Under Armour Recalls Chin Straps for Football Helmets -- Laceration Hazard

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WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the retailer named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled product immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: UA Defender Chin Straps

Units: About 541,000

Retailer: Under Armour, Inc., of Baltimore, Md.

Importer: JR286, Inc., of Redondo Beach, Calif.

Hazard: The metal snap that connects the chin strap to the helmet has sharp edges, posing a laceration hazard when the user’s metal snap comes into contact with another player.

Incidents/Injuries: Under Armour has received six reports of injuries that required stitches.

Description: This recall involves all UA Defender Chin Straps. They were sold in the following colors: white and black, red, midnight, navy and royal and have a hard nylon shell, a padded chin area and a plastic strap with “Under Armour” printed on it. The chin straps have metal clasps that tighten the straps and attach them to the helmet.

Sold at: Sporting goods stores and Under Armour outlet stores nationwide and at www.underarmour.com from January 2008 through September 2011 for about $20.

Manufactured in: China

Remedy: Consumers should immediately stop using the recalled chin straps and contact Under Armour for a free replacement chin strap.

Consumer Contact: For additional information, contact Under Armour

Veteran's Day Thank You

Image by lukemontague via Flickr
It's hard to put into words sometimes how you feel, how to say thanks. Today is not one of those days. My father in law was a World War II bomber pilot, and I have family in the Navy as well as the Army.  Our family is grateful to all who have served. From those in the greatest generation, to those now in harm's way anywhere our US Forces are ... thank you.

A friend of the family - in his 40's, two kids - was called to serve in Afghanistan, and he did two tours. You can't fathom the fear and anguish in a family or the military man until you see it firsthand.

You keep us free, you protect us, you are willing to die for us. My family and I am grateful and pray for your safety.

Public Citizen Calls on FDA to Require Black Box Warning on Label for the Antibiotic Tigecycline

From PC:



The FDA should place a black box warning on an antibiotic used to treat a wide range of infections because of a higher mortality rate associated with taking the drug than other widely used antibiotics, says Public Citizen.


The antibiotic, tigecycline, also known as Tygacil, was approved by the FDA in 2005 to treat complicated skin infections and intra-abdominal infections and in 2009 to treat community-acquired pneumonia.

In 2010, the FDA issued a safety alert to health care professionals informing them of an increased mortality rate associated with the use of intravenous tigecycline compared to that of other antibiotics. The agency said that alternatives to tigecycline should be considered in patients with serious infections. At the same time, the FDA required that the drug label be modified to include data about the increased mortality risk, but these warnings were inadequate, Public Citizen said in the petition. Critical safety information does not appear in a black box warning at the top of the label and fails to describe appropriate restrictions on the use of the drug.

“Given the approximately 30 percent higher rate of mortality in subjects receiving tigecycline, as well the significantly higher rates of failures to cure serious infections, in comparison to subjects treated with comparator antibiotics, the content and placement of the warnings in the current drug label are woefully insufficient,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “Because of the increased death rate and the likely inappropriate use of tigecycline as a first-line, rather than last-resort, antibiotic for serious infections without simultaneous administration of other antibiotics, it is inexcusable that there is currently no black box warning for tigecycline. Such a warning, accompanied by stronger warnings describing appropriate restrictions on its use in other parts of the label, clearly is warranted to more effectively advise physicians about the dangers of using tigecycline to treat serious infections and to better protect public health.”

Public Citizen calls on the FDA to add a black box warning to the antibiotic’s label indicating the increased risk of death and advising that it should be used only as a last-resort antibiotic and then only in combination with one or more bactericidal antibiotics (antibiotics that directly kill bacteria, rather than interfere with bacteria growth). Public Citizen also is petitioning the agency to require an FDA-approved medication guide to be distributed to patients, as well as a “Dear Doctor” letter to physicians, warning them of the dangers of the drug and the need for restricted use.

http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3440

FDA: Warnings on Methylene Blue, Linezolid, and Serotonergics

The FDA has updated warning  to avoid prescribing either methylene blue or linezolid (Zyvox, Pfizer) in combination with serotonergic agents because of the potential to cause serotonin syndrome.


Today, the FDA announced that the risk for this harmful interaction appears to be confined, in general, to 2 specific types of serotonergic drugs: selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors.

Methylene blue is a dye used in diagnostic procedures and in the treatment of conditions ranging from cyanide poisoning to methemoglobinemia. Linezolid is an antibacterial agent. Both drugs inhibit the action of monoamine oxidase A, an enzyme that breaks down serotonin. This allows the levels of the neurotransmitter to rise.

When serotonin builds up to excessive levels in patients taking serotonergic agents, the result can be serotonin syndrome. Its signs and symptoms include confusion, hyperactivity, memory problems, and other mental changes; muscle twitching, excessive sweating, shivering, or shaking; diarrhea; trouble with coordination; and fever.

http://www.medscape.com/viewarticle/751978

Zyprexa: First Verdict is for Eli Lilly

 Eli Lilly & Co. isn’t responsible for the death of college student who was taking the drugmaker’s Zyprexa antipsychotic medication, a jury ruled in the first case to go to trial over the drug.

