BOSTON SCIENTFIC CORPORATION et al v. MIROWSKI FAMILY VENTURES, LLC

Filing 377

ENTRY ON MOTIONS REGARDING EXPERT TESTIMONY: Boston Scientific's motion 195 is DENIED. Mirowski's motion 205 is also DENIED ***SEE ENTRY FOR ADDITIONAL INFORMATION***. Signed by Judge William T. Lawrence on 2/13/2013. (DW)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
BOSTON SCIENTIFIC
CORPORATION, et al.,
Plaintiffs,
vs.
MIROWSKI FAMILY VENTURES, LLC,
Defendant.

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ENTRY ON MOTIONS REGARDING EXPERT TESTIMONY
This cause is before the Court on Plaintiff Boston Scientific Corporation’s Motion in
Limine to Preclude Certain Testimony Based on Estoppel (Dkt. No. 195) and Defendant
Mirowski Family Venture’s Motion in Limine to Exclude Testimony that Contradicts This
Court’s Construction of “Cardioversion” (Dkt. No. 205). The motions are fully briefed and the
Court, being duly advised, rules as follows.
I.

BACKGROUND1

This is not the first time at the rodeo for either party. In 1996, Mirowski and Boston
Scientific’s predecessors jointly sued St. Jude Medical, Inc., for infringement of Mirowski’s ‘288
patent, which was licensed to Boston Scientific’s predecessors.2 The case was tried to a jury in
2001. The jury found claims 4 and 13 of the‘288 patent valid but not infringed by St. Jude.
Following trial, the presiding judge, the Honorable David F. Hamilton, granted judgment as a

1

A more detailed background of this case can be found in the Court’s November 30,
2012, entry on summary judgment at Docket No. 235.
2

In the interest of accuracy, the Court notes that Mirowski was not actually added as a
plaintiff until 2001.

matter of law to St. Jude, finding the patent invalid for obviousness.3 Judge Hamilton also denied
Boston Scientific and Mirowski’s motion for a new trial on infringement of the patent.
Mirowski and Boston Scientific jointly appealed Judge Hamilton’s ruling of invalidity as
to claims 4 and 13 of the patent and infringement as to claim 4 only. On appeal, the Federal
Circuit reversed Judge Hamilton’s invalidity ruling and reinstated the jury verdict that the ‘288
patent was not invalid for obviousness. The Federal Circuit concluded that the district court had
erred regarding a portion of the claim construction not relevant here (the “determining step”) and
it remanded the case for reconsideration of this part of the claim construction and, if necessary, a
new trial of that claim.
The case continued on a long and windy path until, in 2006, Boston Scientific and St.
Jude, and eventually Mirowski, agreed to a narrowing of certain claims. In 2010, the parties
settled the remaining claims and the case was dismissed.
What was once united is now divided. Among other claims, Mirowski now seeks to
recover from Boston Scientific for actions it took during and after the St. Jude litigation that it
argues breached certain of its agreements with Boston Scientific. First, Mirowski argues that
Boston Scientific breached its agreement to pay royalties on ICDs it sold. Second, Mirowski
argues that Boston Scientific breached another of the parties’ agreements when it settled portions
of its claims with St. Jude without first notifying Mirowski and obtaining its approval.
The inquiry now before the Court concerns whether and how, under the doctrine of
judicial estoppel, certain representations the parties jointly made to the Federal Circuit and the
district court preclude testimony now offered by Mirowski’s or Boston Scientific’s experts in

