Consumer Advocate Legal Update : Class Action Lawyers & Attorneys : Khorrami Pollard & Abir Law Firm : Mass Torts, Products Liability

The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed AMAG Pharmaceuticals, Inc.'s websites marketing its drug products, GastroMARK (an oral gastrointestinal imaging agent for delineation of the bowel) and Feraheme (an iron replacement therapy for individuals with kidney disease). 

The DDMAC found the websites for both drug products misleading and in violation of FDA rules.  Pursuant to a warning letter issued on October 18, 2010, it criticized AMAG for omitting the risks associated with the use of its two drug products, suggesting unapproved new uses for the products, and omitting important information about the approved indication for GastroMARK. 

FDA Concerns

• Both websites present numerous efficacy claims for GastroMARK and Feraheme but fail to communicate any of the risks associated with the drugs, e.g., the GastroMARK web page omits the drug's contraindication in patients with known or suspected intestinal perforation or obstruction;

• The GastroMARK website fails to present the complete indication for the drug, including material limitations to the indication, e.g., the GastroMARK web page fails to include that the drug is indicated only in adult patients, and that its usefulness in the lower gastrointestinal tract and retro-peritoneal region is limited by the transit time and dilution; and

• Both websites present both approved and unapproved product information for the products together, which implies that the drugs are effective for unapproved uses. 

According to the FDA, "[t]hese violations are concerning from a public health perspective because they suggest that GastroMARK is useful in a broader range of patients and conditions than has been demonstrated by substantial clinical experience, and that GastroMARK and Feraheme are safer than has been demonstrated by substantial evidence or substantial clinical experience."

As such, the DDMAC requested that AMAG immediately cease the dissemination of its promotional materials for both drugs and submit a written response to its warning letter no later than November 1, 2010.    

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Babies. They’re tiny. They’re cute. They’re fragile. They need to be protected. Luckily, the FDA is taking care of it. On October 26, Reuters reported that the Food and Drug Administration recently warned Mead Johnson Nutrition Company that it had violated federal law in its production of several of its Enfamil powdered infant formula products. In a letter to the company, dated October 18, the FDA explained that Mead Johnson had failed to disclose the specifications for a plastic tub and lid which are part of the packaging for the infant formula. The formula is packaged in a pouch, but labeling on the product suggests it can be stored in the plastic tub. Mead Johnson failed to identify the tubs as a food contact source and failed to provide the FDA with an evaluation of the plastic used to make the tubs and lids. According to the letter, this was a violation of the Food, Drug, and Cosmetic Act and federal regulations. 

The Enfamil products identified in the letter include Enfamil Premium Infant, Enfamil Gentlease, and Enfamil A.R. Mead Johnson responded by saying the company recommends keeping the formula in the pouches, but it recognizes consumers may choose to empty the powder into the tub. The label provided instructions on how to do so safely. The company added that the tubs and lids are made with FDA-approved materials and that it was in the process of responding to the FDA. 

This illustrates how careful manufacturers have to be when making disclosures to the FDA, especially when it comes to products related to infants. After all, infants don’t choose what they eat or how to store the food that they are fed. Since they can’t look after themselves, everyone else has to be vigilant about what goes in those tiny tummies.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

While the CDC is using quantitative data to examine the advantages and disadvantages of "front of package" ("FOP") labeling, the FDA recently put manufacturers on notice of its own plan to launch a more qualitative investigation into certain FOP labels. The FDA's approach involves comparing the nutritional criteria used to support these labels against FDA regulatory requirements, and focuses specifically on foods that make "smart choice" or "heart healthy" type claims. While certain nutritional labeling is mandated, this type of FOP labeling is voluntary, but is nonetheless subject to the requirements of the Food, Drug and Cosmetic Act.