Jurors in state court in Los Angeles deliberated about 11 hours over two days before clearing Lilly of responsibility for the 2007 death of Cody Tadai, a 20-year-old community college student who succumbed to diabetes-related illnesses while taking Zyprexa for mental illness. His family alleged the company hid the drug’s diabetes risks to protect sales.

Source: http://www.businessweek.com/news/2011-11-07/lilly-not-responsible-for-zyprexa-user-s-death-jury-finds.html

FDA has approved Xarelto bloodthinner for atrial fibrillation

From the FDA:


The U.S. Food and Drug Administration today approved the anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of stroke in people 

who have abnormal heart rhythm (non-valvular atrial fibrillation).

Atrial fibrillation occurs in more than 2 million Americans and is one of the most common types of abnormal heart rhythm. In atrial fibrillation, the beating of the heart’s two upper heart chambers (atria) is irregular and poorly coordinated. This leads to blood pooling in these chambers, resulting in blood clots. Non-valvular atrial fibrillation refers to atrial fibrillation in patients who do not have significant problems in their heart valves.

“Atrial fibrillation can lead to the formation of blood clots, which can travel to the brain, blocking blood flow and causing a disabling stroke,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “This approval gives doctors and patients another treatment option for a condition that must be managed carefully.”

A stroke occurs if the flow of blood to a portion of the brain is blocked. If brain cells die or are damaged because of a stroke, symptoms occur in the parts of the body that these brain cells control. Stroke symptoms include sudden weakness; paralysis or numbness of the face, arms, or legs; trouble speaking or understanding speech; and trouble seeing.

The safety and efficacy of Xarelto were evaluated in a clinical trial with more than 14,000 patients comparing Xarelto with the anti-clotting drug warfarin. In the trial, Xarelto was similar to warfarin in its ability to prevent stroke.

For people taking the drug for atrial fibrillation, Xarelto should be taken one time a day with the evening meal so that it will be completely absorbed. 

As with other anti-clotting drugs, Xarelto can cause bleeding that, rarely, can lead to death. Bleeding was the most common adverse event reported by patients treated with Xarelto in the major clinical trial for the prevention of stroke in non-valvular atrial fibrillation. In that trial, Xarelto’s risk of major bleeding was similar to that of warfarin; however, it caused less bleeding into the brain and more bleeding into the stomach and intestines.

Xarelto has a boxed warning to make clear that people using the drug should not discontinue it before talking with their health care professional. Discontinuing the drug can increase the risk of stroke.

Insight Pharmaceuticals Issues A Voluntary Nationwide Recall Of "Nostrilla Nasal Decongestant"

Insight Pharmaceuticals, LLC of Langhorne, Pa., is recalling one lot (34,092 bottles) of Nostrilla Nasal Decongestant nasal spray to the consumer level, because it may contain the bacteria Burkholderia cepacia.

Burkholderia cepacia may cause serious infection in individuals with a compromised immune system or chronic lung condition (i.e. cystic fibrosis).  However, the possibility of infection is remote in healthy individuals.

Nostrilla Nasal Decongestant, lot #11G075, UPC Code 6373673005, was distributed nationwide through normal retail outlets and pharmacies. The product comes in a 1/2 ounce, plastic bottle marked with lot #11G075 on the label and with an expiration date of 05/2014 stamped on the side. No illnesses have been reported to date in connection with this problem.

The recall was initiated following internal investigations which determined the potential presence of a microbial contaminant that exceeds the product specifications and may consequently result in a subpar product. This contaminant has been found sporadically throughout only the respective manufacturing lot, #11G075.

Consumers who have purchased "Nostrilla Decongestant, lot #11G075" are urged to return the product and contact the company at 1-877-546-9059 Monday through Friday from 9 am-5 pm EST time zone.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this produc

The Coming Diabetes Tidal Wave

Image via WikipediaHalf of all American adults are may develop diabetes or pre-diabetes by 2020 unless changes in their activities of daily living are not made, so says the Centers for Disease Control and Prevention.

If current trends continue, the ranks of American adults with excessive blood sugar levels would swell from 93.8 million this year (about 28 million diabetics and 66 million more with pre-diabetes) to 135 million in 2020 – and cost society $3.35 billion by decade’s end. In addition, diabetes is becoming one of the most common chronic diseases in children and adolescents. According to the American Diabetes Association, one in every four children is currently diagnosed with diabetes.



Source: 
http://www.newswise.com/articles/view/582544

Glaxo Settles with US for $3 Billion Sales/Marketing of Avandia

GSK has  agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved uses and other matters, its biggest legal settlement.

Source: http://www.bloomberg.com/news/2011-11-03/glaxo-agrees-to-pay-3-billion-to-settle-u-s-probe-into-sales-marketing.html

FL State App. Court Rules that Lit. Privilege does not Extend to Websites

Image via WikipediaAn interesting read:

After the plaintiffs filed suit against the defendants for (among other things) reach of contract, the defendants placed warnings to the public on their website stating that plaintiffs had violated certain trademarks. A memorandum on the defendants’ website stated that the plaintiffs were selling products and labeling them as D’Lites when they actually were not. The defendants’ website stated that “you need to know the product they are passing off as D’Lites Emporium ice cream is in fact a hoax.”

