Florida Appellate Decisions of Note

Bryant v. Tarma, 21 So.3d 137: Florida does not allow the owner of a single cause of action to split it into more than one lawsuit. Plaintiff brought separate suits - one for property damage, another for injuries - which could only be brought in one action.

SunTrust Bank v. Electronic Wireless Corp., 34 FLW D2461 (Fla. 3d DCA 11/25/09): It is not proper to quash service on the basis that a Summons did not provide information in Spanish and Creole. The FCP's Form 1.902, suggests but does not mandate other languages within the Summons.


Dr. Navarro's Vein Centre of Palm Beach, Inc. v. Miller, 34 FLW D2395 : A Plaintiff who had brought suit versus a doctor, claiming injuries caused by laser hair removal must comply with Florida's medical malpractice pre-suit requirements.

Diaz-Hernandez v. State Farm Fire & Cas. Co., involved an insured who was denied coverage for UM benefits because he failed to join the at fault, uninsured mortorist in an action against the UM carrier, so as to obtain a judgment against the uninsured motorist. The Court held that such requirement violated Florida's UM statute and created unenforceable requirements.

GlucoPro Insulin Syringes Voluntarily Recalled

A voluntary nationwide recall of all GlucoPro Insulin Syringes (Nipro Medical Corporation) is now proceeding according to the FDA.

The alert sent Friday from MedWatch, the FDA's safety information and adverse event reporting program, notes that syringes may have needles that detach from the syringe.

"If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection," the FDA states.

To date, no injuries have been reported, the manufacturer states in a written release.

The recall includes all product codes and lot numbers with expiration dates before 2011-11 (November 1, 2011). The syringes were distributed throughout the United States and Puerto Rico. The manufacturers are recommending that consumers who have these syringes stop using them and return them to the seller for reimbursement.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198445.htm

Savella Raises Concerns at Public Citizen

Public Citizen has ased the FDA pull the fibromyalgia drug Savella from the market.Savella belongs to a class of drugs called serotonin and norepinephrine reuptake inhibitors (SNRIs), which include some antidepressants.

In its petition to the FDA, Public Citizen said that the European Medicines Agency (EMEA), which regulates drugs on the Continent, rejected Savella's approval for fibromyalgia in July 2009, stating that its benefits were "marginal." This was shortly after the FDA approved the drug in January 2009.

Since the drug went on the market in the U.S., approximately 250,000 prescriptions have been filled, with doctors writing more prescriptions every month.

Savella, also known by its generic name milnacipran, was found in two studies to possiblly increase blood pressure, heart rate and suicidal thoughts.

http://www.citizen.org/publications/release.cfm?ID=7723

Meridia: Heart Attack Warning Added to Label; Banning urged n Europe

The FDA is warning doctors that weight loss pill Meridia may increase the risk of heart attack and stroke in patients with a history of heart problems.

The FDAis adding new labeling to the drug, stressing that it should not be used in patients with heart failure, hypertension, irregular heart beats and other problems.

Meridia was introduced into the market in 1997 as a weight loss pill. It's Sibutramine, and can be found as sibutramine hydrochloride monohydrate.

The European Medicines Agency advised doctors to stop prescribing medicines containing sibutramine, which are sold under the names Reductil, Reduxade and Zelium in Europe and Meridia in the United States.

"The risks of these medicines are greater than their benefits," EMEA said in a statement.

The European Commission will consider the recommendation for suspension of marketing approval.

Source

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Merck: Did it Hide Vioxx Data?

A recent study published in the Archives of Internal Medicine has revealed that information about heart risks from pharmaceutical giant Merck's Vioxx drug was available in 2000, four years before the Merck pulled the drug from the market. Because the information was not published and made public, Merck may have sat on it until a later clinical trial openly revealed that the drug was causing strokes and heart attacks.

A Merck spokesman, denied the claims that any link could be observed and complained about the methods used by researchers to come to this conclusion, despite acceptance of the findings following a rigorous peer review process.

Find the abstract here.

FDA About to Weigh in on Tanning Beds

he Food and Drug Administration has finally decided to consider stricter warnings about use of the devices and the risk of cancer. The study released by WHO revealed that use of tanning beds by individuals before the age of 30 increases the risk of melanoma, the deadliest type of skin cancer, by 75 percent.


The FDA says its advisors will hold public hearings on tanning bed safety in March, and that the topics of discussion will be the possibility of stricter regulations, increased cancer warning requirements, and possibly reclassifying tanning beds as a more controlled type of medical device. The current FDA classification for tannings beds puts them on par with bandages.

Source

Quick Tech Take: PDFmyURL.com

PDFmyURL will make a PDF file when you type in a web address. If you just want a PDF of a URL, PDFmyURL.com is a breeze.

From the site:

Simply link the text or image you want people to use for downloading a specific page/url like this:

http://pdfmyurl.com?url=www.opentracker.net


http://pdfmyurl.com/

Recall: Tylenol, Children's Tylenol, Eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children's Motrin, Motrin IB, Benadryl, Rolaids, Simply Sleep and St. Joseph's aspirin

From the company website:

Based on this investigation, McNeil Consumer Healthcare has determined that the reported uncharacteristic smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). This can result from the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials. The health effects of this chemical have not been well studied but no serious events have been documented in the medical literature. A small number of the product lots being recalled were associated with the complaints of an unusual moldy, musty, or mildew-like odor, and some of these lots were found to contain trace amounts of TBA. In December 2009, McNeil Consumer Healthcare also recalled all lots of TYLENOL® Arthritis Pain 100 count with EZ-OPEN CAP related to this issue. McNeil Consumer Healthcare has now applied broader criteria to identify and remove all product lots that it believes may have the potential to be affected, even if they have not been the subject of consumer complaints.

In addition to the product recall, McNeil Consumer Healthcare is continuing their investigation into this issue and is taking further actions that include ceasing shipment of products produced using materials shipped on these wood pallets and requiring suppliers who ship materials to our plants to discontinue the use of these pallets. We will continue to closely monitor and evaluate the situation and consult with the FDA.

Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

http://www.mcneilproductrecall.com/

FDA Warns: Watch out for Counterfeit Alli

Preliminary tests by the FDA revealed that the counterfeit version does not contain orlistat — the active ingredient in the product — but instead contains sibutramine.
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The counterfeit Alli has been sold over the internet in 60-mg capsules as part of a 120-count refill kit.

The FDA warns that sibutramine should not be used in certain patient populations or without physician consent because it may counteract with other medications.

Differences in packaging between the counterfeit and authentic product include:

* Missing lot code on outer cardboard packaging
* Expiration date with the month, day and year (e.g., 06162010) whereas the authentic Alli expiration date includes only the month and year (e.g., 05/12);
* Packaging in a plastic bottle with a slightly taller and wider cap with coarser ribbing;
* Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “Sealed for your protection” and;
* Larger capsules with a white powder, instead of small white pellets.

Link to the FDA post here: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197862.htm

Recall of HappyBaby Products, and the Company's Reply

A well reasoned plain english letter to the public that's timely and worth a read:

I want to be the first to tell you about a voluntary recall we’ve issued for our recently released HAPPYTOT Stage 4 and the new HAPPYBABY Stage 1 and Stage 2 pouch products. In the past few days, we’ve learned of a minor manufacturing issue that has caused a packaging defect that could lead to product spoilage. These products were only shipped in mid-December to a total of 250 stores, but we can never be too careful in letting people know.

There have been no illnesses at all related to this voluntary recall, and while the packaging defect could lead to the development of spoilage, there is no danger or health threat involved based on our thorough investigation and lab results. We’re asking that you don’t feed these products to your child and instead return them to the place of purchase for a full refund. We are voluntarily recalling all packages produced in the last batch, of which we believe there to be a packaging defect that could have affected less than half of one percent. Those products with the defect could swell up and leak. If you have fed any product to your child, we have no indication at all from extensive lab testing that you should be concerned.

