The King Nut Food Supply Company announced an immediate recall of their institutional brands King Nut and Parnell's Pride peanut butter. Minnesota State Health officials linked the country's latest outbreak of Salmonella food poisoning to tainted peanut butter. King Nut is a large scale distributor of peanut butter and other foodservice products to hospitals, schools, and nursing homes. The company does not manufacture their brand of peanut butter.
The peanut butter in question was produced by the Peanut Corporation of America, which issued a statement expressing dismay over the discovery of salmonella bacteria in a King Nut five gallon jar of peanut butter. However, the company instatly struck a defensive position, insisting that the chain of custody of that peanut butter jar had not been fully established, and more conclusive facts needed to be revealed.
Minnesota Health officials established in preliminary laboratory testing that the Salmonella found in a jar of King Nut peanut butter was identical to the strain responsible for the large outbreak of salmonella bacteria food poisoning in the United States since September of 2008. This same salmonella outbreak has been responsible for hundreds of cases of salmonella poisoning and hospitalizations in 42 states.
Saturday, January 31, 2009
Peanut Butter Recalls: Save Your Proofs of Purchases
I've been reading (as have most) about the recall of tainted peanut butter products. I think bad advice is being given in an overly simplistic way - that is, advice to simply "throw away" the bad product.
Obviously, most of the producers of the bad product hope most consumers throw away any proof they may have. I suggest you keep the jar lids as a bare minimum. Keep the proof of purchase or the label. You're going to need it later, perhaps.
Obviously, most of the producers of the bad product hope most consumers throw away any proof they may have. I suggest you keep the jar lids as a bare minimum. Keep the proof of purchase or the label. You're going to need it later, perhaps.
Wednesday, January 28, 2009
Denied Insurance Claim Blog Debuts
Blog just starting, http://deniedclaim.wordpress.com/
Posts include:
Health Insurance Takes a Hit; and
An article about a Court case involving Unum which states:
First Unum Life Insurance Co. has filed a petition for rehearing with the Second Circuit U.S. Court of Appeals, saying that the court “misapprehended key facts and law” when it recently decided that it arbitrarily denied long-term-care disability benefits to a tax attorney with colon cancer.
The court denounced the”arbitrary and capricious nature not only of Unum’s tactics against its insured, as well as its claims practices generally.
Unum’s insured sued First Unum in the U.S. District Court for the Southern District of New York, alleging bad faith denial of claims under an original and conversion policy. The Second Circuit reversed.
Posts include:
Health Insurance Takes a Hit; and
An article about a Court case involving Unum which states:
First Unum Life Insurance Co. has filed a petition for rehearing with the Second Circuit U.S. Court of Appeals, saying that the court “misapprehended key facts and law” when it recently decided that it arbitrarily denied long-term-care disability benefits to a tax attorney with colon cancer.
The court denounced the”arbitrary and capricious nature not only of Unum’s tactics against its insured, as well as its claims practices generally.
Unum’s insured sued First Unum in the U.S. District Court for the Southern District of New York, alleging bad faith denial of claims under an original and conversion policy. The Second Circuit reversed.
GTLA's 2009 Convention Highlights
Georgia Trial Lawyers April 2009 convention has been revamped. From the GTLA site:
With a completely redesigned format, this two-day extravaganza features multiple trackes covering a wide variety of topics for all practics areas!
* Champions Trial Skills College
* Civil Rights
* Class Actions/Mass Torts
* Criminal Defense
* Ethics/Professionalsim
* Evidence/Expert Witnesses
* Family Law
* Investor/Consumer Protection
* Motor Vehicle/Premises Liability
* New Plaintiffs Lawyers
* Professional Negligence
* Product Liability
* Social Security
* Technology
* Trucking
* Workers' Compensation
With a completely redesigned format, this two-day extravaganza features multiple trackes covering a wide variety of topics for all practics areas!