The Plaintiffs then amended the complaint claiming defamation. Disagreeing that a litigation privilege existed regarding the publication, the Court stated:


"We analogize the publication of statements on the internet to calling a press conference with the media or otherwise publishing defamatory information to the newspapers or other media. Other courts have
considered the issue of whether statements to a newspaper or other media are made in connection with a judicial proceeding. In Buckley v. Fitzsimmons, 509 U.S. 259 (1993), the Supreme Court held that a
prosecutor was not entitled to absolute judicial immunity for making defamatory statements at a press conference regarding a criminal prosecution, because comments to the press do not have any functional
tie to a judicial proceeding."

The Court went on to note:

The website publication in this case was not made in  connection with the judicial proceeding. It was not made in the proceedings itself, nor was it made to a participant connected to the proceeding such as a witness. Like statements to the newspapers or press conferences, these statements have n o part in the judicial
proceedings. Instead, they were made to the world at large through the website and accused the plaintiffs of fraud and perpetrating a hoax on the public. These statements were not “necessarily preliminary” to
judicial proceedings, because unlike either Ange or Stewart the statements were not steps in the judicial process."

Read the opinion here: http://www.4dca.org/opinions/July%202011/07-27-11/4D09-4859.op.pdf

Cancer Risk Doubles After Organ Transplant

Says a recent study. In any given year, the risk of developing cancer after a transplant is just 0.7 percent.

Results of the study are published in the Nov. 2 issue of the Journal of the American Medical Association.

In 2010, almost 30,000 solid-organ transplants were performed in the United States, according to background information in the article. Kidney transplants accounted for more than half of that total, followed by livers, hearts and lungs. 

After transplant, the recipient must take powerful immune system-suppressing medications to prevent the new organ from being rejected. 

From the article:

Design, Setting, and Participants Cohort study using linked data on solid organ transplant recipients from the US Scientific Registry of Transplant Recipients (1987-2008) and 13 state and regional cancer registries.

Main Outcome Measures Standardized incidence ratios (SIRs) and excess absolute risks (EARs) 

assessing relative and absolute cancer risk in transplant recipients compared with the general population.

Results The registry linkages yielded data on 175 732 solid organ transplants (58.4% for kidney, 21.6% for liver, 10.0% for heart, and 4.0% for lung). The overall cancer risk was elevated with 10 656 cases and an incidence of 1375 per 100 000 person-years (SIR, 2.10 [95% CI, 2.06-2.14]; EAR, 719.3 [95% CI, 693.3-745.6] per 100 000 person-years). Risk was increased for 32 different malignancies, some related to known infections (eg, anal cancer, Kaposi sarcoma) and others unrelated (eg, melanoma, thyroid and lip cancers). The most common malignancies with elevated risk were non-Hodgkin lymphoma (n = 1504; incidence: 194.0 per 100 000 person-years; SIR, 7.54 [95% CI, 7.17-7.93]; EAR, 168.3 [95% CI, 158.6-178.4] per 100 000 person-years) and cancers of the lung (n = 1344; incidence: 173.4 per 100 000 person-years; SIR, 1.97 [95% CI, 1.86-2.08]; EAR, 85.3 [95% CI, 76.2-94.8] per 100 000 person-years), liver (n = 930; incidence: 120.0 per 100 000 person-years; SIR, 11.56 [95% CI, 10.83-12.33]; EAR, 109.6 [95% CI, 102.0-117.6] per 100 000 person-years), and kidney (n = 752; incidence: 97.0 per 100 000 person-years; SIR, 4.65 [95% CI, 4.32-4.99]; EAR, 76.1 [95% CI, 69.3-83.3] per 100 000 person-years). Lung cancer risk was most elevated in lung recipients (SIR, 6.13 [95% CI, 5.18-7.21]) but also increased among other recipients (kidney: SIR, 1.46 [95% CI, 1.34-1.59]; liver: SIR, 1.95 [95% CI, 1.74-2.19]; and heart: SIR, 2.67 [95% CI, 2.40-2.95]). Liver cancer risk was elevated only among liver recipients (SIR, 43.83 [95% CI, 40.90-46.91]), who manifested exceptional risk in the first 6 months (SIR, 508.97 [95% CI, 474.16-545.66]) and a 2-fold excess risk for 10 to 15 years thereafter (SIR, 2.22 [95% CI, 1.57-3.04]). Among kidney recipients, kidney cancer risk was elevated (SIR, 6.66 [95% CI, 6.12-7.23]) and bimodal in onset time. Kidney cancer risk also was increased in liver recipients (SIR, 1.80 [95% CI, 1.40-2.29]) and heart recipients (SIR, 2.90 [95% CI, 2.32-3.59]).

Conclusion Compared with the general population, recipients of a kidney, liver, heart, or lung transplant have an increased risk for diverse infection-related and unrelated cancers.

http://jama.ama-assn.org/content/306/17/1891.short

Bike Trailer Recall

From the CPSC:

Units: About 2,700 

Manufacturer: Weehoo Inc., of Golden, Colo.

Hazard: The receiver on the trailer's seat post hitch can crack and cause the trailer to detach, posing fall and crash hazards.

