The Myth that "Social Media" is a must for Attorneys (Solo, Small Firm, Big Law)

PT Barnum I rarely write about Social Media. We blog (obviously), have a Twitter account, and post on other blogs - mostly with posts that relate to Georgia law and/or pharmaceutical litigation news. Our office is made up of litigators. We try cases- I am in trial Tuesday of this week for the third time this year.

I regularly read about what marketers and other lawyers say about Social Media. The so called social media are for the most part nothing more than  carnival barkers. What I have just read has me irritated because the post's author is just plain wrong and uninformed.

I read an article titled: Small Firms, Big Lawyers: 7 reasons to Avoid Social Media

From the start the author (Jay Shepherd)  points to a recent report that "had a section about which marketing methods solos and small firms found most effective." Shepherd commented on this report:

"The leading methods were:

• online directories (17.7%);
• word of mouth — which isn’t really a method, but more of a thing that happens (15.5%);
• group-advertising ventures (whatever the hell that is) (13.3%); and
• Yellow Pages (8.9%).

"The takeaway for me from that list is that small-firm lawyers don’t know what they’re doing when it comes to marketing." (emphasis added)

“Word of mouth” means sit back and hope someone tells someone else to hire me, “group-advertising ventures” sounds like some sort of mail-order scam, and I didn’t know they still printed Yellow Pages. ... (Sorry, Yellow Pages advertisers. Oh, wait. You’re not reading this because you’re offline.)"

Jay, you're wrong. First -You obviously don't mind putting down practices  you know nothing about  - 'group-advertising ventures" have been around for years. The ventures may look like the Jim Sokolove model, or Staggerwalt and Associates, or others. Surely you have heard about the Texas group that advertises for IP clients on the web. You knew about those firms, right Jay? Or how www.findlaw.com touts its mass buying power on the web to garner better placement for little ol' small firms like mine.

For our office 'group advertising ventures' in the personal injury area of the law might look like a true 'joint venture' - Anywhere from two to seven  law firms form a group that advertises on the web, radio, tv, or newspapers for a particular type of case . (For example, Katrina levee related property damage claims, or those seeking Dupuy knee work).Our firm gets approached at least 3 times a week by ventures seeking our $$$.  OK, dead horse beaten, on to next mistake.  
   

I don't understand your disdain for word of mouth - maybe you stammer in public, or are too arrogant to mix with 'the common folks.' In the south, word of mouth is proactive.

Word of mouth is speaking at a CLE on any area of the law - like trucking. My good friend and litigator Joe Fried is known simply as The Trucking Lawyer. He will speak at more than 30 CLE seminars this year. Here's his site: http://www.thetruckingattorneys.com. Before you scoff, does your firm have more than $25 million in verdicts like his - in the past 10 months? Clients come to him thanks to word of mouth. Lawyers send him work thanks to word of mouth - where he engages people and talks about his results.
  

Word of mouth is the stock in trade for many smaller town attorneys. Rotary clubs, schools groups, alumni groups, lawyer groups, church groups, bible studies, business chambers - that is where word of mouth works.  In my trial last month - in a tech city that is Atlanta - of 34 potential jurors less than 20% had heard of Twitter, but more than 75% were members of a civic or church group.  

We both agree on the Yellow Pages. If you have received a call from 'the books' you'd know that there is a reason why only 8.9% admitted to paying for placement. In fact, I'd guess that 8.9% of any town's lawyers are on Twitter at all.  

To my amazement, there is still an area not yet at the forefront for lawyers on the web - blogging. It is by far the most successful project my firm has taken on in the past 5 years. Our firm has three separate blogs.

Where is an area with little competition? Specialty sites for niche areas of the law. If you are not familiar with this type of site, go ahead and crap on it, Jay.  For others reading this, take a look at  the lawyers at Water Colorado: http://www.watercolorado.com/water_rights2.shtml or attorneys who handle cattle cases:  http://cattlelawyers.com/default.aspx

Specialty sites should be part of a law firms' tech arsenal long before any Twitter account is set up by an attorney. Web sites now are easy to set up and maintain. If for example, someone needs an immigration attorney in the Vietnamese community, what makes a better first impression - a site focused on that ethnic group, or a site that has a law firm with a .jpg of a gavel, and a nav bar with 22 areas of the law?  Spend 20 hours looking at the competition for the type of work your firm wants - and then set up a site in that area alone.    




Now, on to Twitter: Lawyers who get hornswaggled or even brow beaten into thinking Twitter is a must have should be ashamed of themselves for being so damned gullible. But hey, Jay, lead them to Twitter and away from blogging - hours and hours of time will be wasted on Twitter.

