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Litigation News and Analysis • Legislation • Regulation • Expert Commentary
MEDICAL DEVICES
Westlaw Journal
41738396
VOLUME 21, ISSUE 25 / FEBRUARY 10, 2015
TRANSVAGINAL MESH
6 Ethicon settles first
wrongful-death mesh case
to reach trial
Budke v. Ethicon Inc.
(Mo. Cir. Ct.)
BREAST IMPLANTS
7 6th Circuit rejects Dow
bankruptcy plan breast
implant claimant payments
In re Settlement Facility Dow
Corning Trust (6th Cir.)
TRANSVAGINAL MESH
8 Bard’s $2 million loss
in first transvaginal mesh
trial upheld
Cisson v. C.R. Bard Inc.
(S.D. W. Va.)
PROSTHETIC HIP
9 Suit over cobalt exposure
from hip implant dismissed
Becker v. Smith & Nephew
(D.N.J.)
PAIN PUMP
10 9th Circuit reverses preemption
ruling in pain-pump suit
McClellan v. I-Flow Corp.
(9th Cir.)
SURGICAL STAPLER
11 Discovery limits set in
Minnesota surgical
stapler injury suit
Webb v. Ethicon Endo-Surgery
(D. Minn.)
VASCULAR GRAFT (PATENTS)
12 Bard wins $208 million more
in medical device patent
battle with Gore
Bard Peripheral Vascular v.
W.L. Gore & Assocs. (Fed. Cir.) SEE PAGE 3
CONTINUED ON PAGE 16
COMMENTARY
FDA defines medical device
accessory, proposes new
means for classification
Medical device law practitioner
Jennifer D. Newberger of Hyman
Phelps & McNamara says that although
the U.S. Food and Drug Administration’s
just-released draft guidance officially
defining medical device accessories is
appreciated, it may not offer the level
of help needed.
COMMENTARY
No defect? No problem.
Proving product liability
claims through
circumstantial evidence
Goldberg Segalla attorneys Brian J.
Benoit and Davis J. Kim discuss whether
product liability cases can succeed if
plaintiffs lack evidence of a defect and
offer no expert testimony but can pro-
vide circumstantial evidence and show
that an incident causing a plaintiff’s
harm does not normally occur absent a
defect.
SEE PAGE 4
BONE GROWTH STIMULANT
Hawaii federal court approves revised suit
over Medtronic bone-growth device
By Ronald V. Baker, Senior Legal Writer, Westlaw Journals
A Hawaii woman who claims she was injured be-
cause Medtronic Inc. improperly marketed its Infuse
bone-growth device for unapproved use has won
the opportunity to proceed with her lawsuit against
the company.
Beavers-Gabriel v. Medtronic Inc. et al., No. 1:13-cv-00686,
2015 WL 143944 (D. Haw. Jan. 9, 2015).
Judge J. Michael Seabright of the U.S. District Court for the
District of Hawaii refused to dismiss an amended complaint by
Karla Beavers-Gabriel. He rejected Medtronic’s assertion that
her fraud, breach-of-warranty and other allegations either were
federally preempted by the Medical Device Amendments to the
Food, Drug and Cosmetic Act, 21 U.S.C. § 301, or failed to state
a valid claim.
The plaintiff says the off-label use of Medtronic’s
Infuse device during her spinal operation caused
uncontrolled bone growth and nerve damage. A
spine X-ray is shown here.

© 2015 Thomson Reuters2 | WESTLAW JOURNAL n
MEDICAL DEVICES
Westlaw Journal Medical Devices
Published since June 1994
Publisher: Mary Ellen Fox
Executive Editor: Donna M. Higgins
Managing Editor: Kenneth Bradley, Esq.
Editor: Ronald V. Baker
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Senior Desk Editor: Jennifer McCreary
Desk Editor: Sydney Pendleton
Graphic Designers: Nancy A. Dubin
Ramona Hunter
Westlaw Journal Medical Devices
(ISSN 2155-725X) is published biweekly by
Thomson Reuters.
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TABLE OF CONTENTS
Bone Growth Stimulant: Beavers-Gabriel v. Medtronic Inc.
Hawaii federal court approves revised suit over Medtronic bone-growth device (D. Haw.).............................1
Commentary: By Jennifer D. Newberger, Esq., Hyman Phelps & McNamara
FDA defines medical device accessory, proposes new means for classification .............................................3
Commentary: By Brian J. Benoit, Esq., and Davis J. Kim, Esq., Goldberg Segalla LLP
No defect? No problem. Proving product liability claims through circumstantial evidence.........................4
Transvaginal Mesh: Budke v. Ethicon Inc.
Ethicon settles first wrongful-death mesh case to reach trial (Mo. Cir. Ct.).....................................................6
Breast Implants: In re Settlement Facility Dow Corning Trust
6th Circuit rejects Dow bankruptcy plan breast implant claimant payments (6th Cir.).................................. 7
Transvaginal Mesh: Cisson v. C.R. Bard Inc.
Bard’s $2 million loss in first transvaginal mesh trial upheld (S.D. W. Va.)......................................................8
Prosthetic Hip: Becker v. Smith & Nephew
Suit over cobalt exposure from hip implant dismissed (D.N.J.)........................................................................9
Pain Pump: McClellan v. I-Flow Corp.
9th Circuit reverses preemption ruling in pain-pump suit (9th Cir.)............................................................... 10
Surgical Stapler: Webb v. Ethicon Endo-Surgery
Discovery limits set in Minnesota surgical stapler injury suit (D. Minn.)..........................................................11
Vascular Graft (Patents): Bard Peripheral Vascular v. W.L. Gore & Assocs.
Bard wins $208 million more in medical device patent battle with Gore (Fed. Cir.)......................................12
Needle Device (Trademarks): Grey Matter Med. Prods. v. Schreiner Group
Judge refuses to toss needle device trademark suit (W.D. Wash.)...................................................................13
Transvaginal Mesh: In re Ethicon Inc. Pelvic Repair Sys. Prods. Liab. Litig.
Plaintiffs’ lawyers reject J&J claims of fraud in mesh lawsuits (S.D. W. Va.)...................................................14
Regulatory Action: United States v. 2035 Inc.
U.S. blocks sales of laser treatment product (D S.D.)......................................................................................15
News in Brief......................................................................................................................................................17
Case and Document Index................................................................................................................................18