* Champions Trial Skills College
* Civil Rights
* Class Actions/Mass Torts
* Criminal Defense
* Ethics/Professionalsim
* Evidence/Expert Witnesses
* Family Law
* Investor/Consumer Protection
* Motor Vehicle/Premises Liability
* New Plaintiffs Lawyers
* Professional Negligence
* Product Liability
* Social Security
* Technology
* Trucking
* Workers' Compensation
Tuesday, January 27, 2009
FDA's Device Review Inadequacies: More
Here's this tidbit:
At least 228 medical devices between 2003 and 2007 were approved without a thorough evaluation, including about 24 high-risk devices such as heart defibrillators, artificial hip joints and electrodes for pacemakers, despite assurances from FDA officials that holes in the approval process were being addressed, according to the report by the GAO.
Nearly 230 devices in essence were crammed through the process? Read the complete GAO report here in PDF.
Source here.
At least 228 medical devices between 2003 and 2007 were approved without a thorough evaluation, including about 24 high-risk devices such as heart defibrillators, artificial hip joints and electrodes for pacemakers, despite assurances from FDA officials that holes in the approval process were being addressed, according to the report by the GAO.
Nearly 230 devices in essence were crammed through the process? Read the complete GAO report here in PDF.
Source here.
Saturday, January 24, 2009
FDA Heavily Criticized - Device Testing is Inadequate
From the NYT:
Most medical devices have never been shown to be safe or effective, and for the riskiest devices this must change, Congressional investigators from the GAO have concluded.
'In recent years, the accountability office, Congress’s auditing arm, has chastised the F.D.A. as failing to put into effect its own plan to protect the nation’s food supply, as failing to adequately inspect the foreign drug plants that provide most of the nation’s medicines and as being so hobbled by bureaucratic infighting that it fails to detect emerging drug dangers.
Each time, the agency has largely agreed with the investigators’ findings and promised to do better. The difference this time is that nine scientists within the agency’s device division are echoing critics’ claims of a corrupted review process.'
More here.
This should not come as a surprise, since the alarm has been sounded for years now. Nonetheless, with a failed system desperately in need of a ground up repair, courts simply shrug their shoulders and rely on a preemption preamble to shield device makers from being held accountable in a court. The FDA in its current form is a disgrace to the american public.
This same week, another report shows the mess that is the BPA investigation (the ingredient in some plastic bottles, including baby bottles). From the Trib:
"In late October, an advisory panel to the FDA found fault with the agency's conclusion [regarding BPA]. The panel said that the FDA had only considered studies financed by the plastics industry and had ignored evidence of the potential harm from BPA. The FDA created "a false sense of security" about the safety of BPA, the panel said." Link.
Got that? The FDA ignored evidence it had before it. Should Americans be frightened?
Most medical devices have never been shown to be safe or effective, and for the riskiest devices this must change, Congressional investigators from the GAO have concluded.
'In recent years, the accountability office, Congress’s auditing arm, has chastised the F.D.A. as failing to put into effect its own plan to protect the nation’s food supply, as failing to adequately inspect the foreign drug plants that provide most of the nation’s medicines and as being so hobbled by bureaucratic infighting that it fails to detect emerging drug dangers.
Each time, the agency has largely agreed with the investigators’ findings and promised to do better. The difference this time is that nine scientists within the agency’s device division are echoing critics’ claims of a corrupted review process.'
More here.
This should not come as a surprise, since the alarm has been sounded for years now. Nonetheless, with a failed system desperately in need of a ground up repair, courts simply shrug their shoulders and rely on a preemption preamble to shield device makers from being held accountable in a court. The FDA in its current form is a disgrace to the american public.
This same week, another report shows the mess that is the BPA investigation (the ingredient in some plastic bottles, including baby bottles). From the Trib:
"In late October, an advisory panel to the FDA found fault with the agency's conclusion [regarding BPA]. The panel said that the FDA had only considered studies financed by the plastics industry and had ignored evidence of the potential harm from BPA. The FDA created "a false sense of security" about the safety of BPA, the panel said." Link.
Got that? The FDA ignored evidence it had before it. Should Americans be frightened?
GA: Legislative Bill Tracker on GTLA's website
The Georgia Legislature is in session now, and the Georgia Trial Lawyers Association has a good session tracker for bills that may impact consumers.
You can see the work here.
