News Archives
New study shows failure rate of Medtronic Sprint Fidelis Leads are significantly higher than previously known
More than 235,000 patients received a Medtronic Sprint Fidelis Lead, an electrical cable that connects a defibrillator to a patient’s heart. A Class 1 Recall was issued by the FDA on October 15, 2007, for Medtronic Sprint Fidelis Leads with model numbers 6930, 6931, 6948, and 6949 manufactured from September of 2004 through October 15, 2007. ...
Broward County Jury Awards $8 Million to Smoker's Widow
On February 18, 2009, a Broward County jury ordered Philip Morris to pay $8 million to Elaine Hess, the widow of a smoker who died of lung cancer due to his addiction to nicotine that caused him to chain smoke two packs of cigarettes daily for decades. In apportioning fault for Stuart Hess’ death, the jury found him 58% responsible and Phillip...
New England Journal of Medicine study confirms HRT breast cancer link
New study findings published in the New England Journal of Medicine on February 5, 2009, supports the theory that the decline in U.S. breast cancer rates is largely related to a decrease in combined hormone therapy use among postmenopausal women and was unrelated to changes in frequency of mammography. The study indicated that women on hormones...
Attorneys General from 27 States Reach Settlement with Bayer Corp. over misleading TV ads for birth control product Yaz
On Monday, February 9, 2009, a settlement was reached between Attorneys general from 27 states (including the State of Florida) and Bayer Corp. over misleading TV ads that suggested the oral birth control pill Yaz was approved for and effective in treating PMS and acne. The settlement terms call for Bayer Corp. to spend $20 million correcting...
Pfizer Agrees to Buy Wyeth for $68 Billion
Marking the largest pharmaceutical acquisition in nearly a decade, Pfizer, Inc., the world’s largest drug manufacturer announced today it will buy Wyeth for about $68 billion in a cash and stock acquisition valued at $50.19 per share. The deal happened as New York-based Pfizer is facing a host of issues including the expected loss of $13 billion...
Criticism Mounts over Digitek Recall
The Institute for Safe Medicine Practices (ISMP) Quarter Watch, a monitoring program that evaluates serious Adverse Event Reports submitted to the FDA, published a critical report on January 15, 2009, illustrating how the April 2008 Digitek (digoxin) recall was mishandled by the FDA and the drug manufacturer Actavis. Although the April 2008 recall...
Government Accountability Office's report to Congress declares the FDA is in dire need of improvement
In a report released to Congress today, the U.S. Government Accountability Office (GAO) said its ongoing investigation of the FDA confirmed widespread concerns about serious weaknesses within the FDA that compromise its ability to fulfill its mission of ensuring the safety and efficacy of drugs, medical devices, and biologics. This latest...
Controversy erupts between US Department of Health & Human Services and FDA over missing financial data
On Monday, January 14, 2009, the U.S. Department of Health & Human Services (HHS) published a scathing review of its investigation into the FDA’s oversight of physicians overseeing clinical trials and the sponsoring drug manufacturers in hopes of detecting financial conflicts of interest often disguised as consultant fees, educational...
FDA Scientists complain of widespread FDA managerial misconduct to Obama transition team
A group of nine FDA scientists submitted a letter to the President-elect Obama transition team expressing frustration and outrage regarding the FDA’s scientific review process for medical devices and claim that the system of approving medical devices has been corrupted by current FDA managers. They claim in their letter that questionable...
Federal Medtronic Sprint Fidelis Lead Cases Dismissed with Prejudice on Grounds of Federal Preemption
All Medtronic Sprint Fidelis defibrillator lead lawsuits pending across the country were previously consolidated before Judge Richard H. Kyle of the U.S. District Court for the District of Minnesota. Early on in this litigation, Medtronic filed a motion to dismiss these lawsuits on the basis that federal regulatory preemption blocked the filing of...
