Posts for the 'Defective Products' Category
Medtronic Lead Recall: Update letter sent with information about lead performance
Medtronic, Inc. recently issued an open letter to patients who have one of their recalled Sprint Fidelis defibrillator leads. The letter, which is dated May 9, 2008, notifies patients that the risk of lead problems remains small and the recommendations they are making to doctors are unchanged. More detailed information about lead performance was sent to physicians the same day, to update their October 2007 communication, now that six months have passed since the recall.
>>INFORMATION: Medtronic Defibrillator Lead Recall
Trasylol recall issued
Although Bayer AG agreed to stop marketing their heart surgery injection Trasylol in November 2007, they are now removing any remaining stock of the drug from the U.S. market following a study published in the New England Journal of Medicine. The Trasylol recall was issued after data from a Canadian study confirmed that those treated with the injection faced a substantial increased risk of death.
>>INFORMATION: Trasylol Recall Lawsuits
Digitek Class Action Lawsuits filed
Two weeks after a nationwide Digitek recall, several class action lawsuits have already been filed on behalf of users who took the heart drug. Manufacturing problems resulted in some tablets being sold with twice as much of the active medication as they were supposed to have. While Digitek class action suits are seeking reimbursement for the cost of the prescription medication and funding for medical monitoring, those who have suffered severe injuries or death after taking Digitek, should consider pursuing an individual lawsuit.
Baxter faces Heparin lawsuits following blood thinner recall
A nationwide heparin recall was issued earlier this year after blood thinner manufactured by Baxter International was found to be linked to a sharp increase in severe allergic-type reactions and deaths. Last week another FDA alert was issued after it was discovered that the tainted heparin may still be in supplies carried at hospitals and medical facilities throughout the United States. Although many companies face potential liability for the contamination, Baxter addressed the heparin lawsuits they face during their annual shareholder’s meeting last week.
>>INFORMATION: Baxter Heparin Lawsuits
Ortho Evra recall urged by consumer group
Today the FDA received a petition filed by Public Citizen Health Research Group asking that the agency issue an Ortho Evra recall. The consumer advocacy group asked the FDA to remove the birth control patch from the market due to the risk of serious and potentially fatal injury associated with its use.
>>INFORMATION: Ortho Evra Side Effects
Despite concerns about side effects of Chanitx, Pfizer’s ad campaign resumes
Chantix is a stop smoking drug which was heavily advertised by Pfizer in direct-to-consumer advertisements until earlier this year. Most of the branded ads were pulled after safety concerns emerged about psychiatric side effects of Chantix which could increase the risk of suicide. However, new ad campaigns are beginning to resurface, now with information about the suicide risks disclosed.
>>INFORMATION: Side Effects of Chantix
Digitek recall letters being sent by pharmacies
Following last weeks Digitek recall, people are receiving phone calls and pharmacy letters notifying them that their heart drug may be unsafe. All lots of the Digitek, a generic form of digoxin, were removed from shelves after it was discovered that some tablets could contain twice the appropriate amount of the active drug. This could increase the risk of digitalis toxicity, a serious and potentially fatal illness. In an unusual move, pharmacists are being required to attempt to notify all customers who filled a prescription.
>>FDA LINK: Generic Digoxin Recall
Composix Kugel Hernia Mesh Lawsuits have been filed by over 2,000 people
According to an annual report recently filed by C.R. Bard, Inc, over 2,000 people have already filed Composix Kugel Hernia Mesh lawsuits. Thousands of other potential claims are currently being investigated by attorneys, and many more people could experience hernia repair problems in the future if they had one of the defective Davol/Bard hernia mesh patches implanted to repair a ventral hernia.
>>INFORMATION: Kugel Hernia Mesh Lawsuits
FDA concerned about Fentora problems with wider use
Cephalon, Inc. is attempting to seek FDA approval for Fentora tablets to be used for sudden pain in non-cancer patients who have already developed a tolerance to opioids. An FDA advisory panel is scheduled to meet on Tuesday to review the subject. Documents released in advance of the meeting indicate that the FDA is concerned that wider approval could have a “devastating effect” due to the risk of Fentora overdose and abuse.
Digitek Recall due to risk of Digitalis Toxicity
Last week Actavis Totowa announced a nationwide Digitek recall due to manufacturing defects which caused some of the digoxin tablets to contain double the appropriate amount of active ingredients. This could lead to a substantial risk of a serious and potentially fatal illness, known as digitalis toxicity, especially among those with renal failure. The lawyers at Saiontz, Kirk & Miles, P.A. are reviewing potential Digitek recall lawsuits throughout the United States.
