United States District Court, D. Maryland
LEWIS WILLIAMS, JR., et al.
SMITH & NEPHEW, INC
Lewis Williams, Jr., Angela Williams, Plaintiffs: Gregory
Gene Hopper, Salsbury Clements Bekman Marder and Adkins LLC,
Smith & Nephew Inc., Defendant: Terri Steinhaus Reiskin, LEAD
ATTORNEY, Dykema Gossett PLLC, Washington, DC.
C. Blake, United States District Judge.
Williams, Jr., and his wife, Angela Williams, filed this
lawsuit against Smith &
Nephew, Inc.--maker of the Birmingham Hip Resurfacing System
(" BHR System" ) at the center of this
lawsuit--alleging state law claims of negligence, strict
liability, breach of warranty, and loss of consortium. The
Williamses allege Smith & Nephew deviated, in several ways,
from the requirements the Food and Drug Administration
(" FDA" ) set in its order approving the BHR System
for commercial distribution. In their view, these deviations
ultimately caused Mr. Williams, the recipient of a BHR System
implant, permanent and irreversible harm. Presently pending
is Smith & Nephew's motion to dismiss for failure to
state a claim, which invokes, as defenses, express preemption
under 21 U.S.C. § 360k of the Medical Device Amendments
of 1976 (" MDA" ), implied preemption under
Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S.
341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), and Rule 8
insufficiency. For the reasons stated below, Smith &
Nephew's motion will be granted in part and denied in
1976, Congress passed the MDA " [i]n response to the
mounting consumer and regulatory concern" over medical
devices, which had not previously been subject to federal
regulation. Medtronic, Inc. v. Lohr, 518 U.S. 470,
476, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). The MDA changed
that by imposing on medical devices " a regime of
detailed federal oversight." Riegel v. Medtronic,
Inc., 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892
level of oversight established by the MDA regime varies
according to a medical device's safety risks. Class I
devices--such as elastic bandages and examination gloves--are
least risky, and are therefore " subject to the lowest
level of oversight: 'general controls,' such as
labeling requirements." Id. (quoting 21 U.S.C.
§ 360c(a)(1)(A)). Class II devices--such as powered
wheelchairs and surgical drapes--are subject to "
heightened oversight mechanisms, such as 'performance
standards [and] postmarket surveillance[.]'"
Walker v. Medtronic, Inc., 670 F.3d 569, 572 (4th
Cir. 2012) (quoting 21 U.S.C. § 360c(a)(1)(B)). Class
III devices--such as replacement heart valves and pacemaker
pulse generators--are the most risky, and are subject to
" the highest level of federal oversight."
Id. Accordingly, " [b]efore a new Class III
device may be introduced to the market, the manufacturer must
provide the FDA with a 'reasonable assurance' that
the device is both safe and effective" by completing the
premarket approval (" PMA" ) process.
Lohr, 518 U.S. at 477 (citing 21 U.S.C. §
a " rigorous" process. Riegel, 552 U.S. at
317 (quoting Lohr, 518 U.S. at 477). It requires a
device-maker to provide, among other things: information
concerning a device's safety and effectiveness; " a
full statement of [its] components, ingredients, and
properties" ; the methods and facilities used to
manufacture it; and examples of proposed labeling. 21 U.S.C.
§ 360e(c)(1). " This typically requires a
'multivolume application.'" Walker, 670
F.3d at 573 (quoting Riegel, 552 U.S. at 317). The
FDA then reviews the device, and, after " weighing any
probable benefit to health from the use of the device against
any probable risk of injury or illness from such use[,]"
21 U.S.C. § 360c(a)(2)(C), decides whether to grant
premarket approval. Further, " the FDA may condition its
grant of premarket approval upon certain requirements."
Walker, 670 F.3d at 573. The PMA process takes, on
average, 1,200 hours. Riegel, 552 U.S. at 318.
device receives FDA approval, the MDA " forbids the
make, without FDA permission, changes in design
specifications, manufacturing process, labeling, or any other
attribute, that would affect safety or effectiveness."