Description: 2011 Weehoo iGo bicycle trailers manufactured between April and July 2011 have a steel frame with an adjustable seat for passengers 38 to 52 inches tall, two pedals with straps, an enclosed sprocket and chain, a 20-inch wheel, two pannier pockets, a flagpole and a flag. The seat, pannier pockets and flag are made of red, heavy-duty nylon.

Sold at: Bicycle retail stores nationwide from April to July 2011 for about $390.

Lawsuit Involving Mr. Heater Corp. Resolves

As the cold weather months arrive, here is news about tragedy in Wisconsin:


DeVere R. Clay, 68, and his wife, Barbara J. Clay, 57, and their grandchildren Erin Briney, 10, and Hope Briney, 13, all of Tomah, died of carbon monoxide poisoning while sleeping in the living quarters of their horse trailers in an Alliant Center parking lot during a horse show. A gas-powered heater used to keep the trailer warm malfunctioned.

 
The parents of the Briney children sued the manufacturer of the heater, Mr. Heater Corp., and in June settled for more than $250,000, according to online court records. Jay Urban, the attorney for the Briny children, said his clients actually got much more than that. "I can tell you it was substantial," Urban said.

You cannot see or smell carbon monoxide (CO), but at high levels it can kill a person in minutes. It is the leading cause of poisoning death, with over 500 victims in the United States each year.
Carbon monoxide is produced whenever a fuel such as gas, oil, kerosene, wood or charcoal is burned. The amount of CO produced depends mainly on the quality or efficiency of combustion. A properly functioning burner, whether natural gas or liquefied petroleum gas (LPG), has efficient combustion and produces little CO. However, an out-of-adjustment burner can produce life-threatening amounts of CO without any visible warning signs.

When appliances that burn fuel are maintained and used properly, the amount of CO produced usually is not hazardous. But if appliances are not working properly or are used incorrectly, dangerous levels of CO can collect in an enclosed space. Hundreds of Americans die accidentally every year from CO poisoning caused by malfunctioning or improperly used fuel-burning appliances. Many more people are harmed to some degree each year.

Proper installation, operation and maintenance of combustion appliances in the home are most important in reducing the risk of CO poisoning. Some rules are:

• Never idle the car in a garage, even if the garage door is open. Fumes can build up very quickly in the garage and living area of your home.
• Never use a gas oven to heat your home, even for a short time.
• Never use a charcoal grill indoors, even in a fireplace.
• Never sleep in a room with an unvented gas or kerosene space heater.
• Never use any gasoline-powered engines (mowers, weed trimmers, snow blowers, chain saws, small engines or generators) in enclosed spaces.
• Never ignore symptoms, particularly if more than one person is feeling them. You could lose consciousness and die if you do nothing.

Link: http://www.zacks.com/research/get_news.php?id=294e8509

Lightening Creams: Too Much Mercury?

More than a dozen skin-lightening cosmetic products may pose dangers to health after they were found to have high levels of mercury, an ecological group said. EcoWaste Coalition said the mercury levels in these products were as high as 52,100 parts per million (ppm) – way above the 1 ppm safety limit.


The tests showed 76 percent (19 of 25) of the samples had mercury levels ranging from 1,395 ppm to 52,100 ppm. None of these samples listed mercury as an ingredient. They included:1. Long Dian Tu Glutathione Pearl Natural Whitening Essence Cream, 52,100 ppm.

2. Beauty Girl 10-Day Double Whitening Speckles Removed Essence Cream, 42,400 ppm

3. Jonathan 12-day Clearing Facial Spots Cream, 28,200 ppm

4. Feique Rose Refining Nourishing Set Cream, 21,600 ppm

5. Lianglibai Qingbanxuejizuhetaozhuang Cream, 15,000 ppm

6. Pretty Model Whitening and Freckle Removing Cream, 11,000 ppm

7. Yudantang Aloe Pearl 10-Day Whitening Speckles Removed Essence Cream, 10,700 ppm

8. Women of Flower Whitening and Speckle Removing AB Series Cream, 9,643 ppm

Sourcehttp://www.gmanews.tv/story/236962/nation/group-high-levels-of-mercury-in-19-skin-lightening-creams

Study: Aspirin Reduces Bowel Cancer Risk by 63%

Image via WikipediaTwo aspirin pills a day may keep the oncologist away, according to a study spanning more than a decade published in The Lancet medical journal.

Participants who took 600 milligrams of the common painkiller daily for at least two years had a 63 percent lower rate of colorectal cancer than those who took a placebo, according to the study led by John Burn, a professor of clinical genetics at Newcastle University in England. The participants all were carriers of Lynch Syndrome, a genetic condition that predisposes a person to developing certain cancers.

Link: http://www.businessweek.com/news/2011-10-28/aspirin-reduces-bowel-cancer-risk-by-63-percent-in-study.html

Georgia: Actos Hearing before JPML in Savannah, GA

The first plaintiffs filing a motion to consolidate made a request for all federal Actos claims to be transferred to U.S. District Court Judge G. Patrick Murphy in the Southern District of Illinois. Other plaintiffs have since filed responses requesting that different U.S. District Judges preside over the Actos litigation.

Takeda - responsible for Actos - has asked that the Northern District of Illinois be deemed the situe for all consolidated litigation because that is the location of the drug maker’s headquarters and the location of many of the company's records. Alternatively, the drug maker has asked that the Court centralize the Actos MDL in Western District of Louisiana because at least 16 lawsuits are now pending in that district.