Sample layout:
HB 0024 Work Evidence; revise, supersede, and modernize provisions; provide definitions Willard,Wendell 49th
House Second Readers Judy -
Pre-filed Bills Rules of Evidence
This bill attempts to modernize Georgia's Rules of Evidence and bring those rules more in line with the Federal Rules, both with Civil and criminal, without making substantive policy changes. GTLA has been a part of this process and has attended every meeting for the last 6 months. GTLA will continue to monitor this bill carefully.
It's worth a look.
You can see the work here.
Sample layout:
HB 0024 Work Evidence; revise, supersede, and modernize provisions; provide definitions Willard,Wendell 49th
House Second Readers Judy -
Pre-filed Bills Rules of Evidence
This bill attempts to modernize Georgia's Rules of Evidence and bring those rules more in line with the Federal Rules, both with Civil and criminal, without making substantive policy changes. GTLA has been a part of this process and has attended every meeting for the last 6 months. GTLA will continue to monitor this bill carefully.
It's worth a look.
Wednesday, January 21, 2009
MyDeniedClaim.com Debuts
MyDeniedClaim.com site debuts. From that site:
HOW CAN WE HELP
Helping people battle insurance companies is our life’s work. If you or someone you care about is being mistreated by an insurance company, hopefully we can help. By law, insurance companies have to treat you fairly. Here is some helpful information. We've obtained real results for real people.
HOW CAN WE HELP
Helping people battle insurance companies is our life’s work. If you or someone you care about is being mistreated by an insurance company, hopefully we can help. By law, insurance companies have to treat you fairly. Here is some helpful information. We've obtained real results for real people.
Tuesday, January 20, 2009
FDA Warning Regarding Skin Numbing Products
The Food and Drug Administration has issued an advisory to remind patients, caregivers and health professionals about the potentially serious hazards of using skin-numbing products -- topical anesthetics -- for relieving pain from conditions and medical tests, including mammograms. The warning applies to over-the-counter anesthetics as well as prescriptions.
A topical anesthetic works by blocking the skin's pain sensations. When used, it appears that some of the anesthetic may can pass through the skin and into the bloodstream.
Under these circumstances, the amount of anesthetic medication that reaches the bloodstream is unpredictable and may be high enough to cause life-threatening adverse effects such as irregular heartbeat, seizures, breathing difficulties, coma and even death.
The FDA warning is here.
From the FDA site:
The FDA strongly advises consumers not to:
* make heavy application of topical anesthetic products over large areas of skin;
* use formulations that are stronger or more concentrated than necessary;
* apply these products to irritated or broken skin;
* wrap the treated skin with plastic wrap or other dressings; and
* apply heat from a heating pad to skin treated with these products.
A topical anesthetic works by blocking the skin's pain sensations. When used, it appears that some of the anesthetic may can pass through the skin and into the bloodstream.
Under these circumstances, the amount of anesthetic medication that reaches the bloodstream is unpredictable and may be high enough to cause life-threatening adverse effects such as irregular heartbeat, seizures, breathing difficulties, coma and even death.
The FDA warning is here.
From the FDA site:
The FDA strongly advises consumers not to:
* make heavy application of topical anesthetic products over large areas of skin;
* use formulations that are stronger or more concentrated than necessary;
* apply these products to irritated or broken skin;
* wrap the treated skin with plastic wrap or other dressings; and
* apply heat from a heating pad to skin treated with these products.
Rhino MDL Hearing: 1/29/09
The U.S. Consumer Product Safety Commission is currently considering new standards for Yamaha Motor Corp. USA's Rhino off-road vehicle and other currently unregulated "utility terrain vehicles." The Yamaha Rhino, which was first introduced in 2003 by Yamaha Motor Corp., is a side by side four wheel all-terrain vehicle (ATV), which is a cross between smaller recreational off-road vehicles and larger utility vehicles
Several plaintiffs who have cases are requesting that the 57 Rhino ATV now pending lawsuits be transferred from 33 different U.S. District Courts to one court where they will be coordinated as part of an MDL, or Multidistrict Litigation.