You wrote: "But I can connect to 2,345 people at once on Twitter and tell them about something that’s on my mind or that I think they should read.It would take a lot more time to make all those phone calls or have random acts of lunch." Read this though Jay - 99% of those people don't  really care about your one tweet. It's just noise. 


Here's a thought for attorneys - spend more than an hour a month just updating the firm web page. Learn Google Ad Words. Buy a google ad just for your firm name. Buy a .com that is the same as your office telephone number. Learn the basics of the web - before you get seduced by the allure of Twitter.

Find a listserver somewhere - GTLA has one, the Florida Justice has one - and get active there - post on subjects. Comment, engage.  

Those basics - along with word of mouth - will bring results with hard work and discipline.




 

Alli & Xenical: Calls For Pulling the Drugs from the Market

Image by Newbirth35 via Flickr
The group Public Citizen wants the weight-loss drugs Alli and Xenical be removed from the market because of the growing risk of side effects that include liver damage, pancreatitis and kidney stones.

"These drugs have the potential to cause significant damage to multiple critical organs, yet they provide meager benefits in reducing weight loss in obese and overweight patients," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. Find the info here. 

Pancreatitis is inflammation of the pancreas that can occur in two very different forms. Acute pancreatitis is sudden while chronic pancreatitis "is characterized by recurring or persistent abdominal pain with or without steatorrhea or diabetes mellitus

Hepatotoxicity (from hepatic toxicity) implies chemical-driven liver damage.
The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents, when taken in overdoses and sometimes even when introduced within therapeutic ranges, may injure the organ. Other chemical agents, such as those used in laboratories and industries, natural chemicals (e.g. microcystins) and herbal remedies can also induce hepatotoxicity.

Source for both:  Wiki

FDA to reveiw Trilipix Study

A study of Abbott Laboratories' Trilipix appears to show that women who took the drug in combination with a statin experienced more heart problems than those who just took a statin.

The FDA will meet on May 19th to address the findings of the ACCORD Lipid Study.

Here are the side effects for this drug:

Trilipix Delayed-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Trilipix Delayed-Release Capsules:

Back pain; diarrhea; dizziness; headache; heartburn or indigestion; nausea; sore throat; stomach upset; upper respiratory tract infection.

Seek medical attention right away if any of these SEVERE side effects occur when using Trilipix Delayed-Release Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf pain, swelling, or tenderness; chest pain; coughing up blood; dark urine; decrease in amount of urine produced; fever, chills, or persistent sore throat; loss of appetite; muscle pain, tenderness, or weakness (especially along with fever or unusual tiredness); pale stools; red, swollen, blistered, or peeling skin; severe or persistent headache, dizziness, or lightheadedness; severe or persistent nausea, stomach pain, or vomiting; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.

Read more: http://www.chicagobusiness.com/article/20110425/NEWS03/110429925/abbott-drug-statin-combo-can-cause-heart-problems-fda#ixzz1KieuN1nT

Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia

The FDA notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.

Methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.

What the FDA suggests:

• Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional.
• Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label. Consumers should store benzocaine products out of reach of children. FDA encourages consumers to talk to their healthcare professional about using benzocaine.

Penumbra Coil 400 by Penumbra Inc.: Class 1 Recall - Premature Detachment of the Co

ISSUE: The Penumbra Coil 400 system includes a tool used to implant the coils inside a patient. The pull wire on the delivery tool can slip out of place and allow premature detachment of the coil. Premature detachment of the coil may cause the coil to unintentionally migrate. This can lead to serious injury including blood clots and stroke.

BACKGROUND: The Penumbra Coil 400 is a small platinum coil placed into a brain aneurysm through the blood vessels leading to the brain. Once the device is in place, the body responds by forming a blood clot around the coil mass, which occludes the aneurysm and helps protect the blood vessel from rupturing or leaking.

RECOMMENDATION: On March 4, 2011, Penumbra, Inc. notified their customers and distributors of the recall and instructed to return the product to the company.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251402.htm

GAO Rips FDA

From a recent study:

A damning report on the many shortcomings on the creaky old house that is the FDA. It's a grossly underfunded, undermanned, and mess of an agency. It's decades away from repair, and this report shows that perhaps it's time to dismantle it and start anew: 

Our preliminary findings suggest that shortcomings in FDA’s oversight of the medical device recall process may limit the agency’s ability to ensure that the highest-risk recalls are being implemented in an effective and timely manner. These shortcomings span the entire range of the agency’s oversight activities—from the lack of a broad-based program to systematically assess trends in recalls, to inconsistencies in the way FDA ensures the effective completion of individual recalls.

and this:

Although FDA’s recall data system contains numerous data elements that would allow for analyses of recall data, our preliminary findings suggest that FDA is not using this system to effectively monitor and manage its recall program.

