a native English speaker.

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June 3, 2014

City of Chicago Sues Drug Companies for Pushing Prescription Painkillers

by Levin & Perconti

Chicago Healthcare Daily reports the City of Chicago is suing five drug companies. The city claims that the drug companies are pushing consumer use of prescription painkillers which creates opioid addicts and drives up costs for all consumers. The lawsuit over the prescription drugs asserts that, since 2007, the city has paid for almost $9.5 million worth of prescription opioids. These medicines, while necessary to treat some people’s pain, are highly addictive.

The theory behind the lawsuit is that the drug companies have misled the public both about the risks of using these painkillers and about the benefits of taking the medications. This leaves the patients who take the pills unaware of the costs and benefits of the drugs. These addictive drugs are similar to heroin, which leads some who become addicted to the pills to move on to heroin since it can be both cheaper and easier to obtain. Chicago is not the first to make these claims, as two counties in California already filed similar suits.

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April 30, 2014

Investigative Journalists Demonstrate Severe Prescription Error Problems

by Levin & Perconti

Investigative journalists at Portland’s KATU published an in depth report this week on the severity of the pharmacy error problem. They report that 15,000 people are killed each year by prescription pills in the United States. The theory is that due to the danger these pills can pose, those who dispense them should be held to a high standard. But unfortunately, far too many of those charged with the public safety fall short.

Intoxicated Pharmacists
The KATU team examined the records of thousands of pharmacies and pharmacy workers. The results were shocking. They found one pharmacist who was working not just drunk, but with a blood alcohol content more than twice what the legal limit is in most states. They found pharmacists taking the drugs they were supposed to be dispensing. At least one pharmacist was taking amphetamines and replacing them with empty capsules. Any of these intoxicated people could make serious errors in dispensing medication.

Other Pharmacy Errors
But some of the pharmacists did not need to be intoxicated to make errors. KATU reported on one pharmacist who made 20 different dispensing errors including both providing improper doses and giving patients incorrect medication instructions. Either error can be deadly.

While KATU focused on Oregon prescription errors, the problem happens all over the nation. If you have been a victim of prescription error in Illinois, the best thing to do is contact an experienced medical malpractice attorney. However, the Mayo Clinic, which reports that medication errors injure over one million people a year, does provide information that may help save you from falling victim to this serious problem.

How to Protect Yourself from Pharmacy Errors
The Mayo Clinic stresses that communication is key. Talking to your doctor about the medications he or she prescribes is an important step in making sure you get the correct medication. Learn the name of the drug, what it does, and how long it should take for the medication to make a difference in your condition. Ask your doctor for dosage information and instructions on how often to take the medication. If your pharmacist tells you something different, ask questions of both professionals and find out what the correct information is. Other things you should ask both the doctor and the pharmacist about include:

**Any foods, drinks, or other medications or activities that could interfere with the medicine
**The side effects and what you should do if you suffer from side effects
**What you should do if you accidentally miss a dose of your medication or if you take too much

Asking questions in not the only thing you can do to protect yourself. The Mayo Clinic says you also need to provide information to both the doctor and the pharmacist, so they are aware of any problems the medication may cause you that it wouldn’t cause for the average patient. This information includes:

**Medications you are already on including OTCs
**Any allergies you have, especially allergies to other medications or adverse reactions to other medications
**Any seemingly unrelated chronic or serious health problems
**If you are pregnant or trying to become pregnant

While taking these steps may take time, they also may prevent a pharmacy error that could be deadly.

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March 12, 2014

Medication Reconciliation and Health Care Accountability

by Levin & Perconti

Take only as directed. It’s a warning that’s easy to follow. But what happens when physicians transfer a patient’s care to another provider without knowing what medications that patient has already been prescribed? Serious injury and even death can occur when transitions in care leads to uninformed medication orders. To combat these complications, the medical community has been implementing Medical Reconciliation, a process to compare a patient’s medications across caregivers and pharmacies in order to identify duplications, interactions between medications, and whether patients should continue taking current medications.

Medical Reconciliation should be implemented whenever there is a transition in care where new medications are ordered or existing orders are rewritten. A care transition may include changes in setting, service, practitioner, or level of care. For example, a patient’s daily medication may be suspended during a hospital stay, and the need to restart the medication upon discharge may be overlooked. Or a dosage has been mis-transcribed and when a new physician assumed care, the patient was overdosed and seriously injured. Medical Reconciliation attempts to prevent discrepancies like this.