3

This is just one aspect of the opinion. Cardiac Pacemakers, Inc. v. St. Jude Medical,
Inc., 2002 WL 1801525 (S.D. Ind. 2002).
2

this case. This dispute is relevant to both the first and second issues described above, as it may
shed light on (1) the percentage of Boston Scientific’s ICDs that actually performed the method
of claim 4 (that is, cardioversion) and therefore accrued royalties in favor of Mirowski,4 and (2)
the percentage of St. Jude’s ICDs that actually performed the method of claim 4 and therefore
would yield damages for infringement in favor of Boston Scientific and Mirowski, had the case
not settled.
A. Claim 4 and the District Court Opinion
Claim 4 of the ‘288 patent, and claim 1 from which it depends, states:
1. A method of heart stimulation using an implantable heart stimulator capable of
detecting a plurality of arrhythmias and capable of being programmed to undergo
a single or multi-mode operation to treat a detected arrhythmia, corresponding to
said mode of operation the method comprising the steps of:
(a) determining a condition of the heart from among a plurality of
conditions of the heart;
(b) selecting at least one mode of operation of the implantable heart
stimulator which operation includes a unique sequence of events
corresponding to said determined condition; and
(c) executing said at least one mode of operation of said implantable heart
stimulator thereby to treat said determined heart condition.
4. The method of claim 1, wherein at least one mode of operation of said
implantable heart stimulator includes cardioversion.
At the conclusion of the evidence in the 2001 jury trial, Judge Hamilton instructed the
jury that the term “cardioversion,” as used in claim 4, meant “the application of non-pacing
electrical pulses designed to stimulate sufficient heart tissue to correct an arrhythmia, with
energy levels generally below those used for defibrillation.” June 28, 2001, Tr. of Final Inst. at

4

Of course, as this Court’s summary judgment entry explained, this is not the only way
that Boston Scientific ICDs accrue royalties in favor of Mirowski.
3

3278:8-13, Ex. 1 to No. 206; Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., 2002 WL
1801525 at *38 (S.D. Ind. 2002). The jury returned a verdict that the ‘288 patent was not invalid
for obviousness, but St. Jude had not infringed the ‘288 patent for multimode programming for
ICDs. 2002 WL 1801525 at 2. However, on post-verdict motions, Judge Hamilton held that the
jury’s verdict on validity was not supported by substantial evidence. He granted St. Jude
judgment as a matter of law, holding that the ‘288 patent was invalid for obviousness. 2002 WL
1801525 at *38-44. Mirowski and Boston Scientific appealed.
B.

Federal Circuit Appeal

The Federal Circuit paraphrased the district court’s holding as follows:
The district court, granting St. Jude’s motion for judgment as a matter of law,
found that each of the elements of claims 4 and 13 was previously known. The
court cited references that described implanted cardiac devices that provided
multimode therapy, although none included cardioversion therapy. The court
found that cardioversion therapy was known, and found that “compelling
motivation” to combine therapies in a single implanted device was provided by an
article by Haft, wherein Haft explained that pacing therapy may trigger
ventricular fibrillation. The district court found that Haft identified the problem
solved by the ‘288 patent, and concluded that it would have been obvious to
design a pacing device that could defibrillate if necessary. That is, the court found
that there was a known need to treat mixtures of arrhythmias, and that it would
have been obvious to combine known methods of separate treatment.
Among the cited references, the district court placed weight on a British patent
2,026,870 to Duggan, as providing the motivation to combine treatments of
different arrhythmias. Duggan discusses cardioversion achieved by application
not of a single large shock, as in the ‘288 patent, but by a combination of small
pacing shocks delivered simultaneously to multiple sites on the heart. CPI’s
expert explained that what Duggan taught was a form of pacing and not true
cardioversion, and concluded that Duggan does not propose the combination of
therapies provided by the ‘288 patent, or teach how to achieve a device that
produces this combination.
Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., 381 F.3d 1371, 1376-77 (Fed. Cir. 2004).
The Federal Circuit went on to find that the particular solution at issue here was not rendered
obvious merely because the problem had been identified:
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We think that the district court, in granting JMOL, applied an incorrect standard
to the ultimate question. Recognition of the problem of treating complex heart
arrhythmias does not render obvious the eventual solution. Recognition of a need
does not render obvious the achievement that meets that need. There is an
important distinction between the general motivation to cure an uncured disease
(for example, the disease of multiple forms of heart irregularity), and the
motivation to create a particular cure.
There can of course arise situations wherein identification of the problem is itself
the invention. But in the case at bar the problem was well-recognized: the
problem of treating complex cardiac arrhythmias. The solution of this problem,
according to the trial proceedings, had not previously been achieved. It was
undisputed that before the work of Dr. Mirowski and his team there was no
implantable device that was capable of treating the combination of abnormal
arrhythmias including cardioversion.5 Recognition of an unsolved problem does
not render the solution obvious.
Id. at 1377. Having found that the district court had applied the wrong standard, the Federal
Circuit then assessed the sufficiency of the underlying jury verdict that claim 4 of the ‘288 patent
was not invalid for obviousness. Id. at 1376. The Federal Circuit first reviewed the evidence
heard by the jury.
Expert witnesses for each side presented opposing opinions as to the
unobviousness of the Mirowski invention. St. Jude’s expert testified that in his
opinion persons of ordinary skill in the relevant field would have been motivated
to modify Duggan “if one felt it [cardioversion] would be better accomplished
with a single high energy shock.” CPI’s expert testified that the Duggan reference
teaches away from use of high-energy shock because Duggan is concerned only
with power consumption in ICDs. St. Jude stressed the obviousness of high
energy cardioversion or defibrillation shocks due to the statement in the Haft
article that “antitachycardia pacing could induce fibrillation.” CPI presented
contrary expert opinion, stressing that no reference teaches combining
cardioversion with other cardiac therapies in a single device, or states that it is
feasible to do so.
Id. at 1378. In their brief to the Federal Circuit, the parties argued that this evidence was
sufficient to support the jury verdict of validity.
As an alternative ground for obviousness, St. Jude’s expert opined that one of
ordinary skill in the art would have been motivated to combine prior art
5

