quinta-feira, 8 de maio de 2014

NOESEN v. STATE DEPARTMENT OF REGULATION AND LICENSING PHARMACY EXAMINING BOARD -

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Court of Appeals of Wisconsin.

Neil NOESEN, Petitioner-Appellant, v. STATE of Wisconsin DEPARTMENT OF REGULATION AND LICENSING, PHARMACY EXAMINING BOARD, Respondent-Respondent.

No. 2006AP1110.

-- March 25, 2008

Before HOOVER, P.J., PETERSON and BRUNNER, JJ. On behalf of the petitioner-appellant, the cause was submitted on the briefs of Robert T. Ruth of Ruth Law Office, Madison;  Paul Benjamin Linton of Thomas More Society, Northbrook, IL;  and Thomas Brejcha and Christopher Henning of Thomas More Society, Chicago, IL. On behalf of the respondent-respondent, the cause was submitted on the brief of Bruce A. Olsen, assistant attorney general, and Peggy A. Lautenschlager, attorney general. A nonparty brief was filed by Nicole M. Safar, Chris Taylor, and Jeralyn B. Wendelberger of Madison for Planned Parenthood of Wisconsin, Inc. and Planned Parenthood Advocates of Wisconsin, Inc.;   and Kelda Helen Roys of Madison, for NARAL Pro-Choice Wisconsin Foundation and NARAL Pro-Choice Wisconsin. A nonparty brief was filed by Jacqueline E. Boynton of Milwaukee, for American Civil Liberties Union of Wisconsin Foundation and American Civil Liberties Union Foundation;  Laurence J. Dupuis of Milwaukee for American Civil Liberties Union of Wisconsin Foundation;  and Sondra Goldschein of New York City, for American Civil Liberties Union Foundation.
Neil Noesen appeals an order affirming the Pharmacy Examining Board's decision reprimanding him and placing practice conditions on his license.   The Board concluded Noesen violated the standard of care applicable to pharmacists when he refused to fill or transfer a patient's prescription for an oral contraceptive.   Noesen asserts he was not given proper notice of the standard of care, the discipline violates his state constitutional right of conscience, and the Board abused its discretion by instituting formal disciplinary proceedings instead of issuing an administrative warning.   We reject these arguments and affirm these portions of the order.
¶ 2 Noesen also challenges the Board's assessment of costs, arguing it was an erroneous exercise of discretion to assess the full costs of the action against him.   We agree that the Board failed to properly exercise discretion, and we therefore reverse the portion of the court's order affirming the cost determination.   We remand to the circuit court with directions to remand to the Board for reconsideration of costs.
Background
¶ 3 Noesen became a registered pharmacist in Wisconsin in 1999.   On June 5, 2002, he entered into a contract with RPh On the Go, Inc., a pharmacy placement service.   The contract required Noesen to provide “all services generally performed by a registered pharmacist in the customary manner and extent ordinarily performed at pharmacies, all of which shall be performed in a professionally competent manner․”
¶ 4 In July 2002, RPh assigned Noesen to the K-Mart pharmacies in Menomonie and Rhinelander.   On July 2, 2002, Noesen sent a letter via e-mail to John Scott at RPh, detailing Noesen's conscientious objections.   As relevant to this case, Noesen stated he wished to “exercise my right not to participate in”1 certain tasks, including dispensing birth control pills for contraceptive purposes.2  The letter had also been addressed to the two K-Mart pharmacies, but it was never sent to them.   The letter did not specifically mention a refusal to transfer prescriptions.
¶ 5 In addition to stating his conscientious objections, Noesen proposed a protocol that could be followed if he were presented with a situation that ran contrary to his beliefs.   This protocol provided, in part:
Before starting work each day, I will make my conscientious objection clearly known to the rest of the pharmacy staff.   I will describe that I have a conscientious objection about participating in the provision of contraceptives to patients, receiving phone calls pertaining to contracepting, or the provision of information to patients directly related to contracepting.
When confronted with an objectionable situation, which most likely would be a refill or new prescription for an oral contraceptive, I understand the necessity of responding in a professional manner with the patient(s), medical staff, and pharmacy staff.   I will immediately notify the patient of my conscientious objection and offer to call the prescriber or give the original prescription to the patient if it has not yet been filled.
¶ 6 Prior to Noesen's placement at the K-Mart in Menomonie, an RPh representative informed the store's district manager that Noesen would not dispense contraceptives.   The representative did not indicate Noesen refused to transfer prescriptions and did not forward a copy of the e-mail.   On Noesen's first day at the store, he informed the managing pharmacist, Ken Jordanby, of his conscientious objections, but did not indicate he would not transfer prescriptions and did not provide Jordanby a copy of the e-mail.   Jordanby agreed that in situations where Noesen would not fill prescriptions, and other pharmacists were not available, Jordanby would come into the store to fill the prescriptions.
¶ 7 On July 6, 2002, Amanda Renz went to the Menomonie K-Mart to refill her prescription for birth control pills.   Noesen asked if she intended to use the prescription for contraceptive purposes.   When she informed him that she would, he advised her of his objection and refused to refill the prescription or to tell her where or how she could get it refilled.   There was no other pharmacist available at K-Mart that day to fill the prescription, and Jordanby was unable to come to the store.   Noesen did not know, nor did he attempt to ascertain, when Renz needed to start the new pack of pills or how many doses she would miss if the prescription was not filled that day.
¶ 8 Renz took her empty prescription package to a Wal-Mart pharmacy.   When the pharmacist there called Noesen to transfer the prescription, Noesen refused to give the information necessary for Wal-Mart to fill the prescription,3 believing it would constitute participating in contraception.   Renz was able to have her prescription filled two days later, after missing the first dose of the medication.
¶ 9 Renz filed a complaint and the Department of Regulation and Licensing brought disciplinary proceedings against Noesen.   The Department's complaint alleged that