We caught this problem early on and are erring on the side of caution—that’s how we work at Nurture, Inc. Because the safety and health of our young children are our first concern and because we’re committed to upholding the highest quality standards possible, we’ve decided to voluntarily remove these items from distribution until we can learn more about what is causing the issue.

As a mother-to-be who’s expecting my first child literally in the next few days, I am even more intensely aware of how important it is to serve your children the healthiest and safest food available on the market. Please know that we are taking every step to fix this situation and are working quickly to ensure that these new and incredibly popular pouch products will soon be available to your family. We need to take it one step at a time to make doubly sure our high standards for our product integrity is upheld. Despite this hiccup, our dedication to your family’s safety and health is unwavering.

For more information about the recall and for instructions to determine if your products are included, click here. Also see our list of Frequently Asked Questions as well as lists of the Target and Whole Foods stores at which these pouches were sold. Please don’t hesitate to call us directly with any questions you might have at 718-852-7606 or info@happybabyfood.com This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Sincerely,

Shazi Visram
Imminent Mother-to-be
Founder and CEO

http://www.happybabyfood.com/index.php?option=com_content&view=article&id=186:voluntary-recall-of-new-pouch-products-due-to-packaging-defect&catid=52&Itemid=135

FDA Issues Update on BPA

Bisphenol A (BPA) is an industrial chemical that has been present in many hard plastic bottles and metal-based food and beverage cans since the 1960s.

Studies employing standardized toxicity tests have thus far supported the safety of current low levels of human exposure to BPA However, on the basis of results from recent studies using novel approaches to test for subtle effects, both the National Toxicology Program at the National Institutes of Health and FDA have some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children. In cooperation with the National Toxicology Program, FDA’s National Center for Toxicological Research is carrying out in-depth studies to answer key questions and clarify uncertainties about the risks of BPA.

In the interim:

* FDA is taking reasonable steps to reduce human exposure to BPA in the food supply. These steps include:
o supporting the industry’s actions to stop producing BPA-containing baby bottles and infant feeding cups for the U.S. market;
o facilitating the development of alternatives to BPA for the linings of infant formula cans; and
o supporting efforts to replace BPA or minimize BPA levels in other food can linings.
* FDA is supporting a shift to a more robust regulatory framework for oversight of BPA.
* FDA is seeking further public comment and external input on the science surrounding BPA.

FDA is also supporting recommendations from the Department of Health and Human Services for infant feeding and food preparation to reduce exposure to BPA.

FDA is not recommending that families change the use of infant formula or foods, as the benefit of a stable source of good nutrition outweighs the potential risk from BPA exposure.

Georgia Court of Appeals Alliows Electronic Filing

The Georgia Court of Appeals has begun accepting briefs electronically this week.

Chief Judge M. Yvette Miller said the court expects to allow additional types of electronic filings, such as motions and requests for extensions or oral argument, by the end of January.

E-filing is required by the 11th U.S. Circuit Court of Appeals and the Northern District of Georgia, as well as in many Fulton State Court and some Fulton County Superior Court cases.

Source.

MuscleMaster.com: Voluntary Nationwide Recall of Body Building Products

Northborough, MA – January 15, 2010 – MuscleMaster.com, Inc. ("MuscleMaster.com") announced today that it is conducting a voluntary nationwide recall of all lots and expiration dates of the seventeen below listed dietary supplements sold between June 1, 2009 and November 17, 2009 (hereinafter "Recalled Products").

FDA informed MuscleMaster.com that it believes that the Recalled Products contain ingredients that are steroids. Specifically, FDA advised MuscleMaster.com of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol." While MuscleMaster.com cannot independently confirm the FDA's concerns, that any one or more of the Recalled Products in fact contain these ingredients, MuscleMaster.com is undertaking this voluntary recall out of an abundance of caution and in deference to FDA’s stated concerns.

Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

MuscleMaster.com is recalling the following products:

Advanced Muscle Science Dienedrone, 60 caps
Advanced Muscle Science Liquidrone, 60 ml
Anabolic Formulation M1, 4AD, 60 caps
Anabolic Formulations 1, 4 AD, 60 caps
Anabolic Xtreme Hyperdrol X2
Anabolic Xtreme 3-AD, 90 caps
BCS Labs Testra-Flex, 90 caps
Competitive Edge Labs M-Drol, 90 Caps
Competitive Edge Labs P-Plex, 90 caps
Competitive Edge Labs X-Tren, 90 caps
4Ever Fit D-Drol, 60 caps
Gaspari Novedex XT 60 Caps
Gaspari Halodrol Liquigels, 60 gels
iForce 1,4 AD BOLD 200, 60 Caps
iForce MethaDROL, 90 caps
iForce Dymethazine, 60 caps
Monster Caps, 60 caps

MuscleMaster.com has not received any complaints of illness or injury regarding these products. FDA is concerned the products may present a safety risk to consumers who ingest them. MuscleMaster.com is an internet retailer and did not manufacture or formulate these products. MuscleMaster.com’s decision to implement this recall is not, and should not be construed as, an admission that their decision to sell these products was in violation of the law. In addition it is not, and should not be construed as, an admission that these products are not in compliance with the law. This recall is solely a reflection of MuscleMaster.com’s deference to the FDA’s stated concerns with these products.

Recall of Motrin, Benadryl and Rolaids

Varieties of Motrin, Rolaids and Benadryl- over the counter medications in wide use across the country- are now also being recalled for the “moldy, musty smell” and ensuing illness experienced by some consumers.

The products were recalled due to contamination with a substance that causes vomiting, nausea, diarrhea and other gastrointestinal symptoms. The FDA claims that McNeil knew of the issue with 2,4,6-tribromoanisole, thought to stem from exposure to storage pallets, for more than a year but did not take adequate measures to inform the public of the dangers posed by the affected medication.

New Seroquel Print Ad has 5 PAGES of Disclaimers

Yes you read that right ... from the folks over at bnet.com, take a gander at it - PDF Alert:

http://i.bnet.com/blogs/seroquel-ad.pdf?tag=content;selector-perfector

If a drug has five full pages of "information" or disclosure, or waivers, etc. what does that tell you about taking it? Ask your doctor.

Company Will Not Recall Ozone Generators

A California company won't recall something that isn't "broke" or so says the company rep.

The FDA said Applied Ozone Systems, in Auburn, Calif., claims its ozone generator devices treat cancer, AIDS, hepatitis, herpes and other infections and diseases.

Chuck Ankeney, owner of the company, said he is selling the ozone generators as water purifiers and he's not claiming they are medical devices.

"You do a recall on something that's broke. You don't do it on their claims," he said. "It's all based on misinformation and lies." Source here.

His company has not responded to an FDA letter dated Dec. 21. In the letter, the FDA requests that the company recall its AOS-1M ozone generator and AOS-1MD ozone generator devices.

The company's Web site says these devices, which sell for $750 and $1,200, can be used for colon cleansing, killing bacteria and viruses as well as wound healing. The company states only at the end of a Web page that the generators are not sold as medical devices.

Here is information from the page

Hurricane Katrina: Lawsuit based on Death of Hospital Patient Proceeds in Louisiana

Once the power blinked out, Althea LaCoste's lungs were on their own. She struggled to breathe without the help of a respirator, and even a team of nurses hand-bagging air into her ailing lungs couldn't save her, according to court documents. LaCoste, 73, died before she could be evacuated from Pendleton Memorial Methodist Hospital in the chaotic days after Hurricane Katrina.

LaCoste's death 4½ years ago is at the center of a civil lawsuit being heard here that could have far-reaching implications for hospitals across the country. The lawsuit against Methodist Hospital is the first civil suit alleging negligence of a hospital staff in Katrina's aftermath.

Here is the article: Link.

