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Doctor Faces Manslaughter Charges in Death of Abortion Patient

Kyle Bachus — Tue, 22 Jul 2008 17:59:39 GMT

In a rare move, a Cape Cod grand jury indicted Dr. Rapin Osathanondh on a charge of manslaughter, following the October 13, 2007 death of 22-year-old patient, Laura Hope Smith. While, as Dan Slater noted, “it’s rare that even the most egregious instances of medical malpractice qualify as crimes,” Cape Cod District Attorney Michael O’Keefe told the Boston Globe that during Smith’s surgery, an abortion, “there was an inattention to the kinds of procedures of a lifesaving nature that one would expect in a place where an operation with anesthesia is being performed… There was nobody monitoring her, long enough to result in her death. There were a number of other shortcomings that make up the willful, wanton, and reckless conduct."

The litany of allegations brought by the Massachusetts Board of Registration in Medicine, claim that among these other shortcomings, Osathanondh failed to have someone present to administer and monitor sedation or to assist in resuscitative measures, failed to monitor Smith’s blood pressure, pulse, or heart rate or have oxygen available, failed to timely initiate a 911 call, and “failed to adhere to basic cardiac life support protocol.” Osathanondh is also alleged to have lied to the Board by stating he administered oxygen to Smith and monitored her pulse, that he and the other staff member present were ACLS certified, and that the procedure took place in a different, better equipped room. He is also alleged to have "fraudulently obtained renewal of his medical license by providing false information."

Osathanondh, a Harvard School of Public Health research associate who apparently left a previous hospital “under a cloud of threatened nurses,” is expected to plead not guilty. His attorney told the Globe that “this is a tragedy that sometimes happens in medicine, but it happens; patients die inexplicably in the course of even routine procedures . . . . This is not a matter that belongs in the criminal courts."

Whether it does or not is an extremely close call. That Osathanondh committed malpractice seems to be clear, but where’s the line between medical malpractice and criminal activity? As noted in the comments section at the Wall Street Journal’s legal blog, some facts regarding the type of anesthesia aren’t clear, neither is whether he is charged with voluntary or involuntary manslaughter. Other questions that come to mind: what differentiates this doctor’s conduct from similar egregious forms of medical malpractice? Did the fact that Smith’s death occurred during an abortion play any role in the decision to prosecute? Is the level of care generally lower for these types of procedures? The conclusion that this young woman’s tragic death was avoidable, however, is unquestionable.

Thomas Connell

Summer Intern 2008

J.D. Candidate 2010

University of Colorado

Originally posted at InjuryBoard by Kyle Bachus

Half of Doctors in U.S. Report Medical Errors

Linda Snyder — Fri, 07 Dec 2007 15:28:00 GMT

Recently, researchers found that only half of all U.S. doctors report medical mistakes or unethical colleagues.

Only 46 percent of physicians surveyed stated that they knew of a serious medical error and didn't report it.

The U.S. Institute of Medicine surveyed more than 1,600 physicians in 2003 and 2004; only 31 percents had undergone a competency review in the past three years. About 98,000 people die every year as a result of medical errors in hospitals.

Dr. James Thompson, the chief executive officer of the Federation of State Medical Boards stated that state medical boards don't have their own team of investigators and most are underfunded and understaffed. State medical boards only react to complaints.

In 2005, the National Practitioner Data Bank reported that there was 135 medical malpractice payment reports were made against physicians in Colorado.

For more information on this subject, please refer to the section on Medical Malpractice.

Originally posted at InjuryBoard by Linda Snyder

Longer Stays in Hospice Cause Financial Problems

Linda Snyder — Tue, 27 Nov 2007 11:47:11 GMT

Numerous hospice providers nationwide are facing financial problems due to their patients living longer than expected. You would assume this would obviously be a positive development, yet the effects on hospices' aren't.

Over the last eight years, the federal government has had to demand that hospices exceeding reimbursement limits repay hundreds of millions of dollars to Medicare.

A 2006 report concluded that Medicare spent $6.7 billion on hospice care in the year 2004.

When the Medicare hospice benefit first went into act in 1983, it was designed for patients who were expected to live six months or less. Most of these patients were cancer victims. In recent years, hospice use has increased dramatically for a wider realm of patients with illnesses from Alzheimer's disease and dementia. This has cause the average stay of patients in hospice to rise to 86 days.

