Study: one in seven hospitalized Medicare patients harmed.
The New York Times (11/16, B3, Wilson) reports, "One of every seven Medicare beneficiaries who is hospitalized is harmed as a result of problems with the medical care there, according to a new study from the Office of Inspector General for" HHS, which also "said unexpected adverse events added at least $4.4 billion a year to government health costs and contributed to the deaths of about 180,000 patients a year." In response to the findings, "Dr. Carolyn M. Clancy, director of the federal Agency for Healthcare Research and Quality, said the adverse events were affecting hospital patients at an 'alarming rate' and promised to work to improve it." And, "Dr. Donald M. Berwick, administrator of the Centers for Medicare and Medicaid Services, said it would aggressively pursue recommendations to broaden the definition of adverse events, monitor and prevent them."
USA Today (11/16, Rubin) reports, "The study is the first of its kind aimed at understanding 'adverse events' in hospitals -- essentially, any medical care that causes harm to a patient, according to the Department of Health and Human Services' Office of Inspector General." Notably, "patients in the study, a nationally representative sample that focused on 780 Medicare patients discharged from hospitals in October 2008, suffered such problems as bed sores, infections and excessive bleeding from blood-thinning drugs, the report found."
Tuesday, November 16, 2010
Monday, November 8, 2010
PRODUCTS LIABILITY – DEFECTIVE CHINESE MOTORCYCLE
Jaime D. Jackson recently settled a case against Keeway Motor America, Inc. involving their importation and sale in the United States of what Plaintiff alleged was a defective 250 cc Keeway Dorado motorcycle that had been manufactured by a Chinese manufacturer in China.
Plaintiff was driving her recently purchased Keeway Dorado motorcycle when the front end of the motorcycle began to wobble resulting in her exiting the roadway and crashing. After extensive investigation, it was learned that the upper and lower steering races in the steering assembly were missing some ball bearings in the steering races. This was an assembly defect that occurred at the manufacturing facility in China. The proper number of ball bearings in the steering races is critical to the safety and steering of the motorcycle.
Unfortunately, numerous plaintiffs, as was the case here, are unable to obtain proper jurisdiction over Chinese manufacturers in the United States, because China is not a party to the Hague Convention. However, in this litigation, we came up with creative theories of liability against the importer of the defective motorcycle including citing to regulations promulgated by the National Highway Traffic Safety Administration (NHTSA) that view the importer of motor vehicles (which include motorcycles) as the manufacturer of the product with an obligation to make sure that the product is free from defects and safe for its intended use before being sold in the United States.
It is unfair that injured Americans sometimes may not be able to sue a manufacturer of unsafe products because of arcane laws, however, with these new theories of liability and creative litigation strategies developed by Jaime Jackson other responsible entities such as importers and dealers can be held accountable for selling unsafe products and victims of these unsafe products can obtain justice and be properly compensated for the harm caused by these unsafe products.
Plaintiff was driving her recently purchased Keeway Dorado motorcycle when the front end of the motorcycle began to wobble resulting in her exiting the roadway and crashing. After extensive investigation, it was learned that the upper and lower steering races in the steering assembly were missing some ball bearings in the steering races. This was an assembly defect that occurred at the manufacturing facility in China. The proper number of ball bearings in the steering races is critical to the safety and steering of the motorcycle.
Unfortunately, numerous plaintiffs, as was the case here, are unable to obtain proper jurisdiction over Chinese manufacturers in the United States, because China is not a party to the Hague Convention. However, in this litigation, we came up with creative theories of liability against the importer of the defective motorcycle including citing to regulations promulgated by the National Highway Traffic Safety Administration (NHTSA) that view the importer of motor vehicles (which include motorcycles) as the manufacturer of the product with an obligation to make sure that the product is free from defects and safe for its intended use before being sold in the United States.
It is unfair that injured Americans sometimes may not be able to sue a manufacturer of unsafe products because of arcane laws, however, with these new theories of liability and creative litigation strategies developed by Jaime Jackson other responsible entities such as importers and dealers can be held accountable for selling unsafe products and victims of these unsafe products can obtain justice and be properly compensated for the harm caused by these unsafe products.
