Olmstead v. Bayer Corp. et al
MEMORANDUM-DECISION AND ORDER: The Court hereby ORDERS that Defendants' 6 motion to dismiss Plaintiff's complaint is GRANTED. The Court further ORDERS that that the Clerk of the Court shall enter judgment in favor of Defendants and close this case. Signed by Senior Judge Frederick J. Scullin, Jr. on 8/15/2017. (nmk)
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF NEW YORK
BAYER CORP.; BAYER HEALTHCARE, LLC;
BAYER ESSURE, INC., f/k/a Conceptus, Inc.;
BAYER HEALTHCARE PRAMACEUTICALS, INC.;
and BAYER, A.G.,
OFFICE OF RONALD R. BENJAMIN
126 Riverside Drive
Post Office Box 607
Binghamton, New York 13902-0607
Attorneys for Plaintiff
RONALD R. BENJAMIN, ESQ.
SIDLEY AUSTIN LLP
787 Seventh Avenue
New York, New York 10019
Attorneys for Defendants
JAMES D. ARDEN, ESQ.
NIXON PEABODY LLP
Albany, New York 12207
Attorneys for Defendants
DANIEL J. HURTEAU, ESQ.
SCULLIN, Senior Judge
MEMORANDUM-DECISION AND ORDER
Pending before the Court is Defendants' motion to dismiss Plaintiff's complaint pursuant
to Rule 12(b)(6) of the Federal Rules of Civil Procedure. See Dkt. No. 6.
Statutory and regulatory background
The Food and Drug Administration ("FDA") regulates medical devices pursuant to the
Food, Drug, and Cosmetics Act ("FDCA") and the Medical Device Amendments of 1976
("MDA"). See 21 U.S.C. § 360c et seq. The MDA, in turn, categorizes certain devices as Class
III medical devices when the less stringent classifications cannot provide reasonable assurance of
their safety and effectiveness, and the devices are used either "in supporting or sustaining human
life or for a use which is of substantial importance in preventing impairment of human health," or
they "present a potential or unreasonable risk of illness or injury." 21 U.S.C. § 360c(a)(1)(C).
A Class III medical device is required to undergo FDA's premarket approval process
("PMA") before being marketed to the public. PMA is a "rigorous" process. Medtronic, Inc. v.
Lohr, 518 U.S. 470, 477 (1996). To be awarded PMA, a device manufacturer must submit a
substantial application including
full reports of all studies and investigations of the device's safety and
effectiveness that have been published or should reasonably be known to the
applicant; a "full statement" of the device's "components, ingredients, and
properties and of the principle or principles of operation"; "a full description of
the methods used in, and the facilities and controls used for, the manufacture,
processing, and, when relevant, packing and installation of, such device"; samples
or device components required by the FDA; and a specimen of the proposed
Riegel v. Medtronic, Inc., 552 U.S. 312, 318 (2008) (quoting 21 U.S.C. § 360e(c)(1)).
The FDA will grant PMA only if it finds that there is a "reasonable assurance" of the
device's "safety and effectiveness." 21 U.S.C. § 360e(d). "The agency must 'weig[h] any
probable benefit to health from the use of the device against any probable risk of injury or illness
from such use.'" Riegel, 552 U.S. at 318 (quoting [21 U.S.C.] § 360c(a)(2)(C)). Therefore, the
FDA may "approve devices that present great risks if they nonetheless offer great benefits in
light of available alternatives." Id. Moreover, the PMA includes review of the device's proposed
labeling. In that regard, "[t]he FDA evaluates safety and effectiveness under the conditions of
use set forth on the label," id. (citing [21 U.S.C.] § 360c(a)(2)(B)), "and must determine that the
proposed labeling is neither false nor misleading," id. (citing [21 U.S.C.] § 360e(d)(1)(A)).
After PMA is issued, "the MDA forbids a manufacturer to make, without FDA
permission, changes in design specifications, manufacturing processes, labeling, or any other
attribute, that would affect safety or effectiveness." Id. at 319 (citing [21 U.S.C.]
§ 360e(d)(6)(A)(i) [now at § 360e(d)(5)(A)(i)]). Furthermore, the manufacturer must inform the
FDA if it learns new information about the device and must report when the device has caused or
contributed to death or serious injury. See id. (citing [21 C.F.R.] § 803.50(a)). If at any time the
FDA determines a device is unsafe or ineffective under the terms of its labeling, it may withdraw
premarket approval. See id. at 319-20 (citing [21 U.S.C.] § 360e(e)(1)) (other citation omitted).