The Medicare Payment Advisory Commission, who analyzes Medicare issues for Congress, stated that 220 hospices (one for every 13 providers) had received repayment demands totaling to $166 million.

Medicare's spending on coverage of hospice has tripled from the years 2000 to 2005 to $8.2 billion and 40 percent of Medicare recipients now use this service.

A cap on how much hospice providers can be reimbursed each year cannot exceed the number of patients it serves and a pre-patient allowance has been set by the government each year. The longer lengths of stays have proven to cause problems with the cap, hospice's finances and even shutting down some facilities.

It has been almost 25 years since the Medicare hospice benefit has been in effect and it is about time that lawmakers make a revision, otherwise more hospices may face closing. Hospices remain to be extremely cost-effective for patients when you compare the average daily stay in a hospital to $5,036 and in hospice, $136.

Originally posted at InjuryBoard by Linda Snyder

New bill to help health care workers

Staff Writer — Tue, 06 Feb 2007 11:03:06 GMT

An interesting article in The Denver Post yesterday addresses administrative problems in hospitals that could be to the detriment of health care workers and patients, possilby leading to medical malpractice.

The article tells the story of a hospital cleaning crew supervisor who was fired after repeatedly asking for more staff members to help them do a better job. Nurses and others complained that they were not doing an adequate job of cleaning, while the workers said they did not have enough people to get the job done.

Rep. Morgan Carroll, D-Aurora, is proposing a new bill to the Colorado Legislature protecting health care workers for whistle-blowing. There are currently no OSHA standards in place for these issues. On Thursday, the bill passed the House Health and Human Services Committee.

Originally posted at InjuryBoard by Staff Writer

FDA Announces Recall of Certain Welch Allyn Automated External Defibrillators

Staff Writer — Mon, 31 Jul 2006 18:39:27 GMT

The US Food and Drug Administration (FDA) and MRL, Inc (a Welch Allyn company), recently notified healthcare professionals about the class 1 recall of 1184 automated external defibrillators ([AEDs] Welch Allyn PIC 50, catalog #97108X) manufactured during February 2002 to October 2004; 673 units were sold within the United States.

The recall occured because of an electrical contact problem that may result in the device's failure to provide a defibrillation shock, leading to delay or failure of resuscitative efforts. According to the recent alert from the FDA's safety information and adverse event reporting program the device malfunction may be accompanied by various error messages (eg, "Defib Comm") on the display panel.

To date, 18 cases of device malfunction have been reported, corresponding to 1.5% of the recalled devices; patient resuscitation was delayed in 2 instances. The company noted that many Defib Comm errors are transient, and most are detected by an automatic self-test upon unit start-up. To eliminate the risk for resuscitation failure, devices that display the error message should be serviced before further use.

Free loaner devices are being made available for use during servicing of malfunctioning units. All costs associated with shipping, handling, and replacement of the units' "DEFIB" board will also be covered by the company. Additional information concerning the recall may be obtained by contacting the company at 1-800-462-0777 or 1-847-520-0300.

Originally posted at InjuryBoard by Staff Writer

Court Denies Medtronic's Motion for Summary Judgement

Staff Writer — Fri, 15 Dec 2006 10:37:54 GMT

Defibrillator manufacturer Medtronic asked the US District Court of Minnesota to consider a motion for summary judgement. Their request was based on the claim that federal preemption barred the plaintiffs' claims. The plaintiffs' main complaint sites state law product liability claims sounding in negligence and strict liability. Other claims include violations of state Consumer Protection Statutes, violations of Minnesota false advertising and deceptive trade practices statutes, and misrepresentation by omission. The plaintiffs' seek damages for personal injuries that resulted from their use of Medtronic devices.

The Supremacy Clause of the US Constitution establishes the premise for federal preemption. The clause indicates that any state law conflicting with a federal law or regulation is preempted. Any court considering a preemption challenge is not to pass judgement on the state policy's reasoning, but rather must decide if the policy conflicts with or stands in the way of the purpose and execution of a the federal law.

After thoroughly investigating Minnesota state law, FDA approval requirements, evidence brought forth by the plaintiffs, and other preemption cases, the US District Court of Minnesota found Medtronic failed to show that the plaintiffs' claims were preempted by federal law. Medtronic's motion for summary judgement was denied on November 28, 2006.

