Surgeons Use Transplant Surgery To Remove Tumour
Written by Catharine Paddock, PhD
In a 15-hour operation, surgeons in the US used transplant surgery to remove and replace multiple abdominal organs so they could reach and cut out a tumour in a female patient who had a rare form of cancer...[read article]
Fertility Treatments And The Surprising Power Of The Pill
Free Drug Samples May Burden Patients' Pockets
FDA Classifies Medtronic's Physician Communication Related To Inflammatory Mass Formation From Intrathecal Drug Therapy
CHMP Upholds Negative Opinion For The EU Application For Cimzia(R) In The Treatment Of Crohn's Disease
Massachusetts Health Insurance Connector Approves 10% Premium Increases; State Finance Officer Says Program Is Underfunded
EndoGastric Solutions(TM) Announces Results Of EsophyX(TM) Multi-Center GERD Study
New Hope Available For The Millions Suffering From Chronic Fatigue Syndrome And Fibromyalgia
Time To Initiation Of Pentosan Polysulfate Sodium Treatment After Interstitial Cystitis Diagnosis: Effect On Symptom Improvement
Beyond The Abstract - Insight Into Urogynecologic Features Of Women With Interstitial Cystitis/Painful Bladder Syndrome
Can Psychotherapy Reverse Chronic Post-Traumatic Stress Disorder?
New York Times Examines 'Migration' Of Top Medical Students To Dermatology, Plastic Surgery
StatMedica Defends Medical Tourism
ASA Commemorates Doctors Day 2008
SUFU 2008 Winter Meeting - Genetic Factors In SUI/Pelvic Organ Prolapse
NovaBay Pharmaceuticals Commences Phase I Human Clinical Trial For The Prevention Of Catheter Associated Urinary Tract Infections
Tuesday, March 25, 2008
N.D. Supreme Court sends suit back to district court
Herald Staff Reporter
http://www.grandforksherald.com/articles/index.cfm?id=71390§ion=news
The North Dakota Supreme Court has overturned a district court’s decision in Grand Forks, allowing a woman’s malpractice suit — against Altru Hospital in Grand Forks and a surgeon, Dr. Jamil Tareen, who worked for Altru in 2004 — to proceed.
The case is based on surgery performed by Tareen on Denise White in February 2004 in the First Care Health Center in Park River, N.D. Tareen did a laparotomy, or a surgical incision to White’s abdomen, to remove “extensive pelvic adhesions.” White sued Tareen and Altru, his employer at the time, for negligence because Tareen’s medical license was restricted at the time, a fact she said was concealed from her before her surgery, according to the Court’s decision filed Thursday.
White also alleged Tareen’s surgery caused an injury he failed to diagnose or treat. White served Altru with a complaint in February 2006. After an exchange of counter-claims and other documents, Altru moved for the case to be dismissed based on a statute about a certain required affidavit that was not filed in time by White.
State District Judge Debbie Kleven granted Altru’s motion to dismiss and then denied White’s three motions for reconsideration, to overthrow the judgment against her and to amend her complaint.
The Supreme Court’s decision was based on a complicated analysis of what state law and precedent applies in determining a statute of limitations on such lawsuits, and what that means for someone appealing a lower court’s decision.
All five justices agreed Kleven’s court had “abused its discretion by denying” in December 2006 White’s appeals of the dismissal. The Supreme Court reversed Kleven’s decision and sent the case back to district court for consideration.
http://www.grandforksherald.com/articles/index.cfm?id=71390§ion=news
The North Dakota Supreme Court has overturned a district court’s decision in Grand Forks, allowing a woman’s malpractice suit — against Altru Hospital in Grand Forks and a surgeon, Dr. Jamil Tareen, who worked for Altru in 2004 — to proceed.
The case is based on surgery performed by Tareen on Denise White in February 2004 in the First Care Health Center in Park River, N.D. Tareen did a laparotomy, or a surgical incision to White’s abdomen, to remove “extensive pelvic adhesions.” White sued Tareen and Altru, his employer at the time, for negligence because Tareen’s medical license was restricted at the time, a fact she said was concealed from her before her surgery, according to the Court’s decision filed Thursday.
White also alleged Tareen’s surgery caused an injury he failed to diagnose or treat. White served Altru with a complaint in February 2006. After an exchange of counter-claims and other documents, Altru moved for the case to be dismissed based on a statute about a certain required affidavit that was not filed in time by White.
State District Judge Debbie Kleven granted Altru’s motion to dismiss and then denied White’s three motions for reconsideration, to overthrow the judgment against her and to amend her complaint.
The Supreme Court’s decision was based on a complicated analysis of what state law and precedent applies in determining a statute of limitations on such lawsuits, and what that means for someone appealing a lower court’s decision.
All five justices agreed Kleven’s court had “abused its discretion by denying” in December 2006 White’s appeals of the dismissal. The Supreme Court reversed Kleven’s decision and sent the case back to district court for consideration.