FEBRUARY 10, 2015 n
VOLUME 21 n
ISSUE 25 | 3© 2015 Thomson Reuters
Jennifer D. Newberger is an associate at Hyman Phelps & McNamara
in Washington. She helps medical device clients develop regulatory
strategies; prepare product applications; comply with labeling,
advertising and promotion; and address enforcement actions. She
provides counsel on U.S. Food and Drug Administration aspects of
regulatory due diligence, contracts and transactions, and represents
medical device companies before the FDA. This commentary originally
appeared Jan. 29 on Hyman Phelps’ FDA Law Blog, www.fdalawblog.
net. Reprinted with permission.
COMMENTARY
FDA defines medical device accessory,
proposes new means for classification
By Jennifer D. Newberger, Esq.
Hyman Phelps & McNamara
The question of what constitutes an
accessory has never been well answered.
In a December 1996 guidance document,
Medical Device Quality Systems Manual:
A Small Entity Compliance Guide, the FDA
said that accessory devices are devices
“packaged, labeled, and distributed
separately to a hospital, physician, etc., for
health-related purposes.” Apart from this,
no definition of this statutory term was ever
provided. Despite the lack of a definition for
accessories, the FDA historically classified
accessories either byclassifyingtheaccessory
in the same class as the parent device, or by
issuing a separate classification regulation.
On January 20, 2015, the FDA issued a draft
guidance document putting forth a definition
for accessory, and proposing a new way of
classifying accessories. The draft guidance
defines an accessory as a “device that is
intended to support, supplement, and/or
augment the performance of one or more
parent devices.” This definition is further
parsed as follows:
• “A device supports the performance of a
parent device by enabling or facilitating
that device to perform according to its
intended use.”
• “A device supplements the performance
of a parent device if it adds a new
function or a new way of using the
parent device, without changing the
intended use of the parent device.”
• “A device augments the performance of
a parent device by enabling the device
to perform its intended use more safely
or effectively.”
number of devices than previously believed
to be accessories, and could presumably
include any device that, for any purpose, is
intended to be used with another device.
In addition to questionable examples of
accessories, the draft guidance proposes that
manufacturers consider submitting de novo
classification petitions for device accessories.
The intent behind the proposal may be well-
founded: some accessories may have a lower
risk profile than their parent, and therefore
may warrant being regulated in a lower class.
The application, however, seems flawed.
These distinctions are likely to be difficult to
apply in practice. To provide more clarity, the
FDA gave some examples, some of which
seem questionable. For example, the FDA
states that a rechargeable battery intended
to operate when paired with an automated
external defibrillator is an accessory to the
AED because it is intended to support the
AED by enabling it to defibrillate. It would
not seem that a battery that is required for
the operation and function of the parent
device would be considered an accessory, but
rather part of the parent device itself.
While it is welcome to have the FDA provide a definition of an
accessory, the examples given do not seem to fit the traditional
understanding of an accessory.
As an example of an accessory that
“supplements” the parent, the FDA cited a
pulse oximeter that allows a multi-parameter
monitortodisplayoxygensaturationbutdoes
not change its intended use: to record and
display multiple physiological parameters.
While multi-parameter monitors are cleared
to display specific parameters, including
oxygen saturation, they are rarely cleared for
use with specific devices.
Additionally, a pulse oximeter is a finished
device with its own regulatory classification
that requires 510(k) clearance. It is therefore
not evident that a pulse oximeter would
appropriately be considered an “accessory”
to a multi-parameter monitor. In light of
the examples provided, the definition of an
accessory would seem to include a larger
First, as noted above with respect to the
AED battery, some “accessories” are key
to the functionality of the device, and it
is debatable whether FDA would clear or
approve a submission that did not include a
key part of the product. Second, the utility
of the de novo process for accessories would
be limited because it would apply only to
accessories “of a new type.”
Finally, it is not clear in what circumstances
use of de novo for an accessory would be
appropriate or practical. The FDA proposes
this approach in very high-level, theoretical
terms, but provides no examples of when
de novo classification for an accessory may
actually be suitable.
While it is welcome to, at long last, have the
FDA provide a definition of an accessory, the
examples provided do not seem to fit the
traditional understanding of an accessory.
Furthermore, the proposal to utilize the de
novo pathway is likely to be beneficial only
in limited circumstances that are not entirely
evident. Thus, while the draft guidance does
provide a definition, it will not likely alter the
way in which accessories are cleared. WJ

4 | WESTLAW JOURNAL n
MEDICAL DEVICES © 2015 Thomson Reuters
COMMENTARY
No defect? No problem. Proving product liability claims
through circumstantial evidence
By Brian J. Benoit, Esq., and Davis J. Kim, Esq.
Goldberg Segalla LLP
When and how can a plaintiff be divorced of
the burden to show a specific defect? Illinois
and a majority of jurisdictions have long
held that evidence of a defective product
may be proven through circumstantial
evidence.1
Consistent with Illinois law, the
Restatement (Third) of Torts: Products Liability
§ 3, “Circumstantial Evidence Supporting
Inference of Product Defect” (1998), states, in
relevant part, as follows:
It may be inferred that the harm sustained by
the plaintiff was caused by a product defect
existing at the time of sale or distribution,
without proof of a specific defect, when the
incident that harmed the plaintiff:
(a) was of a kind that ordinarily occurs as
a result of product defect; and
(b) was not, in the particular case, solely
the result of causes other than product
defect existing at the time of sale or
distribution.
Notably, the comments to Restat. (3d) of
Torts:Products Liability § 3tracethe“historical
antecedents to the law of negligence” and
cite specifically to Restatement (Second)
of Torts, § 328D (1965), the restatement
pertaining to res ipsa loquitur. Yet, there are
fundamental differences between product
liability proven through circumstantial
evidence and the theory of res ipsa loquitur.
Understanding the differences between the
two will help the practitioner investigate and
defend a case wherein the plaintiff is relying
on circumstantial evidence to prove a defect
in a product liability case.
Illinois law provides that “a plaintiff may
create an inference that a product was
defective by direct or circumstantial evidence
that: (1) there was no abnormal use of the
product; (2) that there was no reasonable
secondary cause of the injury; and
Brian J. Benoit (L) is partner in the Chicago office of Goldberg Segalla LLP. His practice takes him
to courts across the country defending product manufacturers in catastrophic-loss cases, and often
specializes in the defense of claims involving fires and explosions. Davis J. Kim (R) is an associate
in Goldberg Segalla’s Princeton, N.J., office. In addition to his defense of product manufacturers,
he represents commercial property owners, property managers, general contractors, subcontractors
and manufacturers in personal injury and property damage cases. The original version of this
commentary appeared in the Illinois Association of Defense Trial Counsel’s “IDC Quarterly” at www.
iadtc.org. Reprinted with permission.
defendant’scontrolatthetimeoftheincident,
the incident would not have occurred but
for some fault on the part of the defendant.
Product liability cases differ in that the focus
is not on the fault of the manufacturer, but on
the condition of the product itself at the time
the product leaves the manufacturer.
While there have not been any earth-
shattering Illinois cases demonstrating the
specific thresholds to overcome in order to
prove a strict liability claim absent a specific
There are fundamental differences between product liability
proven through circumstantial evidence and the
theory of res ipsa loquitur.
(3) that the product failed to perform in the
manner reasonably to be expected in light
of its nature and intended function.”2
This
language, in large part, tracks the language
of the Restatement Third. By contrast, the
7th Circuit U.S. Court of Appeals, interpreting
Illinois law, specifically rejected the notion
that res ipsa loquitur is applicable in products
cases.3
Res ipsa loquitur is grounded on the
presumption that since the instrumentality
that created the incident was in the
defect, the Connecticut case of White v.
Mazda Motor of Am., which was recently
ruled on by the Connecticut Supreme
Court, provides unique insight into some of
the issues that need to be addressed when
defending a strict product liability case based
on circumstantial evidence.4
In White, the plaintiff filed a product liability
action against a vehicle manufacturer and
dealership alleging that he was injured when
his vehicle caught fire one month after he
purchased it. The plaintiff specifically alleged
that his injuries were caused by a defective
and unreasonably dangerous condition with
the vehicle. In support of its claim, plaintiff
cited a laundry list of various alleged defects
within the vehicle that may have caused the
fire. Under cross examination, the plaintiff’s
expert admitted that “he was ‘not offering an
opinion that the [vehicle] was defective….’”5
The defendants filed a motion for summary
judgment arguing that the plaintiff failed to
produce any evidence, expert or otherwise,
to establish that the vehicle was defectively
designed or manufactured. The trial court
agreed and granted the defendant’s motion.
On appeal, the plaintiff focused on the
sufficiency of its expert’s opinions and, for
the first time, argued that he could prove his

