Medico-Legal News

July 13, 2011

Actos Bladder Cancer Injuries

Is an Actos recall in the works? As an Actos Bladder Cancer attorney, and Texas medical doctor I am providing this Actos update.

Actos (pioglitazone) is one of the world’s widely prescribed diabetes medications. Also marketed in combination with glimepiride (Duetact) and metformin (Actoplus Met, Actoplus Met XR), Actos is used by millions of patients with Type-2 diabetes. The drug works by controlling blood glucose levels through its action with insulin.

Now, Actos has also been linked to life-threatening side effects. In June 2011, the Food and Drug Administration (FDA) issued a warning to alert patients and healthcare professionals of an increased risk of bladder cancer associated with Actos. This followed another FDA warning, issued in June 2007, with reports of liver damage and cardiovascular problems among patients taking Actos.

If you have been diagnosed with bladder cancer or another condition you feel may be linked to taking Actos, the FDA recommends that you schedule an appointment with your doctor immediately.

Bladder Cancer Risk and Actos Usage

The FDA issued its Actos bladder cancer warning after an interim analysis of a 10-year epidemiological study conducted by the drug’s manufacturer, Takeda Pharmaceuticals. The analysis showed no increased risk of bladder cancer among users as a whole. The longest-term users of Actos and those with the highest cumulative dose of the drug showed increased levels of bladder cancer.

A separate study of Actos, conducted in France, has also linked the drug to bladder cancer. The FDA is aware of these findings and has stated that it intends to conduct a thorough review of the study and its findings. The agency has also stated that it will continue monitoring data from Takeda’s ongoing study.

In the meantime, the FDA has advised patients that taking Actos for longer than a year puts them at risk. The FDA recommends that patients with active bladder cancer avoid taking Actos. Physicians should use caution when prescribing Actos to patients with a history of bladder cancer, weighing the benefits of the drug to the risk of recurrence.

The FDA has also provided the following tips for patients:

Taking Actos may increase your odds of developing bladder cancer
Go to a doctor if you notice that your urine is red in color or if you see blood; if you are experiencing an extreme urge to urinate or pain while doing so; or if you are experiencing pain in your lower abdomen or back
Do not take Actos if you are receiving bladder cancer treatment
Report any side effects you notice to the FDA MedWatch program
Read the medication guide you get with your Actos prescription, which contains detailed information on risks associated with the drug
These warnings and recommendations will appear on the Warnings and Precautions section of the drug’s label, and in the accompanying medication guide.

Actos Side Effects and Potential Injuries

The FDA’s latest Actos warning follows another warning issued in June of 2007. At that time, the agency issued a “black box warning” requiring the manufacturers of Actos and Avandia (known as thiazolidinediones) to include warnings alerting patients and their doctors of cardiovascular and liver problems linked to the drug. Black box warnings appear on the packaging of drugs and are the strongest action taken by the FDA short of a recall.

These warnings were issued after the findings of a Cleveland Clinic study showed that thiazolidinedione use increased the risk of heart attack by as much as 42 percent. The findings also showed an increased risk of hepatitis, liver inflammation, elevated liver enzymes (an indication of liver damage) and liver failure.

July 10, 2011

Miami VA Colonoscopy Hepatitis C Case Goes to Trial

by Dr. Shezad Malik

As a Dallas Medical Malpractice attorney, and Texas medical doctor, I am providing this update regarding the medical malpractice cases in Miami VA hospital with improperly cleaned equipment.

A Miami U.S. Air Force vet who says he contracted hepatitis C from a colonoscopy done at the Miami VA hospital with improperly cleaned equipment will go to trial in Miami federal court. A Coral Gables veteran who filed the medical malpractice lawsuit, claims that an improper colonoscopy at the Miami Veterans’ Administration hospital gave him hepatitis C.

11,000 U.S. veterans received colonoscopies with improperly cleaned equipment at VA hospitals in Miami, Murfreesboro, Tenn., and Augusta, Ga., between 2004 and 2009. Of the veterans who had the procedure at the three facilities, five have tested positive for HIV, 25 for hepatitis C and eight for hepatitis B.

Robert Metzler, now 69, a U.S. Air Force veteran, says he got a colonoscopy at the Miami VA hospital in 2007 and two years later was told he has hepatitis C.

