Miles v. Biomet Orthopedics LLC et al

Filing 140

OPINION AND ORDER: Biomet's 107 MOTION for Summary Judgment is GRANTED; and 115 MOTION for leave to file a second amended complaint is DENIED. ***Civil Case Terminated. Signed by Judge Robert L Miller, Jr on 3/26/17. (jld)

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF INDIANA
SOUTH BEND DIVISION
DYNEL MILES,
Plaintiff
v.
BIOMET ORTHOPEDICS, LLC,
et al.,
Defendants

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) Cause No. 3:14-CV-1983 RLM-MGG
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OPINION AND ORDER
Dynel Miles sued Biomet for damages in connection with the alleged failure
of her hip implant. Biomet moved for summary judgment, arguing that the
applicable statutes of limitations bars her claims based on (1) a proposed date
on which all plaintiffs were on constructive notice of potential claims and (2)
facts specific to the plaintiff. In response, Ms. Miles moved to amend her
complaint “to state with more specificity the chronology of events”, delete her
claim under New York’s General Business Law, and add a claim under Florida’s
consumer protection statute. For the following reasons, I grant Biomet’s motion
for summary judgment and deny Ms. Miles’s motion to amend.

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. Miles, 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. Miles
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 a
reasonable plaintiff on notice by February 10, 2011 that his injury might be

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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
limitations would begin to run then. If 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 he was injured. See, e.g., Fla. Stat. § 95.031(2)(b); 735 Ill. Comp. Stat. 5/13213(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 this publicly available information put any
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

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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
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

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
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).
1

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.
2

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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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
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

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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;
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:

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1. a medical study finding that Vioxx triggered a significant increase in
abnormal cardiovascular events;
2. media reports linking Vioxx to cardiovascular risks;
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,

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at *6 (Del. Super. Sept. 20, 2010) (establishing a bar date in litigation regarding
Astrazeneca’s Seroquel).
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

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sizes of macrophages and fibroblasts,” they then backtrack, explaining that
“similar changes may occur as a precursor to or during the healing process.”
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 have had the cumulative effect
of putting all plaintiffs on constructive notice of a potential claim by February
10, 2011. What Biomet knew 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,

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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.

III. MS. MILES’S BACKGROUND
A Ringloc device was implanted in Ms. Miles’s right hip on December 7,
2005. She began experiencing pain soon afterwards, and was her surgeon told
her on December 30, 2005 that the Ringloc had failed and that she needed
revision surgery. The Ringloc system was removed during revision surgery on
January 2, 2006, with a diagnosis of “failed acetabular component.”
Ms. Miles contacted an attorney in January 2006 to discuss the possibility
of a lawsuit against her surgeon. Ms. Miles also requested a product catalogue
from Biomet to see if she might have a claim against it. She did so after seeing
commercials about lawsuits against other metal-on-metal hip manufacturers.
On October 22, 2014, Ms. Miles filed this suit alleging that the device
implanted in December 2005 was defective and asserting claims for strict
product liability, breach of warranty, negligence, negligent misrepresentation,
fraud, loss of consortium and a violation of New York’s General Business Law.
Ms. Miles amended her complaint in November 2014, to allege that her implant
was defective because it caused excessive amounts of cobalt and chromium to
wear and corrode, leading to rejection of the implant and other bodily harm, and
that the defect caused her implant to fail, requiring the January 2, 2006 revision
surgery. [Doc. No. 5 at ¶¶ 23, 33-34].

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IV. CHOICE OF LAW
When a case is filed directly in the MDL transferee court, the court applies
the law, including the 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 had
been filed in the state where the plaintiff purchased and was prescribed the
subject [product].” Id. (internal quotations omitted). The device in this case was
prescribed, purchased, and implanted in Florida, so Florida choice of law rules
govern. Florida courts apply the law with the “most significant relationship” to
the claim. Brown v. Nat’l Car Rental Sys., Inc., 707 So. 2d 394, 395 (Fla. Dist.
Ct. App. 1998). Because the injury, implant, and revision occurred in Florida,
Florida presumptively has the most significant relationship, so Florida law,
including its statutes of limitations, applies.

