Alison Beavan v. Allergan U.S.A., Inc. ( 2024 )

NOT FOR PUBLICATION WITHOUT THE
APPROVAL OF THE APPELLATE DIVISION
This opinion shall not "constitute precedent or be binding upon any court ." Although it is posted on the
internet, this opinion is binding only on the parties in the case and its use in other cases is limited. R. 1:36-3.
SUPERIOR COURT OF NEW JERSEY
APPELLATE DIVISION
DOCKET NO. A-1501-23
ALISON BEAVAN,
Plaintiff-Respondent,
v.
ALLERGAN U.S.A., INC.,
Defendant-Appellant,
and
ALLERGAN INC., f/k/a INAMED
CORPORATION, ALLERGAN PLC,
and ABBVIE INC.,
Defendants.
_______________________________
Argued November 14, 2024 – Decided November 21, 2024
Before Judges Mawla and Vinci.
On appeal from an interlocutory order of the Superior
Court of New Jersey, Law Division, Morris County,
Docket No. L-0151-21.
Daniel B. Rogers (Shook, Hardy & Bacon, LLP) of the
Florida bar, admitted pro hac vice, argued the cause for
appellant (Schenck Price Smith & King, LLP, and
Daniel B. Rogers, attorneys; Timothy I. Duffy and
Jonathan F. Donath, on the briefs).
Thomas S. Alch and Dennis M. Donnelly argued the
cause for respondent (The Donnelly Law Firm, LLC,
attorneys; Dennis M. Donnelly, on the brief).
Natalie H. Mantell argued the cause for amicus curiae
Healthcare Institute of New Jersey and New Jersey
Business & Industry Association (McCarter & English,
LLP, attorneys; Natalie H. Mantell, of counsel and on
the brief; Leroy E. Foster, on the brief).
Reed Smith, LLP, and Barnes & Thornburg, LLP,
attorneys for amicus curiae The Product Liability
Advisory Council, Inc., and the Chamber of Commerce
of the United States of America (Melissa Geist,
Michael C. Zogby, and Kaitlyn Stone, on the brief).
PER CURIAM
We granted defendant Allergan U.S., Inc. leave to appeal from: two orders
entered on May 26, 2023, denying its motions for summary judgment and to bar
plaintiff Alison Beavan's experts; and a November 13, 2023 order denying
defendant's motion for reconsideration. Having considered the record on appeal,
we affirm in part and reverse in part, for the reasons expressed in this opinion.
Plaintiff had a history of various eye diseases, including non-infectious
chronic uveitis and cystoid macular edema. She also suffered from chronic eye
inflammation and was a smoker, which caused additional inflammation.
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2
In July 2015, plaintiff became a patient of the Retinal Group of
Washington under the care of Dr. William Phillips, a retina specialist and
vitreoretinal surgeon. She received treatments over the course of three years,
including ten injections of Ozurdex in both eyes, a trabeculectomy, two
vitrectomy procedures, a silicone coated Retisert tablet implant, which later
became dislocated, and had a right eye cataract extraction.
This appeal concerns Ozurdex, a prescription drug manufactured by
defendant to treat various eye diseases, including non-infectious uveitis. It is a
dexamethasone implant (pellet) preloaded in a single-use applicator, which is
injected into the vitreous of the eye.
On November 6, 2018, Dr. Phillips administered an Ozurdex injection into
plaintiff's left eye from Ozurdex Lot #E82852. A week later, plaintiff returned
to his office with new complaints of severe left eye blurred vision, decreased
vision, and a blind spot. Dr. Phillips diagnosed plaintiff with retinal detachment.
The following day, he performed a pars plana vitrectomy on plaintiff's left eye
to treat the retinal detachment. Plaintiff was referred to a cornea specialist, Dr.
Jonathan D. Solomon, who diagnosed her with corneal degeneration, secondary
to a contaminated pellet injection in the left eye.
A-1501-23
3
On June 21, 2018, defendant became aware that "[d]uring a routine
manufacturing inspection, a silicone particulate, approximately 300 microns in
diameter, was observed in dispensed Ozurdex implants." Those inspection
results were memorialized in a July 2018 Initial Nevada Field Alert. By mid-
September 2018, defendant began recalling certain Ozurdex lots in foreign
countries where affected lots were distributed and reported the Nevada Field
Alert inspection results to the Food and Drug Administration (FDA).
At that time, defendant knew the defect existed in 2.2% of the units
contained in Ozurdex Lot #E82852. Defendant nonetheless distributed that lot
and twenty-one others to patients in consideration of drug shortage directives
issued by the FDA.
On October 3, 2018, defendant submitted a draft Dear Health Care
Provider (DHCP) letter to the FDA for approval to inform physicians of its
findings regarding the affected lots. The letter advised of the potential product
defect, the clinical implications, and that "extra-vigilance on behalf of clinicians
and patients is required." According to defendant's epidemiology and FDA
expert, before plaintiff received her injection, defendant had made "over
[twenty] attempts to obtain authorization from [the] FDA to communicate [with]
U.S. healthcare providers about the silicone particulate issue." On October 17,
A-1501-23
4
2018, the FDA advised defendant that it believed the defect was "not a safety
concern[,]" but a "product quality" issue. As a result, defendant did not issue
the DHCP letter. Nonetheless, the FDA recommended defendant "address the
problem."
On December 28, 2018, defendant issued an urgent drug recall of Ozurdex
in the United States with FDA approval, which included Lot #E82852. The
reason for the recall was the possibility of a silicone particulate discharge when
dispensed with the unit. The recall notice advised the health hazards associated
with the defective product were: "mild transient visual disturbance or
intraocular inflammatory reaction in sensitive patients[;] . . . corneal reaction if
the particulate migrates to the anterior chamber[;]" and "overall risk probability
is considered low." Defendant conducted a study of Ozurdex on animal subjects
between January and October 2019, which found "no abnormal findings related
to the silicone particles in the . . . eyes by ocular, ophthalmic, intraocular
pressure, or histopathologic examination."