FEBRUARY 10, 2015 n
VOLUME 21 n
case through circumstantial evidence, i.e.,
the malfunction theory.
The Connecticut Appellate Court affirmed
citingtheneedforexperttestimonyinproduct
liability cases despite the existence of the
malfunction theory. The appellate court did
not however consider the malfunction theory
in their ruling which upheld the trial court’s
decision because plaintiff failed to raise it at
the trial court level.
ConnecticutAppellateCourtJusticeThomasG.
West authored a dissenting opinion
however, stating that the plaintiff had
asserted the malfunction theory at the trial
court level and that it could have defeated
summary judgment based on the existence
of circumstantial evidence. Justice West
pointed out that a plaintiff may prove a
product liability case in the absence of direct
evidence of a defect when it is shown that:
(1) the incident that caused the plaintiff’s
harm was of a kind that ordinarily does
not occur in the absence of a product
defect, and (2) any defect most likely
existed at the time the product left the
manufacturer’s or seller’s control and
was not the result of other reasonably
possible causes not attributable to the
manufacturer or seller.6
The dissent further noted that the two above
elements could be established through
“various forms of circumstantial evidence”
which include evidence of:
(1) the history and use of the particular
product, (2) the manner in which the
product malfunctioned, (3) similar
malfunctions in similar products that
may negate the possibility of other
causes, (4) the age of the product in
relation to its life expectancy, and (5) the
most likely causes of the malfunction.
Id.
White was appealed to the Connecticut
Supreme Court.7
During oral argument,
there was substantial discussion on whether
the plaintiff’s expert ruled out all potential
alternative causes. These potential causes,
as discussed by the justices, could have
ranged from a rock puncturing the fuel
tank to a bird taking refuge in the engine
compartment. The plaintiff’s counsel argued
that there was no testimony regarding
alternative causes and, as a result, the “lack
of alternative causes” factor had been met by
the plaintiff.
The justices, however, took the lack of
testimony by plaintiff’s experts regarding
alternative causes to suggest that potential
alternative causes were not eliminated by the
plaintiff’s expert. Similar to res ipsa loquitur
cases, the justices’ questions appeared to
place the burden of eliminating potential
alternative causes on the plaintiff.
In its opinion, the Supreme Court stressed
the general rule that an appellate court
cannot decide an issue for the first time on
appeal. Our appellate courts, as a general
practice, will not review claims made for the
first time on appeal.8
to the Defendant’s motion for summary
and then again at oral argument, the Court
refused to divest itself of the rule that facts
in support of a claim under the malfunction
theory must be affirmatively pled. The court
likened this requirement to the pleading
rules when asserting a claim based on res
ipsa. The court acknowledged the difference
between a res ipsa claim and a claim based
on the malfunction theory, but stated that
the requirement for pleading specific facts to
place the defense on notice was necessary.
Id. at 629-630.
A logical follow-up question to the burden
on plaintiff’s expert in ruling out potential
alternative causes, is whether expert
testimony is even necessary in the first place.
A few cases stand for the proposition that no
expert testimony is required in a malfunction
theory case. Those cases are uncommon and
typically involve an incident in which there
were direct witnesses to the accident.
For example, in Potter v. Chicago Pneumatic
Tool Co., the court held that the plaintiffs,
who alleged that they sustained injuries as a
result of excessive vibration from power tools
used during their employment, did not need
expert testimony to prove a design defect
because “a jury may, under appropriate
circumstances, infer a defect from the
evidence….”9
Despite the burden on the plaintiff, the
defense must take an active role in evaluating
potential alternative causes. It has been
said that a good defense is nice, but it’s
much better to have the ball. The defense
can establish its own alternative causation
scenarios with which to confront plaintiffs’
Despite the burden on
the plaintiff, the defense
must take an active role
in evaluating potential
alternative causes.
The plaintiff therefore, must, in order to put
defendants on notice of the theory of liability,
plead such theory in their complaint. Id.
at 621. In order to effectively plead a claim
under the malfunction theory, the Supreme
Court required that the two main elements
of a malfunction theory claim be plead:
“1) the incident that caused the plaintiff’s
harm was of a kind that ordinarily does not
occur in the absence of a product defect,
and (2) any defect most likely existed at the
time the product left the manufacturer’s or
seller’s control and was not the result of the
reasonably possible causes not attributable
to the manufacturer or seller. Id. at 623.”
The defense can establish its own alternative causation
scenarios with which to confront plaintiffs’ experts or cast
doubt on the elimination of alternative causes.
While there does not need to be a separate
count devoted to the malfunction theory,
the court held that sufficient facts must be
pled to place the defendant on notice of the
allegations. While, the court explained, this
theory lowered the burden of proving direct
evidence of a defect, it raised the burden
on the plaintiff in negating other possible
causes. Id at 626.
In response to Plaintiff’s arguments that the
malfunction theory was raised in response
experts or cast doubt on the elimination of
alternative causes.
To do so may require expert consultation by
the defense at the outset, but will preserve
the defense’s ability to evaluate any evidence
of alternative theories while it still exists.
Evidence in product liability cases can be
very fluid and should be preserved as soon
as possible.
At first glance, the malfunction theory seems
to provide plaintiffs with an “out” when a