V. DISCUSSION
Ms. Miles had to file her claims for product liability, breach of warranty,
negligence and fraud within four years from the time “the facts giving rise to the
cause of action were discovered, or should have been discovered with the exercise
of due diligence.” Fla. Stat. Ann. §§ 95.031(2)(a) and (b) and 95.11.4 But how
much does she need to know for the limitations period to run?
4 Ms. Miles doesn’t dispute Biomet’s assertion that she can’t prevail on her claim under the New
York General Business Law (Count 11) because no relevant conduct occurred in New York, see
Goshen v. Mut. Life Ins. Co., 774 N.E.2d 1190, 1195 (N.Y. 2002), and the claim is barred by the
applicable three-year statute of limitations, which accrues at the time of injury. See Lucker v.
Bayside Cemetery, 114 A.D.3d 162, 175 (N.Y. App. 2013); Wender v. Gilberg Agency, 276 A.D.2d
311, 312 (N.Y. App. 2000), and withdrew the claim in her proposed second amended complaint.

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The statute of limitations begins to run Under Florida law “when the
plaintiff is aware of an injury and the possible involvement of a product.” In re
Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., MDL No. 2004,
2016 WL 873814, at *2 (M.D. Ga. Mar. 4, 2016) (applying Florida law); Univ. of
Miami v. Bogorff, 583 So. 2d 1000, 1004 (Fla. 1991); Babush v. Am. Home
Products Corp., 589 So. 2d 1379, 1381 (Fla. Dist. Ct. App. 1991).
Ms. Miles’s claims accrued by January 2006, when she became aware that
she had injuries related to the Biomet hip implant, sought product information
from Biomet, and contacted an attorney about filing a lawsuit against her
physician. Her complaint was filed more than eight years later, so her claims are
barred under the four-year statutes of limitations.
Ms. Miles argues that the limitations period was tolled until at least 2013
because Biomet “fraudulently concealed” the “true risks” associated with its
metal-on-metal hip implant, and that neither she, nor her physician, was aware
of those risks until blood tests in 2013, 2014 and 2015 revealed increased levels
of Chromium and Cobalt. Her argument is factually and legally unsupported.
Florida’s statutes of limitations can only be tolled for reasons enumerated
in Fla. Stat. § 95.051, See HCA Health Servs. Of Fla., Inc. v. Hillman, 906 So.2d
1094, 1099 (Fla. Dist. Ct. App. 2004), and fraudulent concealment is not among
the exceptions enumerated in that statute.
Florida courts recognize that equitable estoppel can bar a statute of
limitations defense, see Major League Baseball v. Morsani, 790 So.2d 1071, 1077
(Fla. 2001), but require the plaintiff to show “that the defendant willfully induced

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the plaintiff to forego suit until after the limitations period has ended.” In re
Chiquita Brands Int’l, Inc. Alien Tort Statute and Shareholder Derivative Litig.,
690 F.Supp.2d 1296, 1316 (S.D. Fla. 2010) (quoting Fox v. City of Pompano
Beach, 984 So.2d 664, 667 (Fla. Dist. Ct. App. 2008)). Ms. Miles hasn’t made the
required showing.

VI. MOTION TO AMEND
Fed. R. Civ. P. 15(a) governs amendments to pleadings and provides that
leave to amend should be freely given “when justice so requires.”
In the absence of any apparent or declared reason—such as undue
delay, bad faith or dilatory motive on the part of a movant, repeated
failure to cure deficiencies by amendments previously allowed,
undue prejudice to the opposting party by virtue of allowance of the
amendment, futility of the amendment, etc.—the leave sought
should, as the rules require, be freely given.
Foman v. Davis, 371 U.S. 178, 182 (1962).
In her motion, Ms. Miles asserts that the purpose of the amendment is “to
state with more specificity the chronology of events in support of her response to
Defendants’ Motion for Summary Judgment.” But the proposed second amended
complaint attached to her motion would do much more than that. It would drop
her claim under New York’s General Business Law, and would add new claims
(i.e., that the device implanted in January 2006 was also defective and that
Biomet violated Florida’s Deceptive and Unfair Trade Practices Act).
Ms. Miles offers no explanation for why she didn’t move to amend sooner;
she didn’t file a memorandum in support of her motion and hasn’t cited any
authority for the relief she seeks. The deadline for dispositive motions has passed
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and the MDL docket is nearing its final stages. Allowing Ms. Miles to amend her
complaint to add new claims at this late stage would result in undue delay and
unduly prejudice the defendant. Accordingly, I must deny Ms. Miles motion.

VII. CONCLUSION
For the foregoing reasons, Biomet’s motion for summary judgment [Doc.
No. 107] is GRANTED and Ms. Miles’s motion for leave to file a second amended
complaint [Doc. No. 115] is DENIED.
SO ORDERED.
ENTERED: March 26, 2017

/s/ Robert L. Miller, Jr.
Judge
United States District Court

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