Dr. Phillips became aware of the recall in early 2019 and discussed the
matter with plaintiff on January 15, 2019. Prior to her final Ozurdex injection,
plaintiff's vision was 20/100. By February 1, 2019, she was blind in her left eye.
A-1501-23
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On November 5, 2020, plaintiff filed a complaint against defendant 1
alleging: negligence; strict products liability under the New Jersey Products
Liability Act (PLA), N.J.S.A. 2A:58C-1 to 11; and breach of implied warranty.
She sought damages for the complete loss of vision in her left eye, which she
attributed to a dose of Ozurdex that was manufactured by defendant.
The PLA count alleged defendant's product "was defective and dangerous,
both in warning, manufacture and in design, thereby rendering [it] unsafe for its
intended use and that the defects were a direct and proximate cause of the
injury." Defendant's answer denied liability and asserted various defenses,
including that plaintiff's claims were preempted by the Federal Food, Drug, and
Cosmetic Act (FDCA), 21 U.S.C. § 301.
Plaintiff offered expert testimony from Dr. Maziar Lalezary, a Board-
Certified Ophthalmologist and a Vitreo-Retinal Surgical Fellow, who opined the
silicone particulate proximately caused plaintiff's injuries. She also designated
Dr. Phillips to testify regarding causation. Like Dr. Lalezary, he opined the
silicone particulate proximately caused plaintiff's injuries.
Defendant moved for summary judgment on the PLA count and to bar
plaintiff's expert opinions as net opinions. It argued the court should dismiss
1
The other named defendants are not a part of this case.
A-1501-23
6
the complaint because there was no evidence the Ozurdex applicator had a
manufacturing defect or that a silicone particulate ever entered plaintiff's eye.
Defendant also sought summary judgment because its alleged failure to timely
warn of a recall was preempted as a matter of law.
Defendant's motion to bar the experts argued they each failed to provide
a reliable basis to support their opinions that the silicone particulate could cause
inflammation, retinal detachment, corneal damage, or loss of vision. The
experts failed to show the Ozurdex unit administered to plaintiff contained a
silicone particulate that caused her injuries. Also, the experts were unqualified
to opine about how defendant should have warned doctors about the risk of
silicone particulate associated with the Ozurdex recall.
Following oral argument, the trial court issued the May 26, 2023 orders
accompanied by written opinions denying defendant's motions. It found a
dispute of material facts because plaintiff's experts opined the Ozurdex "was
defective with a silicone particulate that proximately caused [p]laintiff's injuries
. . . ." The court noted Dr. Lalezary opined "the particulate caused inflammation
and traction in [plaintiff's] peripheral retina that induced a retinal break and l ed
to her retinal detachment. And subsequently, she had detachment repair that led
to the anterior migration of the Ozurdex pellet." The doctor opined plaintiff's
A-1501-23
7
vision was compromised "because a patient with uveitis that develops a retinal
detachment has a poor prognosis for recovery and vision."
The court also noted plaintiff "present[ed] testimony from [d]efendant's
. . . expert that the disbursement of a silicone particulate would deviate from
[defendant's] own performance standards for the product, and that the Ozurdex
applicator was not designed to dispense a silicone particulate with the . . .
medication." This supported a theory of liability under a deviation from design
specifications or manufacturer performance standards pursuant to N.J.S.A.
2A:58C-2.
Dr. Phillips' testimony also created a dispute of material facts because he
opined the silicone particulate would cause an inflammatory response. In
plaintiff's case, the inflammatory response "persisted even long after the
Ozurdex implant itself was gone." Dr. Phillips noted plaintiff had "multiple
injections before . . . and . . . never had this much inflammation, despite the fact
that she does have uveitis. So something was just different this time to cause
that much inflammation . . . ." The court concluded "Dr. Phillip[s] clearly . . .
opined . . . the alleged particulate created persistent inflammation in [p]laintiff's
eye that proximately caused her injuries."
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8
The trial court held plaintiff's experts did not offer net opinions because
their opinions were "sufficiently based in fact and data to be admissible under
N.J.R.E. 703." Although both experts conceded there was no objective evidence
that a silicone particulate existed, the PLA did not require direct evidence of a
product defect and circumstantial evidence of a defect was enough. The court
noted plaintiff's experts based their opinions "in part, on the fact . . . [p]laintiff
had received nine Ozurdex injections with no complications prior to the
November 6, 2018 procedure, and that the only variable and most likely
explanation for the complications arising after the November 6 . . . procedure is
that the Ozurdex applicator was from a defective lot." Thus, there was a
sufficient basis for plaintiff's experts to conclude there was no direct evidence
of the particulate because both plaintiff and defendant's experts agreed "the
particulate could have been aspirated out or remain[ed] hidden in scar tissue in
[p]laintiff's eye . . . ." The trial court concluded "[t]herefore, . . . the lack of
'objective evidence' goes to the weight of [p]laintiff's expert's testimony, not its
admissibility."
