Protecting Consumers Nationwide

Byetta® (exenatide) was associated with at least 6 cases of hemorrhagic or necrotizing pancreatitis (a severe inflamation of the pancreas) reported to FDA since the drug last came under regulatory scrutiny according to a disclosure released by the FDA on August 18, 2008.   Two of the patients reportedly died.

Breaking News - First Byetta Lawsuit Filed: Moore Labriola LLP and The Schmidt Firm, LLP represent Virginia man who developed pancreatitis FDA seeks more stringent warnings

In the fall of 2007, manufacturer Amylin Pharmaceuticals, Inc. added precautionary language to the label for the drug after FDA reported on 30 cases of pancreatitis associated with the injectable medication.  This followed reports of similar cases published in the medical literature.   

It now appears that the labeling for the drug was inadequate to effectively reduce the risk.  FDA says it is now “working with” Amylin “to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.”

http://www.fda.gov/Cder/drug/InfoSheets/HCP/exenatide2008HCP.htm. 

Questions have now been raised as to why Amylin did not adequately warn about the pancreatitis risk earlier.  Drug manufacturers often “negotiate” with the FDA over changes to drug labeling, especially when the Agency indicates a desire to place a “warning” about certain potential side effects on written information distributed by companies to prescribing doctors.  

In the case of Byetta®, information about pancreatitis is currently contained in a “precautions” section of the label instead of a “warning.”  That will apparently change, according to FDA, but changes in the label will come too late for those who developed derious cases of pancreatitis.       

Do I Have a Byetta Lawsuit?

The attorneys at Moore Labriola, LLP are accepting new Byetta claims in all 50 states.  Please use the form below to contact them directly for a free confidential Byetta case evaluation.  You may also dial (866) 879-3040 24 hrs/day.

COLON CLEANSE PRODUCTS MAKE UNSUBATANTIATED AND FRAUDULENT HEALTH AND WEIGHT LOSS CLAIMS

You have seen them on late-night TV, on the radio, and in print, as well as on the Internet.  A variety of “health products” that share a common characteristic: they all are designed to “cleanse” the large intestine (colon), usually through the action of various herbs and other “natural ingredients.”  

The marketers of these “colon cleansers” make a number of health and weight-loss related claims.  Among them are claims that use of the product will eliminate harmful “toxins” from the body, and even help to “cure” serious diseases such as diabetes and heart problems.  The manufacturers also may claim that use of the product will lead to overall “wellness” and psychological benefits.  Many also claim that colon cleansers will quickly and permanently eliminate areas of body fat, including stomach bulges and “love handles,” more effectively than diet or exercise.    

The vast majority of these products are nothing more than mild laxatives, and the claims being made may be false or misleading.  These products are not approved or tested by the Food & Drug Administration, and the quality of their ingredients as well as the proof of whether they work or not has not been evaluated by FDA. 

Recently, the marketers of one of the most aggressively advertised of these products, 7-Day Miracle Cleanse Program, agreed to settle Federal Trade Commission charges that they falsely claimed that their program would cure cancer and other serious diseases. Among other things, the settlements broadly ban them from involvement in future infomercials for any product, service, or program, except for infomercials for informational publications, and from advertising health-related products in the future in any medium. See: http://www.casewatch.org/ftc/enforcements/7dmc/deaguero_order7.pdf. 

Moore Labriola LLP initiated a class action on behalf of California consumers who purchased then 7-Day Miracle Cleanse product, and the firm is actively investigating a number of other similar products.  If you or someone you know has purchased one of these products, you may be entitled to compensation.   

MOORE LABRIOLA LLP ATTORNEY THOMAS MOORE ADDRESSES FDA OPHTHALMIC DEVICES PANEL ON THE HUMAN TOLL OF ACANTHAMOEBA KERATITIS RELATED TO RECALLED CONTACT LENS SOLUTIONS

On June 11, 2008, the Food & Drug Administration’s Ophthalmic Devices Advisory Committee met to consider a number of issues related to the safety and effectiveness of contact lens care products.  The meeting of the Committee, a panel of outside experts in optometry, ophthalmology and other fields, was convened by FDA in the wake of the recalls of two leading contact lens disinfectant solutions.  Bausch & Lomb’s Renu ® with MositureLoc™ was recalled in 2006 after the product was linked to serious fungal infections.  In May 2007, Advanced Medical Optics, Inc. recalled its Complete® MoisturePlus™ solution after reports reviewed by the Centers for Disease Control and Prevention found a strong association between use of the product and the development of Acanthamoeba keratitis, a site-threatening corneal infection cuased by infestation of a species of protazoa.

