Product Liability Update: March 2020 – Consumer Protection

Foley Hoag LLP publishes this quarterly Update primarily
concerning developments in product liability and related law from
federal and state courts applicable to Massachusetts, but also
featuring selected developments for New York and New
Jersey

MASSACHUSETTS

Massachusetts Superior Court Holds State Attorney
General Unfair And Deceptive Practices Claim Against Opioid
Manufacturer Not Preempted Or Statutorily Exempt As FDA Only
Approved Defendant’s Labeling, Not Marketing Practices, Public
Nuisance Claim Adequately Supported By Allegations Of Interference
With Public Health, And “Learned Intermediary” Doctrine
Based On Adequacy Of Prescriber Labeling Did Not Apply As
Defendant’s Deceptive Marketing Allegedly Affected
Prescribers’ Decisions

In Commonwealth v. Purdue Pharma, L.P., 26 Mass. L.
Rep. 56 (Mass. Sup. Ct. 2019), the Massachusetts Attorney General
sued a pharmaceutical manufacturer in Massachusetts Superior Court
alleging defendant’s marketing and sale of prescription opioid
products violated Mass. Gen. L. ch. 93A, the state unfair and
deceptive practices statute, and caused a public nuisance. The
complaint alleged defendant’s marketing tactics included
targeting physicians already suspected of overprescribing and
dispensing savings cards encouraging patients to stay on opioids
longer, and that these tactics significantly contributed to the
“opioid epidemic” that has caused thousands of
Massachusetts overdoses and deaths. Defendant moved to dismiss both
counts, arguing: (1) the claims were preempted as conflicting with
the United States Food and Drug Administration
(“FDA”)’s approval of the opioids’ sale and
labeling; (2) the FDA approval mandated a liability exemption under
ch. 93A; (3) defendant had not infringed any “public
right” as required for a nuisance claim; and (4) the
“learned intermediary” doctrine precluded liability for
prescriptions written by medical professionals.

The court first noted that preemption would exist if
“compliance with both federal and state [law] [was] a physical
impossibility.” Because the complaint did not challenge
defendant’s FDA-approved opioid labels by claiming defendant
should have given different warnings, but rather alleged
defendant’s marketing activities were inconsistent with the
approved labeling, there was no conflict between state and federal
law and the claims were not preempted.

The court next turned to Mass. Gen. L. ch. 93A, § 3, which
expressly exempts “transactions or actions otherwise permitted
under laws as administered by any regulatory board or officer
acting under statutory authority of the commonwealth or of the
United States.” After noting defendant’s “heavy
burden” to show the federal regulatory scheme permitted the
specific conduct at issue, the court concluded that since the
Commonwealth’s allegations were based on marketing practices
separate from the FDA approved labeling, there was no exemption
under the statute.

Regarding defendant’s argument that the Commonwealth’s
nuisance claim was merely a “poorly disguised, repackaged
products liability claim,” the court noted that since a public
nuisance is conduct that “interferes with the exercise of a
public right by directly encroaching on public property or by
causing a common injury,” the question here was whether
defendant’s conduct involved “a significant interference
with the public health, the public safety, the public peace, the
public comfort or the public convenience.” Citing other
Massachusetts cases that allowed public nuisance claims based on
dangerous products, the court held the complaint sufficiently
alleged conduct that interfered with public health and safety.

Lastly, the court evaluated whether the “learned
intermediary” doctrine, which breaks the chain of causation
between a prescription drug manufacturer and patient if the
manufacturer has adequately warned the prescribing physician,
precluded the Commonwealth’s claims. The court concluded it did
not, as the allegations here were that defendant’s deceptive
marketing conduct had affected the prescribers’ decisions.

