Sandy Sykes, et al v. USA, et al
OPINION filed : AFFIRMED, decision not for publication. Eric L. Clay, Circuit Judge; Jane Branstetter Stranch, Authoring Circuit Judge and Robert Holmes Bell, U.S. District Judge for the Western District of Michigan, sitting by designation.
NOT RECOMMENDED FOR FULL-TEXT PUBLICATION
File Name: 12a1239n.06
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
Nov 29, 2012
SANDY SYKES, Individually,
Plaintiff S Appellant,
SANDY SYKES, Administrator of the Estate
of David John Muir on behalf of David John
Muir; MARGARET MUIR; ROBERT MUIR;
ERIC MUIR; PAUL A. MUIR; KATHERINE
UNITED STATES OF AMERICA;
VETER ANS ADMINISTRATION;
UNIVERSITY OF CINCINNATI MEDICAL
CENTER, nka University Hospital; ROCHE
MOLEC ULAR S YS T EMS , INC .;
CENTOCOR ORTHO BIOTECH
PRODUCTS, L.P., nka Janssen Products, L.P.;
MERCK, SHARP & DOHME
C O R P O R A T ION, f k a S C H E R IN G
C O R P O R A T I O N ; R O C H E
PHARMACEUTICALS, aka Hoffman-La
Roche Inc.; AMGEN MANUFACTURING
LIMITED; DEPARTMENT OF VETERANS
AFFAIRS; MERCK & COMPANY, INC., fka
PFIZER, INC.; GLAXOSMITHKLINE LLC,
Defendants – Appellees.
DEBORAH S. HUNT, Clerk
ON APPEAL FROM THE UNITED
STATES DISTRICT COURT FOR THE
SOUTHERN DISTRICT OF OHIO
Before: CLAY and STRANCH, Circuit Judges, and BELL, District Judge.*
JANE B. STRANCH, Circuit Judge. Sandy Sykes, appearing pro se, appeals the district
court’s dismissal of all claims filed against the United States, the Department of Veterans Affairs,
the University of Cincinnati Medical Center, six individuals, and eight pharmaceutical manufacturers
under various statutes and theories, including the Federal Tort Claims Act, 28 U.S.C. §§ 2671–2680;
42 U.S.C. §§ 1983 & 1985; Bivens v. Six Unknown Agents of the Fed. Bureau of Narcotics, 403 U.S.
388 (1971); the Freedom of Information Act, 5 U.S.C. § 552; the Declaration of Helsinki; and Ohio
state law. The claims relate to injuries allegedly sustained by Sykes’s brother, David J. Muir, during
his participation in clinical drug trials between May 2000 and his death on February 6, 2004. For
the reasons stated below, we AFFIRM the district court’s judgment dismissing the claims under
Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6).
I. STANDARD OF REVIEW
We review de novo an order dismissing claims for lack of subject matter jurisdiction under
Rule 12(b)(1) and for failure to state a claim under Rule 12(b)(6). McCormick v. Miami Univ., 693
F.3d 654, 658 (6th Cir. 2012). In a facial challenge to jurisdiction under Rule 12(b)(1), we construe
the allegations of the complaint as true. Id. In a factual challenge to jurisdiction, we may weigh
evidence to decide whether the factual predicates exist to support subject matter jurisdiction. Id.
To survive a motion to dismiss under Rule 12(b)(6) for failure to state a claim, the complaint
must contain “a short and plain statement of the claim showing that the pleader is entitled to relief”
in order to provide fair notice to the defendant of what the claim is and the grounds upon which it
The Honorable Robert Holmes Bell, United States District Judge for the Western District
of Michigan, sitting by designation.
rests. Fed. R. Civ. P. 8(a)(2); Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). The complaint
“must contain more than conclusions and an unsubstantiated recitation of the necessary elements of
a claim.” McCormick, 693 F.3d at 658. We assume the factual allegations of the complaint are true
and we decide whether the complaint states a plausible claim for relief. See Ashcroft v. Iqbal, 556
U.S. 662, 679 (2009).
When ruling on a motion to dismiss under Rule 12(b)(6), the court may consider public
records and exhibits attached to the complaint without converting the motion to one for summary
judgment under Federal Rule of Civil Procedure 56. Amini v. Oberlin Coll., 259 F.3d 493, 502 (6th
Cir. 2001). The court may also consider documents attached to a motion to dismiss if they are
referred to in the complaint and are central to the plaintiff’s claim. Id.; Weiner v. Klais & Co., 108
F.3d 86, 89 (6th Cir. 1997).