Depuy Orthopedics ASR Hip Implant Recall
Depuy Orthopedics recently recalled 93,000 ASR hip implants. Finally, after they, stopped selling this hip implant in other countries outside the United States.
Tuesday, November 2, 2010
Seatbelt Load Limiters: A Dangerous Safety Defect
SEATBELT LOAD LIMITERS[1]
A load limiting device or torsion bar (hereinafter simply referred to as “load limiter”) were introduced originally by some manufacturers in the early eighties in conjunction with vehicles equipped with airbags. The theory or justification behind such devices are that they are intended to reduce belt induced injuries such as rib fractures by allowing forward movement of occupant’s torso when belt loads exceed some threshold. The release of the webbing allows an occupant to move forward until the occupant’s forward motion is finally arrested by the deployment of the frontal airbag. In theory, this design concept may work; if an occupant were to be involved in a 35 mph NCAP full frontal barrier crash test where the torsion bar releases webbing and the airbag deploys arresting the forward movement of the occupant. In virtually all other crash scenarios, i.e. rollover, offset frontals, frontal impacts where the airbag fails to deploy or any impact where airbags do not deploy, this design is extremely dangerous because it introduces slack into the seatbelt system; thereby failing to restrain the occupant and may permit the occupant to be ejected, or slam into the interior of the vehicle despite the fact that the occupant did exactly what they were supposed to in properly wearing their seatbelt.
In any crash scenario where an occupant was belted, but sustained significant injury, one place to look is whether or not the seatbelt retractor was equipped with a load limiting-type device. As mentioned, common scenarios include rollovers and offset frontal collisions where an occupant may miss the airbag because of the PDOF, or the airbag fails to deploy; since load limiters are designed to work in conjunction with an airbag.
[1] One of the original attempts at purported load limiting was sewing the seatbelt over itself or sewing a fold into the seatbelt webbing, more appropriately called rip stitching. The rip stitching would then pull apart when loaded introducing slack into the seatbelt system. Rip stitching, because it was such a dumb idea, for the most part went away and was replaced by a device referred to as a torsion bar built into the seatbelt retractor. The torsion bar is a metal rod that will twist when sufficient force is applied. The torsion bar will twist under load allowing seatbelt webbing to be released from the retractor thereby introducing slack into the system. The subject of this paper and presentation focuses on the deadly, deceitful and dangerous defect-torsion bars.
A load limiting device or torsion bar (hereinafter simply referred to as “load limiter”) were introduced originally by some manufacturers in the early eighties in conjunction with vehicles equipped with airbags. The theory or justification behind such devices are that they are intended to reduce belt induced injuries such as rib fractures by allowing forward movement of occupant’s torso when belt loads exceed some threshold. The release of the webbing allows an occupant to move forward until the occupant’s forward motion is finally arrested by the deployment of the frontal airbag. In theory, this design concept may work; if an occupant were to be involved in a 35 mph NCAP full frontal barrier crash test where the torsion bar releases webbing and the airbag deploys arresting the forward movement of the occupant. In virtually all other crash scenarios, i.e. rollover, offset frontals, frontal impacts where the airbag fails to deploy or any impact where airbags do not deploy, this design is extremely dangerous because it introduces slack into the seatbelt system; thereby failing to restrain the occupant and may permit the occupant to be ejected, or slam into the interior of the vehicle despite the fact that the occupant did exactly what they were supposed to in properly wearing their seatbelt.
In any crash scenario where an occupant was belted, but sustained significant injury, one place to look is whether or not the seatbelt retractor was equipped with a load limiting-type device. As mentioned, common scenarios include rollovers and offset frontal collisions where an occupant may miss the airbag because of the PDOF, or the airbag fails to deploy; since load limiters are designed to work in conjunction with an airbag.
[1] One of the original attempts at purported load limiting was sewing the seatbelt over itself or sewing a fold into the seatbelt webbing, more appropriately called rip stitching. The rip stitching would then pull apart when loaded introducing slack into the seatbelt system. Rip stitching, because it was such a dumb idea, for the most part went away and was replaced by a device referred to as a torsion bar built into the seatbelt retractor. The torsion bar is a metal rod that will twist when sufficient force is applied. The torsion bar will twist under load allowing seatbelt webbing to be released from the retractor thereby introducing slack into the system. The subject of this paper and presentation focuses on the deadly, deceitful and dangerous defect-torsion bars.
