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Archive for the ‘Press release’ Category

Massachusetts Supreme Judicial Court rules that all cigarettes sold in Massachusetts are defective

Tuesday, June 11th, 2013

FOR IMMEDIATE RELEASE

CONTACT: Edward L. Sweda, Jr. or  Mark Gottlieb

617-373-8462 or 617-373-2026

 2010 Verdict Reflected Juror Outrage at Handouts of Free Cigarettes to Children.

 

Marie Evans at the age Lorillard began handing her free samples of Newports

Marie Evans at the age Lorillard began handing her free samples of Newports

The SJC today unanimously rejected Lorillard Tobacco Co.’s attempt to evade liability in a case brought by Willie Evans, whose mother Marie died in 2002 at the age of 54.  Testimony at trial reported that while Marie was a child growing up in the Orchard Park housing project in the Roxbury neighborhood of Boston, she received free samples of Newport cigarettes.   Marie, who first received the free samples of Newport cigarettes when she was 9 or 10 years of age, became addicted by the time she was 13, according to lawyers for her son, Willie Evans.

Newport, which is Lorillard’s best-selling brand of cigarettes and contains menthol, has been heavily marketed toward the African-American community, a fact that was highlighted at the 2010 trial.

In today’s ruling the Massachusetts high court upheld the compensatory damages of $35 million but reversed a punitive damages award of $81 and sent the case back for a new trial on the issue of punitive damages. The Court found that the jury was not adequately instructed about the negligence claims pertaining to design and marketing.

However, the key finding was that the Court upheld the jury’s finding that Newport cigarettes were not fit to be sold in  Massachusetts (breaching the implied warranty of merchantability).

Lorillard could have and should have sold a safer alternative product that did not addict Ms. Evans and cause her lung cancer. The Court wrote:

We decline to place addictive chemicals outside the reach of product liability and give them special protection akin to immunity based solely on the strength of their addictive qualities.  . . . Rather, we conclude that, in determining as a matter of law whether the evidence presented at trial was sufficient for a reasonable jury to conclude that the plaintiff’s proposed design was a reasonable alternative to the defendant’s product, we must determine whether the design alternative unduly interfered with the performance of the product from the perspective of a rational, informed consumer, whose freedom of choice is not substantially impaired by addiction. Applying that standard to the evidence in this case, we conclude that a reasonable jury could find from the evidence presented that a low tar, low nicotine cigarette constituted a safer reasonable alternative to Lorillard’s Newport cigarettes. (emphasis added)

By “low tar, low nicotine cigarette,” the Court is not referring to brands that were deceptively marketed as “lights.”  It means cigarettes that do not addict and expose consumers to an array of carcinogens. As a matter of law in Massachusetts, any cigarette sold that addicts or maintains the nicotine addiction of consumers is defective.  That would include just about every cigarette sold in Massachusetts.

Mark Gottlieb, Director of the Tobacco Products Liability Project (TPLP), a project of the Public Health Advocacy Institute (PHAI) which is based at Northeastern University School of Law in Boston, was delighted with today’s ruling: “Florida has been a hotbed of tobacco litigation in recent years because cigarettes there are considered defective as a matter of law for a former class of addicted smokers.  About 8,000 cases are awaiting trial in Florida.  After today’s ruling, this is  now the law in Massachusetts with the important difference that it applies to every plaintiff victim of cigarette industry products.  I expect many more cases here to help to address the suffering of victims like Marie Evans who were needlessly addicted in their youth to a deadly product.”

Edward L. Sweda, Jr., Senior Attorney for TPLP, added that, “It is high time that Lorillard is forced to pay the Evans family for the suffering caused by its outrageous practice of giving away deadly and addictive Newport cigarettes to children near housing projects.  This company’s profiteering for decades on the backs of African Americans must come to an end and today’s ruling is an important step in that process.”



