Pizzitolo v. Biomet Orthopedics LLC
OPINION AND ORDER: Biomet's 195 Motion for Summary Judgment is DENIED. Signed by Judge Robert L Miller, Jr on 3/26/2017. (jld)
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF INDIANA
SOUTH BEND DIVISION
BIOMET ORTHOPEDICS, LLC,
) Cause No. 3:12-CV-570 RLM-MGG
OPINION AND ORDER
Vincent Pizzitolo sued Biomet for damages in connection with the alleged
failure of his Biomet M2a Magnum hip implant. Biomet moved for summary
judgment, arguing that all of his claims are time-barred by the applicable
statutes of limitations based on (1) a proposed date on which all plaintiffs were
on constructive notice of potential claims and (2) facts specific to Mr. Pizzitolo. I
deny Biomet’s motion for the reasons that follow.
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. Pizzitolo, 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. Pizzitolo 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 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 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. 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 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
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
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,
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.
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. PIZZITOLO’S BACKGROUND
Mr. Pizzitolo received a Biomet Magnum implant in his right hip in March
2008, and began experiencing pain in his hip in late 2010. He discussed the
problem with his treating surgeon, Dr. Lance S. Estrada, who told Mr. Pizzitolo
that he believed the acetabular cup had slipped and that he would need revision
surgery, which occurred on January 24, 2011. Dr. Estrada stated in an affidavit
that at the time of the revision surgery and until at least December 11, 2012, he
didn’t suspect that the device was defected; rather he believed, and told Mr.
Pizzitolo, that it needed to be replaced because it shifted position.
Mr. Pizzitolo attests that he learned of the DePuy ASR hip implant recall
through a television commercial placed by attorneys around March 2011, and
contacted a law firm to determine whether he had a potential claim against
Biomet for his implant. On September 22, 2011, the law firm sent Mr. Pizzitolo
a letter stating:
Thank you for contacting us regarding your potential product
liability claim against Biomet, Inc. for their M2a-Magnum cup, their
M2a-Magnum Tri-Spike cup, or their M2a-38 mm cup.
When we accepted your claim, it was on an investigational
basis, and further investigation into these devices has led us to
decide not to pursue the litigation. While we recognize that your hip
metal on metal implant is similar to the recalled DePuy implant and
that your problems may very well be related to design problems with
the implant, Biomet has not recalled the device and there is a lack
of incriminating published medical evidence at this time specific to
the Biomet products. Accordingly, [the firm] h[as] not engaged and
will not engage in any activity on your behalf and we will be closing
our file in this matter.
This does not mean that you do not have a valid claim. Since
attorneys’ opinions differ, we encourage you to seek the advice of
other counsel. Please note that there are strict time limits for filing
a lawsuit. Once the time limit expires (if it has not already), you are
forever barred from bringing suit. If you wish to pursue alternative
counsel, we would strongly encourage you to do so as soon as
[Doc. No. 204-4]. After seeing more advertising suggesting that Biomet hip
implants were defective, Mr. Pizzitolo contacted another attorney, and filed his
complaint on February 27, 2012.
IV. CHOICE OF LAW
Mr. Pizzitolo’s complaint was originally filed in the Eastern District of
Louisiana, and is governed by Louisiana choice of law rules. See In re Watson
Fentanyl Patch Prod. Liab. Litig., 977 F. Supp. 2d 885, 888 (N.D. Ill. 2013)
(recognizing that the “choice of law rules that apply are those of the state where
the case originated”). Under those rules, Louisiana law provides the statute of
limitations on Mr. Pizzitolo’s claims. See La. Civ. Code Ann. art. 3549 (“when the
substantive law of this state would be applicable to the merits of an action
brought in this state, the prescription and preemption law of this state applies”).
Products liability claims under Louisiana law must be brought within one
year from the date of injury. La. Civ. Code Ann. art. 3492. The statute of
limitations for redhibition claims varies, but in all cases it is at least one year.
La. Civ. Code Ann. art. 2534.
“[T]he mover bears the burden of proving prescription.” Taranto v.
Louisiana Citizens Prop. Ins. Corp., 62 So. 3d 721, 726 (La. 2011). But “if the
petition is prescribed on its face, then the burden of proof shifts to the Plaintiff
to negate the presumption by establishing a suspension or interruption.” Id. Mr.
Pizzitolo’s complaint was filed on February 27, 2012, more than a year after his
January 24, 2011, revision surgery, the latest possible date of his injury. Mr.
Pizzitolo’s action is time-barred on its face, unless he can prove that the statutes
of limitations were tolled.
Mr. Pizzitolo contends that the limitations periods were tolled until March
2011 under Louisiana’s version of the discovery doctrine, the contra non
valentem doctrine, because he reasonably relied on his surgeon’s statement that
the Biomet device had shifted position, rather than being defective, and didn’t
learn about the DePuy recall or contact an attorney to inquire about a potential
lawsuit until March 2011.