Monday, November 1, 2010
Toyota secretly bought cars to hide problems from public
Toyota secretly bought problem cars, lawsuit says
Toyota Motor Corp. secretly bought back from U.S. consumers vehicles it found with speed-control defects as part of a strategy to hide unintended-acceleration problems from safety regulators and the public, a revised lawsuit claims. The repurchase transactions included strict confidentiality agreements barring consumers from disclosing the problem to anyone and from suing the automaker, according to the amended class-action complaint.
This story should not require registration.
https://home.autonews.com/clickshare/readLink.do?CSAuthKey=kLty_HCuSfo-gkp9DOpqq00-0
Toyota Motor Corp. secretly bought back from U.S. consumers vehicles it found with speed-control defects as part of a strategy to hide unintended-acceleration problems from safety regulators and the public, a revised lawsuit claims. The repurchase transactions included strict confidentiality agreements barring consumers from disclosing the problem to anyone and from suing the automaker, according to the amended class-action complaint.
This story should not require registration.
https://home.autonews.com/clickshare/readLink.do?CSAuthKey=kLty_HCuSfo-gkp9DOpqq00-0
Wednesday, October 27, 2010
BMW recalls fuel pumps
BMW recalls 150,000 vehicles in North America due to fuel pump issues.
CNNMoney (10/27, Smith) reports, "BMW of North America announced a recall Tuesday of more than 150,000 vehicles because of potential problems with their fuel pumps." The ABC News (10/26, Cuomo et al.) "TheLaw" blog noted BMW made the voluntary move "just hours after ABC News aired a report on its investigation into potential problems concerning the fuel pumps in such vehicles."
The Cars.com (10/26, Thomas) "Kicking Tires" blog reported, "BMW has just issued a recall of 130,000 cars featuring its twin-turbo six-cylinder engine because of a faulty fuel pump that can fail when the cars are driving at high speeds. The company and National Highway Traffic Safety Administration received complaints about the cars going into a reduced-power or 'limp home' mode, which allows drivers to safely pull off the road."
CNNMoney (10/27, Smith) reports, "BMW of North America announced a recall Tuesday of more than 150,000 vehicles because of potential problems with their fuel pumps." The ABC News (10/26, Cuomo et al.) "TheLaw" blog noted BMW made the voluntary move "just hours after ABC News aired a report on its investigation into potential problems concerning the fuel pumps in such vehicles."
The Cars.com (10/26, Thomas) "Kicking Tires" blog reported, "BMW has just issued a recall of 130,000 cars featuring its twin-turbo six-cylinder engine because of a faulty fuel pump that can fail when the cars are driving at high speeds. The company and National Highway Traffic Safety Administration received complaints about the cars going into a reduced-power or 'limp home' mode, which allows drivers to safely pull off the road."
Friday, October 1, 2010
Patient Lawsuits helping doctors learn from mistakes
In case you missed it, today’s Wall Street Journal explores how medical negligence claims help physicians avoid diagnostic delays and mistakes, improving patient safety.
According to the article, “Medical professionals are finding lessons in these and other past malpractice cases. By analyzing the breakdowns in care that led to missed, delayed or incorrect diagnoses, insurers and health-care providers are developing programs to avert mistakes. . . . Diagnostic errors are the leading cause of malpractice suits, accounting for as many as 40% of cases and costing insurers an average of $300,000 per case to settle, studies of resolved claims show. Peter Pronovost, a patient-safety researcher at Johns Hopkins University, estimates that diagnostic errors kill 40,000 to 80,000 hospitalized patients annually, based on autopsy studies over the past four decades.”
While opponents of health care reform were fixated on taking away the rights of patients (which would produce practically no savings), they clearly avoided discussing the merits of our current civil justice system: providing recourse to those injured by medical errors and improving the overall quality of America’s health care system.
THE INFORMED PATIENT
SEPTEMBER 28, 2010What the Doctor Missed
Using Malpractice Claims to Help Physicians Avoid Diagnostic Mistakes, Delays By LAURA LANDROhttp://online.wsj.com/article/SB10001424052748703694204575517834198205438.html?mod=googlenews_wsj#articleTabs%3Darticle
A doctor assumes a patient's recurrent cough is a respiratory infection and doesn't order a chest X-ray, missing a deadly lung cancer. A 40-year-old woman dies of a rare blood disease after her abnormal lab test falls through the cracks. A man dies from an obstructed bowel after different doctors treating him fail to share information about his acute abdominal pain.