PHAI’s Gottlieb co-authors article on strategies to reduce cancer from indoor tanning, FDA seeks stronger regulation of lamps

Tuesday, May 7th, 2013

Tanning Bed

An article released today in the American Journal of Preventative Medicine by Holman et al. focuses on strategies to reduce indoor tanning.  Indoor tanning with sun lamps (as opposed to spray tanning)  increases the risk of malignant melanoma, the deadliest form of skin cancer.  This is particularly alarming because about one-third of white women(who are a high risk for skin cancer than others) in the U.S. have used sun lamps to tan within the past year averaging about 27 sessions over that time.  Many indoor tanning salon users are at even greater risk for skin cancer because  74% of tanning salons fail to adhere to FDA guidelines for tanning frequency.   The International Agency for Research on Cancer recently elevated tanning beds to its highest risk category as carcinogenic to humans.   Only 2 states prohibit tanning by minors (CA and VT).

There are some similarities between the way the indoor tanning and tobacco industries operate.   In fact, it appears that the tanning industry may be following the tobacco industry’s lead, particularly in its use of front groups and creating doubt around the science around the harm their products cause.

In 2010, the Federal Trade Commission settled a complaint against the Indoor Tanning Association for making deceptive claims about the risks and the benefits of indoor tanning.

In addition to legislative approaches to the problem and addressing research needs, one important intervention would be for the Food and Drug Administration to change the medical device classification for sunlamp products from class I to class II.  Class I is the medical device class used for tongue depressors. Today, the FDA pre-published proposed rules to reclassify sunlamps as class II devices (they will be published on May 9, 2013 and available here). Class II medical devices include products such as infusion pumps and surgical drapes.

Under the rules proposed today, manufacturers would have to: a) demonstrate to the FDA that indoor tanning lamps are safe for individuals; b) adjust UV wavelength to “appropriate” levels; c) install alarms and timers to prevent sunburn; and d) require users to read labels warning them of the dangers of UV exposure, including discouraging individuals under the age of 18 or those with a family history of cancer. Not only will these new requirements improve safety and reduce exposure to UV radiation indoors, they will also provide a strong reason for states to consider passing new or strengthening existing laws regulating tanning salons.

See: “Strategies to Reduce Indoor Tanning: Current Research Gaps and Future Opportunities for Prevention,” by Dawn M. Holman, MPH; Kathleen A Fox, MPP; Jeffrey D. Glenn, MPA; Gery P. Guy, Jr., PhD; Meg Watson, MPH; Katie Baker, MPH, DrPH(c); Vilma Cokkinides, PhD; Mark Gottlieb, JD; DeAnn Lazovich, PhD; Frank M Perna, EdD, PhD; Blake P Sampson, BS; Andrew B. Seidenberg, MPH; Craig Sinclair; Alan C. Geller, MPH, RN (DOI: 10.1016/j.amepre.2013.02.014)



Big Victory at Florida Supreme Court is Bad News for Cigarette Manufacturers

Monday, March 18th, 2013

Florida smokers and their families who are suing tobacco companies won a resounding victory on March 14, 2013 when the Supreme Court of Florida upheld its landmark 2006 ruling in Engle v. Liggett Group, Inc., 945 So.2d 1246 (Fla. 2006).

By a vote of 6 to 1, Florida’s highest court ruled in favor of the plaintiff in Philip Morris USA, Inc., et al. v. Douglas, 2013 Fla. LEXIS 440, upholding a $2.5 million award in the death of Charlotte Douglas and explicitly rejecting industry arguments that the Florida Supreme Court’s ruling seven years ago violated the Due Process rights of the companies.

The Engle case originated as a class action and went to trial before a jury; that jury in Phase I of the trial found the defendant companies strictly liable, in that the cigarettes that the defendants manufactured and placed on the market “were defective in many ways including the fact that the cigarettes contained many carcinogens, nitrosamines, and other deleterious compounds such as carbon monoxide.”   While the case ultimately was not allowed to proceed as a class action, the Supreme Court of Florida ruled in 2006 that the members of the class could file their own individual cases (so-called “Engle Progeny” cases) and proceed with those cases relying upon the jury’s Phase I findings of liability, including that smoking caused a variety of specific diseases, that nicotine in cigarettes is addictive, that the tobacco defendants placed cigarettes on the market that were defective and unreasonably dangerous and that all of the Engle defendants were negligent.