The court held plaintiff's experts could opine the silicone particulate could
have caused retinal detachment because their opinions were based on the direct
and circumstantial evidence in the summary judgment record, including:
A-1501-23
9
"plaintiff's medical records; deposition transcripts; and defendant's risk
assessment, field alerts, worldwide and domestic recalls, [and] package inserts
regarding the risks of Ozurdex . . . ." Further, it was not reasonable to conclude
plaintiff's experts offered a net opinion "when [d]efendant's own recall
contained those very same warnings of intraocular inflammatory reaction and
corneal reaction as potential safety risks." Defendant was not entitled to
summary judgment due to the totality of the evidence and because plaintiff was
"only required to show that the alleged product defect proximately caused or
was a substantial factor in causing her injuries . . . ." The court concluded
plaintiff had "presented sufficient evidence of a manufacturing defect and
admissible expert opinion that such defect proximately caused [her] injuries to
create a dispute of material fact."
Defendant moved for reconsideration, reiterating the arguments raised in
the summary judgment motion. It asserted there was no: evidence of a silicone
particulate in the Ozurdex treatment plaintiff received on November 6, 2018;
evidence particulate entered plaintiff's eye; reliable methodology proffered by
an expert showing there was a manufacturing defect and Dr. Phillips was
unqualified to testify about the manufacturing process; circumstantial evidence
of a manufacturing defect; and expert evidence on causation either in general or
A-1501-23
10
specific. It also argued the court should have dismissed the second count of
plaintiff's complaint, which was the failure to recall the claim, because it was
not a viable cause of action under the PLA and the PLA preempted the claim.
The trial court again rejected defendant's arguments. It found plaintiff
presented "sufficient evidence . . . to survive a motion for summary judgment
. . . [and] create a dispute of material fact as to whether the alleged defect (i.e.,
the silicone particulate) proximately caused [p]laintiff's injuries, and any other
inconsistencies of fact [are] best reserved for a jury to contemplate." The court
rejected the argument it erred by not dismissing the failure to warn claim
because the PLA claim was indivisible. Therefore, "[i]f the [c]ourt followed
[d]efendant's reasoning, [it] would strike [p]laintiff's request for relief under the
PLA altogether."
The trial court rejected defendant's challenges on the issue of lack of
expert evidence regarding causation and net opinion. It found defendant
presented no law or facts that the court overlooked and reiterated "that Dr.
Lalezary's and Dr. Phillip[s] opinion[s] were sufficiently based in fact and data
to be admissible under N.J.R.E. 703." Although both "experts admitted that
there is no 'objective evidence' that a silicone particulate existed, direct evidence
of a product defect is not required under the PLA to show a product defect
A-1501-23
11
existed." (citing Scanlon v. Gen. Motors Corp., Chevrolet Motor Div., 65 N.J.
582, 592-93 (1974)). The court reiterated a product defect could "be
demonstrated through 'circumstantial evidence and the facts shown,' which [it]
previously found in this matter." It rejected the lack of causation argument
because "[s]ufficient expert testimony [was] shown to create an issue of material
fact as to whether the defective Ozurdex applicator proximately caused
[p]laintiff's injuries."
I.
Our review of a ruling on summary judgment is de novo, applying the
same legal standard as the trial court. Townsend v. Pierre, 221 N.J. 36, 59
(2015). "Summary judgment must be granted if 'the pleadings, depositions,
answers to interrogatories and admissions on file, together with the affidavits, if
any, show . . . there is no genuine issue as to any material fact challenged and
that the moving party is entitled to a judgment . . . as a matter of law.'" Town
of Kearny v. Brandt, 214 N.J. 76, 91 (2013) (quoting R. 4:46-2(c)). We consider
whether "the competent evidential materials presented, when viewed in the light
most favorable to the non-moving party, are sufficient to permit a rational
factfinder to resolve the alleged disputed issue in favor of the non-moving
party." Ibid. (quoting Brill v. Guardian Life Ins. Co., 142 N.J. 520, 540 (1995)).
A-1501-23
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When reviewing an order denying reconsideration, we apply an abuse of
discretion standard. Fusco v. Bd. of Educ. of City of Newark, 349 N.J. Super.
455, 462 (App. Div. 2002). The standard is inherently deferential. Pitney
Bowes Bank, Inc. v. ABC Caging Fulfillment, 440 N.J. Super. 378, 382 (App.
Div. 2015).
We accord no deference to the trial court's conclusions on issues of law
and review those issues de novo. Nicholas v. Mynster, 213 N.J. 463, 478 (2013).
"Preemption determinations are reviewed de novo, as are the issues of statutory
interpretation necessary to the preemption inquiry." In re Alleged Failure of
Altice USA, Inc., 253 N.J. 406, 415 (2023) (citing In re Reglan Litig., 226 N.J.
315, 327 (2016)).
II.
Defendant argues the trial court should have dismissed the failure to recall
claim because it was subsumed into the strict products liability count of
plaintiff's complaint and preempted by the FDCA and its regulation, 21 C.F.R.
§§ 7.40 to 7.59. It asserts FDA regulations for prescription drug recall impliedly
preempt the PLA "failure to warn" law for the manufacture and distribution of
prescription drugs that are approved by the FDA and later subject to recall.
Therefore, defendant's compliance with FDA regulations shields it from liability
A-1501-23
13
for injuries attributable to defective FDA approved drugs. Defendant claims its
preemption argument pertained to federal law and the trial court misunderstood
the issue as preemption under the PLA.
Amici, the Product Liability Advisory Council, Inc. and the Chamber of
Commerce of the United States of America, join in defendant's preemption
argument and its argument that a failure to recall claim is not cognizable under
the PLA. Amici, the Healthcare Institute of New Jersey and New Jersey
Business & Industry Association, argue the court's decision "disrupt[s]" the
PLA.
The trial court did not squarely address federal preemption. Our Supreme
Court recently stated that preemption analysis begins with the assumption that
state police powers are not to be disturbed unless clearly preempted by Congress
through federal legislation pursuant to the Supremacy Clause of the United
States Constitution, Article VI, Clause 2. See Altice, 253 N.J. at 416 (citing
Altria Grp., Inc. v. Good, 555 U.S. 70, 77 (2008)); see also Dewey v. R.J.
