News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation.
Lawyers for consumers and injured people.(No advice on this blog, though)
mark(at)markzamora.com
Rho(D) immune globulin intravenous (WinRho SDF) get a black box warning about the risks of treating patients with immune thrombocytopenic purpura (ITP) after reports of some patients dying from intravascular hemolysis (IVH), per the FDA.
Some ITP patients treated with the immunoglobulin have developed IVH, which can lead to clinically compromising anemia and multisystem organ failure, including acute respiratory distress syndrome, according to an alert sent today by MedWatch, the FDA's safety information and adverse event reporting program.
Other serious complications reported after administration of WinRho SDF are severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation, according to the FDA.
Marketed under the brand names Procrit, Epogen and Aranesp, each can now be prescribed and dispensed only after hospitals and physicians prescribing them have certified that patients have been apprised of the drugs' risks.
New studies have found that cancer patients and others taking this class of medications have had higher rates of tumor growth and of heart attack, heart failure, stroke or bloodclots than patients who are not on the medication. Compared with patients not on medication, patients taking the erythropoeisis-stimulating agents (or ESAs) overall have been found to die sooner as well.
The Florida Supreme Court released its annual certification opinion on February 25. It called for 53 more county judges and 37 more circuit judges, citing rising caseloads around the state. The justices said the court system desperately needs the restoration of the 10 percent of its budget that was cut over the past three years, leading to 290.5 job cuts among supporting staff.
“The budget reductions and loss of positions sustained by the State Courts System over the last two fiscal years continue to be felt in every judicial circuit,” Chief Justice Peggy Quince wrote for a unanimous court. “We cannot overstate the causal relationship between the loss of supplemental resources and the increases in case processing times. When judges must absorb the workload of case managers, staff attorneys, or hearing officers, case processing times inevitably worsen. The net result is court delay.”
In county courts, the loss of traffic court hearing officers means that county judges have to handle nearly an extra 500,000 civil traffic cases a year.
Government meetings have to be open to the public, but that doesn't mean citizens have a right to speak at them, a Florida appeals court ruled.
"Appellants have failed to point to any case construing the phrase 'open to the public' to grant the public the right to speak."
The 1st District Court of Appeal cited previous Florida Supreme Court rulings that The public has no authority to participate in or to interfere with the decision-making process.
Pensacola activists filed suit against Community Maritime Park Associates, saying the board's decisions about a $40 million museum and waterfront park should be nullified because public-comment periods at its meetings were inadequate.
Upholding the right to send anonymous emails, a New Jersey appellate court has rejected a request to unmask a Gmail user who accused a student of underage drinking.
The court ruled that although high school student Alexandra Zubowski alleged she was libeled in the email, she didn't submit an affidavit stating the email's content was false. Without such a document, she had not presented a solid enough case of defamation to be able to unmask the sender, the court ruled.
Worth a read here: http://www.mediapost.com/publications/?fa=Articles.showArticle&art_aid=124213
The Consumer Product Safety Commission is investigating at least 14 deaths involving baby slings. Safety officials warned parents of the potential danger of carrying infants in them. From CBS:
Conference Calll:
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Scan2PDF Mobile: Uses the iPhone to scan documents and convert them to PDF files. It all happens on your phone allowing you to scan documents anywhere - as long as you have your phone.
The software enhances and compresses the output from the camera into a high-quality PDF which is then stored on your phone and can be emailed. Scan2PDF Mobile is compatible with almost all Windows Mobile phones as long as they have a built-in camera with a resolution of at least 1 mega-pixel.
$14.99
http://www.burrotech.com/index.php
ScanR:
scanR Business Center lets you scan, print, and fax from your iPhone 3Gs; it's like a scanner in your phone. Stop hunting around for that misplaced document, article, or invoice; instead save them instantly as searchable Adobe PDF files you can search from your computer, browser, or right on your iPhone.
Key Features:
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• print scans from your iPhone to any nearby fax machine
• streaming view for your files – quickly download what you need to see
• fax around the world directly from the iPhone
• share any file anywhere
• online storage gives access to any of your scans and faxes via web browser or iPhone
$50.
FeelHome:
Windows/Mac/Linux: If you would like to easily access, edit, and save files across multiple computers, free application FeelHome allows you to share files across operating systems and over the web.
Once you install FeelHome on your computer and specify which folders you want to share, you can access those files from the web or from another computer in your virtual FeelHome network.
Diabetics who wear insulin pumps appear more likely to experience problems from improper use than a device defect, members of a U.S. government advisory panel said on Friday.
The Food and Drug Administration said problems with insulin pumps have occurred across the industry and asked the panel of outside experts for ways to minimize risks from malfunctions. Makers of the pumps include Medtronic, Roche, and Johnson & Johnson.
About 375,000 adults with type 1 diabetes used the pumps in 2007, up from 130,000 in 2002, the FDA said.
The maker of Poligrip denture cream will stop making formulas containing zinc, doing so while there are pending lawsuits alleging that years of excessive use caused neurological damage and blood problems in consumers.