TRANSVAGINAL MESH
Ethicon settles first wrongful-death
mesh case to reach trial
(Reuters Legal) – Johnson & Johnson’s Ethicon Inc. subsidiary has agreed to
settle the first wrongful-death lawsuit involving a transvaginal mesh device to
reach trial.
The plaintiff said Ethicon’s Gynecare Prolift
mesh system caused his wife to develop an infection
that contributed to her death.
specific defect cannot be pinpointed. The
recent case law suggests, however, that
the malfunction theory carries with it the
additional burden on a plaintiff to rule
out other potential explanations for the
incident. Therefore, it is the defense attorney
and defense expert’s job to ensure that the
plaintiff’s analysis in excluding all other
causes is grounded in truth and fact. WJ
NOTES
1
Doyle v. White Metal Rolling & Stamping Corp.,
249 Ill. App. 3d 370 (1st Dist. 1993).
2
Doyle, 249 Ill. App. 3d at 377.
3
Welge v. Planters Lifesavers Co., 17 F. 3d 209
(7th Cir. 1994).
4
White v. Mazda Motor of Am. Inc., No.
HHDCV086003322S, 2011 WL 3211221, at *5
(Conn. Super. Ct. June 22, 2011) aff’d, 139 Conn.
App. 39, 54 A.3d 643 (2012) aff’d, 313 Conn. 610,
99 A.3d 1079 (2014)
5
White v. Mazda Motor of Am., 139 Conn. App.
39 (2012)
6
White, 139 Conn. App. at 57 (West, J.
dissenting).
7
The oral argument can be viewed in its entirety
at http://ct-n.com/ctnplayer.asp?odID=9559
8
White v. Mazda Motor of Am. Inc., 313 Conn.
610 (2014)
9
Potter v. Chicago Pneumatic Tool Co., 241 Conn.
199, 217–218 (1997).
Budke v. Ethicon Inc., No. 10CM-CC00085,
settlement announced (Mo. Cir. Ct.,
Camden County Jan 21, 2015).
Adam M. Slater, a lawyer for plaintiff Donald
Budke, said the settlement was reached
Jan. 21, right before closing arguments were
set to begin following a two-week trial before
Judge William Hass in Missouri’s Camden
County Circuit Court. He declined to say how
much Ethicon paid, citing a confidentiality
agreement.
Budke’s 2010 lawsuit was the first wrongful-
death case to reach trial over transvaginal
mesh, which is used to treat stress urinary
incontinence and pelvic organ prolapse,
and that the company had rushed the Prolift
to market without performing critical safety
studies. The company also underreported
the number of reported mesh complications
and failures, according to testimony from one
expert witness, Anne Weber, a gynecologist.
Ethicon’s lawyers said Budke’s death was
not caused by mesh but rather a rare blood-
vessel disorder. The Prolift was safe and
effective as designed, the company has said
in court filings.
Budke’s claims included design defect, failure
to warn and negligence. A claim for punitive
damages was dismissed by the judge mid-
trial, according to Slater.
and which has become the subject of tens
of thousands of lawsuits against multiple
companies. New Jersey-based Ethicon is
facing approximately 35,600 mesh cases in
state and federal courts.
According to Budke’s 2010 lawsuit, his wife,
Joan, was implanted with Ethicon’s Gynecare
Prolift system in 2008 to treat pelvic organ
prolapse. The next year, the mesh caused
an infection that spread throughout her
body, ultimately contributing to her death,
according to the lawsuit.
The complaint claimed the company had
sold a defective device and failed to warn
patients about known mesh risks. A trial
started Jan. 7.
At trial, lawyers for Ethicon and the plaintiff
sparred over the cause of Joan Budke’s
death. Budke’s lawyers said the infection
was a direct result of her mesh implantation,
Ethicon could not immediately be reached
for comment.
Budke’s suit was the first involving a
wrongful-death claim to go to trial against
any mesh manufacturer. Ethicon had
previously won one trial and lost three others
involving personal-injury claims over mesh
devices. WJ
(Reporting by Jessica Dye)
Attorneys:
Plaintiff: Adam M. Slater, Mazie Slater Katz &
Freeman, Roseland, N.J.; Amy C. Gunn and
Anne Brockland, Simon Law Firm, St. Louis; Ben
Anderson, Anderson Law Offices, Cleveland
Defendants: Dan Ball and Bettina Strauss, Bryan
Cave LLP, St. Louis; Paul S. Rosenblatt and
Christy D. Jones, Butler Snow O’Mara Stevens &
Cannada, Ridgeland, Miss.
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FEBRUARY 10, 2015 n
VOLUME 21 n
BREAST IMPLANTS
6th Circuit rejects Dow bankruptcy plan breast implant
claimant payments
By Michael Nordskog, Senior Content Writer, Westlaw Daily Briefing
Payments to a category of breast-implant-injury claimants from a product liability settlement fund created by Dow
Corning’s Chapter 11 plan were not properly authorized, a federal appeals panel has ruled in reversing a district court
decision.
In re Settlement Facility Dow Corning Trust;
Dow Corning Corp. et al. v. Claimant’s
Advisory Committee et al., No. 14-1090,
2015 WL 348899 (6th Cir. Jan. 27, 2015).
Any proposal to make lower-priority
payments before all preferential claims
are settled must “virtually guarantee” that
sufficient funds will remain to pay the higher-
priority claimants, a 6th U.S. Circuit Court of
Appeals panel said.
Dow Corning Corp. filed for Chapter 11 relief in
1995tohammeroutasettlementofthousands
of product liability suits related to breast
implants, according to the panel’s opinion.
Tens of thousands of implant recipients sued
Dow and other implant manufacturers after
the FDA ordered the removal of the products
from the market in 1992. Medical studies had
shown that exposure to silicone gel in the
implants could cause autoimmune reactions
such as lupus and rheumatoid arthritis.
In 1998 the U.S. Bankruptcy Court for the
Eastern District of Michigan confirmed
a reorganization plan providing up to
$2.35 billion to claimants who sought relief
through separate settlement or litigation
trust funds before the end of 2019.
The plan authorized the U.S. District Court for
the Eastern District of Michigan to resolve any
disputes or controversies over interpreting or
implementing the bankruptcy plan.
SETTLEMENT PAYMENT PRIORITIES
The settlement fund agreement created four
payment-priority categories, granting first
priority to payments based on the type of
claim as provided in a settlement value chart.
The second-priority category, consisting of
three subcategories, provided for premium
payments to claimants who had suffered
ruptures of implants, increased payments to
claimants whose conditions worsened, and
reimbursement to Dow for settlements paid
prior to the plan’s effective date, the opinion
said.
The agreement provided that the fund’s
finance committee must seek District Court
approval before distributing any second-
priority payments and could do so only if
“adequateprovisionhasbeenmadetoassure”
that all first-priority claims will be paid.
In 2011 the committee sought to distribute
50 percent of payments under the premium
subcategory before all higher-priority
payments were disbursed, based on an
estimate that more than $150 million would
remain after all priority payments were made.
A claimant’s advisory committee supported
the request, the opinion said.
Dow and affiliated parties opposed the
request, arguing that the ability to pay
out first-priority claims must be “virtually
guaranteed” and disputing the finance
committee’s estimates. They also argued
that all three second-priority subcategories
must be paid simultaneously.
In December 2013 the District Court
authorized the distributions, rejecting the
standard proposed by Dow, and declining to
address the question regarding the other two
subcategories.
The Dow parties appealed.
’VIRTUAL GUARANTEE’ VS.
‘ADEQUATE ASSURANCE’
The 6th Circuit panel said the District
Court abused its discretion by finding the
agreement’s provision for authorizing
second-priority payments required only
“adequate assurance” of payment rather
than a virtual guarantee.
“Adequate assurance” is a term of art from
Section 365(b)(1)(C) of the Bankruptcy
Code, 11 U.S.C.A. § 365(b)(1)(C), regarding
a trustee’s assurance of performance in
assuming a contract or lease after default.
“This level of assurance falls below ‘absolute
guarantee,’ … and can mean ‘a strong
likelihood’ … or ‘more probable than not,’”
the panel said, quoting various bankruptcy
court opinions.
Noting that the District Court construed the
term “assure” in the agreement as being
modified by “adequate provision,” the panel
said it was the other way around. “The
term ‘assure’ provides context for the term
‘adequate provision,’” they said.
Thepanelsaid“assure”means“guarantee”in
the context of the agreement, while stopping
short of requiring an absolute guarantee in
light of possible future uncertainties.
“We adopt the appellant’s terminology of
‘virtual guarantee’ to describe the required
confidence standard,” the panel said,
remanding for further proceedings consistent
with that interpretation.
The panel also reversed the District Court’s
judgment that it had discretion to ignore
reports and testimony offered by Dow to
challenge the finance committee’s estimates.
Finally, while declining to dispose of the
issue, the panel also noted the settlement
agreement’s express requirements that all
subcategories of second-priority claims be
made “on the same basis and with the same
priority.” WJ
Related Court Document:
Opinion: 2015 WL 348899
REUTERS/Benoit Tessier
Tens of thousands of breast implant recipients sued Dow and
other companies after the FDA ordered the removal of the
silicone products, like the one shown here, from the market in
1992.

TRANSVAGINAL MESH
Bard’s $2 million loss in first transvaginal mesh trial upheld
(Reuters Legal) – A federal judge in West Virginia has denied C.R. Bard’s bid to slash damages and get a new trial more
than a year after it was hit with a $2 million verdict in what was the first federal transvaginal mesh case to reach a jury.
Cisson v. C.R. Bard Inc., No. 11-195, order
denying motion for new trial issued (S.D. W.
Va. Jan. 20, 2015).
In a pair of rulings handed down Jan. 20,
U.S. District Judge Joseph R. Goodwin in the
Southern District of West Virginia said Bard
had not shown there were any reversible trial
errors, and rejected the company’s argument
that the $1.75 million in punitive damages
awarded to plaintiff Donna Cisson was too
high.
However, Judge Goodwin also rejected
Cisson’s request to declare unconstitutional
a law from Georgia, where she was implanted
with the device, that requires prevailing
plaintiffs in product liability actions to turn
over 75 percent of their punitive damages to
the state.
Judge Goodwin is overseeing more than
70,000lawsuitsagainstsevenmanufacturers
over transvaginal mesh devices, which have
been consolidated in the West Virginia
federal court.
Cisson’s 2011 lawsuit said she suffered
physical and emotional damage caused
by the Bard Avaulta Plus device she was
implanted with in 2009 to treat pelvic organ
prolapse. Her claims included design defect
and failure to warn.
Jurors returned a verdict for Cisson in August
2013, awarding $250,000 in compensatory
damages and $1.75 million in punitive
damages.
New Jersey-based Bard, a medical
equipment and device manufacturer, asked
Judge Goodwin to throw out the verdict
and hold a new trial, saying that evidentiary
errors had tainted the outcome.
Among those errors, Bard said in court
filings, was Judge Goodwin’s decision to
exclude evidence that the Avaulta Plus
had been approved by the Food and Drug
Administration, as well as a ruling that
allowed plaintiffs to use at trial a document
detailing one supplier’s concerns about using
polypropyleneresin—akeycomponentofthe
mesh — in devices permanently implanted in
humans.
Bard separately moved to slash Cisson’s
punitive damages award to $250,000,
saying $1.75 million was unfairly high and
unjustified by the evidence.
Judge Goodwin disagreed on both counts.
The trial was fair, and the punitive damages
reflected the jury’s view that Bard’s
“longstanding and continuous behavior
strongly indicates reprehensibility,” he wrote.
He also rejected Cisson’s motion to void the
Georgia law, which her lawyers said violated
the 14th Amendment’s Equal Protection
Clause and the Takings Clause in the Fifth
Amendment. The Georgia Supreme Court
had upheld the law, and other states had
affirmed the constitutionality of similar
statutes, Judge Goodwin wrote.
A lawyer for Cisson declined to comment, and
Bard did not immediately return a request
for comment. The company has previously
indicated it intends to appeal the verdict. WJ
Attorneys:
Plaintiff: Henry G. Garrard III, Blasingame Burch
Garrard & Ashley, Athens, Ga.; Paul Farrell,
Greene Ketchum Bailey Walker Farrell & Tweel,
Huntington, W.Va.; Anthony J. Majestro, Powell &
Majestro, Charleston, W.Va.
Defendant: Melissa F. Bird, Nelson Mullins Riley &
Scarborough, Huntington, W.Va.; Lori G. Cohen,
Greenberg Traurig LLP, Atlanta; Daniel Smulian,
Greenberg Traurig LLP, New York