The lawsuits were filed after a 2009 investigation by the VA’s own Administrative Investigation Board revealed more than 11,000 colonoscopies were done at three VA hospitals using equipment that had been rinsed after each patient rather than being sterilized by steam and chemicals as called for by the manufacturer. Investigators who took apart water tubes on some of the equipment that was supposed to be clean and ready for use instead found “discolored liquid and debris.”
The AIB report said the colonoscopies in Miami were done in an environment of inadequate training, lack of supervision and inadequate communication.

U.S. Army veteran Juan Rivera of Miami sued for medical malpractice when he became HIV positive after a colonoscopy at the Miami VA hospital, that case settled out of court in March 2011.

In the Metzler case, court papers filed by the USA in April 2011 argue that the chances that the veteran contracted hepatitis C from the VA equipment are no more than “two in one trillion.” Hepatitis C can’t survive outside a human host for more than four days, the documents say, and “substantially more than four days had passed” between any previous patient with Hepatitis C who had a colonoscopy and the one performed on Metzler.

Metzler’s case is based on the claim that he had a blood test in August 2006 at the VA, with no sign of hepatitis C. His colonoscopy was in June 2007 and he was notified in March 2009 that he needed to come in to the VA for testing because the endoscope used in the procedure may have been contaminated, accodring to his lawyer. A month later, he was told he was positive for hepatitis C.

July 7, 2011

Multaq Study Stopped: Linked to Other Heart Problems

by Dr. Shezad Malik

As a Multaq Dangerous Drug attorney and Texas medical doctor, I am providing this information on a drug company sponsored trial of its drug Multaq, which was halted because of increased cardiovascular side effects and injuries.

Sanofi, maker of dronedarone (Multaq), has stopped its phase 3b trial of its antiarrhythmic drug due to an increase in cardiovascular events seen in patients with permanent atrial fibrillation – an unapproved indication for the antiarrhythmic drug. The PALLAS trial was testing the drug in patients with permanent atrial fibrillation (AF) and at least one other cardiovascular disease risk factor; at present, dronedarone is approved in patients with nonpermanent AF.

According to the primary medical investigator, “. . . there was a significant increase in major cardiovascular events, and in our study that was defined as a composite of stroke, MI, systemic embolism, or cardiovascular death. . . . These were pretty important events.”

Multaq, is approved for patients with the non-permanent kind of atrial fibrillation. The trial, known as the PALLAS study, was testing Multaq’s usefulness in patients with permanent atrial fibrillation (more than 6 months of the abnormal rhythms).

Dronedarone has faced a range of criticisms since its approval in the US in July 2009, including questions about its safety/efficacy tradeoff and the design and execution of the ATHENA study. Just last week, newspapers in France reported that French health authorities had concluded that the efficacy of dronedarone was “insufficient”—an opinion that could lead to the drug being dropped from the country’s drug reimbursement formulary.

Dronedarone, sold by sanofi-aventis, is currently approved to treat atrial flutter and paroxysmal or persistent – but not permanent atrial fibrillation.

The phase 3b trial, called PALLAS, had enrolled 3,148 patients with permanent atrial fibrillation, with 70% showing symptoms for more than two years, according to a company statement. Sanofi did not specify the cardiovascular events seen in the dronedarone-treated patients, or the magnitude of the increase.

In January, sanofi-aventis and the FDA warned that reports of acute liver injury associated with the drug had been received. The statement noted that patients with permanent atrial fibrillation and “vascular risk factors” are at high risk for cardiovascular events.

An earlier trial of dronedarone in patients with relatively severe heart failure, called ANDROMEDA, was halted early when mortality in patients receiving the drug was found to be twice that seen in the control group.

Sanofi-aventis has alerted healthcare professionals to several reports of liver function test abnormalities and hepatocellular injury in patients treated with its atrial fibrillation drug dronedarone (Multaq). The Dear Healthcare Provider letter included two post-marketing case reports of acute liver failure that required transplantation, occurring at four-and-a-half and six months after the start of dronedarone therapy. The patients – both female and about 70 years old – had had normal hepatic serum enzymes before starting the drug.

In the letter, sanofi-aventis instructed healthcare professionals to tell patients to immediately report any symptoms suggestive of hepatic injury. According to the FDA, these include anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching.

Periodic liver enzyme tests, especially in the first six months of treatment, should also be considered, according to the FDA, although it is unknown whether such a strategy will prevent the development of liver injury.

Dronedarone’s prescribing information will be updated to include the guidance from the Dear Physician letter, and will be distributed after the FDA approves it. The agency confirmed that a warning about potential liver injury will be added to the drug’s label.