Glaxo's voluntary action comes as the cases are moving through the lawsuit phase, alleging Poligrip caused nerve damage, leading to a loss of balance, loss of sensation in hands and feet, and leaving some patients paralyzed.
Even though zinc is a very essential requirement for a healthy body, excess zinc can be harmful, and cause zinc toxicity. Excessive absorption of zinc can also suppress copper and iron absorption. The free zinc ion in solution is highly toxic to plants, invertebrates, and even vertebrate fish. The Free Ion Activity Model (FIAM) is well-established in the literature, and shows that just micromolar amounts of the free ion kills some organisms. Source.
The FDA has put a new "black box" warning on the anti-clotting drug Plavix, the second best-selling drug in the world.
A black box warning (also sometimes called a black label warning or boxed warning) is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning.
A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The U.S. Food and Drug Administration (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires.
The new label for Plavix warns that normal doses of Plavix have a potentially deadly lack of effect in 2% to 14% of patients.
Such patients are so-called "poor metabolizers" who carry a variant CYP2C19 gene affecting the enzyme that converts Plavix into its active form.
A less strident warning about poor metabolizers first appeared on the Plavix labels in May 2009. Based on new information from a drugmaker-funded study and other research, the FDA has now strengthened the warning.
HealthDay News had said in 2009 that patients taking the clot-preventing Plavix following stent implantation should stay away from PPIs, or proton pump inhibitors. Stents are implanted in artery-opening cardiac surgeries and PPIs, said HealthDay News, include drugs such as Nexium, Prevacid, and Prilosec.
Data on nearly 17,000 Plavix users—who took the drug for over one year following stent implantation—were analyzed, said HealthDay News, citing Eric J. Stanek, senior director of research at drug distributor Medco Health Solutions. The team found that the incidence of cardiovascular events was 51 percent greater in patients taking the Plavix-PPI combination over those on Plavix alone, said Stanek, according to HealthDay News. "Considering all the available evidence, PPI use should be limited in patients taking clopidogrel, based on the physician's judgment," Stanek said.
Talk to your doctor before you make any decisions regarding medications you are taking.
As far back as November 23, 1998 the Federal Drug Administration (FDA) expressed its concern with the claims made by the drug manufacturer, Bristol-Myers Squibb/Sanofi Pharmaceuticals about Plavix. A number of patients were instructed (as recommended by the manufacturer) to take Plavix along with aspirin.
A study published by the New England Journal of Medicine states that although doctors believed the combination of Plavix and aspirin would reduce the risk of a second heart attack, the study actually found that the combination not only does not help, but doubles the risk of death, heart attack or stroke in people with no history of heart disease. It was also found to be associated with increased risk for moderate and serious bleeding. To further cite the New England Journal of Medicine, the cost and risk of Plavix do not justify its use for the prevention of coronary artery disease and heart attack.
Yes, you read the right - 10,000 products. Some folks forget that the F in FDA stands for Food and Drug Admin. Some say that better represents the letter grade the agency should gets for doing its job.
They include: McCormick, the seller of spices and herbs, expanded a March 5 recall today to include additional “best by” dates of the four products, which include a French onion dip mix.
PepsiCo said yesterday in a statement that it voluntarily recalled its Quaker Baked Cheddar Snack Mix. HVP is a “very minor” ingredient in the seasoning of the snack, which was recalled “out of an abundance of caution,” the Purchase, New York-based company said.
On March 8, a North American unit of Nestle said it was recalling about 6,000 pounds (2,722 kilograms) of a ready-to-eat bacon base product. The same day, Cincinnati-based P&G recalled the two flavors of Pringles.
Wal-Mart’s Great Value Ranch Chip Dip, manufactured for the world’s largest retailer by the T. Marzetti Co. of Columbus, Ohio, has been pulled from the shelves, according to Wal-Mart spokeswoman Anna Taylor.
Kroger, Safeway
Store brand products at drugstore chain CVS Caremark Corporation, and grocery-store chains Kroger Co. and Safeway Inc. have also been recalled, according to the FDA’s site.
No Illnesses
To date, there are no known illnesses associated with the contaminated HVP, which is sometimes referred to as a “natural flavor” on ingredient labels. The FDA has said the overall risk to consumers is low because most products containing HVP are cooked during processing or are cooked by consumers, which would eliminate any salmonella. In uncooked, ready-to-eat products, like chips and dips, the risk is greater.
In an article sure to give you the thought, "Well duh" there is this news:
Congressional investigators say the Food and Drug Administration should pay more attention to the safety of some food ingredients, including one involved in a widespread recall this week.
A report released Friday by the Government Accountability Office points out that some spices, artificial flavors and other ingredients are not subject to frequent safety reviews by the FDA because the agency or manufacturers deem them "generally recognized as safe." A flavor-enhancing hydrolyzed vegetable protein recalled Thursday due to salmonella contamination is among those ingredients.