The process of Medical Reconciliation includes

· Developing a list of current medications
· Developing a list of medications to be prescribed
· Comparing the medications on the two lists
· Making clinical decisions based on the comparison; and
· Communicating the new list to appropriate caregivers and the patient.

For newly hospitalized patients, care providers should obtain and verify the patient’s medication history, documenting that medication history, writing orders for the hospital medication regimen, and creating a medication administration record. Once a patient is discharged, care providers should determine the post-discharge medication regimen, develop discharge instructions for the patient for home medications, educate the patient, and transmit the medication list to the follow-up physician. For patients who aren’t in hospital care, the care provider should document a complete list of current medications and update that list whenever medications are added or changed. The Joint Commission requires that any accredited institution treating patients should have a process in place for Medication Reconciliation.

Medication Reconciliation and Tort Law
Even though most facilities have incorporated a Medical Reconciliation process, caregivers may not adhere fully to that policy. There is still a risk for miscommunication during the transfer process, transcription errors, and incorrect medication histories. When a patient is harmed by errors like these, lawsuits can be a particularly powerful way to hold caregivers accountable.

In some states, laws prevent patients who are harmed from filing lawsuits in certain instances. In Virginia, for example, legislation established a state fund to compensate babies born with brain injuries and prevents families from seeking damages in courts. But lawsuits require explanations from negligent health care providers and help to keep them accountable.

Filing lawsuits against negligent physicians can have a bad rap. Sometimes these suits are seen as frivolous. But in reality, only 6% of incoming civil cases are tort cases, and on average, medical malpractice cases represent only 0.6% of all incoming civil cases. In comparison, 70% of civil cases are contracts-based.

If you or someone you know has been injured due to a physician’s negligence, you don’t need to feel like filing a lawsuit makes you a “sue-happy” person. Rather, lawsuits are vital to both compensating you for your injuries and holding physicians and other caregivers accountable for their actions. The malpractice lawyers at Levin and Perconti are experienced in representing people who have been injured by negligent healthcare providers.

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Dangerous Medication Errors Exist in Many Forms

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February 19, 2014

Dangerous Medication Errors Exist in Many Forms

by Levin & Perconti

A common form of medical negligence concerns medication errors. Approximately 1.5 million people in the United States are affected by a medication error in some way each year. A medication error can occur at any point in time between when the prescription is made for a certain medication to the administration of the drug to a patient. There can also be errors made by the prescription filling pharmacy. An improper medication can exacerbate a patient’s problem, or could even cause death.

Doctor Prescribes the Incorrect Medication
There are many ways in which a doctor could be liable for negligently causing a medication error when preparing a prescription. For example, the doctor could prescribe the incorrect medication to treat a diagnosed condition, which could cause the condition to get worse. A medication error at this stage in the prescription process could be the result of an improper diagnosis made by the doctor in the first place, a human error could be made by the doctor in transcribing the prescription, or the medication error could be the result if the doctor improperly prescribes a dosage amount that is too small or too large. Dosage errors are the most common medication error that occurs due to the doctor’s negligence. The doctor could also be negligent if he or she prescribes multiple medications but fails to consider the potential for hazardous drug interactions that could occur if the patient were to take the prescribed medications together in combination.

Pharmacy Errors
Medication errors can occur at the hands of pharmacy workers. What often happens at this level of the prescription process is that the pharmacist, or more frequently the pharmacy technician, makes a human error. While the doctor’s prescription could be correct, any number of mistakes can happen. There could be a mistake made by the pharmacy in entering patient information into the computer system, mixing up of patient prescriptions, improper dosages prepared for a patient or the pharmacy could fail to identify potentially dangerous medication interactions based on the patient’s prescription history, or the other medications that the patient is currently on. While there are usually oversight procedures in place to prevent against medication errors at the pharmacy level, such as the pharmacist must approve all prescripts that are distributed from the pharmacy, sometimes these errors slip through and ultimately harm a patient.

Administration Mistakes
There are several different ways in which a medication error can occur at the time of administration. For instance, frequently in hospital settings and nursing homes, medications are administered accidentally to the wrong patient or resident. Sometimes, particularly in hospital settings, equipment is used to administer doses of medication to a patient over time. A malfunctioning device could administer more or less than is supposed to be administered in each dose. Similarly, a nurse could have mistakenly set the machine to administer too much or too little drug in each dose.