When it came to recalls that were audited:

Our analysis of 2,196 audit check forms associated with the class I recalls we reviewed found a variety of inconsistencies in how the audit checks were implemented and documented for nearly 90 percent of these recalls. For each of these recalls we found inconsistencies in how different investigators determined whether a recall was effective or ineffective when conducting their audit checks of recalls.

To citizens, the FDA is as useful as FEMA was during Katrina. 

Should Xenical be Recalled?

Public Citizen Director Dr. Sidney Wolfe urges patients not to wait for the FDA to remove the drugs from the market and says to stop taking them immediately. "Unlike other drugs, which have a withdrawal syndrome that you would go through if you suddenly stop, there is no downside to stopping Xenical or Alli," says Wolfe.

Both Xenical and Alli are medications that contain the drug orlistat and work to block the body's ability to absorb dietary fat.

The urging from Public Citizen to remove the drugs from the market follows a May 2010 warning issued by the FDA, noting 13 reports of severe liver injury in patients taking orlistat. Public Citizen stated that 73 cases of kidney stones have also been linked to use of the medications.

Find more at public citizen

More information the Topamax Recall

About 57,000 bottles of the prescription anti-seizure drug Topamax are being recalled due to customer complaints of an "uncharacteristic odor," said J and J.

The recall affects two lots of Topamax 100 milligrams tablets shipped and distributed between Oct. 19, 2010 and Dec. 28, 2010 in the United States and Puerto Rico. The tablets were made by Johnson & Johnson's Ortho-McNeil Neurologics division, CNN.com reported.

There were four consumer complaints about an odor believed to be caused by trace amounts of the chemical TBA (2,4,6 tribromoanisole), which is applied to wooden pallets used to transport and store packaging materials.

http://www.businessweek.com/lifestyle/content/healthday/651924.html

On March 4, 2011, the FDA announced new data suggesting that babies born to women who took Topamax during their first trimester have an increased risk of birth defects.

Birth defects associated with Topamax use include but are not limited to:

• Cleft Lip
• Cleft Palate
• Genital Defects
• Fetal and Skeletal Malformations

A cleft lip or cleft palate occurs when the mouth fails to fully form, causing a split or gap in the roof of the mouth. These deformities may cause developmental issues and can lead to severe ear infections and problems with eating and talking.

Novedex Recall

By now folks have read about the Novedex Recall. 

Possible Side Effects

Potential adverse events associated with the use of anti-aromatases could include:

• Decreased rate of bone maturation and growth
• Decreased sperm production
• Infertility
• Aggressive behavior
• Adrenal insufficiency
• Kidney failure
• Liver dysfunction
• Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events

From the FDA site:

Gaspari Nutrition Incorproated, 575 Prospect Street - Suite 230, Lakewood, NJ, announced  that it is conducting a voluntary nationwide recall of all Lot Codes of the company's dietary supplement product sold under the name Novedex XT, which was marketed "for increasing natural testosterone production" and contains 3,17-keto-etiocholetriene, also known as ATD, an anti-aromatase. Gaspari Nutrition is conducting this consumer level recall after being informed by representatives of the Food and Drug Administration (FDA) that 3,17-keto-etiocholetriene does not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Federal Food, Drug, and Cosmetic Act.

Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX®

Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., today announced it is voluntarily recalling two lots of TOPAMAX® (topiramate) 100mg Tablets.  These two lots were shipped between 10/19/2010 and 12/28/2010 and distributed in the U.S. and Puerto Rico.  While the recall encompasses approximately 57,000 bottles of TOPAMAX®, the company believes there are fewer than 6,000 bottles remaining in the marketplace.  The recall stems from four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

Package Description	NDC Code	Lot Number	Expiry
TOPAMAX® (topiramate) TABLETS 100mg  Bottles of 60 Tablets	50458-641-65	0KG110	06-2012
		0LG222	09-2012

TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which products are transported and stored.  In January 2010, we instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to verify that they do not use pallets made from chemically-treated wood.  An internal investigation is underway with our suppliers to evaluate the potential source of this TBA issue.   In addition, we are working with peer companies to better understand how and where TBA is entering and impacting our supply chains and what we can do to further mitigate this exposure.

Source is the J and J site:   Here.

Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine

From the FDA site:

The U.S. Food and Drug Administration (FDA) is informing the public that it continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor (TNF) blockers, as well as with azathioprine, and/or mercaptopurine.
Crohn's disease and ulcerative colitis cause inflammation of the digestive system. Common symptoms are pain in the abdomen, cramps, and diarrhea. Bleeding from the rectum, weight loss, joint pain, skin problems and fever also may occur. Children with the disease may have growth problems, develop intestinal blockage, and experience malnutrition.

