Fahy v. Biomet Orthopedics, LLC et al
OPINION AND ORDER: The court GRANTS Biomets motion for summary judgment 81 as to Mr. Fahys breach of warranty, negligent misrepresentation, deceptive trade practices and consumer protection claims (Counts 3, 4, 6, 7 and 8), and DENIES Biomets motion as to Mr. Fahys strict liability and negligence claims (Counts 1, 2 and 5). Signed by Judge Robert L Miller, Jr on 3/26/17. (jld)
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF INDIANA
SOUTH BEND DIVISION
BIOMET ORTHOPEDICS, LLC, et al.,
) Cause No. 3:15-CV-218 RLM-MGG
OPINION AND ORDER
John Fahy sued Biomet for damages in connection with the alleged failure
of his Biomet M2a Magnum hip implant. Biomet moved for summary judgment,
arguing Indiana’s statutes of limitations bars all of Mr. Fahy’s claims based on
(1) a proposed date on which all plaintiffs were on constructive notice of potential
claims and (2) facts specific to Mr. Fahy. I disagree with Biomet’s proposed
universal bar date and DENY its motion as to Mr. Fahy’s strict product liability
and negligence claims (Counts 1, 2 and 5), but grant the motion as to the breach
practices/consumer protection claims (Counts 3, 4, 6, 7 and 8), for the reasons
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 Mr. Fahy, 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, Mr. Fahy 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 his 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-cv-1085,
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
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
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
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
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).
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.
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
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.
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,
HipImplants/ucm241604.htm; Information for Patients Who Have Metal-on-Metal
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;
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
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;
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
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
1. the FDA announced it would require an additional warning on the drug’s
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
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.”
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,
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. MR. FAHY’S BACKGROUND
Mr. Fahy received a Biomet Taper implant in his left hip in Minnesota in
February 2010. After the surgery, he developed a staph infection at the surgery
site and began to experience intense pain. The staph infection was unresponsive
to antibiotic treatment, and Mr. Fahy’s surgeon told him that the Taper needed
to be removed due to the failure of the antibiotic therapy. Mr. Fahy underwent
his first revision surgery on April 10, 2010, during which components of the
Taper were removed and an antibiotic spacer was implanted. It wasn’t his last;
Mr. Fahy had other surgeries and procedures on August 11, 2010, June 25,
2011, November 1, 2011, and June 20, 2012 (when he underwent his last
revision surgery), due to infection and fluid build-up. Mr. Fahy asserts that he
first heard of a possible problem with some of the metal-on-metal hips in 2014,
when he saw commercials on late night television and got an email indicating
that there were possible problems with hip implants. He filed suit against Biomet
in the District of Minnesota on May 11, 2015, and the case was transferred to
this MDL docket.
IV. CHOICE OF LAW
“[S]ince federal jurisdiction is based on diversity of citizenship, the choiceof-law rules to be used are those choice-of-law rules of the states where the
actions were originally filed.” In re Air Crash Disaster Near Chicago, 644 F.2d
594, 610 (7th Cir. 1981). Minnesota generally applies the statute of limitations
of the jurisdiction whose substantive law applies. Minn. Stat. § 541.31; Blake
Marine Group, Inc. v. CarVal Investors LLC, 829 F.3d 592, 595 (8th Cir. 2016).4
Although the traditional rule still applies in Minnesota, see Glover v. Merck
& Co., 345 F.Supp. 994, 998-99 (D. Minn. 2004), Biomet urges me to engage in
a multi-factor choice of law analysis and apply Indiana’s shorter statute of
limitations, citing, i.e., Kolberg-Pioner, Inc. v. Belgrade Steel Tank Co., 823
N.W.2d 669, 673 (Minn. App. 2012). Before applying a choice-of-law analysis,
however, I must find that a conflict exists and that both states' laws can be
constitutionally applied (that each state has significant contacts such that
applying its law would not be arbitrary or fundamental unfair). Whitney v. Guys,
Inc., 700 F.3d 1118, 1123 (8th Cir. 2012); Nodak Mut. Ins. Co. v. Am. Family
Mutual Ins. Co., 604 N.W.2d 91, 93–94 (Minn.2000); Jepson v. Gen. Casualty
Co. of Wisconsin, 513 N.W.2d 467, 469 (Minn.1994). Biomet contends that both
requirements have been satisfied. I disagree.
While the statutes of limitations in Minnesota and Indiana differ with
misrepresentation claims, Indiana doesn’t have sufficient contacts to justify
4 Minn. Stat. 541.31, Subdivision 1 provides:
(a)…“[I]f a claim is substantively based:
(1) upon the law of one other state, the limitation period of that state applies; or
(2) upon the law of more than one state, the limitation period of one of those states chosen by
the law of conflict of laws of this state applies.
(b) The limitation period of this state applies to all other claims.
applying its law. This case was filed in Minnesota, by a citizen of Minnesota, and
asserts claims under Minnesota law. The device was sold in Minnesota, the
original and revision surgeries occurred there, and this case will be remanded to
the district court in Minnesota for trial, if Mr. Fahy prevails on summary
judgment. The only connections the case has to Indiana is that it was transferred
here as part of the MDL and the defendants are Indiana citizens. Those limited
contacts with Indiana don’t justify applying Indiana law. See Allstate Ins. Co. v.
