Articles Posted in Hospital Deaths

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State and federal lawsuits filed last week in California are seeking to change current legal thinking and make it harder for medical device makers to avoid responsibility for defective products. According to an analysis published in the Wall Street Journal the suits “could challenge the broad liability protection that medical device makers have enjoyed since a key Supreme Court ruling in 2008.”

The target of the suits is St. Jude Medical, the maker of the Riata line of defibrillators. According to the Journal, the plaintiffs in the suit claim “that problems with the manufacturing and oversight of Riata defibrillator ‘leads’ injured or killed more than 30 patients. Faulty leads, which connect the heart to defibrillators that zap irregular heart rhythms back to normal, caused the devices to fail or needlessly deliver blasts of electricity, the suits allege.”

It might seem obvious that here in Oregon, in Washington or anywhere else in the country companies have an obligation to ensure that the products they sell are safe and function properly, but manufacturers of unsafe medical devices gained unprecedented liability protection via the Supreme Court’s 2008 Riegel v Medtronic case. That ruling, as the Journal reports, granted medical device makers immunity from state unsafe product liability laws on the grounds that medical device safety is a federal issue.

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An editorial published last month by the New York Times raises important questions about the legal and moral responsibility medical device manufacturers have, or ought to have, concerning their products.

The newspaper focused on all-metal hip implants in general and the actions of DePuy Orthopaedics in particular. DePuy is a division of pharmaceutical and medical supply giant Johnson and Johnson. The paper writes that “about 93,000 patients around the world” received DePuy’s all-metal Articular Surface Replacement (ASR) model hip implant until it was recalled in 2010. However, the paper notes, “documents show that as early as 2008 DePuy executives were told by a number of surgeons, including its own consultants, that the device appeared flawed.” The article goes on to note: “That was never disclosed to doctors who were putting the device into patients, nor were other unfavorable internal studies.”

In response DePuy’s president wrote to the Times this week to take issue with the editorial, noting that the ASR had been approved by federal regulatory authorities and that when data indicated that numerous patients were requiring early replacement of their implants the company “recalled the product and immediately supported patients with a reimbursement program for their medical costs.”

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An Oregon wrongful death lawsuit filed recently in Chiloquin raises new questions about the conduct of an area children’s center that has had a rocky relationship with state and local authorities.

According to the Klamath Falls Herald & News, the Oregon wrongful death suit against Kleos Children’s Community and the Klamath County Department of Human Services alleges that “a wheelchair-bound 14-year-old placed at Kleos under the directive of DHS died as a result of complications from two bilateral fractures to both femurs” as a result of a November 2010 accident.

The paper and local television station KOBI report that the suit claims that DHS was negligent in placing the child at a facility that, it says, could not properly address his “medical and physical needs.” The newspaper reports that the suit claims that Kleos was negligent in its treatment of the boy – both in initiating the actions that resulted in the accident, and, later, in its treatment of him following the incident. The boy died a day after suffering the two broken legs “when two employees of Kleos dropped him while trying to move him from his wheelchair to a new location.”

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A lawsuit recently filed in Salem charges both doctors and prison officials with the Oregon wrongful death of a Salem man in 2010. The suit was filed by the alleged victim’s mother, according to a report in the Salem Statesman-Journal.

According to the newspaper, her son, Robert Haws, was a pre-trial detainee two years ago this month “when he got into an argument with another inmate.” The other inmate attacked Haws “hitting his head on concrete and knocking him unconscious. He died at the hospital after undergoing brain surgery and lingering for days on life support.”

At issue are “the hours following the fight and the lengthy delay in treatment for Haws’ injuries,” according to the Statesman-Journal. Haws’ mother believes that the jail staff did not give her son the attention he needed in the minutes and hours immediately after the fight. It also alleges that once Haws reached the hospital doctors treated him as if he were a patient coming down from a drug overdose despite significant evidence that he needed urgent treatment for an Oregon head trauma.

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One might have thought that when considering health policy the safety of hospital patients would be just about everyone’s top priority – medical professionals and legislators (and, of course, patients themselves) alike. After all, there are few areas of our lives in which we base crucial decisions to the judgment of others more than in the realm of health care. Yet as it considers Governor John Kitzhaber’s health care reform bill Oregon’s legislature is not only ignoring simple remedies that could lower costs even as they improve the quality of care in our state, it is also threatening to leave the poor outside the system, with no way to obtain justice when doctors, hospitals and nurses fail to deliver the care patients deserve.

It is distressing to see Oregon’s legislature spending too little time addressing patient safety issues as it considers health reform. As a recent article in The Oregonian notes, the cost savings offered by the proposed legislation lie mostly in the future. Broadly speaking that is good – one of the few things that liberals and conservatives agree on these days is the fact that rising medical costs represent a significant long-term budget problem at both the federal and state levels (how that problem should be addressed is an issue that elicits far less agreement). But as nationwide surveys that have been around for quite some time have shown, there are a number of basic fixes that can be implemented more-or-less immediately which will both reduce costs and improve patient safety.

Even more distressing, however, are aspects of the proposed law that would make it difficult or impossible for patients injured by negligent doctors to defend themselves in court. Under the current version of the legislation, strict limits would be placed on the ability of patients covered under Medicaid or the Oregon Health Plan to seek justice for their injuries at the hands of negligent providers. The result would be to create a two-tiered system of responsibility and accountability, one in which – to use an extreme example – a doctor who amputated the wrong limb of a patient with private insurance would be held accountable for his horrific mistake, but would receive no sanction if the patient in question was too poor to afford private coverage.

