Personal Injury and Social Security Disability Blog

Hospital Fights Claims of Unnecessary Stents

Here's an interesting story out of Baltimore — a hospital admitted that one of its cardiologists unnecessarily placed stents in hundreds of heart patients. But now that some of those patients have retained lawyers, the hospital seems to be changing its story and may deny any negligence. At first thought you might say, so what if people got stents they didn't really need. After all, a stent is a simple device designed to keep an artery open. But people who do have stents usually have to take expensive blood-thinning medication, and may run increased risk of clotting in the future.

The situation was described in detail in the Baltimore Sun, and is an eye-opener for anyone who might need to go to a cardiologist. Here are excerpts from the article:

St. Joseph Medical Center has repeatedly said it wants to do right by its coronary stent patients.

After a complaint last year that star cardiologist Mark Midei was placing stents in the arteries of patients who didn't need them, the Towson hospital removed him from duty, reviewed thousands of medical records and sent letters to nearly 600 people whose stents appeared unnecessary, telling them to go see a doctor. When asked if the hospital bore any legal liability, CEO Jeffrey K. Norman replied: "I suppose we do."

But now that the lawyers have arrived, bearing the threat of hundreds of lawsuits, some say the message has changed. Even as some St. Joseph employees continue to suggest wrongdoing — including its chief of cardiology, who has told at least two patients that his former colleague falsified their records — the hospital's attorneys appear to be girding for a fight.

In its legal filings, the hospital said it "generally denies all allegations of liability." And medical malpractice attorneys preparing cases against St. Joseph say hospital lawyers are gathering experts to argue that Midei did nothing improper, despite the hospital having revoked his practice privileges.

After complaints about Midei were lodged by a patient early last year, reviewers for the hospital looked at X-ray images from the medical files of his stent patients to determine if their arteries had enough blockage — generally at least 70 percent — to justify the procedure. In many cases, they concluded that Midei had recorded significantly more blockage in written records than was revealed in the films, leading officials to send those patients letters.

For some of Midei's patients, even unnecessary stents might have improved their quality of life, at least for a time, by taking away heart pain caused by blockage that didn't meet the 70 percent threshold, cardiac specialists say. But those patients also must live with an increased risk of sudden clotting and other complications, the need to take drugs they otherwise wouldn't, and a general fear that something could go wrong at any point.

Toyota Recalls Corolla and Matrix Models as NHTSA Investigates Engine Stalls

The AP reports, "Toyota recalled 1.33 million Corolla sedans and Matrix hatchbacks in the US and Canada Thursday because their engines may stall," noting that this is one of the largest Toyota recalls since its safety crisis began last year. Meanwhile, GM "is recalling 200,000 Pontiac Vibes in North America due to the same problem, GM spokesman Alan Adler said. The Vibe is similar to the Matrix and was built under a joint venture between Toyota and GM at a now-closed factory in Fremont, Calif." The AP adds that NHTSA "has been investigating the possibility of engine stalling in the Corolla and Matrix models since late November."

Bloomberg News reports that NHTSA has said that the defect "could cause stalling 'at any speed without warning.'" The recall covers model years 2005 to 2008, and follows "at least three reported accidents linked to the defect. The action adds to record recalls in the past year by Toyota City, Japan-based Toyota, including more than 8 million vehicles worldwide for flaws related to unintended acceleration." Bloomberg notes that NHTSA "upgraded its investigation of the defect to an engineering analysis," last week, "a step that can lead the agency to demand a recall. The regulator said cracks in engine control units could occur if improperly cured coating was applied to circuit boards."

The New York Times notes that this is Toyota's 15th recall this year, adding that NHTSA opened its investigation into the issue in December. "On Thursday, Toyota attributed the problem to improper manufacturing of the vehicles' engine control modules, which allowed cracks to develop at certain solder points or in a protective coating on the circuit board. Dealers will replace the control modules, which were made by the Delphi Corporation, a process expected to take about 40 minutes for each vehicle, Toyota said."

From the American Association for Justice news release.