Contacting a Medical Malpractice Attorney
If you believe that you have been harmed by a medication error, you need to discuss the circumstances of your situation with an experienced medical malpractice attorney to determine whether you have a claim, and who is the proper party to bring that claim against. Please contact us today to learn more.

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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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Kickback Scheme Arrests At Chicago’s Sacred Heart Hospital

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March 18, 2013

The Dangers of “Cookbook” Medicine

by Levin & Perconti

Recently the head of the Center for Justice and Democracy published an article at the Huffington Post that offers a good summary of the current debate regarding the intersection of tort reform, medical standards, and patient safety. These debates have been raging for so long that it is easy to assume you have heard every argument in the book. Some assume that opinions on this matters have hardened, and little can be done to sway individuals one way or another.

The truth is that many community have yet to actually thoroughly think through the arguments. Those of us working directly in the legal system on medical malpractice (or those in the medical world), may have considered the issue ad nauseum--but 95% of the community has not. That is why it remains important to stay up to date on the latest issues and be prepared to share accurate and honest information about the matter with friends and neighbors.

In the Huffington Post article, the author reminds of the continuing problem of medical errors--hundreds of thousands of patients are affected each and every year. Reports from a diverse number of places have documented that we have yet to make serious inroads in minimizing these preventable errors.

Sadly, in response, most in the medical community completely shift focus away from the very real problem of patient safety and instead focus on the apparent evil of legal liability following these errors. For quite some time the idea of harmful "defensive" medicine has been echoed, with claims that doctors are ordering "too many test." While there is little data to back up those claims, it does make a convenient argument in the light of budget cuts--allowing the medical lobby to push for legal changes to insulate themselves from liability.

New Argument
Interestingly, the article point to the latest argument made by this lobbying group in an effort to avoid full accountability for harmful mistakes. Some are pushing for new liability rules such that doctors would not be accountable for harm so long as "clinical guidelines" are followed. While this may seem innocuous, it actually represents a significant shift away from traditional legal rules where all community members are held to a reasonable standard based on others in the same situation. Essentially, by shifting to a "clinical guidelines" argument, the idea of patient's receiving individual care would be shattered.

This is not necessarily a new argument. It was discussed years ago and actually made its way into state law in a few cases. However, none of those laws on the on the books today, because it was a clear failure. One of the main problems is that creating clinical guidelines is supremely complications, particularly in certain medical practice areas. Trying to conform everything to a cookie-cutter scenario without any consideration of individual factors is nonsensical. It doesn't work for patient or doctor fairness.

The bottom line is that clinical guidelines should never be turned into legal standards for accountability purposes. It didn't work in the past and won't make sense now.

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Important New Supreme Court Case on Generic Drug Liability

New Kickstarter Push for Medical Errors Documentary

March 15, 2013

Important New U.S. Supreme Court on Liability Following Harm Caused by Generic Drugs

by Levin & Perconti

As reported recently in the New York Times, the U.S. Supreme Court is set to hear a new case that will further clarify legal liability rules as they relate to drug errors and pharmaceutical companies. At the heart of the case is whether a generic drug manufacturer can be held liable for the harm caused by a defectively designed drug.

The original case was filed by a woman who was given a prescription for the pain pill known as sulindac by her doctor. The mild medication was intended to provide some relief for her shoulder pain. In reality, it totally changed the woman’s life--and not for the better. The patient suffered from a reaction to the drug which caused severe burning. Here skin literally “sloughed” off. Ultimately she needed to spend months in a burn unit and was in a coma for even longer. By the end of it all the woman was legally blind and had suffered permanent damage to her lungs and esophagus.

Defective Drug Legal Case
The patient filed a lawsuit against the manufacturer of the generic drug. At trial the woman was awarded $25 million which was upheld by a federal appeals court. However, the defendant pharmaceutical business--Mutual Pharmaceutical Company--appealed again to the U.S. Supreme Court. The high court agreed to take the case and will hear arguments soon.

Liability for generic drugs is one of the most hot-button legal issues being discussed these days. Considering that 80% of all prescribed medications are generic, determining who is responsible when the medication causes harm will have ramifications on many patients. The liability may ultimately rest on the exact legal arguments made.

For one thing, the Supreme Court already found in a previous cases that generic drug makers can not be held liable for harm when insufficient warning labels are argued. In that case, the Court found that the generic drug manufacturer is not responsible for the warning label on these products and so cannot be held liable when those labels are inadequate.

