e-gigarettes: i mgle: i intellectual i adr the fda …
TRANSCRIPT
E-GIGARETTES: THE FDA TARGETS VAPING I MGLE:
WORKERS' GOMP I INTELLECTUAL I PROPERTY ROUNDTABLE
ADR RESOURCE GUIDE
callawyer.com MARCH 2015 S9
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FEATURES 17 12015 ATTORNEYS OF THE YEAR Calijonna Lmvyer's ClAY Awards honor 62 lawyers st:uewide, in 17 areas of the law. by the starr of California Lawyer
28 I IFS, ANDS, OR BUTTS E-ctgareues could be a pathW:t}' for smokers to quit, or the next big thing for Dig Tobacco. The FDA will try to balance public health and ham1 reduction when it issues new rules later this year. by Thomas Peele
DEPARTl\IENTS 4 I EDITOR'S NOTE
5 I LETTERS
10 I SOCIAL MEDIA Defining a "True Threat" The Supreme Coun mulls the boundaries of free express tOn in a case of !)ortcs posted online that :-tppcar to target the defendant's estrnngcd wtfc :md others. by Traci I. Park
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12 I LEGAL EASE Objectivt:!. Seem Object1ve We offer four techniques to enhance a brier~ pct:.u:LSivencss. by Eunice Park
14 I EXPERT ADVICE Litigation Structured settlements offer tax benefits and sccurtt}', even when interest rntcs :tre low. by Patrick C. Farber
35 ITECH Apps Power Small Practices There :1re man>' mobile apps geared speetfic.1ll}· for l:lwyers. but those for genernl use mar be more robust :md less expcns1'·c-or free. by David Ferry
36 1 LEGALLY SPEAKING Deconstructing Bias A convcrs:ttton with E,·a Paterson, one of the nation's leading ci,•il rights advocates.
39 1 MCLE Workers· Compensation Emplorccs injured at work usually can't sue their employers, but !It ere are key exceptions. by Deborah Rosenthal and Craig Peters
51 1 DISCIPLINE REPORT
64 I IN PRO PER Quixote's Last Trial (Maybe) A J esu i 1-priest- t umed-criminal-dcfensclawyer longs for a legacy and finds grnce. by Paul Comiskey
ESQ. 6 1 A LAKEBED REAWAKENS AI the former Owens Lake-for dec:tdcs the single largest source of p:trticulate air pollu1ion in the country-a settlement cle:trs the air. Also. • ln hb free time, law professor George
Disharnt is a musictan. • Mapping C:tlifornia's lawyers: Guess
whtch count}' has the most.
SPONSORED SECTIONS r"·····--· - ··-·-····-···· .. ·~••n••···· ····-· ·· · --· ········ 44 INTELLECTUAL PROPERTY ROUNDTABLE An update wi th Finnegan, llendcrson. Fnrabow, Garrett &: Dunuer; Mayn:tn.l Cooper&: Gale; aud Morgan, Lewis & Bock ius. Co-moderated by jeff Kiclwven. 56 ADVERTISER INDEX
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ne morning last December 1 walked past the no-s moking signs at the gas pumps outside an Oakland 7-Eievcn, and entered through a door beneath the green and orange fa~ade.
Behind the counter, near pints of jack Daniels and Jagermeister, were rows of cigareue packages: Marlbo
ros, Camels, Newports. Next to them was something else: e lectronic cigarettes. They generate vapor-not smokeproduced when the user inhales from a nicotine-laced solution superheated by lithium batteries that atomize the liquid into a mist Inhaling that mist is called vaping.
Less than a decade after e-cigareues hit world markets, vaping has become so popular that the Oxford Dictionaries named it 20145 word of the year.
l went to the 7-Eieven because l wanted to try vaping. "Do you have Njoy singles?" 1 asked the clerk, referring to a brand that comrols about 40 percent of the U.S. market
"Kings or menthol?" "Kings." lie passed me a s mall, rectangular package, wrapped in
red plastic. The package contained a single e-cigarette and cost $7.99.
I walked half a block away, s topping in from of a closed amique store. Along the sidewalk, a couple with a toddler approached. Even 1 hough its widely believed that inhaling nicotine vapor has fewer health risks than smoking tobacco, vaping didn't seem like something that I should do around a kid.