The tobacco companies have argued that, despite the fact that they vigorously presented a defense to these claims during the original Engle trial, applying the Phase I findings to the Engle Progeny trials violates their due process rights.  Even though the R.J. Reynolds Tobacco Co. relied on this argument unsuccessfully in the Martin case a year ago, (see http://www.phaionline.org/2012/03/26/supreme-court-rejects-key-tobacco-industry-appeal-leaving-massive-liability-with-no-end-in-sight/ ),  the companies tried again in Douglas.  Commenting on the original Engle trial, the six-member majority in Douglas said: “As illustrated by hundreds of witnesses, thousands of documents and exhibits and tens of thousands of pages of testimony, the Engle defendants had notice and the opportunity to defend against all theories of liability for each of the class’s claims in the yearlong Phase I trial.”

That six-member majority also noted that the tobacco defendants “argue that the Phase I findings establish, at most, that some of their cigarette were defective for some unspecified reason and that they engaged in some, unspecified tortious conduct.  This, they claim, requires reversal of the verdict for the plaintiff based on strict liability because the Douglas jury was not instructed (and did not find) a causal connection between a specific defect in the defendants’ cigarettes and the injuries alleged.  We disagree and decline the defendants’ invitation to revisit our decision in Engle.”

The majority clearly recognized and emphatically rejected the industry’s fundamental argument.  “At its core, the defendants’ due process argument is an attack on our decision in Engle to give the Phase I findings res judicata – as opposed to issue preclusion – effect in class members’ individual damages actions.   However, res judicata is the proper term, and we decline the defendants’ invitation to rewrite Engle.”

The decision was bad news for the tobacco industry and its friends on Wall Street.  Pro-industry analyst David J. Adelman of Morgan Stanley admitted that the ruling “was even more pro-plaintiff than we expected and will make it more difficult for the industry to successfully defend these claims.”

After the decision was released, Philip Morris USA announced that “it plans to seek further review” of the Douglas decision.  That means yet another attempt to persuade the Supreme Court of the United States to consider the industry’s appeal that Engle Progeny trials that result in plaintiff verdicts somehow violate the companies’ due process rights.  If the Supreme Court of the United States makes the same decision it made a year ago about an almost identical appeal (Martin), the answer to the tobacco companies will be a final “No.”

-Edward L. Sweda, Senior Attorney for the Tobacco Products Liability Project

 



PHAI Publishes Legal Issue Brief on Digital Viral Food Marketing to Kids

Friday, March 8th, 2013

viral_digital_food_marketing_brief_graphic

Food companies used viral digital marketing tactics, such as “tell-a-friend” web campaigns, to induce children to share e-mail addresses of their friends and spread brand advertising of unhealthy foods among their peers.  Even very young children are targeted by these campaigns, which may be considered unfair and deceptive and in violation of state consumer protection laws.

PHAI has prepared a legal issue brief on this topic for state attorneys general as well as stakeholders in children’s health and privacy.  The brief explains the tactics that are used and suggests ways that they can be addressed, particularly under state law.

This work was supported by the Robert Wood Johnson Foundation’s Healthy Eating Research Program (#69293).



PHAI’s Daynard Maps Bold Endgame for Smoking in United States in NY Times Op-Ed

Monday, March 4th, 2013

The Public Health Advocacy Institute at Northeastern University School of Law and its President, Dick Daynard have long sought to make an impact on public health and policy by thinking outside the box. In an op-ed piece published in today’s New York Times, Daynard looks at an endgame for cigarette-caused addiction, disease and death in the U.S. and focuses in on two complementary but independent regulatory strategies.

