May 2010 - CDC Public Health Law News
Thursday, May 20, 2010
From the Public Health Law Program,
Office for State, Tribal, Local and Territorial Support,
Centers for Disease Control and Prevention
From the Public Health Law Program, Office of Strategy and Innovation, CDC
*** Public Pool Inspections. CDC has released a report analyzing code violations discovered during routine swimming pool inspections. "Violations Identified from Routine Swimming Pool Inspections - Selected States and Counties, United States, 2008" is published in the May 21, 2010, issue of the Morbidity and Mortality Weekly Report (MMWR). To view the report, please visit http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5919a2.htm.
*** Amendments to Minnesota's Emergency Preparedness Laws. The Minnesota Legislature recently passed House File 2709 (codified at Minnesota Laws 2010, chapter 224). The bill amended volunteer protections during an emergency or disaster by specifying immunity for certain entities. For the official text of chapter 224, please visit https://www.revisor.mn.gov/laws/?id=224&doctype=chapter&year=2010&type=0.
*** Tobacco Control State Highlights 2010. A new CDC report guides states in developing and implementing high-impact strategies to end the stall in the decline of U.S. smoking rates. To download Tobacco Control State Highlights 2010, please visit http://www.cdc.gov/tobacco/data_statistics/state_data/state_highlights/2010/index.htm.
*** Tobacco Control Legal Update. The latest issue of the Legal Update released by the Tobacco Control Legal Consortium features a new publication summarizing lessons learned about tobacco taxation as a legal public health intervention, and describes the potential impact of increased taxes on sugar-sweetened beverages. The newsletter also includes information about the federal initiative supporting local and state public health prevention and wellness strategies, and new FDA actions under the Family Smoking Prevention and Control Act. To read the newsletter, please visit http://www.publichealthlawcenter.org/
*** Updated Medicare Primer. The Kaiser Family Foundation has released an updated version of its 2010 Medicare primer to reflect key changes that affect Medicare included in the newly enacted health reform law. To access the primer, please visit http://www.kff.org/medicare/7615.cfm.
*** Medical-Legal Studies e-Journal. The Social Science Research Network is publishing a new e-Journal, Medical-Legal Studies e-Journal. The journal is sponsored by the Florida State University Center for Innovative Collaboration in Medicine & Law, and will distribute working and accepted paper abstracts related to the interplay of medicine and law. For more information, please visit http://papers.ssrn.com/sol3/
*** Model Obesity Prevention Resolution. The National Policy & Legal Analysis Network to Prevent Childhood Obesity (NPLAN) has developed a model obesity prevention resolution designed to help diverse communities implement policies to address the obesity epidemic. To learn more, please visit http://www.nplanonline.org/nplan/products/why-adopt-obesity-prevention-resolution.
*** Sodium Reduction Strategies. The Institute of Medicine and the National Academies Press have released Strategies to Reduce Sodium Intake in the United States. The report evaluates and makes recommendations about strategies that could be implemented to reduce dietary sodium intake to recommended levels. For more information, please visit http://www.nap.edu/catalog.php?record_id=12818.
1. Australia wants plain boxes for cigarettes
States and Localities
2. Nevada: Health cost hikes may follow $500M jury award in hepatitis C case
3. New Mexico: Suit: HPV vaccine injured teen
4. Diabetes death watch slipped into health law by Lilly, Novo
5. Walgreen to hold off selling genetic test kits
6. Legal fight over hunger wonder-product
California fast food toys • Illinois cancer cluster study • Massachusetts smoking warnings • Fire truck safety • Michigan smoking ban • New York HIV imprisonment • Wisconsin raw milk • National FDA advisory panel • BPA ban • New tobacco warnings • Poultry standards • Sick airline passengers • China HIV ban • Great Britain tobacco display • Toxic dust • Indonesia American Idol
Cannabis Infringement Notice scheme • Drug criminalization • Drunk driving recidivism • International health regulations • Soda tax • Distracted driving • Hong Kong tobacco control • Plain cigarette packs • Smokeless tobacco regulation • Tobacco regulation • Wyeth v. Levine
Cryopreservation • Wrongful life action • Minor alcohol consumption • Certificate of Need law • Mosquito spraying • Bicycle helmet ordinance • Prescription eyewear • Hepatitis B vaccine • Public Health Service malpractice