FDA believes the risks and benefits of using TNF blockers, azathioprine, and/or mercaptopurine should be carefully weighed when prescribing these drugs to children and young adults, especially for the treatment of Crohn’s disease and ulcerative colitis. Patients should continue to talk to their Healthcare Professionals about the potential risk of HSTCL with use of these medications in order to make the best decision about their medical treatment.

The product labels for Remicade (infliximab) and Humira (adalimumab) have been updated and the product labels for azathioprine and mercaptopurine are being updated to include warnings about HSTCL that have been reported in patients treated with these products
http://www.fda.gov/Drugs/DrugSafety/ucm250913.htm

U-Prosta Recalled

USA Far Ocean Group (Alhambra, CA) voluntarily recalled their product, U-Prosta, a dietary supplement for prostate health .

USA Far Ocean Group is the maker of the product, and it was told by the FDA that laboratory analyses of U-Prosta revealed samples of the product contained terazosin, an active ingredient of an FDA-approved drug to treat Benign Prostatic Hyperplasia (enlarged prostate), making U-Prosta an unapproved drug.


Patients treated for high blood pressure or enlarged prostate who taking U-Prosta could experience some adverse affects, such as hypotension, dizziness or syncope.

 Low blood pressure, or hypotension, occurs when blood pressure during and after each heartbeat is much lower than usual. This means the heart, brain, and other parts of the body do not get enough blood.

Syncope (SIN'ko-pe) is temporary loss of consciousness and posture, described as "fainting" or "passing out.
U-Prosta has been sold and distributed nationwide through retails stores, Internet sales and by mail order. The U-Prosta products involved in this recall are:

U-Prosta Dietary Supplement 60 Capsules 689076499255
U-Prosta Dietary Supplement 30 Capsules 88858100030
U-Prosta Dietary Supplement 1 Capsule No UPC Code

Nutrition Express Voluntarily Recalls Protein Supplements Because Of Possible Health Risk

A company called Nutrition Express  has voluntarily recalled specific products containing whey protein isolate sourced from one supplier because they have the potential to be contaminated with Salmonella. 
 
Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. A limited number of products were sold between December 1, 2010 and February 17, 2011.

About 450 bottles of powdered protein were sold at two retail health food stores only (Lindberg Nutrition located in Torrance and Manhattan Beach), both in Los Angeles County, California. Notice of the recall was immediately posted at both stores. The only other sales channel was a direct-to-consumer channel from Nutrition Express, the exclusive distributor of these products.

The products were shipped directly to consumers in the United States via Federal Express or the U.S. Post Office. All consumers, who bought through this direct channel, were immediately sent letters on February 22, 2011 by Nutrition Express regarding the specific recalled product that they purchased.

Source here. 

Alcohol a major cause of cancer?

Image via Wikipedia

From Yahoo:
 

About one in 10 cancers in men and one in 33 in women in western European countries are caused by current and past alcohol consumption, according to a study released on Friday. For some types of cancer, the rates are significantly higher, it said.

In 2008, for men, 44, 25 and 33 percent of upper digestive track, liver and colon cancers respectively were caused by alcohol in six of the countries examined, the study found. The countries were Britain, Italy, Spain, Greece, Germany and Denmark.

April Darvocet Update: JPML Panel Defers Decision Until Late Summer

Image by amayzun via Flickr

From the JPML Order:

On the basis of the papers filed and hearing session held, the Panel has decided to defer its decision on this Section 1407 motion pending further argument at the July 2011 Panel hearing session. Moving and responding plaintiffs and defendants have made persuasive arguments for and against centralization.

Since this Section 1407 motion was filed on December 15, 2010,less than two weeks after the first case commenced, this litigation has grown from four actions involving one defendant to encompass eighteen currently known actions involving more than a dozen different defendants. Consideration of this Section 1407 motion so soon after a handful of actions were filed, where the contours of the litigation are in flux, leaves the Panel with less than ideal information to make the best possible decision. For example, most of the known parties in this litigation, including ten of the thirteen defendants, have not had an opportunity to express their views on the merits of Section 1407 centralization. This is a potentially complex case. Our desire to make the most informed possible decision counsels further deliberation.

With these considerations in mind, the Panel will issue a show cause order setting forth an additional briefing schedule, and further argument for our July 2011 Panel hearing session. While deferring our ruling does delay the Panel’s decision-making process, in the interim, these cases can proceed in the transferor courts. See Panel Rule 2.1(d). In the longer term, this continuation will assure that all parties have an opportunity to be heard, enhance our decision-making process, and should not prejudice the benefits of centralization, if that is our ultimate judgment. 

Find the Order here: http://www.jpml.uscourts.gov/Panel_Orders/panel_orders.html 

Stop Using Soladek Vitamin Solution

The U.S. Food and Drug Administration is warning consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D.