Walker, 670 F.3d at 573 (quoting Riegel,
552 U.S. at 319). To make any such change, a manufacturer
must submit a supplemental application that is "
evaluated under largely the same criteria as an initial
application." Riegel, 552 U.S. at 319; see
also 21 U.S.C. § 360e(d)(6)(A)(i).
also imposes reporting requirements after a device has been
approved. See Riegel, 552 U.S. at 319
(citing 21 U.S.C. § 360i). A device-maker has, for
the obligation to inform the FDA of new clinical
investigations or scientific studies concerning the device
which the [device-maker] knows of or reasonably should know
of, 21 C.F.R. § 814.84(b)(2), and to report incidents in
which the device may have caused or contributed to death or
serious injury, or malfunctioned in a manner that would
likely cause or contribute to death or serious injury if it
recurred, § 803.50(a).
Id. at 319. The FDA " has the power to withdraw
premarket approval based on newly reported data or existing
information and must [do so] if it determines that a device
is unsafe or ineffective under the conditions in its
labeling." Id. at 319-20 (citing 21 U.S.C.
be described further below, infra section I.A, the
MDA also includes an " express pre-emption
provision[,]" Riegel, 552 U.S. at 316, which is
codified at 21 U.S.C. § 360k.
* * *
Williamses' complaint alleges the following. Smith &
Nephew designs, manufactures, and sells the BHR System, a
" metal-on-metal hip resurfacing prosthesis" made
from a cobalt chromium and molybdenum alloy. (Compl. ¶
5, ECF No. 1.) The BHR System is a Class III device under the
MDA. (Compl ¶ 6.) Accordingly, it is subject to the PMA
2004, Smith & Nephew submitted an application to the FDA for
premarket approval of the BHR System. (Compl. ¶ 7.) On
May 9, 2006, the FDA " conditionally approv[ed]"
the BHR System for commercial distribution. (Compl. ¶ 8;
see also Pls.' Opp'n Ex. 1, Approval Order,
ECF No. 11-1.) As a " condition for distribution,"
the FDA's Approval Order required Smith & Nephew to
comply with specific regulations and provisions of the Food,
Drug, and Cosmetic Act (" FDCA" ). (Compl.
¶ ¶ 8a-8b.) The Approval Order also outlined other
post-approval requirements for Smith & Nephew including, for
example, studies of the longer-term safety and effectiveness
of the BHR System for patients in the United Kingdom and
United States; a training program for doctors using the BHR
System; submission of adverse reaction and device defect
reports to the FDA; and labeling and warning obligations.
(Compl. ¶ ¶ 8c-8l.) The Approval Order warned that
failure to comply with any of these conditions would be
grounds for the withdrawal of FDA approval. (Compl. ¶
9.) Upon receiving FDA approval, Smith & Nephew began
distributing the BHR System. (Compl. ¶ 10.)
September 21, 2006, Mr. Williams received an implant of the
BHR System. (Compl. ¶ 11.) Over half a decade later, in
April 2013, he was admitted to a hospital with coughing,
shortness of breath, fatigue,
weakness, and other symptoms of cardiomyopathy. (Compl.
¶ 12.) His ejection fraction was 15-20%. (
Id. ) In May 2013, Mr. Williams's cardiologist
evaluated Mr. Williams and, after blood testing, confirmed
that he had cobalt and chromium poisoning. (Compl. ¶
13.) The cardiologist believed erosion of the BHR System had
released metal ions into, and poisoned, Mr. Williams's
bloodstream. ( Id. ) Accordingly, the decision was
made to remove the BHR System as soon as possible. (Compl.
¶ 14.) By June 2013, Mr. Williams's ejection
fraction was 8%. ( Id. ) On July 9, 2013, Mr.
Williams's BHR System was removed and replaced with a
ceramic hip replacement system. (Compl. ¶ 15.) The
removed BHR System showed signs of wear and tear. (Compl.