Essure is a method of permanent female contraception. In 2002, FDA granted Essure
PMA as a Class III device, and FDA has never withdrawn or suspended that PMA.
In 2012, Plaintiff spoke with her gynecologist because she wanted to learn more about
permanent birth control. See Dkt. No. 2, "Plaintiff's Complaint," at ¶ 9. According to Plaintiff,
Dr. Carol Miller advised her that Essure was "safe, effective, and permanent." See id. On
January 31, 2013, Plaintiff went to Wilson Hospital to have the device implanted. See id.
According to Plaintiff, after Essure was implanted, "[s]he had her period for six months
straight and was not able to use tampons." See id. at ¶ 10. Furthermore, Plaintiff asserts that,
"[w]ithin three months, [she] began to suffer from severe headaches, something she had rarely
had before." See id. at ¶ 11. Plaintiff also alleges that she experienced "extreme fatigue" and
"developed lower back pain[.]" See id. Moreover, Plaintiff asserts that she was no longer able to
enjoy sexual relations with her husband because the pain was so severe. See id. at ¶ 12.
Plaintiff alleges that, in the summer of 2015, she ran into a friend, who told her she had
an "Essure belly." 1 See id. at ¶ 13. During this conversation, Plaintiff asserts that her friend told
her that the FDA had not approved Essure and that other women were having similar problems
with Essure. See id. at ¶ 14.
Thereafter, Plaintiff's pain increased; and, on September 9, 2016, she went to Wilson
Hospital "literally doubled over in a fetal position because of the severe abdominal pain." See id.
at ¶ 15. A doctor performed an ultra sound but everything appeared normal. See id. at ¶ 16.
Plaintiff was told to follow-up with her own doctor. See id. In October 2016, Plaintiff visited
Dr. Miller and Dr. Kondrup, who ordered a 3-d ultrasound, which revealed that one of the coils
of the Essure was "sticking out of the uterus by about one inch." See id. at ¶ 17.
An "Essure Belly" is apparently a metaphor for being bloated.
Based on the foregoing, Plaintiff sued Defendants in New York Supreme Court, Broome
County, alleging first that Defendants knew or should have known that Essure was dangerous,
yet they represented that it was a safe and effective method of permanent birth control, see id. at
¶¶ 19-28 (negligent misrepresentation); second, that Essure was unreasonably dangerous and
defective, see id. at ¶¶ 29-33 (strict liability); third, that Plaintiff was never warned about the
risks of Essure prior to having the device implanted and was never warned that her adverse sideeffects could be related to Essure, see id. at ¶¶ 34-40 (failure to warn); fourth, that Defendants
warranted that Essure was safe when it was not, see id. at ¶¶ 41-44 (breach of express warranty);
and, finally, that Defendants impliedly warranted that the product was safe, see id. at ¶¶ 45-49
(breach of implied warranty).
Defendants removed this case to federal court asserting this Court's diversity jurisdiction,
see Dkt. No. 1, and thereafter filed the pending motion to dismiss Plaintiff's claims, see Dkt. No.
6. Defendants' principal argument is that the MDA expressly or impliedly preempts Plaintiff's
Standard of review
Courts use a two-step inquiry when addressing a Rule 12(b)(6) motion. "First, they
isolate the moving party's legal conclusions from its factual allegations." Hyman v. Cornell
Univ., 834 F. Supp. 2d 77, 81 (N.D.N.Y. 2011). Second, courts must accept factual allegations
as true and "determine whether they plausibly give rise to an entitlement to relief." Ashcroft v.
Iqbal, 556 U.S. 662, 679 (2009). A pleading must contain more than a "blanket assertion[ ] of
entitlement to relief." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 n.3 (2007). Thus, to
withstand a motion to dismiss, a pleading must be "plausible on its face" such that it contains
"factual content that allows the court to draw the reasonable inference that the defendant is liable
for the misconduct alleged." Iqbal, 556 U.S. at 678 (citation omitted).