by refusing to transfer [the] prescription order in these circumstances, [Noesen] engaged in a pharmacy practice which constitutes a danger to the health, welfare, or safety of a patient by practicing in a manner which substantially departs from the standard of care ordinarily exercised by a pharmacist and which could have harmed a patient.   This is unprofessional conduct as defined by [Wis. Admin. Code] § Phar 10.03(2) and (9) and subjects [Noesen] to discipline pursuant to § 450.10(1)(a), Stats.[[[4]
¶ 10 Following the proceedings, the administrative law judge found, as a factual matter, that the ordinary standard of care for a pharmacist “requires that a pharmacist who exercises a conscientious objection to the dispensing of a prescription must ensure that there is an alternative mechanism for the patient to receive his or her medication, including informing the patient of their options to obtain their prescription.”   The ALJ then determined, as a legal matter, that by failing to inform K-Mart that he would not transfer an oral contraceptive prescription, and “by failing to provide information to the patient ․ regarding her options for obtaining a refill of her prescription which he refused to dispense or transfer,” Noesen had “engaged in practice which constitutes a danger to the health, welfare, or safety of a patient and has practiced in a manner which substantially departs from the standard of care ordinarily exercised by a pharmacist and which harmed or could have harmed a patient, in violation of [Wis. Admin.Code] § Phar 10.03(2).”
¶ 11 The ALJ ordered Noesen be reprimanded and limited his license.   The limitations required, in part, that Noesen notify any pharmacy in writing of, and specify in detail, any practices he would decline and how he would ensure patient access to medication.   The ALJ also ordered Noesen to pay the full costs of the disciplinary proceedings.   The Board adopted the ALJ's proposed findings and order as its own.   Noesen sought circuit court review.   The court concluded the Board reasonably determined Noesen had engaged in unprofessional conduct contrary to the administrative code and affirmed the Board's decision.   Noesen appeals.
Discussion
I. Standard of Care
 ¶ 12 On appeal, we review the agency's decision, not the circuit court's.  Painter v. Dentistry Exam. Bd., 2003 WI App 123, ¶ 8, 265 Wis.2d 248, 665 N.W.2d 397.   As the ALJ noted, the “central issue in this case is whether, by refusing to transfer the patient's prescription on the basis of his conscientious objection, [Noesen] departed from a standard of care ordinarily exercised by a pharmacist and which harmed or could have harmed the patient.”   The existence and nature of professional standards are questions of fact, susceptible to proof through testimony of people in the profession.   Doersching v. State Funeral Dirs. & Embalmers Exam. Bd., 138 Wis.2d 312, 324, 405 N.W.2d 781 (Ct.App.1987).
 ¶ 13 Whether an individual is engaged in unprofessional conduct is a question of fact.  Painter, 265 Wis.2d 248, ¶ 17, 665 N.W.2d 397.   We do not substitute our judgment for the agency's if the factual findings are supported by substantial evidence in the record.  Wis. Stat. § 227.57(6).   We thus set aside an agency's factual determination only when the evidence is such that a reasonable person, acting reasonably, could not have reached the same decision from the evidence.  Sterlingworth Condo. Ass'n v. DNR, 205 Wis.2d 710, 727, 556 N.W.2d 791 (Ct.App.1996).
¶ 14 Noesen first asserts the Department failed to give him “fair notice” of the standard of care, disciplining him based on an “unforeseeable and retroactive” interpretation of “unprofessional conduct.”   He complains nothing in the evidentiary sources relied upon by the Board “would have put [him] on notice that the course of conduct he followed in this case failed to meet minimum professional standards of care.”
 ¶ 15 Licensing statutes are enacted not for the benefit of the individuals licensed, but for the benefit and protection of the public.  Strigenz v. Dept. of Reg. & Lic. Dentistry Exam. Bd., 103 Wis.2d 281, 287, 307 N.W.2d 664 (1981).   These statutes are founded on the state's police power to protect the public welfare and to safeguard the life, health, and property of its citizens.  Id.  “It is not necessary that a written rule declare that a professional person must practice his or her profession in a minimally competent manner.”  Id. at 286, 307 N.W.2d 664.   It is also not necessary for licensing regulations to enumerate each specific act or omission that would constitute unprofessional conduct.  Id. at 290, 307 N.W.2d 664.   No licensed professional “can convincingly argue that he was not on notice that he had to perform professionally in a minimally competent manner for his conduct to be becoming a professional person.”  Id. at 287, 307 N.W.2d 664.
¶ 16 Thus, Noesen was at least on notice of Wis. Admin. Code § Phar 10.03(2), which describes, as unprofessional conduct:
Engaging in any pharmacy practice which constitutes a danger to the health, welfare, or safety of patient or public, including but not limited to, practicing in a manner which substantially departs from the standard of care ordinarily exercised by a pharmacist which harmed or could have harmed a patient[.]
In addition, the contract Noesen signed with RPh required he perform his pharmacy services in a “professionally competent manner.”   Further, Noesen's own actions indicate he was on notice that he was obligated to help patients find an alternate method to obtain prescriptions he refused to fill.   Otherwise, he would not have proposed a protocol for dealing with such a situation, a protocol that specifically acknowledged “the necessity of responding in a professional manner.”
¶ 17 Noesen takes issue with the Board's interpretation of what constitutes a professionally competent manner.   He essentially asserts that the applicable standard is the American Pharmacists Association's (APhA) “Pharmacist Conscience Clause,” which “recognizes the individual pharmacist's right to exercise conscientious refusal․”  He asserts the clause is APhA's official policy and nothing in the clause puts him on notice that his course of conduct in this case fails to meet a minimum standard of care.
¶ 18 However, it is unnecessary for us hash out competing definitions of the standard of care.   The existence and scope of that standard is a factual question.   See Doersching, 138 Wis.2d at 324, 405 N.W.2d 781.   The Board's determination of the standard of care is amply supported by the record-it relied on testimony from the Department's expert witness and APhA's 1997-98 Policy Committee Report, which contained both the conscience clause and a code of ethics for pharmacists.   Noesen merely argues his evidence and his expert were better and more credible, but we will not substitute our judgment for the agency's on fact questions.