The FDA's investigation comes on the heels of research which reflects that when provided with FOP labeling, consumers are less likely to check the nutritional facts on foods, instead relying on the often bold and readily visible FOP claims. In its notice to manufacturers regarding the investigation it noted that they must take care to ensure that the FOP information presented to consumers is "nutritionally sound and well-designed to help consumers make informed and healthy choices and not be false or misleading." In other words, the labeling must be wholly supported by the nutritional content of the product and be presented in a way that does not distract consumers from analyzing the  product's overall nutritional value, or lack thereof.

The recent CDC studies and the investigation being launched by the FDA make it clear that the federal government has seen a recent need to provide more oversight of FOP claims, ostensibly because it has identified areas of concern. Those manufacturers whose claims are now under the microscope should be prepared for a potential backlash, both in the marketplace and in the courtroom, if their claims are determined to be unsupported and misleading. 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

For years, manufacturers have been required to report nutritional information on packaged food products.  With the dramatic increase in obesity in American throughout the last 20 years, many manufacturers have begun to include additional nutritional messages on the front of their food packages.  These messages are referred to as "front-of-package" ("FOP") labeling, and are generally quick summaries of such nutritional data as number of calories, grams of trans fat, saturated fat, etc. 

Congress directed the Centers for Disease Control and Prevention to undertake a two-phase study on these FOPs.  The CDC issued its report on the first phase of the study concentrated on the advantages and disadvantages of the various FOPs utilized by food manufacturers, which will then allow further investigation into which types of FOPs are most effective with consumers during the second phase. 

The report determined that some information is more useful than others when contained in FOPs.  The information it deemed useful included caloric content, serving size, grams of trans fat, grams of saturated fat, and sodium levels.  It further determined that any other information, such as amount of fiber, vitamins, etc., was not as helpful when included in FOPs.

Now that the first phase of the study has been completed, the focus will now be on which types of FOPs have the most effect on the consuming public.  As a result, we're sure to see an increase of FOPs on food product packaging, hopefully ones that aren't false and misleading according to California law. 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Nine Central Washington University students were hospitalized earlier this month after being sickened by “Four Loko” also known as “blackout in a can,” made by Phusion Projects, Inc. of Chicago. This incident led to a ban of “alcohol energy drinks” on Central Washington University’s campus and other college campuses pending an investigation by the Food and Drug Administration into whether or not it is safe to add caffeine to alcoholic beverages. Several states are also reportedly considering outlawing these popular drinks.

Those questioning the safety of these drinks say that the caffeine added to the alcoholic beverages suspend the effects of alcohol consumption, allowing a person to drink far more than they otherwise would. This allows excessive binge drinking by inexperienced drinkers who may not know their limits, and poses a serious danger on college campuses and to youth in general.

Specifically, Washington State Attorney General Rob McKenna called for the drink to be banned, stating that the drinks “present a serious threat to public health and safety.” McKenna has said that his office would review the marketing of these drinks (particularly to minors) to determine whether any consumer protection laws have been violated. The State of Washington had previously raised similar concerns with MillerCoors, LLC and Anhueser-Busch, InBev NV regarding comparable drinks, but no lawsuits were filed because the companies promptly pulled the drinks from shelves. 

Some seem to believe that the incident was blown out of proportion, and that the mixing of caffeinated beverages with alcohol is hardly a new or dangerous practice. There is a general disagreement as to whether this is just an unfortunate incident of college kids being college kids, or a clear indication of the need for further regulation of the sale of caffeinated malt liquors. Either way, state officials have made it clear that they are not waiting for another casualty to occur in order to settle the debate.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On October 26, 2010, Reuters reported that Attorneys General in Illinois, Oregon and California agreed to a $3.3 million settlement over misleading claims that Bayer vitamins reduce the risk of prostate cancer. Bayer had made claims in its packaging and promotional materials that selenium in its men’s vitamins reduced the risk of certain cancers. In June 2010, the FDA concluded that there was very limited credible evidence for qualified health claims for selenium dietary supplements and prostate cancer. In addition to the monetary payments, Bayer was revising its packaging and promotional materials.

