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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October 15, 2014

More Details Surrounding Joan Rivers' Death

by Levin & Perconti

Medical malpractice affects the lives of the both a patient and the people who care about that patient. Whether the malpractice results on a personal injury, or is so severe as to result in wrongful death, many people are hurt. When a beloved celebrity falls victim to a medical professional's mistakes, the loss is felt to a certain degree by all of us. It appears that medical malpractice may very well be the cause of the recent death of much-admired comedian Joan Rivers.

Clinic That Treated Ms. Rivers Deemed Deficient and Could Lose License

ABC News reports that the clinic where Ms. Rivers underwent the procedure that caused her death could lose its federal accreditation. This is because the New York State Health Department's investigation into Yorkville Endoscopy after Ms. Rivers' death found lapses in four categories required for accreditation. The exact details of the lapses have not yet been revealed, but they fall into the following categories:

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October 10, 2014

Texas Medical Malpractice Laws Will Likely Let Hospital Get Away With Missed Ebola Diagnosis

by Levin & Perconti

Medical malpractice laws are at least a little bit different in every state. In Texas, the laws are particularly restrictive, severely limiting when and how patients and their families can be compensated for injuries caused by hospitals' negligence. These sorts of limits undermine the very reasons for having a civil justice system—making wronged parties whole and deterring bad acts. Now it appears that the Texas hospital that failed to diagnose the first American case of Ebola will get away with its serious medical error.

Difficulties in Suing Over Missed Ebola Diagnosis

Reuters reports that Texas' so-called “tort reform” laws have made it one of the most difficult places in the entire United States to recover after being the victim of a medical error. This is particularly true when the medical error causing the injury takes place in an emergency room. An emergency room error is what happened in the Ebola case. The original Ebola patient, Thomas Eric Duncan, visited Texas Health Presbyterian Hospital's emergency room, and told a nurse he had just returned from Liberia. Liberia is one of the countries seriously hit with the current African Ebola crisis. Despite Mr. Duncan's telling a nurse about his travels, and the nurse's documenting the travel, Mr. Duncan was simply sent home with antibiotics. He was not admitted to a hospital for treatment until three days later.

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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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October 2, 2014

New Jersey Supreme Court Allows Hospitals to Hide Results of Medical Malpractice Investigations

by Levin & Perconti

The New Jersey Supreme Court issued a ruling that allows hospitals to hide the results of internal investigations of medical malpractice. This means that in New Jersey, the patients who are injured by these hospitals and their employees may not be able to access information regarding healthcare provider errors.

What Happened in New Jersey?

The case before the New Jersey Supreme Court was C.A. v. Eric Bentolila, M.D. The details of the case have been reported on by NJ.com. In this case, Esther and Gedalia Applegrad filed a medical malpractice suit claiming that their daughter suffered a brain injury and a seizure disorder because of mistakes made at the hospital during her delivery at Valley Hospital in 2007. During the course of the lawsuit, the parents' attorneys entered into a process called discovery. Discovery is the part of litigation where both sides give information to the other side that may be relevant to the outcome of a case. So if it were a bank robbery case instead of a medical malpractice case, this is the part of the litigation where the prosecutor would give the defense any surveillance footage that they had of the bank. In this medical malpractice case, the parents asked the the judge to order the hospital to turn over memos that were called, “Director of Patient Safety Post Incident Analysis.”

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October 1, 2014

Cybersecurity and Your Medical Treatment

by Levin & Perconti

Being sick or injured is stressful enough in and of itself. In addition to the concerns we have for our own health, unfortunately when we seek treatment there is a real risk of suffering from the results of a healthcare provider error or other form of medical malpractice. Now, in the internet age, we also have to be concerned about cybersecurity as it applies to our medical treatment.

FDA Creates Medical Device Security Guidelines

USA Today reports that the Food and Drug Administration (FDA) has finally put guidelines in place regulating the cybersecurity of medical devices. In a press release, the FDA's director of emergency preparadnesss/operations and medical countermeasures, Suzanne Schwartz, said, “There is no such thing as a threat-proof medical device....It is important for medical device manufacturers to remain vigilant about cybersecurity and to appropriately protect patients from those risks.” However, the hope is that the new regulations will help protect patients from cybersecurity threats.