Reynolds Tobacco Co., 121 N.J. 69, 77 (1990). The essential question for any
preemption analysis is "whether Congress intended that the federal regulation
supersede state law." Dewey, 121 N.J. at 77-78 (citing La. Pub. Serv. Comm'n
v. Fed. Commc'ns Comm'n, 476 U.S. 355, 369 (1986)). "Ordinarily, state causes
A-1501-23
14
of action are not pre-empted solely because they impose liability over and above
that authorized by federal law." Feldman v. Lederle Lab'ys, a Div. of Am.
Cyanamid Co., 125 N.J. 117, 136 (1991) (Feldman II) (citations omitted).
Federal law can preempt state laws expressly, impliedly, or through
conflict. Altice, 253 N.J. at 417. Implicit preemption exists when the "'federal
regulation is so pervasive as to make reasonable the inference that Congress left
no room for the State to supplement it,' . . . or when the 'object sought to be
obtained by federal law and the character of the obligations imposed by it may
reveal the same purpose.'" Dewey, 121 N.J. at 77-78 (quoting Rice v. Santa Fe
Elevator Corp., 331 U.S. 218, 230 (1947)); see also Altice, 253 N.J. at 417
(describing implicit preemption as "field preemption"). Field preemption
requires the court to assess through inference or Congressional silence how
pervasive federal laws were intended to preempt state police power. Altice, 253
N.J. at 417.
The question on this appeal is whether the failure to warn strict liability
claim asserted pursuant to the PLA is preempted by the FDCA's regulatory
scheme. The FDA is charged with the control and supervision of numerous
consumer products, including prescription drugs. 21 U.S.C. § 355(d); Merck
Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019). All FDA regulations
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are mandated by the FDCA. 21 U.S.C. §§ 301 to 399. The FDCA prohibits
"[t]he introduction or delivery for introduction into interstate commerce of any
food, drug, device, tobacco product, or cosmetic that is adulterated or
misbranded." 21 U.S.C. § 331(a). In enacting the FDCA, Congress's primary
concern was to protect consumers from unsafe drugs and fraudulent marketing.
Wyeth v. Levine, 555 U.S. 555, 566 (2009).
In the case of prescription drugs, the FDA's role is both broad and
nuanced. It includes initial testing and approval of drugs for sale in the United
States, 21 C.F.R. § 314.105,2 in addition to monitoring its continued safety and
managing recalls thereafter, when necessary, 21 C.F.R. §§ 7.40 to 7.59.
Generally, drug manufacturers seek advance FDA permission to make
substantive changes to their drug labels. Albrecht, 587 U.S. at 304. The FDA
requires that any "major changes" to an NDA be submitted and approved by it,
21 C.F.R. § 314.70(b), while only certain "moderate changes" may require FDA
approval, 21 C.F.R. § 314.70(c).3 However, prior FDA approval is not required
2
The "FDA will approve [a new drug application (NDA)] after it determines
that the drug meets the statutory standards for safety and effectiveness,
manufacturing and controls, and labeling . . . ." 21 C.F.R. § 314.105.
3
21 C.F.R. § 314.70 is known as the "'changes being effected' (CBE) regulation
. . . ." Wyeth, 555 U.S. at 568.
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in cases where the manufacturer seeks to "add or strengthen a contraindication,
warning, precaution, or adverse reaction" to the labeling. 21 C.F.R. §
314.70(c)(6)(iii)(A). "For that reason, . . . 'clear evidence' that the FDA would
not have approved a change to the drug's label prempts a claim, grounded in
state law, that a drug manufacturer failed to warn consumers of the change-
related risks associated with using the drug." Albrecht, 587 U.S. at 302-03
(citing Wyeth, 555 U.S. at 571).
Communications from manufacturers to health care providers advising of
updates on important, new, or updated product information can also be managed
through DHCP letters. These letters constitute "labeling" under the FDCA. See
R.F. v. Abbott Lab'ys, 162 N.J. 596, 626 n.18 (2000) ("Those alternative
methods of warning the [t]est's users suggested by plaintiffs clearly constitute
'labeling' under the FDCA."); see also Kordel v. United States, 335 U.S. 345,
349 (1948) (stating "the boundaries of the prohibited action would then be
defeated" should the FDCA be interpreted to differentiate how and where the
drug labeling literature is distributed).
Federal regulations interpreting the mandates of the FDCA also detail
recall procedure and obligations for prescription drugs in 21 C.F.R. Ch. I, Subch.
A, Pt. 7 "Enforcement Policy." The FDA's recall regulation provides:
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(a) Recall is an effective method of removing or
correcting consumer products that are in violation of
laws administered by the [FDA]. Recall is a voluntary
action that takes place because manufacturers and
distributors carry out their responsibility to protect the
public health and well-being from products that present
a risk of injury or gross deception or are otherwise
defective. This section and §§ 7.41 through 7.59
recognize the voluntary nature of recall by providing
guidance so that responsible firms may effectively
discharge their recall responsibilities. These sections
also recognize that recall is an alternative to a [FDA]-
initiated court action for removing or correcting
violative, distributed products by setting forth specific
recall procedures for the [FDA] to monitor recalls and
assess the adequacy of a firm's efforts in recall.
(b) Recall may be undertaken voluntarily and at any
time by manufacturers and distributors, or at the request
of the [FDA]. A request by the [FDA] that a firm recall
a product is reserved for urgent situations and is to be
directed to the firm that has primary responsibility for
the manufacture and marketing of the product that is to
be recalled.