(In an unrelated note, I read that in Afghanistan, 90% of all automobiles are Toyota Corollas! There is a long explanation having to do with a reluctance to be seen in U.S. or European vehicles, and with the endurance of Corollas. Whatever the reason, that's an astonishingly high percentage for one model from one manufacturer.)

Friday Fun

Six Things From History Everyone Pictures Incorrectly

Texas to Require Insurers to Justify "Unreasonable" Premium Increases

Will Texas really start to crack down on insurance company abuses, or is this just more empty talk from the Texas Department of Insurance? An article in the Dallas Morning News this week quotes state officials as saying they will now question "unreasonable" rate hikes from insurance companies. This change is being forced on the state by new federal legislation.

In Texas, carriers can raise their rates by any amount (up to 50%), at any time, without having to get permission from the state. Not surprisingly, this system has led to large, frequent rate increases by some insurance companies. We can hope for change. Here are excerpts from the article:

The Texas Department of Insurance is about to change its longtime policy of allowing uncontested insurance rate increases of up to 50 percent without interference, officials said.

State regulators will require insurance companies to justify "unreasonable" premium rate increases under the new federal health care overhaul, the Austin American-Statesman reported. State officials say they have always had that authority but have used it sparingly, the newspaper reported.

"In the past, we've looked at rate increases above 50 percent, and we've looked at complaints. That's mainly what we've done as a watchdog," said Katrina Daniel, senior associate commissioner of the department's life, health and licensing program.

She said Texas lacks the resources, including staff and data, to perform regular rate reviews and comparisons.

However, under the new federal law, insurance companies will be required to justify to federal and state regulators "unreasonable" rate increases before imposing them. Companies also will have to post that information on their websites.

The federal government has yet to define what it regards as "unreasonable," Daniel said.

Last week, federal officials distributed $46 million of $250 million in grants to the states. The $1 million Texas received was expected to go toward developing data required for more rate reviews.

"We will be reviewing more rates, for sure," Daniel said.

Insurance companies have argued that rising health care costs have forced their rates to increase.

Compatibility of Hospital Tubes Creates Danger for Patients

I just wrote yesterday about hospital errors causing injuries and deaths needlessly. Now an article from the New York Times brings up a point that most hospital patients would never even consider — you can die because a nurse or aide hooks up your feeding tube to your medication IV, or vice-versa. The article is important reading for anyone about to enter a hospital or who has a friend or relative in the hospital.

The Times reported that "hundreds of deaths or serious injuries" have occurred due "to tube mix-ups" in hospitals. To prevent this problem, "experts and standards groups have advocated since 1996 that tubes for different functions be made incompatible." The failure to make the change is due to "resistance from the medical-device industry and an approval process at the Food and Drug Administration that can discourage safety-related changes." Dr. Kevin McBryde, an FDA reviewer, is among several agency employees who have argued that some of these tubes are unsafe, but was "overruled" by a supervisor. Meanwhile "an international standards group is seeking consensus on specific designs on how tubes for different bodily functions should differ, but the group has been laboring for years and its complete recommendations will take years more." Here are the opening paragraphs:

Thirty-five weeks pregnant, Robin Rodgers was vomiting and losing weight, so her doctor hospitalized her and ordered that she be fed through a tube until the birth of her daughter.

But in a mistake that stemmed from years of lax federal oversight of medical devices, the hospital mixed up the tubes. Instead of snaking a tube through Ms. Rodgers’s nose and into her stomach, the nurse instead coupled the liquid-food bag to a tube that entered a vein.

Putting such food directly into the bloodstream is like pouring concrete down a drain. Ms. Rodgers was soon in agony.

“When I walked into her hospital room, she said, ‘Mom, I’m so scared,’ ” her mother, Glenda Rodgers, recalled. They soon learned that the baby had died.

“And she said, ‘Oh, Mom, she’s dead.’ And I said, ‘I know, but now we have to take care of you,’ ” the mother recalled. And then Robin Rodgers — 24 years old and already the mother of a 3-year-old boy — died on July 18, 2006, as well. (She lived in a small Kansas town, but because of a legal settlement with the hospital, her mother would not identify it.)