According to the FDA, from the drug’s approval in July 2009 through October 2010, about 492,000 prescriptions for dronedarone were dispensed and about 117,000 patients filled prescriptions at U.S. pharmacies.

The drug was approved with a Risk Evaluation and Mitigation Strategy to prevent use in patients with severe heart failure or in those with less severe heart failure who were recently hospitalized for the condition. Such patients had a doubling in the risk of death in a placebo-controlled study.

May 5, 2011

Bisphosphonate Use and Atypical Femoral Fractures

by Dr. Shezad Malik

According to a large European study published this week, Bisphosphonates, a class of drugs used to prevent and treat osteoporosis is associated with an unusual type of thigh fracture.

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According to orthopedic surgeons, they were seeing an increase in cases where are severe fractures in which the thighbone snaps in two. Last October, the federal Food and Drug Administration announced a change in labeling on the drugs to reflect the risk of atypical fractures in patients taking bisphosphonates.

In the current study, published in the New England Journal of Medicine, researchers analyzed data from all 1.5 million women in Sweden who were age 55 or older in 2008. They obtained X-rays of 1,234 of the 1,271 women with fractures and found 59 who suffered the more unusual kind of fracture.

The women with atypical fractures were also compared with 263 controls with fractures in a similar location. The researchers found that 78% of the women with atypical fractures took bisphosphonates, compared with 10% of controls.

Bisphosphonates, which include brands such as Actonel, Zometa and Boniva, are used mainly by post-menopausal women as a way to prevent fractures that are associated with osteoporosis. Some 36.5 million prescriptions were dispensed for the drugs in 2010, and total U.S. sales were more than $4.2 billion.

Bisphosphonates examples include: Alendronate (Fosamax), Etidronate (Didronel), Ibandronate (Boniva), Risedronate (Actonel), Zoledronic acid (Reclast).

Per Aspenberg, a professor of orthopedic surgery at Linköping University in Sweden and a co-author of the study, said the findings indicated a patient’s risk of fracture diminished by 70% after stopping the drugs for a year. Aspenberg noted that if a person has taken bisphosphonates for five years, they could stop taking the drug and its protective effect will last for at least another five years as the risk for atypical fractures decreases. Given this finding, Aspenberg thinks patients should take a drug holiday after five years.

April 4, 2011

Houston Texas Pain Pill Mill Doctor Busted Again

by Dr. Shezad Malik

As a Dallas Medical License Defense Attorney, I am providing this article regarding a Houston Pain Pill Mill Doctor being busted again. It looks like this guy and his cronies did not learn their lesson. This is a quick fire way to lose your medical and pharmacy licenses.

A physician and two pharmacists arrested in a Houston high-volume pill mill operation, had previously faced disciplinary probes for distributing controlled drugs, and all three had been allowed to continue to work despite those allegations, according to professional disciplinary records.

For two years Dr. Gerald Ratinov, the state’s top prescriber of the pain killer drug hydrocodone, has been under investigation by the Texas Medical Board (TMB) for operating another Harris County pill mill. At that site, an unlicensed foreign medical graduate dispensed drugs and patients received pain pills without proper examinations in 2008.

During the TMB disciplinary action, Ratinov, a 76-year-old neurologist, opened the Astrodome Health Clinic in September 2010 — another site described as a pill mill, according to the Drug Enforcement Administration. And at that clinic and two other sites, he supervised unlicensed foreign medical school graduates and others who illegally supplied pills.

Ratinov now faces felony charges for illegally operating three pill mills: the Astrodome Health Clinic, The Abundant Life and Weight Loss Center and the Hobby Medical Center.

20 people face charges resulting from this week’s pill mill sting, which involved three clinics and four pharmacies. The DEA, the Department of Public Safety, the medical and pharmacy boards and other agencies participated.

Two pharmacists arrested this week already had been on probation with the state Board of Pharmacy for previous prescription problems, according to Pharmacy Board records.

March 21, 2011

Denton Texas Medical Doctor License Suspended Over Sex Assault Allegations

by Dr. Shezad Malik

As a Fort Worth Medical Practice Attorney, I want to share this Texas Medical Board bulletin, regarding a Denton, Texas doctor’s fitness to practice medicine. A Denton County doctor who is quoted saying he does “what is best for the patient” is now considered “a continuing threat to the public welfare.”

