Humphrey, 239 F.3d at 1133. The Ninth Circuit decision also went to the appellant's claim under California's Fair Employment and Housing Act (FEHA).
3.
Under the American with Disabilities Act (ADA), 42 U.S.C. §§ 12101–213, § 12111(9), the term “‘reasonable accommodation’ may include — (A) making existing facilities used by employees readily accessible to and usable by individuals with disabilities; and (B) job restructuring, part-time or modified work schedules, reassignment to a vacant position, acquisition or modification of equipment or devices, appropriate adjustment or modifications of examinations, training materials or policies, the provision of qualified readers or interpreters, and other similar accommodations for individuals with disabilities.”
4.
According to the ADA, 42 U.S.C. § 12111(10), “‘undue hardship’ means an action requiring significant difficulty or expense, when considered in light of [such factors as]…(i) the nature and cost of the accommodation needed under this Act; (ii) the overall financial resources of the facility or facilities involved in the provision of the reasonable accommodation; the number of persons employed at such facility; the effect on expenses and resources, or the impact otherwise of such accommodation upon the operation of the facility; (iii) the overall financial resources of the covered entity; the overall size of the business of a covered entity with respect to the number of its employees; the number, type, and location of its facilities; and (iv) the type of operation or operations of the covered entity, including the composition, structure, and functions of the workforce of such entity; the geographic separateness, administrative, or fiscal relationship of the facility or facilities in question to the covered entity.”.
5.
Humphrey, 239 F.3d at 1133.
6.
Id. at 1131.
7.
Id.
8.
Id. at 1132.
9.
Id. at 1133.
10.
Id.
11.
Id. at 1138.
12.
Brief for the United States as Amicus Curiae, on Petition for a Writ of Certiorari to the United States Court of Appeals for the Ninth Circuit, March 7, 2002, Humphrey v. Memorial Hospitals Association, 239 F.3d 1128 (9th Cir. 2001) (No. 00-1860), available at <http://www.usdoj.gov/osg/briefs/2001/2pet/6invit/2000-1860.pet.ami.inv.pdf>.
13.
Memorial Hospitals Association v. Humphrey, 122 S. Ct. 28 (2001).
14.
The Department of Justice is the agency directed by Congress to issue regulations (see 42 U.S.C. § 12186(b)), to render technical assistance explaining the responsibilities of covered individuals and institutions (see 42 U.S.C. § 12206(c)), and to enforce Title III in court (see 42 U.S.C. § 12188(b)). The Equal Employment Opportunity Commission (EEOC) is authorized to issue regulations to carry out Title 1 of the ADA and to enforce it with respect to private employers (see 42 U.S.C. § 12116, § 12117 (a)).
According to the Council's reading of recent Supreme Court ADA jurisprudence, the Court has held that the Department of Justice (DOJ) regulations, as issued under Congress' direction, should be accorded the highest deference (see Bragdon v. Abbott, 524 U.S. 624 (1998)).
17.
The Council notes that the Supreme Court, in Sutton v. United Airlines, 527 U.S. 471 (1999), accorded considerably less value to the provisions in EEOC's ADA regulations addressing the definition of disability.
18.
Humphrey, 239 F.3d at 1138.
19.
Here, the government noted that the Court of Appeals did not affirm the lower court's holding of no material issue on the rejection of a leave of absence, but rather stated that “‘this factual dispute is not material to our ruling on appeal.’” Id. at 9.
20.
(quoting Humphrey, 239 F.3d at 1137).
21.
Id. (quoting Humphrey, 239 F.3d at 1139).
22.
Humphrey, 239 F.3d at 1139. The Circuit Court found that Memorial was not entitled to summary judgment on the issue of whether a leave of absence was a reasonable accommodation in Humphrey's case in its “qualified individual” analysis. Id. at 1137.
23.
Brief for the United States, supra note 12, at 9.
24.
Id. at 10. The government points out that Memorial cited no cases adopting a per se rule in the context of an employee who has not categorically rejected a proposed accommodation. Rather, the government distinguished a Sixth Circuit case (Hankins v. The Gap, Inc., 84 F.3d 797 (6th Cir. 1996)) on a factual basis: The case presented a request for an otherwise unreasonable accommodation in the context of a generally available alternative of which the employee failed to take advantage.