¶ 19 More important, however, it does not matter what we would hold the standard of care to be, because we conclude Noesen failed to conform to even his own proposed standard.   Once Noesen determined Renz was using her prescription for contraceptive purposes, Noesen knew there were no circumstances under which he would help fill her prescription.   Even the conscience clause he cited “supports the establishment of systems to ensure [the] patient's access to legally prescribed therapy․”
¶ 20 In short, Noesen abandoned even the steps necessary to perform in a “minimally competent” manner under any standard of care.   He prevented all efforts Renz made to obtain her medication elsewhere when he refused to complete the transfer and gave her no options for obtaining her legally prescribed medication elsewhere.   The Board could therefore properly conclude he violated a standard of care applicable to pharmacists:  it does not matter which standard, because Noesen's behavior “substantially departs” from all of them.5  See Wis. Admin. Code § Phar 10.03(2).
¶ 21 The Board also held Noesen's actions harmed or could have harmed Renz, the second component of unprofessional conduct after a violation of the standard of care.   See id.   Noesen takes issue with this element as well, because it is undisputed Renz did not become pregnant that month and he contends “it is clearly unreasonable to conclude” she could have become pregnant given the miniscule increase in risk from her missed dose.
¶ 22 Noesen's determination not to fill Renz's prescription resulted in her missing the first day's dose of medication.   Instead, she took that dose on the second day, as well as taking the second day's dose, per the manufacturer's instructions for missed doses.   Noesen seizes on the statistically small-0.2%-increased risk of pregnancy from a missed dose.   However, there is no established minimum increase in risk requirement that saves Noesen.   He concedes, and his expert concedes, that even a single missed dose of a birth control pill raises the risk of unplanned pregnancy.   Pregnancy, in turn, has the potential for serious and sometimes fatal side effects for the mother, such as gestational diabetes, anemia, thromboembolic disease, or eclampsia.   True, Renz suffered none of these, but the potential for harm is enough to violate the standard of care.   Wis. Admin. Code § Phar 10.03(2);  see also Painter, 265 Wis.2d 248, ¶¶ 14, 19, 665 N.W.2d 397.
¶ 23 Moreover, Renz testified she suffered emotional harm from the stress of worrying about a possible unplanned pregnancy.   Noesen does not dispute she suffered this harm, nor does he contend it is insufficient as “harm” under the administrative code.   The Board thus properly concluded Noesen's actions did, or could have, harmed Renz. Coupled with the failure to meet the standard of care, Noesen engaged in unprofessional conduct, subjecting himself to discipline.
II. Right of Conscience
 ¶ 24 Noesen contends that, by disciplining him for failing to transfer a prescription, the Board has violated his right of conscience.   He suggests the State could “establish standards for accommodating the religious and moral beliefs of pharmacists” and “adopt policies regarding access to prescription records that would not require a pharmacist to violate his right of conscience.”
 ¶ 25 The Wisconsin Constitution offers more expansive protections for freedom of conscience than those offered by the First Amendment.  Peace Lutheran Church & Academy v. Village of Sussex, 2001 WI App 139, ¶ 14, 246 Wis.2d 502, 631 N.W.2d 229.   When an individual makes a claim that state law violates his or her freedom of conscience, we apply the compelling state interest/least restrictive alternative test.  State v. Miller, 202 Wis.2d 56, 66, 549 N.W.2d 235 (1996).   Under this test, the challenger must prove (1) that he or she has a sincerely held religious belief, (2) that is burdened by application of the state law at issue.   Upon such a showing, the burden shifts to the state to prove (3) that the law is based in a compelling state interest, (4) which cannot be served by a less restrictive alternative.  Id.  This test is strictly applied;  the burden cannot be generic but must be related to the exercise of a religious belief.   Peace Lutheran, 246 Wis.2d 502, ¶ 15, 631 N.W.2d 229.   However, the United States Supreme Court has “never held that an individual's religious beliefs excuse him from compliance with an otherwise valid law prohibiting conduct that the State is free to regulate.”  Id., ¶ 20 (citations omitted).
¶ 26 There is no doubt about, or challenge to, the sincerity of Noesen's religious convictions under the first prong.   However, the circuit court noted, the discipline imposed here only requires Noesen “to make the extent of his religious belief and objections known to his employer before the commencement of his practice at the pharmacy.   This will facilitate, rather than burden, [Noesen's] ability to exercise his conscientious objection in the future.”   We agree with the circuit court's analysis-Noesen has not shown, as required by the second prong of the test, that he is burdened by the application of a standard of care, Wis. Admin. Code § Phar 10.03(2), or the discipline imposed by the Board.   Because we conclude Noesen has not fulfilled his portion of the compelling state interest/least restrictive alternative test, we need not discuss the remaining prongs.6
III. Warning vs.  Reprimand
 ¶ 27 The authority to choose among penalties is discretionary with the Board.  Doersching, 138 Wis.2d at 328, 405 N.W.2d 781.   Under Wis. Stat. § 450.10(1)(b)1, the Board “may reprimand the licensee or deny, revoke, suspend or limit the license or any combination thereof” of any licensee found to have engaged in unprofessional conduct.   Before a warning may be issued, however, Wis. Stat. § 440.205 and Wis. Admin. Code § RL 8.03 (Nov. 2007) set forth specific findings that must be present.   The Board must find:  (1) a specific instance of misconduct;  (2) the misconduct is a first occurrence;  (3) the misconduct is a minor violation;  and (4) an administrative warning will protect the public.   If these findings are not made, issuing a warning would be an erroneous exercise of discretion.
¶ 28 Noesen contends that, assuming he engaged in unprofessional conduct, the Board erroneously exercised its discretion by instituting formal disciplinary procedures rather than giving him an administrative warning.   He argues he has no prior instances of misconduct, this was a minor infraction, and a warning would be sufficient to protect the public.