Massachusetts Appeals Court Holds Plaintiff’s
Counsel’s Closing Argument Improper In Referring To Himself And
Jurors As “Us” And Defendants As “Them,” And
Asking Jurors To Do “The Right Thing” For “Big
Companies” That Refuse To Accept “One Shred Of
Responsibility,” But Post-Verdict Objection To Argument Must
Be Resolved Under New Trial Standard Rather Than Mere Possibility
Of Jury Effect

In Fitzpatrick v. Wendy’s Old Fashioned Hamburgers of
New York, Inc., 96 Mass. App. Ct. 410 (2019), plaintiff sued a
fast food chain and its beef supplier in Massachusetts Superior
Court for breach of the implied warranty of merchantability and
violation of Mass. Gen. L. ch. 93A, the state unfair and deceptive
practices statute, after she bit into a small piece of bone in her
hamburger, splitting her molar in two and leading to numerous
surgeries and dental procedures over the following two years.

At the jury trial of the warranty claim (the 93A claim was
reserved for the court), plaintiff noted the meat supplier had not
x-rayed the hamburger after its final grind process, while
defendants argued the grind was finer than required by industry
standards and the finest that would meet a customer’s taste
expectations. During closing arguments, plaintiff’s counsel
referred to “[u]s, the average people, not them,”
suggested “we” don’t “go to [the chain’s
restaurants] and expect to get injured,” and argued that
defendants, “one of the largest fast food companies and one of
the largest beef manufacturers in the world,” refused to
accept “one shred of responsibility”—
“[t]hat’s what they do, these big companies.” Counsel
also asked the jurors to imagine being injured in the future and
being able to look back and conclude “we did the right
thing.”

The trial court denied defendants’ motion for a mistrial but
reminded the jury, among other things, not to be swayed by
prejudice, that lawyers’ arguments were not evidence and the
jury’s job was to determine whether plaintiff had proved her
case, not “deter any conduct or to punish any party” or
decide based on “whether a party is a big company or a small
company.” After the jury awarded plaintiff more than $150,000,
however, the court granted a mistrial, ruling counsel’s
argument improperly created an “us versus them
dichotomy,” suggested the jury act as “the voice of the
community,” asked jurors to place themselves in
plaintiff’s shoes, interjected counsel’s own personal
beliefs, and resorted to the “so-called reptile approach”
whereby a lawyer appeals to the “primitive and
survival-based” part of the brain to “trigger a
juror’s fear of danger to the community as a result of a
defendant’s conduct.” After a retrial resulted in only a
$10,000 award, plaintiff appealed.

The Massachusetts Appeals Court held the trial court erred in
failing to consider whether lesser measures would have sufficed to
remedy counsel’s conduct. In addition, because the motion the
lower court ultimately granted came after the jury’s verdict,
it should have been considered under the standard for a new trial
motion, i.e., whether the verdict was so “markedly against the
weight of the evidence” as to suggest the jurors were
“misled, were swept away by bias or prejudice, or for a
combination of reasons, including misunderstanding of the
applicable law, failed to come to a reasonable conclusion.”
Instead, the judge had applied the factors for prejudicial error,
including whether the improper argument “possibly”
affected the jury’s conclusion, and also did not explain why
her curative instructions were inadequate since jurors are presumed
to follow instructions.

Regarding the propriety of plaintiff’s counsel’s
closing, the appellate court agreed it was improper for the same
reasons cited by the trial court. Due to that court’s
application of the wrong legal standard, however, the appellate
court remanded so defendants’ post-verdict motion from the
first trial could be resolved under the appropriate standard.

