11th Circuit Research Articles

Court Refuses to Overturn Drug-Formulary Rebate Plan

Back to table of contents Previous article Next article Legal NewsFull AccessCourt Refuses to Overturn Drug-Formulary Rebate PlanKate MulliganKate MulliganSearch for more papers by this authorPublished Online:1 Mar 2002https://doi.org/10.1176/pn.37.5.0017Florida may continue requiring pharmaceutical companies to offer the state supplemental rebates in exchange for their products being included on Florida’s list of preferred Medicaid drugs, according to a December 28 ruling by the U.S. District Court in Northern Florida.Under federal law, states are allowed to claim rebates on Medicaid prescription drugs from the manufacturers. In a survey conducted by the Kaiser Commission on Medicaid and the Uninsured in 2000, most states estimated that they recoup between 17 percent and 22 percent of Medicaid’s total outpatient prescription drug expenditures through manufacturers’ rebates.The Florida legislature passed a law last May that authorized the creation of a list of preferred Medicaid prescription drugs that would include only those brands for which the manufacturers would grant rebates of an additional 10 percent. As a result of the rebates, the state expects to save at least $100 million this fiscal year, according to an article in the January 3 Wall Street Journal.In addition, the law allows drug manufacturers to provide disease-management or health-education programs instead of offering the supplemental rebates, options that would produce savings of at least $16 million.So far Pfizer and Bristol-Myers Squibb have opted to provide such programs. Pfizer instituted a disease-management program for chronically ill patients, and Bristol-Myers Squibb is developing a program for minority populations with depression, HIV, or certain cancers.The Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in August in the U.S. District Court for Northern Florida alleging that the law violates a federal rule that all prescription drugs must be available to Medicaid recipients unless a drug offers no clinically meaningful benefit.The court found that although the list steered doctors and their patients toward certain drugs, Florida did not prohibit access to drugs not on the list.Doctors are able to request verbal authorization for an off-list drug from a phone bank of pharmacists and pharmacy technicians.Wade Myers, M.D., president of the Florida Psychiatric Society (FPS), said, “We are all too familiar with ‘authorization obstacles’ that interfere with the provision of timely, quality patient care. Just how responsive can we expect this phone bank to be? Burdens for patients—like delays in receiving medication and increased costs—loom on the horizon in this arrangement.”John Bailey, D.O., an FPS council member, expressed a similar view. “Given the advances in psychopharmacology we can offer our patients, third-party tinkering with rebates, formularies, and preferred-drug lists is ethically questionable. As physicians, the decision that we record on the prescription pad represents the most informed judgment for what is right for the patient. Anything else is second guessing.”Jan Fails, assistant general counsel of PhRMA, said in a press release, “[T]he Florida statute clearly authorizes creation of a formulary and not simply a preferred drug list.” PhRMA plans to appeal the lower court ruling to the 11th Circuit Court of Appeals.Florida’s action is one of number of state initiatives intended to address the rising cost of prescription drugs (Psychiatric News, January 18; February 1). On January 18 the Michigan Court of Appeals lifted a circuit court’s order that blocked the state health department from implementing its proposed drug formulary.According to a front-page story in the New York Times on January 14, 2001, Idaho Governor Dirk Kempthorne (R) said, “Prescription drugs are rapidly becoming our single largest Medicaid expenses. Prescriptions are expected to cost 40 percent more this year than they did a year ago.”The National Conference of State Legislatures (NCSL) found that as of October 2001, 26 states had passed some type of pharmaceutical regulation law. NCSL cites “a relatively new trend” in which bills seek to use Medicaid-style rebates, other discount rates, or current “lowest-available price” as a basis for a retail price, instead of providing a direct state-funded subsidy.The Web site of the National Conference of State Legislatures is www.ncsl.org. ▪ ISSUES NewArchived

US INTERNET SERVICE PROVIDER LIABILITY: ISP: YOU’VE GOT MAIL — AND IGNORING IT COULD BY-PASS THE SAFE HARBOR OF THE DMCA

The Digital Millennium Copyright Act (DMCA) added a safe harbor provision shielding an Internet service provider (ISP) from liability for copyright infringement under certain circumstances. The effectiveness of the safe harbor defence depends on what the ISP does upon receipt of notification of copyright infringing activity from a copyright owner. In a recent Court of Appeals decision (ALS Scan Inc. v RemarQ Communities Inc. (Case No. 00-1351, United States Court of Appeals, 4th Circuit, 6 February 2001)), one ISP learned that a failure to respond properly and expeditiously to even an imperfect DMCA notification is at the ISP’s peril. Alan Wernick reports on the decision and its implications.

A ‘Con Law’ Casualty or Victory?