¶ 29 It is evident that the Board did not consider a warning sufficient to protect the public, and it may be inferred that the Board did not consider this a minor violation.   The opinion notes:
[Noesen's] testimony gave the distinct impression that satisfying his own personal moral code was his only concern.  [Noesen] did not even acknowledge that he had caused or could have caused harm to a patient.   In fact, [Noesen] argued that others were to blame for the problem-the patient, Ken Jordanby, the Wal-Mart Pharmacist and the Pharmacy Examining Board.   Rather than accepting and acknowledging his responsibility as a professional pharmacist, [Noesen] would have the Board conclude that it was the obligation of others to interpret the extent of his conscientious objections and to ensure that an alternate arrangement was in place so that patients would receive their health care.
[Noesen] clearly needs training in the ethics of his profession․  In addition, the Order imposes limitations that will guide [Noesen] in the responsible exercise of his conscience․  Respondent is allowed to work as a pharmacist and to exercise his beliefs about contraception;  he is merely prevented from doing so in a manner where he deprives patients of their legal health care rights ․ The imposition of the proposed discipline, training and practice guidelines strike the appropriate balance between the interests of an objecting pharmacist and the need for protection of the public in this action.  (Emphasis added.)
Because the Board considered a warning insufficient to protect the public, it appropriately exercised its discretion by imposing discipline instead.   See Wis. Stat. § 440.205;  Wis. Admin. Code § RL 8.03.
IV. Imposition of Costs
 ¶ 30 Under Wis. Stat. § 440.22(2), the Board may, in its discretion, “assess all or part of the costs of the proceeding” against the licensee if the Board takes disciplinary action as a result.   We give due weight to the Board's exercise of discretion.  Wis. Stat. § 227.57(10).   In reviewing the exercise of discretion, we look to determine whether the decision maker examined the relevant facts, applied the proper standard of law, and reached a reasonable conclusion.  Doersching, 138 Wis.2d at 328, 405 N.W.2d 781.   Noesen contends the Board erroneously exercised its discretion by imposing the full costs against him in this case.
¶ 31 Here, the Board assessed costs because:
First, the Department of Regulation and Licensing is a “program revenue” agency, which means that the costs of its operations are funded by the revenue received from its licensees.   Second, licensing fees are calculated based upon costs attributable to the regulation of each of the licensed professions and are proportionate to those costs.   This budget structure means that the costs of prosecuting cases for a particular licensed profession will be borne by the licensed members of that profession.   It is fundamentally unfair to impose the costs of prosecuting a few members of the profession on the vast majority of the licensees who have not engaged in misconduct.   The cost of this proceeding should not be borne by or passed along to the other members of the profession who abide by the rules of practice and follow the law.   Since [Noesen] is found to have engaged in unprofessional conduct, he should be held responsible for the full costs of this proceeding.
 ¶ 32 An exercise of discretion must be “based upon the relevant facts by applying a proper standard of law and represents a determination that a reasonable person could reach.”  Verhaagh v. LIRC, 204 Wis.2d 154, 160, 554 N.W.2d 678 (Ct.App.1996).   We conclude that the Board failed to exercise its discretion because it gave no consideration to the facts of the case.   By concluding only that the profession should not bear the costs, the Board has created a bright line rule that fails to account for any other factors-aggravating or mitigating.7  Indeed, imposing costs simply to prevent them from being passed on to others is a concern that would apply to any disciplinary proceeding.   While the “program revenue” nature of the Department is one factor that may fairly be considered in the cost determination, the exercise of discretion contemplates more than application of a rigid rule or invocation of an omnipresent policy.   The portion of the order affirming the Board's decision on costs is reversed and is remanded to the circuit court with directions to remand to the Board for reconsideration of costs only.
Order affirmed in part;  reversed in part and cause remanded with directions.
FOOTNOTES
1.   Noesen defined “participate in” as “to perform, assist in, recommend, counsel in favor of, make referrals for, dispense or administer drugs for, or otherwise promote, encourage, or aid.”   We recognize the broadness of “aid” might arguably include transferring prescriptions.   However, such an expansive word choice has the effect of refusing to perform at even a minimum of professional competency.   Such a result is untenable.   See infra, ¶¶ 19-20.
2.   Specifically, Noesen objected to a “procedure involving a drug or device that may prevent the implantation of a fertilized human ovum.   This includes, but is not limited to, drugs which are prescribed as contraceptives․”
3.   A prescription transfer must be completed by communication between two pharmacists.   See Wis. Admin. Code § Phar 7.055(1)(a) (Jan. 2006).
4.   All references to the Wisconsin Statutes are to the 2005-06 version unless otherwise noted.   All references to the Wisconsin Administrative Code are to the January 2002 version unless otherwise noted.
5.   Noesen asserts that the Wal-Mart pharmacist also violated the standard of care when she failed to advise Renz of other ways to obtain her prescription.   Whether this is true has absolutely no bearing on whether Noesen violated his duty in the first place and is completely irrelevant here.
6.   Were we to reach the remaining prongs, Noesen concedes “that the State has a compelling interest in public health and safety, and that this interest includes ensuring that legally prescribed drugs are not improperly withheld from those for whom they have been prescribed.”   Thus, the only remaining question would be whether this state interest can be served by a less restrictive alternative.
7.   See, e.g., Jarman v. Welter, 2006 WI App 54, ¶ 7, 289 Wis.2d 857, 711 N.W.2d 705 (error for court commissioner to set forth general policy regarding calculation of child support when law calls for exercise of discretion).
¶ 1 HOOVER, P.J.
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Wonder Woman: The Life, Death, and Life After Death of Henrietta Lacks, Unwitting Heroine of Modern Medical Science | Baltimore City Paper