During the public comment segment of the FDA meeting on June 11, FDA officials and the Advisory Committee were addressed by Thomas M. Moore, co-founding partner of Moore Labriola LLP of Newport Beach, California. Moore, whose firm is currently acting as co-lead counsel in a large number of lawsuits brought against the manufacturers of recalled contact lens solutions, discussed the human toll caused by corneal infections associated with these products. 

Following Moore’s comments and those of several medical and scientific experts, the Advisory Committee made a numerous recommendations to FDA concerning the future regulation of contact lens care products. The panel’s recommendations included more stringent pre-marketing testing requirements, including tests showing the effectiveness of contact lens solutions against Acanthamoeba, as well as more specific warnings and instructions on the labels of these products in order to increase consumer awareness of their proper use and their significant limitations in the control of infectious agents that commonly contaminate contact lenses.

The following is from the official FDA transcript of Mr. Moore’s comments made to the Ophthalmic Devices Advisory Committee on June 11:

“Good morning.  My name is Thomas Moore, and here is my financial disclosure.  My law firm currently represents a large number of Americans from across the country who contracted devastating corneal infections associated with their use of ineffective multi-purpose contact lens care solutions.

Every single one of my clients wishes that they could be here today.  They have waited a long time to see critical public health issues surrounding contact lens care products taken up by FDA in what is a truly public forum with both industry and non-industry voices being heard.

I’m simply a messenger, probably an inadequate one, attempting to relate to you the thoughts and concerns of the many individuals whose lives have been forever changed by their use of this product, and the hopes that future infections can be reduced, or prevented entirely.

I can’t more aptly describe the latest outbreak of acanthamoeba infections as prominent ophthalmologist, Dwight Cavanagh, did recently when he called it a train wreck in slow motion.  Indeed, the train started to wreck many years ago in the 1990s when multi-purpose solutions began to replace proven disinfection techniques, such as heat and hydrogen-peroxide systems.

My clients are hard pressed, as lay people, to understand why manufacturers designed multi-purpose solutions that relied on PHMB in concentrations that they knew full well were ineffective against acanthamoeba.  My clients are understandably angered when they learn that FDA never required testing against acanthamoeba.

They also find the International Standardization Organization’s justification for omitting acanthamoeba as a challenge organism in efficacy testing as nothing less than bizarre.  The ISO, an organization that at least appears to be largely controlled or influenced by industry, has consistently maintained that there is a lack of consensus as to how acanthamoeba testing should be conducted.

ISO and FDA have thus reasoned that such testing should not be required, even if it means that products ineffective against this devastating disease will be cleared for marketing.

The great irony is that at the same — the same manufacturers who lobbied against acanthamoeba testing as a regulatory hurdle nevertheless conducted, and in many cases published, the very tests that they said could not be done in a scientifically valid manner.

Paradoxically, some would say outrageously, manufacturers such as Advanced Medical Optics and others, are even now using such internal testing as the basis for advertising claims that their current PHMB-based products provide enhanced effectiveness against acanthamoeba strains.

If the testing is valid, it should have been required as a regulatory matter.  If it isn’t, it should not be allowed as a basis for marketing claims.  It’s as simple as that.

In 1998, one of your colleagues, Debra Schonberg, and her colleagues were prescient in their article entitled “The Epidemic of Acanthamoeba Keratitis: Where Do We Stand?”  When they opined that the risk of acanthamoeba keratitis was likely underestimated, even after the 1980s outbreak, and that a major risk factor was, quote, the continued existence of ineffective lens disinfection systems, indeed, it was apparently known early in the marketing of PHMB-based solutions that these products showed great variability in their effectiveness against acanthamoeba trophozoites, and little or no effect against acanthamoeba cysts.

It should have, therefore, come as no surprise when starting in 2003, the same year that Complete Moisture Plus was launched in this country, ophthalmology centers started to see increasing cases of AK at their institutions.

These outbreaks, which were reported at numerous U.S. and international ophthalmology meetings, should have been a wake-up call, but several years later, and after two major lens solution recalls, testing and labeling standards have not changed.

My clients wholeheartedly applaud FDA for convening this meeting.  However, I must tell you that there is an element of mistrust as to the motives and objectives of FDA and the contact lens branch, in particular.  This has largely emanated from a lack of transparency on the part of FDA insofar as the general public is concerned.

It is a perception based partly on statements by industry and FDA officials that at least appear to place much of the blame for these infections on so-called consumer noncompliance, as opposed to the lack of solution efficacy. 