However, claiming that a warning label did not address a particular risk is not the only way that an injured patient may seek accountability. In this most recent case, the plaintiff is instead arguing that the drug itself was defectively designed. For their part, the defendant company is claiming that the logic in the warning label case is the same here: they have no control over the design and therefore cannot be held liable when it is defective.

Yet, there is good reason for the court to see things otherwise. Lower courts reasoned that even if the actual design was not under its control, the company was still not required to sell the product. If it was defective, it should have been pulled from the shelves, regardless of whether they or someone else designed it. If the court’s find otherwise, then many are wondering if the generic drug industry will essentially be immune from liability, and patients will have next to no recourse when harmed by these products.

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The Law & The Dr. Reinstein Fraud Case

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March 14, 2013

The Law & The Doctor Reinstein Fraud Case

by Levin & Perconti

When reading about the case against Dr. Michael J. Reinstein in Chicago, most community members understand in general terms what was going awry. All medical decisions, whether at the hospital, nursing home, clinic, or elsewhere need to be made with the best interests of the patient in mind. When other factors influence the decision (i.e. money), then the process has broken down.

But how does this sort of conduct implicate legal issues? In Dr. Reinstein’s case he is alleged to have over-prescribed a certain dangerous medications for his own personal gain--he was paid by the makers of the drug to push the product. But, it isn’t as if the Doctor intentionally harmed patients, and in certain cases the patients may actually have benefited from clozapine. Most understand how incredibly inappropriate and potentially harmful this conduct is, but the legal underpinning of the lawsuit related to these issues is less well known.

False Claims Act
As described in reports on the matter from the Chicago Tribune, the federal lawsuit that was filed against the doctor last November is mostly rooted in the federal law known as the False Claims Act. This law essentially seeks to prohibit the exact conduct that allegedly occurred in this case--the use of Medicare and Medicaid funds to pay for services that are motivated by financial interests (and not quality patient care).

When the attorney general in the case referred to the Medicaid fraud suit as the largest in the city’s history, that was mostly based on the total number of allegedly false claims that were made by Reinstein. For example, documents filed in the suit allege that over 140,000 such claims were submitted over the course of many years. This presumably refers to each instance where public coffers paid for one of his patients to receive a clozapine prescription. Additionally, the lawsuit claims that in at least 50,000 claims the doctor falsely stated that he personally monitored the condition of patients who received the medication. Those patients were scattered across a few dozen nursing homes in the area. According to the suit, that personal monitoring was non-existent. The doctor was apparently less concerned about ensuring his patients needed the drug and responded well to it, and more concerned with doling out the medication as much as possible so that he could remain useful to pharmaceutical companies who were providing him financial support

As part of the False Claims Act, the government is able to seek out “triple damages.” This is a critical deterrent tool. In most lawsuit, the purpose is to make the injured party “whole.” In this case, the injured party is the federal government--who spent money unnecessarily. Therefore, under normal circumstances, the government would be able to seek repayment of all the funds spent on fraudulent claims.

But if the maximum that the government can recover is what they paid out, then there is minimal deterrent effect. That is because the medical professionals have little to lose by trying to game the system. If they are not caught, then they keep the fraudulently obtained money. If they are caught, then they repay it. But that all changes with triple damages. In those cases, the party committing fraud can be held to repay three times the amount improperly received. In that way, any professional tempted to engage in this conduct might think twice, understanding the severe financial consequences upon discovery.

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Medicaid Waste: Billions Spent on Poor Care

Failing to Blow the Whistle

March 13, 2013

Reminder on Dangers of Medicaid Fraud & Prescription Drug Damage

by Levin & Perconti

This week the House GOP budget chairman, Rep. Paul Ryan, released a proposed budget plan that, he claims, would eliminate the federal deficit in ten years. To accomplish such a feat, the proposal calls for significant cuts in various programs, including Medicare and Medicaid. It eliminates the provisions of the Affordable Care Act (Obamacare), while keeping the revenue enhancements in place.

While we all might have different views on how to handle these budgetary issues, virtually everyone agrees that waste and misspent funds within these programs should be rooted out. When we are considering eliminating support for programs that many vulnerable community members depend on, at the very least it is critical to ensure that the money that we are spending is going toward vital services and not unnecessarily enriching those abusing the process.

Yet, cases still pop up of doctors (and entire facilities) failing to follow Medicare and Medicaid guidelines--milking significant funds from public coffers unnecessarily. Not only that but significant harm can actual befall patients as a result of this misconduct.