I disagree with a hospital industry's statement in that article that:"A verdict against the hospital would open up a Pandora's box for other unrelated incidents," Also, a professor remarked: "The LaCoste lawsuit could make hospitals across the country liable if their power gets knocked out by snowstorms, tornadoes or other calamities, says Edward Sherman, a Tulane University law professor following the case."

Here, you have a case not relating to medical malpractice, in a state where the laws are different that those of any other state. As one authority explains: Great differences exist between Louisianan civil law and common law found in all other American states. Property, contractual, business entities structure, much of civil procedure, and family law are still strongly influenced by traditional Roman legal thinking. Louisiana law retains terms and concepts unique in American law: usufruct, forced heirship, redhibition, and lesion beyond moiety are a few examples.

Second, it's one thing to read the pleadings, the issues, and the allegations/admitted facts. It's quite another to suggest that a snowstorm that knocks out power will now cause liability to arise in say Iowa because of one jury verdict in Louisiana.

If you do nothing else this year, read The Great Deluge. It's a detailed look at what happened just before, during, and after Katrina not only in New Orleans but in the Gulf South.

Powerful Opinion Piece on Georgia's Victims of Medical Wrongdoing

This is a must read. I take it whole cloth from http://georgiajustice.blogspot.com/:

In Georgia, Middle Ground for Victims of Medical Wrongdoing?
How many hoops should you have to jump through to get justice? It's a fair question that many people struggle with. Yesterday, the CEO of a Georgia medical services company suggested - in an opinion piece submitted to a GA newspaper - that to be sure that Georgians who have been harmed by negligent medical care are worthy of justice we should subject them to one more hoop. Not coincidentally, it's a hoop that benefits only medical professionals and insurance companies – the only two interest groups that profit when injured patients are prevented from securing justice.

What the author of the opinion has proposed is that, instead of allowing victims of medical malpractice the same Constitutional Right to Trial by Jury enjoyed by all other Georgians, people harmed by medical wrongdoing/malpractice would have to get permission to have a jury trial from a “screening panel” comprised of members of the medical and insurance industries, the same industries that want to avoid compensating injured patients. This approach is wrong and adds an unnecessary, ineffective layer to our civil justice system.

The fact is all medical malpractice cases brought in Georgia have already been through multiple screening hoops. The first hoop is that you have to have had something very bad happen as a result of malpractice. Your next hoop is that you have to find a lawyer willing and able to take your case. That lawyer will tell you that there is another, special hoop that protects only professionals charged with negligence. In order to pass through that hoop, the patient must find a medical professional willing to publicly criticize their colleague and sign a document swearing that malpractice happened. So far your case has been screened three times: Something bad happens. You find a lawyer who will invest in helping you find justice. And, you find another doctor who agrees that there was malpractice and is willing to say so. Then there’s a fourth screening before you can have a jury hear your case: the judge must screen the case, too.


Our Founding Fathers created the world's best independent screening panels when they imbedded the right to a trial by jury in our Constitution. You are entitled to a jury of your peers, not a two step process, the first of which is a trial by jury of the defendant's colleagues. We trust the people of our communities to fairly resolve our disputes when we are unable to resolve them ourselves.

The CEO cites an approach tried in Maine as being the right fit for us here in Georgia. He fails to mention that this approach is regularly criticized by the Supreme Court of Maine as being inadequate and harmful to the people of Maine. He cites, as a reason for needing “screening panels,” a Georgia case involving a plastic surgeon who carelessly destroyed the blood supply to a woman’s face and left her horribly disfigured. He suggests that this woman – who was horribly injured through no fault of her own and who successfully navigated all of the legal hurdles to hold the wrongdoer accountable for herself and other patients – has not done enough. He says she needs to clear yet another hurdle to prove herself worthy of a jury trial. The suggestion is outrageous and it serves no purpose but to deny those who have been harmed their fair measure of justice.


Why should patients who have been harmed by medical malpractice have to go through two trials when everyone else only has to go through one? Why should medical professionals get special treatment? It's a question with an obvious answer: They shouldn't.

Risperdal and Invega Lawsuits filed

Lawsuits have been filed n behalf of boys and young men who developed serious side effects - including the growth of breasts - while taking the antipsychotic medications Risperdal and Invega.

The drugs are made by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., which is part of Johnson & Johnson.


Risperdal and Invega are antipsychotic drugs with similar chemical structures and side effects, Sheller said. In children and adolescents, Risperdal is FDA-approved for treatment of schizophrenia, bipolar mania, and symptoms of autism.

From Drugs.com:

Important information about Risperdal

Risperdal is not for use in psychotic conditions related to dementia. Risperidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

Do not give Risperdal to a child without a doctor's advice.

While you are taking Risperdal, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking this medication. Risperdal can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of Risperdal. Stop using this medication and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.

There may be other drugs not listed that can affect this medication. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Philips Issues Voluntary Recall Notice: Avalon Fetal Monitors

The Food & Drug Administration prompted Philips Healthcare (AEX:PHI) to issue a voluntary recall notice on four models of its Avalon fetal monitor after receiving complaints that the devices were providing inaccurate readings.

The Dutch company, which houses its U.S. headquarters in Andover, Mass., received numerous complaints about Avalon monitor models FM20, FM30, FM40 and FM50.

Philips did not believe a recall was necessary, but the federal watchdog agency compelled it to provide further instructions on how to use the devices properly and issued a voluntary recall notice in the January edition of Patient Safety News, which is sent out to healthcare providers.


Here's the Notice: PDF Alert.

Tysabri: Four More Cases of PML

Biogen Idec Inc (BIIB.O) said on Wednesday that four more patients taking its multiple sclerosis drug Tysabri had developed a potentially deadly brain infection known as PML in November, bringing the total to 28.

The biotech company said it will release the number for December soon.

Progressive multifocal leukoencephalopathy (PML), also known as progressive multifocal leukoencephalitis, is a rare and usually fatal viral disease that is characterized by progressive damage (-pathy) or inflammation of the white matter (leuko-) of the brain (-encephalo-) at multiple locations (multifocal).(Via Wiki



Source here.

Faulty Catheters Recalled

Plymouth-based Ev3 Inc. has recalled several models of a catheter that may crack during medical procedures and cause serious injury, according to the Food and Drug Administration.

The federal agency said the recall of Ev3's Trailblazer support catheter was initiated Nov. 6, 2009, but the recall notice was posted on the FDA's website today.

The FDA, citing eight models and 27 lots of the Trailblazer catheter, gave the recall its most-serious designation -- Class 1 -- which means there is "reasonable probability that use of these products will cause serious adverse health consequences or death."

The FDA said the devices were manufactured from Sept. 11 to Sept. 29, 2009, and distributed from Sept. 21 to Oct. 27, 2009.

Source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm196266.htm

FDA: 26 New Drugs in 2009; 25 in 2008

Image via Wikipedia

Federal regulators approved 26 new medicines in 2009 compared with 25 in 2008, though several key drugs that were expected to reach store shelves didn't.

The U.S. Food and Drug Administration approved 26 first-of-a-kind medicines in 2009, more than in any of the prior four years, according to an analysis by the research firm Washington Analysis.

New products include two drugs to treat advanced kidney cancer: GlaxoSmithKline's (GSK) Votrient and Novartis AG's (NVS) Afinitor. Also approved were a new blood thinner from Eli Lilly & Co. (LLY) and Daiichi Sankyo Co. (4568.TO), called Effient, and a medicine from Sanofi-Aventis SA (SNY), Multaq, that restores heart rhythm.

Effient and Multaq are being closely watched by analysts as they can be used to treat large populations and have the potential to be billion-dollar-a-year drugs.

Source here.

Gov't Panel seeks Blackbox Warning for MRI Drugs

MRI imaging drugs from GE Healthcare (GE.N) and Covidien (COV.N) appear linked to a higher risk of a potentially fatal skin disease for some patients than similar products.