The first strategy, available to the FDA under its authority granted in 2009 by Congress through the Family Smoking Prevention and Tobacco Control Act, is to reduce the nicotine content of cigarettes (and cigarette-like products) to non-addictive levels. Reducing nicotine yields of tobacco products (to anything above zero) is specifically mentioned in the law and, given strong evidence that it would benefit public health, there is nothing stopping the FDA from taking this bold step. While many smokers will quit if cigarettes do not deliver sufficient nicotine to maintain their addiction, others may chose to use tobacco products with higher levels of nicotine. But because cigarettes are, far and away, the most toxic product available for delivering nicotine, making them non-addictive is the only responsible thing to do. It will help existing smokers to quit or move to less dangerous sources of nicotine, stop smoking experimentation by youth from becoming a deadly addiction, and dramatically reduce non-smokers’ exposure to tobacco smoke. Public polling, while limited, consistently shows significant support, even by smokers, for reducing nicotine in cigarettes.

The second strategy relies on states and even communities regulating the sales of cigarettes under the principles of a proposal that has gained some traction outside of the U.S., called the Smokefree Millennial Generation. I feel it should be named in honor of the late Dr. C. Everett Koop who once challenged America of become a smokefree nation by 2000. The idea is that if a person’s birth year begins with the number “2,” that person shall not purchase cigarettes (or little cigars or other cigarette-like products). The legal authority for states and communities to enact such sales restrictions was clearly stated in the legislation that granted the FDA regulatory authority over tobacco (although communities could be preempted in some states). This proposal would gradually phase out smoking, beginning with the Millennials in 2018, wherever it was enacted. As more states adopted this policy, there would be fewer places willing to sell cigarettes to 18-year-olds who are unlikely to have the mobility to get a sufficient cross-border supply to initiate or maintain addiction.

While each of these strategies would face likely legal challenges that would delay but probably not overturn the regulatory policies in question, as well as public relations and implementation challenges, the time has finally come to put an end to smoking and smoking-caused disease by focusing narrowly on the highest impact policies that would dramatically reduce smoking rates in a decade. It is PHAI’s hope that today’s op-ed will generate a discussion and support among public health and tobacco control leaders so we can work together to truly achieve our shared goal of sharply reducing preventable death and disease. Eliminating smoking may seem way outside the box, but it is the best place to start.



PHAI project releases White paper and policy brief addressing occupational injuries and illnesses among low-wage workers

Thursday, December 13th, 2012

A new white paper quantifies the numbers and costs of occupational injuries and illnesses to the U.S. low-wage workforce, and a companion policy brief explains the findings’ importance to policymakers.

White Paper: Numbers and Costs of Occupational Injury and Illness in Low-Wage Occupations
Policy Brief: Mom’s off Work ‘Cause She Got Hurt: The Economic Impact of Workplace Injuries and Illnesses in the U.S.’s Growing Low-Wage Workforce

NEW POLICY BRIEF EXAMINES IMPACT OF OCCUPATIONAL INJURIES AND ILLNESSES AMONG LOW-WAGE WORKERS, WHICH COST $39 BILLION IN 2010

WASHINGTON, D.C.—Low-wage workers, who make up a large and growing share of the U.S. workforce,  are especially vulnerable to financial hits that can result from on-the-job injuries and illnesses, according to a policy brief released today by researchers at the George Washington University School of Public Health and Health Services (SPHHS). The policy brief, “Mom’s off Work ’Cause She Got Hurt: The Economic Impact of Workplace Injuries and Illnesses in the U.S.’s Growing Low-Wage Workforce,” was released along with a white paper showing that such workplace injuries and illnesses cost the nation more than $39 billion in 2010.

“Workers earning the lowest wages are the least likely to have paid sick leave, so missing work to recuperate from a work-related injury or illness often means smaller paychecks,” says the lead policy brief author Celeste Monforton, a professorial lecturer in environmental and occupational health at SPHHS. “For the millions of Americans living paycheck to paycheck, a few missed shifts can leave families struggling to pay rent and buy groceries.”

The policy brief analyzes and contextualizes for policymakers research by health economist J. Paul Leigh of University of California, Davis. At the request of Monforton and her colleague Liz Borkowski, an SPHHS researcher, Leigh returned to data he analyzed for a 2011 study published in the Milbank Quarterly. (See a summary of that study at http://on.natgeo.com/XcfnBi.)