Massachusetts Federal Court Refuses To Consider Adequacy
Of Plaintiffs’ Specific Causation Evidence On Motions Designed
To Address General Causation, And Holds Neither Counsel’s
Statements Nor Experts’ Deposition Testimony Conceded
Plaintiffs Lacked General Causation Evidence Where Statements Were
Not Unambiguous Concessions Or Were Accompanied By Explanations
Showing They Were Not Concessions

In In re Zofran Ondansetron Prods. Liab. Litig., 2019
U.S. Dist. LEXIS 183884 (D. Mass. Oct. 23, 2019), a multi-district
litigation (“MDL”) in the United States District Court
for the District of Massachusetts, numerous plaintiffs alleged that
defendant’s prescription anti-nausea drug, when taken by
pregnant women, crossed the placental barrier and caused various
birth defects. Defendant moved for summary judgment against a
subset of plaintiffs based on lack of general-causation evidence
that the drug could cause injuries other than cardiac defects and
isolated cleft palate (i.e., cleft palate in the absence
of other orofacial defects). Two plaintiffs opposed the motion
individually, and 48 filed an omnibus opposition.

The two individual plaintiffs had children who suffered
additional defects alongside either cardiac defects or cleft
palate, respectively. Defendant argued there was no evidence the
drug could cause heart defects in a patient with the first
child’s particular “constellation of defects,” or
cleft palate along with the second child’s other defects given
that they were independently associated with cleft palate. The
court held, however, that defendant’s arguments went to
specific causation, i.e., whether the children’s cardiac and
palate defects were actually caused by the drug in light of their
other conditions. As general causation was the only issue being
considered by the court at this stage, and there was a genuine
factual dispute regarding the drug’s ability to cause cardiac
and cleft palate defects, the court denied summary judgment against
the two plaintiffs.

The other 48 plaintiffs alleged their children suffered cleft
lip with or without cleft palate. Defendant first argued
plaintiffs’ counsel had made a judicial admission that there
was no general causation evidence for orofacial defects other than
isolated cleft palate. In response to a question from the court,
plaintiffs’ counsel had said, “If there are defects
outside of heart and palate . . . I don’t believe the
scientific evidence has caught up to proving these, if they are
simply existing on an independent basis outside of a heart or a
palate.” Generally, judicial admissions arise only from
deliberate waivers that expressly concede the truth of an alleged
fact for the purposes of trial. Here counsel’s statement was in
response to a question about defects “that are not either
cardiac or orofacial” and therefore was not an admission
because the context was not specific to palate injuries as
differentiated from other orofacial injuries.

Defendant also argued that deposition testimony by
plaintiffs’ expert embryologist and epidemiologist conceded
there was no evidence the drug caused cleft lip, either with or
without cleft palate. Both experts had agreed the phenotypes for
isolated cleft palate and cleft lip with or without cleft palate
were pathogenetically and etiologically distinct, and the
epidemiologist agreed “the epidemiological evidence currently
only supports an association with isolated cleft palate.” The
court noted, however, that the embryologist had also explained that
distinct phenotypes could mean that a substance could cause only
one of the defects, or that it could cause both by a common
mechanism, and the epidemiologist had explained that evidence from
other fields could establish general causation without violating
epidemiological principles. Accordingly, neither expert had
conceded a lack of general causation, and since at least two of
plaintiffs’ other experts had opined the drug could cause cleft
lip with or without cleft palate, the court denied summary judgment
against the 48 plaintiffs.

Massachusetts Federal Court Holds FDA Expert’s
Opinions About Effect On Labeling Of Animal And Adverse Event Data
Allegedly Not Fully Disclosed To Agency Admissible Where Based On
Regulatory Record Even Without Independent Analysis Of Underlying
Data, Opposing Expert’s Opinions Based On FDA Guidance And
Practices But Not Drug-Specific Agency Statements Also Admissible,
But Expert’s Opinions About Defendant’s Marketing Practices
Inadmissible As Not Involving Regulatory Expertise