IN 1992 the school board for Chatham County, Georgia, which includes Savannah, adopted a Safe School Plan. The plan generally called for zero tolerance for drugs, alcohol, and weapons. In 1993 the board followed up with a specific Drug-Free Workplace Policy (DFWP) for its employees. Its purpose is to deter users and abusers of alcohol, drugs and controlled substances. Under this policy, whenever supervisor observations or objective circumstances reasonably [generate] a suspicion that an employee might possess or be using these substances, the employee will be tested for drugs within two hours. An employee's refusal to consent to the test or to a search of his or her personal property located at the school is cause for discipline, at the board's sole discretion, up to and including termination. Finally, the policy requires that [a]ny employee who tests positive . . . [for] alcohol, drugs or controlled substances will be terminated. In 1994 the district selected Sherry Hearn, a Savannah High School teacher of social studies, including U.S. history and constitutional law, as teacher of the year. In April 1996, when Hearn marked her 27th year in the district and was only three years from being eligible to retire with full benefits, the district and the county police conducted a drug lockdown and random search at the high school. Hearn's car was in the school's rear parking lot, unlocked and with its passenger side window down. The county police department's drug-sniffing dog alerted at Hearn's vehicle. The school security employee instructed the police officer to let the dog enter the car through the open passenger window. The dog alerted on the car's closed ashtray. Without obtaining Hearn's consent or a warrant, the school security employee then entered the car, opened the ashtray, and found a partially burned, hand-rolled cigarette. The officers field-tested it for marijuana, and the cigarette tested positive. They then took the cigarette, along with the vehicle's faculty parking permit from the dash, to the school's principal, Linda Herman, and informed her of these events. When Herman summoned Hearn from class, she denied any knowledge of the cigarette or possession of any marijuana. One of the county police officers Mirandized Hearn, telling her that she would probably be charged with criminal possession of marijuana. Herman informed Hearn that, under the DFWP, she must take a test within two hours. Hearn refused, stating that she thought that they might have been violating her constitutional rights and that she wanted to consult with her attorney to determine if this impression was correct. Herman gave Hearn a warning letter that directed her to take the test within the requisite period and stated that to comply may result in disciplinary action. Hearn, however, continued to refuse. The next morning, after a delay in reaching her attorney and obtaining his advice, Hearn took a test on her own, and it was negative.1 Nevertheless, as a result of her failure to comply within the prescribed period, the superintendent suspended her, pending a board termination hearing for insubordination and other good and sufficient cause. After the hearing, at which Hearn was represented by counsel, the board voted to terminate her contract. She appealed to the state board of education, which upheld the local board's termination decision. On 15 April 1997, Hearn filed suit in federal district court, claiming that the search of her car was illegal under both the board's own policy, which requires an employee's consent or a search warrant in order to search an employee's personal property at school, and the U.S. Constitution. On 25 February 1998, the court granted the district's motion for summary judgment, thus deciding against Hearn without a trial. One month later, Hearn filed for review by the 11th Circuit Court of Appeals. …

A D-Grading Experience?

IN THE PUBLIC schools of Owasso, Oklahoma, which is a suburb of Tulsa, some of the teachers - like those in many other districts in the nation - have students grade one another's assignments and tests. The students call out their grades to the teacher when they get their papers back. During the 1997-98 school year, Kristja Falvo, a mother of three students enrolled in Owasso's public schools, complained about the practice to the school counselors and, eventually, to the superintendent. She contended that it severely embarrassed her children, who were then in the fifth, sixth, and seventh grades. The fifth- and seventh-graders were regular students, and the sixth-grader was a mainstreamed special student. In October 1998, after her complaints had fallen on deaf ears, Falvo filed a Section 1983 civil rights suit in federal court, alleging that the grading practice violated the privacy rights implicit in the 14th Amendment and explicit in the Family Education Rights and Privacy Act, previously known as the Buckley Amendment and now often referred to as FERPA. She named as individual defendants the superintendent, the assistant superintendent, the principal, and - as a group - the participating teachers. She named the school district as the institutional defendant. On 26 April 1999, the federal district court granted the motion of the individual defendants for a summary judgment - a decision in their favor without a trial. In doing so, the district court ruled that the challenged practice did not implicate a privacy interest protected by the 14th Amendment and that the grades subject to this practice were not education under FERPA. Falvo immediately sought reconsideration by the district court, arguing that, even if her other two children were not protected, her middle child had a 14th Amendment claim based on a legitimate expectation of privacy with regard to his grades in light of the Individuals with Disabilities Education Act (IDEA). On 2 June 1999, the court denied her motion because she had failed to include this new claim in her original suit. Undaunted, on 28 June 1999, Falvo filed for review by the 10th Circuit Court of Appeals. On 31 July 2000, the 10th Circuit affirmed the lower court's ruling on the general 14th Amendment claim but reversed its FERPA ruling.1 While acknowledging that the 14th Amendment implicitly protects against governmental disclosure of certain types of highly personal or intimate information, the appellate court concluded that the grades in question did not fit this limited category. In response to Falvo's argument that FERPA and the IDEA created a legitimate expectation of privacy with regard to students' grades, the court cited 10th Circuit precedent clarifying that privacy statutes and regulations may help demarcate, but do not create, constitutionally protected privacy. As to the statutory claim, the court first ruled that Section 1983, the generic civil rights legislation passed in the wake of the Civil War, may serve as a remedy to enforce FERPA. The rationale for this threshold ruling was that FERPA's enforcement scheme, which is the administrative responsibility of the Family Policy Compliance Office of the U.S. Department of Education (FPCO) and which is ultimately limited to termination of federal funding, is not sufficiently comprehensive to imply a congressional intent to foreclose a Section 1983 remedy. Second, turning to the merits of the case, the 10th Circuit concluded that the students' grading of other students' papers, even without the subsequent calling out of grades, violated FERPA's prohibition of any policy or practice that permits the disclosure, without consent, of education records, which are defined in the Act as records . . . and other materials which (i) contain information directly related to a student; and (ii) are maintained . . . by a person acting for [an educational] agency or institution. …