Leigh zeroed in on approximately 31 million people—22% of the U.S. workforce—in 65 occupations for which the median wage is below $11.19 per hour. Janitors, housecleaners, restaurant workers, and others earning that wage full-time will bring home just $22,350 per year—an amount that means a family of four must subsist at the poverty line.

Leigh calculated that in 2010, 596 low-wage workers suffered fatal on-the-job injuries and 12,415 died from occupational ailments such as black lung disease or certain kinds of cancer. Another 1.6 million suffered from non-fatal injuries, and 87,857 developed non-fatal occupational health problems such as asthma. The costs of the 1.73 million injuries and illness amounted to $15 billion for medical care and another $24 billion for lost productivity—the cost when injured or sick workers cannot perform their jobs or daily household duties.

The policy brief explains that workers’ compensation insurance either does not apply or fails to cover many of these costs, which can bankrupt families living on the margin. In some cases, employers do not have to offer this kind of insurance to employees. And even workers that do have the coverage often get an unexpected surprise after an on-the-job injury or illness: Insurers generally do not have to provide wage replacement until the worker has lost between three and seven consecutive shifts. And workers at the low end of the wage scale are often discouraged from reporting on-the-job injuries as work-related—which leaves them with no insurance benefits at all, the brief said.

Leigh calculates that insurers cover less than one-fourth of the costs of occupational injuries and illnesses. The rest falls on workers’ families, non-workers-compensation health insurers, and taxpayer-funded programs like Medicaid.

“When low-wage workers miss even a few days of pay while recovering from an occupational injury or illness, the effects spread quickly,” Borkowski says, noting that fewer than one in five low-wage workers has access to paid sick leave. “They will usually have to cut back on their spending right away, which affects the local economy.” And families with children might skip meals or cut back on the heat, money-saving tactics that can put vulnerable family members such as children at risk of developmental delays and poor performance in school.

The brief suggests that policymakers should address this public health problem more forcefully by improving workplace safety and strengthening the safety net to reduce the negative impacts caused by the injuries and illnesses that still occur. “On average, more than 4,000 workers are injured on the job each day,” Monforton notes. “If we make workplaces safer, we not only stop losing billions of dollars each year, but we also could reduce the pain and suffering and financial impact on thousands of low-wage, hard-working Americans and their families.”

Both the policy brief and white paper were funded by the Public Welfare Foundation.



NYC’s new soda size restrictions should survive any legal challenge

Thursday, September 13th, 2012

Today the New York City Board of Health approved first-in-the-nation limits on the maximum size of sugary drinks served in restaurants, theaters, and sports venues. The vote was 8-0 in favor of adopting the regulation with one abstention. Grocery and convenience stores are exempt and diet drinks, juices, and drinks that are 50% of more milk (or milk substitute) are excluded.

While the measure drew ire from critics throughout the political spectrum, and has been inaccurately characterized as a “ban,” it has succeeded in invigorating the debate on the role of sugary drinks in obesity and the role of government to encourage  mindful consumption.  Such mindful consumption will begin 6 months from today when the new rule should go into effect.

In the meantime, there may be efforts by big drink stakeholders to challenge the regulation.  One such group, New Yorkers for Beverage Choices, a group closely aligned if not controlled by the American Beverage Association, has hinted at such a challenge.  The pro-business think tank, the Washington Legal Foundation, has published comments on the measure that suggest the basis for a legal challenge. A credible legal challenge could result in the granting of a injunction that could delay or derail the beverage size restriction. However, there appears to be little chance that such a challenge will lead to any measure of success.

The Washington Legal Foundation’s primary legal argument to oppose the measure is that it is the type of action that is normally reserved for legislation rather than rule-making by an administrative agency. The problem with that argument is that regulating serving sizes of sugary drinks in food establishments is clearly within the New York City Department of Health and Mental Hygiene’s authority to protect the public’s health under the City Charter’s sec. 558 and to engage in rule-making under sec. 1043.  The Washington Legal Foundation public comments cite to a 1980s case, Boreali v. Axlerod. The case involved an early New York non-smoking rule that was overturned primarily because the state’s Public Health Council considered the economic impact of the restriction on businesses and offered waivers for those that could show financial hardship. This went beyond the Public Health Council’s legal authority to issue rules based solely on protecting health.  Here, however, there is no waiver process and no consideration by the Board of Health of the economic impact this rule might have on businesses.