In In re Zofran (Ondansetron) Prods. Liab. Litig., 2019
U.S. Dist. LEXIS 190372 (D. Mass Nov. 1, 2019), plaintiffs in a
multi-district litigation (“MDL”) in the United States
District Court for the District of Massachusetts alleged their
children suffered a variety of birth defects caused by
defendant’s prescription anti-nausea drug. Among other things,
plaintiffs claimed defendant failed to disclose a series of
Japanese animal studies to the United States Food and Drug
Administration (“FDA”) and to accurately inform the
agency about certain adverse event reports. Plaintiffs alleged that
with proper disclosure FDA would not have approved the drug under
pregnancy “Category B,” meaning that animal studies had
failed to demonstrate a birth defect risk and there were no
adequate and well-controlled studies in humans, as opposed to
“Category C” or “Category D,” which would have
warned of a risk based on either animal studies or adverse event
data. Plaintiffs also claimed that, following FDA approval,
defendant should have updated its labeling to reflect the studies
and adverse event reports.

Each side offered a regulatory expert to support its positions
and moved to preclude the opposing expert’s opinions.
Plaintiffs argued the defense expert was unqualified, and employed
an unreliable methodology, to opine that the Japanese animal
studies would not have changed the drug’s Category B labeling,
as the expert was a clinician rather than toxicologist and had
failed to even consider one of the studies. The court, however,
noted the expert did not claim to independently interpret any of
the studies but rather only to determine that on the full
regulatory record, including the studies and defendant’s
scientists’ interpretation of them, the pregnancy
categorization was appropriate. Based on her thirteen years of
regulatory experience, which included work on FDA’s Pregnancy
Labeling Task Force, the expert was qualified to give these
opinions, and analyzing the regulatory record and applicable
standards was a sufficiently reliable method.

Plaintiffs also sought to preclude the expert’s opinions
that defendant had adequately disclosed the human adverse event
reports, arguing the opinions were unreliable because the expert
had not analyzed the raw data underlying the reports. Once again,
the court concluded the expert’s review of the reports and
comparison of them to the entirety of FDA’s safety database
matched what the agency itself would have done and was therefore
sufficiently grounded in the regulatory record and standards. And
on both the animal and human data, questions about the rigor of the
expert’s analysis went to the weight rather than admissibility
of her opinions.

As to plaintiffs’ regulatory expert, defendant argued his
opinion that FDA would not have approved a Category B pregnancy
labeling if they had disclosed the Japanese animal studies was
speculative and without reliable basis, as it was not based on any
actual FDA statements or actions. The court, however, concluded the
expert’s reliance on FDA guidance documents as well as his own
eleven years of FDA experience rendered his methodology
sufficiently reliable. For similar reasons, the court rejected
defendant’s argument that the expert’s opinion that
defendant should have reported the human adverse events differently
was unreliable as not based on any specific FDA regulations,
concluding such deficiencies went only to the testimony’s
weight.

Finally, the court granted defendant’s motion to preclude
plaintiffs’ expert’s opinions that defendant’s
off-label marketing for use in pregnancy-related nausea and
vomiting created a false sense of the drug’s pregnancy safety
and failed to inform prescribers and patients about the drug’s
true risks. The expert’s testimony in this regard was
essentially only “a narrative summary of [defendant’s]
internal documents,” and drew “on little, if any, of his
regulatory expertise.”

NEW YORK/NEW JERSEY SUPPLEMENT

New York Federal Court Holds Plaintiff’s Ignoring
Warning Not To Move Deep Fryer Without Draining Reduces But Does
Not Bar Failure-To-Warn Claim Where Not Sole Cause Of Accident,
Surveillance Video Not Needed To Prove Causation Nor Does
Third-Party Spoliation Of Same Bar Recovery, And Expert’s
Design Defect Opinions Admissible Despite Lack Of Testing And
Calculations Where Based On Examination Of Product And Detailed
Schematics

In Hernandez v. Pitco Frialator, Inc., 2019 U.S. Dist.
LEXIS 187690 (W.D.N.Y. October 28, 2019), plaintiff sued the
manufacturer of a wheel-mounted deep fryer in the United States
District Court for the Western District of New York, alleging he
suffered second- and third-degree burns when the fryer tipped over
while he was moving it, spilling oil onto him. The fryer bore a
label warning against moving it unless hot liquids were completely
drained, and the manual added that “splashing hot liquids can
cause severe burns.” Plaintiff asserted, among others,
negligence and strict liability claims for failure to warn that the
fryer was top-heavy and for design defect in failing to incorporate
either bottom weighting to lower the fryer’s center of gravity,
a separate handle to increase its stability during movement or a
securable cover to prevent spills on tipping over. Defendant moved
for summary judgment on all claims.