Plaintiffs claim that each developed of bladder cancer as a side-effect of taking Actos, and that Takeda neither researched the medication properly nor issued proper warnings about the risk.

While Takeda’s attorneys do not agree with all of the plaintiffs’ assertions, they agree that the case qualified for a MDL consolidation in order to reduce or eliminate duplicative discovery and contradictory rulings.

A schedule for oral arguments on the consolidation motion is expected when the U.S. Judicial Panel on Multidistrict Litigation holds a hearing on December 1, 2011 in Savannah, Georgia. We'll be attending the hearing that day.

Lilly pulls sepsis drug Xigris

 Eli Lilly and Co withdrew its sepsis drug Xigris from all markets after the product, deemed a potential big seller when it was approved a decade ago, failed to improve survival in a clinical trial.

Sepsis is a severe, often life-threatening illness caused by the immune system's over-aggressive response to infections -- releasing inflammatory proteins that cause shock and shut down multiple organs. The condition occurs in 1 to 2 percent of all hospitalizations in the United States.

Xigris, which has never reached its lofty initial sales projections, had global sales of about $100 million in 2010. It has garnered total sales of $1.5 billion since being approved in the United States in 2001 and in Europe the following year.

http://www.reuters.com/article/2011/10/25/elililly-idUSN1E79O08320111025

Source here: 

Listeria outbreak: Victims file lawsuits: Collection an issue?

“Jensen Farms is not a major corporation that has significant financial assets,” says Fred Pritzker, a Minneapolis-based attorney specializing in food-poisoning cases who is representing two victims in Illinois and New York. “When you factor in the severity of the illness and the number of deaths and illnesses that will be attributed to this in the days and weeks to come, you just know they don’t have nearly enough assets to fully compensate them.”


So begins the report on the Listeria outbreak: Read more here. 

Encision Announces Voluntary Recall of Certain Electrode Product

Encision Inc. (ecia:PK), a medical device company owning patented surgical technology that is emerging as a standard of care in minimally-invasive surgery, announced today that it initiated a voluntary recall on August 24, 2011 of certain electrode tips used in its AEM® surgical systems after determining that certain tips could become susceptible to breaking off as a consequence of aggressive cleaning of the tip. The tips covered by the voluntary recall are Encision's ES388X Series Reusable Suction-Irrigation Electrodes. All of the affected instruments will be replaced at no charge to the customer. 


Encision has contacted customers by letter and will provide them with replacement instruments as soon as they are available. The Company has developed a replacement instrument and is currently working with the FDA to obtain approval of the replacement. Until the FDA provides its approval, the Company will not be able to provide replacement products to customers. In the interim, the Company has provided customers with the prior version of the product, which is not susceptible to the same issues as the recalled product.


Read more at the source.

Sprycel Warning from the FDA

The FDA  issued a warning regarding the safety of  leukemia drug Sprycel. Sprycel is indicated for treating certain adults suffering from Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL). The drug, which has treated approximately 32,882 patients since launch, blocks the action of an abnormal protein that causes tumor growth.

The US regulatory body stated that treatment with the drug may elevate the risk of high blood pressure in the lungs’ arteries. The disorder is referred to as pulmonary arterial hypertension (PAH). The FDA stated that due to high blood pressure the heart has to work harder to pump sufficient blood through the lungs. Consequently, the heart muscles stand the risk of becoming weak which may cause them to loose the ability to perform the above function. Breathlessness, fatigue and swelling of body parts (such as the ankles and legs) are the common symptoms associated with PAH.

Source here. 

Johnson & Johnson Wins Zero Verdict Over Levaquin's Side Effects

Johnson & Johnson on Friday won a significant lawsuit concerning whether it adequately alerted doctors to the risks in prescribing Levaquin.

J & J is facing more than 2,000 lawsuits from plaintiffs who claim the company was slow in fully warning doctors about reports linking Levaquin to tendonitis and tendon ruptures. In a New Jersey state court in Atlantic City, lawyers for the drug maker told jurors that the Levaquin label had included information about tendon problems since the FDA approved the drug in 1996.

Read more here.

Should You Take a Multivitamin?

From ABC News:

Home Fires Prompt Dehumidifier Recall Reannouncement from LG Electronics

From the CPSC:

LG Electronics Tianjin Appliance Co., in cooperation with the U.S. Consumer Product Safety Commission (CPSC), is urging consumers to check if they have recalled Goldstar or Comfort-Aire dehumidifiers. The firm is re-announcing the recall of about 98,000 of the dangerous dehumidifiers that pose a serious fire and burn hazard, and are believed to be responsible for more than one million dollars in property damage.
The power connector for the dehumidifier’s compressor can short circuit, posing fire and burn hazards to consumers and their property.
The dehumidifiers were first recalled in December 2009 following eleven incidents, including four significant fires. Since that time, the company has received sixteen additional incident reports of arcing, smoke and fire associated with the dehumidifiers, including nine significant fires. No injuries have been reported. Fires are reported to have caused more than $1 million in property damage including:

• $500,000 in damage to a home in Gibsonia, Pa.
• $200,000 in damage to a home in New Brighton, Minn.
• $183,000 in damage to a home in Hudson, Mass.
• $192,000 in damage to a home in Valparaiso, Ind.
• $139,000 in damage to a home in Salem, Ohio
• $129,000 in damage to a home in Brielle, N.J.
• $ 95,000 in damage to a home in Philadelphia, Pa.