A second issue raised by the Washington Legal Foundation is that the problem of obesity is an important issue of concern to society and that dealing with such social issues is best left to legislative bodies rather than regulatory agencies.  Citing again to the Boreali case, WLF suggests that this is a matter that it should only be addressed by elected officials and not agency appointees.  Essentially, they are making a philosophical rather than a legal argument.  Legally, this rule-making is very clearly within the agency’s purview.

In yesterday’s New York Times, an attorney who has previously represented New York restaurants suggested that the rule could be overturned on Constitutional grounds.  This would be a reference to the Commerce Clause (Art. I, Sec. 8, Clause 3 of the U.S. Constitution) which grants Congress the power to regulate commerce among the states.  If a state or, as in this case, a political subdivision of a state, passes a law or rule that substantially affects interstate commerce, it is possible that a court would find that the Commerce Clause reserved that power to Congress and the law or rule would be found to be unconstitutional. However, in this instance, there is virtually no argument that could be made that the beverage size rule could affect interstate commerce any more than the cup size could be found to be a form of free speech that the rule unconstitutionally restricts.  Neither argument is credible enough to argue in a court room.

There is virtually no chance that the rule will be successfully challenged.  Either threats of litigation will not materialize or, if they do, will be quickly dismissed. That result will encourage other communities to replicate the courageous  action taken in new York City by Mayor Bloomberg and the Board of Health.

-Mark Gottlieb, J.D., Executive Director
Public Health Advocacy Institute at Northeastern University School of Law

 



US Court of Appeals for DC Circuit deals painful blow to FDA, public health and consumers

Friday, August 24th, 2012

For Immediate Release

Mark Gottlieb, executive director of the Public Health Advocacy Institute at Northeastern University School of Law in Boston states:

“Today’s ruling leaves the FDA in a very difficult position as it seeks to execute the intent of Congress which specifically called for large graphic warnings on cigarette packs.  By this Court’s logic, the small Surgeon General textual warnings might also violate the cigarette companies’ rights to commercial free speech because there is inadequate scientific proof that those labels reduce smoking rates.  Surely a product that addicts and kills nearly a half million Americans each year is one that demands warnings that garner serous attention by consumers.  Todays’ decision is an improper imposition of the Court’s judgment in public health matters over that of the FDA’s evidence-based approach.  Ultimately, an appeal to the U.S. Supreme Court, although risky, seems inevitable. “

The case is R.J. Reynolds Tobacco Company, et al. v. Food & Drug Administration, et al. (No. 11-5332).

Download the decision here.

U.S. Court of Appeals for DC Circuit deals painful blow to FDA, public health and consumers

Today the U.S. Court of Appeals for the D.C. Circuit, in a 2-1 ruling, affirmed the February 29, 2012 ruling of Judge Richard Leon that stopped the U.S. Food and Drug Administration (FDA) from implementing regulations to require large graphic warnings on cigarette packs and on all cigarette advertising. The Court ruled that requiring the five cigarette companies bringing the lawsuit to include the 9 graphic images selected by the FDA violated their First Amendment rights.

Questions about the how much the government can limit the speech of corporations and, in this case, how much the government can compel speech by corporations, evolved over time through decisions issued the U.S. Supreme Court.  Different standards apply depending on the circumstances.  At issue in this case is which standard is appropriate.

The District Court applied a standard known as strict scrutiny which is the most stringent standard. It is generally used when state action affects fundamental Constitutional right is threatened.  Here, the Court of Appeals used the Central Hudson Intermediate Scrutiny Standard.  This standard requires the government to show that: a) it has a important interest in the issue at hand; b) that the regulation directly advances that interest; and c) that the restriction on speech is no more extensive than required to achieve its purpose.   The Court of Appeals found that the FDA failed to demonstrate adequately that the graphic warnings would achieve its interest in reducing smoking rates through scientific evidence.  It also found that an alternative government interest in effectively communicating health information to consumers is too vague to qualify as a substantial government interest.

