June 15, 2015

Soft Tissue Dermal Fillers a Risk

by Levin & Perconti

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

What Are Cosmetic Soft Tissue Dermal Fillers?

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

Cosmetic Soft Tissue Dermal Fillers Pose a Risk According to FDA

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

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

How Patients Can Protect Themselves

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

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

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

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

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

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

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Medical Malpractice Lawsuit Against Medical Spa

April 7, 2015

Drug Maker Fighting FDA Efforts to Approve Generic Abilify

by Levin & Perconti

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

What is Abilify?

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

Continue reading "Drug Maker Fighting FDA Efforts to Approve Generic Abilify" »

January 20, 2015

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

by Levin & Perconti

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

FDA Drug Approvals Reach 18-Year High

Continue reading "A Risky Situation: FDA Drug Approvals at 18-Year High" »

January 9, 2015

FDA First: Panel Approves Generic Copy of Expensive Biologic Drug

by Levin & Perconti

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

FDA Panel Approves Generic Version of Biologic Drug

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

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January 4, 2015

Understanding Possible Victoza Litigation

by Levin & Perconti

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

What is Victoza?

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

What are the Problems with Victoza?

Continue reading "Understanding Possible Victoza Litigation" »

December 15, 2014

Recovering Cancer Patient Killed by Pharmacy Errors

by Levin & Perconti

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

Oregon Cancer Patient Given Wrong Drug to Treat Anxiety

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

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December 9, 2014

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

by Levin & Perconti

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

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

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December 6, 2014

California Delayed Action on Translating Drug Labels

by Levin & Perconti

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

California Delayed Action on Translating Prescription Drug Labels

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

Continue reading "California Delayed Action on Translating Drug Labels" »

November 29, 2014

FDA Panel Recommends Against Strictest Warning for Steroid Shots

by Levin & Perconti

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

Panel Rejects Strict Warnings

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

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November 21, 2014

Deadly Pharmacy Errors Likely Caused by Corporate Greed?

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.

Continue reading "Deadly Pharmacy Errors Likely Caused by Corporate Greed?" »

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.

Continue reading "FDA Allows Drugmaker to Test Experimental Drug on Ebola Patients" »

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.

See Related Posts:

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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.

Continue reading "Judge Blocks FDA's Attempt to Make Generic Version of Sedative Precedex Available" »

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.

Continue reading "FDA Drug Event Data Now More Easily Available" »

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.

See Other Blog Posts:

New Malpractice Suit Dubbed “Death by Forceps”

Failure to Diagnose: Parents of Young Doctor File Medical Malpractice Lawsuit

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.

See Other Posts:

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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.

See Other Blog Posts:

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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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