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September 27, 2014

Report Released on Top 10 Patient Safety Strategies

by Levin & Perconti

The Agency for Healthcare Research and Quality (AHRQ) released a report earlier this year that details the top ten patient safety strategies that could be immediately implemented by healthcare providers. If every hospital were to enact these recommendations then hospitals would be safer for all of us. Fewer patients would face serious injuries or even death because of what happens to them inside the place where they go to get well. This sort of prophylactic action could ultimately decrease the number of medical malpractice cases and ultimately drive down malpractice insurance costs, meaning doctors and hospitals would benefit as well.

What is the AHRQ?

The AHRQ is a part of the United States Department of Health and Human Services. According to the agency's website, the mission of the AHRQ, “is to produce evidence to make healthcare safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used.” This mission resonates with many people who have been victims of medical malpractice and with the attorney who represent them. While recovering financial loses is part of the goal in a personal injury or wrongful death case, in most cases the injured party also has a strong desire to prevent other people from being injured in the future.

What are the Report's Recommendations?

The AHRQ came up with ten strategies that the agency believes have the potential to vastly improve patient safety and save lives if they are widely implemented. Agency Director Carolyn M. Clancy, M.D. said of the strategies, “We have the evidence to show what really works to make care safer...Armed with this knowledge about what works and how to apply it, we can continue to advance our efforts to ensure patient safety.” The ten recommended patient safety strategies, as listed in an agency press release, include the use of:

1. Preoperative checklists and anesthesia checklists to prevent operative and postoperative events.

2. Bundles that include checklists to prevent central line-associated bloodstream infections.

3. Interventions to reduce urinary catheter use, including catheter reminders, stop orders, or nurse-initiated removal protocols.

4. Bundles that include head-of-bed elevation, sedation vacations, oral care with chlorhexidine, and subglottic-suctioning endotracheal tubes to prevent ventilator-associated pneumonia.

5. Hand hygiene.

6. The do-not-use list for hazardous abbreviations.

7. Multicomponent interventions to reduce pressure ulcers.

8. Barrier precautions to prevent healthcare-associated infections.

9. Use of real-time ultrasonography for central line placement.

10. Interventions to improve prophylaxis for venous thromboembolisms (Thromboembolisms are blockages of blood vessels caused by a stationary blood clot).

If used, these strategies can especially help prevent healthcare associated infections, bedsores, and medication errors. The report does not just list strategies, however. It also details evidence about the implementation of these strategies and provides information about the context in which they have been used. The hope is that this additional information will allow healthcare providers to adapt the strategies to their own facilities and needs. Some of these strategies are already used in many hospitals, while some are still relatively uncommon.

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September 24, 2014

CMS Reverses Decision to Stop Publicly Reporting Medical Errors

by Levin & Perconti

Medical errors are made every day. We, as members of the public, rely on government agencies to provide us with information about what sort of errors are happening, where they are happening, and under what conditions they happen. There is no reliable way for one private individual to gather that information, and without it it would be impossible to determine the safety of our healthcare system. Medical malpractice claims would provide some information, but not every case of medical error results in a malpractice suit. Fortunately, one government agency recently released a prior decision to quit publicly reporting this sort of information.

The Oshkosh Northwestern reported the reversal earlier this month. According to its report, originally the Hospital Compare website reported on how often “hospital-acquired conditions” occurred at U.S. hospitals. Then it stopped reporting on medical errors despite making assurances in 2013 that it would not discontinue the public reporting. USA Today reports that, during the period of non-reporting, the agency was not publicly releasing data about medical mistakes as horrifying as doctors leaving instruments inside patients or giving them the wrong type of blood. Now the agency is again reversing course and making more information publicly available.

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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.

See Related Posts:

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September 17, 2014

Some Hospitals are Failing to Sterilize Surgical Instruments

by Levin & Perconti

Failing to sterilize surgical instruments is one type of medical malpractice. This sort of health care provider error can result in serious infections, and sometimes, even death. The severe consequences of a failure to sterilize hospital equipment have lead to hospitals putting strict measures into place to insure that only proper equipment is used on patients. However, despite there being universal agreement on the importance of sterilization of instruments, two different news agencies are reporting this month on two different hospitals in two different cities that used unsterilized equipment on patients.

Hospital Used Unsterilized Surgical Equipment

NBC News Channel 11 KARE reports that Abbott Northwestern hospital in Minneapolis, Minnesota used unsterilized equipment in surgeries earlier this month. A hospital employee who spoke to KARE said, “This is … incredibly unacceptable and dangerous.” Fourteen unsterilized instrument sets were released into service. Four of them were actually used on patients. Those four patients have all been contacted by the hospital and have been offered testing for infections. So far no information has been released to the public about how this happened or how the problem was eventually discovered.

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