The Dr. Reinstein Example in Chicago
Perhaps the most cogent example of this situation in the Chicago area is that of Dr. Michael J. Reinstein. As the Chicago Tribune reported on in a series of articles last November, Dr. Reinstein is accused of taking kickbacks from drug companies and illegally prescribing one particular drug to thousands of patients will various mental illnesses in our region.

Late last year a lawsuit was filed against the doctor that the attorney general called “the largest civil case alleging prescription medication fraud against an individual ever brought in Chicago."

Essentially the lawsuit suggests that the doctor provided “assembly line” care to many patients--usually those with mental illness living in nursing homes in the city’s north side neighborhoods. In particular, red flags were raised about Reinstein’s massive use of the drug clozapine. It is an antipsychotic medication that has long been on the radar of those worried about overuse of these medication. It has been linked to several deaths. Data suggests that Reinstien’s clozapine prescriptions were so numerous that he individually ordered more use of the medication than was prescribed by all the physicians in the state of Texas combined.

The quantity of the clozapine prescriptions raised red flags, prompting further investigation. It wasn’t long before more information was uncovered. Specifically, the doctor is accused of taking kickbacks from two different companies. First, he allegedly received “support” from the makers of clozapine. Even when the drug’s patent expired (and cheaper alternatives became available), the doctor continued to prescribe the original. It wasn’t until the makers of clozapine stopped making payments to the doctor that he switched over to other versions for this patients, claim the suit.

Perhaps not surprisingly, the makers of the generic version of the drug also entered into unique “arrangements” with the doctor, including payment of “research” fees and “speaker” fees. The lawsuit even goes so far as noting how the pharmaceutical company which made the generic drug paid for various trips and entertainment expenses for the doctor and his associates. It wasn’t until the suspicious relationship began public that the payments finally stopped.

See Other Blog Posts:

Medicaid Waste: Billions Spent on Poor Care

Failing to Blow the Whistl

January 10, 2013

Safety Plan for Electronic Records Released By Government

by Levin & Perconti

The Affordable Care Act (Obamacare) was passed in 2010. However, it was only last year that its constitutionality was upheld, and it is only this year (and subsequent years) that much of the plan actually takes effect. We can expect much discussion, argument, and confusion related to the bill as it rolls out. Hopefully the goals outlined in the measure are met and healthcare for all of us becomes more affordable and safer.

One of the most well-known components of the bill include a push to move toward electronic health records (EHRs). It seems natural that as technology advances the medical community would take advantage of the many benefits of electronic records, with easy storage, comparison, transfer, and safety checks. Of course, the switch is not without its issues, as it is incumbent that the transfer be done carefully to avoid issues like theft, unauthorized transmission, or glitches which risk the health and safety of patients.

Federal Government Patient Safety Plan
To help with that smooth transition, the federal government recently released information on a patient safety plan as it relates to EHRs. The Boston Globe recently provided a helpful story that discusses the situation.

The new plan was released by the federal agency charged with overseeing the switch to EHRs--The National Coordinator for Health Information Technology. The effort is entitled, “Health IT Patient Safety Action and Surveillance Plan” and it is now available for public comment. In releasing the report the officials noted that ensuring safety will be a joint effort, needing investment from many different actors including the IT industry, medical community, patient safety groups, and the government. You can view the full report for yourself by clicking here.

Many Concerns
These guidelines come on the heels of an Institute of Medicine (IOM) report from last year which raised alarm bells about the risks posed by EHRs. The IOM report
shared different concerns that many in the industry were making about the lack of government action on the safety front. In particular, the institute shared specific cases where patients suffered serious injury or even died as a result of poor safety related to electronic records and medical malpractice.

Since these guidelines are the first crack at getting the potential problem under control, there will undoubtedly be many suggestions on what can be improved. In roughly summarizing the approach, one involved partied noted that “It’s this challenging chicken-and-egg problem. The plan, which is subject to public comment through Feb. 4, is a reasonable start, in part because it puts more pressure on hospitals and doctors to monitor safety.”

An important decision was made not to make certain aspects of this safety process mandatory. That is because there was a risk that innovation might have been stifled if a single approach was adopted and forced upon everyone. Considering this is all very new, it is logical for different stakeholders to explore the various options that might work best to promote patient safety. Hopefully, with the extra leeway at the start, these entities can find strategies that work best which can then be adopted by other institutions down the road. It will be interesting to see how all of this develops in the coming months.

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