"Australia wants plain boxes for cigarettes"
New York Times (04/29/2010) Bettina Wassener and Meraiah Foley
As of July 1, 2010, restrictions on the packaging of tobacco products sold in Australia will go into effect. Tobacco products will have to be sold in the "plainest of packaging," with few to no logos, brand images, or colors. Any form of promotional text would be restricted to brand and product names in a standard color, position, type style, and size, similar to the boxes that carry generic prescription drugs. The restrictions on packaging will be accompanied by a 25 percent increase in the excise tax on tobacco products, increasing the cost of a packet of 30 cigarettes to around $15.40 (U.S.). The leading tobacco companies are strongly against the measures, calling them "disproportionate and misguided." Manufacturer Imperial Tobacco said, "Plain packaging has not been introduced in any country in the world and there is no evidence to support the government's notion that this will reduce consumption." The manufacturer further asserted that its legal rights would be infringed upon with the enactment of the restrictions. In a statement, it said, "Plain packaging would seriously harm our brands and infringe the intellectual property rights in which both Imperial Tobacco and its shareholders have invested." Manufacturers Phillip Morris International and British American Tobacco echoed the concerns of Imperial Tobacco, saying plain packaging would represent "an unconstitutional expropriation of valuable intellectual property, violating a variety of Australia's international trade obligations," and that it "would not hold up to close scrutiny." The World Health Organization however, disagrees, and called the Australian move towards stronger tobacco control "a major breakthrough." Susan Mercado, the organization's regional advisor for the Tobacco Free Initiative, said "Australia has taken a stand against all forms of advertising of a product that kills half of the people who use it." The Australian government is also pleased to be receiving the additional tax revenue, which it expects to amount to $5 billion Australian dollars over five years.
"Health cost hikes may follow $500M jury award in hepatitis C case"
Las Vegas Sun (05/17/2010) Steve Kanigher
On May 7, 2010, a Clark County, Nevada jury found the pharmaceutical companies Teva Parental Medicines and Baxter Healthcare liable to Hepatitis C victim Henry Chanin for $5.1 million dollars in compensatory damages and a state-record breaking $500 million dollars in punitive damages. Henry Chanin, the plaintiff in the case, acquired Hepatitis C at a clinic where the staff reused syringes to dispense the sedative propofol to its patients, causing an outbreak of the disease. The jury found that Teva and Baxter were liable because they were producing 50-milliliter vials of propofol, as opposed to producing single use vials, which encouraged reuse by health care professionals on multiple patients, and consequently, the spread of the virus. As a result of the high damages verdict, there has been debate as to who would bear the burden of the costs associated with paying the judgment. Dr. Annette Teijeiro, an anesthesiologist and president of the Clark County Medical Society, feels most of the burden will fall on the medical clinics and doctors' offices the two companies serve rather than patients, as many others have asserted. Dr. Teijero explained that doctors would find it difficult to pass these costs to patients because they are typically locked into multiyear contracts with HMOs and other insurers that supply patients in exchange for an agreement to provide medical care at predetermined prices. "To pass on the costs, doctors would have to renegotiate their contracts. Why would an insurance company agree to renegotiate a contract for a higher amount?" The national Safe Injection Practices Coalition, which includes the Nevada State Medical Association, the Centers for Disease Control and Prevention, and various patient advocacy groups, is pushing for more single-dose and single-vial packaging, as well as multi-dose vials that are clearly marked for single patients, and is not troubled by the possibility of an increase in costs. Larry Matheis, the Coalition's Executive Director, explains, "It will lead to increased costs because those people will be spending money on things they didn't spend as much money on before. But the end result is that we should have a safer system."
[Editor's note: For more information on the case, please visit https://www.clarkcountycourts.us/
Anonymous/CaseDetail.aspx?CaseID=6680477. For more information on Hepatitis C, please visit http://www.cdc.gov/hepatitis/C/index.htm.]