Medical professionals are finding lessons in these and other past malpractice cases. By analyzing the breakdowns in care that led to missed, delayed or incorrect diagnoses, insurers and health-care providers are developing programs to avert mistakes. For example, some doctors are using electronic alerts and reminders to order tests, follow up on lab reports and close the loop with specialists to whom they refer patients.
Diagnostic errors are the leading cause of malpractice suits, accounting for as many as 40% of cases and costing insurers an average of $300,000 per case to settle, studies of resolved claims show. Peter Pronovost, a patient-safety researcher at Johns Hopkins University, estimates that diagnostic errors kill 40,000 to 80,000 hospitalized patients annually, based on autopsy studies over the past four decades.
Studies of malpractice-claims data show that diagnostic errors often don't have a single cause. There are often at least three breakdowns that lead to missed or delayed diagnoses. Patients play a role as well: They may not seek care on a timely basis, fail to show up for tests or fail to follow instructions, such as not fasting before a blood test or not adequately emptying the bowels before a colonoscopy.
One concern is that using claims data to educate doctors will lead to more "defensive medicine," in which doctors order more tests and procedures than needed to protect themselves against malpractice suits. In a study in the June Archives of Internal Medicine, 91% of physicians surveyed reported that doctors practice defensive medicine; the majority of physicians also agreed that legal protections against unwarranted malpractice suits are needed to decrease the unnecessary use of diagnostic tests.
"Medicine is often a crapshoot and an odds game," and doctors can miss a diagnosis even if they adhere to guidelines on when to order a test, says Dr. Pronovost. Reducing diagnostic errors, he says, will require a focus on larger system failures, such as preventing lab results from getting lost and developing checklists to help doctors distinguish between, say, a "low-risk" headache and a "high-risk" headache.
Diagnostic mistakes most often involve cancer, with breast cancer the most commonly missed or delayed diagnosis. Last year, a jury awarded $2.5 million in a case brought by Barbara Glasow, who, before she died in May 2009, sued St. Luke's Hospital in Bethlehem, Pa., claiming the hospital and one of its doctors failed to diagnose her breast cancer in May 2004, when she came to see him for a lump on her chest. According to the suit, the doctor told her it was a cyst. By February 2005, it had broken in two and began to bleed. A biopsy determined that it was breast cancer. Her attorney, Steven Margolis, is pursuing the award, plus interest, totaling $2.9 million on behalf of her family. St. Luke's is appealing the case, and the hospital declined to comment.
Oakland, Calif.-based managed-care giant Kaiser Permanente also uses malpractice-claims data for educational purposes. But it relies on close tracking and follow-up of patients with abnormal test results to avoid missed diagnoses, says breast cancer surgeon Susan Kutner. Over the past 15 years it has identified 420,000 abnormal biopsies and 320,000 abnormal mammograms. As a result, 450 patients were found to have a new or recurrent cancer or an abnormal biopsy "who would not have been found if we did not bring them in proactively," Dr. Kutner says.
The Veterans Health Administration is developing programs to help doctors more closely follow up on abnormal lab results, which it delivers through an electronic medical record system. VA studies show that doctors are often overwhelmed by alerts and may not follow up, even when an alert says the test is abnormal. Hardeep Singh, chief of the health quality and policy program at the Houston VA research center, says its studies also show that if both a primary-care doctor and a specialist get test results, each assumes the other will follow up.
"Patients may think that if something was wrong, my doctor would have told me," says Dr. Singh. "But no news is not necessarily good news, and patients need to be empowered to follow up on their lab results and participate more actively in their care."
While malpractice claims represent only a fraction of all medical cases, "they are reflective of deeply rooted problems that are much more widespread in health care," says Robert Hanscom, vice president of loss prevention and patient safety for Crico/RMF, a malpractice insurer that covers Harvard University-affiliated hospitals and doctors. Mr. Hanscom says cases linked to diagnostic errors appear to be on the rise as primary care doctors, struggling with heavy case loads, take shortcuts or don't act on their patient's symptoms. Also hospitals are concerned about trial lawyers who may seek high monetary damages.