Soladek is marketed with claims that the product treats “hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy.” The product is sold in a box labeled in Spanish and containing a vial of the solution.

FDA recently received information that tested samples of Soladek contained levels of vitamin A and vitamin D that were many times the recommended daily allowances for these vitamins.  Intake of excessively high levels of these vitamins poses a risk to human health.

The FDA also received seven reports of serious health problems occurring in consumers using the product. The problems include decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea. Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma.

Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects.

Consumers who are in possession of Soladek should stop using the product immediately. Any consumers who have been using Soladek and are experiencing any of the above symptoms should see a doctor immediately. 

Soladek cannot currently be marketed legally in the United States because U.S. law prohibits the sale of products claiming to treat disease conditions without review and approval by the FDA.  However, the reports of adverse events and other information leads the FDA to conclude that Soladek may be available illegally in the country; therefore, the agency is issuing this warning.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm248588.htm

IV Meds Update - Birmingham, AL 4/4/11

Alabama health officials trying identify the source of bacteria suspected in the deaths of nine hospital patients and the sickening of 10 others said last week that the officials found the same bacteria in a pharmacy in Birmingham.

The pharmacy, IV Meds, of Birmingham, had prepared the intravenous feeding solutions that were administered to all of the patients in six hospitals in the state. Bacteria in their blood matched bacteria in a bag of the suspect product found in the pharmacy, he said.

Source:

Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)

The FDA rolled out a "Bad Ad" program last week that should make waves in the Pharma industry.

From their site:

FDA's educational outreach program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.

The "Bad Ad" Program is administered by the agency’s Division of Drug Marketing, Advertising, and Communications in the Center for Drug Evaluation and Research. It will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.

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Frequently Asked Questions

1. Can I report anonymously?
Yes, anonymous complaints often alert FDA to potential problems.  However, complaints accompanied by names and contact information are helpful in cases for which FDA needs to follow-up for more information.
2. Will DDMAC be able to stop the misleading promotion?          
In many cases, yes, especially if evidence is provided.  Evidence can include the actual promotional materials or documentation of oral statements made by company representatives.
3. What will happen to my complaint once I have contacted DDMAC?          
The information you provide will be sent to the Regulatory Review Officer in DDMAC responsible for this class of drugs.  The reviewer will evaluate it and determine if it may serve as the basis for a potential enforcement action or as valuable information for our ongoing surveillance activities.
4. How do I learn more?
To learn more about DDMAC in-service training for large medical group/hospitals or to speak directly with a DDMAC Reviewer, call 301-796-1200.

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Recognize & Report: Contact Information

Division of Drug Marketing, Advertising, and Communications (DDMAC)⁵
Phone:           877-RX-DDMAC
                    (877-793-3622)
E-Mail:           BadAd@fda.gov
Write:            FDA/CDER/DDMAC
                    5901-B Ammendale Rd,                                        
                    Beltsville, MD 20705-1266  
Fax:              301-847-8444

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Source: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm

Fertility drug link to fatal disease?

Outside the US  there's news of an investigation into the safety of fertility drugs which may show that  the hormones - derived from pregnant or menopausal women's urine - could carry proteins similar to those linked to the fatal Creutzfeldt-Jakob disease.

This is news from the online journal PLoS One, for the first time confirmed the presence of the proteins in the drugs. They were not of the mutated form linked to the human version of mad cow disease, but the findings suggested these too might survive the production process. Source. 

Creutzfeldt-Jakob disease (CJD) is a rare, degenerative, invariably fatal brain disorder. It affects about one person in every one million people per year worldwide; in the United States there are about 200 cases per year. CJD usually appears in later life and runs a rapid course. Typically, onset of symptoms occurs about age 60, and about 90 percent of individuals die within 1 year. In the early stages of disease, people may have failing memory, behavioral changes, lack of coordination and visual disturbances. As the illness progresses, mental deterioration becomes pronounced and involuntary movements, blindness, weakness of extremities, and coma may occur.

There are three major categories of CJD:

• In sporadic CJD, the disease appears even though the person has no known risk factors for the disease. This is by far the most common type of CJD and accounts for at least 85 percent of cases.
• In hereditary CJD, the person has a family history of the disease and/or tests positive for a genetic mutation associated with CJD. About 5 to 10 percent of cases of CJD in the United States are hereditary.
• In acquired CJD, the disease is transmitted by exposure to brain or nervous system tissue, usually through certain medical procedures. There is no evidence that CJD is contagious through casual contact with a CJD patient. Since CJD was first described in 1920, fewer than 1 percent of cases have been acquired CJD.