¶ 16.) After removal, Mr. Williams's cobalt levels,
cardiomyopathy, and ejection fraction immediately began to
improve. (Compl. ¶ 17.) But the " long term toxic
exposure" had caused " permanent, irreversible
damage." ( Id. )
October 6, 2014, the Williamses filed their four-count
complaint. Count I alleges negligence. The Williamses allege
that, with respect to its development and distribution of the
BHR System, Smith & Nephew had the " duty to comply with
and not deviate from the PMA requirements contained in the
BHR System's FDA approval order[,]" the conditions
of approval attached to that order, and " other federal
statutory and regulatory requirements" applicable to the
BHR System. (Compl. ¶ ¶ 19-21.) These duties were
ongoing--that is, they existed even after the FDA had issued
its Approval Order. ( See Compl. ¶ ¶
22-25.) " In parallel with" these duties, Maryland
law imposed on Smith & Nephew " post-sale duties" :
to monitor the sale and use of the BHR System; discover
defects associated with the BHR System's use; and warn
the government, doctors, and users about those defects.
(Compl. ¶ 26.) Furthermore, " Maryland law treats
violations of federal statutes and regulations as evidence of
common law negligence . . . ." (Compl. ¶ 27.) Smith
& Nephew allegedly " failed to comply with and not
deviate from the[se] conditions . . . ."  (Compl.
¶ 28.) And those failures meant that " the FDA,
doctors implanting BHR [S]ystems, and the public" did
not know about the difficulties doctors and patients had with
the BHR System, as well as the metal poisoning risks
associated with the device. (Compl. ¶ 29.) Had the FDA
or Mr. Williams's doctors known about these risks, Mr.
Williams would not have experienced the " longstanding
exposure to high levels of cobalt and other metals in [his]
blood" that ultimately harmed him. ( Id. )
Moreover, had the FDA or Mr. Williams's doctors been
" fully informed" of the metal
poisoning risks associated with the BHR System, other
preventive action could and would have been taken. (Compl.
¶ ¶ 30-31.) As a proximate result of Smith &
Nephew's failures, Mr. Williams received a BHR System
implant that " released high levels of cobalt and other
metal ions into [his] bloodstream and caused him to develop
metal poisoning, cardiomyopathy, heart damage, and other
injuries." (Compl. ¶ 32.) The Williamses clarify
that this count is " based solely on Smith &
Nephew's failure to comply with the PMA approval order
and the conditions and requirements set by federal regulatory
and statutory law" and that they seek damages for
violations of these duties " to the extent, and only to
the extent, that they run parallel to the federal conditions
and requirements." (Compl. ¶ 34.)
II alleges strict liability on the theory that the BHR System
was " defective and unreasonably dangerous," both
when it entered the stream of commerce and when it was
implanted into Mr. Williams's body, as a result of
deviations from the FDA's requirements. (Compl. ¶
36.) As a result of these design and
manufacturing defects, Mr. Williams suffered and continues to
suffer harm. (Compl. ¶ ¶ 37-38.) The Williamses
again clarify they allege strict liability only insofar as
state requirements under that claim parallel federal ones.
(Compl. ¶ 39.)
III alleges breach of both express and implied warranty based
on repeated assurances to Mr. Williams's doctors that the
BHR System " was a safe medical device, free from known
or unknown defects and hazards." (Compl. ¶ 41.)
Smith & Nephew's sales materials allegedly referred to
the BHR System's durability in relation to other hip
replacement systems. ( Id. )
IV alleges loss of consortium based on the "
interfere[nce] with and injur[y] [to]" The
Williamses' marital relationship. (Compl. ¶ 47.)
November 21, 2014, Smith & Nephew moved to dismiss for
failure to state a claim.
ruling on a motion under Rule 12(b)(6), the court must "
accept the well-pled allegations of the complaint as
true," and " construe the facts and reasonable
inferences derived therefrom in the light most favorable to
the plaintiff." Ibarra v. United States, 120
F.3d 472, 474 (4th Cir. 1997). " Even though the
requirements for pleading a proper complaint are
substantially aimed at assuring that the defendant be given
adequate notice of the nature of a claim being made against
him, they also provide criteria for defining issues for trial
and for early disposition of inappropriate complaints."
Francis v. Giacomelli, 588 F.3d 186, 192 (4th Cir.
2009). " The mere recital of elements of a cause of
action, supported only by conclusory statements, is not
sufficient to survive a motion made pursuant to Rule
12(b)(6)." Walters v. McMahen, 684 F.3d 435,
439 (4th Cir. 2012) (citing Ashcroft v. Iqbal, 556
U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009)). To
survive a motion to dismiss, the factual allegations of a
complaint " must be enough to raise a right to ...