II. FACTUAL ALLEGATIONS OF THE AMENDED COMPLAINT
The plaintiffs below included Sandy Sykes individually and as administrator of the estate of
David J. Muir, Katherine Muir, Margaret Muir, Robert Muir, Eric Muir, and Paul Muir. Represented
by counsel, the plaintiffs initially filed suit on October 4, 2010.
According to the amended complaint filed on December 29, 2010, plaintiffs’ relative, David
J. Muir, died on February 6, 2004. An autopsy revealed the cause of natural death was peritonitis
due to a perforated sigmoid colon and peritoneal adhesions. The autopsy confirmed that Muir
suffered from hepatitis C and cirrhosis of the liver.
Before 2000, Muir was severely injured in a house fire. He suffered third-degree burns over
sixty-five percent of his body, which required skin grafts, amputation of one hand and amputation
of the fingers on the other hand. Because of these injuries, Muir took methadone for continuous
pain. He also suffered from severe depression and had attempted suicide. Between 2000 and his
death in February 2004, Muir received medical treatment at the Cincinnati Veterans Administration
Medical Center and its affiliated locations (VA), and at the University of Cincinnati Medical Center
and its affiliated locations (UCMC).
The plaintiffs alleged that, between May 2000 and February 6, 2004, Muir was enrolled in
human research studies or clinical drug trials at the VA and UCMC for the treatment of hepatitis C
in veterans, and was enrolled to participate in the studies even though he did not qualify due to his
pre-existing physical and mental conditions. The plaintiffs further alleged that the studies were
administered or supervised by Charles L. Mendenhall, M.D., the study doctor; Gary Roselle, M.D.,
Medical Director of the VA; and Judith M. Harrer, BS Pharm., Ph.D., the investigational drug
pharmacist for the Cincinnati VA Medication Development Research Unit. Although plaintiffs also
named as defendants Jeffrey Goldsmith, M.D., Robert Weesner, M.D., and Joseph Morelli, M.D.,
the amended complaint lacked specific factual allegations concerning these physicians. The
plaintiffs alleged that all of the individuals acted within the scope of their employment.
The complaint further alleged that, as a participant in the studies, Muir was subjected to the
use of certain medical testing devices and was prescribed certain pharmaceuticals and
pharmaceutical test kits contrary to the standards or dosages approved by the U.S. Food and Drug
Administration for these products. It alleged that the manufacturers of the pharmaceuticals and
devices sponsored the studies and allowed their products to be used for purposes outside FDAapproved indications, and Muir was not advised by the VA, UCMC, or the drug manufacturers about
any adverse warnings applicable to the pharmaceuticals that were administered to him. Muir signed
at least two consent forms agreeing to participate in studies, but the plaintiffs asserted that the forms
were defective in that they did not disclose alternative and safer courses of treatment, did not include
proper witness signatures, and did not include adequate descriptions of the compensation or
treatment that the VA would provide Muir for any injury he sustained as a result of the studies.
According to the plaintiffs, Muir ingested orally or was injected with approximately ten drugs
over a four-year period, including Epogen, Neuprogen, Procrit, Peginterferon, Pegasys, Copegus,
Bupriopion, Intron A, Rebetol, Rebetron Combination Therapy, and Gabapentin. Muir suffered
adverse reactions to one or more of these pharmaceuticals, which the plaintiffs alleged ultimately
led to his death. After Muir died, the plaintiffs repeatedly requested complete copies of Muir’s
medical records from the VA, UCMC, the U.S. Department of Veterans Affairs, and the University
of Cincinnati Institutional Review Board, but the plaintiffs claimed that their requests were denied.
III. PROCEDURAL HISTORY AND STATUS OF APPEAL
The amended complaint alleged eleven counts: (1) failure to obtain proper and informed
consent; (2) medical negligence; (3) negligent diagnosis/failure to diagnose; (4) medical malpractice
and wrongful death; (5) negligent supervision; (6) violations of the Freedom of Information Act;
(7) equitable estoppel; (8) violation of 42 U.S.C. §§ 1983 and the Eighth and Fourteenth
Amendments; (9) conspiracy under 42 U.S.C. § 1985; (10) violation of the Declaration of Helsinki,
and (11) negligence. The plaintiffs alleged the first nine counts against the VA, UCMC, and the
individual defendants. They also alleged the first and ninth counts against the pharmaceutical
defendants, Roche Molecular Systems, Inc.; Centocor Ortho Biotech Products, L.P., nka Janssen
Products, L.P.; Merck, Sharp & Dohme Corporation fka Schering Corporation; Roche
Pharmaceuticals, aka Hoffman-La Roche Inc.; Amgen Manufacturing Limited; Merck & Company,
Inc., fka Schering-Plough Corporation; Pfizer, Inc.; and GlaxoSmithKline LLC. The eleventh count
was asserted only against the pharmaceutical defendants. Alleging that all of the defendants were
jointly and severally liable, the plaintiffs sought $5 million in compensatory and punitive damages.
