An article in this week’s New England Journal of Medicine, entitled “A Pivotal Medical-Device Case” raises an important issue about the fairness of our civil justice system. Here is the link to the article.
http://content.nejm.org/cgi/content/full/358/1/76?query=TOC.

The issue raised by the article is not a new one, but the Defendant is asking the the United States Supreme Court to give broad and sweeping new protection to companies who manufacture defective and dangerous medical devices, even if those devices kill or seriously injure patients. The case discussed in the article is Riegel v. Medtronic, in which the patient was seriously injured because the balloon utilized in a coronary angioplasty surgery ruptured. The Plaintiff in the lawsuit claims that the balloon device was defective. The legal issue is now whether the injured patient is deprived of a legal remedy simply because the Food and Drug Administration had approved the device for use.

The history of medical device liability in this country is not generally known to the public. Some remember the Dalkon shield cases of the 1970’s, in which thousands of women either died or were seriously injured as a result of defective IUD devices. Following those cases, Congress gave the FDA authority to regulate the design and approval of medical devices. Yet, an injured patient has still retained the right to access to the justice system if injured by a defective product, even though the FDA has approved the product. The question before the Supreme Court in Riegel is whether the intent of Congress in granting such authority to the FDA, was to completely remove from the justice system the ability to adjudicate cases claiming that a medical device is defective. So, ask yourself if you would like for the FDA, with all of its political ramifications and lobbying influence, to determine whether an injured patient can have access to the justice system.

Recent news has pointed out the influence of pharmaceutical and medical companies, and their lobbyists, on the FDA approval process and on doctors’ decisions regarding drugs and medical devices. http://www.americastunnelvision.com/editable/medication_error.html. The Supreme Court is now considering whether that influence, with all of its attendant dangers, will deprive patients injured by medical devices of their day in court. Although this case has not received the coverage it deserves in the press, it is vitally important for the rights of injured patients.

Michael Townes Watson, author of America’s Tunnel Vision—How Insurance Companies’ Propaganda Is Corrupting Medicine and Law. www.StopMedicalError.com.

By his count, Dr. Douglas A. Dorsay has performed nearly 2,000 angioplasties, a procedure where a surgeon threads a catheter through the bloodstream to clear blockages.

By state officials’ count, he did so flawlessly — until one morning in March 2006.

The Florida Board of Medicine disciplined Dorsay in August for his surgical error. He was one of six Southwest Florida doctors, and 73 statewide, with cases before the body in August.

What makes him different is that he is willing to talk about it.

The Sarasota vascular surgeon said he agreed to discuss his case in depth with the Herald-Tribune because both doctors and the public harbor misconceptions about medical errors.

“I’m not trying to hide from it,” Dorsay said. “All of us have made mistakes.”

State records show about 40,000 active, licensed physicians in Florida. Some 1,750 had at least one disciplinary action. Hundreds more have lost their licenses, given them up or moved out of state.

Experts say that countless more errors and near-misses never get reported to state medical boards. Doctors and hospitals worry that disclosing their errors will draw lawsuits and drive away patients — fears that are unfounded, some studies have found.
 

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The doctor walked into the hospital room with a discomforting mission. He was there to admit a medical mistake and apologize to his patient, a woman with breast cancer.

The staff had given her the same injection twice by accident, causing her white cell count to soar, said Dr. Divyesh Mehta, chief of oncology at the University of Illinois at Chicago Medical Center. He recommended she stay in the hospital an extra day or two.

“This is our responsibility, and we are very sorry for it,” Mehta said, recalling the conversati

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For the first time, organizations that represent medical institutions are developing policies to bring an end to medical secrecy in Canada, eventually making disclosing medical errors a routine part of medical care.

Ontario leads the way, with changes to legislation moving through the Legislature that will make the records of all health professionals available to the public.

Patients will be able find out if a physician is under investigation, has been accused of medical malpractice or professional negligence, and whether disciplinary action has been taken against a care provider or limits placed on a physician’s licence.

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Healthcare reform and providing care for uninsured patients are the leading concerns of medical students across the nation. Students also report extensive experience with healthcare technology and believe it will have the greatest impact on improving patient care. Results of the second annual Future Physicians of America survey released today, which was conducted by Epocrates, Inc., and Gerson Lehrman Group, Inc., captures the opinions of 1,000 medical students.
These future physicians are ready to see change in the U.S. healthcare system, from insurance coverage to technology use.

Wrong-site surgery data received by the Patient Safety Authority shows that every other day in Pennsylvania healthcare facilities an actual adverse event or near miss of a wrong-site surgery occurs. The Authority released its 2007 June Patient Safety Advisory containing the data in a press conference held in Harrisburg today.
“To be frank, wrong-site surgeries in Pennsylvania should never occur. However, every other day in Pennsylvania we have a report of a wrong-site surgery being caught either before or after the start of an operation,” said Dr. Stan Smullens, chief medical officer of the Jefferson Health System and vice-president of the Patient Safety Authority Board of Directors. “However, we are not alone. Wrong-site surgeries are no more common in Pennsylvania than they are in other states. We also have in common with other states the problem of trying to fix them.”
In a 30-month time period (June 2004 - December 2006) the Authority received 427 near misses and serious events of wrong-site surgeries. Of those, 253 were near misses or did not reach the patient.
“Of those events that reached the patient in the operating room, sixty- nine percent were wrong side surgeries, fourteen percent were wrong body part surgeries, nine percent were wrong procedure and eight percent were wrong patient,” added Smullens. “The most common sites where the wrong-site occurred were extremities, eyes and spine. Orthopedic and ophthalmologic procedures were the most common for wrong-site surgeries.”

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In health-care circles surgeons have long been regarded as rock stars. They’re viewed with awe by patients and treated with deference by hospital staff. But surgeons, like some temperamental guitarists, might do well to improve their interpersonal skills.

Evidence is mounting that surgeons’ failure to communicate with patients and co-workers is a leading cause of avoidable surgical errors. A recent analysis of 460 malpractice claims that had been resolved found that nearly 20% of them were filed largely, if not entirely, because of communication breakdowns. The sobering results appear in the current issue of the Journal of the American College of Surgeons.

A group of 40 surgeons who reviewed the claims found that surgeons frequently failed to listen to patients, nurses and family members. Surgeons also missed chances to pass along information that might have prevented errors. And they often neglected to solicit information from others—hoping that all was well rather than probing for evidence to the contrary. “This was an effort to be really critical of ourselves and look at the common threads in the worst cases where surgeons have gotten into trouble,” says Thomas Russell, executive director of the ACS, which funded the study.

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CBS’ “Evening News” on Tuesday profiled Donald Berwick, president and CEO of the Institute for Healthcare Improvement, who is leading a campaign to reduce medical errors in hospitals. More than 3,000 hospitals are participating in the campaign, which aims to reduce hospital-acquired infections, medication errors and other adverse events through standardized safety, communication and sterilization procedures. According to Berwick, between 44,000 and 98,000 U.S. residents die annually as a result of care they received in hospitals. He said, “You need to build a hospital like you build an airplane, so that everything works right, and that there’s a kind of automatic excellence in the system instead of … relying on human effort.” Berwick said the campaign also helps hospitals reduce costs. He added, “A lot of people ask, how can you afford to improve? And the answer is, you can’t afford not to.” The segment also includes comments from Brian Koll — director of infection control at Beth Israel Medical Center, which is participating in the campaign — and a patient at the hospital (Couric, “Evening News,” CBS, 2/6).Become one of the Thousands Who Have Now Discovered Insurance Company Secrets, even though they Never Thought They Could. We will pay for the shipping –click here:
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