Slater v. Biomet Inc et al

Filing 149

OPINION AND ORDER: The court GRANTS Biomets motion for summary judgment Doc. No. 117 as to Ms. Slaters breach of warranty and statutory claims (Counts III-V), and DENIES Biomets motion as to her products liability and negligence claims (Counts I-II). Signed by Judge Robert L Miller, Jr on 3/26/17. (jld)

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF INDIANA
SOUTH BEND DIVISION
KIMBERLY SLATER,
Plaintiff,
v.
BIOMET, INC., et al.,
Defendants.

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Cause No. 3:14-cv-1055 RLM-MGG

OPINION AND ORDER
Kimberly Slater sued Biomet for damages in connection with the alleged
failure of her Biomet M2a Magnum hip implant. Biomet moved for summary
judgment, arguing that her claims are time-barred based on (1) a proposed date
on which all plaintiffs were on constructive notice of potential claims and (2)
facts specific to Ms. Slater. I disagree with Biomet’s proposed universal bar date
and analysis as to Ms. Slater’s products liability and negligence claims.

I. STANDARD OF REVIEW
Summary judgment is appropriate when the pleadings, discovery
materials, disclosures, and affidavits demonstrate no genuine issue of material
fact, such that the movant is entitled to judgment as a matter of law. Protective
Life Ins. Co. v. Hansen, 632 F.3d 388, 391-92 (7th Cir. 2011). I must construe
the evidence and all inferences that reasonably can be drawn from the evidence
in the light most favorable to Ms. Slater, as the non-moving party. Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). As the moving party, Biomet bears

the burden of informing me of the basis for its motion, together with evidence
demonstrating the absence of any genuine issue of material fact. Celotex Corp.
v. Catrett, 477 U.S. 317, 323 (1986). If Biomet meets that burden, Ms. Slater
can’t rest upon the allegations in the pleadings, but must “point to evidence that
can be put in admissible form at trial, and that, if believed by the fact-finder,
could support judgment in [her] favor.” Marr v. Bank of Am., N,A., 662 F.3d 963,
966 (7th Cir. 2011); see also Hastings Mut. Ins. Co. v. LaFollette, No. 1:07-cv1085, 2009 WL 348769, at *2 (S.D. Ind. Feb. 6, 2009) (“It is not the duty of the
court to scour the record in search of evidence to defeat a motion for summary
judgment; rather, the nonmoving party bears the responsibility of identifying the
evidence upon which he relies.”); Hammel v. Eau Galle Cheese Factory, 407 F.3d
852, 859 (7th Cir. 2005) (summary judgment is “not a dress rehearsal or practice
run; it is the put up or shut up moment in a lawsuit, when a party must show
what evidence it has that would convince a trier of fact to accept its version of
events”).

II. THE PROPOSED BAR DATE
First, Biomet asks me to establish a bar date applicable to all plaintiffs.
Biomet argues that enough information was publicly available to put any
reasonable plaintiff on notice by February 10, 2011 that her injury might be
connected to Biomet’s M2a Magnum metal-on-metal hip implant. As Biomet sees
it, if a plaintiff was injured on or before February 10, 2011, the statute of

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limitations would begin to run then. For a plaintiff was injured after February
10, 2011, the statute of limitations would begin to run on the date of injury.
The discovery rule postpones the accrual of a cause of action until the
plaintiff knew, or through exercise of reasonable diligence should have known,
that she was injured. See, e.g., Fla. Stat. § 95.031(2)(b); 735 Ill. Comp. Stat.
5/13-213(d); N.C. Gen. Stat. § 1-52(16); Wash. Rev. Code § 7.72.060(3); Martin
v. Arthur, 3 S.W.3d 684, 690 (Ark. 1999); In re Med. Review Panel of Howard,
573 So. 2d 472, 474 (La. 1991); Moreno v. Sterling Drug, Inc., 787 S.W.2d 348,
351 (Tex. 1990).
Biomet contends that the following publicly available information put a
reasonable plaintiff on notice of a potential claim by the proposed bar date: the
device’s Instructions for Use, articles in medical journals, press reports, and the
Food and Drug Administration’s websites. The Instructions for Use for Biomet’s
metal-on-metal hip implants disclosed that using the device could pose a risk of
exposure to metal debris, including osteolysis, metal hypersensitivity, and
elevated metal ion levels. Eight 2010 medical journal articles raised concerns
about the risks associated with metal-on-metal hip implants, including an
editorial in the Journal of Arthroplasty, the official, peer-reviewed journal of the
Association of Hip and Knee Surgeons. See Ross Crawford et al., Metal on Metal:
Is it Worth the Risk?, J. ARTHROPLASTY, Sept. 2010, at 1.1