'A majority of the Food and Drug Administration panel felt current data showed GE's Omniscan and Covidien's Optimark were associated with a higher risk of nephrogenic systemic fibrosis (NSF) for patients with severe kidney disease, panel chairman Robert Harrington said.' Source.

Nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs. Its cause is not fully understood, but it seems to be associated with exposure to gadolinium (which is frequently used as a contrast substance for MRIs) in patients with severe kidney failure. It does not have a genetic basis.

In NSF, patients develop large areas of hardened skin with fibrotic nodules and plaques. Flexion contractures with an accompanying limitation of range of motion can also occur. NSF resembles scleromyxedema at the histologic (microscopic) level; it shows a proliferation of dermal fibroblasts and dendritic cells, thickened collagen bundles, increased elastic fibers, and deposits of mucin.

A black box warning is a notice on the packaging of a prescription drug which warns patients and prescribers that the drug has potentially dangerous side effects. This warning system is primarily used by the Food and Drug Administration (FDA), an American regulatory agency which oversees the safety of pharmaceuticals produced and sold in the United States. Other national regulatory agencies may use different systems to indicate that drugs are potentially dangerous.

When a drug receives a black box warning, it means that studies on the drug have suggested that it can have dangerous or even deadly side effects. Black box warnings are often added retrospectively as the result of information about a drug which has been uncovered in the course of routine usage. When doctors start reporting high levels of dangerous side effects for a prescription drug, the FDA may hold a review to decide whether or not the drug requires a black box warning.

The “black box” in “black box warning” refers to the bold black border which is drawn around the warning. The border is designed to draw attention to the warning, and to offset it from other information which may be present in pharmaceutical packaging. Thanks to widespread public awareness of the implications of a black box warning, a black box on drug packaging serves as an alert that the drug is dangerous even before people read the text of the warning.

OsmoPrep Lawsuits Filed

Four plaintiffs filed a complaint in North Carolina claiming that the use of a Salix Pharmaceuticals drug led to kidney damage.

The case revolves around the drug OsmoPrep, which is used to cleanse the intestines in preparation for a colonoscopy. A statement claims the parties sustained a variety of serious kidney injuries and that some of the injuries resulted in the need for dialysis. The statement says that the medical name for the plaintiffs’ condition is called acute phosphate nephropathy.

The U.S. Food and Drug Administration placed a “black box” warning – the most severe admonition possible – on OsmoPrep in December 2008. The FDA said that OsmoPrep and another Salix bowel cleanser, Visicol, carry the risk of kidney damage.

Source here.

Twitter: Value for your Law Practice?

Image via CrunchBase

I just completed my first year using Twitter.com. Twitter is -- reduced to its most basic - a real time scroller (like the ones you see on FOX News and CNN) for the goings on in life - news, rumors, gossip, etc. That holds true today. The news on Urban Meyer's resignation came to me via Tweet on my iPhone.

I had heard and read from many who said Twitter was an "absolute must" for a law firm or lawyer. After one year, I can't say it's a must. I am able to assess it and make these conclusions:

1.Twitter as a breaking news source: Quite good. I follow Anderson Cooper and others. On Twitter you were able to get a near ring-side seat for events ranging from the attacks in Mumbai to the ridiculous balloon boy.

2.Twitter for expanding your blog's visibility: For me, this one gets a partial grade of a C, as I think it's to be developed. This blog is ranked highly among lawyer blogs in terms of popularity (even in my niche). Twitter has given my blog a little push when I 'tweet' about a new blog post. Increasing my visibility as a lawyer is of course a goal. Where the end result for me and my firm's visibility is Google results. I have seen a small uptick.

3.Twitter for gaining new clients or potential clients:I practice consumer law - helping those who were injured because someone else was at fault in some act. I can tell you that Twitter had zero effect in developing clients. I first started - naively to be candid - to believe that Twitter would be mechanism for business development. Not so. In the future? Maybe. Just not now for me at least. If you're a personal injury lawyer who has actually developed clients from Twitter, I want to hear from you. If you're a personal injury lawyer, you make a mistake if you think Twitter will increase your client base.

With several different websites for my firm, I will tell you that websites (and blogs) will be by far the best way to spend your time if you you hope to develop business from the web for the near future.

On this blog earlier this year, I posted what one lawyer thought of Twitter:

9 Reasons You Need Social Media Marketing in 2009. Among those are:

4. More Social = more Search.
More Search = More Customers.
More customers = More business.

That is simply not the case in the PI area.


I have switched from believing that (in my field) Twitter would work to increase my client base, to one where I decided to follow other lawyers with helpful news and information. This leads to the next item:

4. Twitter as a resource: I have been able to locate vendors and support persons thanks to Twitter. I did so by actively seeking someone to, for example, help me with service of process in a Pacific state.I was able to find a vendor for office products. Could I have used Google to accomplish the very same thing? Probably, but I wanted to see what Twitter could or could not do.

I have tried to use Twitter to refer a number of matters, and it's just not there yet. In my practice, groups like the AAJ and my state bars are the best source for me to find someone to assist on a legal matter. According to Lextweet.com, there are 5856 lawyers with some form (inactive or active) of Twitter account. One list serve I belong to has more than 7,000 member subscribers.

It's probably too early to give Twitter a ringing endorsement, and too early to pan it. For me it's one more piece of my overall business effort. The 'ground war' is going to meetings, having lunches and visits with lawyers, and joining affinity groups in my city. The "air war" is my web presence, and Twitter will likely be a part of that effort.


This is my list of items so far. I'll be updating with more items later.

Comparison of Free Online Storage Sites

I've been checking out online backup storage for my office, and I have found many possible solutions. Worth checking out is a post on Lifehacker that compares many of the sites.

Take a look here, and good luck with your selection.

Recall of Tylenol Arthritis Pain Caplets

A voluntary recall of Tylenol Arthritis pain caplets is being expanded because of consumer reports of a moldy odor.

The recall affects the 100-count bottles. The FDA says the recall is specific to bottles with the distinctive red "EZ open" cap.

It's based on consumer reports of a foul smell on the medicine associated with nausea, stomach pain, vomiting and diarrhea.

The pills’ musty odor comes from trace amounts of a chemical known as 2, 4, 6-tribromoanisole, according to the company, which is believed to be from the breakdown of another chemical in wooden pallets used to transport and store the drug

From NPR: How A Bone Disease Grew To Fit The Prescription (Fosamax)

Interesting read at NPR about Osteoporosis and Fosamax. Osteoporosis is a disease that causes bones to become thinner, more porous and break more easily. It mostly affects elderly women, who can be devastated by a fall that breaks their hip. One in five elderly women who break a hip will die within a year. Osteopenia, it turns out, is a slight thinning of the bones that occurs naturally as women get older and typically doesn't result in disabling bone breaks.

NPR writes: "This is the story of how pills for osteopenia ended up in one person's
medicine cabinet, and in the medicine cabinets of millions of women like her all over the United States.

Read it here.

FDA: No Cancer Link to Vytorin

The FDA says an extensive data review shows there's no evidence that Merck's cholesterol drug Vytorin causes cancer, a suspicion raised last year by a patient study.

Still, the Food and Drug Administration says it cannot definitively rule out whether Vytorin is linked to a higher risk of cancer or death from cancer.

The FDA says it's examined all of the data from the study that first raised the alarm about a possible risk. It also has reviewed interim data from two very large studies that are still in progress.

Source here.

Nestle Gets FDA Letter Regarding Boost

In an early December letter to Nestle, the FDA told the company that it had mislabeled its Boost drink, which comes in flavors like chocolate, vanilla and strawberry, “as a medical food for the medical condition of ‘failure to thrive’ and also for ‘pre/post surgery, injury or trauma, chronic illnesses.’”

The FDA informed that federal guidelines explain that “medical foods must be for the dietary management of a specific disorder, disease, or condition for which there are distinctive nutritional requirements and must be intended to be used under medical supervision.”