"Suit: HPV vaccine injured teen"
Albuquerque Journal (05/03/2010) Olivier Uyttebrouck
http://www.abqjournal.com/news/state/03232364179newsstate05-03-10.htm (subscription required)
A New Mexico mother filed suit against the U.S. Secretary of Health and Human Services in the U.S. Court of Federal Claims on April 14, 2010, alleging that the Gardasil vaccine severely injured her 16-year-old daughter. Tracy Wolf claims that after her daughter Alexis received the three-dose vaccine in 2007 and 2008, she was diagnosed with a seizure disorder, encephalitis, and other health problems. Before receiving the vaccination, Alexis had been diagnosed with type-1 diabetes and cerebral palsy. Gardasil, manufactured by Merck and Co., prevents the most common types of human papillomavirus (HPV) that cause cervical cancer and genital warts, and is recommended for girls ages 11 and 12. HPV is the most common sexually transmitted infection in the United States. Although Gardasil has received praise from physicians and public health officials since its approval by the Food and Drug Administration (FDA) in 2006, some parents, like Ms. Wolf, have claimed the vaccine has adverse side effects. "Everybody agrees that cervical cancer is a terrible disease, but Gardasil's potential risks outweigh the low risk of developing cervical cancer," said William Ronan, Ms. Wolf's attorney. The FDA, however, says Gardasil is safe and effective, and an analysis conducted by the FDA and the Centers for Disease Control and Prevention (CDC) found that 32 deaths reported after Gardasil injection were not likely attributable to the vaccine. "People can be well today and sicker than a dog tomorrow, and it doesn't have anything to do with a vaccine," said Cossette Wheeler, a University of New Mexico microbiologist who helped develop Gardasil.
[Editor's Note: For more information about the HPV vaccine, please visit http://www.cdc.gov/vaccines/vpd-vac/hpv/default.htm#vacc.]
"Diabetes death watch slipped into health law by Lilly, Novo"
Bloomberg Business Week (04/30/2010) Drew Armstrong
Novo Nordisk A/S, the world's top supplier of insulin, and Eli Lilly & Co., the largest U.S. manufacturer of insulin, successfully lobbied U.S. lawmakers to have a provision added to the new healthcare reform law that will encourage doctors to list diabetes as a cause of death when a patient dies from complications from the disease. Although "[n]obody dies from diabetes itself, . . . the complications are responsible for huge rates of morbidity and mortality," said Donny Wong, a physician with Decision Resources Inc. According to statistics from the Centers for Disease Control and Prevention (CDC), 72,499 Americans were reported as dying from diabetes complications in 2006, but Novo claims that doctors and coroners underreport deaths from the disease. By not listing diabetes on a death certificate, physicians "certainly underestimate the impact," said Robert Anderson, chief of the Mortality Statistics Branch at the CDC. A higher rate of death from diabetes complications may result in more public and private funding for treatment, detection, and prevention, according to Michael Mawby, Novo's Washington lobbyist. The new law "increase[s] the chance that any given diabetic patient is diagnosed, increase[s] the change the patient is treated with drugs, increase[s] the intensity of the treatment," said Jack Scannell, an analyst with Sanford C. Bernstein & Co. Regulations have not yet been enacted to clarify how the new law will be applied, but in addition to the reporting requirements, states may be required to publish reports on how they are improving diabetes care, and medical schools may be required to provide more training in diabetes care.
[Editor's Note: For more information about diabetes, please visit http://www.cdc.gov/diabetes/.]
"Walgreen to hold off selling genetic test kits"
Associated Press (05/12/2010) Matthew Perrone
Walgreen Co., the largest U.S. drugstore chain, announced on May 12, 2010, that it will not proceed with the sale of the first over the counter genetic test after the Food and Drug Administration (FDA) questioned the efficacy of the kits. The FDA wrote a letter to the manufacturer, Pathway Genomics, noting that the company had not submitted the kits for FDA review, which is required by federal law for medical devices. "These kits have not been proven safe, effective or accurate and patients could be making medical decisions based on data from a test that hasn't been validated by the FDA," said Erica Jefferson, an FDA spokeswoman. Other companies have sold genetic test kits online without FDA review, but the agency said that Pathway Genomics crossed "sanctioned boundaries" by planning to sell the kits in retail pharmacies. The kits test for genes associated with diseases such as prostate cancer, diabetes, and cystic fibrosis using a saliva swab submitted by the consumer. Public health experts and physicians worry about the impact of the low cost, mass-marketed kits because the connection between genetic variations and disease outcomes is still poorly understood. "I think it's going to be a headache for both primary care physicians and for consumers themselves who are going to get these reports back and not know what to do with the information," said Dr. Peter Kraft, professor of epidemiology at Harvard School of Public Health. The FDA has requested a response from Pathways by May 25.
[Editor's note: To read the FDA's letter to Pathway Genomics, please visit http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm211866.htm.]