Significantly, the FDA made findings about selenium dietary supplements as it relates to other site-specific cancers. The FDA concluded that there is no credible evidence to support qualified health claims for selenium dietary supplements and a reduced risk of urinary tract cancers other than bladder cancer, lung and other respiratory tract cancers, colon and other digestive tract cancers, brain cancer, liver cancer, or breast cancer. However, FDA concluded that there is very limited credible evidence for qualified health claims for selenium dietary supplements and bladder cancer,  prostate cancer, and thyroid cancer, provided that the qualified claims are appropriately worded so as not to mislead consumers. 

This settlement and the FDA findings should remind all dietary product manufacturers to use caution when making health benefit claims about their products and to appropriately limit claims so as not to mislead consumers.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Botox is most famous for its ability to smooth wrinkles on aging faces. It is also approved to treat eye muscle disorders, neck spasms and excessive underarm sweating. Although the FDA has approved the drug for chronic migraines, studies have failed to show that it works for occasional headaches or occasional migraines.  

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Hormone treatment after menopause was originally studied by the Women’s Health Initiative (WHI) as part of a clinical trial established in 1992 to assess its relationship to coronary heart disease. Those studies were halted in 2002 when the results indicated that women taking a combination of estrogen and progestin had a higher risk of heart disease, stroke, and invasive breast cancer when compared to women taking a placebo. Now, a new study published October 20, 2010 in the Journal of the American Medical Association (JAMA) reports that these breast cancers associated with hormone treatment are more aggressive, more advanced, and have a higher mortality rate. 

The WHI continued to follow the women with breast cancer after the main trial had ended. Some earlier observational studies had suggested that hormone therapy induced breast cancers were less advanced and had a lower risk of death. However, this new WHI finding strongly contradicts those suggestions.   Combined hormone therapy increased the incidence of invasive breast cancer and in many cases the cancer had spread to the lymph nodes making it a more deadly form of cancer. Most significantly, it was found that the use of hormone therapy made the detection of breast cancer more difficult resulting in the cancer being diagnosed at a more advanced stage. 

For many years, menopausal women were treated with a combination of drugs to treat hot flashes and mood swings. Premarin, manufactured by Wyeth, contained estrogen, while Provera, manufactured by Pfizer’s Pharmacia and Upjohn, contained progestin.  In 1995, Wyeth combined the two hormones to form the medication, PremPro. Following the initial findings of the WHI in 2002 that linked estrogen and progestin to increased incidences of breast cancer, sales decreased dramatically. Sales of Premarin and PremPro were approximately $213 million in 2009, down from almost $2 billion prior to 2002. 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

• CAOC's Women's & Minority Caucus in San Francisco,CA - November 18
• CAOC's 49th Annual Convention in San Francisco, CA - November 18-21
• CAOC's Donald L. Galine Annual Hawaii Travel Seminar in Maui,HI -  November 27 - December 4
• AAJ's Winter Convention in Miami,FL - February 5-9,2011

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The U.S. Department of Education announced on Sept. 24 that it would move forward with tighter regulations on the for-profit education sector, which are designed to protect students from misleading recruitment practices and from running up huge debts, among other issues. The proposal the Department of Education released last month would require for-profit schools to ensure that their graduates earn at least enough to start repaying federally backed student loans. If not, the schools would risk losing access to those loans.  Students at for-profits have a higher likelihood of retaining debt than not-for-profit schools. In fact, students at for-profits are twice as likely to default as students at nonprofits. Proponents of the new rule say they are not interested in driving for-profits out of business, just in stopping students from borrowing more than they can afford to repay. The Department of Education says these regulations will heighten its ability to penalize institutions that have significantly misrepresented their programs to prospective students.  Additionally, the proposed regulations will crack down on loopholes which allowed for-profit schools to avoid legislation forbidding recruiters from being compensated based on the number of students that they are able to recruit. Such limits would help to curb some high-pressure sales tactics that for-profit colleges enlist via recruiters.

The for-profit education business has responded with an aggressive campaign to rally public opinion to its side. For-profits have been urging students to write letters to the government during the comment period on the rule. The Department of Education received about 90,000 comments critiquing the proposed regulations in the 90 days following their announcement. Following this response, the Department has agreed to meet with representatives of for-profit schools and education advocacy groups on Nov. 4 and 5 at department headquarters in Washington.