I will tell, you ladies and gentlemen, that the vast majority of my many clients were very diligent in their use and care of contact lenses.  They did not sleep in their lenses, or reuse or top off solutions, or rinse their cases with tap water.  Some rubbed, and some didn’t.  And on that score, they weren’t any more confused by AMO’s no rub marketing claims than their optometrists were.

The minority who AMO and others would likely consider as noncompliant patients wonder why a company would market a solution with such a slim margin of safety, and without any indication on the label of the risk of acanthamoeba infections.

In addition to feeling that they are being blamed for their infections, my clients are concerned that industry’s role on these outbreaks has not been sufficiently scrutinized in a fair, objective, and public forum, while FDA maintains a close working relationship with manufacturers.

It has been unwilling, until today, to allow the public access to important data about these products, or a voice in the debate on these critical public health issues.

By way of example, my clients made a series of Freedom of Information Act requests over a year ago seeking access to documents concerning the evolution of testing standards, the clearance of the AMO Complete Moisture Plus product for marketing, and events leading up to the recall of that product.

Most of these requests have not been complied with.  An appeal by my clients to the Department of Health and Human Services designed to expedite access to these materials was denied on the grounds that there was, quote, no showing of an immediate threat to the public health.

In addition, FDA has, at least thus far, deemed confidential all briefing documents submitted by it and the solution manufacturers to this Advisory Committee.  Perhaps that will change in the coming days.

FDA’s conduct in this regard is inconsistent with my long experience in dealing with other divisions and branches.  Similar information, including safety and efficacy data in new drug applications, for example, is routinely furnished to the public by the drug branches in a timely manner, and with few redactions.

So there is no question in my mind that FDA has the discretion to release these records, and I hope they will do so soon.  Inevitably, a lack of transparency necessarily leads to rumors.  The notion that FDA has delayed changes to testing standards because most marketed multi-purpose solutions would not pass those tests is a common perception; that FDA delayed calling this Committee meeting for months or years at the request of manufacturers is another.

Still another is that FDA and CDC disagreed vehemently with each other as to whether the recall of the AMO product should be voluntary or subject to FDA Class I Recall Protocols.  Now, these perceptions may be accurate or inaccurate.  But without transparency in the regulation of the contact lens care products industry, victims of corneal infections related to solutions may see the Agency’s relationship with industry as collusive, rather than cooperative.

FDA often talks in terms of acting in the interest of stakeholders.  We should all hope that FDA considers its most important stakeholders to be consumers who use the products the Agency regulates.

There is an enormous opportunity that presents itself today which goes far beyond politics, corporate profits, or lawsuit recoveries.  There is an opportunity for FDA to change the direction of the contact lens care industry, and by so doing, make contact lens wear substantially safer for millions of Americans.

This can only be achieved by adding to the diversity of voices FDA listens to, starting with this Committee, and by instituting a transparent process in which testing and labeling issues are carefully considered, and resolved in a way that best protects the public health.

My clients and I thank you for this opportunity to speak, and simply ask that FDA and the Advisory Committee make the health of consumers their number one priority.  Thank you.”

Do I Have an Acanthamoeba Keratitis Lawsuit?

If you or somebody you know has developed Acanthamoeba Keratitis while using a contact lens solution, you should contact our law firm immediately.  You may be entitled to compensation for your Acanthamoeba Keratitis related injuries by filing a lawsuit against the manufacturers of the contact lens solution you have used.

Please use the form below to contact our law firm for a free case review.  You may also call toll free 24 hrs/day by dialing (866) 879-3040.

By Thomas M. Moore, Esq.
Partner, Moore Labriola LLP

Growth of the Supplement Industry

During the past 15 years, the segment of the health care industry with the largest sales growth surprisingly has not been prescription or over-the-counter drug makers. Rather, the most explosive growth has come from manufacturers and marketers of so-called dietary supplements. These products range from vitamins and minerals to weight loss concoctions and cold remedies, as well as a wide array of herbal and botanical compounds touted for everything from boosting the immune system, to sexual enhancement, to curing hangovers.

Surveys indicate that more than 60% of Americans aged 18 and older regularly use some type of dietary supplement. Almost half take daily “multi vitamins” and a quarter regularly use herbs and other “specialty” supplements. The vast majority of supplement users believe that these products can prevent or treat illnesses or manage weight, and most consider supplements to have health benefits exceeding conventional drugs, or offer the same benefits with fewer risks.

Supplements Largely Unregulated

Both prescription drugs are highly regulated by the Food & Drug Administration. Before such products can be marketed in the United States, manufacturers must convince FDA scientists that they are both reasonably safe and that they actually work as intended.