As I let the family pass, I glanced at the back of my Njoy's packaging. The lnbel read: WARNING: Njoy products are not smolling cessation products and have not been tested as such. Njoy products arc intended for use by adults of legal smoking age (18 or older in Califomia) and not by children, women wlw arc pregnant or /Jrrastfeeding, or persons with, or at rislz of, heart disease, Jligh blood pressure, diabetes or t.ahing medicine for depression or asth111a.
That language was part of a deal then-state Auorney Generaljerry Brown reached with distributo rs in 2010. Sou era Inc., doing business as Njoy, agreed not to market its products to minors, and to pull from California retail shelves e-cigarettes with flavors :mractive to kids--such as strawberry, chocol:uc, cookies-and-cream, and mint. (People \\ Sotlela , Inc., No. RG10528622 (Alameda Super. Ct.).)
I looked up again. The toddler was down the block. I flipped open the spring-loaded lid of the case with In}' thumb, exposing what looked like the filter end of a traditional cigareue. I pulled it out.
Thomas Peele is iln 1nvostigat1ve reporlor for the Bay Area News Group.
COM~ENTS, letters.caltawyer 'tdailyjournalcom
There were no instntctions. At the colored filter end was a small ho le. I brought it to my lips and inha led sharply, which triggered the superheating process. The vapor smelled and tasted like the tobacco in cigare ues I had flirted \\ith as a teenager. I exhaled what looked like smoke. The vapor quickly dissipated. I repeated this twice more.
The nicot ine buzz came quickly. I don't smoke. My drug or choice is a different Stimulant-caffeine. But what the Njoy delivered was far differem from the effects of black coffee. A slight sensation rippled in my chest. My throat felt ho t. The s mell of tobacco clung to me well after the vapor hnd vanished.
Outside a coffee shop nearby, a homeless man who looked about 60 years o ld was begging for money. He's a neighborhood character and a heavy smoker who coughs and hacks chronically. Sometimes l sec him scouring the gutter for cigarcue buns, desperate to salvage a drag or two. I asked if he wamed my Njoy.
"It's supposed to be less harmful than cigareues," l said, feeling a scraping in the back of my throat and what seemed like sharp prickles in m>' chest. I held the Njoy out to him.
He looked at me through yellowing eyes, slowly shaking his head. "Naah," he said. "I ain't tntsting nothing ain't real. That ain't no cigareue."
Here was a piece of srreet-comer wisdom that touched on the gist of the comroversy: Do e-cigareues reduce harm by delivering nicotine in a safer form, o r do they simply encourage smoking tobacco'
Let's say this fellow took my Njoy and turned from smoking to vaping. Wi thout daily exposure to the deadly tar in cigareues, h is health might improve-maybe delaying medical problems that will undoubtedly be society's burden. And while passersby or others who sit near him might be exposed to secondhand vapor, research suggests it is less harmful than secondhand tobacco smoke.
But s uppose 1 hat instead of g iving away my Njoys, I
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kept them nnd got hooked on nicotine. I'd be inhnling whntever toxins are in the nicotine liquid, and emitting secondhand vapor. I'd be harming myself nnd perhaps the people around me.
The concept of harm rednclion is elusive and difficult to quanlify. More safe does not mean safe. Less risk than smoking tobacco docs not mean no risk from vaping. E-cigareucs still contain unknown and p01emially harmful substances. My homeless neighbor seemed to grasp this in an instant.
What is known about vaping is that it's the new cool: sleek, techy, and edgy enough to be outlawed in many venues. It is rapidly auracting young ndults, who, according to the state Department of Public Health , are three times more likely to be vapers than people over 30. And last year for the first time, teens consumed more e-cigarettes than traditional smokes.
That makes vaping a pressing legal and public health concern. The U.S. Food and Drug Administration, in fact, is gearing up to issue nalional e-cigareue regulations later this year.
Quitting Claims My father smoked. At the height of his nddiction he was up to around four packs a day, so much tobacco that though he'd quit more thnn 25 years before he died, his death certificate listed smoking as the cause for the cancer that ravaged him.
