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Medical Device Products Liability

When you are injured during a medical procedure, your first reaction may be to blame your medical practitioner.  However, the injury may have been a direct result of a faulty medical device, not the hands of your doctor.  Medical devices may not perform correctly during procedures, which can lead to serious harm on the patient’s behalf.  Sometimes, medical devices have major defects that make them unsafe.  These defects may be the result of poor design or manufacturing.  Unfortunately, the faults of a medical device can go undetected, placing a patient’s well-being at risk.     

Medical Device Products Liability is an area of law that is currently expanding.  Products liability claims are being brought against medical device manufacturers by patients who have experienced injury due to faulty equipment.  These claims include, but are not limited to, devices such as:

  • Heart valves
  • Latex Gloves
  • Prescription Drugs
  • Pacemakers
  • Laser and orthopedic tools

Medical Device Products Liability Attorney
If you have suffered an injury due to the fault of a defective medical device, you may be entitled to seek damages from the device manufacturer, your physician, or the supplier. Remember, if the device was not defective, or the manufacturer had exercised more precaution, you would not have sustained an injury.

Medical device products liability is a complex and complicated area of law.  Dr. Tew understands the intricate nature of most products liability cases.  He has helped clients throughout Texas with cases involving lasik surgery, and the lasers used during lasik procedures.  He has also represented numerous clients with cases involving PCA pumps and narcotics overdoses, which were caused by device failure or inadequate monitoring. 

Dr. Tew can help you advise you of your individual rights and the laws surrounding medical device products liability.  With his trial skill, Dr. Tew can take on world class medical experts during the legal process.  As an M.D. with over 25 years of experience, Dr. Tew knows when a medical expert is deviating from standard medical facts or distorting the records. 

To discuss your case with Dr. Tew, call 713-532-0043.
 
Contact Dr. Tew for more information. 

A Few Statistics on Hospital Medical Errors

Medical Errors
 “Findings from several studies of large numbers of hospitalized patients indicate that each year a million or more people are injured and as many as 100,000 die as a result of errors in their care. This makes medical care one of the leading causes of death, accounting for more lost lives than automobile accidents, breast cancer or AIDS.”-- Statement of Lucian Leape, M.D., Member, Quality of Health Care in America Committee, Institute of Medicine, Adjunct Professor, Harvard School of Public Health, Concerning Patient Safety and Medical Errors Before the United States Senate Subcommittee on Labor, Health and Human Services, and Education,  January 25, 2000

“An average of 195,000 people in the USA died due to potentially preventable, in-hospital medical errors in each of the years 2000, 2001 and 2002, according to a new study of 37 million patient records”—“In Hospital Deaths from Medical Errors at 195,000 per Year USA,” Medical News Today citing  HealthGrades Patient Safety in American Hospitals, November 9, 2004

“The equivalent of 390 jumbo jets full of people are dying each year due to likely preventable, in-hospital medical errors, making this one of the leading killers in the U.S.”—Dr. Samantha Collier, HealthGrades’ vice president of medical affairs

Medication Errors
“7,000 people are killed in U.S. hospitals each year when they receive the wrong medicine or the wrong dosage”—“To Err Is Human: Building a Safer health System, Institute of Medicine of the National Academies, November 29, 1999
“Medication errors are among the most common medical errors, harming at least 1.5 million people every year, says a new report from the Institute of Medicine of the National Academies.  The extra medical costs of treating drug-related injuries occurring in hospitals alone conservatively amount to $3.5 billion a year, and this estimate does not take into account lost wages and  productivity or additional health care costs, the report says.”—“Preventing Medication Errors,” Institute of Medicine of the National Academies, July 20, 2006

PCA Pump Overdoses
“Interviews with medical experts in Canada and the United States, along with a review of FDA incident reports reveal:

  1. Dozens of deaths and near-fatal drug overdoses have occurred in hospitals nationwide involving the infusion pump, a bedside device used to deliver measured doses of painkiller intravenously.
  2. Human error is the leading cause of death involving infusion pumps
  3. Two independent medical watchdog groups as well as the agency that sets national standards for hospitals have issued warnings about the potential for deadly mistakes on infusion pumps and have called for hospitals to take precautions.
  4. The risk of deaths could be greatly reduced by a simple change in the pump's preprogrammed settings.

Abbott Laboratories… says there is nothing wrong with its product, the Lifecare PCA Plus II. Instead of a new design, Abbott advocates better training of nurses—“Flawed drug pump caused hospital deaths nationwide.” (Knight Ridder Newspapers), copyright 2000 Knight-Ridder/Tribune News Service

“The risk of patient harm due to medication errors with PCA pumps, the most common form of PCA error, is 3.5-times the risk of harm to a patient from any other type of medication administration error.  The FDA’s Manufacturer and User Facility Device Experience (MAUDE) Database for 2004, a voluntary database for reporting problems with devices, reports 21 deaths related to PCA pumps versus 16 deaths for all other large volume infusion pumps (LVP). The installed number of LVPs is approximately 10-times greater than the number of PCA pumps, suggesting the risk of death from an adverse event with a PCA pump is at least 10-times greater than with LVPs.”—“PCA Presents Serious Risks,Frank J. Overdyk, MSEE, MD, http://www.apsf.org/resource_center/newsletter/2005/summer/06pca.htm, accessed October 5, 2006

Based on “case files in the FDA's MedWatch program, a national reporting system for medical device incidents, since mid-1996 there have been 141 infusion pump deaths—17 on the Lifecare.”—Canadian Journal of Anesthesia 50:328-332 (2003)

 

© 2004 Brian H. Tew, M.D.,J.D. - All Rights Reserved
Unless otherwise indicated, attorneys listed in this site are not certified by the Texas Board of Legal Specialization. This web site is designed for general information only. The information presented at this site should not be construed to be neither formal legal advice nor the formation of a lawyer/client relationship.


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