The MDA contains the following express preemption clause:
(a) General rule
Except as provided in subsection (b) of this section, no State or political
subdivision of a State may establish or continue in effect with respect to a device
intended for human use any requirement
(1) which is different from, or in addition to, any requirement applicable
under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other
matter included in a requirement applicable to the device under this
21 U.S.C. § 360k(a). 2
This express preemption clause makes clear that state laws that impose obligations
"different from or in addition to" the requirements of the MDA are expressly preempted. 21
U.S.C. § 360k(a)(1); see also Riegel, 552 U.S. at 321 (quotation omitted). Thus, common law
claims challenging the safety of an FDA-approved medical device may survive preemption only
if they are "premised on a violation of FDA regulations" where state law provides a damages
remedy for such violations. Riegel, 552 U.S. at 330. In such a case, the common law claims run
Plaintiff's argument that there is a strong presumption against preemption and that this
presumption applies to the MDA's express preemption clause is frivolous. See Puerto Rico v.
Franklin California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016) (holding that, when the
"statute 'contains an express pre-emption clause,' we do not invoke any presumption against preemption but instead 'focus on the plain wording of the clause, which necessarily contains the best
evidence of Congress' pre-emptive intent'" (quotation and other citation omitted)).
"'parallel,' rather than add to, federal requirements." Id. (quoting Lohr, 518 U.S., at 495, 116 S.
Ct. 2240) (other citation omitted).
The MDA also provides that all actions to enforce FDA requirements "shall be by and in
the name of the United States." 21 U.S.C. § 337(a). The Supreme Court, in Buckman Co. v.
Plaintiffs' Legal Comm., 531 U.S. 341 (2001), construed § 337(a) as barring suits by private
litigants "for noncompliance with the medical device provisions." Id. at 349 n.4. In other words,
a plaintiff's cause of action is impliedly preempted when it is premised solely on a violation of
”Riegel and Buckman create a narrow gap through which a plaintiff's state-law
claim must fit if it is to escape express or implied preemption. The plaintiff must
be suing for conduct that violates the FDCA (or else his claim is expressly
preempted by § 360k(a)), but the plaintiff must not be suing because the conduct
violates the FDCA (such a claim would be impliedly preempted under
In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir.
2010) (quoting Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009)). Accordingly,
avoiding express and implied preemption is a difficult task that has been compared to
"navigating between Scylla and Charybdis." Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1340
(10th Cir. 2015) (citation omitted).
The first step of this onerous task is for the plaintiff to identify a parallel federal law upon
which she has based her state-law claims. Defendants contend that Plaintiff's complaint utterly
fails this first step. In that regard, Defendants assert that, "[i]n the entirety of her Complaint,
Plaintiff does not allege that [Defendants] violated a single federal law, regulation, or other
requirement." See Dkt. No. 6-1 at 13.
In response, Plaintiff describes the Current Good Manufacturing Practices ("CGMPs"),
see 21 C.F.R. § 820.1 et. seq.; however, Plaintiff fails to explain how Defendants violated the
CGMPs. 3 More importantly, the CGMPs "'are intended to serve only as "an umbrella quality
system" providing "general objectives" medical device manufacturers must seek to achieve.'"
Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 278-79 (E.D.N.Y. 2009) (quotation omitted);
accord In re Medtronic, 592 F. Supp. 2d at 1157 (referring to CGMPs as "simply too generic,
standing alone, to serve as the basis for Plaintiff's manufacturing-defect claims"). "Since these
regulations are open to a particular manufacturer's interpretation, allowing them to serve as a
basis for a claim would lead to differing safety requirements that might emanate from various
lawsuits." Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582, 588 (E.D.N.Y. 2009). Thus,
allowing a suit to continue on the basis of the CGMPs would necessarily impose "standards that
are 'different from, or in addition to' those imposed by the MDA -- precisely the result that the
MDA preemption provision seeks to prevent." Id. (citations omitted)
Thus, Plaintiff has failed to identify a single parallel federal statute or regulation related
to any of her claims. Therefore, the Court concludes that, as a matter of law, the MDA expressly
preempts Plaintiff's claims. 4
Plaintiff also cited several federal regulations and statutes ostensibly relevant to her claims. See
Dkt. No. 14 at 5 n.3. However, Plaintiff failed to make any attempt to connect this string of
citations to the factual allegations in her complaint.