The use of the term here is puzzling, as cardioversion is a form of treatment, not an
arrhythmia.
5

pacemakers that use multiple pacing modes, like Haft and Pequignot with “high
energy cardioversion or defibrillating shocks” due to the alleged teaching in Haft
that “antitachycardia pacing could induce fibrillation.” But, as noted above, claim
4 requires “cardioversion,” not “defibrillation.” It is claim 5, which CPI did not
assert, that requires “defibrillation.” And the jury heard substantial testimony that
defibrillation shocks, not cardioversion shocks, revert fibrillation. In addition, the
jury heard testimony that, at least at the time of the invention, defibrillation
energy levels were different than cardioversion energy levels. Accordingly,
substantial evidence supports the jury’s finding that one of ordinary skill would
not have been motivated in March 1981 to add cardioversion to a pacing device to
revert fibrillation induced by pacing because cardioversion, unlike defibrillation,
would not necessarily revert fibrillation.
2002 Br. to Fed. Cir. at 48-49, Ex. 3 to No. 196. The Federal Circuit agreed and adopted the
parties’ argument:
It was not disputed that before the ‘288 invention this combination of modes of
treatment had not been achieved. CPI pointed out that claim 4 requires
cardioversion, not defibrillation, and that the Haft article is concerned with
fibrillation. The jury heard testimony that defibrillation shocks, not cardioversion
shocks, revert fibrillation. The jury also heard testimony that defibrillation energy
levels are different from cardioversion energy levels. While the jury also heard
testimony that “cardioversion and defibrillation are so similar to practically be the
same therapy,” other witnesses disputed this position.
Whether the prior art provides the suggestion or motivation or teaching to select
from prior knowledge and combine it in a way that would produce the invention
at issue is a question of fact. Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340,
1348 (Fed.Cir.2000). These issues were extensively explored at the trial,
including evidence of the commercial success and the interest of others in
licensing the Mirowski inventions. The record contains substantial evidence
whereby a reasonable jury could have reached the verdict that it would not have
been obvious in March 1981 to provide an ICD that includes cardioversion. In
view of this evidentiary support, the district court’s grant of JMOL cannot stand.
See Continental Air Lines, Inc. v. Wagner-Morehouse, Inc., 401 F.2d 23, 30 (7th
Cir.1968) (the jury verdict must be sustained, even if the judge would have
reached a different conclusion, if the verdict is supported by substantial evidence).
The grant of JMOL is reversed, and the jury verdict is reinstated that the ‘288
patent is not invalid for obviousness.
381 F.3d at 1378. While reinstating the jury’s verdict on validity, the Federal Circuit reversed
and remanded to the district court for a new claim construction on an unrelated issue and, if
necessary, a new trial.
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C.