See also Joseph Daniel et al., Renal Clearance of Cobalt in Relation to the Use of Metalon-Metal Bearings in Hip Arthroplasty, 92 J. BONE & JOINT SURGERY 840 (2010); C.
Delaunay et al., Metal-on-Metal Bearings Total Hip Arthroplasty: The Cobalt and
Chromium Ions Release Concern, 96 ORTHOPAEDICS & TRAUMATOLOGY: SURGERY &
RESEARCH 894 (2010); Brian M. Devitt et al., Cobalt Ions Induce Chemokine Secretion in
1

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Biomet argues that news reports from early 2010 reporting on the risks of
metal debris with metal-on-metal hip implants also put plaintiffs on notice of
potential claims. See, e.g., Barry Meier, As Use of Devices Grows, Studies Raise
Concerns, N.Y. TIMES, Mar. 4, 2010.2 More news reports followed DePuy’s August
2010 recall of two ASR metal-on-metal hip implants. See, e.g., Natasha Singer,
Hip Implants Are Recalled by J. & J. Unit, N.Y. TIMES, Aug. 27, 2010.3
Last, Biomet contends that the FDA notified the public when it launched
two websites discussing potential health risks of metal-on-metal hip implants by
February 10, 2011. See Concerns about Metal-on-Metal Hip Implant Systems,
FOOD

&

DRUG

ADMIN.

(last

updated

Feb.

10,

2011),

https://web.archive.org/web/20110214064145/http://www.fda.gov/MedicalD

a Variety of Systemic Cell Lines, 81 ACTA ORTHOPAEDICA 756 (2010); Monika Huber et al.,
Postmortem Study of Femoral Osteolysis Associated with Metal-on-Metal Articulation in
Total Hip Replacement, 92 J. BONE & JOINT SURGERY 1720 (2010); Takao Imanishi et al.,
Serum Metal Ion Levels after Second-Generation Metal-on-Metal Total Hip Arthroplasty,
130 ARCHIVES ORTHOPAEDIC & TRAUMA SURGERY 1447 (2010); Ajay Malviya et al., Metalon-Metal Total Hip Arthroplasty, 92 J. BONE & JOINT SURGERY 1675 (2010); Michael C.
Parry et al., Thresholds for Indirect DNA Damage Across Cellular Barriers for Orthopaedic
Biomaterials, 31 BIOMATERIALS 4477 (2010).
See also Barry Meier, When New Hips Go Bad, N.Y. TIMES, Mar. 4, 2010; Barry Meier,
Alert Follows Withdrawal Of Hip Device, N.Y. TIMES, Mar. 10, 2010; Harvard Health
Letters, Hip Replacement Candidates Have Several Surgical Options, SUN-SENTINEL, Mar.
24, 2010; Sue Scheible, You Don’t Have to Be Old to Get a New Knee, Hip or Shoulder,
NEB. CITY NEWS-PRESS, Apr. 5, 2010; Peter Benesh, Stryker Promotes Hip Technology,
INVESTOR’S BUS. DAILY, Apr. 16, 2010.
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See also Jonathan D. Rockoff & Jon Kamp, J&J’s Latest Recall: Hip-Repair Implants,
WALL ST. J., Aug. 27, 2010; Nora Tooher, Litigation Mounts over DePuy Hip Replacement