Wonder Woman: The Life, Death, and Life After Death of Henrietta Lacks, Unwitting Heroine of Modern Medical Science | Baltimore City 

WONDER WOMAN
The Life, Death, and Life After Death of Henrietta Lacks, Unwitting Heroine of Modern Medical Science
PHOTO COURTESY THE LACKS FAMILY
Henrietta Lacks

By Van Smith | Posted 4/17/2002

Page 1 of 4.   1  2  3  4  

On Feb. 1, 1951, Henrietta Lacks--mother of five, native of rural southern Virginia, resident of the Turner Station neighborhood in Dundalk--went to Johns Hopkins Hospital with a worrisome symptom: spotting on her underwear. She was quickly diagnosed with cervical cancer. Eight months later, despite surgery and radiation treatment, the Sparrows Point shipyard worker's wife died at age 31 as she lay in the hospital's segregated ward for blacks.
Not all of Henrietta Lacks died that October morning, though. She unwittingly left behind a piece of herself that still lives today.
While she was in Hopkins' care, researchers took a fragment of Lacks' tumor and sliced it into little cubes, which they bathed in nutrients and placed in an incubator. The cells, dubbed "HeLa" for Henrietta Lacks, multiplied as no other cells outside the human body had before, doubling their numbers daily. Their dogged growth spawned a breakthrough in cell research; never before could investigators reliably experiment on such cell cultures because they would weaken and die before meaningful results could be obtained. On the day of Henrietta's death, the head of Hopkins' tissue-culture research lab, Dr. George Gey, went before TV cameras, held up a tube of HeLa cells, and announced that a new age of medical research had begun--one that, someday, could produce a cure for cancer.
When he discovered HeLa could survive even shipping via U.S. mail, Gey sent his prize culture to colleagues around the country. They allowed HeLa to grow a little, and then sent some to their colleagues. Demand quickly rose, so the cells were put into mass production and traveled around the globe--even into space, on an unmanned satellite to determine whether human tissues could survive zero gravity.
In the half-century since Henrietta Lacks' death, her tumor cells--whose combined mass is probably much larger than Lacks was when she was alive--have continually been used for research into cancer, AIDS, the effects of radiation and toxic substances, gene mapping, and countless other scientific pursuits. Dr. Jonas Salk used HeLa to help develop his polio vaccine in the early '50s. The cells are so hardy that they took over other tissue cultures, researchers discovered in the 1970s, leading to reforms in how such cultures are handled. In the biomedical world, HeLa cells are as famous as lab rats and petri dishes.
Yet Henrietta Lacks herself remains shrouded in obscurity. Gey, of course, knew HeLa's origins, but he believed confidentiality was paramount--so for years, Henrietta's family didn't know her cells still lived, much less how important they had become. After Gey died in 1970, the secret came out. But it was not until 1975, when a scientifically savvy fellow dinner-party guest asked family members if they were related to the mother of the HeLa cell, that Lacks' descendants came to understand her critical role in medical research.
The concept was mind-blowing--in a sense, it seemed to Lacks' family, she was being kept alive in the service of science. "It just kills me," says Henrietta's daughter, Deborah Lacks-Pullum, now 52 and still living in Baltimore, "to know my mother's cells are all over the world."
In the 27 years since the Lacks family serendipitously learned of Henrietta's unwitting contribution, little has been done to honor her. "Henrietta Lacks Day" is celebrated in Turner Station each year on Feb. 1. In 1996, prompted by Atlanta's Morehouse College, that city's mayor proclaimed Oct. 11 Henrietta Lacks Day. The following year, Congress passed a resolution in her memory sponsored by Rep. Robert Ehrlich (R-Md.), whose 2nd District includes Turner Station, and the British Broadcasting Corp. produced a documentary on her remarkable story. Beyond that, however, virtually nothing has been done to celebrate Lacks' contribution--not even by Hopkins, which gained immeasurable prestige from Gey's work with her cells.
Lacks-Pullum is bitter about this. "We never knew they took her cells, and people done got filthy rich [from HeLa-based research], but we don't get a dime," she says. The family can't afford a reputable lawyer to press its case for some financial stake in the work. She says she has appealed to Hopkins for help, and "all they do is pat me on my shoulder and put me out the door."
Hopkins spokesperson Gary Stephenson is quick to point out that Hopkins never sold HeLa, so it didn't make money from Henrietta's contribution. Still, he says, "there are people here who would like something done, and I'm hoping that at some point something will be done in a formal way to note her very, very important contribution."
Lacks-Pullum shares those hopes, but she is pessimistic. "Hopkins," she says, "they don't care."
Lost in the acrimony over ethical and financial issues stemming from Henrietta Lacks' cells, though, is Henrietta Lacks herself. A descendant of slaves and slaveholders, she grew up farming the same land on which her forebears toiled--and that her relatives still farm today. As part of an aspiring black middle class with rural roots, she left her childhood home to join a migration to Baltimore, where Bethlehem Steel was eager to hire hard workers from the country. She was in the midst of realizing an American dream when her life was cut short. And her cells helped realize society's larger dreams for health and knowledge. As such, she's been called a hero, a martyr, even a saint. But during her life, as Ehrlich said to his colleagues in Congress, Henrietta Lacks "was known as pleasant and smiling, and always willing the lend a helping hand." That she did, in more ways than she ever knew.

quarta-feira, 7 de maio de 2014

Internação Hospitalar na modalidade "diferença de classe" - Ponto e Contraponto

PONTO

Os pacientes do SUS e o Direito às acomodações superiores.