Remand to Judge Hamilton

On remand to the district court, St. Jude attempted to raise new claim construction
arguments that were unrelated to the claim limitation reversed on appeal. Boston Scientific and
Mirowski objected to St. Jude’s attempts to relitigate other parts of the court’s claim
construction:
[A]lmost a decade into the case, St. Jude now advances six brand new claim
construction arguments relating to other limitations in claim 4. In so doing, St.
Jude essentially asks this Court to start over from scratch, as if it had never
construed the claims in the first place and as if there had been no appeal. But St.
Jude cannot erase history. The fact is that this Court already construed claim 4 of
the ’288 patent, St. Jude did not dispute the presence of any limitation other than
“determining a condition” at trial, and St. Jude did not raise this Court’s claim
construction on appeal. Accordingly, the Court’s prior constructions are law of
the case and this Court should reject St. Jude’s attempts to reconstrue any other
claim limitations.
Nov. 4, 2005, Br. on Construction of Claim 4 at 2, Ex. 9 to No. 207. In a related brief, Boston
Scientific and Mirowski went on:
[T]he Court already interpreted the term “cardioversion” in its jury instruction and
St. Jude never objected or appealed from that instruction. In particular, the Court
instructed the jury that “for purposes of claim 4, the term ‘cardioversion’ applies
to the application of non-pacing electrical pulses designed to stimulate sufficient
heart tissue to correct an arrhythmia, with energy levels generally below those
used for defibrillation.” . . . Nothing in the Court’s construction limits
cardioversion to “manual cardioversion” and, rightly so, as St. Jude never
previously suggested as much.
Dec. 2, 2005, Br. on Construction of Claim 4 at 17-18, Ex. 7 to No. 207. Judge Hamilton agreed,
noting that “St. Jude did not dispute [the] court’s constructions either at trial or on appeal.”
Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., 418 F. Supp. 2d 1021, 1030 (S.D. Ind. 2006).
Ultimately, Judge Hamilton saw “no need to revisit the elements of Claims 1 and 4 other than the
one issue raised on appeal.” Id. at 1031.

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D.

The Present Conflict

The present dispute concerns whether representations made by the parties during the
Federal Circuit appeal and remand described above preclude or require characterizing testing
done at implantation of an ICD as “cardioversion” under Judge Hamilton’s definition. If so, the
parties argue, then certain expert witnesses may not testify at trial.
A brief overview of cardiac arrhythmias and their treatment is necessary to understand
the present dispute. At the risk of oversimplification, arrhythmias can be characterized by their
speed and regularity: a beat that is too slow (bradycardia), a beat that is too fast, but regular
(tachycardia), and a beat that is too fast and irregular (fibrillation). Such arrhythmias can afflict
the atria of the heart (the smaller, upper chambers that fill with blood) or the ventricles (the
larger, lower chambers that pump blood into the body), and are characterized accordingly (e.g.,
atrial fibrillation, ventricular fibrillation, etc.).
At implantation, the implanting physician induces an arrhythmia in the patient. Testing
shocks are then delivered and their effect – success or failure at correcting the arrhythmia – is
noted. Depending on the result, the physician may go through several rounds of testing. Two
facets of implantation testing are pivotal here: (1) the arrhythmia induced by the physician is
often ventricular fibrillation; and (2) the shocks delivered during testing (and that may
successfully revert the induced fibrillation) are administered at an energy level less than the
energy at which the device is ultimately programmed to defibrillate.6 Mirowski seizes on the
latter fact, and argues that, because the device is ultimately programmed to defibrillate at a
higher (often, the maximum) energy level than that used during testing, testing is cardioversion.