The investigators said the FDA has not done enough to review the substances and recommends the agency require companies making or using them to provide the government with more information.
Other substances "generally recognized as safe" include salt, trans fats found in partially hydrogenated vegetable oils, spices, artificial flavors, emulsifiers, binders, vitamins, minerals and preservatives intended to enhance a food's taste, texture, nutritional content or shelf life, according to the report, which notes increasing public concern about salt and trans fat.
The FDA can't keep up with approved drug products, or timely act to ask to have unsafe drugs removed from the market, yet somehow it will keep up with unsafe spices and proteins? Congress needs about 16 billion more in the FDA's budget to get it to be in the woefully underfunded stage.
Thomas Medical Products has announced a class I recall for its Transseptal Sheath Introducer Kit, citing concerns about increased risk for device breakage.
The recall was initiated on Feb. 1, 2010 and applies to all devices manufactured and distributed from Oct. 1, 2006 to Dec. 27, 2009. The products included in the recall can also be identified under the trade names HeartSpan, CHANNEL FX, Torflex and Braided Guiding Introducer Kit.
FDA said that the company mangers had received the samples that tested positive for salmonella on January 21st.
Basic Food Flavors is known for producing hydrolyzed vegetable protein, which essentially enhances the flavor in processed food items. It is available in the form of a powder which is supposed to be mixed with the food.
The FDA was first informed about the contamination problem by a food manufacturer in February, following which the inspectors visited the plant. They reported of the dirty utensils and equipments and some other problems that are home to bacteria breeding.
“In one area where paste mixers and belt dryers were positioned in the drain near the area, the hydrolyzed vegetable protein was turned from paste to powder. We sensed an odor in the vicinity of this drain", reported the inspectors.
Federal health authorities announced the recall of a commonly used flavor enhancer after samples of the product were found to contain salmonella.
It may be in the thousands according to the director at the Office of Food Safety at the Food and Drug Administration's Center for Food Safety and Applied Nutrition, about the product, called hydrolyzed vegetable protein, also called HVP.
The bacterium, identified as Salmonella Tennessee, was found in HVP manufactured by Basic Food Flavors Inc. of Las Vegas, Nevada.
HVP is used in processed foods, including soups, sauces, chilis, stews, hot dogs, gravy, seasoned snack foods and dressings.
"We are working hard to respond to this particular outbreak; we also are working hard to put in place the kinds of preventive control measures to prevent this kind of contamination from happening in the first place," said FDA Commissioner Dr. Margaret A. Hamburg.
This is a video that discussed Atlanta Oculoplastic Surgery v. Nestlehutt, which challenges the provisions of Senate Bill 3, passed in 2005 by the Georgia General Assembly, that caps noneconomic damages that a jury may award to a victim of medical malpractice at $350,000.00.
The case arose from a medical malpractice claim filed by Adam Malone and Frank Ilardi on behalf of their clients Betty Nestlehutt and her husband Bruce Nestlehutt in the Fulton County State Court in October of 2008. Married for over 50 years, the Nestlehutts raised two children and they shared a real estate business. Bruce handled the behind-the-scenes work, and Betty, a people-person by nature, focused on client and public interaction. Competition was tough and as Betty aged she found that more and more clients seemed to prefer younger agents. So, at seventy-one years of age, Betty Nestlehutt, after much thought and consideration, sought consultation with Dr. Harvey P. Cole of Atlanta Oculoplastic Surgery, P.C. concerning bags under her eyes and lines around her mouth. Dr. Cole recommended she undergo several surgical procedures including a simultaneous CO2 laser resurfacing and full facelift.
Having both the CO2 laser resurfacing and full facelift done together is well-known by practicing cosmetic surgeons to be risky, as the chance of damaging the facial blood supply is greatly increased on a patient of Betty’s age and complexion. However, based on her doctor’s recommendation, Betty went through the combination of procedures and the blood supply to her face was, in fact, severely damaged.
After the surgery, the skin on Betty’s face struggled to live without its usual blood supply and after a 3-week period, died completely, leaving the once fair-skinned wife and mother with huge, gaping wounds from her temple to her jaw line, covering both sides of her face and over both of her cheeks to her chin. Betty Nestlehutt’s face, quite literally, fell off.
In the Nestlehutt case, a Fulton County, Georgia jury awarded Mrs. Nestlehutt well over $350,000.00 for permament injuries she received to her body due to medical malpractice by her physicians. After a trial, the Fulton County jury found Mrs. Nestlehutt's case to be meritorious and awarded her substantially more than the $350,000.00 cap. When judgment was about to be entered, however, the Fulton County trial court judge ruled that the cap of $350,000.00 found in SB3 was unconstitutional.
The U.S. Food & Drug Administration (FDA) is working to reduce risks from dangerous problems that affect what it described as tens of thousands of diabetics. While the FDA has not provided specific insulin pump manufacturers names in its report, there are known insulin pump makers, including Medtronic Inc, Roche Holding AG, and Johnson & Johnson.