FDA will not accept just any type of proof. Prescription drug manufacturers must submit controlled studies which examine the effects of proposed new drugs on animal and human subjects in comparison to subjects given a placebo (sugar pill). These so-called “double-blinded placebo controlled” studies are the only valid way it can be scientifically demonstrated that a health-related product actually works. Not so in the case of most dietary supplements.

Unfortunately, Americans are largely unaware of the way in which most dietary supplements are developed and regulated. Most people readily assume that these products are subject to the same testing and regulations that govern over-the-counter drugs. Nothing could be further from the truth. Instead, the recent proliferation of these products has occurred not because they have been scientifically proven safe or effective, but because a federal law implemented in 1994 largely eliminated FDA oversight of dietary supplements. That law, combined with the increasing influence of the Internet and television mass marketing campaigns in the form of “infomercials,” has created what some have called a “Wild, Wild West” of unregulated products and misleading, often false, advertising.

The Dietary Supplement Health and Education Act

In 1994, the powerful diet supplement and vitamin industries lobbies successfully convinced Congress to pass the Dietary Supplement Health and Education Act (DSHEA). This cleverly but deceptively-named statute significantly reduced FDA oversight of supplement products. The law allowed supplement manufacturers to market their products without having to submit evidence that they work or that they are safe. FDA can take action against a manufacturer when the Agency discovers that a supplement on the market poses “a significant or unreasonable risk of injury.” Unfortunately, this usually doesn’t occur until some number of consumers have been injured or killed, as was the case with ephedra-containing diet pills in the 1990’s.

DSHEA does prohibit supplement manufacturers from making unsubstantiated advertising claims that their products are effective in the treatment or prevention of specific diseases or medical conditions. However, a huge loophole in the statute allows supplement companies to make so-called “structure and function claims” without FDA approval as long as the product label carries the language: “This statement has not been evaluated by the FDA.” This means while a company cannot legally claim that a supplement cures a specific illness, it can, for example, nevertheless advertise that the product “helps support a healthy immune system.” Unfortunately, consumers are often misled by such advertising claims, and reasonably assume that supplements can treat or cure any number of medical conditions.

The Federal Trade Commission has the authority to challenge false and misleading advertising involving supplement products. In fact, FTC has brought a number of enforcement actions against weight control and other supplement companies over the past several years. However, the Agency lacks the resources to investigate and prosecute the vast majority of offenders due to the sheer number of products on the market at any given time.

Many Products Lack Valid Scientific Evidence of Safety and Effectiveness

The troubling fact is that the many of dietary supplements on the market today contain ingredients that lack valid scientific evidence that they work. Moreover, many commonly used supplements such as Echinacea and zinc advertised to fight colds, and black cohosh (Cimicifuga racemosa) advertised for the treatment of symptoms associated with menopause, have been studied by reputable scientific institutions which have found little or no evidence validating claimed preventative or curative properties. Even so, many supplement distributors continue to mislead the public by making unsupported scientific claims, or by relying upon company-sponsored “studies” done outside the U.S. using dubious methodologies.

Why do People Buy Products that Don’t Work?

You might think that reasonably bright people would avoid products that don’t work. The problem is that in the case of many types of dietary supplements, there is a tendency to automatically believe that “natural” is better. Also, supplement manufacturers benefit from the well known “placebo effect,” a phenomenon where individuals subjectively believe their symptoms are improved after taking a substance they think contains an effective active ingredient. In fact, most all pharmaceutical studies that are “placebo controlled” show that some subset of patients unknowingly “treated” with sugar pills will report temporary alleviation of symptoms.

Some supplement manufacturers also count on so-called “confirmation bias” on the part of consumers to help convince the public that a product works. For example, it is extraordinarily difficult to “disprove” that a supplement claimed to prevent colds by “boosting the immune system” actually worked in a person who took the product and didn’t get a cold. Was it the supplement, or was it the fact that the person’s immune system was already adequate to fight the virus? Or perhaps the person was not adequately exposed to the cold virus in the first place.

Even consumers who feel like they got “ripped off” may be unlikely to seek redress. They often feel that the amount spent on an ineffective product may be less that the value of their time in getting a refund. More problematic is the fact that while many supplement manufacturers offer “money back guarantees,” the process is frequently filled with paper work obstacles, and consumers may be charged hefty “shipping and handling” charges for the return of unused product.