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It is one of the things we all most fear – and over which we have the least control – when entering the hospital: preventable errors. Recently, Portland’s main newspaper has been reporting on an equally disturbing problem related to preventable errors and Oregon medical malpractice: the fact that because some of the reporting hospitals do regarding their mistakes seems to be coming up short. As a result, there is not as much data available to doctors and medical administrators as there should be. That, in turn, may mean that some hospital errors are going unaddressed because word of them is not making its way through the state health system.

The issue was brought to light by a recent article in The Oregonian. The paper noted that “at least 34 patients died as a result of preventable mistakes in Oregon hospitals last year.” The real issue, however, is that fully one-third of Oregon’s hospitals “chose not to report a single error in 2010.” As the paper notes, “this strains credulity.”

Hospital reporting is an issue I’ve addressed before – and one that should command a lot more public attention than it does. It is, of course, natural that few people like to acknowledge error, but when reporting data could lead to better procedures and, eventually, a drop in Oregon hospital deaths we have entered a realm where pride has no place.

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The US Supreme Court heard arguments this week in a case that raises important issues about personal privacy, patients relationships with their doctors and what some see as corporate America’s right to see people’s personal data because doing so may aid their marketing efforts.

According to the Burlington Free Press, the case turns on “a Vermont law that restricts the use of doctors’ prescription records for marketing purposes.” Pharmaceutical companies have challenged the law, arguing that they need to know which doctors are prescribing generic as opposed to brand-name drugs so that they can target their marketing to doctors who, they feel, should opt for generic medicines less often. The Free Press reports that 35 states, the District of Columbia, the US Justice Department and “organizations representing more than 100,000 physicians” back the law, while “numerous business and research groups, including the US Chamber of Commerce” oppose it. The measure went into effect last year. A Federal District judge upheld it, but was reversed by the 2nd US Circuit Court of Appeals.

From a patients’ perspective challenges to this law raise several potentially disturbing issues. As patients we presume our conversations with out doctors are private. It is unclear from the court arguments whether personally identifiable information is being shared with drug companies. Also, should patients have some right to know whether their doctor’s prescribing decisions were effected by a marketing hard-sell from drug manufacturers? Considering the number of scandals in recent years surrounding medical marketing these are very legitimate questions for patients to ask.

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Following up a story I wrote about in February, The Oregonian reports that federal regulators have cleared Portland Adventist Medical Center of wrongdoing in a high-profile case in which a man died of a heart attack in the hospital’s parking lot.

As regular readers will recall, 61-year-old Birgilio Marin-Fuentes suffered a heart attack as he drove into Adventist’s parking facility on February 10. He crashed his car into a wall, but lay in the vehicle unnoticed for more than 20 minutes despite the presence of surveillance cameras in the facility and the fact that the emergency room door was only a short distance away.

Police eventually arrived to help the stricken man. There is some dispute over how the hospital acted at this point. Some accounts say a police officer who ran to the emergency room was rebuffed by desk staff there and told the emergency needed to be telephoned in before hospital staff could respond – despite the emergency being on their own property. Hospital spokespersons have rejected that version of events. Martin-Fuentes died shortly after being moved inside the hospital building.

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A report released this week by the consumer watchdog organization Public Citizen raises serious questions about the conduct of state medical boards, according to an analysis published by the Los Angeles Times. The charges, in turn, raise broader questions about the conduct of hospitals and doctors and the prevalence in our health care system of doctors who are problematic at best. Here in Oregon it must make conscientious citizens wonder whether instances of medical malpractice or even wrongful deaths have been allowed to occur as a result of insufficient professional oversight.

As outlined by Public Citizen on the group’s website (see link below) the study examined 20 years of data (1990-2009) regarding doctors who have had “one or more clinical privilege actions,” meaning that they have had some or all of their hospital or emergency privileges withdrawn because of misconduct, incompetence or some other professional infraction. It then compared these numbers with the numbers of physicians sanctioned over the same period by state medical boards. The analysis yields a shocking result: nationwide, 55% of doctors disciplined by their hospitals suffered no further punishment from their state licensing board.

When thinking about the possible implications of this information for Oregon medical malpractice we can take some comfort from the fact that our state had one of the better records on this score. In Oregon, 41.48% of doctors who had some or all of their hospital privileges revoked over the study period suffered no state-imposed sanction. That number is obviously far too high, though it is better than what one finds in most other states (for comparative purposes: Colorado had the lowest rate of unsanctioned doctors at 31.63%; Hawaii was worst with a truly shocking 77.08%).

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A California nursing home has been ordered to pay the largest fines allowed under state law following the death of a patient. For us here in Oregon this nursing home neglect and abuse case, though it comes from out-of-state, serves as a powerful reminder of the important role courts and regulators play in keeping watch over those charged with helping vulnerable seniors.

According to a report in the Orange County Register the case stems from the death of 93-year-old Donald Bodkin, who, the paper reports, “died in September from an undetected ruptured intestinal ulcer and infection.” Bodkin was not a long-time resident of the home but, rather, had checked in only a few weeks earlier for a temporary stay while recovering from hip surgery.

The paper reports that the state believes the home did not assess Bodkin’s condition properly, failed to tell his doctor once the symptoms became obvious and ignored warnings from both family members and an occupational therapist “that he was lethargic and in pain.” The nursing home has expressed regret for Bodkin’s death but said in a statement that it does not believe the actions of any of its staff “caused or contributed to this unfortunate event.”

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