25.
Humphrey, in contrast, requested a reasonable accommodation that would not require going outside of generally available job benefits. Also, an Eighth Circuit case (Mole v. Buckhorn Rubber Products, Inc., 165 F.3d 1212 (8th Cir. 1999).
26.
cert. denied, 528 U.S. 821 (1999)) presented no conflict again on the facts. Here, the employer made numerous good faith attempts at accommodation and the employee did not inform her employer that she needed a new accommodation.
27.
Id.
28.
Id. at 11.
29.
It also found a conflict between Humphrey and the Eleventh Circuit's burden of proof standard in Duckett v. Dunlop Tire Corp., 120 F.3d 1222 (1997). As to the intra-circuit conflict, the government emphasized that parties to subsequent actions may urge adherence to Mustafa or seek en banc resolution. The government found review of the inter-circuit conflict premature, as only two circuits had weighed in on the burden of proof and neither did so with much analysis.
30.
Id. at 17.
31.
Id.
32.
National Council on Disabilities, supra note 15.
33.
National Council on Disabilities, “National Council on Disabilities Deeply Concerned by Supreme Court Decision on Americans with Disabilities Act,” April 29, 2002, available at <http://www.ncd.gov/newsroom/news/r02-360.html>.
34.
The Council's statement came in response to the Court's decision in US Airways, Inc. v. Barnett, 122 S. Ct. 1516 (2002), in which the Court held “that a request for reassignment to keep an employee with a disability working would most likely be found unreasonable when it conflicts with the terms of an employer's seniority system.”
citing BlanckP., “Transcending Compliance: 1996 Follow-up Report on Sears, Roebuck and Co.”.
38.
“High Court Lets Stand Ninth Circuit Ruling on Hospital Duty to Explore Accommodation,”BNA's Health Law Reporter, 11, no. 16 (April 18, 2002), quoting Memorial's petition for certiorari.
39.
Pacer Center, supra note 31.
40.
StyleR.P., “EEOC Guidance on ‘Reasonable Accommodation,’” National Association of Personnel Services, at <http://www.napsweb.org/words3.htm> (last visited May 3, 2002).
41.
21 U.S.C. §§ 801–950 (1994).
42.
Oregon v. Ashcroft, 192 F.Supp.2d 1077 (D. Or. 2002).
(“Practitioners shall be registered to dispense … controlled substances in schedule II, III, IV, or V if they are authorized to dispense … under the law of the State in which they practice”); see alsoUnited States v. Moore, 423 U.S. 122, 140–41 (1975).
48.
Id. (citing 21 U.S.C. § 824(a) (1983)).
49.
Id. (quoting 21 U.S.C. § 823(f) and also citing 21 U.S.C. § 824(a)(1)(4)) (internal quotation marks omitted).
50.
Id. (citing 21 C.F.R. § 1306.04).
51.
21 U.S.C. § 841(b) (1994).
52.
Id.
53.
Id. at 1081–82 (m).
54.
SeeLee v. State of Oregon, 891 F. Supp. 1429 (D. Or. 1995), vacated 107 F.3d 1382 (9th Cir. 1997).
55.
Oregon, 192 F.Supp.2d. at 1082.
56.
Id.
57.
Id.
58.
Id.
59.
See Lethal Drug Abuse and Prevention Act, H.R. 4006, 105th Cong. (1998), and Pain Relief Promotion Act, H.R. 2260, 106th Cong. (1999).
60.
Oregon, 192 F.Supp.2d. at 1083.
61.
Id.
62.
Id. at 1084.
63.
Id. at 1088 (quoting the defendants' memorandum, at 20).
64.
Id. at 1090–91.
65.
See Id. at 1084–85.
66.
See Id. at 1092.
67.
Id. at 1078.
68.
LowensteinE.WanzerS.H., “The U.S. Attorney General's Intrusion into Medical Practice,”New Engl. J. Med., 346 (2002): 447–48.