Because of the severity of the risks, CPSC and LG Electronics are concerned with the lack of consumer response to the recall. Only two percent of the 98,000 consumers who purchased these units have received a free repair, which means that consumers and their property remain at serious risk.
Anyone who has the recalled dehumidifiers is strongly encouraged to immediately stop using them, unplug them, and contact LG Electronics for the free repair.
The recall involves the 30 pint portable dehumidifiers sold under the Goldstar and Comfort-Aire brands. The dehumidifiers are white with a red shut-off button, controls for fan speed and humidity control, and a front-loading water bucket. “Goldstar” or “Comfort-Aire” is printed on the front. Model and serial number ranges included in this recall are listed in the table below. The model and serial numbers are located on the interior of the dehumidifier, and can be seen when the water bucket is removed.

Brand	Model No.	Serial Number Range	Sold at
Goldstar	GHD30Y7	611TAxx00001 through 08400 611TAxx08401 through 40600 612TAxx00001 through 20400 612TAxx21001 through 30600	Home Depot
Goldstar	DH305Y7	612TAxx00001 through 00600 701TAxx00001 through 16800 702TAxx00001 through 03000	Walmart
Comfort-Aire	BHD-301-C	611TA000001 through 001697 612TA000001 through 004200 701TA000001 through 000578 710TA000001 through 000599	Various retailers, including Ace Hardware, Do It Best and Orgill Inc.

The recalled dehumidifiers were sold at The Home Depot, Walmart, Ace Hardware, Do It Best, Orgill Inc., and other retailers nationwide from January 2007 through June 2008 for between $140 and $150. They were manufactured in China.

CooperVision Continues the Voluntary Recall of Avaira™ Toric Contact Lenses

From the FDA:

 CooperVision, Inc. is continuing to work with the FDA, distributors, customers, eye care practitioners and lens wearers to complete the worldwide recall initiated on August 19, 2011 on certain lots of Avaira™ Toric contact lenses.

“Our first priority is always the health and safety of all CooperVision lens wearers and as such we responded quickly to complaints from our customers by initiating a voluntary recall” said Christine Moench, vice president, Global Regulatory Affairs and Quality Assurance. “We want to ensure that all consumers are aware of this action and know where to go for more information.”

If you wear Avaira Toric contact lenses and experience any symptoms, CooperVision recommends that you stop wearing the lenses immediately.  Contact your eye care practitioner for advice.

If you wear Avaira Toric contact lenses and are not experiencing symptoms, CooperVision recommends that you:

• Go to the CooperVision recall web page at www.coopervision.com/recall, and enter the lot number of your package to determine whether your lenses have been recalled.
• Alternatively, you may contact us on our toll-free consumer hotline (1-855-526-6737)
• If your lenses have been recalled, immediately remove your existing lenses, discontinue lens wear; and return your lenses to your eye care practitioner or point of purchase. 

The recall was initiated because of the unintended presence of a residue on certain lots of Avaira Toric lenses, which may cause hazy vision, discomfort, or eye injuries requiring medical treatment. Not everyone experiences the same symptoms. Since the initiation of the recall, the company has received some additional complaints of severe eye pain. Avaira Toric contact lens wearers that experience any symptoms should stop wearing the lenses immediately and speak with their eye care practitioner.

We have ongoing relationships with practitioners to continue to identify all the affected lots in the market. To date, the recall has impacted approximately 600,000 Avaira Toric contact lenses in the U.S. 

http://www.fda.gov/Safety/Recalls/ucm275772.htm

FDA: Brewer's Yeast Tablets Recalled Due to Milk Allergen Issue

The maker of the supplement, NOW Foods, voluntarily recalled selected lots of its brewers yeast tablets because they contain a milk product not listed on the label, the Food and Drug Administration said.

The FDA urged people with allergies or a severe sensitivity to milk to stop taking the tablets "immediately" because they could suffer "a serious or life-threatening allergic reaction."

The FDA said the tablets, produced between March and June 2011, were sold nationwide under the product codes 2410 and 2412. From the FDA:

 October 12, 2011 - NOW Foods is voluntarily recalling selected lots of its Brewer’s Yeast Tablets (Product Code 2410 and 2412) due to the presence of an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products and should stop taking them immediately. People who do not have a milk allergy or sensitivity need not take any action.

The recall covers Brewer’s Yeast tablets, 10 grain, 650 mg, in bottle sizes of 200 tablets (product code 2410) and 500 tablets (product code 2412). The products were distributed throughout the United States and other countries. The affected U.S. lot numbers for product 2410 are 1334119, 1354098, and 1362375. The affected U.S. lot numbers for product 2412 are 1347607, 1334773, and 1358774. These lots were produced between March and June 2011. The product code is located on the label and the lot number is located on the bottom of the package. All other NOW Foods products, including Brewer’s Yeast product code 2420, are not affected and are not involved in this recall.