CJD belongs to a family of human and animal diseases known as the transmissible spongiform encephalopathies (TSEs). Spongiform refers to the characteristic appearance of infected brains, which become filled with holes until they resemble sponges under a microscope. CJD is the most common of the known human TSEs. 

Source. 

Multaq Liver Damage ? Update for April 2011

Image via Wikipedia
Multaq (dronedarone) is a popular antiarrhythmia drug manufactured and marketed by Sanofi – Aventis SA, has been linked by the US FDA to acute liver damage, severe liver toxicity, acute hepatic failure, acute liver failure and other complications and damage of the liver and hepatic system, often requiring surgery and in acute cases, a liver transplant.

Multaq is used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter) during the past 6 months. Multaq (dronedarone) is said to reduce the risk of patient hospitalization for these heart arrhythmia problems. Since the FDA’s approval of Multaq in July 2009 until October 2010, almost a half a million Multaq prescriptions have been dispensed.  During that same time, approximately 147,000 patients filled Multaq prescriptions at retail pharmacies in the United States on an outpatient basis. In addition to outpatient Multaq prescriptions filled at retail pharmacies, a significant number of Multaq prescriptions have been filled and dispensed in hospital settings on an inpatient basis.

As of late January of 2011: 857 people reported to have side effects when taking Multaq. Among them, 21 people (2.45%) have Abnormal Liver Function Test Results. In this study of Multaq users, 21 people tested abnormal for liver function while taking Multaq. The length of Multaq use as well as gender and age of the users, and severity of the abnormal liver function test were included.

From the FDA site:


FDA has received several case reports of hepatocellular liver injury and hepatic failure in patients treated with dronedarone, including two post-marketing reports of acute hepatic failure requiring transplantation. Because these reactions are reported voluntarily from a treatment population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The two cases of acute hepatic failure requiring transplantation occurred at 4.5 and 6 months after initiation of dronedarone in patients with previously normal hepatic serum enzymes. Both patients were female and approximately 70 years of age. In the first case, the patient had underlying intermittent atrial fibrillation, arterial hypertension and stable coronary artery disease. She was treated with dronedarone for 4.5 months. Two weeks prior to hospitalization she reported increased exhaustion and tiredness. One week prior to admission she discontinued dronedarone, and at the time of admission she was noted to have jaundice, coagulopathy, transaminitis and hyperbilirubinemia, which progressed to hepatic encephalopathy over the next nine days. A pre-transplant workup did not reveal another etiology of liver failure. In the second case, the patient had a medical history of paroxysmal atrial fibrillation and Sjogren's syndrome. Following 6 months of treatment with dronedarone she developed weakness, abdominal pain, coagulopathy, transaminitis and hyperbilirubinemia.

She was transplanted 1 month later; no alternative etiology for liver failure was identified in the transplant work-up. In both cases, the explanted liver showed evidence of extensive hepatocellular necrosis.
Multaq (dronedarone) is approved to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent history of AF/AFL and associated cardiovascular risk factors (age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥ 50 mm or left ventricular ejection fraction <40%) who are in sinus rhythm or who will be cardioverted.

Dronedarone is contraindicated in patients with NYHA Class IV heart failure or NYHA Class II - III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA Study), patients given dronedarone had a greater than two-fold increase in mortality. Such patients should not be given dronedarone.

http://www.fda.gov/Drugs/DrugSafety/ucm240011.htm

Alabama: Nine are dead after an Infection Outbreak

Nine Alabama hospital patients who were treated with contaminated intravenous feeding bags have died and the maker has pulled the product off the market.

Ten more people treated with the bags that provide nutrients through IV tubes also were sickened by the outbreak of serratia marcescens bacteria, health officials said.

A single pharmacy, Birmingham-based Meds IV, made the bags. Williamson said the company has notified its customers of the contamination and discontinued production.

When Select Specialty Hospital in Birmingham learned one of its suppliers may have distributed bags containing the bacteria, it started investigating and stopped using the Meds IV product, said the hospital's chief executive officer.

http://www.msnbc.msn.com/id/42330246/ns/health-infectious_diseases/?gt1=43001

Topamax News from the FDA (3/29/11)

The FDA has recently issued a warning about the epilepsy and migraine drug Topamax because of a claim that it may increase the risk of causing birth defects. The FDA’s Topamax warning came after recently released data showed that women taking the drug while pregnant were 21-times more likely to give birth to a child with cleft lips or cleft palate deformities.





In addition to that warning the FDA upgraded the drug to its Pregnancy Category D. This means that the drug has a known risk of causing birth defects. Because the oral cleft defects associated with Topamax occur early in pregnancy, the FDA also has informed women of childbearing age who are taking Topamax to talk with their doctor about alternative treatment options.