According to the FDA panel papers, here are"Device Problems:"
The most frequently reported device problem in MDR’s related to insulin infusion pumps was ‘unknown,’ and the top five reporters identified “unknown” in 5421 of 16640 reports (19.7% of reports). The second most frequent device problem reported was “replace,” which accounted for 2385 entries (9% of reports).
Patient Problems included:
Patient Problems
The most frequently reported patient problems were 1) hospitalization, and 2) blood glucose high. Of the 16640 MDRs from the top five manufacturers, hospitalization was identified in 7967 reports (21% of reports) while blood glucose was identified in 6236 reports (16.6% of reports). The other most frequently reported patient problems reported were:
Diabetic Ketoacidosis (8% of reports)
Hyperglycemia (8% of reports)
Treatment with medication (6% of reports)
Blood glucose low (4.7% of reports)
Therapy/non‐surgical treatment (4% of reports)
Insulin pumps are primarily used by people with Type I diabetes, a condition in which the pancreas produces little or no insulin, a hormone needed to help the body properly use sugars from foods. People with Type 1 diabetes need to administer insulin daily whether through a pump or other methods like shots.
The more common form of diabetes, Type 2, which is often associated with obesity and typically develops later in life, is managed with oral medications designed to help the body properly use insulin, although some cases do require insulin.
The FDA said the number of Type I diabetics using insulin pumps has increased, with about 375,000 U.S. users in 2007, up from about 130,000 in 2002.
Recalls:
MiniMed Insulin Pumps
The thin plastic tubes are used with the MiniMed Paradigm Medtronic insulin pump to deliver insulin to diabetes patients. The infusion set is typically replaced every three days. However, thousands of patients may have been sold infusion sets that may not allow the insulin pump to vent air pressure properly, potentially resulting in the device delivering too much or too little insulin.
Over or under delivery of insulin from an insulin pump could have serious and catastrophic consequences for diabetes patients.
Medtronic announced that approximately 60,000 Quick-set infusion sets used with the Medtronic MiniMed Paradigm insulin pumps could be defective and not work properly. Therefore, they recalled an estimated 3 million of the infusion sets with reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with an “8”.
Accu-Check:
Accu-Check Spirit insulin pumps were previously recalled by Disetronic Medical Systems Inc., a unit of the Roche Group, because of a potential defect in the “up” and/or “down” buttons of some devices. Malfunctioning buttons could prohibit users from changing any programmed setting on the Accu-Check Spirit insulin pumps. Another earlier recall was issued for battery caps included with some varieties of Aimas insulin pumps. According to Animas Corp, the defective battery caps could cause the pumps to stop administering insulin, putting patients at risk of hyperglycemia or hypoglycemia.
Insulin Overdose Symptoms
Diabetes patients who begin to develop any of the following signs or symptoms should seek medical attention immediately as they may be experiencing an insulin overdose:
Hypoglycemia
One of the most dangerous risks associated with insulin overdose is hypoglycemia, a condition in which a person’s blood sugar (glucose) is too low. Symptoms include: cold sweats, confusion, double vision, convulsions, fatigue and general discomfort. Severe hypoglycemia can result in seizures, coma and death.
Call us today if you believe that an improperly functioning insulin pump has harmed you. Call Rob Bunch today. 256-764-0095
The U.S. Food and Drug Administration recently sent letters to 16 firms – including five RTD beverage companies – citing ingredient and health claim violations.
The agency’s letter to POM Wonderful said POMs expansive health claims – including boasts that it may help with blood pressure, prostate cancer and erectile function – elevate POM to the level of unapproved drug rather than a food product.
POM’s label lists its nutrition content, the FDA said, by omitting the name of its antioxidant. The label also boasts a high level of “phytochemicals,” which are not eligible for a nutrition panel call-out because the FDA has not established a recommended daily intake for the substance.
The agency slapped Nestle’s Juicy Juice with a warning in December for violating regulations specific to children’s foods and beverages. Its “no sugar added” claim is not authorized for products intended for children under the age of 2, the FDA said. First Juice received a similar warning this month, but the FDA went further with Nestle, calling the labels on the offending products “misleading.” Juicy Juice’s Orange Tangerine and Grape products both claim, in bold letters, to be 100 percent juice, but clarify in smaller letters that they are not 100 percent Orange Tangerine or Grape juice.
New Jersey state courts have designed claims relating to Yaz as a mass tort, and will be centralized under one judge for coordinated handling.
New Jersey’s Administrative Office of the Courts ordered on February 18 that the litigation will be assigned to Judge Brian R. Martinotti in Bergen County Superior Court. All pending and future New Jersey state court Yaz lawsuits, Yasmin lawsuits and Ocella lawsuits filed over Bayer’s popular birth control pills will be handled by Judge Martinotti, who will oversee the case management and trial issues.
Bayer Healthcare Corp. stated its oral contraceptives Yasmin and Yaz contained possible side effects, the pills' maker said in response to lawsuits.