To cut costs, he bought cigarette-makings in bull<. Every evening he'd sit on the floor, watch Walter Cronkite report the news, and load tobacco, fthers, and paper into a Laredo rolling machine. He'd slide a handle and pop out smokes-about 80 cigarettes a night, enough to get him through the next day.
Nothing, it seemed, could slake his crnving for nicotine. Then in the early 1970s a bad cold forced him to bed, nnd never-endmg coughs rang through the house as he hacked up blackened phlegm. He thought he already had cancer. He didn"t, but it scared him enough to endure miserable weeks of withdrawal. No nicotine gum , no pa tch. Cold turkey. Black coffee. I lands that shook. Objects hitting walls as his temper erupted at the slightest pro,·ocation.
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Could vaping have brought him down more humanely? Perhaps. But my father never had the chance to see if vaping could have helped him quit. Neither did the fatJ1er of Hon Lik, a phannacis t in the People's Republic of China. But when Lik's father died of lung cancer, Lik-who also smoked hca'"ily-began experiments in harm reduction. He released a version of e-cigarencs in 2003.
By April 2006 the devices were being sold in Europe; they hit American markets the ne.xt year. Today, the fastest growing share of the market is vaping pens-tank systems with a cartridge of navored nicotine liquid and a larger battery that can produce more heat.
In September 2008 two shipments of c-cigarettes from China were detained on arrival at Los Angeles lntemalionnl Airport. The FDA claimed the cargo qualified as a drugdevice combination, defined under the Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 32l(g)(l )(C)) as an article "intended to affect the structure or any function of tJ1e body."
Smoking Everywhere, a Florida-based distributor that was to receive the shipments, challenged that authority in federal court, and was soon joined by Sottera. The compnnies argued that the Supreme Court in FDA '~ Brown & Williamson Tobacco Corp. (529 U.S. 120 (2000)) held that Congress never intended the fDCA to grant the agency jurisdiction to regulate cigareues or other tobacco products. They contended e-cigarettes weren't meant "for any thera-
"UNDER THE CONSUMER PROTECTION LAWS OF CALIFORNIA. YOU'RE GOING TO HAVE A CAUSE OF ACTION IF COMPANIES ARE ADVERTISING IN A MISLEADING FASHION." -MICHAEL F. RAM, CONSUMER SAFE1Y ATTORNEY IN SAN FRANCISCO
peutic purpose, as a smoking cessation aiel," but rather were "marketed, labeled, and sold solely to provide adult consumers with alternative 'smoking' pleasure, without the inconveniences of traditional tobacco smoking." (Smohing Everywhe1e, Inc.'~ FDA, No. 09-CV-00771 (D.D.C. filed Apr. 28, 2009).)
A year later, U.S. District judge Richard]. Leon agreed and issued a preliminary injunction. "This case appears to be yet another e.xamplc of FDA's aggressh·e efforts to regulate recreation tobacco products as drugs or devices under the FDCA," he wrote. (Smolling Eve,ywhere, luc., v. FDA, 680 F. Supp. 2d 62, 78 (D.D.C. 2010).) Leon's ruling was upheld on appeal, and the FDA declined to seck Supreme Coun review. (Sotlcra, Inc. \! FDA, 627 F.Jd 891 (D.C. Cir. 2010).)
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Leon was particularly annoyed that the federal agency lutd apparently blocked e-cigarcttc imports in anticipation of the Family Smoking Prevention and Tobacco Control Act (Pub. L. No. 111-31), enacted shonly after the plaintiffs filed suit. The 2009 act granted the FDA new authority to regulate "any product made or derived fro m tobacco that is intended for human corLSumption ''-including e-cigareues. (21 U.S.C. § 32l(rr)(l).)
"(N)orwithstanding that Congress has now taken the unprecedented step of granting FDA jurisdiction over those products, FDA remains undeterred," Leon wrote.
Before the agency could propose new federal rules, however, California Auorncy General Brown sued Smoking Everywhere under the state's Health and Safety Code-and prepared a complaint against Sottera -alleging that the two distributors targeted minors and misled consumers. The companies quickly settled, paying fines and promising not to market e-cigarenes to minors or to claim that thei r products arc safer than traditional cigarcu es. (Sec People v. Smohiug Everywh ere, Inc., No. RG 10493637 (Alameda Super. Ct. s tipulated judgment filed Nov. 2, 2010); and People v. Soctcra, Inc., No. RG10528622 (Alameda Super. Ct. consent judgment fil ed Sept. 10, 2010).)