From the FDA site: 


RECOMMENDATION: Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional. Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.


http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245777.htm

Link Between High Doses of Cholesterol Meds (Altorvistatin) and Diabetes?

Folks who take Lipitor in higher does may face a slightly increased risk of developing type 2 diabetes according to a recent study published this week  -- generically as atorvastatin) and other cholesterol-lowering statin drugs to a small increase in users' risk of diabetes.

The study does seem to suggest that risks may exist among those who may likewise have the well established  risk factors for type 2 diabetes -- including excess weight, high blood sugar, elevated triglycerides (a type of blood fat) and high blood pressure.

From the Journal site:

Objectives: We sought to examine the incidence and clinical predictors of new-onset type 2 diabetes mellitus (T2DM) within 3 large randomized trials with atorvastatin.

Background: Statin therapy might modestly increase the risk of new-onset T2DM.

Methods: We used a standard definition of diabetes and excluded patients with prevalent diabetes at baseline. We identified baseline predictors of new-onset T2DM and compared the event rates in patients with and without new-onset T2DM

Find more information here: http://content.onlinejacc.org/cgi/content/abstract/57/14/1535

Key Case on Daubert and Admissibility of Expert Evidence

Image by Kevandy via Flickr
On the heels of the SCOTUS opinion in Zicam is this opinion, a 1st Circuit Opinion. Worth a read if you litigate anywhere in the USDCT:   

Milward  -first_circuit

View more documents from mzamoralaw.

Ethicon Inc., a Johnson & Johnson co., is voluntarily recalling hundreds of thousands of surgical drain products after customers complained that the packaging might not be sterile.

The notice on Ethicon's Inc.'s says, "The company identified the potential for the sterile barrier of the product packaging to be compromised after receiving customer complaints." The company also states that it has not received any reports of adverse events related to this issue, and it has notified the U.S. FDA.

The recall affects multiple lots of Blake Silicone Drains, Blake Silicone Drain Kits, Blake Cardio Connectors, J-VAC Reservoirs and J-VA Drain Adapters, with distribution dates of May 10, 2010 through February 28, 2011.

They include:


BLAKE® Silicone Drain
BLAKE® Silicone Drain Kit
BLAKE® Cardio Connector
J-VAC™ Reservoir
J-VAC™ Drain Adapter

Nationwide Recall of U-Prosta, a Product Marketed As a Dietary Supplement That Contains Undeclared Terazosin Hydrochloride

From the FDA:

There is a nationwide recall of the Company's supplement product sold under the name “U-Prosta Natural support for prostate health”. The Company has been informed by representatives of the U.S. Food and Drug Administration (FDA) that lab analysis by FDA of U-Prosta samples found the product contains terazosin, the active ingredient of an FDA-approved drug used to treat Benign Prostatic Hyperplasia (enlarged prostate), making U-Prosta an unapproved drug.

The most likely adverse health consequences that could occur with the use of this product would be hypotension, dizziness, or syncope. Patients who are currently being treated with prescription medications for high blood pressure or enlarged prostate would be at increased risk of these events. In these patients, the hypotensive events may be more severe. No illnesses have been reported to the company to date in connection with this product.

Link here

Consider donating to Japan through the Red Cross

American Regent Initiates Voluntary Nationwide Recall of Dexamethasone Sodium Phosphate Injection

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From the FDA :

A voluntary recall was initiated because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates. Potential adverse events after intravenous administration of solutions containing particulates, may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation. Intramuscular administration could result in foreign body inflammatory response, with local pain, swelling and possible long term granuloma formation. American Regent is undertaking this recall in consideration of the potential for safety issues, if these lots of product are administered to patients.

Dexamethasone Sodium Phosphate Injection, USP, is a synthetic adrenocortical steroid used to treat a variety of inflammatory and allergic conditions. See the Full Prescribing Information at www.americanregent.com¹ for a complete listing of indications and uses.

The product was distributed to wholesalers and distributors nationwide.
Hospitals, emergency rooms, infusion centers, clinics, physician offices and other healthcare providers and facilities should not use American Regent Inc., Dexamethasone Sodium Phosphate Injection, USP 4mg/mL, 1mL Single Dose Vials, 5mL and 30 mL Multiple Dose Vials with the lot #s listed in the attached Appendix for patient care and should immediately quarantine any product for return.

Source.http://www.fda.gov/Safety/Recalls/ucm247526.htm 

Light Posting Week Because of Trial

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It's been a light posting week because I've been in a jury trial all week. I'll be posting again regularly starting this morning.

Pain Drug Embeda Recalled Because of Formula Defect

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100,000 bottles of the  pain medication Embeda were recalled due to a defect in the drug's formula. Pfizer Inc., the drug manufacturer, said in a statement that Embeda would not be available for months due to a stability defect in the extended-release product.