The court first rejected defendant’s argument that
plaintiff’s contributory negligence in failing to follow the
fryer’s warnings barred his claims, since under New York law a
plaintiff’s negligence does not bar, but only proportionately
reduces, recovery under both negligence and strict liability. As
for defendant’s argument that plaintiff’s “glaring
misuse” of the fryer at least barred his strict liability
claims, while that would be true if the misuse were the sole
proximate cause of the accident, here the jury could find the
fryer’s top-heaviness also contributed.

With respect to design defect, the court rejected
defendant’s argument that plaintiff could not prove causation
because the restaurant had not preserved surveillance video of the
incident, noting there was no precedent for requiring video
evidence to prove causation and in any event a defendant could not
escape liability based on a third party’s alleged spoliation of
evidence. The court also rejected defendant’s argument that as
a matter of law the fryer was not unreasonably dangerous because
its risks were obvious and avoidable with ordinary care, noting
that while the risk hot oil could splash was readily foreseeable,
the risk of a tip-over due to top-heaviness was not. The court
similarly rejected defendant’s argument its warning against
moving the fryer with hot oil was adequate as a matter of law, and
not even necessary because the risk was obvious, noting again that
the tip-over risk was not obvious.

Lastly, the court rejected defendant’s challenges to the
admissibility of plaintiff’s expert’s design defect
opinions. Although the expert was not a professional engineer and
had never operated or designed a fryer, his multiple engineering
degrees, including a Ph.D. in mechanical engineering, and thirty
years’ experience in product design rendered him adequately
qualified. Defendant also argued the expert’s opinions that the
fryer should have incorporated an additional handle or weighted
bottom were unreliable because they were not supported by any
testing, calculations or specific designs, or assessment of the
risk or cost. The court, however, found the expert’s
methodology, which included his personal inspection of the fryer
and review of “detailed schematics,” was sufficient, and
that issues such as the cost of alternative designs could be
addressed through cross-examination. The court thus denied
defendant’s summary judgment motion in its entirety.

New York Federal Court Holds Operator Of Online
Marketplace Not Liable In Tort Or Warranty For Damage Caused By
Defective Product Sold By Third Party Through Marketplace Because
Defendant Never Took Title To Product And Thus Was Not Part of
Distribution Chain

In Phila. Indem. Ins. Co. v. Amazon.com, Inc., 2019
U.S. Dist. LEXIS 209144 (E.D.N.Y. December 4, 2019), an insurer
brought claims for strict liability, negligence and breach of
warranty in the United States District Court for the Eastern
District of New York against the operator of an online marketplace,
alleging that a defective blender sold by a third party through the
marketplace had caused property damage to the insured’s
policyholder. Under its written agreement with the third party, in
exchange for approximately 15% of the sales price, defendant had
listed the blender for sale on its website, processed payment,
warehoused and shipped the blender and agreed to provide customer
service. The agreement also provided, however, that defendant never
took title to the blender.

Defendant moved for summary judgment, arguing it could not be
held liable on any of the insurer’s claims because it did not
manufacture, distribute or sell the blender. The court agreed,
noting that under New York law, strict liability, negligence and
breach of warranty all extend only to entities within the
distribution chain such as manufacturers, wholesalers, retailers or
distributors. Defendant would only qualify as part of that chain if
it had taken title to the blender, which it had not. Accordingly,
it was entitled to summary judgment.

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