Posted on 13th March 2009 by Gordon Johnson in Uncategorized
defibrillator, faulty medical devices, heart device malfunction, heart device wires, heart devices, heart disease, Medtronic, Medtronic deaths, Medtronic lawsuit, Sprint Fidelis
Date: 3/13/2009
By MATTHEW PERRONE
AP Business Writer
WASHINGTON (AP) — Medtronic, the world’s largest medical device maker, said Friday that 13 patients may have died as a result of problems with its heart device wires that were first disclosed in 2007.
The Minneapolis-based company pulled its Sprint Fidelis defibrillator leads off the market in October 2007 after identifying five patient deaths that may have been caused by the cracked wires.
In a letter sent to physicians Friday, Medtronic raised the number of estimated deaths to 13. The company notes that four of those deaths occurred when physicians tried to extract the wires. Medtronic has recommended patients leave the devices in because the risk of surgery may outweigh the risk of a device malfunction.
“This is likely to be the best choice for the majority of patients,” the company advised physicians.
Defibrillator leads connect patients’ hearts to implanted defibrillators that send an electrical shock if it senses a life-threatening abnormal heart rhythm. A fractured lead can prevent the device from sending a lifesaving shock or cause painful, unnecessary shocks.
Roughly 268,000 of the Fidelis leads have been implanted in patients worldwide, according to the company.
The Food and Drug Administration has received 107 reports of patient deaths where the devices may have played a role. Most of those reports were not filed by physicians, Medtronic notes, but “by family members or attorneys with minimal supporting data.”
After reviewing 89 of those reports, an outside group of physicians assembled by Medtronic judged that 13 deaths may have been caused by problems with the wires.
In recent months, federal judges have thrown out thousands of patient lawsuits against Medtronic, ruling that federal regulations shield the company from lawsuits filed at the state level. Those decisions were based on a Supreme Court decision last year that the federal FDA is the final arbiter of medical device safety.
Democrats in Congress are currently working to pass legislation to overturn that decision.
Shares of Medtronic fell $1.03, or 3.6 percent, to $27.55 in after-hours trading.
Copyright 2009 The Associated Press.
Posted on 13th March 2009 by Gordon Johnson in Uncategorized
drug fraud, drug recalls, expired drugs, expired medications, expired OTC medicines, Hong Kong drugs, Hong Kong pharmaceuticals, Hong Kong recalls, Marching Pharmaceutical Ltd.
Date: 3/13/2009
By DIKKY SINN
Associated Press Writer
HONG KONG (AP) — Hong Kong police have arrested four employees of a drug manufacturer for allegedly lying about the expiration dates on more than 200 over-the-counter medicines, officials said Friday.
Marching Pharmaceutical Ltd. has had its license suspended for one month while authorities look into claims the company was selling medicines with expiration dates that went beyond a product’s shelf life, a Health Department spokesman said on condition of anonymity, citing internal policy.
Authorities have also ordered the company to recall 216 products — including dozens of cough syrups and antifungal creams, he said.
The spokesman said the products being recalled are low-risk drugs and that there was no immediate risk to human health.
Police arrested four employees Thursday in connection with the case. They have been released on bail pending further investigation, police spokesman T.K. Ng said.
Nobody has fallen ill from using the company’s products, but the Health Department spokesman said “some of the documents provided by this company are not consistent, so we’ve asked police to step in and investigate.”
Repeated calls to MPL rang unanswered Friday.
Copyright 2009 The Associated Press.
–According to http://www.news.gov.hk
Department of Health Chief Pharmacist Anthony Chan stressed that the case only involved product stability – not safety of the products which were low-risk drugs.
The recalled products are low-risk drugs. Most are non-prescription products including vitamins, minerals and cough and cold preparations. Others are prescription topical preparations such as skin creams.
The manufacturer has set up a hotline, 2781 6320, to answer questions.