The pain medication contains naltrexone, an opiate antagonist drug, and did not meet degrading standards when tested by the manufacturer. Naltrexone discourages misuse and abuse of Embeda as naltrexone disintegrates when chewed or crushed.

According to a press release from the company, Embeda has been recalled from U.S. wholesalers and retailers, and patients may continue to take the medication as prescribed. All dosages of Embeda extended-release capsules may be subject to recall.

Source here. 

Seroquel: $68.5 Million Settlement to U.S. States Over Seroquel Marketing

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In a lawsuit against the makers of Seroquel, Astra Zeneca - it was claimed that the company marketed Seroquel for uses that weren’t approved by the U.S. Food and Drug Administration, the federal and state governments claimed. AstraZeneca promoted the drug, approved for schizophrenia and bipolar disorder, for dementia, depression and anxiety in violation of federal drug rules, according to the states.


The company agreed to pay $68.5 million to 37 U.S. states and the District of Columbia to resolve allegations that the company deceptively marketed its anti-psychotic drug Seroquel.

 Link here.

Risk of oral clefts in children born to mothers taking Topamax (topiramate)

From the FDA

The U.S. Food and Drug Administration (FDA) is informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate (Topamax and generic products) during pregnancy.

The benefits and the risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death. Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients. If the decision is made to use topiramate in women of childbearing age, effective birth control should be used. Oral clefts occur in the first trimester of pregnancy before many women know they are pregnant.

Topiramate was previously classified as a Pregnancy Category C drug, which means that data from animal studies suggested potential fetal risks, but no adequate data from human clinical trials or studies were available at the time of approval. However, because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks.

Kaletra (lopinavir/ritonavir) oral solution dangers?

Image by Magalie L'Abbé via FlickrFrom the FDA:



The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals of serious health problems that have been reported in premature babies receiving Kaletra (lopinavir/ritonavir) oral solution.

Kaletra oral solution contains the ingredients alcohol and propylene glycol. Premature babies may be at increased risk for health problems because they have a decreased ability to eliminate propylene glycol; this could lead to adverse events such as serious heart, kidney, or breathing problems.

A safe and effective dose for babies less than 14 days of age (whether born premature or full term) has not been established.

Because the consequences of using Kaletra oral solution in babies immediately after birth can be severe or possibly fatal, the label is being revised to include a new warning. The use of Kaletra oral solution should be avoided in premature babies until 14 days after their due date, or in full-term babies younger than 14 days of age unless a healthcare professional believes that the benefit of using Kaletra oral solution to treat HIV infection immediately after birth outweighs the potential risks. In such cases, FDA strongly recommends monitoring for increases in serum osmolality, serum creatinine, and other signs of toxicity.

Kaletra oral solution is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in pediatric patients 14 days of age (whether premature or full term) or older and in adults. Taking antiretroviral medications for HIV will not cure the infection, but can help children and adults with HIV-1 infection stay healthier for a longer period of time.

Leaky Insuline Pump Cartridges Recalled

J and Jhas recalled hundreds of thousands of potentially leaky insulin pump cartridges that could lead to serious health problems and death.

It also has been warned by the Food and Drug Administration over manufacturing concerns for heart devices made at its Cordis unit's San German, Puerto Rico, facility.

J&J's Animas unit, the maker of the recalled cartridges and insulin pumps in which they are used by diabetics, said in a letter to patients last month that it found some of the cartridges can leak, resulting in delivery of less insulin than intended.

Insufficient insulin can cause high blood sugar and a serious condition known as diabetic ketoacidosis, which can be fatal. A leaking cartridge could also cause the pump to fail to sound an alarm if there were blockage in the infusion set, Animas said.

Link

J and J Faces Kickback Charge

Johnson & Johnson must defend a lawsuit by the DOJ claiming the company paid kickbacks to influence sales of its antipsychotic drug Risperdal to nursing home patients.

J&J asked the judge to dismiss the complaint, arguing that payments it made to Omnicare Inc., the largest U.S. pharmacy for nursing home patients, were allowable rebates and not illegal kickbacks. U.S. District Judge Richard Stearns ruled in federal court in Boston that the case may proceed against J&J, the world’s largest maker of health-care products.

Source

Actos (Diabetes Drug) Under Investigation by State of Texas

The Attorney General of Texas has asked drug makers Takeda Pharmaceutical Co. and Eli Lilly & Co. to produce documents as part of an investigation related to the diabetes drug Actos, the companies has informed this week.


  Lilly received a civil investigative demand from the Texas official in December, Lilly disclosed in an annual report filed with the Securities and Exchange Commission.The demands seeks "production of a wide range of documents and information related to Actos

Source:  here.