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Device, LAWYERS WEEKLY USA, Oct. 4, 2010; Nelson Daranciang, Woman Sues over Hip Implant
Device, HONOLULU STAR-ADVERTISER, Oct. 27, 2010; Steve Daniels & Silvia Gambardella, Hip
Implant Recalled Amid Concerns About Heart Failure, Dementia, ABC NEWS, Dec. 1, 2010; Barry
Meier, The Implants Loophole, N.Y. TIMES, Dec. 17, 2010; Barbara Peters Smith, The Enemy
Within, SARASOTA HERALD TRIB., Dec. 21, 2010.

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evices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetal
HipImplants/ucm241604.htm; Information for Patients Who Have Metal-on-Metal
Hip

Implants,

FOOD

&

DRUG

ADMIN.

(last

updated

Feb.

10,

2011),

https://web.archive.org/web/20110528045143/http://www.fda.gov/MedicalD
evices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetal
HipImplants/ucm241766.htm. These websites warned that metal-on-metal hip
implants might leave debris that could damage bones and tissue surrounding
the implant, and encouraged people to contact their physicians if they
experienced any symptoms. Biomet argues that the combined effect of the
Instructions for Use, journal articles, press reports, and FDA warnings put a
reasonable person on notice of the connection between Biomet’s device and an
injury from exposure to metal and metal debris no later than February 10, 2011.
Three district court decisions in MDL dockets inform Biomet’s analysis. In
In re Avandia Marketing, Sales Practices and Products Liability Litigation, Judge
Rufe held that a bar date was appropriate because the cumulative effect of
publicity about a prescription drug’s relationship to adverse cardiovascular
events was sufficient, as a matter of law, to put an individual who had been
injured on notice that Avandia could be to blame. No. 07-MD-01871, 2012 WL
3205620, at *4 (E.D. Pa. Aug. 7, 2012). This publicity included:
1. a New England Journal of Medicine study finding that Avandia
increased the risk of heart problems by forty-three percent;

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2. a joint statement from the American College of Cardiology, the American
Diabetes Association, and the American Heart Association expressing
concern and advising patients to speak to their physicians;
3. an FDA advisory committee conclusion that Avandia increased heart
risk;
4. FDA action requiring that a warning be added to Avandia’s label;
5. the drug manufacturer sending letters to healthcare professionals on
studies linking Avandia and heart health;
6. the drug manufacturer publishing a “Dear Patient” letter about the risks
of heart problems;
7. a wave of media attention following the above, including lead stories on
the national nightly news; and
8. numerous lawsuits filed against the drug manufacturer, leading to the
formation of the MDL.
Id. at *3. Evidence that Avandia prescriptions dropped by forty-five percent and
sales by fifty-four percent as of the proposed bar date showed that these events
“were regarded as significant by physicians, patients, and attorneys.” Id. at *4.
In the MDL docket involving Vioxx, Judge Fallon applied a bar date to
multiple plaintiffs based on:
1. a medical study finding that Vioxx triggered a significant increase in
abnormal cardiovascular events;
2. media reports linking Vioxx to cardiovascular risks;

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3. a new Vioxx label that the manufacturer submitted, the FDA approved,
and resulted in substantial press coverage;
4. filing of a class action; and
5. the manufacturer removing Vioxx from the market, triggering “arguably
the largest and most-publicized prescription drug withdrawal in this
country's history.”
In re Vioxx Prods. Liab. Litig., 522 F. Supp. 2d 799, 803, 808, 814 (E.D. La.
2007). The court held that “[b]oth the national and local media coverage of the
withdrawal of Vioxx from the market were sufficient to put the plaintiffs on notice
of a potential link between their alleged injuries and the use of Vioxx.” Id. at 808.
In the Zyprexa litigation, Judge Weinstein held that a bar date was
appropriate when:
1. the FDA announced it would require an additional warning on the drug’s
label;
2. leading medical associations issued a consensus statement concluding
that Zyprexa posed a risk; and
3. the drug manufacturer distributed a “Dear Doctor” letter to physicians
nationwide informing them of the label change.
In re Zyprexa Prods. Liab. Litig., 727 F. Supp. 2d 101, 107 (E.D.N.Y. 2010); see
also Burrell v. Astrazeneca LP, No. CIV.A. 07C01412(SER), 2010 WL 3706584,
at *6 (Del. Super. Sept. 20, 2010) (establishing a bar date in litigation regarding
Astrazeneca’s Seroquel).