What Exactly are You Buying? Even They Don’t Know

While the mass marketing of diet supplements without scientific substantiation of their effects is bad enough, consumers would perhaps be more concerned to know that a disturbingly high percentage of these products either don’t contain the active ingredients listed in the label or contain amounts of certain ingredients that are less than or in excess of what is labeled. For example, independent tests of 21 multi-vitamin products for adults and children found that only 10 met manufacturer claims and other quality standards. The same independent laboratory found that only 42% of herbal supplements made with Echinacea, ginseng, or garlic had the right ingredients, in the right dose, and without lead contamination.

The real problem is that unlike prescription and over-the-counter drugs, which are manufactured pursuant to rigid quality control standards enforced by FDA, diet supplement manufacturers are not subject to any mandatory rules requiring that the minerals, herbs, and botanical ingredients they are purportedly selling to consumers are authentic, unadulterated, or produced in appropriate doses.

What Can You Do to Protect Yourself from Supplement Fraud?

First and foremost, protect yourself and your family by always consulting with your doctor before ingesting any vitamin or other dietary supplement product. Remember, many of these substances, especially herbal compounds, may have unanticipated side effects, or may adversely interact with medications you are taking.

Educate yourself. Never make a decision to use a diet supplement product based solely on advertising or “informercials.” There are a number of excellent dietary supplement reference materials and objective, informative sites on the Web. In particular, the National Institute of Health’s Office of Dietary Supplements provides a free data base of scientific literature on the most commonly used supplements. (See http://dietary-supplements.info.nih.gov/Health_Information/IBIDS.aspx). In addition, there are numerous consumer protection sites dealing with diet supplements and other forms of medical quackery. (See www.quackwatch.org).

Look with a healthy skepticism at supplement advertisements, especially those based on “testimonials.” The Federal Trade Commission has published a number of “red flags;” particular types of claims involving supplements such as weight management products, which should alert consumers to the possibility that a product being advertised may not perform as claimed. (See http://www.ftc.gov/bcp/conline/pubs/health/frdheal.htm). A good rule of thumb is: if it sounds too good to be true, it probably is.

Finally, even though the federal government has only limited authority to regulate ineffective or unsafe dietary supplements and supplement advertising, consumers who unwittingly purchase such products may have legal remedies under state consumer fraud statutes.

Do I Have a Dietary Supplement Lawsuit?

If you have been the victim of false or misleading diet supplement advertising, or if you have been injured by a supplement product, you may be able to bring a civil action, either as an individual, or on behalf of a consumer “class.”

Please use the form below to contact our law firm for a free confidential case evaluation.

Protecting Consumers Nationwide …

Moore Labriola LLP is dedicated to representing injured consumers throughout the United States who have been injured by defective, dangerous, and toxic products, pharmaceuticals, and medical devices. We also represent consumers who have been deceived and misled by sellers of dietary falsely advertised dietary supplements and consumer goods. We represent our clients in individual actions, group actions, and state and nationwide class actions. We are committed to obtaining justice for our clients, promoting safer products, and ensuring truthful and candid product marketing.

Moore Labriola LLP possesses sophisticated legal skills and the financial resources necessary to handle complex cases. Our attorneys are nationally recognized as “Some of the Country’s Most Prominent Complex Litigation and Products Liability Attorneys” and have been received the distinguished honor of being named as Super Lawyers. They have managed, litigated, and successfully resolved thousands of cases, including some of the nation’s most noteworthy tort and class action litigations, at the trial and appellate levels. They pride themselves to thinking outside of the box to achieve the best result for each client. These skills ensure a high rate of litigation success with maximum results.

Meet the Founding Attorneys

Thomas M. Moore
Partner
Moore Labriola, LLP
Thomas M. Moore is nationally recognized as one of the country’s most prominent complex litigation and products liability attorneys.

During a 23 year career, Tom has managed, litigated, and successfully resolved thousands of cases, including many of the nation’s most noteworthy tort and class action litigations.
Tom is the recipient of the prestigious AV rating from Martindale Hubbell based on peer and judicial assessments that he is recognized by the bar for the highest levels of skill and integrity. He has for many years appeared in the International Who’s Who of Buisness Lawyers, and has been named to the list of California Super Lawyers.

Ronald T. Labriola
Partner
Moore Labriola, LLP

Ronald Labriola is a name partner in Moore Labriola LLP. He focuses his practice on the litigation and trial of complex product liability matters involving pharmaceuticals and medical devices. He also devotes a significant portion of his practice to individual and class action matters involving consumer fraud and unfair trade practices.

Ronald was recently named to the list of California Super Lawyers. He is a member of several professional organizations, including the Defense Research Institute. A full list of appellate works, clients, and references is available upon request.