US Court of Appeals for the 11th Circuit. Elian Gonzalez v. Reno (1 June 2000)

US Court of Appeals for the 11th Circuit. Elian Gonzalez v. Reno (1 June 2000)

United States v. Theodore T. Rybicki, 93 F.3d 754 (4th Circuit, September 26, 1996) (1996 U.S. App. LEXIS 25008)

United States v. Theodore T. Rybicki, 93 F.3d 754 (4th Circuit, September 26, 1996) (1996 U.S. App. LEXIS 25008)

DuPont loses Benlate birth defect trial

DuPont loses Benlate birth defect trial A Florida jury has awarded $4 million to the family of six-year-old boy who was born without eyes—a condition the family claims was caused by prenatal exposure to DuPont's Benlate DF fungicide. The four-week trial was held in the 11th Circuit Court in Dade County. The lawsuit is the first to come to trial linking birth defects to Benlate. For more than three years, DuPont has been waging legal battle against farmers claiming the fungicide damaged or killed crops. The plaintiffs' lead attorney, James L. Ferraro, says the verdict could pave the way for lawsuits in 40 other cases of deformed or missing eyes that victims blame on Benlate. Stacey J. Mobley, DuPont senior vice president for external affairs, calls the verdict a blow to science and to our jury system. Birth defects are human tragedy. The jury in this case was nonetheless faced with the ...

Maryland Program For Black Students To Admit Other Races, Maintain Mission

Eight years ago, the Meyerhoff Scholars Program at the University of Maryland, Baltimore County (UMBC), opened a special door to talented black male high school students wanting to study science or engineering. A year later, the program accepted black women. This year, students of other races are being invited to apply. The decision is not surprising. In 1994, the U.S. Court of Appeals for the 4th Circuit disallowed an exclusively black scholarship program at the University of Maryland, College Park. Last year, in a trend-setting decision, the Board of Regents for the University of California system abolished admissions based on race. And just two weeks ago, the U.S. Court of Appeals for the 5th Circuit invalidated an affirmative action program at the University of Texas, Austin. Caught in the thick of the debate on affirmative action, universities and colleges nationwide are reexamining programs and admissions that target race. The Meyerhoff program was created in 1988 ...

Two Recent Decisions on Disclaimers Highlight Potential Pitfalls for the Unwary Practitioner

Two recent decisions that considered the consequences of disclaimers highlight the need for estate practitioners to exercise care their use in estate administration. In Estate of Monroe, disclaimers that complied with all relevant technical requirements were, nevertheless, held invalid by the Tax Court. In Estate of DePauli, disclaimers that did not satisfy the relevant technical requirements were, nevertheless, deemed qualified. In DePauli, in addition the question of whether the disclaimer was qualified, the 10th circuit had to decide to whom the disclaimed interest would pass as a result of the disclaimer. This article review the two decisions and highlights the particular issues that practitioners should address when determining whether to recommend the use of disclaimers in estate administration.

4th circuit limits rule 11 in removal cases

Alternatives to the High Cost of LitigationVolume 5, Issue 7 p. 107-108 Article 4th circuit limits rule 11 in removal cases First published: July 1987 https://doi.org/10.1002/alt.3810050705AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume5, Issue7July 1987Pages 107-108 RelatedInformation

Documentation In The Small Forensic Engineering Office

In order for the forensic engineer to be effective in his or her task, the forensic engineer must possess a number of qualities that allow that task to be accomplished successfully. One of these qualities is credibility. Unless the forensic engineer has credibility, the task at hand can not be brought to a successful conclusion. In a recent decision the 11th Circuit Court of Appeals found that where the only evidence was conflicting expert testimony a new trial was granted on the trial Judges finding of credibility, and when the resolution of a case boils down to credibility, the jury must be permitted to determine the weight to be given to each witnesss testimony. In other words, the jury will decide which expert witness has more credibility. Lets briefly look at the definition of the word credibility; it is derived from the word credit, which, according to Webster, means