More than 50 women in Indianapolis have filed suit against the company, joining dozens of women nationwide who allege the birth control pills caused heart attacks, strokes, blood clots and other health problems, The Indianapolis Star reported Monday.
Yasmin and Yaz contain drospirenone, which the lawsuits allege can lead to dangerously high levels of potassium.
Bayer officials said the contraceptives are safe when used properly and that all packages of oral contraceptives, including Yasmin and Yaz, carry warnings of possible side effects.
The FDA has issued a Class 1 recall for several models of Baxter HomeChoice automated dialysis systems because of a defect that can cause the machines to overfill a patient’s abdominal cavity with fluid. Reports of at least one death and several serious injuries have been associated with the problems.
The FDA classified the action as a Class 1 medical device recall, meaning that the defective product has the likely potential of causing serious injury or death.
It has been confirmed that at least one death and several serious injuries have occurred among users of the dialysis machines that overfilled their abdominal cavities, causing a condition known as Increased Intraperitoneal Volume (IIPV).
Dialysis is used to replace kidney function in patients suffering from kidney failure. Peritoneal dialysis machines, like the Baxter HomeChoice and Home Choice Pro devices, pumps a sterile glucose solution into the abdominal cavity around the intestines, which absorbs waste products from the blood through osmosis before being drained out of the body. Peritoneal dialysis is known for its ability to be used at home by patients without assistance.
IIPV can cause a number of problems and potentially fatal injuries, including abdominal wall or diaphragmatic hernias, heart failure, acute hypertension, pulmonary edema, hydrothorax, decreased pulmonary function, pericardial effusion, and peritonitis. Children and non-verbal patients are considered to be most at risk. Children’s abdominal cavities are smaller and can be injured faster by IIPV than an adult, and non-verbal patients and children may not be able to adequately communicate that there is a problem.
According to a Baxter press release, signs of IIPV can include:
* Difficulty breathing
* Vomitting
* Feeling full or bloated
* Abdominal pain or discomfort
* Swelling of the genitals, belly button or groin
* Leakage of fluid from the peritoneal dialysis catheter
* Unexpected increase in blood pressure
* Children crying during therapy without apparent reason
The recall affects all Baxter HomeChoice Automated Peritonela Dialysis Systems with the product codes 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R, 5C4474D, and 5C4474DR. The recall also affects Baxter HomeChoice PRO Automated Peritoneal Dialysis Systems with the product codes 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300 and T5C8300R. Both systems have been distributed to patients since 1994.
The FDA warned that patients and caregivers should watch for any signs of IIPV. If any signs of IIPV are noticed, the device should be stopped immediately and a manual drain initiated. Then a doctor should be contacted immediately.
More information here: http://www.baxter.com/press_room/press_releases/2010/03_02_10_homechoice.html
A growing number of lawsuits are being filed against the manufacturers of popular products like Super Poligrip and Fixodent, alleging that the zinc in the adhesives is leading to serious neurological problems — and in one case, death.
The suits claim that denture adhesive manufacturers GlaxoSmithKline (Super Poligrip) and Procter & Gamble (Fixodent) failed to adequately warn consumers that ingesting the high levels of zinc found in many of their products could be dangerous.
Zinc is an essential mineral found in foods such as shellfish, meat, beans and cereals, and it's also sold in supplement form. Zinc helps wounds heal, keeps the immune system functioning properly and is required for proper sense of taste and smell. In denture products, zinc helps dentures adhere better to the gums.
From Neurology.org:
Background: Chronic, excess zinc intake can result in copper deficiency and profound neurologic disease. However, when hyperzincemia is identified, the source often remains elusive. We identified four patients, one previously reported, with various neurologic abnormalities in the setting of hypocupremia and hyperzincemia. Each of these patients wore dentures and used very large amounts of denture cream chronically.
Objective: To determine zinc concentration in the denture creams used by the patients as a possible source of excess zinc ingestion.
Methods: Detailed clinical and laboratory data for each patient were compiled. Tubes of denture adhesives were analyzed for zinc content using dynamic reaction cell-inductively coupled plasma-mass spectrometry. Patients received copper supplementation. Copper and zinc levels were obtained post-treatment at varying intervals.
Results: Zinc concentrations ranging from about 17,000 to 34,000 µg/g were identified in Fixodent and Poli-Grip denture creams. Serum zinc levels improved in three patients following cessation of denture cream use. Copper supplementation resulted in mild neurologic improvement in two patients who stopped using denture cream. No alternative source of excess zinc ingestion or explanation for hypocupremia was identified.
Conclusion: Denture cream contains zinc, and chronic excessive use may result in hypocupremia and serious neurologic disease.
A Texas resident has filed a lawsuit against TF Supplements, alleging he became jaundiced, suffered extreme pains in his side and suffered uncontrollable itching several weeks after taking P-Drol, a steroid precursor. It is marketed to fitness enthusiasts and weight lifters for its alleged muscle-building capabilities.