(c) Recall is generally more appropriate and affords
better protection for consumers than seizure, when
many lots of product have been widely distributed.
Seizure, multiple seizure, or other court action is
indicated when a firm refuses to undertake a recall
requested by the [FDA], or where the agency has reason
to believe that a recall would not be effective,
determines that a recall is ineffective, or discovers that
a violation is continuing.
[21 C.F.R. § 7.40.]
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Recall measures can be initiated by the FDA and the manufacturer. 21
C.F.R. §§ 7.45 and 7.46. "Firm-initiated recall" provisions autonomously permit
manufacturers the authority to remove or correct a defective product prior to
FDA recall review and approval. The relevant regulation states:
(a) A firm may decide of its own volition and under any
circumstances to remove or correct a distributed
product. A firm that does so because it believes the
product to be violative is requested to notify
immediately the appropriate [FDA] district office . . . .
Such removal or correction will be considered a recall
only if the [FDA] regards the product as involving a
violation that is subject to legal action, e.g., seizure.
....
(b) The [FDA] will review the information submitted,
advise the firm of the assigned recall classification,
recommend any appropriate changes in the firm's
strategy for the recall, and advise the firm that its recall
will be placed in the weekly FDA Enforcement Report.
Pending this review, the firm need not delay initiation
of its product removal or correction.
[21 C.F.R. § 7.46.]
However, any attempt to enforce or restrain violations of the FDCA "shall
be by and in the name of the United States." 21 U.S.C. § 337. In Cornett v.
Johnson & Johnson, our Supreme Court examined the boundaries of FDA's
preemption and concluded that "regardless of how a plaintiff styles a state claim,
if the claim depends on the alleged violation of a federal requirement, it is
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functionally equivalent to a claim grounded solely on the federal violation, and
is impliedly preempted." 211 N.J. 362, 385 (2012), abrogated on other grounds
by McCarrell v. Hoffmann-La Roche, Inc., 227 N.J. 569 (2017). In other words,
there is no private cause of action for allegations built upon FDCA violations.
Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 349 (2001).
Accordingly, there can be no private cause of action alleging failure to recall
pursuant to 21 C.F.R. § 7.40. At oral argument, plaintiff confirmed she did not
assert a cause of action based on a failure to recall.
Cornett involved a failure to warn claim under the PLA that was expressly
preempted by the Medical Devices Amendments of 1976 (MDA)4. 211 N.J. at
390-91. The Court explained the FDA is vested with exclusive authority to
enforce a delicate and robust regulatory scheme created by Congress and "[a]
fraud-on-the-FDA claim has the potential to interfere with this delicate balance."
Id. at 390. Therefore, failure to warn claims based on FDA violations are
impliedly preempted by 21 U.S.C. § 337. Ibid. The Cornett Court held:
If discovery reveals that the failure to warn claim is
nothing more than a private action to enforce FDA
statutes and regulations, or that plaintiffs' claim is no
4
"[T]he MDA expressly pre-empts only state requirements 'different from, or
in addition to, any requirement applicable . . . to the device' under federal law,
§ 360k(a)(1)." Riegel v. Medtronic, 552 U.S. 312, 321 (2008) (omission in
original).
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more than a challenge to the approval of the device or
label, or that proof of fraud on the FDA is an element
of their claim, or that defendants' off-label promotional
activities fall within the MDA safe harbor, defendants
may move for summary judgment, and the trial court
should not hesitate to grant such relief, if appropriate.
[Id. at 391 (citing NCP Litig. Tr. v. KPMG, LLP, 187
N.J. 353, 384-85 (2006)).]
It is only when "plaintiffs' failure to warn claim is based on other
allegations of wrong-doing apart from defendants' failure to comply with FDA
disclosure requirements, [that] it is not preempted." Id. at 390. These State
claims exist "parallel" to the federal requirements. Id. at 385 (citing Riegel, 552
U.S. at 330).
In Wyeth, the plaintiff received a dose of a prescription drug via an
intravenous push, which was injected into an artery rather than a vein, leading
to amputation of the plaintiff's arm. Id. at 559. The plaintiff's suit against Wyeth
alleged it failed to adequately warn about the risk administering the drug via an
intravenous push. Id. at 559-60. The Court held state law failure to warn claims
against a drug manufacturer were not preempted by federal law specifically
when applied to approved FDA drug labeling. See id. at 581. The failure to
warn claim was not preempted because the manufacturer was unilaterally
permitted to strengthen a drug warning based on its responsibility for post -
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marketing surveillance and to update the labeling with new safety information.
Id. at 573. Indeed, "the very idea that the FDA would bring an enforcement
action against a manufacturer for strengthening a warning pursuant to the CBE
regulation is difficult to accept—neither Wyeth nor the United States has
identified a case in which the FDA has done so." Id. at 570.
The Wyeth Court noted an absence of express preemption of prescription
drugs in the FDCA's seventy-year history, despite "certain awareness of the
prevalence of state tort litigation . . . ." Id. at 575. It concluded that
Congressional inaction supported the conclusion that state lawsuits were not an
obstacle to FDA objectives, and "Congress did not intend FDA oversight to be
the exclusive means of ensuring drug safety and effectiveness." Ibid.
Defendant argues the FDA's recall regulations are comprehensive and
occupy the entire field, which forecloses a state from regulating prescription
drug recalls. It points us to In re Human Tissue Prod.'s Liab. Litig., 488 F. Supp.
2d 430, 433 (D.N.J. 2007), and Clark v. Actavis Grp. HF, 567 F. Supp. 2d 711,
717 (D.N.J. 2008), in support of the notion the FDA intended to assume all
control over monitoring recalls and recall communications. However, these
cases were decided prior to Wyeth and Cornett, and we are not bound by these
rulings.