Source here.

IKEA High Chair Recall

IKEA Home Furnishings is recalling LEOPARD Highchairs sold exclusively at IKEA stores nationwide from October 2009 to November 2009. The snap locks used to secure the seat to the frame can break and allow the seat and child to drop through the frame, posing a fall hazard. Detached snap locks can pose a choking hazard.

This recall involves all colors of the LEOPARD highchairs sold as a seat and a frame individually. The seat and tray has an adhesive label affixed to the underside with the words LEOPARD and “Made in Italy,” an eight-digit article number and a five-digit supplier number (19589).

Consumers should return the highchairs to any IKEA store for a full refund.

Consumers can also contact IKEA at (888) 966-4532 anytime, or visit at www.ikea-usa.com. More info at www.recalls.org.

Polaris ATV Recall

Polaris Industries Inc. is recalling 2009-2010 Polaris All-Terrain Vehicles (ATVs) sold nationwide from February 2009 to November 2009. The front suspension ball joint stem can separate from the steering knuckle and cause the rider to lose steering control, posing a risk of injury or death.

This recall involves model year 2009 and 2010 Polaris Sportsman ATVs with certain VIN numbers. A list of the recalled ATVs can be found at www.recalls.org.

AstraZeneca’s Swine Flu Nasal Spray Recalled for Lower Potency

AstraZeneca Plc recalled 4.7 million doses of its nasal spray version of the swine flu vaccine after routine tests showed a decline in potency, U.S. regulators said.

The doses remain safe, and people who have already been inoculated don’t need to get vaccinated again, said Norman Baylor, director of vaccines research and review for the U.S. Food and Drug Administration. About 3,000 of the affected doses remain in warehouses, and AstraZeneca will send recall notices to clinics that may have unused vials of the vaccine.


The link is here.

Prempro Verdict: $8 Million

A Philadelphia jury in January 2007 awarded Mary Daniel compensatory damages of $1.5 million in her lawsuit against Pfizer’s Wyeth subsidiary over its Prempro menopause treatment. The panel recommended she get more than $8 million in punitive damages if an appeals court found she was entitled to such an award because of bad conduct by the company, people with direct knowledge of the figure said.

The $8 million figure was sealed pending an appeal. A judge in Philadelphia refused last month to make it public. A Pennsylvania appellate court heard arguments in Wyeth’s challenge to the verdict on Dec. 1. Wyeth wants the jury’s $1.5 million compensatory award thrown out. Daniel’s lawyers are seeking to have punitive damages added to it.

Source and more here.

Does Chelation Therapy Cause Heart Injuries?

Chelation therapy is a recognized treatment for heavy metal (such as lead) poisoning. EDTA (Ethylenediamine tetraacetic acid) is injected into the blood and binds the metals, allowing them to be removed from the body in the urine.A potent chelator of cations, especially calcium, it is FDA-approved only for rapid, emergency treatments of hypercalcemia or digitalis toxicity,and for those indications it has long been obsolete. Source.

Na2EDTA is specifically contraindicated for “generalized arteriosclerosis.” Its labeling includes a “black box” warning: “The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy." You can find the warning here: http://www.circare.org/foia2/endrate_ppi19740716.pdf



Chelation therapy is not approved by the FDA to treat coronary artery disease, but some physicians and alternative medicine practitioners use it for this purpose.

In August 2002, the National Center for Complementary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI), which are both components of the National Institutes of Health (NIH), announced the launch of the Trial to Assess Chelation Therapy (TACT). This placebo-controlled, double-blind study involves participants age 50 years and older who’ve had a heart attack, and is expected to reach a total enrollment of 1,950. Participants are representative of the U.S. population.

Last August, the federal Office of Human Research Protections began a probe into whether the people in the study were being fully informed of risks and adequately protected. Researchers then suspended enrollment.

The most common immediate side effects of oral chelation therapy include: skin rashes, redness and swelling, headaches, diarrhea, nausea, fainting, fatigue, joint pain, body aches, cramps and convulsions.

Kidney damage from chelation therapy has resulted in permanent damage requiring ongoing dialysis. Deaths have also occurred during chelation therapy from kidney failure and cardiac arrhythmia.

Death and permanent injury have resulted from chelation therapy, even in doctor-supervised clinical trials. The American Heart Association warns of severe and life-threatening side effects and does not endorse chelation as a treatment for heart disease.

Other observers have reported cases of hypocalcemia leading to cardiac arrhythmias and tetany; kidney damage; decreased blood clotting ability with abnormal bleeding; thrombophlebitis and embolism; hypoglycemia and insulin shock; severe vasculitis and autoimmune related hemolytic anemia, dermatitis with pruritus and generalized eczema; and extensive clumping of platelets in the blood of some patients with atherosclerosis and other chronic diseases.

M-Drol and P-Plex -Link to Liver Injuries?

Both M-Drol and P-Plex were supplements were marketed on the Internet by a company in Galveston, Texas called TF Supplements.

Some say that the main ingredients in M-Drol and P-Plex are methylated compounds known to cause liver damage. It has been claimed that the supplements were manufactured by a company called Competitive Edge Labs, a foreign corporation working in Virginia. Making and distributing the supplements is not against the law.

If you took either or both of these and have liver injuries now, call us.

Law Tech: 2009's Most Useful Tech Items

Here are tech apps/hardware that I think are "best" when it comes to helping my office in the practice and business of law:

1.iPhone- I'm old enough to remember when computers for lawyers were a rarity. In 1991 I remember an older partner literally yelling at me that "computers are for secretaries!" when he saw a PC on my desk. Could anyone today imagine practicing law without one?

I'd put the iPhone on the list of essential tools. If you don't have one, in my opinion you are at a disadvantage. Apps for it are key - Dragon dictate, access to key documents, email with PDF capability, the ability to fill out, sign and annotate any PDF document while away from the office (Zosh), and more. The blog iPhoneJD.com is a must read. If you're one of those dinosaurs who proudly proclaims that you only use your phone to make calls, well, the meteor is headed your way, and it has an Apple logo on it. If you have a smart phone like a BBerry, at least you're getting closer.


2.Speak Write: This is a transcription service. A transcript is processed by trained professionals located in the U.S. and Canada, without the use of voice recognition software. You can dictate from anywhere and receive your completed work via email, 24 hours a day, 7 days a week, in about 3 hours. Since you can dictate using a variety of methods, no special equipment or software is required; you can be signed up and dictating within minutes. Speak-write.com


3.Scansnap:


Especially for smaller firms like ours, the Fujitsu ScanSnap scanner takes the complication out of document imaging with one-touch ease of use. It's the size of a football, is sturdy (I've dropped it twice), lightning fast, and relatively inexpensive. I've taking it to document reviews and have been able to have 1000's of pages scanned while reviewing papers.



4.Google Desktop: Google Desktop is desktop search software made by Google for Mac OS X, Linux, and Microsoft Windows. The program allows text searches of a user's e-mails, computer files, music, photos, chats, and Web pages viewed.

We have indexed the documents on our servers, and now can search our "google-style" for items. Cost? Free.





5.Dual Monitors: More and more you are seeing dual monitors. I have two, and it helps a great deal. Using dual monitors allows you to eliminate scrolling and window switching. You may not even be aware of how often you are moving things around now. It’s very easy to get used to two monitors and to determine the best way for you to work with them.

On my desk, our client database and contacts are on one monitor, and my work items are on another.

I also have two 23" monitors, and that's been a great help as well.

6.RingCentral: RingCentral Office delivers a virtual PBX, VoIP phone service and IP phone as one complete system. It's cheap, and here is how I use it: I sign up for an account, and then use that number to track any google ad words buy we use. At any one time, I may have 2-4 web sites active with either google ad buys or simply as informational sites. It helps me measure the success of the site separate and apart from any emails or forms filled out. It's cheap, easy to use and yes, there's a free app for that for the iPhone. On the iPhone it looks like this:



7.Phonetag: From their site: PhoneTag automatically converts your voicemail into text and delivers it directly to your mobile phone, Blackberry, Goodlink enabled phone and/or your email account; so you can read your voicemail.