Of 1,137 malpractice cases between 2005 and 2009, diagnostic errors accounted for 26% of Crico/RMF's claims. But among the 456 "high severity" cases that resulted in serious patient harm or death, nearly half were diagnostic errors.
"People may show up with a series of symptoms or complaints that aren't taken seriously at the moment, or a physician…doesn't see the complaint as something new to be concerned about," says Ann Louise Puopolo, a nurse and patient-safety program director at Crico/RMF. For example, in missed or delayed colorectal cancer cases, patients often showed up with some kind of rectal bleeding, a usual sign that further testing is needed, but was not performed, says Ms. Puopolo.
Crico/RMF is offering continuing medical-education credits to doctors who study its analysis of the closed malpractice cases. And in a program it is co-sponsoring at Brigham and Women's Hospital in Boston, researchers are working with 16 primary-care practices in Massachusetts, using lessons from the claims to help them avoid common pitfalls like failing to consider that a patient with persistent symptoms might need a diagnostic test, and failing to follow up on abnormal test results when they come in.
"These errors may be less visible and dramatic than getting the wrong leg cut off, but a delay in diagnosis can adversely affect a patient's long-term outcome," says Gordon Schiff, associate director of patient-safety research at Brigham and Women's. Malpractice cases "let us drill down and learn deeper lessons, like what could have been done differently," Dr. Schiff says.
According to the article, “Medical professionals are finding lessons in these and other past malpractice cases. By analyzing the breakdowns in care that led to missed, delayed or incorrect diagnoses, insurers and health-care providers are developing programs to avert mistakes. . . . Diagnostic errors are the leading cause of malpractice suits, accounting for as many as 40% of cases and costing insurers an average of $300,000 per case to settle, studies of resolved claims show. Peter Pronovost, a patient-safety researcher at Johns Hopkins University, estimates that diagnostic errors kill 40,000 to 80,000 hospitalized patients annually, based on autopsy studies over the past four decades.”
While opponents of health care reform were fixated on taking away the rights of patients (which would produce practically no savings), they clearly avoided discussing the merits of our current civil justice system: providing recourse to those injured by medical errors and improving the overall quality of America’s health care system.
THE INFORMED PATIENT
SEPTEMBER 28, 2010What the Doctor Missed
Using Malpractice Claims to Help Physicians Avoid Diagnostic Mistakes, Delays By LAURA LANDROhttp://online.wsj.com/article/SB10001424052748703694204575517834198205438.html?mod=googlenews_wsj#articleTabs%3Darticle
A doctor assumes a patient's recurrent cough is a respiratory infection and doesn't order a chest X-ray, missing a deadly lung cancer. A 40-year-old woman dies of a rare blood disease after her abnormal lab test falls through the cracks. A man dies from an obstructed bowel after different doctors treating him fail to share information about his acute abdominal pain.
Medical professionals are finding lessons in these and other past malpractice cases. By analyzing the breakdowns in care that led to missed, delayed or incorrect diagnoses, insurers and health-care providers are developing programs to avert mistakes. For example, some doctors are using electronic alerts and reminders to order tests, follow up on lab reports and close the loop with specialists to whom they refer patients.
Diagnostic errors are the leading cause of malpractice suits, accounting for as many as 40% of cases and costing insurers an average of $300,000 per case to settle, studies of resolved claims show. Peter Pronovost, a patient-safety researcher at Johns Hopkins University, estimates that diagnostic errors kill 40,000 to 80,000 hospitalized patients annually, based on autopsy studies over the past four decades.
Studies of malpractice-claims data show that diagnostic errors often don't have a single cause. There are often at least three breakdowns that lead to missed or delayed diagnoses. Patients play a role as well: They may not seek care on a timely basis, fail to show up for tests or fail to follow instructions, such as not fasting before a blood test or not adequately emptying the bowels before a colonoscopy.