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I can’t say that, as a matter of law, the notice to a reasonable plaintiff of a
potential claim against Biomet approached what happened in the Avandia, Vioxx
and Zyprexa cases. First, in both the Avandia and Zyprexa cases, the
manufacturer published or distributed letters alerting patients or physicians to
the risks associated with the product. This would have been the simplest way for
Biomet to put all of its customers on notice of a potential claim, and Biomet
chose not to do so.
Second, two of the three cases included substantially more press coverage
than that surrounding Biomet. For example, in the Vioxx case, Judge Fallon
noted that the press coverage was “arguably the largest and most-publicized
prescription drug withdrawal in this country's history.” In re Vioxx Prods. Liab.
Litig., 522 F. Supp. 2d at 803. In addition, the coverage in Vioxx was the result
of the company pulling its product from the market. Biomet didn’t opt to make
such a clear signal to consumers of its product’s potential risk.
Third, two of the three cases included statements from leading medical
associations highlighting risks associated with the product. Biomet points to no
such statements here.
Fourth, Biomet doesn’t demonstrate how a reasonable plaintiff would have
seen or understood the Instructions for Use that Biomet argues should have put
her on notice. They’re directed to the operating surgeon, not the patient. While
the Instructions for Use caution about “histological reactions involving various
sizes of macrophages and fibroblasts,” they then backtrack, explaining that
“similar changes may occur as a precursor to or during the healing process.”

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They explain that “[p]articulate wear debris and discoloration from metallic and
polyethylene components of joint implants may be present in adjacent tissue or
fluid,” which could “result[ ] in osteolysis.” They explain a report associating
articulating surfaces and “increased genotoxicity.” They also add necessary
caveats, that the report “did not assess either the clinical relevance of the data
or make any definite conclusions as to which metal ions or interactions . . . might
be responsible for the observed data,” cautioning that “an association does not
necessarily mean a causal relationship.” Biomet might show how a reasonable
surgeon would have been aware of the product’s risks, but doesn’t show how a
reasonable plaintiff should have seen or understood the document.
Last, in two of the three cases, either a class action had been filed or an
MDL formed, with the consequent publicity and attorney advertising. The Biomet
MDL wasn’t formed until well over a year after Biomet’s proposed bar date.
Under even the most liberal construction of the states’ “discovery rules,”
Biomet doesn’t show that these materials would’ve had the cumulative effect of
putting all plaintiffs on constructive notice of a potential claim by February 10,
2011. Biomet’s knowledge that it possessed by the proposed bar date can’t be
attributed to the reasonable plaintiff. Biomet didn’t target information to patients
notifying them of the possible risks or demonstrate that reasonable plaintiffs are
reading medical journals or the FDA website. Without a torrent of press coverage
surrounding a decision to pull the product from the market or to change its label,
Biomet hasn’t shown that a reasonable plaintiff would know of a potential claim.
I decline Biomet’s request to establish a February 10, 2011, bar date.