Since then, at least seven States and mo re than 100 d tics and coumies in California have e nac ted e-cigarette regulations.
Finally, last April, the FDA proposed a new rule "deeming" certain tobacco products to be subject to regul:uion: c-cigarenes, cigars, pipe tobacco, nicotine gels, water pipe or hookah tobacco, and "clissolvables not already under the FDA:s authority."
FDA Commissioner Margaret A. Hamburg, in a May lencr to the New Yorh Times, called the rule a critical first step that "will bring an end to the completely unregulated e-cigarenc marketplace.'' Noting that the agency had financed four studies of nicotine ' 'apo r, Dr. Hamburg wrote that it is "commiued to the science-based regulation of these producL<; to bener protect public health.''
The deeming rule would ban e-cigarette sales to minors nationwide, require proof of age to buy the devices, and require producers to register with the FDA and provid e de tails on ing red ie nts, manufacturing processes, and other scientific data. But the proposal doesn 't address flavored hquids, including those that cri tics say are aimed at youth. As Mitchell Zeller,
FDA Commissioner Margaret A. Hamburg deemed e-clgarettes to be "tobacco products:·
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"ADDICTION IS WHAT IS REALLY BEING SOLD." -STATE SEN. MARK LENO, SAN FRANCISCO
Njoy holds about 40 percent of the $2.5
billion e-cigarette market.
director of the fDA:s Center for Tobacco Products, explained to the Times, that would require a proving of harm, which isn't possible until regulatory control over the products is established.
Sending a Message In California, Brown's 2010 consent judgments address many of the perceived hazards of c-cigarettes. Among otl1cr provisions, Smoking Everywhere and Sottcra agreed to audit manufacturing to ensure produc t safe ty and not to advertise c-cigarettes as smoking-cessation devices or claim that the devices are safer than cigarenes or \viii improve a users health.
Still , the settlements pem1it the two distributors to market e-cigarettes as an alternative to smoking traditional cigarettes, provided the ad "states conspicuously that e-cigarettes are sold for purely recreational purposes and not for treating nicotine
addiction . a nd that nico tine causes addiction."
Rival dis tributors were under no such restric tio ns, permiuing them to market e-cigareues and vaporizers extensively. According to a study by the Centers for Disease Control and Prevention, as of 2013 more than 36 percent o f smokers in the United States had tried electronic cigarettes, and 8.5 percent of all adults had tried them.
Two putative class actions brought
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"THESE ARE NICOTINE-CONTINUITY PRODUCTS. THEY MAY VERY WELL DAMAGE THE LUNGS WITH VERY UNNATURAL THINGS. THERE'S NO REASON TO THINK THEY'RE SAFE." -DR. ROBERT JACKLER, STANFORD UNIVERSITY MEDICAL SCHOOL
last year in California have challenged the legality of some I advertising messages. The ftrst, ftled in federal coun in Los Angeles, alleges that Njoy uses unfair and deceptive practices in its e-cigareue marketing campaign, violating the state's Consumers Legal Remedies Act (Civil Code §§ 1 750-1784) and Unfair Competition Law (Bus. & Prof. Code § 17200). (In rc NjO)\ Inc. Consumer Class Action Litigation, No. CV-14-00428 (C.D. Cal. filed jan. 17, 2014).) At issue are slogans such as "All the pleasures of smoking without all the problems"; "Everything you like about s moking without the things you don't"; "Finally, smokers have a real alternative"; and ~cigarettes, you've met your match."
U.S. District Court judge Margaret M. Morrow, presiding in the consolidated cases, was full of questions about e-cigareues at a hearing last May. "How big a market is this, and what is the sense of the plaintiffs as to the po tential recovery here?'' she asked janine L Pollack, a class action specialist and partner in the Kew York office of Wolf Haldenstein Adler Freeman &: Herz.
"Thee-cigarette market is growing at leaps and bounds," Pollack replied. "l think it:S half a billion to a billion [dollars ! .... There's an expectation that it will grow exponentially in the next few years."