A-1501-23
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Plaintiff's PLA complaint was crafted as a single count, which alleged
Ozurdex was "defective and dangerous, both in warning, manufacture and in
design." The complaint did not allege a failure to warn alone, but also a
manufacturing defect and a failure to warn post-sale, neither of which are
preempted by the FDCA.
There is a "longstanding coexistence of state and federal law and the
FDA's traditional recognition of state-law remedies . . . ." Wyeth, 555 U.S. at
581. A claim alleging wrongdoing "falls within a traditional area of state
concern" provided that "fraud on the FDA is not an element of the claim and it
can be proved by evidence other than by evidence of fraud on the FDA."
Cornett, 211 NJ. at 390.
We reject defendant's argument the FDA's uniform drug recall protocol,
21 C.F.R. § 7.40(a), shields drug manufacturers from their duty to alert the
public of known unsafe and hazardous products released to the public
completely. This would undermine the intent and purpose of the FDCA, which
"as a whole was designed primarily to protect consumers from dangerous
products." Feldman II, 125 N.J. at 148 (quoting U.S. v. Sullivan, 332 U.S. 689,
696 (1948)).
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In all FDCA labeling and recall protocols there are exceptions for
manufacturers to enhance their product warnings. See 21 C.F.R. §
314.70(c)(6)(iii)(A) (noting FDA approval is not required in cases where the
manufacturer seeks to "add or strengthen a contraindication, warning,
precaution, or adverse reaction" to the labeling). The FDCA product recall
protocol does not require the manufacturer to wait for FDA approval before
notifying the public of its safety concerns. A "firm may decide of its own
volition and under any circumstances to remove or correct a distributed product"
when it believes it to be violative. 21 C.F.R. § 7.46(a). Pending FDA recall
review, "the firm need not delay initiation of its product removal or correction."
21 C.F.R. § 7.46(b). These principles are underscored by the fact that here
defendant issued the DHCP alerting physicians about the defective lot of
Ozurdex. There is no rational basis to conclude this was somehow in conflict
with FDCA regulations.
We also reject defendant and amici's arguments that a failure to recall
claim is not cognizable under the PLA regardless of preemption. Excepting the
causation issue addressed in the next section, the summary judgment record
contained enough evidence to support plaintiff's claim she was damaged due to
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defendant's failure to warn her of the defective Ozurdex lot, which was known
to defendant at the time she was injected with Ozurdex.
"Under New Jersey law[,] a manufacturer is strictly liable for damages
resulting from use of its products when the manufacturer fails to produce and
distribute a product that is fit, suitable, and safe for its foreseeable purposes."
Feldman II, 125 N.J. at 144. In the case of a "failure to warn" claim, the Court
explained:
A manufacturer is obligated to communicate a warning
based on subsequently-acquired knowledge of a danger
"as soon as reasonably feasible." Feldman v. Lederle
Lab'ys (Feldman I), 97 N.J. 456 (1984). "Generally
speaking, the doctrine of strict liability assumes that
enterprises should be responsible for damages to
consumers resulting from defective products regardless
of fault." Id. at 450. When liability is premised on the
failure to warn or an inadequate warning, the issue
becomes whether the manufacturer knew or could have
known of the danger and, if so, whether it "acted in a
reasonably prudent manner in marketing the product or
in providing the warnings given." Id. at 451-52.
[Feldman II, 125 N.J. at 144.]
While manufacturers in compliance with FDA labeling requirements are
entitled to a rebuttable presumption that the warning labeling was adequate,
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N.J.S.A. 2A:58C-4,5 the PLA permits a plaintiff to allege the manufacturer was
aware of "after-acquired knowledge of harmful effects" and failed to disclose
them in violation of the PLA.6 Cornett, 211 N.J. at 388. As we noted, labeling
includes a DHCP communication. Abbott Lab'ys, 162 N.J. at 626 n.18. Because
plaintiff's failure to warn claim is based on the allegation defendant "withheld
information from the general public and the medical community" regarding the
distribution of defective Ozurdex lots and the potential harm the affected lots
could cause patients, plaintiff's claim overcame the PLA's rebuttable
presumption of warning label adequacy. Cornett, 211 N.J. at 390 (citing Perez
v. Wyeth Lab'ys Inc., 161 N.J. 1, 25 (1999)).
For these reasons, the trial court correctly held the PLA claim was not
preempted. Plaintiff asserted a viable PLA claim based on defendant's failure
to warn patients of the product defect.
5
"If the warning or instruction given in connection with a drug or device or
food or food additive has been approved or prescribed by the [FDA] under the
[FDCA] . . . , a rebuttable presumption shall arise that the warning or instruction
is adequate." N.J.S.A. 2A:58C-4.
6
"[W]here the product manufacturer knowingly withheld or misrepresented
information required to be submitted under the agency's regulations, which
information was material and relevant to the harm in question, punitive damages
may be awarded." N.J.S.A. 2A:58C-5.
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III.
A.
Defendant argues the trial court erred by failing to dismiss the complaint
due to plaintiff's failure to present a manufacturing expert with experience in
biomaterials, biocompatibility, biomechanics, and microscopic silicone
particulate to establish there was a particulate in the injection plaintiff received
and therefore causation. It alleges the recall notice of the Ozurdex lot was not
competent evidence to establish plaintiff was injured by a defective dose of
Ozurdex. Amici, the Healthcare Institute of New Jersey and New Jersey
Business & Industry Association, join in this aspect of defendant's argument.
Defendant claims plaintiff's experts offered net opinions because they
could not opine about the manufacturing defect and had no idea if a particulate
entered plaintiff's eye and was the cause of her injury. It asserts the trial court
did not fulfill its gatekeeping role, and instead permitted evidence of the recall
"and temporal association to substitute for qualified expert opinion derived from
application of reliable methodology to the facts."