Final regulations are scheduled for publication on or around November 1, 2010, and will go into effect on July 1, 2011. The impact of the rule on students and for-profit schools won't be clear until the new rule is issued in November.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Botox Shots Approved for Migraines, article in the Wall Street Journal. On Friday, the FDA approved Botox from Allergan as a treatment to prevent migraines, a little more than a month after the company agreed to pay $600 million to settle allegations that it had illegally marketed the drug for unapproved uses like headaches for years. Another article on this topic was published in the New York Times on October 15th.

When Drugs like Avandia Cause Problems they are suppose to Prevent, Oct.16th New York Times. In the past weeks, the FDA has noticed that two types of drugs that were suppose to prevent serious medical problems were, in fact, causing them.

The Court’s Pre-emption Test, article published on October 18th in the New York Times. Where state efforts to protect citizens and compensate victims don’t conflict with federal law, pre-emption should not be used as a weapon.

Breast Cancer seen as Riskier with Hormone, October 19th Wall street Journal and New York Times articles. Research found that hormone therapy for breast cancer speeds up the growth of the tumor.

Judge signals she’ll let Ruling on Military Policy stand, October 19th in the New York Times. Do we give the military the power to have absurd rules for fear of preventing a slippery slope or is there a way to have the military follow the constitution and still operate?
 

Payments to Doctors by most Pharma Companies still remains secret, published in Pro Publica on Oct. 20th. Consumers hoping to know more about the Doctor payments by Pharmaceutical companies will have to wait until 2013 for such disclosures to be made industry-wide.

Wall Street Journal article, MySpace apps leak user data, October 23rd. A Wall Street Journal investigation found that MySpace and popular applications of the networking site have been transmitting data to outside advertising companies that could be used to identify users.

For-profit Colleges Oppose Tighter Regulations. Part of a government plan to more closely regulate the for-profit education sector in the United States has been delayed, following an outcry from school supporters. Article in the New York Times, Oct.24th.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Earlier this month mortgage giant Bank of America announced that it would be freezing foreclosures sales nationwide amidst allegations of possible foreclosure fraud inherent in its mortgage servicing policies.  Bank of America’s action was partly in response to attorney generals from various states announcing investigations into the lender’s foreclosure process.  More layers were revealed just last week when deponent-mortgage servicers in a Florida suit against Bank of America brought by defaulting homeowners testified that it was common practice to sign loan serving documents without reading them.  Many other banks have also acknowledged employing these “robo-signers”.  In response to Bank of America’s decision to halt foreclosures, Harry Reid, the Senate Majority Leader, who had been hard on Bank of America in the past, stated “I thank Bank of America for doing the right thing.”

Now, just ten days after announcing its nationwide foreclosure freeze, Bank of America claims it has sufficiently reviewed its foreclosure process, and thus presumably corrected it, to allow the bank to restart foreclosure sales.  And Bank of America isn’t alone.  GMAC, too, claims it has cleaned up its mortgage servicing procedures, and has announced it will be refilling cases.  Understandably, consumer attorneys are skeptical.  So while Bank of America and other mortgage lenders alike will continue foreclosing on defaulting homeowners, the bright side may be that the banks’ opposition will continue to grow as word spreads of lender culpability among homeowners facing foreclosure.  Stay tuned.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On October 18, 2010, the Wall Street Journal reported the results of their investigation which found that many of the most popular applications or “apps” on Facebook have been transmitting the names of Facebook users and, in some cases, the names of their friends to dozens of internet advertising and tracking companies. Apps are pieces of software that let Facebook users play games or share information.

The Journal reported that at least one data gathering firm, RapLeaf, Inc., linked Facebook user IDs to its own database, which it sells. The apps are extremely important o Facebook as it transforms Facebook into a hub of activity and extends the usefulness of its network. Seventy-percent of Facebook users reportedly use apps and the apps are a source of revenue for Facebook itself, which sells it own virtual currency to pay for games. 