Paul L. Gale, Njoy's lawyer and a partner in the Irvine office of Troutman Sanders, told judge Morrow that the 2010 consent judgment would be the cornerstone o f Njoy·s defense. That agreement, he said, "covered everything that [the plaintiffs are) complaining about. We've been in full compliance with that consent decree since then."
At the hearing Gale also said that deeming regulations pending at the FDA could affect his defense. He affirmed that he anticipated raising "some preemption issues," but did not elaborate. The consent judgment expressly permits modification of the agreement should it "become preempted by federal law or regulation."
The litigators declined to be interviewed, and Njoy:S CEO, Craig Weiss, did not respond to multiple messages.
In October, Morrow dismissed the complaint, ruling that plaintiffs had failed to show they relied on Njoy's ads. Even a "somewhat relaxed" reading of the "particularity" requirement under rule 9(b) of the Federal Rules of Civil Procedure, she wro te, wouldn't permit the case to proceed.
"Plaintiffs o ffer no information regarding when, or even if, each of the named Plaintiffs viewed the !Njoy] website and/or operating instructions," Morrow s ta ted . ''Without
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such facts, these conclusory allegations do not come within a country mile of satisfying Rule 9 (b) ."
After another failed attempt, the plaintiffs filed a third amended complaint in November, and Gale moved to dismiss with prejudice. "Njoy was under no duty to disclose either the ingredients on its label, or the fact that a few handpicked, publicly available studies that looked at different products found that more study is needed regarding longterm health effects o f e-cigarette usage," he argued. Gale also disputed allegations that Njoy promotes its products as ''generally safe or safer than traditional cigaretles.'' Morrow has scheduled a hearing on the motion later this month.
The second lawsu it, this one in Los Angeles Superior Court, makes stmilar claims against Fumizer LLC, a Glendale-based distributor of e-cigarettes. The plaintiffs assen that in what they dcsetibe as an owners manual, Fumizer boasts its '·very good quality"' e-cigareues are "healthy" and "can help you quit s moking. " The lead plaintiff also alleges that one of Fum izers e-cigarettes exploded in his home, s tarting a fire that destroyed personal property. (Sheppard v. Fumizer, LLC, No. BC 558403 (L.A. Super. Ct. filed Sept. 22, 2014).)
The complaint calls the marketing claims at issue "contradictory and hypocritical" smce the bhcls on Fumizer:S e-ciga-
In re Njoy. Inc. plaintiffs attorney Janine L Pollack: and defense counsel Paull. Gale.
rene packaging warn that the product is not a smoking-cessation device. "This is a 60-year-old flashback to Big Tobacco telling us that 'Four out of five doctors prefer Camels,'·· says auomey jerusalem Beligan, who works with lead counsel john P. Bisnar, a principal at Bisnar Chase in Newpon Beach. The suit seeks unspecified damages for "deceptive, false and misleading" representations and advertisements. Fumizer had no t replied to the complaint by press time.
Doing Less Harm Both of the Los Angeles suits allege that the distributors of e-cigarcucs imply through their marketing that the devices reduce hann associated \vlth using tobacco-despite abundant studies showing tha t e-cigarettcs themselves a rc no t
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~-------------------------------- .. ~ .... --~:~~~~ harmless. A study of e-cigarette canridges by the FDA:s Division of Pharmaceutical Analysis found ~detectable levels o f known carci nogens and toxic chemicals to which users could potemiaUy be exposed."
.. There have been clnims that the secondhand vapor is just water vapor that's not harmful," says Andy Tan, an assistam professor of social and behavioral sciences at Harvards School of Public Health. "That:S not rrue. The health concerns arc still unknown."
Nicotine vapors co ntain propylene glycol, for instance, a synthet ic liquid that absorbs water and is used to make polyester compounds, de-icing solutions, and fake smoke for theatrical productions. When eaten as fl food additive, the FDA considers propylene glycol "generally recognized as safe."
But what happens when vaporized and sucked deeply into the lungs? There isn't enough scientific evidence to know if the compound is also safe to
inhale-though researchers are skeptical. Another additive is diaceryl, commonly used to give but
ter navoring to microwave popcorn and some e-cigarcttcs. When inhaled, it has been found to cause irreversible lung scarring-or "popcorn lung disease," nicknamed after the food-plant workers exposed to diacetyl.