FEBRUARY 10, 2015 n
VOLUME 21 n
PROSTHETIC HIP
Suit over cobalt exposure from hip implant dismissed
A woman who alleged a defective metal hip implant exposed her to high levels of cobalt has not provided enough
factual details to proceed with her product liability action, a New Jersey federal judge has ruled.
Becker et al. v. Smith & Nephew Inc. et al.,
No. 2:14-cv-05452 WHW-CLW, 2015 WL
268857 (D.N.J., Jan. 20, 2015).
Senior U.S. District Judge William H. Walls of
the District of New Jersey granted defendant
Smith & Nephew’s motion to dismiss the suit,
finding the “bare-bones” allegations in the
complaint could not support a claim for relief
under the New Jersey Products Liability Act,
N.J. Stat. Ann. § 2A:58C–1.
Plaintiff Deborah Becker has not specified
how the implant allegedly deviated from
its intended design or manufacturer
specifications or explained how Smith &
Nephew failed to adequately warn her, Judge
Walls said.
Becker underwent surgery in 2007 to install
a hip implant designed and manufactured by
Smith & Nephew, according to the suit.
Smith & Nephew issued a voluntary recall of
the metal implant in June 2012, but Becker
did not receive notice until April 2013, the
complaint said.
She said in the suit that she had the implant
removed that September after blood work
allegedly revealed high levels of cobalt in her
system.
Excessive exposure to cobalt can lead to
diseases of the heart muscle and nerve and
thyroid problems, according to the National
Institutes of Health.
Becker said Smith & Nephew was strictly
liable for her injuries under the New Jersey
Products Liability Act. She also asserted
claims for negligence, breach of express or
implied warranties, failure to warn, punitive
damages, and loss of consortium on behalf
of her husband.
Smith & Nephew argued in a dismissal
motion that the complaint was “fatally
flawed” because it does not specify the
particular model of hip implant at issue or
Becker’s alleged injuries.
Becker failed to indicate which theory of
products liability she intended to pursue
— manufacturer defect, design defect or
failure to warn — and she did not plead the
required elements of any theory, according to
a memorandum in support of the motion to
dismiss.
Smith & Nephew also said the exclusive
remedyforpersonalinjuryclaimsarisingfrom
product use in New Jersey is the Products
The plaintiff received her metal hip implant in 2007. Smith & Nephew recalled the device in June 2012, but the plaintiff says she did not
receive notice until April 2013. A diagram of a hip implant is shown here.
Courtesy of West Medical Litigator
Doctors removed the
plaintiff’s metal hip implant
after blood work revealed
high levels of cobalt in her
system, the suit said.
Liability Act, which does not recognize
common law claims of negligence or breach
of implied warranty.
Becker did not timely respond to the motion,
but her counsel sent a letter to the District
Court in December asking that the motion be
denied and enclosing her purported medical
records.
Judge Walls declined to accept the
supplementary materials and agreed with
Smith & Nephew that the complaint does
not allege enough facts to support a product
liability claim under any of theory of recovery.
The suit does not specify how the implant
was defective or how it proximately caused
Becker’s alleged injuries, Judge Walls said.
The judge said Becker’s negligence and
breach-of-warranty claims are subject
to dismissal under the Products Liability
Act, and the punitive damages and loss of
consortium claims fail because they are
derivative.
He gave Becker 90 days to amend her suit.
WJ
Attorneys:
Plaintiffs: John S. Voynick Jr., Renda & Voynick,
Cedar Grove, N.J.
Defendant: Glenn S. Kerner, Goodwin Procter
LLP, New York
Opinion: 2015 WL 268857

PAIN PUMP
9th Circuit reverses preemption ruling in pain-pump suit
(Reuters Legal) – A federal appeals court has ordered a new trial in a lawsuit over injuries allegedly caused by a
pain-medication pump made by I-Flow Corp. and DJO Inc., after finding the lower court had mistakenly believed that
the plaintiff’s jury instructions regarding state law claims were preempted by federal law.
McClellan v. I-Flow Corp. et al., No. 11-35109,
2015 WL 294292 (9th Cir. Jan. 23, 2015).
In a unanimous Jan. 23 opinion, a three-
judge panel of the 9th U.S. Circuit Court of
Appeals said plaintiff Christina McClellan’s
proposed instructions related to state law
claims for negligence and strict liability
did not encroach on the U.S. Food and
Drug Administration’s authority under
the Medical Device Amendments of 1976,
which established the federal framework for
regulating medical devices.
“[T]here is no suggestion that Congress intended
to displace traditional tort law by making all policing of
medical labels and warnings the exclusive province of the
FDA,” the 9th Circuit said.
The case went to trial in 2010. McClellan’s
attorneys requested that jurors be instructed
on applicable federal safety standards
and the legal consequences of violating
those laws to prove her allegations that the
company had acted negligently under state
law.
But U.S. District Judge Ann Aiken in Oregon
denied that request, saying McClellan’s
argument that the companies had violated
federal law was preempted.
Judgment was returned for the defendants,
and McClellan appealed to the 9th Circuit,
arguing that the preemption decision was
wrong.
In response, I-Flow and DJO pointed to
Buckman v. Plaintiffs’ Legal Committee,
531 U.S. 341 (2001), a 2001 ruling from the
U.S. Supreme Court. Plaintiffs in that case
accused Buckman Co. of misleading the
FDA to secure approval for bone screws. But
the high court held that those claims were
preempted because allowing plaintiffs to
sue in state court would impede the agency’s
ability to police medical devices.
In its opinion, the 9th Circuit rejected I-Flow
and DJO’s attempt to apply Buckman.
McClellan was not arguing that the
defendants had defrauded the FDA, but
rather that the companies should have given
better warnings, they wrote.
“[T]here is no suggestion that Congress
intended to displace traditional tort law by
making all policing of medical labels and
warnings the exclusive province of the FDA,”
wrote U.S. Circuit Judge Alfred Goodwin,
joined by Circuit Judges Harry Pregerson and
Morgan Christen.
The panel vacated judgment and ordered a
new trial.
Lawyers for McClellan and I-Flow did not
return requests for comment. A lawyer for
DJO, Richard Nakamura, said the company
was reviewing the decision. WJ
Attorneys:
Defendant-appellant (I-Flow): Andrew G. Klevorn,
Katten Muchin Rosenman, Chicago
Defendant-appellant (DJO): Richard H. Nakamura
Jr., Morris Polich & Purdy, Los Angeles
Plaintiff-appellee: Leslie W. O’Leary, Williams
O’Leary, Portland, Ore.
Opinion: 2015 WL 294292
McClellan filed suit in 2007 in the U.S.
District Court for the District of Oregon
claiming that, following shoulder surgery,
she was implanted with the PainBuster
pump to provide a continuous infusion of
pain medication. The PainBuster was made
by I-Flow, which was acquired in 2009 by
Dallas-based Kimberly Clark Corp., and
DJO Inc., a San-Diego based medical device
company.
She said problems with the device caused
her to develop chondrolysis of the shoulder,
which causes the loss of cartilage in the
main shoulder joint, and that she had been
inadequately warned about that risk.