One concern is that using claims data to educate doctors will lead to more "defensive medicine," in which doctors order more tests and procedures than needed to protect themselves against malpractice suits. In a study in the June Archives of Internal Medicine, 91% of physicians surveyed reported that doctors practice defensive medicine; the majority of physicians also agreed that legal protections against unwarranted malpractice suits are needed to decrease the unnecessary use of diagnostic tests.
"Medicine is often a crapshoot and an odds game," and doctors can miss a diagnosis even if they adhere to guidelines on when to order a test, says Dr. Pronovost. Reducing diagnostic errors, he says, will require a focus on larger system failures, such as preventing lab results from getting lost and developing checklists to help doctors distinguish between, say, a "low-risk" headache and a "high-risk" headache.
Diagnostic mistakes most often involve cancer, with breast cancer the most commonly missed or delayed diagnosis. Last year, a jury awarded $2.5 million in a case brought by Barbara Glasow, who, before she died in May 2009, sued St. Luke's Hospital in Bethlehem, Pa., claiming the hospital and one of its doctors failed to diagnose her breast cancer in May 2004, when she came to see him for a lump on her chest. According to the suit, the doctor told her it was a cyst. By February 2005, it had broken in two and began to bleed. A biopsy determined that it was breast cancer. Her attorney, Steven Margolis, is pursuing the award, plus interest, totaling $2.9 million on behalf of her family. St. Luke's is appealing the case, and the hospital declined to comment.
Oakland, Calif.-based managed-care giant Kaiser Permanente also uses malpractice-claims data for educational purposes. But it relies on close tracking and follow-up of patients with abnormal test results to avoid missed diagnoses, says breast cancer surgeon Susan Kutner. Over the past 15 years it has identified 420,000 abnormal biopsies and 320,000 abnormal mammograms. As a result, 450 patients were found to have a new or recurrent cancer or an abnormal biopsy "who would not have been found if we did not bring them in proactively," Dr. Kutner says.
The Veterans Health Administration is developing programs to help doctors more closely follow up on abnormal lab results, which it delivers through an electronic medical record system. VA studies show that doctors are often overwhelmed by alerts and may not follow up, even when an alert says the test is abnormal. Hardeep Singh, chief of the health quality and policy program at the Houston VA research center, says its studies also show that if both a primary-care doctor and a specialist get test results, each assumes the other will follow up.
"Patients may think that if something was wrong, my doctor would have told me," says Dr. Singh. "But no news is not necessarily good news, and patients need to be empowered to follow up on their lab results and participate more actively in their care."
While malpractice claims represent only a fraction of all medical cases, "they are reflective of deeply rooted problems that are much more widespread in health care," says Robert Hanscom, vice president of loss prevention and patient safety for Crico/RMF, a malpractice insurer that covers Harvard University-affiliated hospitals and doctors. Mr. Hanscom says cases linked to diagnostic errors appear to be on the rise as primary care doctors, struggling with heavy case loads, take shortcuts or don't act on their patient's symptoms. Also hospitals are concerned about trial lawyers who may seek high monetary damages.
Of 1,137 malpractice cases between 2005 and 2009, diagnostic errors accounted for 26% of Crico/RMF's claims. But among the 456 "high severity" cases that resulted in serious patient harm or death, nearly half were diagnostic errors.
"People may show up with a series of symptoms or complaints that aren't taken seriously at the moment, or a physician…doesn't see the complaint as something new to be concerned about," says Ann Louise Puopolo, a nurse and patient-safety program director at Crico/RMF. For example, in missed or delayed colorectal cancer cases, patients often showed up with some kind of rectal bleeding, a usual sign that further testing is needed, but was not performed, says Ms. Puopolo.
Crico/RMF is offering continuing medical-education credits to doctors who study its analysis of the closed malpractice cases. And in a program it is co-sponsoring at Brigham and Women's Hospital in Boston, researchers are working with 16 primary-care practices in Massachusetts, using lessons from the claims to help them avoid common pitfalls like failing to consider that a patient with persistent symptoms might need a diagnostic test, and failing to follow up on abnormal test results when they come in.
"These errors may be less visible and dramatic than getting the wrong leg cut off, but a delay in diagnosis can adversely affect a patient's long-term outcome," says Gordon Schiff, associate director of patient-safety research at Brigham and Women's. Malpractice cases "let us drill down and learn deeper lessons, like what could have been done differently," Dr. Schiff says.
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