Did In)' Njoy King contain diacety l? Probabl)• not-ll wasn't buuer-navored. But how could 1 know? E-cigareues don't come with a complete list of ingredients.
O ther toxins so metimes found in e-cigarctte vapor include nitrosamincs-a class of carcinogenic compoundsand diethylene glycol, an ingredient in antifreeze.
Currently there arc no rules governing the conten ts of nicotine liquids, and thousands of navors are available. "lf you want cat-piss or camel-dung navor, its no t illegal," says Robert Proctor, a history professor at Stanford University who studies the tobacco indusuy
With few exceptions, Proctor says, e-cigareue marketers are cautious about claiming their products can cure smoking addictions, and he adds that their goal is to sell as many of the new devices as possible. "They are very careful \vith their word magic," he says.
Proctor sees great irony in the spread of e-cigarettes. The fact that the)' are trumpeted as a lesser evil ~could cause
"HARM REDUCTION IS THE CRUX OF THE DEBATE, NOT JUST BETWEEN THE INDUSTRY AND REGULATORS BUT ALSO WITHIN THE PUBLIC HEALTH COMMUNITY." -ANDY TAN, HARVARD SCHOOL OF PUBLIC HEALTH
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E-cigarette aerosol contains at least 1 1 on California's Prop 65 list of chemicals known to cause
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more harm and prolong th e !tobacco I epidemic" by acwally increasing nicotine consumption.
Dr. Robertjacklcr, a professor at
A public service ad placed by the California Department of Health in 2014.
Stanfo rd Medical School's Researc h into the lmpact of Tobacco Advertising program, seems even more skeptical. "Do e-dgareues help established smokers to quit?" jackler asks. The devices "may have a role, but the success rate is disappointing." And if smokers can vape in places where smoking isn't allowed, it may even boost their nicotine consumption. "These arc nicotine-continuity products," jackler adds. "They may very well damage the lungs ... \vith very unnaturnlthings. There:S no reason to think they're safe."
Dr. Pruc Talbot, a professor o f cell biology at UC Riverside, used a smoking machine that mimics a human dragging on e-cigareu cs to dete rmine how much suction it takes to produce aerosol and get a hit of nicotine. "Some of !the produc ts ! required quite hard puffs to activate and get vapor," she rold me.
Of course, free-market proponents of e-cigarettes argue that there is no reason to think they are unsafe until proven otherwise. Sally L Sate!, a resident scholar at the American Enterprise Institute, urged in a january op-ed article in the New )or h Times that the FDA hold oiT issuing final regulalions, citing more than 135,000 public comments sent to the agency aft er its deeming-rule announcement last year. Her concern: the "hugely burdensome regulatory [ramework" in the 2009 Tobacco Con trol Act for any new product. This includes "pre-market review," forcing companies to demonstrate "not only that each specific product was beneficial to intended users (adult s mokers), but [also] the consequences to teens and nons m okers. Gathering these data would be vastly lime consuming and expensive."
Sate! recommended rlun the FDA issue interim safety guidelines "that would not carry the force of law" but could
CALLAWYER.COM I MARCH 2015 33
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"bolster smokers' confidence that a safer way to inhale nicotine exists."
Meanwhile, warning cries over the apparent dangers of vaping are growing louder, including cautions (Tom public health advocates such as the World Health Organization and the American College of Chest Physicians.
In October, a tobacco specialist for the Paris-based International Union Against Tuberculosis and Lung Disease called for a ban on e-cigareues until they're proven safe. "Of course, more research is needed to establish the degree of danger, but until this research is done, me e-cigareues should be banned," Tara Singh Bam told a conference in 1\loscow.
In january, the New England journal of Medicine published a peer-reviewed study by five scientis ts at Portland State University who fou nd that vaping a t a high voll'age causes formaldehyde-releasing agents to develop-exposing users to a carcinogen. That same month, the California Departmem of Public lleahh issued a 21-pagc report concluding that "e-cigarellcs do not emit a harmless water vapor, but a concoction of chemicals toxic to human cells in the fonn of an aerosol." At least ten of the chemicals found in the aerosol are on the state's Proposition 65 list of substances known to cause cancer, birth defects, or o lher reproductive harm.