Medical Board Suspends License of Denton Physician

On March 14, 2011, a disciplinary panel of the Texas Medical Board temporarily suspended, with notice, the medical license of Ramon A. Cruz, M.D., of Denton, after determining that Dr. Cruz’s continuation in the practice of medicine constitutes a continuing threat to the public welfare.

The panel found that Dr. Cruz, Lic. No. K3703, engaged in sexually inappropriate behavior with several patients. Four incidents, including an alleged sexual assault, were reported by patients to Denton Police. Patients reported four incidents to Denton police, including one alleged sexual assault.

His accusers say he used “aggressive behavior” toward them dating back to 2008, but no action was taken until this week. Documents reveal one patient accused Cruz of putting “his hand down the front of her pajama pants.” Another patient alleges the doctor was “grabbing her from behind and putting his hand under her shirt.”

Since the suspension, four additional women contacted police saying they also were victims of Dr Cruz, who touched them sexually and made inappropriate remarks, according to police reports.

One woman described three occasions when she either was in his office or in a hospital room. She said on one occasion she was hospitalized and drowsy on pain medication when he came into the room, lifted the sheet to look at her body and then leaned over and kissed her, according to the police report.

Another woman reported to police that he kissed her and made sexual comments to her during two visits to his office in September 2009.

A third woman said that during 2003 and 2004, when she was his patient, he tried to kiss her and touch her, a police report states.

The fourth woman reported to police she was hospitalized when he touched her and kissed her against her wishes.

Most of the women who have reported the doctor’s behavior so far have said they did not report it because they thought no one would believe them.

The panel found that Dr. Cruz’s actions demonstrate a pattern of inappropriate behavior, which is a continuing threat to public health and safety. The suspension remains in effect until the Board takes further action.

January 16, 2011

Sheriff Charged in Texas Nurse Whistle-Blowing Case

by Dr. Shezad Malik

A Fort Worth Nurse license attorney, I am providing the latest update to a story I had commented on involving 2 nurses in West Texas.

A state grand jury in Winkler County, Tex., has indicted the sheriff, the county attorney and a hospital administrator for their roles in orchestrating the prosecution of two whistle-blowing nurses after they had reported allegations of malpractice.

The sheriff, Robert L. Roberts Jr., and county attorney, Scott M. Tidwell, each face six counts, including misuse of official information and retaliation, which are third-degree felonies. Stan Wiley, the administrator of Winkler County Memorial Hospital, in the West Texas town of Kermit, was indicted on two counts of retaliation.

Read full story here at the New York Times.

November 10, 2010

Texas Medical Board Disciplines 77 Doctors

by Dr. Shezad Malik

As a Fort Worth Texas Medical License Defense Attorney I am writing to update the following actions by the Texas Medical Board.

The Texas Medical Board met October 28-29, 2010. Since its August 26-27 board meeting, the Texas Medical Board has taken disciplinary action against 77 licensed physicians. The actions included 11 violations based on quality of care; 9 violations based on unprofessional conduct; 4 based on other states’ action; 1 based on peer review actions; 1 based on criminal convictions; 8 voluntary surrenders; 1 suspension; 3 revocations; 10 based on inadequate medical records; 1 based on inadequate supervision; 18 corrective orders; 1 cease and desist order; and 10 orders for minor statutory violations.

If you have been subjected to a TMB Inquiry Letter or TMB Disciplinary Process, then please contact the Fort Worth Texas Medical License Defense Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 214-390-3189 or Contact Me Online.

November 4, 2010

Houston Medical License Attorney

by Dr. Shezad Malik

Houston Physician Services & Professional License Defense

Having worked in both academic teaching hospitals and private hospitals through out the United States, Dr. Malik understands, perhaps better than most, the hard work and effort it takes to achieve the medical license and then to maintain it. Dr. Shezad Malik Law Firm concentrates in the representation of physicians and medical professionals in all matters relating to their professional license defense.

We focus on:

November 3, 2010

Austin Medical License Defense Attorney

by Dr. Shezad Malik

Texas License and Medical Staff Privileges

We provide Medical License Defense for all types of medical practitioners. We represent and counsel health care provider clients in licensure and medical staff privilege matters. We handle matters on behalf of physicians, dentists, pharmacists, podiatrists, chiropractors, nurses and other licensed health care providers in Texas and other states.

For a health care provider there can be serious consequences of State licensing actions or hospital adverse actions including criminal actions, actions by other states or hospitals, negative reports to state and national data banks and to third party payors.