"Legal fight over hunger wonder-product"
BBC News (04/19/2010) Hugh Schofield
Two American non-profit organizations have filed suit in the U.S. District Court for the District of Columbia against French company Nutriset to have its patent for Plumpy'nut overturned. Plumpy'nut, a paste made of peanut butter, powdered milk, sugar, and vegetable oil fortified with vitamins and minerals, is considered the standard ready-to-use therapeutic food and credited with transforming the treatment of acute malnutrition in Africa. Plumpy'nut does not have to be mixed with clean water, so malnourished children may be treated at home rather than being hospitalized, lessening the number of aid workers needed to treat them. The plaintiffs claim they have been prevented from manufacturing a similar, cheaper product, and the demand from aid agencies is not being met by Nutriset. "By their actions, Nutriset are preventing malnourished children from getting what they need to survive," said Mike Mellace of the Mama Cares Foundation, a plaintiff in the suit. Mellace further argued, "Plumpy'nut is not some secret formula. Basically it's fortified Nutella." Nutriset argues the patent is needed to safeguard the production of Plumpy'nut in the developing world from cheap American surpluses. The Plumpy'nut patent is not universal, and the company has created a network of partnerships and franchises to manufacture the product locally in Africa. "We want poor countries to be able to produce the nutrients they need in a sustainable way," said Remi Vallet, Nutriset's communications manager. The company claims that allowing American companies to produce a similar product would put the African companies out of business. The company further argues Nutriset has the capacity to meet demand from aid agencies. "No child in the world has even [sic] been denied access to the product as a result of the patent issue," said Adeline Lescanne, Nutriset general manager.
California: Santa Clara County bans toys if fast food meals do not mean nutritional standards
"Citing obesity of children, county bans fast-food toys"
New York Times (04/27/2010) Jesse McKinley
Illinois: Judge rules that brain cancer cluster research cannot be heard by jury
"Cancer study ruled inadmissible"
Northwest Herald (05/16/2010) Kevin P. Craver
Massachusetts: Department of Public Health proposal requires graphic warnings about smoking
"State to force stores to post graphic signs vs. smoking"
Boston Globe (05/13/2010) Stephen Smith
Massachusetts: Federal authorities urge state to enact seat belt and brake testing laws
"U.S. urges firetruck safety changes"
Boston Globe (04/21/2010) Donovan Slack
Michigan: State becomes 38th to prohibit smoking in public areas and the workplace
"Michigan finally makes the non-smoking grade"
Oakland County Legal News (05/03/2010) Cherie Curry
New York: Man could be imprisoned indefinitely if state proves he has mental abnormality
"NY wants man who spread HIV locked up indefinitely"
Associated Press (04/28/2010) Carolyn Thompson
Wisconsin: State allows farms to sell unpasteurized milk directly to consumers
"Wisconsin legalization of raw milk seen as benchmark"
Associated Press (05/05/2010) Scott Bauer
National: Philip Morris calls for removal of panel members for alleged conflicts of interest
"FDA denied request to remove tobacco-panel members"
Associated Press (04/29/2010) Michael Felberbaum
National: Food industry threatens to withdraw support for food safety bill over BPA ban
"Food safety bill's ban on BPA resisted"
Washington Post (04/26/2010) Lyndsey Layton
National: Tobacco warnings must fill 20% of advertising space
New bold warnings on tobacco ads
New York Times (05/03/2010) Tara Parker-Pope
National: Agriculture Department's new rules meant to reduce cases of foodborne illness
"Poultry safety standards tightened"
Los Angeles Times (05/11/2010) Andrew Zajac
National: Airlines must notify health officials under U.S. regulations and international guidelines
"Review: Many sick airline passengers aren't reported"
USA Today (04/22/2010) Alison Young
China: China lifts ban on travelers with HIV, sexually transmitted infections, and leprosy
"China lifts ban on visitors who are H.I.V. positive"
New York Times (04/28/2010) Michael Wines
Great Britain: Health Act 2009 bans display of tobacco products in retail outlets
"Cigarette makers seek review of display ban"
The Times (04/27/2010) Dominic Walsh
Great Britain: Children's birth defects caused by toxic dust from steelworks
"Toxic dust families agree to pay-out"
BBC News (04/16/2010)
Indonesia: American Idol winner's concert sponsored by tobacco company
"American Idol winner sparks smoking debate"