69.
Washington v. Glucksberg, 521 U.S. 702, 737 (1997) (O'Connor, I., concurring) (internal quotation marks and citations omitted).
70.
Mangieri v. DCH Healthcare Authority, 2002 U.S. App. LEXIS 18482 (11th Cir. Sept. 4, 2002).
71.
Id. at *11.
72.
Id. at *1, *3.
73.
Id. at *2.
74.
Id. at *4.
75.
Id.
76.
Id.
77.
Id.
78.
Id. at *5.
79.
Creating a civil action for deprivation of rights, Civil Rights Act of 1871 (commonly referred to as Section 1983).
80.
Mangieri, supra note 1, at *5.
81.
Mangieri, supra note 1, at *9, quoting Perry v. Sindermann, 408 U.S. 593 (1972).
82.
Mangieri, supra note 1, at *6, quoting Board Of County Commissioners v. Umbehr, 518 U.S. 668, at 684–86 (1996).
83.
Mangieri, o, at *10, quoting McClintock v. Eichelberger, 169 F.3d 812 (3d Cir. 1999) (finding no violation when a contractor's bid was rejected because his prior expired contracts had been unrelated).
84.
Mangieri, supra note 1, at *11.
85.
Id.
86.
Id.
87.
Connick v. Myers, 461 U.S. 138, 146–47 (1983) (whether speech addresses a matter of public concern is determined by the content, form, and context of a given statement as revealed by the whole record).
88.
Pickering v. Board Of Education, 391 U.S. 563, 568 (1968).
89.
Mt. Healthy City School District Board of Education v. Doyle, 429 U.S. 274, 287 (1977).
90.
Brandenburg v. Hous. Auth. Of Irvine, 253 F.3d 891, 897 (6th Cir. 2001).
91.
Id.
92.
Withiam v. Baptist Health Care, 98 F.3d 581 (10th Cir. 1996).
93.
Nicholas v. Pennsylvania State University, 227 F.3d 133 (3rd Cir. 2000).
94.
Id. at 144.
95.
Mt. Healthy City School District, supra note 20, at 285.
96.
See, e.g., Brandenburg v. Hous. Auth. Of Irvine, 253 F.3d 891 (6th Cir. 2001) (holding that while the comments for which an executive director was fired were of public concern, the public's interest in defendant's efficient provision of public housing services outweighed the plaintiff's interest in speaking out, as her speech created actual tension in her relationship with the defendant and posed a real threat to the effective functioning of the defendant as a public entity).
97.
Ragsdale v. Wolverine World-Wide, 122 S.Ct. 1155 (2002).
98.
See Family and Medical Leave Act, 29 U.S.C. § 2601 (1993, as amended 2002).
99.
Id.
100.
Section 2653 of the Act states in part that the Act shall not “be construed to discourage employers from adopting or retaining leave policies more generous than any policies that comply with the requirements under this Act.” 29 U.S.C. § 2653 (2002).
101.
See 29 U.S.C. § 2654 (2002).
102.
See 29 C.F.R. § 825.208(a). (2001).
103.
29 C.F.R. § 825.301(c) (2001).
104.
See 29 U.S.C. § 2619(a) (2002).
105.
Id.
106.
SeeRagsdale, 122 S. Ct. at 1166.
107.
29 C.F.R. § 825.700(a) (2002).
108.
SeeRagsdale v. Wolverine World-Wide, 218 F.3rd 933 (2000).
109.
SeeRagsdale, 122 S. Ct. at 1159.
110.
See 29 U.S.C. § 2617(a)(1)(A)(i) (2002).
111.
Ragsdale, 122 S. Ct. at 1162.
112.
See Id. at 1161.
113.
Id.
114.
Id. at 1162.
115.
Id. at 1164.
116.
See 29 U.S.C. § 2654 (2002).
117.
SeeRagsdale, 122 S. Ct. at 1164.
118.
Id.
119.
Id. at 1169.
120.
Id. at 1166.
121.
quoted in Ragsdale, 122 S. Ct. at 1168.