The United States Attorney for the Southern District of Ohio certified under 28 U.S.C.
§ 2679 and 28 C.F.R. § 15.3 that all six individual defendants were employees of the United States
Department of Veterans Affairs and that they acted within the scope of their federal employment at
the time of the incidents alleged in the amended complaint. Based on these certifications, the
individual defendants asked the district court to substitute the United States as a party and dismiss
them from the suit. All of the defendants moved to dismiss the amended complaint. The plaintiffs
moved for leave to file a second amended complaint.
At the conclusion of briefing on the motions, the magistrate judge issued a comprehensive
Report and Recommendation (R & R). The magistrate judge recommended that the district court
substitute the United States as the sole federal defendant and dismiss the individual defendants,
dismiss all counts of the amended complaint against all defendants, and deny as futile the plaintiffs’
motion to file a second amended complaint. Counsel for the plaintiffs then withdrew from further
Sandy Sykes pro se filed lengthy objections, with attached exhibits, to the R & R, and
responses to the objections were filed. After conducting de novo review, the district court adopted
the R & R, substituted the United States as the sole federal defendant, dismissed the individual
defendants, granted the motions to dismiss, and denied the plaintiffs’ motion for leave to file a
second amended complaint. Judgment was entered the same day.
Sandy Sykes pro se filed a timely notice of appeal from the final judgment. Although the
notice of appeal purported to effectuate an appeal on behalf of all plaintiffs, including the estate of
David J. Muir, only Sandy Sykes signed the notice of appeal. Title 28 U.S.C. § 1654 provides that
“[i]n all courts of the United States the parties may plead and conduct their own cases personally or
by counsel,” but the statute does not allow a plaintiff to appear pro se where the interests of others
are at issue. Shepherd v. Wellman, 313 F.3d 963, 970 (6th Cir. 2002). In addition, the administrator
of an estate may not litigate claims on behalf of the estate pro se if the estate has beneficiaries other
than the pro se litigant, as is the case here. See id. The same rule applies under Ohio state law
because allowing a pro se litigant to represent others would constitute the unauthorized practice of
law. See Williams v. Griffith, No. 09AP-28, 2009 WL 2469523, at *4 (Ohio Ct. App. Aug. 13,
2009). Therefore, the only appellant before us is Sandy Sykes in her individual capacity.
In addition to the voluminous record below, we have reviewed Sykes’s pro se filings on
appeal, including her initial appellate brief filed on September 21, 2011, her Amended Appeal filed
on October 24, 2011, and her Amended Appeal filed on December 5, 2011. We have considered the
nine briefs filed by Appellees, as well as Sykes’s two reply briefs. We have also considered Sykes’s
Motion To Supplement Record On Appeal, filed December 16, 2011. We deny the motion to add
additional exhibits to the record because our review is confined to the allegations of the amended
complaint and the documents referenced in it.
We are sympathetic to the tragic circumstances endured by David Muir, and we recognize
the sincerity and passion with which members of his family have pursued this litigation. Having
carefully reviewed the record before us, however, we conclude that Sykes cannot prevail on any of
the claims included in the amended complaint.
A. Federal tort claims
The Federal Tort Claims Act (“FTCA”), as amended by the Federal Employees Liability
Reform and Tort Compensation Act of 1988 (“the Westfall Act”), 28 U.S.C. §§ 1346(b), 2671–2680,
provides that a suit against the United States shall be the exclusive remedy for persons who wish to
bring claims for damages resulting from negligent acts of federal employees committed within the
scope of their employment. See Dolan v. United States, 514 F.3d 587, 593 (6th Cir. 2008). Where
the Attorney General, through his designee, the United States Attorney, 28 C.F.R. § 15.3, certifies
that a defendant federal “employee was acting within the scope of his office or employment at the
time of the incident out of which the claim arose,” 28 U.S.C. § 2679(d)(1), it is appropriate for the
court to substitute the United States as the sole defendant, and thereafter, the court must assess the
plaintiff’s claims under the FTCA. Dolan, 514 F.3d at 593. The district court followed the proper
procedures when it substituted the United States as the sole federal defendant and dismissed the
individual defendants from the suit.