We're hearing that at least one Defendant wants to have the cases transferred to the United States District Court in Georgia. My bet is that is where the litigation will end up, at least when it comes to federal court cases.
An MDL is a federal procedure which allows multiple cases with common underlying facts to be consolidated for pretrial litigation in a manner similar to how a Yamaha Rhino class action lawsuit would be managed. However, throughout the litigation the cases remain individual claims, and if the litigation does not settle or otherwise resolve during pretrial proceedings, the cases are returned to the original jurisdiction where they were filed for a jury trial.
The Judicial Panel on Multidistrict Litigation will consider the Motion filed by some of the plaintiffs to form a Yamaha Rhino ATV Products Liability MDL at a hearing scheduled for January 29, 2009 at the U.S. Courthouse and Federal Building in Fort Myers, Florida.
Several plaintiffs who have cases are requesting that the 57 Rhino ATV now pending lawsuits be transferred from 33 different U.S. District Courts to one court where they will be coordinated as part of an MDL, or Multidistrict Litigation.
We're hearing that at least one Defendant wants to have the cases transferred to the United States District Court in Georgia. My bet is that is where the litigation will end up, at least when it comes to federal court cases.
An MDL is a federal procedure which allows multiple cases with common underlying facts to be consolidated for pretrial litigation in a manner similar to how a Yamaha Rhino class action lawsuit would be managed. However, throughout the litigation the cases remain individual claims, and if the litigation does not settle or otherwise resolve during pretrial proceedings, the cases are returned to the original jurisdiction where they were filed for a jury trial.
The Judicial Panel on Multidistrict Litigation will consider the Motion filed by some of the plaintiffs to form a Yamaha Rhino ATV Products Liability MDL at a hearing scheduled for January 29, 2009 at the U.S. Courthouse and Federal Building in Fort Myers, Florida.
Thursday, January 15, 2009
Sprint Fidelis Litigation: Court Dismisses Cases Based on Preemption
My office investigated issues relating to Sprint Fidelis and their recall back in 2007. What are Sprint Fidelis Leads? Made by Medtronic Sprint Fidelis Leads are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that protect patients when life-threatening heart rhythms occur.
I was concerned about how preemption would play out regarding these, so we decided to pass. I felt badly for folks who had these recalled leads in their bodies; the looming preemption effect would turn out to be significant.
Last week, a Court dismissed all cases involving the leads. The decision is here. (PDF)
All 21 counts of the Master Complaint were dismissed. With prejudice. Will there be an appeal? Talking to lawyers who chose to take a chance by filing suit in the hopes that an injured person would obtain some measure of justice, as of yet many are undecided as to what to do. Many lawyers are now waiting on two major developments: The Wyeth v. Levin SCOTUS decision, and likely legislation in Congress regarding preemption.
Stay tuned.
I was concerned about how preemption would play out regarding these, so we decided to pass. I felt badly for folks who had these recalled leads in their bodies; the looming preemption effect would turn out to be significant.
Last week, a Court dismissed all cases involving the leads. The decision is here. (PDF)
All 21 counts of the Master Complaint were dismissed. With prejudice. Will there be an appeal? Talking to lawyers who chose to take a chance by filing suit in the hopes that an injured person would obtain some measure of justice, as of yet many are undecided as to what to do. Many lawyers are now waiting on two major developments: The Wyeth v. Levin SCOTUS decision, and likely legislation in Congress regarding preemption.
Stay tuned.
Study: Antipsychotic Drugs Increase MI Risks
Heart attack risks were near two times great for those people taking antipsychotic drugs such as Zyprexa and Risperdal - at least that is what a study found, released by the NEJM. The article is here.
The risk of heart attack for people getting the newer drugs, actually increased with their dosage, says thestudy authors.
Here is the Conclusion: Current users of typical and of atypical antipsychotic drugs had a similar, dose-related increased risk of sudden cardiac death.
The risk of heart attack for people getting the newer drugs, actually increased with their dosage, says thestudy authors.
Here is the Conclusion: Current users of typical and of atypical antipsychotic drugs had a similar, dose-related increased risk of sudden cardiac death.
Tuesday, January 13, 2009
Is the Current Economy Creating More "TV" Lawyers?