I love it.

There you have it. Email me if any of those help.

SCOTUS to review Texting Privacy Ruling

The Supreme Court has granted certiorari regaarding a federal appeals court in California that reading text messages sent on devices provided by the employer violated the worker's privacy rights and amounted to an "unreasonable search" barred by the U.S. Constitution. The case is City of Ontario v. Quon, 08-1332.

The city appealed to the Supreme Court, saying employers typically have policies in place establishing that workers have no expectation of privacy in electronic communications on employer-owned equipment.

The PDF opinion may be found here.

Source here.

Roman Blind Recall

The federal government - via the CPSC - has issued a recall of Roman Blinds that they could suffocate kids.

For the first time, the safety commission now recommends using only cordless window treatments in any home where children live or visit, such as a grandparent's house or day care center.


From USA Today:

HOW TO MAKE KIDS SAFER

1. Install only cordless window treatments in all homes where children live or visit, especially in children's bedrooms.

2. Move all cribs, beds and furniture away from windows.

3. If not using cordless shades, cut the ends of pull cords, so that the loop can't form a noose.

4. Don't allow cords to dangle. Wrap cords around a hook that's high off the floor out of a child's reach.

5. If using Roman shades with hidden strings on the back side, raise the shades high enough so children can't reach them.

Another Recall on an OTC Cold Remedy

The FDA reports that P&G has made a voluntary recall of specific lots of their Vicks brand nasal spray in the US, Germany and the UK.

The recall comes as a result of P&G finding the bacteria B. cepacia in these particular batches. There have been no reports of illness, and most healthy individuals should not be effected from this bacteria; however, the bacteria could cause serious illness in those with compromised immune systems such as those with Cystic Fibrosis or other chronic lung conditions.

The lot number in the US that is being recalled is 9239028831, which is for Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml Nasal Spray.

Antidepressants May Raise Women's Stroke Risk

That, according to a report released this week.You may find the abstract at the Archives of Internal Medicine.

Older women who ingest such antidepressants may have a small but statistically significant increased risk of stroke and death compared to women not on the medications, a new study finds.

"But statistical significance can be different from clinical significance," stressed Dr. Jordan W. Smoller, an associate professor of psychiatry at Harvard Medical School, and lead author of a report in the Dec. 14 issue of Archives of Internal Medicine. "It is possible that a statistically detectable effect may not be a problem for most people." Source.

The Report's conclusion: "In postmenopausal women, there were no significant differences between SSRI and TCA use in risk of CHD, stroke, or mortality."

FDA Warning on Steris Sterilizer

The Food and Drug Administration has warned doctors and hospital administrators that a widely used surgical tool sterilizer made by Mentor-based Steris no longer has the agency's "safe and effective" stamp and should not be used.

The product, called System 1, is used to sterilize medical tools such as endoscopes, bronchoscopes and other devices. It is used in hospitals, outpatient surgical centers and some physicians' offices.

Source here.

Alka Seltzer Recall

Bayer Healthcare is recalling 100,000 packages of Alka-Seltzer cold capsules because some lack warnings of possible drowsiness. The recall applies to Alka-Seltzer Plus Day & Night Liquid Gels. Bayer blamed the label omission on human error and said steps are being taken to prevent this from happening again.

Consumers who purchased packages from lot 296939L can contact Bayer for a refund at (800) 986-3307.


I like the product, and a thumbs up for Bayer's effort to recall the product.

Dietary Supplement Recall

Atlas Operations Inc. is recalling dietary supplements for sexual enhancement sold under about 37 brand names. The products might contain an ingredient not declared on their labels. The undeclared ingredient is similar to a Food and Drug Administration-approved drug used to treat erectile dysfunction, making these recalled products not approved drugs.

The interaction of the ingredient with some prescription drugs could lower blood pressure to dangerous levels. No illnesses or incidents have been reported, according to the Pompano Beach, Fla., company.

The products are being sold as dietary supplements online and in retail stores throughout the nation. Laboratory results found that products tested from certain batches of these brands contain the undeclared ingredient: Rock Hard, 72 Hours, Stamin It, Finally On Demand, Sexual Surge, Staminil and Vierect.

The recalled products have the following numbers in the middle of their lot codes: 494, 520C, 520B, 520A, 520, 521, 705, 706, 779 or 807.

AP source here, FDA here.

Slim-Fast Recall

Image via Wikipedia

The Food and Drug Administration (FDA) has issued a nationwide recall on cans of Slim-Fast ready to drink beverages because of a possible contamination with Bacillus cereus, a microorganism that can cause infected people to suffer from diarrhea, nausea and vomiting.


The recall involves all Slim-Fast ready to drink beverages in cans, regardless of flavor, best-by date or UPC number, the FDA said. No other Slim-Fast products are affected by the recall.

The company is in the process of identifying and correcting the production issue and will resume production and shipment as soon as the problem is remedied.

Consumers who have recently purchased ready to drink Slim-Fast beverages in cans are urged to discard them immediately and contact the company at 1-800-896-9479 for a full refund.

Source here.

FDA Investigating Brain Scans

Federal health regulators are investigating reports of dangerous radiation levels at two more California hospitals, following earlier unsafe medical scans at a Los Angeles facility.

The Food and Drug Administration is probing the use of CT scans at Glendale Adventist Medical Center and Providence St. Joseph Medical Center in Burbank, Calif. The brain scans are used to diagnose strokes.

For more, go here, the NYT Online.

First Gadolinium Trial Set to Begin in early 2010

On Monday a suit against Bayer Healthcare will begin in January, in front of San Francisco Superior Court Judge Curtis Karnow.

Peter Gerber's lawsuit accuses Bayer of negligently designing, testing and marketing Magnevist, a drug used to help doctors read MRIs, is one of hundreds of suits in California and elsewhere alleging that diagnostic drugs containing gadolinium have caused nephrogenic systemic fibrosis. And according to Gerber's lawyer, his suit is the first to be scheduled for trial.

Magnevist is a contrast agent used to improve magnetic resonance imaging. In 2007 the U.S. Food and Drug Administration requested that gadolinium-based agents such as Magnevist carry boxed warnings about the risk of contracting nephrogenic systemic fibrosis for patients with kidney problems.

Nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs. Its cause is not fully understood, but it seems to be associated with exposure to gadolinium (which is frequently used as a contrast substance for MRIs) in patients with severe kidney failure. It does not have a genetic basis.

In NSF, patients develop large areas of hardened skin with fibrotic nodules and plaques. Flexion contractures with an accompanying limitation of range of motion can also occur. NSF resembles scleromyxedema at the histologic (microscopic) level; it shows a proliferation of dermal fibroblasts and dendritic cells, thickened collagen bundles, increased elastic fibers, and deposits of mucin.

Most patients with NSF have undergone hemodialysis for renal failure, some have never undergone dialysis and others have received only peritoneal dialysis. Many patients have taken immunosuppressive medications and have other diseases, such as hepatitis C. Four of the five gadolinium contrast agents approved by the U.S. Food and Drug Administration have been principally implicated in NSF, including Omniscan, Multihance, Magnevist, and OptiMARK.

The first cases of NSF were identified in 1997.

Source here.

Trucking: Speed Limits to in crease

Image via Wikipedia

A new law takes effect next month increasing the speed limit for semi truck drivers from 55 to 65 miles per hour, but there are differing opinions on whether the new law is a good one.


"If everyone goes the same speed, it has to be safer," he said. "I think it's been proven other states' accident rates went down and I think it will also take a lot of pressure off the drivers. I don't think a lot of people want to go faster because of the threat of a speeding ticket."