34 MARCH 2015 I CALLAWYERCOM
This year, state Sen. Mark Leno (D-San Francisco) introduced SB 140. which would allow state regulation of e-cigarettcs by defining Lhem as tobacco products, thus barring their usc at work, in schools, on public transportation, and in resraumnts and bars. "Addiction is what is really being sold," says Lcno. Last year SB 648, sponsored by state Sen. Ellen Corbell (D-San Leandro) to ban e-cigareue sales from vending machines, was defeated in an Assembly committee.
California's retiring U.S. Senator Barbara Boxer was one of six Democratic senators who recently wrote to FDA Commissioner Hamburg asking for "standarclized le-cigareuc] consumer protections that are suicdy based on scientific evidence . ., Citing the FDA's proposal to require a label warning that reads, "This product contains nicotine de lived front tobacco. Nicutinc is an addictive chemical," lhc senators urged the agency to go further and "address health risks that e-cigarettes pose."
UC Riverside's professor Talbot reminded me that some 20 years after the United States began mass-producing cigarenes in the early 1900s, lung cancer rates began to rise. And yet, another half century would elapse before the dangers of smoking became known and health wamings appeared on cigarette packaging.
Until similar definitive research results on vaping's heallh continued on p~ge 57
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Ex. 2044, Page 11 of 13
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effects are available, it may be prema- in nicotine vapor. [B]ut the industry's Even so, one of tobacco-control ture to file personal injury claims. Still, clear message is that e-cigarettes are advocates' biggest fears is that vaping "[w ]e have a history in the United entirely safe. Under the consumer pro- will help "re-normalize" tobacco use. States of filing cases quickly after there's tection laws of California, you're going "There is a whole generation of young some notice that a product is said to be to have a cause of action if companies people that has no television exposure hazardous," says Deborah R. Hensler, are advertising in a misleading fashion." to tobacco products," notes Harvard's an expert on class action litigation at Tan. If vaping commercials are intro-Stanford Law School. For example, Protecting PubUc Health duced on TV, he fears, using e-ciga-lawsuits alleging harm from silicone In August, 29 state auomeys general reues could become the norm, or at breast implants were filed under pres- urged the FDA to extend its deeming least "acceptable." sure from women's groups before the rule to limit e-cigarette flavors and Still, Tan concedes that harm reduc-health dangers of implants were fully Internet sales, and to bring applicable tion remains "the crux of the debate researched. marketing rules in line with those for -not just between the industry and
"It's difficult if there aren't regula- traditional cigarettes. regulators, but also within the public tions that are being violated," Hensler But tougher rules could have unin- health community." adds. "But one of the roles of private tended consequences, says Stephen D. One of the most passionate debates litigation is to incentivize regulation." Sugarman, a law professor at UC Berke- over harm reduction took place in Los
Michael F. Ram, a partner who ley and the author of two books on Angeles last year, when the City Coun-specializes in consumer-safety cases tobacco regulation. When smokers cil unanimously passed an ordinance at Ram, Olson, Cereghino &: Kopczyn- switch to vaping it's "a plus for public to ban vaping wherever smoking is ski in San Francisco, agrees. "I don't see health," he contends. The same goes already prohibited. But there was a sep-a downside, societally, to [litigating] when people take up vaping instead of arate vote on a proposal to exempt bars now," he says. "Even if there's need for starting to smoke. "The FDA is in a and nightclubs from the ban. further study, [we have concerns] tough spot: What if [e-cigarettes) turn The exemption was defeated, but based on findings that there are toxins out to be safe and helpful?" only after City Council President Herb
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lfs. Ands. or Butts
j. Wesson Jr. made a personal appeal. Wesson, who has smoked heavily since his early twenties, said he's failed in numerous auempts to quit. He fears kids \vill stan out vaping and Lit en transition to smoking. "I will not suppon anything--anythhJg-that might attract one new smoker," he told the council.
Wesson said he began smoking one summer while working in a factory. After shiftS, the older men tOok him to bars. "They'd order a 13udweiser and they'd smoke and talk. It was just so cool. One guy leans over to me and says, 'Young blood, you want a cigarwe?'"