FEBRUARY 10, 2015 n
VOLUME 21 n
SURGICAL STAPLER
Discovery limits set in Minnesota surgical stapler injury suit
By Ronald V. Baker, Senior Legal Writer, Westlaw Journals
Ethicon Endo-Surgery Inc. must produce adverse incident reports and other documents related to its TX model surgical
stapler in a suit that alleges a woman was injured when one of the tools malfunctioned during a throat operation.
Webb v. Ethicon Endo-Surgery Inc.,
No. 13-1947, 2015 WL 317215 (D. Minn.
Jan. 26, 2015).
U.S. District Judge John R. Tunheim of the
District of Minnesota ordered Ethicon to
produce data related to problems with the
entire line of TX surgical staplers, which
dates back to 1996, for plaintiff Susan Webb.
The judge said the requested material
is narrowly tailored to products similar
to the Model TX60B surgical stapler
used during Webb’s 2009 operation.
The hand stitching eventually allowed
a postoperative leak, leading to Webb’s
re-hospitalization, corrective surgery, and
what she calls “persistent and permanent
health effects.”
The suit includes claims for strict product
liability, negligent manufacture and breach
of the warranty of merchantability.
Aside from moving to quash Webb’s
discovery requests, Ethicon sought to limit
any discovery, if approved, to the TX60B
model stapler.
The plaintiff says she was injured when an Ethicon TX60B
surgical stapler used during a tumor removal procedure failed,
forcing her surgeon to hand-stitch the incision.
He adopted a magistrate judge’s report and
recommendation on Ethicon’s motion for
protective orders and a request to quash
Webb’s discovery request.
Webb sued Ethicon in 2013, claiming she
sustained permanent injuries when the
TX60B surgical stapler her surgeon tried
to use during a procedure to remove an
esophageal tumor failed to fire. Because the
device could not close an internal incision,
the surgeon was forced to hand-stitch a
suture line, the suit said.
It told the court that a search for data on all
similar TX model proximate linear staplers
could cost it $62,400. That, the company
said, would pose a disproportionate financial
burden given that Webb claims damages
“well in excess of $50,000.”
In an Aug. 8, 2014, discovery order, U.S.
Magistrate Judge Jeanne J. Graham partially
granted Webb’s discovery motion, restricting
its scope to the TX model line.
Judge Tunheim said Judge Graham
“appropriately took expense, burden,
and likely benefit into account” in her
recommendations. He noted that Judge
Graham heard testimony from Ethicon
research and development project director
Michael Cronin, who explained that requiring
discovery beyond Ethicon’s TX model
products would offer little benefit, given the
differences in design and manufacture of
non-TX staplers.
“The magistrate judge concluded that a key
issue in this case is how the stapler used in
Webb’s surgery compares to similar staplers
that may share a record of analogous
accidents or injuries, and these stark
differences are highly relevant to that issue,”
Judge Tunheim said. WJ
Attorneys:
Plaintiff: William L. Tilton, Michael J. Gross,
George R. Dunn and Grace Davies, Tilton &
Dunn, St. Paul, Minn.
Defendant: David R. Noteware, Janelle L. Davis
and Timothy E. Hudson, Thompson & Knight,
Dallas; Kim M. Schmid and Sheryl A. Bjork,
Bowman & Brooke, Minneapolis
Memorandum opinion and order:
2015 WL 317215
See Document Section B (P. 31) for the
memorandum opinion and order.

VASCULAR GRAFT (PATENTS)
Bard wins $208 million more in medical
device patent battle with Gore
(Reuters Legal) – C.R. Bard Inc. has won the latest round in a patent fight
with W.L. Gore & Associates Inc. over prosthetic vascular grafts used in sur-
gery, in a decision that will increase a judgment that has already reached
$1 billion.
Bard Peripheral Vascular Inc. et al. v. W.L.
Gore & Associates Inc., No. 2014-1114,
2015 WL 151557 (Fed. Cir. Jan. 13, 2015).
The U.S. Court of Appeals for the Federal
Circuit on Jan. 13 affirmed that Gore had
willfully infringed Bard’s patent. Lawyers
familiar with the case said the decision would
increase the award by another $208 million.
The appeals court had ruled in 2012 that
Gore infringed a patent for a vascular graft
but, in an en banc decision by all the judges
In the latest round, Gore had argued that the
infringement was not willful because a Gore
employee, Peter Cooper, originally supplied
the tubing used to make the graft and was
thus an unnamed co-inventor.
The appeals court also rebuffed Gore’s
assertion that only C.R. Bard had standing
to allege infringement, not others named as
plaintiffs: Bard Peripheral Vascular Inc. and
David Goldfarb, who was granted the original
patent.
Bard received nearly $1 billion in damages in
2013, and this decision will add another $208
million or so, according to lawyers familiar
with the case.
A Gore spokeswoman said that the company
was disappointed in the ruling but that the
decision would not cause disruption.
“We have paid Bard all outstanding damages
owed pursuant to the court’s orders, except
for approximately $208 million in willfulness
damages, which have been in escrow
pending the outcome of this appeal,” said
Jenny Maher in an email. WJ
(Reporting by Diane Bartz)
Attorneys:
Plaintiffs-appellees: Michael W. McConnell,
Kirkland & Ellis, Washington
Defendant-appellant: James W. Poradek, Faegre
Baker Daniels LLP, Minneapolis
Opinion: 2015 WL 151557
See Document Section C (P. 37) for the opinion.
C.R. Bard Inc. received
nearly $1 billion in damages
in 2013, and this decision
will add another
$208 million or so,
according to lawyers
familiar with the case.
in the court, asked the U.S. District Court in
Arizona, where the case began in 2003, to
reconsider its decision that Gore had willfully
infringed. Bard Peripheral Vascular et al. v.
W.L. Gore & Assocs., 682 F.3d 1003 (Fed. Cir.
2012).
The lower court again found that the
infringement was willful. Bard Peripheral
Vascular et al. v. W.L. Gore & Assocs., 2013 WL
5670909 (D. Ariz. Oct. 17, 2013).
UNCOVER
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Learn more at TRexpertwitness.com/
intelligence.

FEBRUARY 10, 2015 n
VOLUME 21 n
NEEDLE DEVICE (TRADEMARKS)
Judge refuses to toss needle device
trademark suit
A dispute over when a trademarked device used to protect health care work-
ers from needle injuries was first used in commerce was sufficient to doom
a competing device manufacturer’s motion for summary judgment in an
infringement suit against it, a federal judge has ruled.
Grey Matter Medical Products LLC v.
Schreiner Group LP et al., No. 13-5861, 2015
WL 106199 (W.D. Wash., Tacoma Div.
Jan. 7, 2015).
Grey Matter Medical Products raised
sufficient factual questions about when
its NeedleTrap device had been used in
commerce to defeat the motion by Schreiner
Group, U.S. District Judge Benjamin H. Settle
of the Western District of Washington said.
Matter had abandoned the mark and that
the plaintiff had no trademark to enforce
under state law.
In response, Grey Matter countered that
its market research, a 2005 sales pitch,
disclosures to manufacturers, and Food
and Drug Administration approval activities
established its right to use the trademark.
Judge Settle denied Schreiner’s motion,
saying that under the “totality of the
circumstances,” Grey Matter had submitted
sufficient evidence to defeat the motion
on the issue of commercial use. He noted,
however, that the FDA approval activities are
one of the “less traditional” trademark uses
that Congress intended to protect.
Grey Matter also submitted sufficient
evidence of sporadic use of the trademark to
defeat Schreiner’s claims of abandonment,
and evidence of website activity in
Washington state created material questions
of fact regarding its state law claims, the
judge said. WJ
Order: 2015 WL 106199
REUTERS/Gael Gonzalez
Under the “totality of the circumstances,” the plaintiff had
submitted sufficient evidence to defeat the defendant’s
summary judgment motion on the issue of commercial use.
Grey Matter sued Schreiner on Oct. 1, 2013,
for alleged infringement of its NeedleTrap
trademark, used in connection with a one-
handed device to recap needles.
According to the judge’s order, Grey Matter
owner Cory Dobak developed the device to
protect health care workers from being stuck
by needles.
Dobak said the NeedleTrap mark was first
used in commerce in August 2005, when
he transported the device from Oregon to
a hospital in Spokane, Wash. Grey Matter
registered the trademark in March 2009.
Schreiner markets a similar device called the
Needle-Trap, for which it sought trademark
registration in 2012. The U.S. Patent and
Trademark Office denied the application
because of Grey Matter’s existing trademark.
Under federal trademark law, 15 U.S.C. § 1127,
the “use in commerce” requirement for a
trademark is met when a mark is placed on
goods which are then “sold or transported in
commerce.”
Schreiner moved for summary judgment last
November, asserting that Grey Matter’s mark
had not been used in commerce, that Grey
WESTLAW JOURNAL
PHARMACEUTICAL
This publication provides
up-to-date information
on developments in
litigation, legislation, and
regulation involving the
pharmaceutical industry,
with reproductions of the
leading court opinions,
complaints, briefs, and
responses. The lawsuits
covered range from
product liability suits
to patent infringement,
and from wrongful death
to FDA approval. This
publication is critical to
anyone who needs to
keep up-to-date on FDA
regulation, negligence and
standards of care, generic
competition, Daubert
issues, trade secrets, and
wrongful death.