On July 28, 2009, the FDA issued a public health advisory warning stating that consumers should stop taking steroids marketed as dietary supplements and advised anyone who took the steroids and subsequently showed signs of liver problems to seek immediate medical attention.
Rosiglitazone (AVANDIA). More than 1000 reports of patient deaths were received for
rosiglitazone in the first three quarters of 2009, more than any other drug we monitor. Rosiglitazone is an oral medication for treating Type 2 or adult onset diabetes. Most deaths were attributed to cardiovascular causes, a problem for which the FDA has required warnings. While these cases do not appear to signal previously undetected risks of rosiglitazone, the large number of reports alleging serious and fatal injuries associated with rosiglitazone further reinforces concerns about its cardiovascular safety. The company, GlaxoSmithKline, told us it believed most reports were generated by lawsuits.
In February 2010 the FDA announced it was conducting an overall safety review of
rosiglitazone and would present its findings to a special advisory committee meeting in July.
"Rosiglitazone should be removed from the market," concluded Dr. David Graham and Dr. Kate Gelperin, both epidemiologists with the FDA. Linkavandia
A boxed warning highlighting serious safety concerns, including reported deaths, with the use of Exjade drug to remove excess iron from the blood, has been added to the medicine's label.
The FDA said the prescribing information for Exjade would now carry a highlighted warning, often called a black box, noting that the drug may cause renal impairment, including kidney failure; hepatic impairment, including liver failure; and gastrointestinal hemorrhage.
Deferasirox (marketed as Exjade) is a rationally-designed oral iron chelator. Its main use is to reduce chronic iron overload in patients who are receiving long-term blood transfusions for conditions such as beta-thalassemia and other chronic anemias.It is the first oral medication approved in the USA for this purpose. (Wiki)
This week the FDA has made public a January 2010 letter to the Eggo waffle maker Kellogg Co in which the FDA has stated the maker had not gone far enough to address food safety violations at its Atlanta frozen food plant.
In 2009, an inspection found bacterial contamination and sanitation violations such as improper handling of trash and food, and insufficiently sanitized equipment, at least according to the FDA.
The FDA's letter was written 1/27/10 after Georgia's Ag Department found Listeria bacteria in Eggo Buttermilk Waffles last summer. (Source here)
Kellogg's plant had "significant deviations" from the manufacturing practices for food manufacturers and Kellogg's response so far had not addressed the violations, according to the FDA.
Kellogg has stated that it has fully addressed all of the violations and that its response to the FDA letter would be filed shortly.
In the new study, reported in the American Journal of Gastroenterology, researchers analyzed 17 cases of liver damage among Hydroxycut users that had not yet appeared in the medical literature. Nine of the cases had been reported to the FDA, while eight were seen by the authors of the study.
Here's the study's conclusion:
CONCLUSIONS: Hydroxycut has been clearly implicated as a cause for severe liver injury that may lead to acute liver failure and death. Weight-loss supplements represent a class of dietary supplements that should be regarded as capable of causing severe hepatic toxicity when the usual causes of identified liver injury cannot be otherwise elucidated. Am J Gastroenterol advance online publication.
Didanosine, the second drug approved for the treatment of HIV infections and one of the oldest weapons in the AIDS armamentarium, has been found to produce rare cases of potentially fatal liver disease in patients taking it for long periods, the Food and Drug Administration announced Monday. Didanosine, marketed by Bristol-Myers Squibb under the brand names Videx and Videx EC (an extended release version), was approved by the FDA in 1991, joining AZT as the only drugs then approved to treat HIV. It is a reverse transcriptase inhibitor, blocking the action of the key enzyme used by HIV in replicating. It has limited value when used alone because the virus rapidly mutates to overcome it, and is thus generally used in drug cocktails.
Dilantin (generic name: phenytoin) is a widely-prescribed antiepileptic drug issued for treatment of partial and generalized tonic clonic seizures associated with epilepsy. The drug, developed in 1938 and currently marketed by Pfizer, has been linked to Stevens Johnson Syndrome (SJS).
Stevens Johnson Syndrome is a severe, life-threatening condition which affects the skin and the mucous membranes. SJS typically begins with a flu-like period of fever, sore throat and headache. Victims then develop circular lesions that cover a majority of the skin. The lesions can develop into blisters and occasionally complete skin detachment.
Many experts agree that a reaction to Dilantin can cause the onset of this horrible disease. While Dilantin has been recalled numerous times since its introduction, it is still prescribed today.
Most common side-effects:
• Nausea, vomiting, constipation, or diarrhea
• Mild dizziness or drowsiness
• Tender or swollen glands
• Swollen or painful gums
• Headache
• Muscle twitches
• Increased facial hair
• Swelling of breasts
• Insomnia
More severe side-effects are:
• An allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives)
• Hallucinations
• Slurred speech or staggering walk
• A rash
• Changes in vision
• Agitation
• Low blood pressure
• Slow or irregular heartbeats
• Abdominal pain, dark urine, light colored stools, or jaundice (yellow skin or eyes)
• Easy bruising or bleeding
• Swollen or tender gums
If you believe your Dilantin use has put you or a loved one in danger call or email us right away.