Plaintiff also argues that Essure's PMA is "invalid" supposedly because Defendants have failed
to comply with various conditions in their PMA. See Dkt. No. 14 at 8-9. Plaintiff's position
assumes that failure to comply with PMA conditions automatically invalidates the PMA;
however, the Code of Federal Regulations vests authority and discretion in the FDA to withdraw
premarket approval from a device if there is a violation of conditions. In that regard, "the
regulations specifically empower the FDA to 'issue an order withdrawing approval of a PMA if,
from any information available to the agency, FDA determines that . . . (2) Any postapproval
requirement imposed by the PMA approval order . . . has not been met.'" McLaughlin v. Bayer
Leave to amend -- statute of limitations
Normally, under these circumstances, the Court would permit Plaintiff to amend her
complaint as a matter of course to attempt to allege a plausible claim that is not preempted.
However, in this case, Defendants additionally argue that Plaintiff's entire complaint is time
barred, thus making any proposed amendment futile.
Under New York law, a plaintiff must commence a personal injury action or products
liability action within three years of the date of accrual. See N.Y. C.P.L.R. § 214(5). This
statute of limitations begins to run "from the date of discovery of the injury by the plaintiff or
from the date when through the exercise of reasonable diligence such injury should have been
discovered by the plaintiff, whichever is earlier." N.Y. C.P.L.R. § 214-c(2). Furthermore, "[t]he
three year limitations period runs from the date when plaintiff first noticed symptoms, rather than
when a physician first diagnosed those symptoms[.]" Galletta v. Stryker Corp., 283 F. Supp. 2d
914, 917 (S.D.N.Y. 2003) (citations omitted). Therefore, "the significant date is when [P]laintiff
began experiencing symptoms, not when [a doctor] diagnosed them." Id. (citing Wetherill v. Eli
Lilly & Company, 89 N.Y.2d 506, 515, 655 N.Y.S.2d 862, 678 N.E.2d 474 (1997)) (other
Plaintiff commenced this action on January 31, 2017. Accordingly, any claim based on
an injury Plaintiff discovered, or should have discovered, prior to January 31, 2014, is timebarred.
Corp., 172 F. Supp. 3d 804, 815 n.6 (E.D. Pa. 2016) (quoting 21 C.F.R. § 814.46(a)). Plaintiff
does not allege that the FDA has withdrawn Essure's PMA; thus, the PMA remains effective.
Plaintiff's complaint alleges that she first began to feel symptoms related to the Essure
device as early as immediately after the device was implanted but no later than three months
afterwards, i.e., approximately April 30, 2013. See Dkt. No. 2 at ¶ 10 (alleging she had had her
period for six months straight and had to take the birth control pill); ¶ 11 (alleging that, "[w]ithin
three months, [she] began to suffer from severe headaches, . . . extreme fatigue[, and] . . . lower
back pain"); ¶ 12 (alleging that she was unable to enjoy sexual relations). Clearly Plaintiff began
experiencing symptoms more than three years before she filed this case. It is of no consequence,
therefore, that Plaintiff did not learn that the cause of her injury might have been the result of the
Essure device until the summer of 2015
Nor can the so-called "two-injury" rule save her case. "Pursuant to the rule, 'the Statute
of Limitations starts to run anew upon the discovery of a second injury' caused by the same
wrong[.]" Suffolk Cty. Water Auth. v. Dow Chem. Co., 121 A.D.3d 50, 60 (2d Dep't 2014)
(quotation and other citation omitted). "However, the two-injury rule does not apply to an injury
which is the 'outgrowth, maturation or complication of the original contamination[.]'" Id.
(quoting DiStefano v. Nabisco, 282 A.D.2d at 705) (other citations omitted). "Rather, the second
injury must be 'separate and distinct' and arise independently of prior injuries . . ., and must be
'"qualitatively different from that sustained earlier. . . ."'" Id. (internal quotation and other
In this case, Plaintiff's complaints of pain in 2016 are qualitatively similar to the injuries
she allegedly suffered as early as 2013. Furthermore, the alleged coil protrusion is merely an
"outgrowth, maturation, or complication of the original contamination." Id. Therefore, the Court
finds that Plaintiff's claims are time-barred and, therefore, allowing Plaintiff to amend her
complaint under these circumstances would be futile.
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Having reviewed the entire file in this matter, the parties' submissions, and the applicable
law, and for the above-stated reasons, the Court hereby
ORDERS that Defendants' motion to dismiss Plaintiff's complaint, see Dkt. No. 6, is
GRANTED; and the Court further
ORDERS that that the Clerk of the Court shall enter judgment in favor of Defendants
and close this case.
IT IS SO ORDERED.
Dated: August 15, 2017
Syracuse, New York
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