Opposing testimony came from j eff Stier, a senior fellow at the National Center for Public Policy Research, a conservative think tank in Washington,
"The FDA is in a tough spot: What if
[e-cigarettes] turn out to be safe and helpful?"
- STEPHEN D. SUGARMAN, UC BERKELEY SCHOOL OF LAW
D.C., focused on free-market policies. "Vaping isn't smoking," he reminded the council members. E-cigarcttes "don't normalize smoking-they normalize nonsmoking."
Forcing people who might quit cigarettes through vaping to "go outside with the smokers" is nonsense, Stier argued. "If you put them outSide \vith the smokers, they're going to go back to smoking."
Wesson countered that allowing vaping in bars and clubs would only spread its populari ty. "I can't sit in silence," he said. "ISmokingl kills. and it \viii probably kill me."
As the debate over harm reduction swirls, the FDA isn't likely to wait decades for definitive scientific evidence on vaping's long-term heailh dfects ... , Medical! SLUdies are being done much quicker now," says professor Talbot. "It shouldn't take 40 years.
"People are watching." ®
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·rcch continued from pogo 35
Third-party keyboards Prices vary. some are free; for iOS and Android
Speaking of fumbling across miniature keyboards, Apple's
.... latest iOS update includes the ability to switch out your iPhone's or iPads standard on-screen keyboard. Several apps already popular on Android purport to offer quicker, easier typing. Swype letS you drag (i.e., swipe) your !Inger from leuer tO leuer to create whole words \vithout hunting and pecking for the right speJling. There is a learning curve, but the resultS arc impressive.
SwiftKey looks pretty much like your standard iPhone keyboard, but the app has a pow
erful component that learns what you typically type in each app. The end result, multiple reviewers say, is that the keyboard can practicaJly predict whole sentences.
Fleksy's claim to fame is speed: The app holds the Guinncss World Record for fastest text
message typed on a touch screen, and its predictive capacit}' is so smart that in some cases users can type every single letter incorrectly and still end up with the word they'd hoped for.
Task management apps $9.99 a month and up; for iOS and Android
-~· Loaded \vith femurcs linked to its full-service version, Bi ll-4Time is geared for profes
sional services providers. It lets you plan, check paymentS received, and perform other tasks related to billing-all in one place. The app is free with a desktop subscription.
519.99 for iPhone. 529.99 for iPad; for iOS only
Version 2 of the popular taskmanaging app Omn ifocus 2
~~• came out last year with a slew of new features. It is designed to help you wrangle all of the large projectS that make up your job. Big projectS can be broken into bite-size pieces and Licl<ed off as you power through them. The app
can also separate your work Oow into "contextS," organizing your to-do list by area and allowing you to segregate client matters, accounting work, and home tasks, for example.
$6.99: for iOS only
Hours is likely the preuiest time-cracking app you can find
111':~1 for the iPhone. But it also may be d1e most intuitive and useful, according to reviewers from Forbes to TechCrunch. In addition to letting you track your time by project, the app works with a calendar to show how you've allocated all your time. It also can gently remind you to stan or stOp your meter, depending on your habitS. And all the data is exportable to PDFs or spreaclsheetS.
Email management apps Both are free; for iOS and Android
A handful of new email apps --. claim to surpass the standard applications that ship on
Android and iPhoncs; two may well deliver. The first, Acompli, bought by Microsoft in December (reportedly for more than $200 million), aims to be as powerful as a desktop email platform. It can unify all of your email addresses in one in box, integrate \vith your calendar in a tap, and enable you to quickly open files you recently sent or received. The Verge, a tech website, says it's the prime app for anyone who relies on Microsoft Exchange.
The second contender is actually Googles second release for mobile devices. ln box by
Gmail, still available onJy by invitation, automatically sortS email messages by type-under "promotions," "purchases," or "travel ,'' for example-and keeps track or when a package will be delivered or whether your night is delayed. lnbox also can serve as a to-do List, and it lets you "snooze" emails that don't require immediate attention but that you may wish to answer later. Soon, we may al1 be able to sunnount the tyranny of the overflo,ving in box, on the go. tn
COMMENTS? letters.callawyer@dailyjou·naLcom
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