Hague, 449 U.S. 302, 312–13 (1981). Minnesota law, including its statutes of
limitation, therefore applies. See Minn. Stat. § 541.31; Blake Marine Group, Inc.
v. CarVal Investors LLC, 829 F.3d at 595; Glover v. Merck & Co., Inc., 345
F.Supp.2d at 999; American Mutual Liability Ins. Co. v. Reed Cleaners, 122
N.W.2d 178, 180 n. 1 (Minn. 1963); In re Daniel’s Estate, 294 N.W. 465, 469
With one exception, Biomet based its arguments exclusively on Indiana
law, which doesn’t apply. Biomet made a cursory argument in a footnote to its
memorandum that Mr. Fahy’s product liability and breach of warranty claims
“are time-barred even under Minnesota law.” [Doc. No. 82 at p. 12, n.9]. Citing
Minn. Stat. § 541.05, Subd. 2 (strict liability claims “arising from the
manufacture, sale, use or consumption of a product shall be commences within
four years”) and Minn. Stat. § 336.2-725(2) (“A breach of warranty occurs when
tender of delivery is made, except that where a warranty explicitly extends to
future performance of the goods and discovery of the breach must await the time
of such performance the cause of action accrues when the breach is or should
have been discovered.”)
A cause of action for strict product liability accrues Under Minnesota law
when there is: “(1) a cognizable physical manifestation of the disease or injury,
and (2) evidence of a causal connection between the injury or disease and the
defendant’s product, act, or omission.” Huggins v. Stryker Corp., 932 F.Supp.2d
972, 984 (D. Minn. 2013) (quoting Hildebrandt v. Allied Corp., 839 F.2d 396, 398
(8th Cir. 1987)); see also Block v. Toyota Motor Corp., 5 F.Supp.3d 1047, 1058
(D. Minn. 2014); Mack v. Stryker Corp., Civ. No. 10-2993, 2010 WL 4386898, at
*2 (D. Minn. Oct. 28, 2010).
The summary judgment record doesn’t indicate that Mr. Fahy had actual
or constructive knowledge of a possible connection between the Taper and injury
from metal debris when he had his first revision on April 12, 2010. Mr. Fahy
knew that the Taper implant had to be removed in April 2010 because of a staph
infection that didn’t respond to antibiotic treatment, but there’s no indication
the hip implant caused the original staph infection or the recurring infections
that required later revisions. With the complexities of medical treatment, that
information might not have been enough to put him on inquiry notice as to the
failure of the device itself.5 That’s what Minnesota law requires, I can’t resolve
5 For reasons previously stated, Biomet’s suggestion that Mr. Fahy knew or should of known of
a causal connection between the device and his injury by February 10, 2011 based on its “bar
date” argument is unpersuasive. Assuming for the sake of argument, that Mr. Fahy had actual
or constructive knowledge no later than June 20, 2012, when he had his final revision surgery,
the strict liability claims in his complaint fell within the applicable four year statute of limitations.
this question of fact on summary judgment. Biomet’s motion is denied as to the
strict liability claims (Counts 1 and 2).
Different provisions govern the remaining claims. Mr. Fahy’s breach of
warranty claims have a four-year limitations period that generally accrues “when
tender of delivery is made.” Minn. Stat. § 336.2-725(2). “Tender of delivery” was
the time of implant, February 2010, so four years elapsed before Mr. Fahy filed
Minnesota has a “discovery rule” for breach of warranty claims too, but
only when the “warranty explicitly extends to future performance of the goods
and discovery of the breach must await the time of such performance.” See Minn.
Stat. § 336.2-724(2). Neither party mentions the existence or nonexistence of an
explicit warranty of future performance. Without such an explicit warranty, the
breach of warranty claims (Counts 3, 7 and 8) are time-barred and Biomet’s
motion is granted as applied to them.
Mr. Fahy’s negligence and negligent misrepresentation claims are timely
under Minnesota’s six-year statute of limitations for personal injury actions,
Minn. Stat. § 541.05 subd. 1(5). See Huggins v. Stryker Corp., 932 F.Supp.2d
972, 984 (D. Minn. 2013). Biomet doesn’t contend otherwise, but argues in the
alternative that Mr. Fahy’s negligent misrepresentation claim and his claims
under Minnesota’s deceptive trade practices and consumer protection laws
should be dismissed because both require proof of causation, and Mr. Fahy
hasn’t shown that he reasonably relied on any statements by Biomet or its
employees in deciding which device to use. In response, Mr. Fahy simply asserts
that causation is a disputed fact and that the issues on summary judgment were
supposed to be limited to Biomet’s statute of limitations defense. But he
presented no evidence that would support his position or authority that would
limit the scope of Biomet’s summary judgment motion to statute of limitations
The scheduling order entered in MDL 2391 on December 21, 2015
provided that: “If the [summary judgment] motion asserts grounds other than
the statute of limitations, the PSC may seek additional time in which to conduct
discovery on those additional issues, in accordance with Fed. R. Civ. P. 56(d).”
[Doc. No. 3047 at ¶ 3(C)]. Mr. Fahy didn’t ask me for additional time and hasn’t
pointed to any evidence that would support judgment in his favor on his
negligent misrepresentation, deceptive practices, or consumer protection claims.
Biomet’s motion for summary judgment must be granted with respect to those
claims. See Hastings Mut. Ins. Co. v. LaFollette, No. 1:07-cv-1085, 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”).
The court GRANTS Biomet’s motion for summary judgment [Doc. No. 81]
as to Mr. Fahy’s breach of warranty, negligent misrepresentation, deceptive trade
practices and consumer protection claims (Counts 3, 4, 6, 7 and 8), and DENIES
Biomet’s motion as to Mr. Fahy’s strict liability and negligence claims (Counts 1,
2 and 5).
ENTERED: March 26, 2017
/s/ Robert L. Miller, Jr.
United States District Court
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