According to the article, the biggest apps allegedly involved are FarmVille, Texas HoldEm Poker and Frontierville. The issue affects tens of millions of Facebook users, including those who set their profile as completely private. It is reportedly unclear how long the breach took place and Facebook claims it is making attempts to “dramatically limit’ the exposure of users’ personal information.

Another article in today’s New York Times  reveals that privacy advocates and technology experts are split on the significance of the breach. Privacy advocate, Peter Eckersley, argues that by transmitting a user’s ID to advertisers, the advertisers could link the ID to information collected about the user anonymously on the Web, thereby giving the advertiser the “magic key to tracking you online”. Others downplay the significance claiming that knowledge of a user’s ID does not enable anyone to access private user information without explicit consent and that credit card companies and magazines have access to far more personal information about customers than any Facebook app.

One thing is certain; this activity will result in litigation. Such breaches likely violate Facebook’s Terms and Conditions and Privacy Policy and well as state computer crime laws, federal Electronic Privacy and Stored Communications Acts and other consumer protections statutes.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

KPA employees joined together to raise funds and walk in the AIDS Walk on Sunday, October 17th in support of APLA. Team Khorrami was among the groups to raise $2,000 or more, Congratulations!

30,000 participants walked the 6.2 miles last Sunday through West Hollywood, raising a total of $2,787,711.00 for APLA.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The October 15th CAOC Women’s Caucus networking reception was exclusively sponsored by Shawn Khorrami, Khorrami Pollard & Abir LLP.
KPA dedicates time and resources to promote attendance and leadership at premier events and continues their initiative to develop plaintiff attorneys through sponsorships.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

KPA is welcoming their newest associate, Andrew Brown.

Andrew will focus his time at KPA on pharmaceutical mass torts, products liability, and class action cases. He is committed to join KPA in their fight to protect those individuals who have been wronged.

Andrew received his Juris Doctor from Boston University School of Law, and his Bachelor of Arts in English Language and Literature from the University of Chicago. Andrew is admitted to the State Bar of California

Who is Andrew Brown?

Q:  What is the last book you read?  A: 

2666 by Roberto Bolaño

Q:  Quote or mantra you live by?  A:  I don’t really have a specific quote or mantra that I live by but I guess I would say I try to follow the Golden Rule.

Q:  Who would you say your role model is?  A:  One of my role models is recently retired U.S. Supreme Court Justice John Paul Stevens.

Q:  Any memorable or interesting court room stories you can share?  A:  Before I went to law school I worked as a newspaper reporter for a small daily newspaper in my hometown.  One of the events I had to cover as a reporter was the trial of a local teenager who was charged with manslaughter after killing a 6-year-old girl.  The teenager was driving down a hill on a country road when his brakes failed.  At the bottom of the hill a school bus was stopped.  He drove to the right of the school bus and just as he was passing it the little girl stepped off the bus and he hit her.  He was acquitted of the charges. It was an emotional trial that raised a lot of tough questions about blame and guilt.  It was one of the things that really influenced my decision to go to law school.  I still think about it sometimes.

Q:  What do you feel is the most rewarding part about being a plaintiff attorney?  A:  Helping people.  Specifically, I would say helping them access our legal system, which can be very intimidating if you are not familiar with it.  And sometimes intimidating even if you are familiar with it!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

For the 2^nd year, KPA has registered a team for the AIDS Walk on October 17^th to help raise funds to fight against HIV. KPA employees are proud to once again participate in this opportunity to help all the men, women and children impacted by AIDS. KPA participated in the AIDS walk for the first time in 2009 and raised enough funds to be ranked 16^th out of the 1,600 teams registered.

Founding partner Shawn Khorrami is also a member of the APLA Board of Directors and will be walking with the team.

To learn more about the AIDS walk and help us fundraise, go to www.aidswalk.net/losangeles

• Email This
• Print
• Comments
• Trackbacks
• Share Link