September 20, 2014

FDA Panel Wants to Limit Testosterone Drugs

by Levin & Perconti

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

Panel Recommends New Labels

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

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

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

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

FDA Rejects Oral Testosterone Replacement Drug

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

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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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September 13, 2014

Joan Rivers' Doctor No Longer Performing Procedures

by Levin & Perconti

Earlier this month beloved comedian Joan Rivers passed away. It is still unclear precisely what caused her death in a New York hospital. Whether her death was the result of a surgical error or some other form of medical malpractice is not yet known. However, what is known is that the doctor who was performing a procedure on her when she became ill is no longer performing procedures.

Doctor No Longer Performing Procedures

ABC News reports that the doctor who performed the endoscopy on Joan Rivers shortly before she went into cardiac arrest has been asked to step down at Yorkville Endoscopy. The doctor, Dr. Lawrence Cohen, is the clinic's former medical director and is a gastroenterologist. The clinic told ABC News that Dr. Cohen, “is not currently performing procedures at Yorkville Endoscopy; nor is he currently serving as medical director.” The clinic gave no official reason, but an unnamed source said that the doctor was asked to step down because he allowed a specialist who was not authorized to practice at the clinic to examine Ms. Rivers.

The New York Daily News reports that an unnamed source claims that an ear, nose and throat specialist who accompanied Ms. Rivers to the clinic performed an unplanned biopsy on her vocal cords. The clinic denies that the procedure occurred. However, the source claims that the procedure did occur once something was spotted on Rivers' vocal cords during the procedure, and that Ms. Rivers had not previously given consent for a biopsy. The New York Times confirms that the specialist was present at the clinic in the operating room during the procedure. The health department and the medical examiner are both currently investigating Ms. Rivers' death. It is not clear what lead to the breathing problems that resulted in cardiac arrest—it could have been the procedure itself, or it could have been a mistake with the propofol that was allegedly administered during the procedure.

What we Know About Ms. Rivers' Death

The Washington Post, relying in part on previous reporting by The New York Times, reported earlier this week on what we know about how Ms. Rivers died. A family spokesperson has said that Ms. Rivers was at the Yorkville Endoscopy Clinic so that doctors could work on her vocal cords. A friend of Ms. Rivers told ABC News that the procedure was a diagnostic one to determine why her voice had become raspy. There have been conflicting reports stating that Ms. Rivers took ill during the procedure when a doctor attempted to perform a biopsy on her vocal cords, but the facility claims that it does not perform vocal cord biopsies. The facility also claims that it has never administered general anesthesia.

Whatever happened during the procedure, eventually the clinic called 9-1-1 and reported that a patient was in cardiac arrest. An ambulance took Ms. Rivers to Mount Sinai Hospital. Throughout this whole process various medical personnel attempted to revive her. She was admitted to the hospital, and eventually passed away seven days later.

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September 10, 2014

Lawsuit Alleges Doctor Didn't Inform Patient of Cancer

by Levin & Perconti

Doctors are in a unique position. Due to their training and experience, we rely on them and trust them in much the same way that very young children rely on and trust their parents. When a doctor violates that trust by failing to provide us with necessary information, the results can be catastrophic. Failing to tell a patient about a diagnosis can be just as bad as a missed diagnosis, because it prevents the patient from taking action. This sort of medical malpractice is extremely dangerous and can have life threatening consequences. That is exactly what is alleged to have happened in a lawsuit in the Chicago area.

Doctor Didn't Tell Patient About Cancer

The Chicago Tribune reported on the lawsuit. According to the suit, a urologist told Edward Hines that he was cancer-free after the doctor removed a tumor from his bladder in early 2011. One week after the surgery, a pathology report showed that Mr. Hines had bladder cancer. Unfortunately, the doctor did not inform Mr. Hines of this result. Of course, the doctor disagrees with this statement of facts and claims that he told Mr. Hines about the cancerous lesion.
According to the suit, however, because the doctor never passed the news along to Mr. Hines, Mr. Hines did not learn about the cancer until he visited a different doctor later that year. Mr. Hines filed suit, but ultimately passed away, so the suit had to be taken over by his daughter Amber Hines. She claims that her dad would have been more likely to survive the cancer if he had known about it earlier. She said in an interview, “We went an entire year without treatment, which was extremely devastating.”