Hodiernamente, temos sido freqüentemente questionados por parte de médicos, Clínicas e hospitais quanto à possibilidade de o paciente que assim o desejar, ser internado pelo SUS em acomodações ?superiores?, arcando este ou seu responsável pelos custos originados desta opção. Tal questionamento mostra-se oportuno porque até então, o paciente que internava pelo SUS, estava impedido de fazer pagamento complementar a qualquer título, em obediência à Resolução 283 do Inamps em vigor.

Ocorre que esta questão foi recentemente discutida e analisada no Acórdão do Supremo Tribunal Federal (n. 262.268-5/RS) - proferido em Recurso Extraordinário, confirmando decisão do Tribunal de Justiça do Rio Grande do Sul, que havia reconhecido direito de paciente internado pelo SUS, pagar a diferença de classe. O Supremo Tribunal Federal, ao julgar a causa, estabeleceu que o direito à saúde como está assegurado na Constituição Federal não deve sofrer embaraços impostos por autoridades administrativas, no sentido de reduzi-lo ou de dificultar o acesso a ele. Afirmou ainda o STF que o acórdão do TJRS ao afastar a limitação da Resolução n. 283/91 do Inamps, teve em vista o objetivo maior, que é o da assistência à saúde.

Encontra-se então ?pacificado? na jurisprudência do Supremo Tribunal Federal o entendimento de que é direito do paciente pagar a chamada ?diferença de classe?, mesmo internado pelo SUS, não podendo ser aplicada a Resolução 283/1991 do Inamps, que impedia o pagamento complementar.

Corroborando este entendimento, alguns órgãos resolveram agir em defesa dos pacientes, no intuito de garantir-lhes o direito à complementaridade ainda que atrelada aos serviços ofertados pelo Sistema Único de Saúde. Recentemente a Associação Catarinense de Medicina (ACM) e o Comitê Interassociativo e intersindical de Defesa do Consumidor (DECONOR) promoveram ação civil pública na Justiça Federal contra o INSS e a União para ?garantir aos usuários do Sistema Único de Saúde em Santa Catarina a utilização de acomodação hospitalar diferenciada? e o fizeram contra a Resolução n. 283, de 30/08/91 (a mesma analisada pelo STF) que veda à unidade assistencial a cobrança ao paciente ou a seus familiares de complementaridade a qualquer título.

O MM Juiz Federal da 1a. Vara, ao decidir a questão, concluiu: ?A Lei n. 8.080/90 (Lei Orgânica da Saúde) não veda às pessoas que desejarem melhores acomodações e serviços, a utilização dos serviços proporcionados pelo SUS, observado tão somente o pagamento da diferença decorrente do tratamento personalizado. Isto posto, hei por bem julgar procedente o pedido, determinando à União Federal que se exima de dar cumprimento à Regulamentação enfrentada, oficiando-se a autoridade responsável pela execução do programa assistencial do SUS para que, desde já, permita aos participantes do sistema a opção por tratamento decorrente de sua escolha?.

Aquele Conselho Regional já havia se pronunciado sobre o tema através do Parecer-Consulta n.326/96. O Conselheiro Relator do Cremesc, Dr. Nelson Grisard, esclareceu: ?Por convicção anteriormente esposada e agora reforçada pelo posicionamento judicial supra, meu parecer é de que podem os segurados do SUS, portadores de AIH, ser internados pelo SUS em acomodações diferenciadas fora das cláusulas contratuais, arcando os mesmos ou seus responsáveis pelas diferenças de custos advindas incluindo-se nestas, os honorários profissionais, devendo haver anuência expressa e por escrito pelo paciente ou seu responsável.?

Á título de argumentação, parece-nos correto tal entendimento mormente porque inexiste prejuízo à Previdência Social na internação de paciente em leito semi-privativo, vez que o mesmo arcará com a diferença entre o valor custeado pelo SUS e o valor cobrado pelo hospital. De outro vértice, não há que se falar em quebra de isonomia entre os pacientes do SUS,vez que inocorre tratamento desigual, mas apenas a faculdade de atendimento diferenciado em situação diferenciada, sem ampliação de direito previsto da Constituição Federal e sem ônus extra para o sistema público, como já dito.

No que tange aos honorários profissionais, o Consultor Jurídico do Cremers, Jorge Alcibíades P. de Oliveira, comentando a decisão do STF, salientou: ?...por óbvio, o paciente nesse caso, uma vez que pode pagar a diferença ao hospital, também haverá de poder ajustar honorários com o médico assistente, como era antes da Resolução n. 283.?

Este é também o nosso posicionamento. Parecendo-nos certa a possibilidade de o paciente contratar a ?diferenciação? das acomodações certa é também a necessidade de contratar os serviços médicos, garantindo um tratamento isonômico a todos os pacientes atendidos naquelas condições.

Em suma, o Conselho de Classe do Estado de Santa Catarina, os órgãos regionais de defesa do consumidor e também a Justiça Federal (seja em 1a. 2a., ou 3a instâncias.-STF), já se manifestaram favoráveis ao direito de o paciente optar por acomodações superiores às ofertadas pelo SUS, arcando com a diferença de valores. O que não significa, por outro lado, que a cobrança estaria ?legalmente amparada?. Isto porque tais entendimentos, num primeiro momento, beneficiam especificamente os processos em curso ou os que forem ajuizados tendo por objeto a questão aqui analisada. Seriam, em última análise, valiosas jurisprudências para serem utilizadas num âmbito litigioso, se necessário.