Everyone has seen the injury lawyers on TV. Everywhere, and for many of us the ads from injury lawyers are inescapable.
I travel extensively throughout the south, and in the past 4-8 months, and especially the last two months, I have seen lawyers advertising in areas other than personal injury.
I am now seeing on TV and hearing on radio ads for bankruptcy lawyers with increasing regularity. This week alone, three different firms' ads on the radio alone. Divorce lawyers, criminal law attorneys, even in Florida a lawyer advertising that he can help you stop or workout a foreclosure.
I see billboards for many of these new entrants in the media markets. Some billboards are filled with nonsense, including a roster - in small print no less - of ALL of the types of work a firm does.
For those jumping into advertising, time and again I see the same mistakes. Lawyers simply fail in the basics, such as mentioning the law firm number enough times. Worse, there is a difficult to recall number (a big pet peeve of mine on radio ads). In one ad, the attorney used (592)406-2758. It was a mess, and only repeated twice.
My suggestions:
1.If you choose to advertise, get a toll free or local number, and make sure each is easy to remember. 866 is ok; perhaps use a vanity number, like my friend's use of 888-4ACCUTANE.
2.If you mention a .com in any ad, make it easy. I also heard something like, stopforeclosuresnowlaw.net. Can anyone spell that, much less remember it?
Buy a .com that is the same as your number, so that the ad can have a tag that says, "our website's the same as our number." Bill Harrell in Jacksonvile, FL goes this route, and it is memorable.
3.Don't give me 60 seconds of crap, a lecture filled with jargon. Without music. Radio ads should max out at 30 seconds, and 15 seconds works just as well. I actually heard an ad start with something like, "At the firm of Big and Pompous, we are skilled in the following areas ... ." Really? "In the following areas?" I don't know anyone other than lawyers who talks like that.
4. Speak english. When I spoke with a lawyer from the NE asking for help with an ad, the lawyer and I fought over, and I kid you not, her insistence to say in an ad, "If you took {drug here} and have any of the following sequelae ... " Use terms like "we can help." Don't use, call now for a free consultation, as if using those words separates you from the pack. They don't. I know.
5. Billboards- 1 billboard may make you feel better, but in a city like Atlanta, you might as well just throw your money in the trash. I see one firm's billboard on the way to the airport. It's been there for a couple of years, and trees' leaves partially obscure it in the spring and summer. I asked the lawyer if it worked, and he said, "not really." The number? You got it, hard to recall.
My best suggestion - use an agency to develop a marketing. Alas, the lawyers who could benefit most from suggestions like there probably won't take the time to scan the internet for posts like these. You know the lawyers ... either so worried about their current approach or so arrogant about what 'works' that they won't take the time to perform due diligence.
I travel extensively throughout the south, and in the past 4-8 months, and especially the last two months, I have seen lawyers advertising in areas other than personal injury.
I am now seeing on TV and hearing on radio ads for bankruptcy lawyers with increasing regularity. This week alone, three different firms' ads on the radio alone. Divorce lawyers, criminal law attorneys, even in Florida a lawyer advertising that he can help you stop or workout a foreclosure.
I see billboards for many of these new entrants in the media markets. Some billboards are filled with nonsense, including a roster - in small print no less - of ALL of the types of work a firm does.
For those jumping into advertising, time and again I see the same mistakes. Lawyers simply fail in the basics, such as mentioning the law firm number enough times. Worse, there is a difficult to recall number (a big pet peeve of mine on radio ads). In one ad, the attorney used (592)406-2758. It was a mess, and only repeated twice.
My suggestions:
1.If you choose to advertise, get a toll free or local number, and make sure each is easy to remember. 866 is ok; perhaps use a vanity number, like my friend's use of 888-4ACCUTANE.
2.If you mention a .com in any ad, make it easy. I also heard something like, stopforeclosuresnowlaw.net. Can anyone spell that, much less remember it?
Buy a .com that is the same as your number, so that the ad can have a tag that says, "our website's the same as our number." Bill Harrell in Jacksonvile, FL goes this route, and it is memorable.