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III. MS. SLATER’S BACKGROUND
Ms. Slater received a Biomet M2a Magnum implant in North Carolina in
March 2007. She says she began to experience hip pain seven to nine months
later. She underwent four revision surgeries between May 2008 and April 2009.
The second revision, in June 2008, was performed to provide irrigation,
debridement, and to replace the femoral head. The surgery uncovered a large
collection of fluid and metallosis. The third revision, in January 2009, was
performed to deal with an infection, and it uncovered metal debris. Ms. Slater
said she never saw her operative reports.
Ms. Slater says that around the fourth revision she “knew something was
wrong,” but that she “didn’t know what it was.” Ms. Slater contacted an attorney
in 2009 to discuss a potential medical malpractice claim. The attorney told her
that she didn’t have a malpractice case against the surgeon but said nothing
about Biomet. Ms. Slater says she didn’t know the implant was metal-on-metal
or that it was made by Biomet until 2013. She contacted an attorney again in
2013 in response to a television commercial and then filed on April 13, 2014.

IV. CHOICE OF LAW
When a case is filed directly in the MDL transferee court, the court applies
the law, including choice-of-law rules, of the state where the case originated.
E.g., In re Watson Fentanyl Patch Prods. Liability Litig., 977 F. Supp. 2d 885,
888 (N.D. Ill. 2013). It’s “appropriate to treat a foreign direct-filed case as if it

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had been filed in the state where the plaintiff purchased and was prescribed the
subject [product].” Id. (internal quotations omitted). The Magnum was
prescribed, purchased, and implanted in North Carolina, so North Carolina law
governs. Under North Carolina law, statutes of limitations are procedural, and
so North Carolina courts apply North Carolina statutes of limitations, Boudreau
v. Baughman, 368 S.E.2d 849, 857 (N.C. 1988), as will I.

V. DISCUSSION
A personal injury plaintiff must file within three years of when the cause
of action accrues. N.C. Gen. Stat. § 1-52(5). Personal injury claims “shall not
accrue until bodily harm to the claimant or physical damage to his property
becomes apparent or ought reasonably to have become apparent to the claimant,
whichever event first occurs.” § 1-52(16).
How much did Ms. Slater need to know for the three-year limitations
period to start running? In simpler contexts, a plaintiff’s knowledge that there’s
a problem is sufficient to start the limitations period. For example, knowledge
that a roof leaks puts a plaintiff “on inquiry as to the nature and extent of the
problem.” Pembee Mfg. Corp. v. Cape Fear Constr. Co., 329 S.E.2d 350, 354
(N.C. 1985). There’s an obvious potential cause to a leaky roof – poor installation
by the roofer.
Medical claims often involve a more complex trigger. “Especially in the
medical field, plaintiffs may lack the expertise to know whether the ill effects they
have suffered are a result of someone’s wrongdoing, or merely an unexpected

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result, or inevitable or unforeseeable risk of their treatment.” Black v. Littlejohn,
325 S.E.2d 469, 481 (N.C. 1985).4 Revision surgery within months of a hip
implant could, without additional information, mean medical malpractice, a
problem with the device, an unpreventable infection, or any other “inevitable or
unforeseeable risk of [ ] treatment.” Id.
In medical situations, “[w]here causation of an injury is unknown, the
action accrues when both the injury and its cause have been (or should have
been) discovered. Where the injury and causation are known, but not that there
has been any wrongdoing, the action is held to accrue when the plaintiff
discovered, or by due diligence should have discovered, the wrongdoing.” Id. at
482 (italics omitted). In the Black case, the plaintiff received drastic surgery for
an illness that, years later, she learned could have easily been treated with a
drug. Id. The claim accrued only on discovery of the simpler procedure years
later, which alerted her to her doctor’s negligence. Id. Needing revision alone,
even needing four revisions, mightn’t be a strong enough clue of the wrongdoing,
especially when Ms. Slater claims not have known of metallosis.
Ms. Slater admits that she knew something was wrong by the time of the
fourth revision surgery – enough to have contacted an attorney about a potential
malpractice claim. This knowledge would be enough to trigger the limitations
period as to a malpractice claim. But “the action is held to accrue when the