De qualquer sorte, optando o paciente pela internação na modalidade ?diferença de classe?, tal deve ser feita através de contrato escrito, com a concordância expressa do paciente ou responsável. A ausência desta precaução pode sujeitar o médico e o Nosocômio a demandas judiciais.

Dra. Silvia Waltrick Bernardi é advogada, pós-graduada em direito empresarial. Assessora, Consultora e Advogada de Clínicas Médicas/Odontológicas e profissionais da área da Saúde. Autora da obra: ?A Prática Médica e o Código de Defesa do Consumidor?, editora:Gênesis, 2001.


site Brasil Medicina

CONTRAPONTO

Diretor da CDP falará no STF sobre diferença de classe no SUS           

24/04/2014 | Fonte: Assessoria de Comunicação CDP | Acessos: 194
O diretor da CDP, advogado Gladimir Chiele, atuará como expositor na Audiência Pública do Supremo Tribunal Federal sobre diferença de classe na internação hospitalar bancada pelo SUS. Chiele é procurador do Município de Canela no Recurso Extraordinário 581.488, cuja matéria possui repercussão geral e pode ser um divisor de águas para manter o sistema único de saúde como está ou provocar uma alteração de forma profunda, capaz de deteriorar o atendimento em curto espaço de tempo. O relator da matéria é o Ministro Dias Toffoli.
O pagamento da diferença de classe é uma reivindicação do Conselho Regional de Medicina do RS e tem por objetivo realizar a internação de qualquer usuário pelo SUS, com a possibilidade de pagamento de uma diferença de classe para uma acomodação superior dentro da unidade hospitalar. Assim, estaria se validando um grande retrocesso no sistema, mudando-o substancialmente para pior, na medida em que ficaria institucionalizado o ‘fura-fila’ do sistema.
Hoje, qualquer cidadão pode ter acesso ao sistema único, desde que ingresse pela porta única de entrada, ou seja, pela unidade pública de atendimento básico ou pelas emergências. Assim, todos os cidadãos são igualados e podem exercer os mesmos direitos de utilização da estrutura SUS, pois devem enfrentar eventuais filas de espera para o encaminhamento pelo sistema público. Após entrar no SUS, o paciente terá todo o atendimento de qualidade que o sistema disponibiliza, tanto para quem tem recursos, como para os mais necessitados.
O pagamento da diferença de classe irá furar a fila de entrada, passando o usuário a ingressar pela lateral do sistema, criando um novo grupo de privilegiados que pagarão a consulta médica ou se valerão do plano de saúde, mas não terão a fila da porta única para enfrentar. Com uma remota aprovação desta pretensão, o usuário somente pagará o médico e a hotelaria do hospital. Todo o tratamento, com uso de equipamentos de alto custo, medicamentos e exames de alta complexidade e de elevados custos, serão bancados pelo sistema público, com o dinheiro de todos os contribuintes. É o melhor dos mundos.
A consequência nefasta disso será a redução imediata de leitos destinados ao SUS que não terão pagamento da diferença, o aumento dos leitos privativos e semi privativos, o fura fila nas internações e o aumento do tempo de espera para os mais necessitados serem atendidos e internados. Uma equação absolutamente inadmissível que tornará o SUS um sistema injusto e desleal para quem mais precisa.
O procurador de Canela no processo acima referido, denunciará a verdadeira atrocidade que seria cometida contra o SUS se a postulação do CREMERS restar vencedora, inviabilizando o SUS nos moldes operados hoje e retrocedendo ao período anterior a 1988, quando o sistema foi implantado."Voltaremos ao tempo da carteirinha do INAMPS, onde eram atendidos aqueles que tinham vinculo de trabalho e os demais eram tratados como indigentes", diz Chiele.

Site Consultoria Direito Público

Recepção da internação hospitalar na modalidade "diferença de classe"

Monografia
Autor
 
Charles Ho
Ano2005
OrientadorRodrigo Pagani
Acórdãos citados RE 207.970-7; RE 226.835-6; RE 255.086-8; RE 261.268-5;
Resumo da Monografia


A internação hospitalar na modalidade “diferença de classe” consiste na possibilidade de optar por melhores acomodações e/ou tratamento médico dentro do sistema do SUS, com o pagamento da diferença de custos.
Deste modo, o paciente poderia optar por acomodações com padrão de conforto diferente do oferecido pelo SUS, como, por exemplo, a troca da enfermaria do SUS por um quarto privativo em um hospital privado, e/ou ter atendimento por profissional de sua escolha, com o pagamento acertado entre o paciente e o profissional.
Teoricamente, a “diferença de classe” seria permitida pela falta de vedações na legislação. Isto mudou em 1991, com a Resolução n. 283 do extinto INAMPS que veda a complementaridade a qualquer título à unidade assistencial.
Entretanto, a “diferença de classe” aceita pelo STF é aquela somente aplicada nas acomodações, não no tratamento recebido. E estas acomodações diferenciadas são justificadas pela gravidade e natureza da doença do paciente que pleiteia o direito à “diferença de classe”.