122.
The dissent observed that the majority did not reject the use of a categorical penalty per se in implementing the Family and Medical Leave Act. Rather, the majority rejected the Secretary's particular penalty of an additional twelve weeks as too harsh. SeeRagsdale, 122 S. Ct. at 1169.
123.
Id. at 1169.
124.
quoted in Ragsdale, 122 S. Ct. at 1160.
125.
Ragsdale, 122 S. Ct. at 1169.
126.
Id.
127.
Compare Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191 (codified at § 42 U.S.C. § 1320d (1996)) with 45 C.F.R. §§ 160, 164 (2001).
128.
M.A.K. v. Rush-Presbyterian-St. Luke's Medical Center, 764 N.E.2d 1 (Ill. 2001).
129.
Public Health Service Act, 42 U.S.C. § 290dd-2 (1994).
130.
42 C.F.R. § 2.31(a)(1) (2000).
131.
M.A.K., 764 N.E.2d at 6.
132.
Confidentiality of Alcohol and Drug Abuse Patient Records, 52 Fed.Reg. 21,796 (June 9, 1987).
133.
M.A.K., 764 N.E.2d at 7.
134.
Id.
135.
Id.
136.
“Illinois: Consent Forms for Release of Records for Alcohol Treatment Upheld by Court,”BNA's Health Law Reporter, 11, no. 10 (March 7, 2002): 373.
137.
M.A.K., 764 N.E.2d at 13.
138.
Id. at 17.
139.
Id. at 18.
140.
Id.
141.
Id.
142.
See In re Pharmatrak, Inc. Privacy Litigation, No. CIV.A.00-11672-JLT, 2002 WL 1880387, *1 (D.Mass., Aug. 13, 2002).
143.
For the year 2001, Johnson & Johnson spent $12.0 billion on “Selling, Marketing, and Administrative” versus $3.6 billion on “Research” expenses; Pfizer spent $11.3 billion on “Selling, Informational, and Administrative” versus $4.8 billion on “R&D” expenses; Merck spent $6.2 billion on “Marketing and Administrative” versus $2.5 billion on “Research and Development” expenses; GlaxoSmithKline spent £8.4 billion on “Selling, general, and administrative” versus £2.7 billion on “Research and Development.”
Hypertext Markup Language (HTML) is a standard language that gives computers instructions detailing how to display a web page. See generally National Center for Supercomputing Applications (University of Illinois at Urbana-Champaign), “A Beginner's Guide to HTML,” at <http://archive.ncsa.uiuc.edu/General/Internet/WWW/HTMLPrimer.html> (last updated Jan. 24, 2001).
148.
Cookies are small files that contain unique alphanumeric data. SeeIn re Doubleclick, Inc. Privacy Litigation, 154 F.Supp.2d 497, 502–503 (S.D.N.Y.2001).
149.
Cookies have many legitimate functions such as storing individual preferences and repeatedly entered information, which facilitates shopping and the personalization of news and services. The user can control cookies by disabling or rejecting cookies through their browser security parameters. In addition, users may delete cookies through their browser program or by deleting the actual cookie file on their computer. Id.
The file is generally a one pixel by one pixel invisible graphic interface file (GIF). See In re Pharmatrak, 2002 WL 1880387, at *2.
153.
Pharmatrak officials were quoted as saying “[Pharmatrak] may develop products and services which collect data that, when used in conjunction with the tracking database, could enable a direct identification of certain individual visitors.” However, the officials also pointed out that Pharmatrak would not take advantage of any such information.
154.
See O'HarrowR.Jr., “Firm Tracking Consumers on Web for Drug Companies,”Washington Post, Aug. 15, 2001,): at E1.
155.
In re Pharmatrak, 2002 WL 1880387, at *2.
156.
See Id.
157.
See Schoers v. Pfizer, Nos. 00 Civ. 6121 (DAB), 00 Civ. 6122(DAB), 00 Civ. 6173(DAB), 00 Civ.6980(DAB), 00 Civ. 7954(DAB), 00 Civ. 8900(DAB), 2001 WL 64742 (S.D.N.Y. Jan. 24, 2001). In April 2001, the Judicial Panel on Multi-District Litigation ordered the New York actions transferred to Massachusetts District Court.