TRANSVAGINAL MESH
Plaintiffs’ lawyers reject J&J claims of fraud in mesh lawsuits
(Reuters) – Lawyers for thousands of women suing Johnson & Johnson’s Ethicon Inc. over transvaginal mesh devices are
fighting back against the company’s claim that illegal phone solicitations may have resulted in baseless lawsuits.
In re Ethicon Inc. Pelvic Repair System
Products Liability Litigation, No. 2:12-
md-2327, response brief filed (S.D. W. Va.,
Charleston Div. Jan. 22, 2015).
Plaintiffs’ lawyers said in a court filing Jan. 22
therewas“noevidenceoffraud”taintingnearly
23,000 federal mesh injury lawsuits, which
have been consolidated before U.S. District
Judge Joseph R. Goodwin in the Southern
District of West Virginia.
The filing came in response to a Jan. 14
motion from Johnson & Johnson asking
Judge Goodwin to allow an investigation into
whether women are being illegally solicited
to join mesh litigation by unknown callers,
some of whom seemed to have knowledge
of private medical data. The company said
it was concerned the calls may have resulted
in bogus claims.
J&J has asked Judge Goodwin to make
plaintiffs offer proof they had been injured
by an Ethicon device, and have their lawyers
answer questions under oath about any
knowledge of solicitation calls.
While strongly denouncing the “rogue
call center’s shenanigans,” lead plaintiffs’
lawyers said J&J was using the calls to justify
imposing unnecessary and burdensome
measures that “would grind this litigation to
a screeching halt.”
Lead plaintiffs’ counsel said they had raised
a similar issue more than a year ago with
Judge Goodwin, after several clients told
them they had received, unsolicited, a letter
from a call center bearing the U.S. Food and
Drug Administration’s logo and promising
$25,000 in compensation. They turned the
letter over to the judge and asked him to
investigate, the filing said.
“We thought it was improper at the time, and
still do,” said plaintiffs’ lawyer Henry Garrard
in an email.
J&J could show no direct link between the
calls and plaintiffs’ firms, the filing said.
Furthermore, random sampling of the
Ethicon cases last year showed that plaintiffs
had all been implanted with mesh, although
a handful had mistakenly identified the
maker of their device, the filing said.
Ethicon spokeswoman Samantha Lucas said
the company was still reviewing the filing.
“Based on the reports we received, we were
compelled to report these activities to the
judge,” she said in a statement.
Ethicon is one of seven companies that
collectively face more than 70,000 suits
before Judge Goodwin over transvaginal
mesh devices, used to treat stress urinary
incontinence and pelvic organ prolapse.
Women claim the devices were defective,
resulting in painful complications like
infection, nerve damage and bleeding. WJ
(Reporting by Jessica Dye; editing by Alexia
Garamfalvi and David Gregorio)
WestlaW journal insurance Bad Faith
this publication brings you detailed, timely and comprehensive
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FEBRUARY 10, 2015 n
VOLUME 21 n
REGULATORY ACTION
U.S. blocks sales of laser treatment
product
(Reuters Legal) – The U.S. government has won an injunction blocking a
South Dakota company from selling laser devices for home use that
purportedly treat a wide range of illnesses including AIDS and cancer.
United States v. 2035 Inc. et al., No. 5:14-
cv-5075, 2015 WL 213170 (D.S.D., W. Div.
Jan. 14, 2015).
The Department of Justice said Jan. 16 that
Judge Jeffrey L. Viken of the District of South
Dakota had entered a preliminary injunction
against QLasers PMA and its president,
Robert Lytle, two days earlier.
In October the DOJ sued Lytle, who was a
dentist until 1998 when he lost his license,
claiming he marketed his QLaser products as
a medical treatment without approval from
the Food and Drug Administration.
QLaser’swebsiteclaimstheproductsuse“bio
photonic energy that actually communicates
with the cells” to treat ailments.
The DOJ claimed Lytle had marketed
his products as a treatment for diseases
including cancer, AIDS and diabetes. It
said the FDA had approved two of Lytle’s
products for short-term pain relief in arthritis
patients but had never approved them for
any other use, and there was no evidence
that they were effective.
According to the October lawsuit, the
FDA repeatedly told Lytle he was violating
federal law, but he refused to stop selling his
products.
Judge Viken said in his Jan. 14 order that the
government was likely to succeed on the
merits.
South Dakota U.S.Attorney Brendan Johnson
said in a press release that the injunction
would give consumers “a new sense of
confidence.”
Lytle, who does not have an attorney, could
not be reached for comment. WJ
(Reporting by Brendan Pierson)
Attorneys:
Plaintiff: Camela C. Theeler, U.S. attorney’s office,
Sioux Falls, S.D.
Defendant: Robert L. Lytle, Rapid City, S.D., pro se
Order: 2015 WL 213170
QLaser’s website claimed the products use “bio photonic energy that actually communicates with the cells” to treat ailments, the
Department of Justice said.
WESTLAW JOURNAL
HEALTH LAW
As the health litigation
arena becomes more
complex, and laws
and regulations keep
changing, you can rely on
this reporter to provide
comprehensive coverage
of the latest developments
in all aspects of the field
of health care law. Each
issue details cases and
legislation regarding
such topics as hospital
billing, health insurance
disputes, health provider
contracts, malpractice,
legislation such as
EMTALA, ERISA, and
HCQIA, abortions, medical
devices, pharmaceuticals
and vaccines, diet drugs,
medical marijuana, AIDS,
the duty of care and
confidentiality.