The district court ruled that, for purposes of the FTCA, any tort claims accrued at the latest
on the date of David Muir’s death on February 6, 2004. A tort claim against the United States is
barred unless it is presented in writing to the appropriate federal agency within two years after the
claim accrues. 28 U.S.C. § 2401(b). Sykes filed an administrative claim (Standard Form 95 or SF
95) with the VA dated December 23, 2005, alleging that Dr. Charles Mendenhall engaged in deceit
and coercion to enroll Muir in VA drug trials without his informed consent, which eventually led to
Muir’s wrongful death. Sykes amended the SF 95 on May 4, 2006, to add the claim that the VA
failed to safeguard Muir’s rights and welfare. The VA denied the amended SF 95 by letter dated
February 5, 2008.
Sykes requested reconsideration, which the VA denied by letter dated
December 11, 2008. The denial letter informed Sykes that she had six months from the date of the
letter to file suit in federal court. Id.; 28 U.S.C. § 2401(b). Thus, Sykes was required to file suit no
later than June 11, 2009, but the original complaint was not filed until October 4, 2010, sixteen
months after the deadline. Although Sykes filed six additional SF 95s with the VA expanding upon
her various claims, none of them were filed within two years after Muir’s death. Therefore, we agree
with the district court that the tort claims asserted in the amended complaint were time-barred due
to the two-year and the six-month filing limitations of the FTCA. See Ellison v. United States, 531
F.3d 359, 361–62 (6th Cir. 2008).
On appeal, Sykes argues that the SF 95 she filed with the VA dated February 19, 2010, was
not a duplicate SF 95 as alleged by the United States. She also contends that the objections and
exhibits she filed below in response to the R & R provided evidence that the VA failed to investigate
any of the SF 95s she submitted, requiring her to engage in a six-year investigation to uncover the
fraudulent scheme to enroll Muir in biomedical research without his knowledge and consent. These
arguments, even if accepted as true, cannot change the fact that Sykes submitted the February 19,
2010 SF 95 to the VA more than six years after Muir’s death, well after the two-year period for filing
administrative claims had expired. See id. All of the SF 95s that Sykes filed on or after March 25,
2008, are time-barred. See id.
Sykes contends that the district court erred in determining that the doctrine of equitable
tolling does not apply to the administrative tort claims she filed. While we acknowledge the debate
in the federal courts concerning whether the FTCA time limitations are jurisdictional and therefore
not amenable to equitable tolling after John R. Sand & Gravel Co. v. United States, 552 U.S. 130
(2008), we need not resolve that question to decide this case. Even assuming equitable tolling
applies, Sykes has not shown her entitlement to equitable tolling. She argues on appeal that, despite
all due diligence, she was “unable to obtain complete and unredacted copies of David J. Muir’s
Scientific Research Records to ascertain who sponsored the Human Experiments he was enrolled
into beginning on May 15, 2000, two months after becoming a [VA] patient.” This assertion is not
sufficient to establish entitlement to equitable tolling because Sykes has not attempted to satisfy at
least four of the five factors relevant to the equitable tolling analysis: “(1) lack of actual notice of
the filing requirement; (2) lack of constructive knowledge of the filing requirement; (3) diligence in
pursuing one’s rights; (4) absence of prejudice to the defendant; and (5) a plaintiff’s reasonableness
in remaining ignorant of the notice requirement.” Glarner v. United States Dep’t of Veterans
Admin., 30 F.3d 697, 702 (6th Cir. 1994). Because Sykes had either actual or constructive
knowledge of the filing requirements, and because she has not explained why the alleged lack of
medical records prevented her compliance with the FTCA’s deadlines, the district court did not err
in refusing to apply equitable tolling to excuse the late filing of SF 95s with the VA and the late
filing of the original complaint.
The tort claims Sykes asserted against the United States are barred by the time limitations
within the FTCA and Sykes has not shown entitlement to equitable tolling. Therefore, the district
court properly dismissed those claims.
B. Civil rights claims
1. Federal defendants
To the extent Sykes asserted constitutional claims for damages against the United States and
the individual federal defendants in their official capacities, her claims fail as a matter of law. The
assertion of constitutional claims against the individual federal defendants as agents of the United
States is, in effect, a suit against the United States. Blakely v. United States, 276 F.3d 853, 870 (6th
Cir. 2002). The United States has not waived its sovereign immunity in suits for money damages
because of alleged constitutional violations. See id.; Davis v. U.S. Dep’t of Justice, 204 F.3d 723,
726 (7th Cir. 2000).