158.
In re Pharmatrak, 2002 WL 1880387, at *1.
159.
See Id.
160.
See id., at *3. Plaintiffs used Curtin's findings to support a claim that Pharmatrak collected names, addresses, telephone numbers, dates of birth, sex, insurance status, medical conditions, education levels, and occupations, and contents of email communications (including names of recipients and subject lines). Id.
161.
Id.
162.
18 U.S.C. § 2511(1) “Except as otherwise specifically provided in this chapter, any person who — (a) intentionally intercepts, endeavors to intercept, or procures any other person to intercept or endeavor to intercept, any wire, oral, or electronic communication … shall be punished [by fines and/or imprisonment].” “(2)(d) It shall not be unlawful … for a person not acting under color or law to intercept … electronic communication where such person is a party to the communication or where one of the parties to the communication has given prior consent to such interception unless such communication is intercepted for the purpose of committing any criminal or tortious act ….”.
163.
SeeDoubleclick, 154 F.Supp.2d at 502–05.
164.
SeeIn re Pharmatrak, 2002 WL 1880387 at *6.
165.
SeeChance v. Avenue A. Inc., 165 F.Supp.2d 1153 (W.D.Wash. 2001). In a manner exactly analogous to Pharmatrak, Avenue A. deposited cookies via a communication with the user's computer that was initiated by HTML code programmed into the user's actual web destination.
166.
Chance v. Avenue A. Inc., 165 F.Supp.2d at 1162.
167.
SeeIn re Pharmatrak, 2002 WL 1880387 at *6.
168.
Id. at *7.
169.
18 U.S.C. § 2701(a) “Offense … whoever — (1) intentionally accesses without authorization a facility through which an electronic communication service is provided; or (2) intentionally exceeds an authorization to access that facility; and thereby obtains, alters, or prevents authorized access to a wire or electronic communication while it is in electronic storage in such system shall be punished as provided in subsection (b) [specifying fines and imprisonment].” “(c) Exceptions. — Subsection (a) of this section does not apply with respect to conduct authorized — (1) by the person or entity providing a wire or electronic communications service; (2) by a user of that service with respect to a communication of or intended for that user …”.
170.
In re Pharmatrak, 2002 WL 1880387 at 7.
171.
See United States v. Moriarty, 962 F.Supp. 217 (D.Mass. 1997);
172.
see also, In re Pharmatrak, 2002 WL 1880387 at 8.
173.
Id.
174.
18 U.S.C. § 1030(a) “Whoever — (2) intentionally accesses a computer without authorization or exceeds authorized access, and thereby obtains (C) information from any protected computer if the conduct involved an interstate or foreign communication … shall be punished [by fine or imprisonment] ….”
175.
“(g) Any person who suffers damage or loss by reason of a violation … may maintain a civil action for compensatory damages and injunctive relief or other equitable relief.”.
176.
“(e)(8) the term ‘damage’ means any impairment to the integrity or availability of data … or information, that — (A) causes loss aggregating at least $5,000 in value during any 1-year period to one or more individuals; (B) modifies or impairs, or potentially modifies or impairs, the medical examination, diagnosis, treatment, or care of one or more individuals …”.
177.
SeeAvenue A. Inc., 165 F.Supp.2d at 1159.
178.
EF Cultural Travel BV, et. al. v. Explorica, 274 F.3d 577, 585 (1st Cir. 2001).
179.
SeeIn re Pharmatrak, 2002 WL 1880387 at 8.
180.
Id.
181.
See Pallarito, supra note 3.
182.
Users can find such options under the “Preferences: Advanced” menu in Netscape Navigator, or “Internet Options: Security” in Internet Explorer. Former Pharmatrak CEO Wes Sonnenreich noted that users can control whether or not, for example, Pharmatrak could deposit a cookie on the user's computer. See O'Harrow, supra note 9.
183.