The presence of a milk allergen in the two affected products was discovered during an FDA inspection of NOW’s supplier of Brewer’s Yeast tablets and confirmed through allergen testing by NOW. No illnesses or adverse events have been reported to date.

NOW Foods is providing information on this voluntary recall to all of its retailers who purchased these products and is encouraging retailers to make every effort to contact their customers to facilitate returns.

All consumers may return the affected product to the place of purchase or to NOW Foods for a full refund. No receipt is necessary. Consumers with additional questions may call the NOW Foods Customer Service Department at 1-888-NOWFOODS (1-888-669-3663).

Consumers without milk allergies or sensitivity can continue taking the tablets

Read more: http://www.foxnews.com/health/2011/10/13/fda-brewers-yeast-tablets-recalled-due-to-milk-allergen-issue/#ixzz1b05pUqIg

Report on Transvagainal Mesh Failures

From MSNBC, a report on the failure of mesh implants


100,000 mesh patients in 2010 In 2010, the agency says, doctors performed at least 100,000 prolapse repairs using surgical mesh, and about three-quarters of them were transvaginal. From 2005 to 2007, the FDA received more than 1,000 reports of adverse events related to the mesh in women treated for pelvic organ prolapse or stress urinary incontinence. From 2008, when the FDA first revealed its safety concerns, to 2010, the agency received nearly 3,000 more.

Read more here.http://www.msnbc.msn.com/id/43886793/ns/health-health_care/#.TpraaHJu5Rw

Uprizing 2.0: Recall - Undeclared Drug Ingredient: Synthetic Steroid

Image via WikipediaFrom the FDA site:



ISSUE: FDA notified the manufacturer that lab analyses found that the product, sold as a testosterone booster, contains superdrol, a synthetic steroid, making it an unapproved new drug. Acute liver injury is known to be a possible harmful effect of using products containing synthetic anabolic steroids. In addition, use of synthetic anabolic 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.

BACKGROUND: On August 5, FDA made Superior Metabolic Technologies Inc aware that Uprizing 2.0 contains superdrol, which is banned by the FDA. Uprizing 2.0 was distributed through retail health food stores in Alabama, Arizona, California, Georgia, Mississippi, New Jersey, South Carolina, and Texas.

Sprycel (dasatinib): Drug Safety Communication - Risk of Pulmonary Arterial Hypertension

The FDA notified healthcare professionals that Sprycel (dasatinib) may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). In reported cases, patients developed PAH after starting Sprycel, including after more than one year of treatment.

Information about this risk has been added to the Warnings and Precautions section of the Sprycel drug label.

BACKGROUND: Sprycel (dasatinib) is used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).

RECOMMENDATION: Healthcare professionals should evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to starting Sprycel and also during treatment. If PAH is confirmed, Sprycel should be permanently discontinued.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm275176.htm

Are Smart Lawyers Suddenly Stupid when it comes to Social Media?

I ask this question because it seems like sharp,  intelligent, hard working lawyers suddenly get hoodwinked when it comes to certain forms of "Social Media" and the carnival barkers that seek to profit from consulting in that area.


First, what is Social Media?  In our law firm it's a blog like this one. It's a collaborative blog like the Trial Lawyers Resource Center (www.tlrcblog.com). An old fashioned list server is to me a social media vehicle.
Social media sites include Facebook and even that old former hangout myspace.com. Still others include slideshare.net, or even www.youtube.com.


Where I have a major problem is the sites like Twitter and now the recently arrived Google + as vehicles for lawyers to "generate referrals" - to make money. I've been using Twitter for nearly three years. It's clearly not ready for prime time as a referral source in my area of the law (personal injury and consumer rights).


What bothers me the most is the growth of hucksters who tout Twitter and now Google + as the key place for lawyers to grow their practices. They are not,  and this week we have ... ahem ... Exhibit A, Google +.


Here is the headline from an online site this week (October 2011) : Google+ Traffic Plummets: Is The Social Network Doomed? To be fair, that social site is untested. For consultants, it was damn the torpedoes, full steam ahead, with articles like these:Google+ for Lawyers. The article was written July 12, 2011 just 90 days ago.


 The author wrote silliness like: "for attorneys serious about social marketing and SEO, I don’t think we can afford not to get involved."  But wait,  there is more from that article:  "Google + is gearing up to be the place to reinvent ourselves as the new experts in our fields."   Read that out loud - not just the place to be to perhaps help the bottom line, but the place to "reinvent ourselves" as experts. That is just plain wrong. Another author wrote that when Google+ reaches critical mass, "it will be silly not to be there." Link


I'm just happy that these folks don't predict the weather. 


For lawyers, don't make the mistake of devoting so much time to social media when your own law firm's web site (usually) is not very good. Stick to the basics. A well designed website, thoughtful google ad buys, a youtube channel, even a blog or three should be the focus. 


Because you're stupid if you think the flavor of the month will generate cases. 


Disagree with me? ageorgialawyer (at) yahoo.com
    

US Halts Plavix-Aspirin Combo In Stroke Study, Citing Bleeding

Image via WikipediaWorth a read:

A U.S. government institute has halted part of a stroke-prevention study because the combination of the drugs Plavix and aspirin was linked to increased rates of bleeding and death versus aspirin alone.

Read more here. 

