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).