See id. Sarah Andrews, a policy analyst at the Electronic Privacy Information Center is concerned that empowering the Internet users is not the best way to protect privacy, stating “[i]t's unfair to actually expect an average consumer to do that [responding to the suggestion that users can disable cookies].” Associated Press, “Firm Tracks Access of Medical Info,” Daily News, Aug. 17, 2002, at <http://www.thirdage.com/news/archive/000817-03.html>.
184.
PowellJ.H., “Ruling Boots Drug Lawsuit,”Boston Herald, Aug. 21, 2002, at 28.
185.
Electronic Privacy Information Center, Tracking Privacy, Speech, and Cyber-Liberties Bills in the 107th Congress, available at <http://www.epic.org/privacy/bill_track.html>, updated Sept. 17, 2002.
186.
In the Matter of Microsoft Corporation, FTC File No. 012 3240 (Aug. 8, 2002);
187.
Crowley v. Cybersource Corp. and Amazon.com Inc., 166 F.Supp.2d 1263 (N.D. Cal. 2001);
188.
Klimas v. Comcast Corp., No. 2:02cv72054 (E.D. Mich. filed May 21, 2002);
189.
In the Matter of Eli Lilly and Company, Docket No. C-4047, FTC File No. 0123214 (May 8, 2002);
In re Norplant Contraceptive Products Liability Litigation, 215 F.Supp.2d 795 (E.D.Tex. 2002).
193.
Id. at 800.
194.
Id. at 826.
195.
Id. at 799.
196.
Id.
197.
Id. at 800.
198.
Id.
199.
In re Norplant Contraceptive Products Liability Litigation, 955 F.Supp. 700, 702–03 (E.D.Tex. 1997).
200.
aff'd, 165 F.3d 374 (5th Cir. 1999).
201.
Id. at 705.
202.
Id. at 706.
203.
The court held that “the physician, as the learned intermediary, has a duty to review the materials before passing them on to the patient in order to ensure that any such materials that the physician chooses to pass on will accurately inform the patient about the drug.” “[I]f a physician became a mere conduit for Wyeth materials, then it is the physician who is responsible for allowing that to happen.” Id. at 703, 708–09.
204.
Id. at 709.
205.
“Although it may be true that physicians may seek to provide greater freedom to their patients in selecting an appropriate form of contraception, Norplant is nevertheless a prescription drug … physicians play a significant role in prescribing Norplant and in educating their patients about the benefits and disadvantages to using it.” “As long as a physician-patient relationship exists, the learned intermediary doctrine applies.” see In re Norplant Contraceptive Products Liability Litigation, 165 F.3d 374, 379, supra note 8.
206.
In re Norplant Contraceptive Products Liability Litigation, supra note 1, at 801.
For those who failed to list the location where they had Norplant inserted, the court noted its order compelling the inclusion of the location of implant in the complaint, with failure to comply resulting in dismissal without prejudice. In re Norplant Contraceptive Prod. Liab. Litig., supra note 1, at 811.
225.
Although these plaintiffs filed in New Jersey and Wyeth-Ayerst Laboratories, Inc.'s principal place of business is in New Jersey, the state was not the location of the occurrence of the injury (which the court took to be the implantation of Norplant), residence of plaintiffs, or the place where the relationship between plaintiffs' and defendants' relationship centered. Id. at 813–16.
226.
Id.
227.
Id. at 812.
228.
Id. at 818.
229.
Id. at 818–20.
230.
Id. at 818–19.
231.
Id. at 820.
232.
Id. at 821.
233.
Id. at 825–26.
234.
Id. at 826.
235.
Id. at 827.
236.
Despite recognizing that health-care providers may have been unclear regarding the likelihood and severity of Norplant, the court found that they knew of the twenty-six adverse reactions and thus were sufficiently warned. “The issue is whether a warning was given which notified the physician of each side effect.” Id. at 826.
237.
Id.
238.
Id. at 827, citing In re Norplant Contraceptive Prod. Liabl. Litig., 165 F.3d 374, 379.
239.
supra note 8.
240.
Id.
241.
Id.
242.
Id. at 829.
243.
Id.