The ruling follows Judge Seabright’s April
2014 decision in the product liability suit,
in which he granted Medtronic’s dismissal
motion but allowed Beavers-Gabriel to file
an amended complaint. Beavers-Gabriel v.
Medtronic Inc. et al., 15 F. Supp. 3d 1021 (D.
Haw. 2014) (see Westlaw Journal Medical
Devices, Vol. 21, Iss. 5, 21 No. 5 WJMEDDEV 5).
Beavers-Gabrielallegesthatduringher2008
spinal operation her surgeon used the Infuse
device in an “off label” manner not specified
by U.S. Food and Drug Administration
labeling.
The FDA’s approval of the Infuse system is
limited to anterior lumbar interbody fusion,
or ALIF, surgeries, according to the judge’s
order. The device consists of a sponge-like
pad soaked with a bone-growth-promoting
protein, rhBMP-2, and placed inside a
Medtronic metallic screen-like enclosure
called the LT-Cage.
Beavers-Gabriel says that, at the suggestion
of Medtronic sales representatives, her
surgeon instead placed rhBMP-2 both inside
and outside cages made by other companies
and failed to use the anterior approach,
operating from the front of the body, as the
FDA required.
The off-label use of the device caused
uncontrolled bone growth and spinal nerve
damage, she says.
Her amended complaint asserted causes of
actionforfraudulentmisrepresentation,fraud
by omission, negligent misrepresentation,
strict product liability for failure to warn the
FDA, negligent failure to warn the FDA and
breach of express warranty.
Medtronic moved for dismissal, again
alleging federal preemption and lack of
plausible claims. Judge Seabright denied
the motion and allowed the suit to proceed.
The judge called “misdirected” Medtronic’s
assertion that Beavers-Gabriel’s fraud-by-
omission claim was an attack on Infuse’s
FDA-approved labeling, which the company
said did, in fact, warn that off-label surgical
procedures could cause unwanted bone
growth.
Those materials typically directed surgeons
to off-label uses, since Graham does not
perform ALIF procedures, the judge said.
Beavers-Gabriel also says that Graham
relied on Cloward, who attended nearly every
procedure in which he used Infuse, to provide
updated dosing rates for off-label Infuse
surgeries.
Beavers-Gabriel claims that Cloward gave
dosing suggestions even though “there is
insufficient evidence on proper dosages of
rhBMP-2 for use in unapproved procedures.”
Judge Seabright also decided that Beavers-
Gabriel sufficiently claims that Medtronic’s
failure to report off-label-related adverse
events to the FDA caused her harm in the
long run. With Medtronic keeping such data
from the FDA, the judge said, surgeons like
Graham chose Infuse based partially on
incomplete FDA information.
He said the plaintiff does not need to provide
evidence of specific Medtronic reporting
failures because the information she offers
sufficiently indicates there were general
reporting lapses.
“Thus, these allegations suggest that
Medtronic’s alleged widespread failure to
report adverse events to the FDA contributed
to Dr. Graham’s decision to use the Infuse
device for the plaintiff’s surgery,” Judge
Seabright said. WJ
Attorneys:
Plaintiff: Marlene J. Goldenberg and Stuart L.
Goldenberg, GoldenbergLaw, Minneapolis;
Wayne D. Parsons, Honolulu
Defendant: Corlis J. Chang and Thomas Benedict,
Goodsill Anderson Quinn & Stifel, Honolulu;
Lisa M. Baird and Michael K. Brown, Reed Smith,
Los Angeles
Order: 2015 WL 143944
See Document Section A (P. 19) for the order.
Bone-growth device
CONTINUED FROM PAGE 1
The judge said the plaintiff
sufficiently claims that
Medtronic’s failure to report
off-label-related adverse
events to the FDA caused
her harm in the long run.
The claims, Medtronic said, impermissibly
challenge the label’s sufficiency.
Beavers-Gabriel’s fraud-by-omission claim,
the judge said, is not aimed at Infuse’s
labeling. Instead, it targets Medtronic’s
alleged failure to disclose relevant
information on the off-label use of Infuse to
the FDA and her surgeon, Dr. Jon Graham.
Judge Seabright said the fraud claim can
proceed because it does not challenge the
device’s labeling.
“Indeed, the representations and omissions
plaintiff has identified are not directed to
labeling,butratherdirectedtothestatements
and omissions Medtronic has made outside
of the labeling and in promoting the Infuse
device for off-label purposes (and after the
labeling was approved),” the judge said.
He noted that Beavers-Gabriel has data to
support her negligent-misrepresentation
claim through her allegation that Medtronic
representative Geoff Cloward responded to
Graham’s request for literature on Infuse with
subjective promotional materials.

FEBRUARY 10, 2015 n
VOLUME 21 n
NEWS IN BRIEF
BREAST CANCER PATIENT SAYS INFECTION CAUSED MEMORY LOSS
A breast cancer patient alleges in Oregon state court that an infected tissue expander device
caused her to suffer permanent disfigurement and memory loss. The suit says physicians at
Oregon Health and Sciences University failed to recognize the severity of Kathleen S. Houck’s
infection and provide necessary treatment. Houck, who was diagnosed with breast cancer in
January 2011, underwent chemotherapy treatment and surgery to implant a tissue expander
device. The expander became infected and caused Houck pain, and OHSU physicians performed
six corrective surgeries to clean the expander before removing it entirely, the suit says. Houck
alleges the lingering infection caused her to develop cellulitis and a painfully tight scar. She
seeks $590,000 in economic damages for medical expenses and lost income, plus $409,000
for pain and suffering.
Houck v. Oregon Health and Sciences University et al., No. 15-CV-00043, complaint filed (Or.
Cir. Ct., Multnomah County Jan. 2, 2015).
Complaint: 2015 WL 40468
FDA APPROVES FIRST GLUCOSE MONITORING MOBILE APP
The U.S. Food and Drug Administration has approved Dexcom Inc.’s Dexcom Share glucose
monitoring mobile app, allowing people with diabetes to quickly share data from a blood sugar
monitoring device with a doctor or other medical professional. In a Jan. 23 announcement the
FDA said that while similar units are on the market, the Dexcom Share is the first to receive
the agency’s certification. The externally worn unit uses a small sensor, implanted just under
the skin, to provide a stream of data on the user’s glucose levels. The regular reporting allows
patients to quickly determine if their blood sugar rates are out of range and must be adjusted.
The system does not replace the need for real-time or standard, at-home blood glucose meters,
the FDA said.
MINORS SHOULD LIMIT USE OF BONE GROWTH SUBSTITUTES, FDA SAYS
People under age 18 should not routinely receive treatment using bone graft substitutes that
contain synthetic peptides or recombinate proteins, the U.S. Food and Drug Administration said
in a Jan. 21 statement. The agency said that while the use of such devices has caused excess bone
growth, fluid accumulation and inhibited healing in adults, the issues are more critical in those
under 18, who are smaller and whose bones are still growing. Any product that affects bone
growth could have a negative impact on skeletal growth by altering normal bone formulation
and growth, the FDA said. Potential problems include the tightening of bone clearances around
the spinal cord.
WESTLAW JOURNAL
HEALTH CARE
FRAUD
This reporter provides
up-to-date coverage of
federal civil and criminal
actions involving health
care fraud. The publication
features commentary
from leading health care
practitioners and provides
nationwide reporting on
litigation and legislation
involving Medicare/
Medicaid fraud, consumer
fraud, nursing home fraud,
False Claims Act, qui tam
actions, the anti-kickback
statute, misappropriation,
and breach of fiduciary duty

CASE AND DOCUMENT INDEX
Bard Peripheral Vascular Inc. et al. v. W.L. Gore & Associates Inc., No. 2014-1114, 2015 WL 151557 (Fed. Cir. Jan. 13, 2015)........................................... 12
Document Section C......................................................................................................................................................................................................37
Beavers-Gabriel v. Medtronic Inc. et al., No. 1:13-cv-00686, 2015 WL 143944 (D. Haw. Jan. 9, 2015)................................................................................1
Document Section A..................................................................................................................................................................................................... 19
Becker et al. v. Smith & Nephew Inc. et al., No. 2:14-cv-05452 WHW-CLW, 2015 WL 268857 (D.N.J., Jan. 20, 2015).....................................................9
Budke v. Ethicon Inc., No. 10CM-CC00085, settlement announced (Mo. Cir. Ct., Camden County Jan 21, 2015).............................................................6
Cisson v. C.R. Bard Inc., No. 11-195, order denying motion for new trial issued (S.D. W. Va. Jan. 20, 2015)........................................................................8
Grey Matter Medical Products LLC v. Schreiner Group LP et al., No. 13-5861, 2015 WL 106199 (W.D. Wash., Tacoma Div. Jan. 7, 2015)........................13
Houck v. Oregon Health and Sciences University et al., No. 15-CV-00043, complaint filed (Ore. Cir. Ct., Multnomah County Jan. 2, 2015)..................17
In re Ethicon Inc. Pelvic Repair System Products Liability Litigation, No. 2:12-md-2327, response brief filed (S.D. W. Va.,
Charleston Div. Jan. 22, 2015)............................................................................................................................................................................................. 14
In re Settlement Facility Dow Corning Trust; Dow Corning Corp. et al. v. Claimant’s Advisory Committee et al.,
No. 14-1090, 2015 WL 348899 (6th Cir. Jan. 27, 2015)........................................................................................................................................................7
McClellan v. I-Flow Corp. et al., No. 11-35109, 2015 WL 294292 (9th Cir. Jan. 23, 2015).................................................................................................. 10
United States v. 2035 Inc. et al., No. 5:14-cv-5075, 2015 WL 213170 (D.S.D., W. Div. Jan. 14, 2015)............................................................................... 15
Webb v. Ethicon Endo-Surgery Inc., No. 13-1947, 2015 WL 317215 (D. Minn. Jan. 26, 2015)............................................................................................. 11
Document Section B.......................................................................................................................................................................................................31

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