More here.

FDA Fails to make safety changes Post Vioxx

The Food and Drug Administration still hasn't restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal.

That's according to congressional investigators who found that the FDA has yet to follow through on changes suggested in 2006 to help the agency detect problems with drugs taken by millions of Americans. Those recommendations came after the embarrassing and dangerous episode with Vioxx, a blockbuster pain drug the FDA approved in 1999, only to pull from the market in 2004 after linking it to heart attack and stroke.

More from the AP story.

Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes

Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.

Lawsuit: Denture Cream Caused Illness

From the Denver Post:

Doctors and specialists spent two years testing Rae Ann Schmaltz, initially believing she had multiple sclerosis but later looking for anything, including tropical diseases and Lou Gehrig's disease. She endured endless poking and prodding, including 160 blood tests, urine tests, MRIs, even spinal taps. All were negative.

And then, prodded by Schmaltz's 19-year-old daughter, they looked in her mouth.

Doctors now believe Schmaltz suffers from a copper deficiency caused by an abundance of zinc found in the Poligrip she used to secure her dentures.

For more, go here.

Federal Rules of Civ. Pro.: Computation of Time/Date Changes on 12/9/09

From the Judicial Conference Report:

“The principal simplifying change in the amended time-computation rules is the adoption of a “days-are-days” approach to computing all time periods. Under some of the current rules, intermediate weekends and holidays are omitted when computing short periods but included when computing longer periods. By contrast, under the proposed rules amendments, intermediate weekends and holidays are counted regardless of the length of the specified period. Other changes in the amended time-computation rules clarify how to count forward when the period measured is after an event (for example, 21 days after service of a motion) and the deadline falls on a weekend or holiday; and how to count backward when the period measured is before an event (for example, 14 days before a scheduled hearing) and the deadline falls on a weekend or holiday. The proposed amendments also provide for computing hourly time periods, to address recent legislation affecting court proceedings in which deadlines are expressed in hours (for example, 72 hours for action)."

Here is a list:

* The one-day period in Rule 6(c)(2) becomes seven days. The adjustment would extend the time for a party to serve any affidavit opposing a motion to seven days before a hearing.
* The one-day period in Rule 54(d) becomes 14 days. The increased time period corrects an unrealistic short time period for the clerk to give notice before taxing costs.
* The three-day period in Rule 55 becomes seven days.
* Five-day periods in Rules 32, 54, and 81 become seven days.
* The five-day period in Rule 6(c)(1) becomes 14 days. The adjustment extends the time for a party to serve a written motion and notice of hearing before the scheduled hearing date.
* Ten-day periods in Rules 12, 14, 15, 23, 38, 59(c), 62, 65, 68, 72, 81, and Supplemental Rule C become 14 days.
* Ten-day periods in Rules 50, 52, and 59(b), (d), and (e) become 28-day periods. The adjustment extends the present inadequate time allowed to prepare and file postjudgment motions. To prevent unfair results from these unrealistic short time periods, courts have avoided the rule by delaying entry of judgment or permitting timely filing of a barebones motion but permitting the brief to expand the stated grounds.
* The less-than-11-day period in Rule 32 becomes less than 14 days.
* Twenty-day periods in Rules 12, 15, 27, 53, 71.1, 81, Forms 3, 4, and 60, and Supplemental Rules B, C and G become 21 days.
* Rule 6(b)’s reference to provisions for extending the times set by enumerated provisions in Rules 50, 52, 59, and 60, and Rule 59(c)’s reference to a 20-day extension are eliminated.
* The timing provisions in Rules 56(a) and (c) are replaced by new provisions that recognize authority to set deadlines for summary-judgment motions by local rule or by court order and, in default of a local rule or court order, that allow a motion to be made at any time until 30 days after the close of all discovery. The new provisions also establish default times for response and reply.

Vicks Nasal Spray Recall

The Procter & Gamble Company has announced it is voluntarily recalling three lots of its Vicks Sinex nasal spray in three countries: the United States, Germany and the United Kingdom.

The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. B. cepacia poses little medical risk to healthy individuals.

P&G detected this problem during routine quality control at the plant and promptly took action. The company's analysis to date shows this problem is limited to a single batch of raw material mixture involving three lots of product. These three lots were sold only in the United States, Germany and the United Kingdom

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries. P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 (Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml., Nasal Spray) and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

Anyone who has these specific lots of this product can call P&G for a replacement coupon or refund at 877-876-7881

FDA Recalls Dietary Supplement

The FDA recalled three types of dietary supplements known as RockHard Weekend after the supplements were found to contain ingredients related to the active ingredients found in Viagra. The ingredient, sulfoaildenfil, was not listed by the company on the packaging label.

Sulfoaildenfil could cause serious injury or even death in some individuals. Sulfoaildenfil may interact with nitrates, an ingredient found in medicines that treat diabetes, heart disease, high blood pressure, and other conditions. This interaction may cause the person’s blood pressure to drop to dangerously low levels and could result in death.

RockHard Weekend is made by RockHard Laboratories and distributed nationwide. The products involved in the recall could have been purchased at several national retailers, gas stations and local markets. They were sold in both pill and liquid form. The Food and Drug Administration (FDA) recall includes the Blister Pack, 3ct. Bottle and 8ct Bottle.

Blair Expands Recall of Robes, Jackets and Tops

A Pennsylvania clothing company has expanded a recall of highly flammable bathrobes, as a Connecticut woman says the company's negligence led directly to her mother's fiery death. Blair LLC, based in Warren, Pa., initially recalled 162,000 of its chenille robes in April, as it announced that it had received reports of three deaths blamed on the robes' extreme flammability.


Blair and the Consumer Product Safety Commission (CPSC) have expanded that recall, as six additional deaths are linked to at least four types of chenille robes and other chenille products produced by the same manufacturer.

The expanded recall covers around 300,000 items. Products covered by the recall include full length women's chenille robes, women's chenille jacket, women's chenille lounge jackets, and women's chenille tops.

Recalled robes bear the item numbers 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. According to the CPSC, the items are one-piece garments made of plush sculpted chenille, a shaped stand collar, and horizontal chenille front and back yolks and cuffs. The robes have a full-button front with seven matching button closures.

Affected items were sold both in Blair catalogs and on the company's website, as well as Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from January 2003 through March 2009.

Vertebral Body Replacement Recall - Georgia/Florida News

I wrote about the recall in a prior post. Here's the lot information:

The recall applies to devices manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009. The devices included are:

• Part No. 04.808.001; Description: Ti Synex (TM) II Central Body 14 mm – 19 mm
• Part No. 04.808.002; Description: Ti Synex (TM) II Central Body 17 mm – 25 mm
• Part No. 04.808.003; Description: Ti Synex (TM) II Central Body 21 mm – 29 mm
• Part. No.04.808.004; Description: Ti Synex (TM) II Central Body 25 mm – 33 mm
• Part No. 04.808.005; Description: Ti Synex (TM) II Central Body 29 mm – 44 mm
• Part No. 04.808.006; Description: Ti Synex (TM) II Central Body 37 mm – 52 mm
• Part No. 04.808.007; Description: Ti Synex (TM) II Central Body 45 mm – 71 mm
• Part No. 04.808.008; Description: Ti Synex (TM) II Central Body 58 mm – 84 mm
• Part No. 04.808.009; Description: Ti Synex (TM) II Central Body 71 mm – 97 mm
• Part No. 04.808.010; Description: Ti Synex (TM) II Central Body 84 mm -110 mm
• Part No. 04.808.011; Description: Ti Synex (TM) II Central Body 97 mm -123 mm

Class 1 recalls are the FDA’s most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.

Vertebral Body Replacement Recall

Our office is investigating these claims:

FDA has notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ at six to fifteen months post implantation were received. Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery.


Surgeons and hospitals in possession of the subject devices must stop implanting them immediately. This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.