The contra non valentem doctrine “is based on the theory that when the
claimant is not aware of the facts giving rise to his or her cause of action against
the particular defendant, the running of prescription is . . . suspended until the
tort victim discovers or should have discovered the facts upon which his or her
cause of action is based.” In re Med. Review Panel of Howard, 573 So. 2d 472,
474 (La. 1991). “Prescription does not run against one who is ignorant of the
facts upon which his cause of action is based, as long as such ignorance is not
willful, negligent[,] or unreasonable.” Id. “When prescription begins to run
depends on the reasonableness of a plaintiff's action or inaction . . . in light of
plaintiff's own information and the diagnoses he received.” Raborn v. Albea, 144
So. 3d 1066, 1072 (La. Ct. App. 2014). Under Louisiana law, the limitations
period is tolled if the plaintiff “reasonably relied on [his] treating physician
regarding the cause” of the injury. Lapuyade v. Rawbar, Inc., 190 So. 3d 1214,
1224 (La. Ct. App. 2016). Ignorance of the true cause of the injury isn’t willful or
inexcusably negligent when a plaintiff relies on a treating physician’s opinion
that is supported by medical records. Id. at 1225.
Dr. Estrada attested that “at no time prior to December 11, 2012, did he
know, appreciate, suspect, or tell Mr. Pizzitolo that the Biomet hip implant device
was defective or that he was aware that there was anything wrong with it, other
than that it needed replacement because it had shifted position.” [Doc. No. 2045]. Medical reports from a pre-surgery appointment and the operative report
include Dr. Estrada’s opinion that the device had slipped or shifted. [Doc. Nos.
204-6 and 204-7].
Biomet argues that Lapuyade doesn’t control because Mr. Pizzitolo was on
constructive notice at the time of his surgery of potential claims based on the
warnings disclosed in the device’s Instructions for Use. As already discussed,
Biomet hasn’t demonstrated how a reasonable plaintiff (including Mr. Pizzitolo)
would have seen or understood the Instructions for Use. Biomet’s reliance on
Raborn v. Albea, 144 So. 3d 1066 (La. Ct. App. 2014) to support its argument is
misplaced. In Raborn, the court held that the plaintiff was on constructive notice
of an implanted medical device’s defect despite a physician’s failure to diagnose
the defect because the product’s insert disclosed the adverse effects of the device
that the plaintiff experienced. Id. at 1072–1073. The court found that the
product’s “insert, which was available to [the plaintiff] at the time of his surgery,”
disclosed the risks associated with the product. Id. at 1072. But Mr. Pizzitolo
presented evidence indicating that the Instructions for Use weren’t available to
him [Doc. No. 204-2], and Biomet hasn’t presented any evidence to the contrary.
Mr. Pizzitolo stated in his affidavit that he asked Dr. Estrada what caused
his injury and his physician told him that “the hip had slipped or come loose,”
requiring revision surgery. [Doc. No. 204-1]. In a separate affidavit, Dr. Estrada
attested that he told Mr. Pizzitolo that the implant “needed replacement because
it had shifted positions” and disclosed that he didn’t suspect that the device was
defective, and medical records from December 2010 and January 2011 reiterate
Dr. Estrada’s opinion that the device had slipped or shifted. [Doc. Nos. 204-5,
204-6 and 204-7]. Mr. Pizzitolo’s discussion with his treating surgeon about the
cause of his injury demonstrated reasonable diligence and his reasonable
reliance on his surgeon’s opinion tolls the statutes of limitations. Lapuyade v.
Rawbar, Inc., 190 So. 3d 1214, 1224 (La. Ct. App. 2016).
But for how long?
Biomet argues that Mr. Pizzitolo’s admission that he consulted with
attorneys in early 2011 demonstrates that he had notice of his claims before
March 2011. But Mr. Pizzitolo attested that he was “fairly certain” that he learned
of the DePuy ASR hip implant recall through a television commercial no earlier
than March 2011 and then contacted a law firm handling ASR cases to determine
whether he might have a claim against Biomet. [Doc. No. 204-1]. Contacting a
lawyer to pursue a product liability claim against Biomet demonstrates that Mr.
Pizzitolo was on notice of his claim. The only evidence in the record as to the date
of Mr. Pizzitolo’s outreach to an attorney, however, is his assertion that he was
“fairly certain” it followed him seeing a television commercial no earlier than
March 2011. The law firm’s letter responding to Mr. Pizzitolo’s inquiry is dated
September 22, 2011.
Based on the evidence presented, a reasonable jury could find that
Mr.Pizzitolo was on notice of his claims by March 2011, that the statutes of
limitations for his products liability and redhibition claims were tolled until that
time, and that his claims were timely filed.
For the foregoing reasons, Biomet’s motion for summary judgment [Doc.
No. 195] is DENIED.
ENTERED: March 26, 2017
/s/ Robert L. Miller, Jr.
United States District Court
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