6

The parties explain that this procedure, which appears curious to the layman, ensures
that, if the patient goes into cardiac arrest after implantation, the device is sure to succeed in
reverting an arrhythmia. Better safe than sorry, they say.
8

Boston Scientific seizes on the former, urging that, because cardioversion treats tachycardia and
defibrillation treats fibrillation, testing is defibrillation, not cardioversion. Each party asserts that
the other’s position is precluded by judicial estoppel and accordingly seeks the exclusion of the
other’s expert witnesses who are poised to testify to the parties’ respective positions.
II.

STANDARD

Judicial estoppel is an equitable concept providing that a party who prevails on one
ground in a lawsuit cannot turn around and in another lawsuit repudiate that ground. United
States v. Hook, 195 F.3d 299, 306 (7th Cir. 1999). In other words, judicial estoppel protects this
Court from manipulation by “chameleonic litigants” who seek to prevail, twice, on opposite
theories. In re Airadigm Comm’ns, Inc., 616 F.3d 642, 661 (7th Cir. 2010). Although the
doctrine has no precise bounds, certain prerequisites exist for its application: (1) the facts at issue
should be the same in both cases; (2) the latter position must be clearly inconsistent with the
earlier position; (3) the party to be estopped must have convinced the first court to adopt its
position; and (4) the party to be estopped will derive an unfair advantage if not estopped. See id.;
Hook, 195 F.3d at 306.
III.