Black v. Littlejohn analyzes the limitations period for medical malpractice claims, which
requires determining when “the injury . . . is discovered or should reasonably be discovered by
the claimant.” N.C. Gen. Stat. § 1-15(c). Even though the case analyzes a different statute’s
“discovery rule,” the reasoning applies just as well to § 1-52(16).
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plaintiff discovered, or by due diligence should have discovered, the wrongdoing.”
Id. The possibility that the device itself failed inside her, “the wrongdoing,” didn’t
occur to Ms. Slater until years later when she saw an attorney advertisement
suggesting so.
Biomet might prevail on its statute of limitations defense, but not on
summary judgment. There’s a genuine issue of material fact as to when Ms.
Slater knew or should’ve known of the alleged wrongdoing, the failure of the
implant. Her knowledge that something was wrong, with the complexities of
medical treatment, might not have been enough to put her on inquiry notice as
to the failure of the device itself. That’s what North Carolina law seems to require
and it’s a question of fact that can’t be resolved now. Biomet’s motion is thus
denied as to the product liability and negligence claims (Counts I-II).
Different provisions govern the remaining claims. Ms. Slater’s breach of
warranty claims have a four-year limitations period that accrues “when the
breach occurs, generally “when tender of delivery is made.” N.C. Gen. Stat. § 252-725(1), (2); see Boudreau v. Baughman, 368 S.E.2d 849, 854 (N.C. 1988)
(applying limitations period to implied warranty claims). “Tender of delivery” was
the time of implant, March 2007. Four years thus elapsed before Ms. Slater filed.
There’s a “discovery rule” for breach of warranty claims too, but only when
the “warranty explicitly extend[ed] to future performance of the goods and
discovery of the breach must await the time of such performance.” § 25-2-725(2).
Neither party mentions the existence or nonexistence of an explicit warranty of
future performance. Without evidence of such a warranty, the breach of warranty

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claims (Counts III-IV) are time-barred and Biomet’s motion is granted as applied
to them.
Ms. Slater also sues under the North Carolina Unfair and Deceptive Trade
Practices Act. Actions for damages under this statute must be brought within
four years of when “the cause of action accrues,” § 75-16.2, “at the time of the
invasion of the plaintiff’s right,” Newton v. Barth, 788 S.E.2d 653, 662 (N.C. Ct.
App. 2016). Fraud or misrepresentation under the UDTPA accrue based on the
“discovery rule” described above. S.B. Simmons Landscaping & Excavating, Inc.
v. Boggs, 665 S.E.2d 147, 150 (N.C. Ct. App. 2008); Hunter v. Guardian Life Ins.
Co., 593 S.E.2d 595, 601 (N.C. Ct. App. 2004). But Ms. Slater doesn’t argue
fraud or misrepresentation; she argues that Biomet violated the statute simply
through sale of a defective product. Biomet says the cause of action accrued
“when the violation occur[ed],” Hinson v. United Fin. Servs., Inc., 473 S.E.2d
382, 387 (N.C. Ct. App. 1996), upon sale of the defective product. Ms. Slater
doesn’t address the issue in her response brief. In particular, she makes no
argument that the “discovery rule” should apply here too. Biomet’s motion is
thus granted as to the UDTPA claim (Count V).5

5 Ms. Slater also argues that Biomet waived its statute of limitations arguments when it didn’t
file a timely responsive pleading. See Fed. R. Civ. P. 8(c)(1); Wood v. Milyard, 132 S. Ct. 1826,
1832 (2012). On February 14, 2014, I granted a stay of “[a]ll case specific responsive pleadings
deadlines, including the filing of answers . . . until such time as the parties agree that the
obligations contemplated by the Settlement Agreement have been completed.” [Doc. No. 1418].
The parties haven’t presented any such agreement and so the stay is still in effect. Biomet didn’t
waive any affirmative defense by not filing an answer.

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VI. CONCLUSION
The court GRANTS Biomet’s motion for summary judgment [Doc. No. 117]
as to Ms. Slater’s breach of warranty and statutory claims (Counts III-V), and
DENIES Biomet’s motion as to her products liability and negligence claims
(Counts I-II).
SO ORDERED.
ENTERED: March 26, 2017
/s/ Robert L. Miller, Jr.
Judge
United States District Court

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