Their deaths were among hundreds of deaths or serious injuries that researchers have traced to tube mix-ups. But no one knows the real toll, because this kind of mistake, like medication errors in general, is rarely reported. A 2006 survey of hospitals found that 16 percent had experienced a feeding tube mix-up.

Circuit Breaker Model is Defective and Potentially Dangerous

Here is a very short summary of a very important article from the Dallas Morning News. If you live in an older home in North Texas you need to check your circuit breaker box to make sure it's not a Federal Pacific Stab-Lok model. I checked ours, and we're safe, but if you do have one of these models you are in risk of losing your home to a fire. Read the article for details and go check your breaker box.

The Dallas Morning News reports on "Federal Pacific Stab-Lok, a type of circuit breaker in thousands of North Texas homes that is now widely thought by engineers, electricians and house inspectors to be defective – and dangerous." Concerns began to surface about the circuit breakers thirty years ago, but "after testing the devices for about two years, the Consumer Product Safety Commission said the government lacked sufficient data to warrant a recall." More recently, however, "engineers studying them independently have found that the circuit breakers can overload and cause fires." According to one expert, there may be as many as "20 million homes nationwide" that still use the Stab-Lok circuit breaker. "If your house was built during the '60s, '70s or '80s, it probably has one of these breakers. About 90 percent of houses we see from that time have them," said one inspector.

Preventable Errors Killed 32 Patients in Oregon Hospitals Last Year

This article from OregonLive.com is specific to Oregon, but I have no doubt that it would apply to the entire country, probably in proportion to the number of hospital beds in each state.

Hospitals are trying to improve their safety records, partly because of the work of medical malpractice trial lawyers, partly because of high insurance premiums, and of course partly because they do care about their patients. Still, as more than one doctor has told me privately "a hospital is a dangerous place for a patient." My personal doctors always recommend outpatient services when possible and hospitalization only when absolutely necessary because too many bad things can happen to a patient while in a hospital. Here are excerpts from this informative article:

At least 32 patients died as a result of preventable errors in Oregon hospitals last year, according to a report released Thursday by the Oregon Patient Safety Commission. The commission, created by the Legislature in 2003, represents a collaborative effort between the state and the health care industry to reduce serious medical errors. Fifty-six of Oregon's 58 hospitals are participating in the voluntary program.

Hospitals reported 136 incidents in 2009. In 22 percent of cases, patients suffered minimal or no detectable harm. But half of the incidents resulted in serious injury or death. In nine cases, a surgical team operated on the wrong body part or the wrong patient. Surgeons accidentally left objects in patients 21 times – despite the commission setting a target of eliminating this type of error.

Oregon hospitals made progress in three other patient safety targets set by the 17-member commission: establishing electronic medical records, adopting evidence-based safety practices, and promoting a workplace culture of safety. According to the report, 61 percent of Oregon hospitals have developed electronic medical record systems with built-in error checking and decision support, significantly more than the national average of 51 percent.

And 87 percent of Oregon hospitals met targets for giving surgical patients antibiotics on time, up from 75 percent compliance at the beginning of 2008. Oregon's performance is about equal to the national average on this measure, the report noted.

"There's lots to point to that says people are taking this serious," said Jim Dameron, administrator of the patient safety commission. "People are making a good faith effort to improve quality and make care safer for patients."

Reports of objects accidentally left in surgical patients have declined from a high of 50 in 2007, but the number has persisted at around 40 incidents a year since 2002, leading the commission to conclude that hospitals have not made meaningful progress in reducing such errors. "There is no indication that it's going down, which is frustrating," Dameron said. "Oregon is not unique there. It's a stubborn problem."

Another area of stalled progress is notifying affected patients in writing about every serious adverse event. Doing so is a requirement of participating in the patient safety program. Last year, hospitals provided written notification about half of the time, 43 out of 80 cases in which it was required, according to the commission's report.