In addition, the amended complaint did not state that the individual defendants were sued in
their individual capacities as federal government agents, but even if they were, the plaintiffs failed
to allege any viable claims against them under Bivens v. Six Unknown Agents of the Fed. Bureau of
Narcotics, 403 U.S. 388 (1971). A Bivens action is governed by the same personal injury statute of
limitations that applies to a § 1983 action. McSurely v. Hutchison, 823 F.2d 1002, 1005 (6th Cir.
1987). In Ohio cases, the two-year statute of limitations found in Ohio Rev. Code. § 2305.10
governs. Browning v. Pendleton, 869 F.2d 989, 990 (6th Cir. 1989) (en banc). Because suit was
brought more than two years after any claims against the individual defendants could have accrued,
the Bivens claims are time-barred.
2. State defendants
All civil rights claims brought under 42 U.S.C. §§ 1983 and 1985 against the University of
Cincinnati Medical Center are barred by Eleventh Amendment immunity. We have previously held
that the University of Cincinnati is an arm of the State of Ohio that is immune from suit in federal
court. Johnson v. Univ. of Cincinnati, 215 F.3d 561, 571 (6th Cir. 2000). Furthermore, “[t]he
university’s hospital is an agent of the university that is entitled to its immunity from suit in federal
court.” Thomson v. Harmony, 65 F.3d 1314, 1319 (6th Cir. 1995). Therefore, the district court
lacked jurisdiction over these claims. To the extent the amended complaint included civil rights
claims against the individual defendants in their individual capacities as UCMC employees under
§ 1983 or § 1985, those claims are barred by the Ohio two-year statute of limitations applicable to
personal injury actions. See Browning, 869 F.2d at 990.
C. Remaining claims
Sykes contends on appeal that the district court erred in determining that the Institutional
Review Board was responsible for protecting the rights and welfare of clinical trial participants.
Sykes contends, to the contrary, that the study sponsor is responsible for protecting those rights,
citing 21 C.F.R. Parts 50 & 812. She asserts that she has been unable to determine who served as
sponsor of the clinical trials in which Muir participated because the defendants failed to provide
unredacted copies of Muir’s medical records that would have disclosed such information.
We resolved a similar argument in Abney v. Amgen, Inc., 443 F.3d 540 (6th Cir. 2006), where
we held that “under the FDA’s regulatory scheme it is not the pharmaceutical companies that are
charged with ensuring trial participants’ well being. Rather, it is the Institutional Review Board that
is meant to ‘protect the rights and welfare’ of trial participants during a clinical trial.” Id. at 551.
The district court followed Abney and in addition held that any claims against the pharmaceutical
defendants would be barred by the statutes of limitations. Ohio Rev. Code §§ 2305.10(A),
2125.02(D). Sykes has not offered a sufficient reason why we should overturn these holdings, nor
did she include in her appellate filings any developed arguments concerning any other claims against
the pharmaceutical and medical device defendants. Issues mentioned in a perfunctory manner,
without any effort to develop them on appeal, are deemed waived. See McPherson v. Kelsey, 125
F.3d 989, 995–96 (6th Cir. 1997).
We have carefully reviewed the district court’s resolution of Sykes’s other claims and find
no error. The plaintiffs failed to state a claim under the Freedom of Information Act (FOIA),
5 U.S.C. § 552, because they did not allege that they made a proper FOIA request, that the records
requested fall within FOIA, and that they exhausted administrative remedies prior to filing suit in
federal court. See Davis v. City of Dearborn, No. 2:09-cv-14892, 2010 WL 3476242, *6 (E.D. Mich.
Sept. 2, 2010). Specifically, the plaintiffs did not allege that they complied with 38 C.F.R.
§§ 1.550–1.562, the FOIA procedures followed by the Department of Veterans’ Affairs. Moreover,
FOIA does not apply to state entities like UCMC. See Grand Cent. P’ship, Inc. v. Cuomo, 166 F.3d
473, 484 (2d Cir. 1999).
Finally, Sykes has not cited any cases to establish that there is a private cause of action under
the Declaration of Helsinki. Courts have uniformly held that no private right of action exists under
the Declaration of Helsinki. See e.g., Ammend v. BioPort, Inc., 322 F. Supp. 2d 848, 872–73 (W.D.
Mich. 2004) (and cases cited therein). Rather, the Code of Federal Regulations governs the conduct
of human research in the United States. See id.
The district court properly dismissed the amended complaint under Rules 12(b)(1) and
12(b)(6). We further agree with the district court that permitting the plaintiffs to file a second
amended complaint would have been futile for all of the reasons stated in the district court’s opinion.
Accordingly, we affirm the judgment of the district court.
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