DISCUSSION

Boston Scientific argues that Mirowski’s current position is inconsistent with its
arguments before the Federal Circuit. At its core, Mirowski’s position before this Court is that
cardioversion may revert fibrillation. In order to determine whether this position conflicts with
its position before the Federal Circuit, the Court turns now to the parties’ briefs. In its brief
before the Federal Circuit, Boston Scientific and Mirowski wrote,
As an alternative ground for obviousness, St. Jude’s expert opined that one of
ordinary skill in the art would have been motivated to combine prior art
pacemakers that use multiple pacing modes, like Haft and Pequignot with “high
energy cardioversion or defibrillating shocks” due to the alleged teaching in Haft
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that “antitachycardia pacing could induce fibrillation.” But, as noted above, claim
4 requires “cardioversion,” not “defibrillation.” It is claim 5, which CPI did not
assert, that requires “defibrillation.” And the jury heard substantial testimony that
defibrillation shocks, not cardioversion shocks, revert fibrillation. In addition, the
jury heard testimony that, at least at the time of the invention, defibrillation
energy levels were different than cardioversion energy levels. Accordingly,
substantial evidence supports the jury’s finding that one of ordinary skill would
not have been motivated in March 1981 to add cardioversion to a pacing device to
revert fibrillation induced by pacing because cardioversion, unlike defibrillation,
would not necessarily revert fibrillation.
2002 Br. to Fed. Cir. at 48-49, Ex. 3 to No. 196. Boston Scientific argues that Mirowski’s
position conflicts with its prior representation to the Federal Circuit that “defibrillation shocks,
not cardioversion shocks, revert fibrillation.” Mirowski argues, however, that its representation
must be viewed in context and points to the last sentence of this paragraph – “cardioversion,
unlike defibrillation, would not necessarily revert fibrillation.” The Court agrees with Mirowski
that its representation must be read as a whole. When read as a whole, Mirowski’s representation
to the Federal Circuit that cardioversion would not necessarily revert fibrillation is not
inconsistent with its position before this Court that cardioversion may revert fibrillation.
As Mirowski’s current position is not inconsistent with its representation to the Federal
Circuit, judicial estoppel is not warranted. The Court turns now to Mirowski’s motion on the
same issue.
According to Mirowski, Boston Scientific is estopped from offering expert testimony not
based on Judge Hamilton’s construction of “cardioversion.” Boston Scientific asserted the
finality of the claim construction on appeal, Mirowski argues, and therefore Boston Scientific
cannot now be heard to argue that the claim construction is anything other than that held by
Judge Hamilton.
The Court does not read Boston Scientific’s current position to be that Judge Hamilton’s
claim construction is invalid or no longer applicable. Its position is that, “to apply the Court’s
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definition, one must understand defibrillation,” Boston Scientific’s Resp. at 9, No. 238, and its
experts provide that explanation. This statement makes clear that Boston Scientific does not seek
to throw out Judge Hamilton’s claim construction. See also Expert Rep. of Dr. Zipes at ¶ 20 (“It
is my opinion that the court’s definition of cardioversion inherently requires that the shock be
delivered during the QRS complex to treat ventricular tachycardia, and that cardioversion is not a
shock to treat ventricular fibrillation.”). As such, there is no conflict with its prior position before
Judge Hamilton on remand, and judicial estoppel is not warranted.
One additional point bears mention. Mirowski is correct in its assertion that, on its face,
Judge Hamilton’s definition does not depend on the type of arrhythmia it treats. However, Judge
Hamilton’s claim construction does depend on the meaning of defibrillation, a determination that
neither party has shown this Court was made by Judge Hamilton. One must know what energy
levels are generally used for defibrillation before one can apply Judge Hamilton’s claim
construction. Yet as Mirowski points out, “the terms are not absolute and the appropriate energy
level for a shock may vary by patient, as the Court recognized through its reliance on the word
‘generally.’” Mirowski’s Reply at 7, No. 245. The issue is thus not whether Judge Hamilton’s
construction of claim 4 should be used – the parties agree that Judge Hamilton’s claim
construction is final, non-appealable, and should be applied – but what the term “defibrillation”
means as used in that construction. There is precedent to suggest that this Court may construe the
term “defibrillation” in order to permit application of the claim construction, although the inquiry
before the Court would be complicated by the fact that the term “defibrillation” occurs elsewhere
in the patent. Adv. Fiber Techs. (AFT) Trust v. J & L Fiber Servs., 674 F.3d 1365, 1373(Fed. Cir.
2012) (“In those cases in which the correct construction of a claim term necessitates a derivative
construction of a non-claim term, a court may perform the derivative construction in order to

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elucidate the claim’s meaning.”). However, in the course of preparing this case for trial, the
parties have repeatedly represented to the Court that this is not a patent case and that the patents
are only marginally relevant to the issues in this case. More to the point, the parties disavowed
the need for a Markman hearing in this case from the beginning and have not wavered from that
position. See Case Management Plan at 4 n.1 (“Although this case does require resolution of
substantive issues of patent law . . . the parties do not allege infringement and invalidity claims
that would make the Case Management Plan for Patent Cases appropriate. Nor do the parties
anticipate the need for a Markman hearing.”); see also Boston Scientific’s Mot. to Preclude
Mirowski from Presenting Case-Within-a-Case Evidence for the Underlying Delaware Case
Without Proper Claim Construction, No. 275 (filed January 10, 2013); Mirowski’s Resp., No.
300 (filed January 17, 2013). Furthermore, the parties have not provided to the Court the
evidence and argument it would need to construe this term. The instant motions present the
dispute to the Court in the sole context of judicial estoppel and the Court has found that judicial
estoppel is not applicable. Accordingly, the Court declines to preclude either party’s experts on
this ground and declines to preclude either party’s experts on the ground that their testimony is
inconsistent with “defibrillation” as used in Judge Hamilton’s claim construction.
IV.

CONCLUSION

Boston Scientific’s motion is DENIED. Mirowski’s motion is also DENIED.
SO ORDERED:

02/13/2013
_______________________________
Hon. William T. Lawrence, Judge
United States District Court
Southern District of Indiana

Copies to all counsel of record via electronic communication.

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