FAF Inc. Recalls Children’s Necklaces Sold Exclusively at Walmart Stores Due to High Levels of Cadmium
WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.
Name of Product: Children’s Metal Necklaces
Units: About 55,000
Importer: FAF Inc., of Greenville, R.I.
Hazard: The recalled necklaces contain high levels of cadmium. Cadmium is toxic if ingested by young children and can cause adverse health effects.
Incidents/Injuries: None reported.
Description: The recalled jewelry is shaped as a metal crown or frog pendant on a metal link chain necklace in a crown hinged box. The packaging has the words, “Disney” and “The Princess and the Frog” on it and contains the following model numbers and UPC codes:
Crown Model # 4616-4187 UPC # 72783367144
Frog Model # 4616-4190 UPC # 72783367147
Cadmium poisoning is an occupational hazard associated with industrial processes such as metal plating and the production of nickel-cadmium batteries, pigments, plastics, and other synthetics. The primary route of exposure in industrial settings is inhalation. Inhalation of cadmium-containing fumes can result initially in metal fume fever but may progress to chemical pneumonitis, pulmonary edema, and death.[24]
Cadmium is also a potential environmental hazard. Human exposures to environmental cadmium are primarily the result of the burning of fossil fuels and municipal wastes.[25] However, there have been notable instances of toxicity as the result of long-term exposure to cadmium in contaminated food and water. In the decades leading up to World War II, Japanese mining operations contaminated the Jinzu River with cadmium and traces of other toxic metals. As a consequence, cadmium accumulated in the rice crops growing along the riverbanks downstream of the mines. The local agricultural communities consuming the contaminated rice developed Itai-itai disease and renal abnormalities, including proteinuria and glucosuria.[26] Cadmium is one of six substances banned by the European Union's Restriction on Hazardous Substances (RoHS) directive, which bans certain hazardous substances in electronics.
Cadmium and several cadmium-containing compounds are known carcinogens and can induce many types of cancer.[27]
Research has found that cadmium toxicity may be carried into the body by zinc binding proteins; in particular, proteins that contain zinc finger protein structures. Zinc and cadmium are in the same group on the periodic table, contain the same common oxidation state (+2), and when ionized are almost the same size. Due to these similarities, cadmium can replace zinc in many biological systems, in particular, systems that contain softer ligands such as sulfur. Cadmium can bind up to ten times more strongly than zinc in certain biological systems, and is notoriously difficult to remove. In addition, cadmium can replace magnesium and calcium in certain biological systems, although these replacements are rare.
Source is wiki. http://en.wikipedia.org/wiki/Cadmium#Toxicity
[Posted 01/28/2010] FDA notified healthcare professionals of a Class I recall of Hettich Centrifuges with 2050 and 2076 plastic rotors, used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. The recall was initiated because the plastic centrifuge rotor may crack, break apart and be forcefully ejected through the plastic centrifuge housing at a high rate of speed. This may result in serious personal injury and damage to the surrounding area.
The device separates the red blood cells from plasma to determine the patient’s hematocrit. These recalled devices were distributed from January, 1999 through November, 2009. Hospitals, clinics and laboratories who have the listed centrifuge/rotor combination should immediately stop using the plastic rotors and contact Hettich to have these affected rotors replaced with metal rotors. The centrifuges can be identified by reading the model number on the front of the instrument or the name tag on the rear of the centrifuge; the rotors have the model numbers 2076 or 2050 stamped on them.
WASHINGTON, DC – The U.S. Consumer Product Safety Commission and Health Canada, in cooperation with the firm named below, today announced a voluntary recall of the following products. Consumers should stop using recalled products immediately unless otherwise instructed.
Name of Product: Glass Water Bottles
Units: About 11,000 in the United States and 1,200 in Canada
Importer: Starbucks Coffee Company, of Seattle, Wash.
Hazard: The glass water bottle and/or its stopper can shatter when the consumer is removing or inserting the stopper, posing a laceration hazard to consumers.
Incidents/Injuries: The firm has received 10 reports of either glass stoppers or water bottles shattering, including eight reports of hand lacerations.
Description: This recall involves clear glass water bottles with SKU number 11003503. The 20-ounce water bottles have the words “Glass Water Bottle” printed on a blue label affixed to the bottle.
Sold at: Starbucks company-operated stores and at Starbucks locations in Safeway and Target stores nationwide during January 2010 for about $9.
Manufactured in: Taiwan
Remedy: Consumers should immediately stop using the glass water bottles and return the product to the Starbucks location where purchased to receive a full refund. Starbucks is also offering a complimentary beverage, of any size, to consumers upon return of the glass water bottles.