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September 7, 2014

Blood Pressure Kiosks Not to be Trusted, FDA Warns

by Levin & Perconti

Many Americans struggle with high blood pressure. And even amongst those who do not, many have family members or friends who do. So quite often when we are in the pharmacy, super store, or grocery store we sit down at the blood pressure kiosk, slide an arm into the sleeve, and check our reading. When it is high, we may contact a doctor, but when it is normal or low we breath a sigh of relief and worry no more. A new report, however, says that perhaps we should not rest so easy, because those kiosk readings can be quite inaccurate. And an inaccurate reading can result in a delayed diagnosis of hypertension, which can have serious health consequences. While these kiosks often have warnings on them indicating that they should not be relied on as medical devices, many people do not take those warnings seriously, or read them at all.

FDA says Blood Pressure Kiosks Inaccurate

The Food and Drug Administration (FDA) issued an advisory recently about self-service blood pressure kiosks like the ones often found in pharmacies. The advisory explains that correct cuff size is a “critical factor” in measuring blood pressure, and that the cuffs on public kiosks do not fit every user. If the cuff is too small it can result in an artificially high blood pressure reading. If, on the other had, the cuff is too large it may not work at all or, more dangerously, it may result in an artificially low blood pressure reading.

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August 30, 2014

Anesthesiology in a World Without a Civil Justice System—Part 4

by Levin & Perconti

The American Association of Justice (AAJ) recently released an article discussing what the country would be like without a civil justice system. In honor of that work we have been addressing various parts of the medical field and how patients would be much worse off without the medical malpractice portion of the civil justice system. This week we are addressing malpractice in anesthesiology.

Medical Malpractice Law Has Decreased Malpractice in Anesthesiology

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August 25, 2014

FDA Warns Patients About Uterine Fibroid Treatment Procedure

by Levin & Perconti

Usually when we think about the risks of surgery, we think about direct risks like surgical error or medical malpractice resulting in postoperative infections or complications. Unfortunately, that is not the only kind of risk one needs to consider when deciding whether to undergo a procedure. Unfortunately patients also need to consider whether and to what extent undergoing the procedure may increase their risk of other health problems in the future. The Food and Drug Administration (FDA) is currently warning against one such risk.

FDA Warns that Surgical Technique Increases Cancer Risk

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August 22, 2014

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

by Levin & Perconti

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

FDA Rules Generic Manufacture Okay, but Court Steps in

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

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August 19, 2014

How Wrong Site Surgeries Show Consequences of No Civil Justice System – Part 3

by Levin & Perconti

The American Association for Justice (AAJ) recently published a list of ways in which our society would be substantially different if we did not have a civil justice system. The civil justice system is basically our whole justice system except for the criminal system. It includes things like medical malpractice cases, nursing home abuse cases, products liability cases, and many other areas of law. So in honor of the AAJ's efforts to get out the word about the importance of our civil justice system, we are looking in depth at some of the areas of the medical profession that would be wildly different without a civil justice system. These week we are addressing a truly shocking type of surgical malpractice that would go ungoverned without a civil justice system: wrong site surgeries.

How Common are Wrong Site Surgeries?

Wrong site surgeries are one type of medical malpractice that should never happen. If everyone is doing their job correctly, and proper safety procedures are followed, it should be impossible for a surgeon to wind up operating on the wrong part of a person's body, or even worse, on the wrong person altogether. Unfortunately, it happens all too often. A report by Medscape from just three years ago found that wrong site surgeries happen about forty times a week nationwide.What is an Example of a Wrong Site Surgery?

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August 15, 2014

Levin & Perconti Wins $1.25 Million Settlement

by Levin & Perconti

The medical malpractice attorneys won a $1.25 million settlement for a client in a wrongful death case. The deceased in the case went to a hospital in July of 2009. During his stay in the hospital he ultimately died.

Sixty-Nine-Year-Old Man Dies Because of Missed Diagnosis

While the sixty-nine-year-old man was in the hospital he received an anticoagulation medication. Anticoagulation medications reduce the blood’s ability to coagulate, or change from a liquid to a semi-solid state. Then he received an MRI of his lumbar spine. That evening he suffered from multiple vasovagal episodes and low blood pressure. Vasovagal episodes involve a rapid drop in a patient’s heart rate which decreases the flow of blood to the brain and can cause fainting. The next morning the gentleman went into fatal cardiac arrest.His death was ultimately attributed to an undiagnosed retroperitoneal hemorrhage. A retroperitoneal hemorrhage is when blood accumulates in the retroperitoneal space. The retroperitoneal space is a space in the abdominal cavity. There are multiple things that can contribute to such a hemorrhage, but one of them is anticoagulation. Other causes include a ruptured aortic aneurysm, a ruptured renal aneurysm, acute pancreatitis, and malignancy.

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