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do site Sociedade Brasileira de Direito Público
 

STF decidirá sobre internação hospitalar no SUS e "diferença de classe"

ECTE.(S)           : CONSELHO REGIONAL DE MEDICINA DO ESTADO DO RIO GRANDE DO SUL
RE581488

Ementa 

EMENTA DIREITO CONSTITUCIONAL E ADMINISTRATIVO. AÇÃO CIVIL PÚBLICA. ACESSO DE PACIENTE À INTERNAÇÃO PELO SUS COM A POSSIBILIDADE DE MELHORIA DO TIPO DE ACOMODAÇÃO RECEBIDA MEDIANTE O PAGAMENTO DA DIFERENÇA ENTRE OS VALORES CORRESPONDENTES. INTELIGÊNCIA E ALCANCE DA NORMA DO ART. 196 DA CONSTITUIÇÃO FEDERAL. MATÉRIA PASSÍVEL DE REPETIÇÃO EM INÚMEROS PROCESSOS. REPERCUSSÃO GERAL RECONHECIDA.
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Despacho de Convocação de Audiência Pública Assunto: Internação hospitalar com “diferença de classe” no Sistema Único de Saúde O SENHOR MINISTRO DIAS TOFFOLI, Relator do Recurso Extraordinário nº 581.488/RS, no uso das atribuições que lhe confere o art. 21, inciso XVII, do Regimento Interno do Supremo Tribunal Federal CONVOCA audiência pública para ouvir o depoimento de autoridades e expertos sobre a modalidade “diferença de classe” de internamento hospitalar no Sistema Único de Saúde (SUS). A referida audiência diz respeito a recurso extraordinário, com repercussão geral reconhecida, interposto pelo Conselho Regional de Medicina do Estado do Rio Grande do Sul (CREMERS) contra acórdão da Quarta Turma do Tribunal Regional Federal da 4ª Região, a qual negou provimento à apelação e manteve a sentença de improcedência da ação civil pública ajuizada pelo recorrente, cujo objetivo era permitir a prática comumente denominada de “diferença de classe” no Sistema Único de Saúde (SUS), prática essa que consiste na melhoria do tipo de acomodação recebida por paciente internado pelo SUS e a contratação pelo usuário de profissional de sua preferência, mediante o pagamento da diferença respectiva. A questão trazida à Corte apresenta relevância jurídica e social e envolve valiosos interesses jurídicos, como o acesso universal e igualitário às ações e aos serviços de saúde e a complementaridade da participação do setor privado na saúde pública. Por sua vez, o debate reclama análise que ultrapassa os limites do estritamente jurídico, porquanto demanda abordagem técnica acerca, por exemplo, do impacto administrativo e econômico da “diferença de classe” no Sistema Único de Saúde (SUS) e do seu efeito nos procedimentos de triagem e no acesso ao SUS. A realização da audiência pública permitirá a oitiva de especialistas, de representantes do poder público e da sociedade civil, visando obter informações técnicas, administrativas, políticas, econômicas e jurídicas acerca da questão debatida, de modo a subsidiar a Corte com o conhecimento especializado necessário para o deslinde da causa em juízo. A audiência será realizada em um único dia, 26 de maio de 2014, tendo cada expositor o tempo de quinze minutos para sustentar seu ponto de vista, sendo facultada aos participantes a juntada de memoriais. O funcionamento da audiência pública seguirá o disposto no art. 154, III, parágrafo único, do Regimento Interno do Supremo Tribunal Federal. Os interessados, os entes estatais e as entidades da sociedade civil poderão manifestar seu desejo de participar da audiência e indicar expositor até o dia 22 de abril de 2014, exclusivamente pelo endereço eletrônico diferencadeclasse@stf.jus.br. Para tanto, deverão consignar os pontos que pretendem defender e indicar o nome de seus representantes. A relação dos inscritos habilitados a participar da audiência pública estará disponível no portal eletrônico do Supremo Tribunal Federal a partir de 28/04/2014. Quaisquer documentos referentes à audiência pública poderão ser encaminhados por via eletrônica para o endereço diferencadeclasse@stf.jus.br. A audiência pública será transmitida pela TV Justiça e pela Rádio Justiça (art. 154, parágrafo único, V, do Regimento Interno do Supremo Tribunal Federal), assim como pelas demais emissoras que requererem a autorização pertinente. Tal pedido deve ser encaminhado à Secretaria de Comunicação Social do Supremo Tribunal Federal. Publique-se o Edital de Convocação. Expeçam-se convites aos Excelentíssimos Senhores Ministros do Supremo Tribunal Federal para que integrem a mesa e participem da audiência pública. Expeça-se convite ao Excelentíssimo Senhor Presidente do Congresso Nacional. Expeça-se convite ao Excelentíssimo Senhor Procurador-Geral da República. Expeça-se convite ao Excelentíssimo Senhor Advogado-Geral da União. Expeçam-se convites às partes do RE nº 581.488, ao Ministério da Saúde; ao Conselho Nacional de Saúde (CNS); ao Conselho Nacional de Secretários Estaduais de Saúde (CONASS); ao Conselho Nacional de Secretários Municipais de Saúde (CONASEMS); ao Conselho Federal de Medicina (CFM) e à Federação Nacional dos Estabelecimentos de Serviços de Saúde (FENAESS). Comunique-se ao Diretor-Geral, à Secretaria Judiciária, à Secretaria de Administração e Finanças, à Secretaria de Segurança, à Secretaria de Documentação, à Secretaria de Comunicação Social, à Secretaria de Tecnologia da Informação e à Assessoria de Cerimonial, para que providenciem pessoal de informática, taquigrafia, som, imagem e segurança, bem como os equipamentos e demais suportes necessários para a realização do evento. Publique-se. Brasília, 20 de março de 2014. Ministro Dias Toffoli Relator Documento assinado digitalmente

(RE 581488, Relator(a): Min. DIAS TOFFOLI, julgado em 20/03/2014, publicado em DJe-057 DIVULG 21/03/2014 PUBLIC 24/03/2014)