3.Don't give me 60 seconds of crap, a lecture filled with jargon. Without music. Radio ads should max out at 30 seconds, and 15 seconds works just as well. I actually heard an ad start with something like, "At the firm of Big and Pompous, we are skilled in the following areas ... ." Really? "In the following areas?" I don't know anyone other than lawyers who talks like that.
4. Speak english. When I spoke with a lawyer from the NE asking for help with an ad, the lawyer and I fought over, and I kid you not, her insistence to say in an ad, "If you took {drug here} and have any of the following sequelae ... " Use terms like "we can help." Don't use, call now for a free consultation, as if using those words separates you from the pack. They don't. I know.
5. Billboards- 1 billboard may make you feel better, but in a city like Atlanta, you might as well just throw your money in the trash. I see one firm's billboard on the way to the airport. It's been there for a couple of years, and trees' leaves partially obscure it in the spring and summer. I asked the lawyer if it worked, and he said, "not really." The number? You got it, hard to recall.
My best suggestion - use an agency to develop a marketing. Alas, the lawyers who could benefit most from suggestions like there probably won't take the time to scan the internet for posts like these. You know the lawyers ... either so worried about their current approach or so arrogant about what 'works' that they won't take the time to perform due diligence.
Sunday, January 11, 2009
FDA Scientists Complain to Obama About Managerial Misconduct
Here is something worth watching: News from the FDA's scientists. A group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the FDA.
"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, written on the agency's Center for Devices and Radiological Health letterhead.
The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx.
In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.
"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said.
Why does this matter? Because all is not as it seems when it comes to medical device approval it now seems. So, when a Court considers the FDA's preamble in knocking out potentially legitimate injury claims, it shows that the very foundation of a drug's approval is shaky, IMO. It's not a clean system, and obviously protectionist legislation solved nothing.
More here.
"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, written on the agency's Center for Devices and Radiological Health letterhead.
The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx.
In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.
"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said.
Why does this matter? Because all is not as it seems when it comes to medical device approval it now seems. So, when a Court considers the FDA's preamble in knocking out potentially legitimate injury claims, it shows that the very foundation of a drug's approval is shaky, IMO. It's not a clean system, and obviously protectionist legislation solved nothing.
More here.
Monday, January 05, 2009
Another Fentanyl Patch Recall
PriCara®, announced that one lot of 50 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and one lot of 50 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).
The company has identified a condition in the manufacturing equipment that has since been corrected. The condition resulted in a cut-system defect in a small number of affected patches in the lots being recalled.
ALZA Corporation of Mountain View, CA, an affiliate of PriCara, manufactured the patches being recalled. DURAGESIC 50 mcg/hr (fentanyl transdermal system) patches and Sandoz Inc. 50 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir.
The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel.
As per the approved product labeling for DURAGESIC, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are cut or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly wash exposed skin with large amounts of water only; do not use soap, alcohol, lotions, oils or other products to remove the medicine gel because they may increase the medicine's ability to go through the skin.
Source here.
The company has identified a condition in the manufacturing equipment that has since been corrected. The condition resulted in a cut-system defect in a small number of affected patches in the lots being recalled.
ALZA Corporation of Mountain View, CA, an affiliate of PriCara, manufactured the patches being recalled. DURAGESIC 50 mcg/hr (fentanyl transdermal system) patches and Sandoz Inc. 50 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir.
The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel.
As per the approved product labeling for DURAGESIC, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are cut or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly wash exposed skin with large amounts of water only; do not use soap, alcohol, lotions, oils or other products to remove the medicine gel because they may increase the medicine's ability to go through the skin.
Source here.
Sunday, January 04, 2009
Article Detailing Antibiotics' Dangers (Cipro, Levaquin)
From the AJC and excellent reporter Alison Young:
"When Dr. J.T. Cooper hobbles around his Marietta medical office, the boot brace on his right foot is a reminder of a danger posed by some of the most popular —- and misprescribed —- antibiotics on the market.
Like thousands of others who have taken Levaquin, Cipro and other fluoroquinolone antibiotics, Cooper suffered a near-rupture of his Achilles tendon. Tendon side effects have been reported for at least 20 years, but drug makers only began sending letters to doctors warning them of the problem in recent months."