244.
According to the defendants, causation requires both general causation — that Norplant implants are capable of causing plaintiffs' alleged exotic conditions or injuries, and specific causation — that Norplant did, in fact, cause each condition. As a preliminary matter, evidence of general causation must be provided in the form of expert testimony constituting “scientific knowledge.” The court noted the importance of epidemiological data that is statistically significant. Defendants cited expert witness testimony that there is no reliable scientific evidence that Norplant can cause any of the exotic side-effects, or even that Norplant creates an increased risk of these conditions. Id. at 829–32.
245.
Id. at 832.
246.
Id. at 832–33.
247.
The court noted that plaintiffs had three years to engage in discovery. Id. at 832.
248.
Id. at 833.
249.
Id.
250.
Id. at 806–08.
251.
“Medical services are in large measure provided by managed care organizations. Medicines are purchased in the pharmacy department of supermarkets and often paid for by third-party providers. Drug manufacturers now directly advertise products to consumers on the radio, television, the Internet, billboards on public transportation, and in magazines …. The question … is whether our law should follow these changes in the marketplace or reflect the images of the past.” Perez, supra note 21, at 1247.
252.
Food and Drug Administration, FDA Public Health Web Notification: Human Tissue Processed by Cryolife, Inc. (August 2002), at <http://www.fda.gov/cdrh/safety/humantissue.html> (last visited Oct. 10, 2002). The order also specified that soft tissue processed since October, but not yet sold, should be withheld until further notice.
253.
Letter from Barbara Wood, acting director of Atlanta office of the U.S. Food and Drud Administration, to Steven G. Anderson, CEO of Cryolife, Inc. (Sept. 5, 2002), at <http://www.cryolife.com/news/FDAAgreement200209.PDF> (last visited Oct. 10, 2002).
BlakesleeS., “Surgeons Are Warned About Heart Valves,”The New York Times, Aug. 28, 2002,): at A15.
256.
BlakesleeS., “Recall is Ordered at Large Supplier of Implant Tissue,”The New York Times, Aug. 15, 2002,): at A6.
257.
Id.
258.
Id.
259.
Food and Drug Administration, supra note 1.
260.
BlakesleeS., supra note 5.
261.
Id.
262.
Id.
263.
Id.
264.
Id.
265.
Letter from DanL. Murrell for Ballard H. Graham, Director of Atlanta District Office of FDA, to Steven G. Anderson, President and CEO of Cryolife, Inc. (June 17, 2002), at <http://www.fda.gov/foi/warning_letters/g3355d.htm> (last visited Oct. 10, 2002);
266.
see also Food and Drug Administration, supra note 1.
267.
BlakesleeS., supra note 5.
268.
Id. For information on specific claims, see also “New Lawsuit Claims Cryolife Supplied Contaminated Cadaver Tissue: Mercer v. Cryolife Inc.,”Andrews Medical Devices Litigation Reporter4, 9, no. 11 (Aug. 23, 2002).
West's Federal Administrative Practice, Part 7, Chapter 41B, § 3836 (3d. ed. 2001).
280.
BlakesleeS., supra note 5.
281.
McNaughtonD., supra note 22.
282.
Id.
283.
KalbC.CarmichaelM., “Nasty Infections,”Newsweek, Aug. 26, 2002, at 48.
284.
BlakesleeS., supra note 4.
285.
SchultzS., supra note 19.
286.
BlakesleeS., supra note 5.
287.
Id.
288.
Id.
289.
KalbC.CarmichaelM., supra note 31.
290.
Letter from Belinda Collins, director of Denver district office of the FDA, to Mr. Thomas Cycyota, President and CEO of Allosource, Inc. (July 2, 2002), at <http://www.fda.gov/foi/warning_letters/g3433d.htm> (last visited Oct. 10, 2002).
291.
News Release, Osteotech, Inc.,: Osteotech Temporarily Suspends Certain Tissue Processing Operations And Initiates Voluntary Retrieval of Tissue (September 30, 2002), at <http://www.osteotech.com/finnews.htm> (last visited Oct. 10, 2002).