The recall involves part numbers 04.808.001-011, Synex II Central Body, Titanium (all lots).

FDA: Alcohol and Caffiene -Safe Together?

The FDA has contacted nearly 30 makers of caffeinated alcoholic beverages that it will look into the legality and safety of the products.

The FDA has not approved the use of caffeine in alcoholic drinks, so the drinks can only be lawfully marketed if the substance is "Generally Recognized As Safe," or GRAS. For a substance to be GRAS, there has to be evidence of it's safety.

Source here.

My question- what happens to Bourbon and Cokes? Irish Coffee? Will some be relegated to seeking out Rum and Caffeine Free Diet Coke?

FDA issues Class I recall of Edwards Lifesciences aortic catheter

The FDA has issued a Class I recall of Edwards Lifesciences CardioVations EndoClamp aortic catheter, after reports that the device can rupture during cardiac procedures.

The device is a balloon catheter used during bypass operations to block and monitor pressure within the aorta and deliver a drug to stop the heart, "may spontaneously rupture during surgery," according to the FDA recall.

The recalled devices, model numbers EC1001 and EC65, were manufactured between August, 2008 and August, 2009 and distributed from November, 2008 through September, 2009.


Source here.

Thank you Veterans

Today I hope folks will take a moment to say thank you to those veterans who have served our country in good times and bad, in the USA and elsewhere. They stand ready to make the ultimate sacrifice for our country.

In our groups of friends, I'm lucky to call one of our active military a friend. Whether it's a simply greeting, or something more elaborate is up to you.

Thank you from our family to those who served and serve now.



The above photo is from this article -

The State of Georgia is moving aggressively to help refugees of the nation of Georgia who suffered because of the recent hostilities with Russia. Twelve hundred pounds of emergency supplies were packed at Dobbins Air Reserve Base, destined for the more than 9,000 permanently displaced refugees living in tents and makeshift shelters in Georgia.

The supplies consist of medicines and medical supplies, medical protective clothing, and landmine first aid kits. The humanitarian assistance supplies are being donated by US Aid for International Development, US Public Health Service, and the Georgia National Guard.

This delivery is made possible by the coordinated effort of the Atlanta-Tbilisi Sister City Committee with the help of the Georgia National Guard.

Assisting in the packaging of the humanitarian aid was Letha Nesbitt, Subcommittee Chairman for Humanitarian Aid for the Atlanta-Tbilisi Sister City Committee and members of the Georgia Army and Air National Guard.

Recall of Certain Lots of Tylenol Arthritis

Good to see the folks at McNeil Consumer Healthcare taking a pro-active stance. From their site:

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is initiating a voluntary recall of a limited number of product lots of TYLENOL® Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP. McNeil is initiating the recall after identifying an uncharacteristic smell or taste associated with these lots that led to a small number of consumers reporting nausea and related symptoms. This recall includes five product lots only (Full list of lot numbers provided below), and does not include any other lots of TYLENOL® Arthritis Pain Caplet 100 count with EZ-OPEN CAP or any other TYLENOL® Arthritis Pain products. McNeil is implementing this recall as a precaution.

Consumers who purchased TYLENOL® Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) or log on to the internet at www.tylenol.com. Consumers who have medical concerns or questions should contact their healthcare provider.

Link: http://www.jnj.com/connect/news/all/20091106_120000

Last week, the Georgia Court of Appeals issued an opinion holding that State Farm, as a UIM carrier could pursue UM subro against a tortfeasor even though the insured had
signed a Limited Release.

Will this decision make it more difficult to settle a claim if the UM carrier doesn't waive subrogation? Stay tuned.

Excerpts from the decision:

The issue in this case is whether an uninsured motorist insurer can sue a tortfeasor for subrogation after the tortfeasor has been released from personal liability except to the extent that insurance coverage, other than the tortfeasor's personal liability policy, exists. Because we answer this question in the affirmative, we affirm the judgment of the trial court.

Accusure Insulin Syrine Recall

Accusure insulin syringes (Qualitest Pharmaceuticals, Inc) distributed nationwide from January 2002 through October 2009 are being voluntary recalled because of the possibility of detachment of the needles from the syringes.

The current recall is an expansion of a recall made in August for syringes produced between January 2007 and June 2008 as a result of the manufacturer receiving a complaint about a syringe not included in the first recall.

According to Carole Ben-Maimon, MD, senior vice president of corporate strategy for the manufacturer, the recall affects about 250 million syringes, although she told Medscape Medical News that many of those syringes have already been used. "It is not clear how many are still in circulation," she said.

"If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection," according to a statement from MedWatch, the FDA's safety information and adverse event reporting program.

"All Accusure Insulin Syringes regardless of lot number are subject to this recall," a company press release states. Lot numbers are found on the white paper backing of each individual syringe, according to the US Food and Drug Administration report.

The distributed syringes are of the following descriptions and NDC numbers: 28 G, 1/2 cc, NDC 0603-6995-21; 28 G, 1 cc, NDC 0603-6996-21; 29 G, 1/2 cc, NDC 0603-6997-21; 29 G, 1 cc, NDC 0603-6998-21; 30 G, 1/2 cc, NDC 0603-999-21; 30 G, 1 cc, NDC 0603-7000-21; 31 G, 1/2 cc, NDC 0603-7001-21; and 31 G, 1 cc, NDC 0603-7002-21.

For more go here.

Recall: Madol,Tren, Turinsabol and Andro

The business Bodybuilding.com has recalled 65 dietary supplement products sold online that may contain steroids, says the U.S. Food and Drug Administration.

The national and international recalls announced by the Boise, Idaho-based company include all lots and expiration dates of dietary supplements that might contain ingredients that are or should be classified as steroids, including "Superdrol," "Madol," "Tren," "Turinabol," and "Androstenedione."

From emaxhealth.com:

The FDA states they have conducted a two-year investigation in which products bought from bodybuilding.com were later tested positive for steroids. Unlike foods and drug products, dietary supplements are not approved for safety or efficacy by the FDA before they hit the market. Instead, under the Dietary Supplement Health and Education Act of 1994 (DSHEA), it is up to the manufacturer to make sure the product is safe. The FDA can only take action after the products are on store shelves.

The FDA conducted an investigation on September 24 at the Boise, ID warehouse and informed the company that that it believes that the recalled products may contain anabolic steroids. The following ingredients were called into question: superdrol, madol, tren, androstenedione, and turinabol. Anabolic steroids are considered controlled substances in the United States.

Most of the recalled items are taken for body mass and muscle building, and include brand names such as Advanced Muscle Science, Competitive Edge Labs, Diabolic Labs, IDS, Kilo Sports, and Myogenix. A full list of recalled lots is available on the both the FDA website and on bodybuilding.com.

Bodybuilding.com says that it has not yet had an opportunity to independently confirm the FDA’s concerns, but that they are focused conducting the voluntary recall as a precaution to protect the health of its customers. The company also states that it has contacted the manufacturers of the products and has received assurances that each is in compliance with federal law and do not contain unlawful ingredients.

Link here.

Prempro Verdict Appeal

Pfizer Inc. doesn’t have to pay more than $27 million in punitive damages to an Arkansas woman who blamed her breast cancer on the company’s menopause drugs, an appeals court ruled in ordering a new trial on the award.

The U.S. Court of Appeals in St. Louis today upheld a jury’s March 2008 finding that the hormone-replacement drugs helped cause Donna Scroggin’s cancer and its award of actual damages. The three-judge panel also backed a judge’s decision to throw out the punitive award to Scroggin, who alleged two Pfizer units ignored or downplayed the risks of the drugs.

“Scroggin presented sufficient evidence to submit the question of punitive damages to the jury,” the appeals court said in its 41-page ruling. “The evidence presented could allow a jury to find or infer that Wyeth was guilty of malicious conduct within the meaning of Arkansas law.”

Source and more at the link.