:In 2007, U.S. patients received more than 40 million prescriptions for fluoroquinolone antibiotics, according to IMS Health, a health care information company. Some studies have found these drugs are often misprescribed, chosen first by doctors when other antibiotics are more appropriate —- or when none are needed."
Read more here.
While rare, the tendinitis and tendon rupture side effects can be disabling, making it difficult or impossible to use the affected limb. In some cases surgery is required to repair the tendon. Cooper said he was hospitalized for six days and lost two weeks of work. After weeks in the boot brace, he is only now being allowed brief periods out of it, in a special shoe. It will be the end of the month before he can start driving again.
The experience, he said, is prompting him to limit prescribing fluoroquinolones for his patients when other antibiotics will work, and to try to get the word out to other doctors and patients.
“I don’t want other people to experience the same thing,” said Cooper, 73.
"When Dr. J.T. Cooper hobbles around his Marietta medical office, the boot brace on his right foot is a reminder of a danger posed by some of the most popular —- and misprescribed —- antibiotics on the market.
Like thousands of others who have taken Levaquin, Cipro and other fluoroquinolone antibiotics, Cooper suffered a near-rupture of his Achilles tendon. Tendon side effects have been reported for at least 20 years, but drug makers only began sending letters to doctors warning them of the problem in recent months."
:In 2007, U.S. patients received more than 40 million prescriptions for fluoroquinolone antibiotics, according to IMS Health, a health care information company. Some studies have found these drugs are often misprescribed, chosen first by doctors when other antibiotics are more appropriate —- or when none are needed."
Read more here.
While rare, the tendinitis and tendon rupture side effects can be disabling, making it difficult or impossible to use the affected limb. In some cases surgery is required to repair the tendon. Cooper said he was hospitalized for six days and lost two weeks of work. After weeks in the boot brace, he is only now being allowed brief periods out of it, in a special shoe. It will be the end of the month before he can start driving again.
The experience, he said, is prompting him to limit prescribing fluoroquinolones for his patients when other antibiotics will work, and to try to get the word out to other doctors and patients.
“I don’t want other people to experience the same thing,” said Cooper, 73.
Friday, January 02, 2009
Healon D Recall News
FDA Announces Class I Recall of Ophthalmic Surgical Device:
The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif.
OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.
On Oct. 30, 2008, AMO voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS). At that time, AMO informed customers of the number and nature of adverse event reports associated with OVD from that lot, and included a fax reply form for quick communication.
However, as of December 3, 2008, AMO had retrieved only 964 units of the 1,450 that had been distributed in the United States.
AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.
TASS is a post-operative, acute inflammation of the anterior segment of the eye (the front third of the eye including the cornea, iris and lens). TASS has been linked to solutions and devices used during eye surgery, such as OVDs, intraocular lenses and irrigation solutions.
The FDA urges anyone in possession of any units from the recalled lot, whether units were purchased from the company or provided as a sample by a sales representative, to remove them from inventory, and contact AMO at 1-877-AMO-4Life to make arrangements for return. The lot number of the device is displayed on the side panel of each unit.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to AMO by calling 1-877-AMO-4LIFE and to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif.
OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.
On Oct. 30, 2008, AMO voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS). At that time, AMO informed customers of the number and nature of adverse event reports associated with OVD from that lot, and included a fax reply form for quick communication.
However, as of December 3, 2008, AMO had retrieved only 964 units of the 1,450 that had been distributed in the United States.
AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.
TASS is a post-operative, acute inflammation of the anterior segment of the eye (the front third of the eye including the cornea, iris and lens). TASS has been linked to solutions and devices used during eye surgery, such as OVDs, intraocular lenses and irrigation solutions.
The FDA urges anyone in possession of any units from the recalled lot, whether units were purchased from the company or provided as a sample by a sales representative, to remove them from inventory, and contact AMO at 1-877-AMO-4Life to make arrangements for return. The lot number of the device is displayed on the side panel of each unit.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to AMO by calling 1-877-AMO-4LIFE and to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
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