B.
A plaintiff may recover damages under the PLA for a: product
manufacturing defect; failure to warn; or product design defect. See N.J.S.A.
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2A:58C-2. "A product is deemed to be defective if it is not reasonably fit,
suitable, or safe for the ordinary or foreseeable purpose for which it is sold."
Myrlak v. Port Auth. of N.Y. & N.J., 157 N.J. 84, 97 (1999). In a manufacturing
defect case, "a plaintiff must prove that the product was defective, that the defect
existed when the product left the manufacturer's control, and that the defect
proximately caused injuries to the plaintiff, a reasonably foreseeable or intended
user." Ibid. This can be accomplished through "direct evidence, such as the
testimony of an expert who has examined the product, or, in the absence of such
evidence, to circumstantial proof." Id. at 98. A plaintiff who cannot prove a
defect through direct or circumstantial evidence can do so by negating all other
causes for the dangerous condition. Id. at 99.
"The law is 'settled in this State that in a products liability case[,] the
injured plaintiff is not required to prove a specific manufacturer's defect.'" Id.
at 98 (quoting Moraca v. Ford Motor Co., 66 N.J. 454, 458 (1975)). Evidence
"that a product is not fit for its intended purposes 'requires only proof .· .· . that
"something was wrong" with the product.'" Ibid. (quoting Scanlon, 65 N.J. at
591). However, "[t]he mere occurrence of an accident and the mere fact that
someone was injured are not sufficient to demonstrate the existence of a defect."
Ibid.
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Here, no one disputes that expert testimony is required to identify the
manufacturing defect alleged by plaintiff. This is because Ozurdex is the sort
of product that "is so esoteric that jurors of common judgment and experience
cannot form a valid judgment as to whether the conduct of the party was
reasonable." Rocco v. N.J. Transit Rail Operations, Inc., 330 N.J. Super. 320,
341 (App. Div. 2000) (quoting Butler v. Acme Mkts., Inc., 89 N.J. 270, 283
(1982)).
Plaintiff's PLA claim did not rely solely on the recall of the Ozurdex lot
that was administered to her. Her claim was also based on testimony from
defendant's corporate representative who said the Ozurdex "applicator was not
designed to release silicone particulate." There was also the Field Alert Report
defendant sent to the FDA, which stated the defective units containing the
silicone particulate were "intrinsic to the manufacturing process and not an
external contaminant." Defendant's DHCP letter further admitted the discovery
of a silicone particle dispensed with the Ozurdex implant during a routine
manufacturing inspection, albeit only 2.2% of the injectors in Ozurdex Lot
#E82852, contained particulate. Defendant also conducted a root cause
investigation, which identified manufacturing issues, and implemented
corrective action to eliminate "creation of the particle" during the manufacturing
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process. Clearly, plaintiff's claim was based on more than the recall notice, and
we reject defendant's arguments to the contrary.
The sufficiency of circumstantial evidence is a factual determination. See
Moraca, 66 N.J. at 458. "If the proofs permit an inference that the accident was
caused by some defect, whether identifiable or not, a jury issue as to liability is
presented." Ibid. However, a plaintiff must present sufficient evidence the
alleged product defect proximately caused her injuries. See Myrlak, 157 N.J. at
97. A jury must not be given circumstantial evidence about a product's alleged
defect and then left to speculate. "The product itself must be of a type permitting
the jury, after weighing all the evidence . . . to infer that in the normal course of
human experience an injury would not have occurred . . . had there not been a
defect attributable to the manufacturer." Scanlon, 65 N.J. at 593.
Plaintiff presented the testimony of Drs. Lalezary and Phillips, both of
whom opined with a reasonable degree of certainty that the silicone particulate
proximately caused her injury. Dr. Lalezary testified the silicone particulate
was injected in plaintiff's eye and was a substantial factor in causing her
blindness. He explained
the particulate caused inflammation and traction in her
peripheral retina that induced a retinal break and led to
her retinal detachment. And subsequently, she had
detachment repair that led to the anterior migration of
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the Ozurdex pellet. That compromised her vision
because a patient with uveitis that develops a retinal
detachment has a poor prognosis for recovery and
vision.
Dr. Phillips testified the silicone particulate ultimately caused plaintiff to
lose vision. He found
what was interesting and remarkable in her case was the
persistent inflammation, so that knowledge of the
silicone particulate [from the recall] gave [him] a
potential cause for why she was getting so much
inflammation despite the fact that she still had the
Ozurdex implant, which usually treated her
inflammation fairly well. . . . Knowing that the silicone
particulate could be there gave [him] at least a potential
reason for the inflammation that wasn't responding to
treatment.
According to Dr. Phillips, the particulate did not cause plaintiff's retina to
detach because
the detachment can occur spontaneously. It can occur
just with the injection. . . . Where it could come into
play as sort of affecting both would be from the
inflammatory response. [T]here's really nothing
unusual about retinal detachment. Those we treat every
day, all the time. The corneal swelling, corneal
specialists do corneal transplants for that all the time.
The thing that was unusual in this particular instance
for her was the amount of inflammation. So if I'm
trying to tie the silicone particulate into anything, it's
the inflammatory response that she had that persisted
even long after the Ozurdex implant itself was gone.
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The presence of the particulate was "the only thing that was different. [Plaintiff]
had already had multiple injections before, and she'd even had surgery before
. . . . So she had been through many procedures before and just never had this
much inflammation, despite the fact that she does have uveitis."