Originally posted at InjuryBoard by Staff Writer

Medical Errors and Death in Hospitals

Staff Writer — Fri, 21 Apr 2006 20:36:47 GMT

A recent study by HealthGrades indicates that the most serious problem in U.S. hospitals is medical error. This study ranked hospitals in New York, New Jersey, Nevada, Tennessee and the District of Columbia as those ranking lowest in patient safety.

For more information about the medical errors study...

Originally posted at InjuryBoard by Staff Writer

Medtronic Fails to Warn Public of Malfunctioning Battery

Staff Writer — Fri, 15 Dec 2006 10:30:57 GMT

According to Medtronic's website, "Medtronic is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world." Medtronic manufactures cardiac resynchronization therapy defibrillators (CRT-D's) and implantable cardioverter-defibrillators (ICD's). These devices are used on patients with heart conditions and are surgically implanted into the chest. ICD's work by monitoring a patient's heart rhythm and shock the heart when the rhythm becomes abnormal to regulate the patient's heart. CRT-D's work in a similar fashion by sending electrical pulses to the heart under failure conditions.

On February 11, 2005, Medtronic released a public advisory warning physicians and users of a malfunctioning battery found in some of their ICD and CRT-D models. The faulty batteries rapidly deplete because of a shortening mechanism found in the batteries. Medtronic reported that less than .5% of the batteries tested had this shortening mechanism, but that the mechanism can cause a loss of function in the devices. A loss of function can cause serious injury to the device's users but no patient injuries or deaths were reported at the time of the public advisory release.

Although Medtronic fulfilled its obligation to inform healthcare providers and users with information regarding their products' potential risks and faults, court records show that Medtronic discovered the shortening mechanism in their batteries in early 2003 during routine testing. The FDA requires that a manufacturer must submit a report to the FDA "no later than 30 calender days" after it "become[s] aware of information, from any source, that reasonably suggests that a device [it] markets has malfunctioned and this device . . . would be likely to cause or contribute to a death or serious injury." Despite their knowledge of the malfunctioning battery, Medtronic waited over 2 years to report their findings to the FDA. Medtronic's faulty battery has led to several law suits against the company with plaintiffs seeking damages for personal injuries that resulted from their use of Medtronic's devices.

Originally posted at InjuryBoard by Staff Writer

Defibrillators and Pacemakers

Staff Writer — Mon, 02 Oct 2006 20:51:57 GMT

On September 29, 2006, The Heart Rhythm Society (HRS) finalized recommendations for revising the system used by industry, regulators and clinicians to monitor and publicize implantable-device performance problems. Key goals of the recommendations include:
â€¢ improved recognition of potential device malfunctions
â€¢ postmarket surveillance and reporting of any problems
â€¢ communication among industry, federal agencies, clinicians and patients
This document is one of several fixes to the system used by device companies and the US Food and Drug Administration to track and respond to malfunctions in pacemakers and implantable cardioverter defibrillators (ICDs). The shortcomings of the present system were widely criticized in 2005 after a highly publicized recall of Guidant ICDs with potentially fatal design flaws; Guidant was criticized, too, for how they responded to the recall. Even though the company reported the problems to the FDA, they did not promptly inform clinicians and the public.

The final HRS document is essentially unchanged from the April 2006 draft. The guidelines have been published online and are scheduled for publication in the October 2006 issue of the society's journal Heart Rhythm.

Originally posted at InjuryBoard by Staff Writer

FDA Warning to Medtronic on Defibrillators

Staff Writer — Fri, 29 Sep 2006 19:17:34 GMT

The FDA issued a warning to Medtronic, Inc. on Friday, September 29, 2006 regarding the delayed filing of a post market surveillance interim report on the AneuRx Stent Graft System. According to Medtronic, Inc. the letter is not related to the quality, design or manufacture of the product. However, the purpose of the Postmarket study is to make sure the device is appropriately labeled for use in designated patient populations and to confirm the necessary training and experience for users of the device which is used to treat patients suffering from life-threatening Abdominal Aortic Aneurysms. The System was commercially approved in 1999 and the interim postmarket surveillance report, initially issued in 2002, has been filed on an annual basis until now.

The FDA has issued alerts and recalls affecting more than 337,000 defibrillators since 1990. There has been a reduced market for defibrillators since that time and a reported 8% decrease in the last 12 months.

Originally posted at InjuryBoard by Staff Writer