Monday, March 10, 2008
Adhesions Medical Headlines ARDvark Blog
Drugs In US Drinking Water
Written by Catharine Paddock
A five month investigation by the Associated Press has discovered that small quantities of drugs, including antibiotics, sex hormones, and anti-seizure compounds, have been found in public drinking water supplied to over 40 million Americans across the US...[read article]
Combo MRI/PET Scanner
Colorectal Cancer Gene Identified By Case Western Reserve University Researchers
Survey Of Hospital Execs Reveals Stark Differences Among Health Insurance Companies
Study Finds IONSYS™, A New Needle-Free System For Management Of Acute Postoperative Pain, Requires Less Staff Compared To IV PCA Treatment
Fellowship Supports Super Bug Crackdown
Early Data On Cimzia® Shows Promise In Crohn's Patients Without Infliximab
New Treatment Strategy For Crohn's Disease Shows Promise
Multicenter Trial On Minimally Invasive Fibroid Treatment
Bloody Diarrhea Can Indicate Ischemic Colitis
New Colorectal Cancer Screening Guidelines Focus On Prevention
Flat Colon Lesions Identified And Removed Using Colonoscopy
Statement On BBC Newsnight Report On Gaviscon, British Generic Manufacturers Association
Federal Court Invalidates Bayer's Patent On Yasmin Birth Control Pill
Massive Las Vegas Hepatitis C Scare Causes Public Health Crisis - Edward M. Bernstein & Associates Files Lawsuits
Los Angeles Times Examines Product Liability Lawsuits, Potential For Court To Shield Drug Makers
MRSA Is A Slow Moving Hurricane That Cannot Be Averted Says Infection Expert
Potential For New Antibiotics From Synthetic Peptoids
SUFU 2008 Winter Meeting Pelvic Organ Neurophysiology: Implications For Chronic Pelvic Pain And The Overlap Of Chronic Pelvic Pain
Followup Of Patients With Interstitial Cystitis Responsive To Treatment With Intravesical Bacillus Calmette Guerin Or Placebo
Written by Catharine Paddock
A five month investigation by the Associated Press has discovered that small quantities of drugs, including antibiotics, sex hormones, and anti-seizure compounds, have been found in public drinking water supplied to over 40 million Americans across the US...[read article]
Combo MRI/PET Scanner
Colorectal Cancer Gene Identified By Case Western Reserve University Researchers
Survey Of Hospital Execs Reveals Stark Differences Among Health Insurance Companies
Study Finds IONSYS™, A New Needle-Free System For Management Of Acute Postoperative Pain, Requires Less Staff Compared To IV PCA Treatment
Fellowship Supports Super Bug Crackdown
Early Data On Cimzia® Shows Promise In Crohn's Patients Without Infliximab
New Treatment Strategy For Crohn's Disease Shows Promise
Multicenter Trial On Minimally Invasive Fibroid Treatment
Bloody Diarrhea Can Indicate Ischemic Colitis
New Colorectal Cancer Screening Guidelines Focus On Prevention
Flat Colon Lesions Identified And Removed Using Colonoscopy
Statement On BBC Newsnight Report On Gaviscon, British Generic Manufacturers Association
Federal Court Invalidates Bayer's Patent On Yasmin Birth Control Pill
Massive Las Vegas Hepatitis C Scare Causes Public Health Crisis - Edward M. Bernstein & Associates Files Lawsuits
Los Angeles Times Examines Product Liability Lawsuits, Potential For Court To Shield Drug Makers
MRSA Is A Slow Moving Hurricane That Cannot Be Averted Says Infection Expert
Potential For New Antibiotics From Synthetic Peptoids
SUFU 2008 Winter Meeting Pelvic Organ Neurophysiology: Implications For Chronic Pelvic Pain And The Overlap Of Chronic Pelvic Pain
Followup Of Patients With Interstitial Cystitis Responsive To Treatment With Intravesical Bacillus Calmette Guerin Or Placebo
Unplanned Unmasking in Trial Cited in Warning Letter
In a SyntheMed clinical trial, an evaluation that should have been given by a blinded surgeon was performed by the same person responsible for the initial surgery and randomization of trial participants, according to a recent FDA warning letter.
Therefore, the surgeon was not blind to the randomization, the letter said. Although the name of the product is redacted, the letter noted that the study design requires a cardiac surgeon, masked to the randomization assignment, to assess the severity of adhesions at the investigational surgical site.
In its response, SyntheMed said the clinical investigator was reminded in 2005 that, according to the protocol, the surgeon performing the surgery could not conduct the assessment.
The response said in the future, monitors will be trained to ensure that when protocol violations occur, an appropriate corrective action plan will be used to prevent further violations. The FDA found the response inadequate as it does not include a written plan for reporting protocol deviations.
The company did not respond to a request for comment
Source: FDA
Therefore, the surgeon was not blind to the randomization, the letter said. Although the name of the product is redacted, the letter noted that the study design requires a cardiac surgeon, masked to the randomization assignment, to assess the severity of adhesions at the investigational surgical site.
In its response, SyntheMed said the clinical investigator was reminded in 2005 that, according to the protocol, the surgeon performing the surgery could not conduct the assessment.
The response said in the future, monitors will be trained to ensure that when protocol violations occur, an appropriate corrective action plan will be used to prevent further violations. The FDA found the response inadequate as it does not include a written plan for reporting protocol deviations.
The company did not respond to a request for comment
Source: FDA
Subscribe to:
Posts (Atom)