The alternative standard that could have applied is known as the Zauderer standard.   This standard allows disclosures to be required so long as they are reasonably related to the government’s interest in preventing consumer deception.  The Court of Appeals today relied on decisions that held that without such disclosures there is a serious risk that consumers will be misled.  Then the Court notes that in the legislation that gave the FDA authority of cigarettes (the Family Smoking Prevention and Tobacco Control Act of 2009) several provisions were included to protect consumers from deception such as prohibiting cigarette makers from using descriptors such as “light” or “mild.”  Because Congress included those provisions and said nothing about cigarette packaging or advertising being inherently deceptive, it ruled that the Zauderer standard did not apply. The majority opinion was written by Judge Janice Rogers Brown who was joined by Senior Circuit Judge A. Raymond Randolph.

In a vigorous dissent written by Judge Judith W. Rogers, it is argued that the Court should have applied the Zauderer standard because the warnings are provided to address misleading commercial speech.  She cites to the landmark decision U.S. v. Philip Morris that found the industry liable for violating federal racketeering law and states that it is “beyond dispute that the tobacco companies have engaged in a decades-long campaign to deceive consumers . . .” The government must only show that the targeted speech creates a possibility of deception where misleading commercial speech is involved and the Zauderer standard of review, which FDA would be able to meet, should apply.

The result is that the regulations for implementing the graphic warnings are rendered void and the matter is referred back to the FDA.  The agency can now appeal this decision and seek an en banc review by the full D.C. Circuit Court of Appeals, appeal to the U.S. Supreme Court, or accept the ruling.  Were it to appeal the ruling, it could result in a reversal  which would allow the warnings to go forward or it could result in a Supreme Court decision that could limit the ability of government to require disclosures or warnings that go well beyond cigarettes and expand the boundaries of commercial free speech.

Conceivably, FDA could begin the rulemaking process again and try to state the government interest in a manner that would not require the precise type of scientific evidence of effectiveness that the Court deemed necessary in today’s ruling.  Some of the graphic images could be replaced with others that might be more in keeping with the Court’s requirement for communication information rather than “ideology,” which was referred to in its opinion.  Those rules would inevitably result in new litigation by the plaintiffs in this action but could yield a better result.  However, today’s decision, which goes against the best practices internationally in public health approaches to tobacco and creates an extremely onerous standard of review for warnings might be just bad enough to justify the risk of an appeal.



PHAI joins the Center for Digital Democracy and others in complaint to FTC over children’s websites’ “Tell-A-Friend” tactics

Wednesday, August 22nd, 2012

Today the Public Health Advocacy Institute at Northeastern University School of Law in Boston has joined a coalition of children’s, health, privacy and consumer advocacy organizations in a complaint to the U.S. Federal Trade Commission against several children’s websites for violations of the Children’s Online Privacy Protection Act (COPPA). The offending children’s websites use a “Tell-A-Friend” feature to induce children to provide e-mail addresses of their peers.  The websites involved include McDonald’s HappyMeal.com, General Mills’ ReesesPuffs.com and TrixWorld.com, Doctor’s Associates’ SubwayKids.com, Viacom’s Nick.com, and Turner Broadcasting’s CartoonNetwork.com.

The Tell-A-Friend tactic uses a game or other child-targeted activity as a way to engage children in an immersive  marketing experience and then directs users to share the activity with friends by entering multiple e-mail addresses.  Those children will receive an e-mail that may or may not appear to be from their friend urging them to go to a child-targeted marketing website. This viral marketing tactic creates and reinforces brand awareness providing value to the advertiser.  All of this occurs without prompts for any parental consent and, in McDonald’s case, may involve distributing a photograph of the child taken by webcam to recipients of the e-mail message.