"Most hospitals do a pretty good job of oral disclosure, but clearly they don't do the written notification," Dameron said. Diane Waldo, a registered nurse and director of quality and clinical services for the Oregon Association of Hospitals and Health Systems, said hospital leaders worry that written notifications could alienate patients.

"They've made a big effort to address this and meet with patients and families," Waldo said. "They believe a letter could be received as cold and wonder, is it helpful at all to the relationship?"

It's possible that hospital leaders are concerned about exposing their institutions to greater legal liability.

Eight hospitals have shown that compliance is possible. They've notified patients of adverse events in writing for every serious harm event since reporting began in 2006, according to the commission.

The reporting system may underestimate the extent of preventable errors. For instance, hospitals reported eight health-care-associated infections to the commission last year -- far less than the number identified in the state's independent infection reporting program. Among intensive care patients alone, that program identified 75 central-line-associated blood stream infections. The patient safety commission asks hospitals to report "serious harm" infections only, which could account for part of the discrepancy. But the commission asserts that hospitals probably underreport serious infections in the patient safety program.

Bill Introduced to Provide One-Time $250 Payment to SS Recipients

The Chairman of the House Ways and Means Social Security Subcommittee, Rep. Earl Pomeroy (D-ND), has introduced H.R. 5987, The Seniors Protection Act of 2010, that would provide a one-time $250 payment to retired and disabled Social Security and SSI beneficiaries (and to veterans) if there is no cost-of- living adjustment (COLA) announced for 2011.

Any COLA for 2011 will be determined in October by comparing the change in the Consumer Price Index (CPI-W) from the third quarter of 2009 to the third quarter of 2010. It is likely that there will be no increase. There was a large increase in energy costs in the summer of 2008, which resulted in a 5.8% COLA, paid starting in January 2009. However, prices dropped in the fall of 2008 and have not regained the level of the third quarter in 2008. As a result, there was no COLA for 2010 because there was no increase from the third quarter of 2008 to the third quarter of 2009.

If there is no COLA for payments in 2011, it will be the first time since automatic COLAs began that Social Security and SSI benefi ciaries did not receive a benefit increase for two consecutive years.

Friday Fun

One of the few consumer product categories that seems to be resistant to inflation is technological devices, such as computers, music equipment, etc. Or to put it more accurately, you now get more for your money than in the old days. One example was detailed in an article earlier this summer on TheEnterpriseBlog.

The blog post compared the entertainment equipment you could buy in 1964 from Radio Shack with the equipment you could buy today, for about the same relative amount of money. I was in high school in 1964, and had only the money I was making from my minimum-wage part-time jobs. But I was every bit as much a gadget freak then as now, so this comparison is fascinating to me. I hope you find it interesting also.

FDA Raises Safety Concerns About Potential Fibromyalgia Drug

Wall Street Journal reports that the FDA revealed safety concerns about Jazz Pharmaceuticals Inc.'s potential fibromyalgia drug Rekinla (sodium oxybate), which faces a review on Friday from the FDA's arthritis and drug-safety advisory committees. The drug is currently approved to treat narcolepsy under the brand name Vyrem, but would be dosed in a different way to treat fibromyalgia. Jazz also is proposing to sell the drug under a different restricted distribution program than currently used for narcolepsy, which would involve 15 specialty pharmacies, but the FDA said that two restricted distribution programs may create confusion among prescribers and be burdensome to the healthcare system. The FDA also said it was concerned about having two different brand names for the drug.

However, the AP reports that the FDA said the drug "effectively treated pain from fibromyalgia in two company-run studies," though "regulators have concerns about the misuse and abuse of the drug, which has been used as an illegal stimulant and a date rape drug." FDA reviewers also "cautioned that an approval for fibromyalgia would greatly expand the drug's patient population, making it harder to control."

Bloomberg News adds that according to a Jazz-sponsored study published last year in the Journal of Clinical Sleep Medicine, "Ten cases of abuse occurred among the 26,000 narcolepsy patients worldwide who received Xyrem from 2002 to 2008," and the drug "also was linked to one death and two cases of sexual assault." Reuters and NPR also cover the story.

From the American Association for Justice news release.