Associated Press (04/20/2010) Margie Mason
"A tale of CIN-the Cannabis Infringement Notice scheme in Western Australia"
Addiction (05/2010) Simon Lenton and Steve Allsop
"The trouble with drink and drugs: why prohibition and criminalization matter"
Addiction (05/2010) Harry G. Levine and Craig Reinarman
"Risk of alcohol-impaired driving recidivism among first offenders and multiple offenders"
American Journal of Public Health (05/2010) William J. Rauch and others
"Capacity of public health surveillance to comply with revised international health regulations"
Emerging Infectious Diseases (05/2010) Kia E. Armstrong and others
"Taxing soft drinks and restricting access to vending machines to curb child obesity "
Health Affairs (05/2010) Jason M. Fletcher, David Frisvold, and Nathan Tefft
"Reducing distracted driving"
Journal of the American Medical Association (04/14/2010) Peter Jacobson and Lawrence Gostin
"Hong Kong: a model of successful tobacco control in China"
The Lancet (04/17/2010) Jeffrey P Koplan, Wang Ke An, and Ronald MK Lam
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60398-4/fulltext (subscription required)
"Plain cigarette packs in Australia"
The Lancet (05/08/2010)
"Smokeless tobacco-proposals for regulation"
The Lancet (05/08/2010) Nigel Gray and Stephen S Hecht
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60516-8/fulltext (subscription required)
"Tobacco product regulation - a public health approach"
New England Journal of Medicine (05/13/2010) L. Deyton, J. Sharfstein, and M. Hamburg
"Wyeth v Levine: implications for public health policy and practice"
Public Health Reports (05/2010) Stephanie David and Sara Rosenbaum
http://www.publichealthreports.org/archives/issuecontents.cfm?Volume=125&Issue=3 (subscription required)
Iowa: Denial of order compelling disinterment in order to cryopreserve bodily remains reversed
Alcor Life Extension Foundation v. Richardson
Court of Appeals of Iowa
Case No. 09-1255
Filed May 12, 2010
Opinion by Judge Mansfield
New York: "Wrongful life" action for failure to discover birth defects prior to abortion cutoff dismissed
DeChico v. Northern Westchester Hospital Center
New York Supreme Court, Appellate Division, Second Department
Filed May 11, 2010
Opinion en banc
http://www.law.com/jsp/nylj/PubArticleNY.jsp?id=1202458239489&iDeChico_v_Northern_Westchester_Hospital_CenterI&hbxlogin=1 (subscription required)
New York: Municipal authority to prohibit knowing passive hosting of alcohol consumption by minors upheld
People v. Heil
City Court, City of Rye, New York
Case Nos. 09-156, 09-157
Filed April 21, 2010
Opinion by Judge Latwin
North Carolina: Constitutional challenge to Certificate of Need law for new facilities and equipment dismissed
Hope-A Women's Cancer Center v. State
Court of Appeals of North Carolina
Case No. COA09-844
Decided May 4, 2010
Opinion by Chief Judge Martin
Tennessee: Board of health's mosquito spraying plan not in conflict with local ordinance
Sumner v. Metropolitan Board of Public Health
Court of Appeals of Tennessee
Case No. M2008-02159-COA-R3-CV.
Filed May 11, 2010
Opinion by Judge Cottrell
Texas: Challenge to Dallas bicycle helmet ordinance based on preemption by state motorcycle helmet law dismissed
State v. Portillo
Court of Appeals, Eighth District of Texas at El Paso
Case No. 08-09-00187-CR.
Filed April 30, 2010.
Opinion by Justice Rivera
Federal: State law prohibiting offering prescription eyewear and eye examinations at the same location upheld
National Association of Optometrists & Opticians, et al. v. Brown
U.S. District Court, Eastern District of California
Case No. CIV S-02-1464 LKK/DAD
Decided April 28, 2010
Opinion by Senior District Judge Karlton
http://www.caed.uscourts.gov/caed/StaticOther/page_1581.htm (subscription required)
Federal: Multiple sclerosis diagnosis after Hepatitis B vaccinations compensable under National Childhood Vaccine Injury Act
Cloer v. Secretary of Health and Human Services
U.S. Court of Appeals, Federal Circuit
Case No. 2009-5052
Decided May 6, 2010
Opinion by Chief Judge Michel
Federal: Public Health Service Act precludes malpractice suits against Public Health Service personnel
Hui v. Castaneda
Supreme Court of the United States
Case No. 08-1529
Decided May 3, 2010
Opinion by Justice Sotomayor
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The News is published by the Public Health Law Program, Office of State, Tribal, Local, and Territorial Support, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (DHHS). Lindsay Culp, M.P.H., Editor. Special thanks to Tara Ramanathan, J.D., M.P.H. , and Vinay Chopra for their help on this issue.
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