Mark Gottlieb, Executive Director of PHAI, noted that, “COPPA was enacted by Congress to protect children under 13 from divulging any personal information to commercial interests on the Internet without the consent of a parent. By inducing young kids to provide the e-mail addresses of their peers, the companies involved here are certainly violating the spirit of COPPA and, it would appear, the letter of the law as well through these “Tell-A-Friend” practices.  This is something that state attorneys general could also investigate under their consumer protection authority because these tactics are unfair and deceptive.”

In addition to the Center for Digital Democracy which has published the complaints on its website, PHAI was joined by the American Academy of Child and Adolescent Psychiatry, Berkeley Media Studies Group, Campaign for Commercial Free Childhood, Center for Media Justice, Center for Science in the Public Interest, Children Now, Consumer Action, Consumer Federation of America, Consumer Watchdog, ChangeLab Solutions, Global Action Project, Media Literacy Project, Privacy Rights Clearinghouse, Public Citizen, and the Rudd Center for Food Policy & Obesity at Yale University.



Health Groups Ask Federal Trade Commission to Investigate Merck’s Use of “Madagascar 3: Europe’s Most Wanted” Characters to Market Children’s Claritin®

Wednesday, June 20th, 2012

Wednesday, June 20, 2012

FOR IMMEDIATE RELEASE

Contact: Cara Wilking, 617-373-5699

Today, the Public Health Advocacy Institute (PHAI) at Northeastern University School of Law in Boston, joined by 10 other organizations, sent a letter to the U.S. Federal Trade Commission (FTC) asking that it investigate Merck & Co. Inc.’s  Madagascar 3-themed marketing campaign for its flagship pediatric allergy medication, Grape-Flavored Chewable Children’s Claritin®.

“Marketing medicine directly to children at all, much less through entertainment tie-ins, is well beyond the pale and is not only inherently unfair, it is downright dangerous,” said Mark Gottlieb, executive director of PHAI.

To promote its June release of the Madagascar 3: Europe’s Most Wanted movie, Dreamworks licensed its Madagascar characters to Grape-Flavored Children’s Claritin®. It also licensed the characters to market other children’s foods including fruit-flavored Airheads candy, General Mills (Betty Crocker) Fruit Snacks, and McDonald’s Happy Meals. The use of the same characters on candy and gummy snacks and Children’s Claritin® creates the impression that the medicine is candy and could lead children to over consume the product at great risk to their health.

The FTC regulates over-the-counter (OTC) drug marketing and has protected children from marketing of vitamin supplements, and by extension OTC drugs, since 1977 when it found the use of Spider-Man to market vitamins to children to be unfair and deceptive (In re Hudson Pharmaceutical Corp., 89 F.T.C. 82 (1977)).

Merck’s campaign utilizes customized Madagascar 3 packaging including “5 Free Stickers.”with Madagascar 3 characters and containing “5 Free Stickers.” Mail-in movie ticket voucher promotions were prominently placed at retail outlets such as Walgreens and downloadable Children’s Claritin® Madagascar-themed activity games further targeted children. Merck also enlisted its “Children’s Claritin® Mom Crew” members to create social media buzz. Mom Crew members held Madagascar-themed viewing parties for children featuring product samples, coupons, DVD’s, popcorn containers and, Madagascar stickers and then featured the children’s parties on their blogs and websites.

Cara Wilking, a PHAI senior staff attorney who authored the letter, added, “the FTC stepped in and stopped this practice a generation ago. Apparently OTC drug-makers like Merck need to be reminded that targeting kids is unfair, deceptive, and unacceptable.”

PHAI, Berkeley Media Studies Group, Campaign for a Commercial-Free Childhood, Center for Digital Democracy, ChangeLab Solutions (formerly Public Health Law & Policy), Corporate Accountability International, Eat Drink Politics, Public Citizen, The Public Good Law Center, Public Health Institute and Prevention Institute request immediate action by the FTC to stop this practice before it becomes widespread.




Copyright Public Health Advocacy Institute (PHAI) at
Northeastern University School of Law