You are here: Home / Archives for Cases

Supreme Court Declines Tobacco Industry’s Petition for Certiorari, Paves Way for FDA to Design Graphic Package Labels

April 25, 2013 by

On April 22, 2013, the U.S. Supreme Court declined to hear a case filed by tobacco companies challenging certain aspects of the 2009 Family Smoking Prevention and Tobacco Control Act (the Act) (P.L. 111-31) without comment, paving the way for the FDA to require anti-smoking images to appear on tobacco product labels. Anti-smoking advocates applaud the decision, but the tobacco industry promises more litigation. Implementation of the FDA’s graphic labeling requirement is far from reality, as an earlier federal court decision blocked the FDA from implementing the labeling requirement, forcing the agency to rethink the images and propose new rulemaking.

Petition for Certiorari

According to the tobacco companies’ petition for certiorari in American Snuff Co. v U.S., the Family Smoking Prevention and Tobacco Control Act “imposed myriad restrictions on truthful, non-misleading speech to adult tobacco consumers concerning lawful tobacco products. The industry specifically took issue with labeling requirements that would require companies to include graphic anti-smoking images on tobacco products taking up 30 to 50 percent of the front and back of product labels. The nine FDA-approved images included a man exhaling smoke through a tracheotomy hole, a cadaver post-autopsy, a premature baby in an incubator, and an infant surrounded by smoke.

Underlying Case

In 2012, the U.S. Court of Appeals for the Sixth Circuit ruled that the graphic labeling requirements were reasonably related to the prevention of consumer deception. It further found constitutional provisions prohibiting tobacco companies from advertising the decreased risks of modified risk tobacco products without prior FDA approval and prohibiting marketing through brand-name sponsorships, merchandise, sample products, and free gifts upon purchase.

Conflicting Ruling

However, later that year, the U.S. Court of Appeals for the District of Columbia Circuit ruled for R.J. Reynolds Tobacco Company in a separate case, R.J. Reynolds Tobacco Co.v Food & Drug Administration. It specifically found that the FDA did not submit evidence that the inclusion of graphic images on tobacco labels would accomplish its goal of reducing smoking rates. It thus vacated the FDA regulation and remanded it to the agency.

Impact

Although the Supreme Court’s action seems to give credence to the FDA’s labeling decision, the Obama administration has already stated that it will not continue to defend the labels, forcing the agency to consider new labeling in order to conform with the District of Columbia appellate court ruling. The FDA will then need to enter the federal rule-making process, which could last years; the agency could face challenges along the way. Cigarette labels were last updated nearly 30 years ago—it seems it could be several more years before they change again.

Filed Under: Cases, Food & Drug Administration, HHS, News, SCOTUS, Tobacco

AMA Urges Supreme Court to Invalidate Patents on Human Genes

April 18, 2013 by

The American Medical Association (AMA) is urging the U.S. Supreme Court to end patents on human genes in an amicus brief it filed with other health care organizations in Association for Molecular Pathology v Myriad Genetics, Inc. The brief defended a ruling by the Federal Circuit that invalidated patents held by Myriad Genetics on the BRCA1 and BRCA2 genes.

“Exclusive patent rights over human genes conflict with long-standing principles of medical ethics regarding the sharing of natural scientific information to further advance science, technology and medical care,” said Jeremy Lazarus, MD, President of the AMA. He asserted that blocking medical innovations that provide insight into natural human biology interferes with diagnosis and treatment of patients and inhibits new medical discoveries.

Court Proceedings

In 2009, the American Civil Liberties Union Foundation (ACLU) and the Public Patent Foundation (PPC) filed a declaratory judgment action alleging that certain of Myriad’s patents were ineligible under sec. 101 of the Patent Act. The district court invalidated Myriad’s claims, and Myriad appealed. A divided panel of the Federal Circuit reversed, with each judge writing a separate opinion on the patentability of human genes.

Supreme Court Precedent

The AMA argued in its amicus brief that human gene patents conflict with the Supreme Court’s holding on subject matter eligibility in Mayo Collaborative Services v Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), which held that laws of nature, natural phenomena, and abstract ideas are not patentable subject matter. Myriad did not invent the DNA sequences covered by the patents, the AMA argued; rather, Myriad removed them from the body using common, longstanding techniques.

Interference With Diagnosis and Treatment

Further, the AMA asserted, because a patent on the sequence of a human gene grants the patent holder complete control over that sequence for the life of the patent, the patent holder can prohibit health care providers from using even unpatented methods to learn the sequence of a patient gene. According to the AMA, the patenting of the BRCA1 and BRCA2 breast cancer mutations has forced patients to undergo tests that are inferior and more expensive than what are available in other countries. It also prevents women from getting an independent second opinion on positive test results, which could cause them to have their breast or ovaries removed due to a false positive on a BRCA1 or BRCA2 test.

Filed Under: Cases, News, Patents, SCOTUS

Planned Parenthood Files Cross-Petition for Certiorari in Indiana Medicaid Funding Case

March 28, 2013 by

Planned Parenthood of Indiana (Planned Parenthood) has asked to broaden the scope of any Supreme Court review of the Indiana law that bars it from any state contracts. As we reported recently, the Indiana Department of Social Services has petitioned the Supreme Court to review the ruling of the Seventh Circuit Court of Appeals invalidating the state statute.

The State Statute

Indiana Code sec. 5-22-17-5.5 provides that no state agency may make a contract with or award a grant of state or federal funds to any entity that operates a facility where abortions are performed. The statute does not apply to hospitals or ambulatory surgical centers. Planned Parenthood was a provider of family planning and other services under the state’s Medicaid program; it also received federal funding through the state to provide disease intervention services under a separate program. Although the state expended its own money for Medicaid, the funding for disease intervention came entirely from the federal government. Planned Parenthood filed a lawsuit in federal court challenging the constitutionality of the statute as applied to its receipt of funds under both the Medicaid and the disease intervention program.

The Previous Court Rulings

The district court ruled that the Indiana law was invalid as to both the Medicaid contracts and the funding under the disease intervention program. The state law specifically violated Soc. Sec. Act sec. 1902(a)(23), which guarantees Medicaid beneficiaries free choice among qualified providers. The court held that the state did not have authority to exclude providers from Medicaid participation for reasons unrelated either to their professional competence or to the prevention of fraud or abuse. As to the disease intervention program, the court ruled that the state did not have authority to impose additional qualifications for receipt of federal funds. It entered a preliminary injunction against discontinuing Planned Parenthood’s funding without needing to address the claim that the state law imposed an unconstitutional condition on the receipt of federal funds.

The Seventh Circuit affirmed the district court’s holding concerning the states’ ability to deny Medicaid participation to qualified providers. However, it reversed the injunction as to the disease intervention program because Congress had not imposed any specific obligations on the state other than to spend the money on programs to prevent sexually transmitted diseases. The court also rejected Planned Parenthood’s argument that the state statute imposed an unconstitutional condition on the receipt of Medicaid funds because of prior rulings that the refusal to fund abortions did not interfere with a woman’s constitutional right to choose abortion. It is this argument that Planned Parenthood seeks to present to the Supreme Court if and only if it grants Indiana’s petition for review.

Filed Under: Cases, Centers for Medicare and Medicaid, HHS, Medicaid, News, State Level
«Older Posts
Newer Posts»