Consumer Contact: For additional information, contact Starbucks at (877) 492-6333 between 8 a.m. to 11 p.m. ET Monday through Friday, or visit the firm’s Web site at www.starbucks.com
Opening arguments in a negligence lawsuit by Dee Spears against Botox manufacturer Allergan Inc. are set for today in Orange County.
At issue is the safety of the blockbuster drug, especially in the higher dosages that are used to treat children with cerebral palsy.
It is believed to be the first Botox case alleging a fatal reaction to reach trial, and is one of several pending suits related to the drug's cosmetic and non-cosmetic uses.
The trial comes less than a year after federal authorities mandated "black box" labels that warn of potentially serious reactions to Botox. And it opens a window on the Irvine-based drug maker's own records of reported ill effects, showing that the company knew of some serious problems linked to neurotoxins such as Botox as early as 2005.
More at the source: http://www.latimes.com/news/local/la-me-botox27-2010jan27,0,1928030.story
The Europeans banned the drug because the FDA found that an extra 1 percent or more of users develop heart problems after taking it. There were 86,000 European users in the past year, the BBC reported, which means that 860 have damaged hearts because of Meridia.
There's a tussle brewing between Tylenol maker Johnson & Johnson and makers of a shipping about the foul odor problem that is at the root of a recent recall of Tylenol and other products.
An undisclosed number of containers of Tylenol, Motrin and other over-the-counter drugs were recalled earlier this month after consumers complained of feeling sick from an "unusual" odor.
From cnn.com:
"In a letter sent Jan. 22 to Johnson & Johnson's CEO William Welson, and obtained by CNNMoney.com, the National Wooden Pallet and Container Association (NWPCA) said McNeil's statement has "caused immense damage to the industry."
The chemical in question is called "2,4,6-tribromoanisole" or TBA. It results from a breakdown of another chemical called "tribromophenol" or TBP, which is used in some countries as a preservative on wooden pallets But TBP is not approved for use in the United States.
"There are more than 1.2 billion pallets in service in the United States each day. To the best of our knowledge, wood pallets and containers have never been the source of either TBA or TBP," NWPCA president Bruce Scholnick said in the letter."
The government Tuesday formally barred truckers and bus drivers from sending text messages while behind the wheel, putting the federal imprimatur on a prohibition embraced by many large trucking and transportation companies.
"We want the drivers of big rigs and buses and those who share the roads with them to be safe," said U.S. Transportation Secretary Ray LaHood. "This is an important safety step, and we will be taking more to eliminate the threat of distracted driving."
Although both houses of Congress are considering bills restricting texting and 19 states have banned the practice, LaHood said existing rules on truckers and bus drivers give him authority to issue the prohibition. LaHood said drivers of commercial vehicle caught texting could be fined up to $2,750.
There is a 3 year Statute of Limitations in N.C. and S.C.:
From several sites:
Rosiglitazone (AVANDIA). More than 1000 reports of patient deaths were received for
rosiglitazone in the first three quarters of 2009, more than any other drug we monitor. Rosiglitazone is an oral medication for treating Type 2 or adult onset diabetes. Most deaths were attributed to cardiovascular causes, a problem for which the FDA has required warnings. While these cases do not appear to signal previously undetected risks of rosiglitazone, the large number of reports alleging serious and fatal injuries associated with rosiglitazone further reinforces concerns about its cardiovascular safety. The company, GlaxoSmithKline, told us it believed most reports were generated by lawsuits.
In February 2010 the FDA announced it was conducting an overall safety review of
rosiglitazone and would present its findings to a special advisory committee meeting in July.
"Rosiglitazone should be removed from the market," concluded Dr. David Graham and Dr. Kate Gelperin, both epidemiologists with the FDA. Linkavandia
The NTSB crash report says phone records show Sanchez sent more texts on the job than on weekends. That wasn’t his only violation of company policy. Sanchez invited friends into the cab, and even told them where to hide in case inspectors came on board. He’d been reprimanded for various problems nearly half a dozen times.
A judge has ruled 18 people who contracted hepatitis C from the Endoscopy Center of Southern Nevada can receive a settlement in their cases against Dr. Dipak Desai.
Judge Allan Earl said each of those 18 patients will each receive an undisclosed amount of money for their case. The money will be paid by the Nevada Mutual Insurance Company.
The settlement with 18 former patients of the clinics blamed for the outbreak was made by Nevada Mutual Insurance Co. on behalf of doctors and nurse anesthetists who handled their treatment.
A jury has ordered a medical device company to pay a Portland, Oregon man and his wife $4.75 million, finding I-Flow Corp. liable for damaged cartilage in Matthew Beale's right shoulder.
According to Beale's lawsuit, I-Flow encouraged surgeons to use a pain pump in an unapproved and unsafe manner for patients recovering from shoulder-joint surgery. A pain pump delivers pain medication via a catheter to the affected spot.
I-Flow and other manufacturers face similar lawsuits alleging that such pumps have caused severe cartilage deterioration, called chondrolysis, in patients around the country.
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.
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.
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.
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.
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.
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.
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.
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
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
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.
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.
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:
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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