We apply an abuse of discretion standard in review of a trial court's
decision to admit expert testimony. In re Accutane Litig., 234 N.J. 340, 348
(2018). Summary judgment "is an extraordinary measure to be taken only with
extreme caution, especially when a cause of action rests upon expert testimony. "
Kisselbach v. Cnty. of Camden, 271 N.J. Super. 558, 569 (App. Div. 1994).
Even a "weak" medical report should be presented to a jury and if later found
unreliable, may be subject to involuntary dismissal pursuant to Rule 4:37-2(b).
Ibid."The net opinion rule is a 'corollary of [N.J.R.E. 703] . . . which forbids
the admission into evidence of an expert's conclusions that are not supported by
factual evidence or other data.'" Townsend, 221 N.J. at 53-54 (alterations in
original) (citing Polzo v. Cnty. of Essex, 196 N.J. 569, 583 (2008)). An opinion
that is "circular," or contains "bare conclusions, unsupported by factual
evidence, is inadmissible." Buckelew v. Grossbard, 87 N.J. 512, 524 (1981).
Experts must "give the why and wherefore that supports the opinion, rather than
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a mere conclusion" and must "be able to identify the factual bases for their
conclusions" and "explain their methodology." Townsend, 221 N.J. at 54-55(quoting Borough of Saddle River v. 66 E. Allendale, LLC, 216 N.J. 115, 144
(2013), and Landrigan v. Celotex Corp., 127 N.J. 404, 417 (1992)). At its core,
"[t]he net opinion rule is a 'prohibition against speculative testimony.'" Ehrlich
v. Sorokin, 451 N.J. Super. 119, 134 (App. Div. 2017) (quoting Harte v. Hand,
433 N.J. Super. 457, 465 (App. Div. 2013)).
Dr. Lalezary is a Board-Certified Ophthalmologist and a Vitreo-Retinal
Surgical Fellow, who has published on the topic of retinal detachment and is
well versed in the applicable standard of care. His report recounted that he
reviewed: plaintiff's medical records from her treating physicians, Drs. Phillips
and Solomon; the deposition transcripts of plaintiff, Drs. Phillips and Solomon,
and the associate vice president responsible for defendant's U.S. recalls;
materials produced by defendants, including a Benefits-Risk Assessment and
Field Alerts for Ozurdex; and the 2018 recall notice. Based on this information,
the doctor opined with a "reasonable degree of medical certainty" that a silicone
particulate was "unintentionally dispensed from the defective actuator" and that
it "likely incited retinal detachment" which ultimately resulted in plaintiff's loss
of vision.
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Dr. Phillips also opined the particulate was the proximate cause of
plaintiff's injury. He based his knowledge on: plaintiff's medical history and
his treatment of her; the facts and circumstances surrounding the Ozurdex recall
as it pertained to plaintiff; and the cause of plaintiff's loss of vision despite other
potential causes.
Our difficulty is not with the theory of causation espoused by each expert
or that causation could be established through a differential diagnosis. This is
certainly permitted. See Creanga v. Jardal, 185 N.J. 345, 357-58 (2005). A
physician is "not required to rule out all alternative possible causes of [the
plaintiff's] illness. Rather, only 'where a defendant points to a plausible
alternative cause and the doctor offers no explanation for why [the doctor] has
concluded that was not the sole cause, that doctor's methodology is unreliable.'"
Heller v. Shaw Indus., Inc., 167 F.3d 146, 156 (3d Cir. 1999) (quoting In re
Paoli R.R. Yard PCB Litig., 35 F.3d 717, 758 n.27 (3d Cir. 1994)).
However, the issue here is the utter lack of evidence to support the
existence of both general and specific causation. Plaintiff's experts' theory of
causation is based on evidence that does not exist and would leave a jury to
speculate whether there was ever a particulate in the applicator or particulate
injected into plaintiff's eye.
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There was no evidence the Ozurdex injection plaintiff received was
defective and no evidence of a particulate in her eye. Defendant's experts
disagreed the particulate would cause a detachment in her eye. The Retisert
silicone insert, which was ten times larger than the alleged Ozurdex particulate,
dislocated contemporaneously with her injury and could have been a cause of
her injury. Plaintiff also had other underlying medical conditions that could
have caused the injury, including: chronic eye inflammation, inflammation from
smoking, and a history of ophthalmic procedure and intravitreal injections. For
these reasons, the differential diagnosis was unavailing.
Lastly, our Supreme Court recently adopted the Daubert7 factors to help
guide trial courts to assess the reliability of scientific or technical expert
testimony. State v. Olenowski, 253 N.J. 133, 149 (2023). Those factors are as
follows:
(1) Whether the scientific theory can be, or at any time
has been, tested;
(2) Whether the scientific theory has been subjected to
peer review and publication, noting that publication is
one form of peer review but is not a "sine qua non";
(3) Whether there is any known or potential rate of error
and whether there exist any standards for maintaining
or controlling the technique's operation; and
7
Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993).
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(4) Whether there does exist a general acceptance in the
scientific community about the scientific theory.
[In re Accutane, 234 N.J. at 398 (citing Daubert, 509
U.S. at 593-95).]
Aside from the lack of objective factual evidence of causation, there was
no evidence presented by plaintiff's experts to convince us their theory of
causation would pass muster under Daubert. The record is devoid of testing,
error rates, peer reviews, publications, or general acceptance in the scientific
community to support the method of causation in this case.
For these reasons, we are constrained to conclude the trial court should
have barred plaintiff's experts because they did not establish general or specific
causation. Defendant should have been granted summary judgment due to the
lack of proof of causation. As summary judgment in defendant's favor was
appropriate, we need not reach the arguments raised on the appeal regarding the
denial of reconsideration.
Affirmed in part and reversed in part. We do not retain jurisdiction.
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