The Dangerous World of Counterfeit Prescription Drugs

Image via WikipediaAn interesting read over at CNBC:

Counterfeit pharmaceuticals are undoubtedly a billion-dollar industry, though some estimate it to be much larger. Peter Pitts, president of The Center for Medicine in the Public Interest and former FDA associate commissioner, estimates that in 2010, activities related to counterfeit drugs generated $75 billion.

Read more here. 

Our Law Firm (and I) Named to the Darvocet MDL Plaintiffs' Leadership

The Propoxyphene Multi District Litigation (MDL) is based in Kentucky and was recently established. The United States District Court Judge recently issued an  Order Appointing Counsel to Leadership Positions and the Court accepted our application.

You may read the Order here (PDF). 

Aussie Company Faces FDA Accusation about Manufacturing Practices

udits carried out by the FDA in 2010 and 2011 revealed "objectionable conditions and practices" within CSL, the privatised Commonwealth Serum Laboratories, News Limited reported on Thursday.

Allegations include that CSL took six months to start investigating the cause of dark particles in the national stockpile of swine flu vaccines.

The FDA's most recent audit, carried out in March, found CSL's investigation of febrile fits among children immunised with Fluvax, its seasonal flu vaccine, was "inadequate".

Source here. 

Will the FDA Ask That Yaz Be Removed from the Market?

There are preliminary results that a FDA-funded study of Yaz and similar drospirenone-based contraceptives show they carry a 1.5-fold increase in the risk of  blood clots compared to older hormonal contraceptives. That study follows six others, four of which have shown an increased clot risk for Yaz and its ilk.
 
The DrugCite database of adverse event information culled from the FDA shows that blood-clot events are more common for pills containing drosperinone than for levonorgestrel, an older version of the progestin ingredient in contraceptive pills:

• Most Common Drospirenone Adverse Events
  
• Pulmonary Embolism: 119
• Deep Vein Thrombosis: 99
• Gallbladder Injury: 57
• Thrombosis: 20
• Most Common Levonorgestrel Adverse Events
• Pulmonary Embolism: 17
• Deep Vein Thrombosis: 10
• Thrombosis: 9
• Gallbladder Injury: 0

Source here

FDA Recalls Several Medtronic SynchroMed II Infusion Pumps

The FDA has asked for a recall of Medtronic's SynchroMed II implantable infusion pump, models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.

From the FDA site:


Product: SynchroMed II Implantable Infusion Pump, models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.
Medtronic has a Device Identification web page where customers can enter the serial number for any SynchroMed II infusion pump to determine if their pump is being recalled.

Use: The SynchroMed II Implantable Programmable Drug Pump is part of the SynchroMed II Infusion system designed to contain and administer prescribed drugs to a specific site. The SynchroMed II Pump is supplied in 20 ml and 40 ml reservoir sizes. In the United States, the SynchroMed II Pump is indicated when patient therapy requires the chronic infusion of the drugs or fluids. This infusion pump is indicated to deliver morphine sulfate, ziconotide and baclofen for the treatment of chronic pain, severe chronic pain and severe spasticity, respectively. It is also indicated for delivery of floxuridine and methotrexate for the treatment of primary or metastatic cancer.

Recalling Firm:
Medtronic, Inc – Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568

Reason for Recall:
There is a potential for reduced battery performance in the SynchroMed II infusion Pump. Medtronic’s analysis of the problem indicates it is related to the formation of a film within the pump battery. This problem can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms. For example, patients receiving intrathecal baclofen therapy for severe spasticity are at risk for baclofen withdrawal syndrome, which can lead to a life-threatening condition if not treated quickly and effectively.

Medtronic encourages patients to carry their patient identification cards with them at all times and to contact their physicians immediately if they experience a return of symptoms or hear a device alarm.
SynchroMed II infusion pumps were recalled for the same battery issue in July 2009.

Lawsuit over Bone Deterioration Allegedly Caused by Nexium filed in Texas

Good work by the folks at Pharmalot.

Lawsuit was filed alleging  that AstraZeneca is to blame for bone deterioration and bone fractures allegedly attributed to the Nexium acid reflux pill.

Read more here.  

Public Citizen: Time to Recall the Surgical Mesh

Mesh products made of non-absorbable synthetic material can erode and cause pain, bleeding and urinary incontinence, Public Citizen, based in Washington, said in a statement today. The mesh is implanted through incisions made in the wall of the vagina to reinforce the tissues around the pelvic organs.

Public Citizen says that 67,500 women had the non-absorbable mesh implanted last year. The FDA has  1,503 reports of complications associated with the material from January 2008 to December 2010 when used to repair pelvic organ prolapse, the agency said in a safety warning July 13.

http://www.bloomberg.com/news/2011-08-25/fda-should-recall-surgical-mesh-for-women-public-citizen-says.html

Birth Control Pill Recall

Qualitest Pharmaceuticals, an oral contraceptive manufacturer, has announced a recall of several varieties of birth control pills due to a packaging error that may be affecting users' dosage schedules.


In the affected birth control pill packages, the card used to track dosage is misaligned and may result in women taking the hormone-free "filler" pills on days when they should be taking active pills. "Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible," a Food and Drug Administration (FDA) statement says.


More here