IN THE SUPERIOR COURT OF THE STATE OF DELAWARE
)
MIREK MACHALA, )
)
Plaintiff, )
) C.A. No.: N16C-12-231-PRA
v. )
)
BOEHRINGER INGELHEIM )
PHARMACEUTICALS, INC.; BOEHRINGER )
INGELHEIM INTERNATIONAL GMBH; )
BOEHRINGER INGELHEIM VETMEDICA, )
INC.; and BOEHRINGER INGELHEIM USA )
CORPORATION, )
)
Defendants. )
Submitted: April 13, 2017
Decided: June 29, 2017
Upon Defendants Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim
USA Corp.’s Motion to Dismiss Plaintiff’s Complaint
GRANTED
James D. Heisman, Esquire, Napoli Shkolnik, LLC, Wilmington, DE, Attorney for Plaintiff
Mirek Machala
Michael P. Kelly, Esquire, Daniel J. Brown, Esquire, McCarter & English, LLP, Wilmington,
DE, Eric E. Hudson, Esquire, Butler Snow, LLP, Memphis, TN, Attorneys for Defendants
Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corp.
DAVIS, J.
I. INTRODUCTION
This is a products liability case arising out of the use of the drug Pradaxa. Plaintiff Mirek
Machala filed a Complaint (the “Complaint”) against Defendants Boehringer Ingelheim
Pharmaceuticals, Inc. (“Boehringer Pharmaceuticals”), Boehringer Ingelheim International
GmBH (“Boehringer International”), Boehringer Ingelheim Vetmedica, Inc. (“Boehringer
Vetmedica”), and Boehringer Ingelheim USA Corp. (“Boehringer USA”) (collectively,
“Defendants”). The Complaint asserts causes of action for: (i) Strict Liability, (ii) Strict Liability
– Design Defect, Marketing Defect and Manufacturing Defect, (iii) Negligence, (iv) Breach of
Express Warranty, and (v) Breach of Implied Warranty.
On February 16, 2017, Defendants Boehringer Pharmaceuticals and Boehringer USA
(together, “the Boehringer Defendants”) moved to dismiss the Complaint and filed Defendants
Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corp.’s Motion to
Dismiss Plaintiff’s Complaint (the “Motion to Dismiss”).1 The Boehringer Defendants allege
that the claims in the Complaint are barred by Delaware’s two-year statute of limitations. Mr.
Machala opposes the Motion to Dismiss and responded to the Motion to Dismiss on March 31,
2016 with Plaintiff’s Opposition to Defendants’ Boehringer Ingelheim Pharmaceuticals, Inc.’s
and Boehringer Ingelheim USA Corp.’s Motion to Dismiss Plaintiff’s Complaint (the
“Response”).
The Court held a hearing and heard oral argument on the Motion to Dismiss on April 7,
2017. At the conclusion of the hearing, the Court asked the parties to submit additional briefing
on the issue of whether Delaware’s Borrowing Statute applies to and bars the claims in this case.
On April 13, 2017, the Boehringer Defendants filed Defendants Boehringer Ingelheim
Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corp.’s Supplemental Brief in Support of
its Motion to Dismiss Plaintiffs’ Complaints Pursuant to Rule 12(b)(6) (the “Supplemental
Motion”)2 and Mr. Machala’s counsel filed Letter Brief in Further Opposition to Defendants’
Motion to Dismiss Plaintiff’s Complaint (the “Supplemental Response”). After receiving the
1
The other named Defendants, Boehringer Vetmedica and Boehringer International, do not appear or join the
Motion to Dismiss. The Boehringer Defendants represent in the Motion to Dismiss that these additional defendants
have not yet been served. Defs.’ Mot. at p. 1, fn. 1.
2
The Supplemental Motion addresses issues raised in this case and a related case (C.A. No. N16C-12-282-PRA)
before the Court involving the same Defendants.
2
Supplemental Motion and the Supplemental Response, the Court took the Motion to Dismiss
under advisement.
This is the Court’s decision on the Motion to Dismiss. For the reasons set forth below,
the Court GRANTS the Motion to Dismiss.
II. RELEVANT FACTS3
Mr. Machala is an individual and resident of the District of Columbia.4 Boehringer
Pharmaceuticals, Boehringer USA, and Boehringer Vetmedica are Delaware corporations doing
business in Delaware.5 Boehringer International is a foreign corporation with a principal place
of business in Rhein, Germany.6
Defendants were involved in the manufacturing, marketing, advertising, and distribution
of the drug Pradaxa.7 Pradaxa is a blood-thinning medication used to reduce the risk of stroke
and blood clots in certain individuals.8 Pradaxa was approved by the Food and Drug
Administration (“FDA”) on October 19, 2010, making it the first new treatment alternative to
Coumadin.9 Prior to FDA approval, Coumadin was the only oral anticoagulation available in the
United States for reducing stroke and systemic embolism in patients with atrial fibrillation.10
After FDA approval, Defendants promoted Pradaxa as a viable alternative to Coumadin
in patients with atrial fibrillation.11 Defendants’ marketing campaign emphasized that Pradaxa,
3
As the Motion to Dismiss is a motion filed under Superior Court Civil Rule 12 (“Civil Rule __”), the Court will,
unless otherwise indicated, be using the facts as alleged in the Complaint (“Pl.’s Compl.”). See, e.g., Central Mortg.
Co. v. Morgan Stanley Mortg. Capital Holdings LLC, 227 A.3d 531, 536 (Del. 2011)
4
Pl.’s Compl. ¶ 1.
5
Id. ¶¶ 2, 4–5.
6
Id. ¶ 3.
7
Id. ¶ 6.
8
Id. ¶ 7.
9
Id. ¶ 8.
10
Id. ¶ 9.
11
Id. ¶ 10.
3
unlike Coumadin, did not require blood monitoring, dose adjustment, or changes to diet.12
Pursuant to this marketing campaign, Mr. Machala’s doctors received promotional materials
from Defendants, and Mr. Machala also received direct-to-consumer advertisements.13 Based on
the information contained in these promotional materials, Mr. Machala began taking Pradaxa for
atrial fibrillation on January 1, 2013.14 Subsequently, Mr. Machala suffered a stroke on
December 18, 2013 and was admitted to the hospital in the District of Columbia for several
days.15
On December 16, 2016, Mr. Machala filed the Complaint against Defendants. In short,
the Complaint alleges that through their marketing campaign, “Defendants overstated the
efficacy of Pradaxa with respect to preventing stroke and systemic embolism, failed to
adequately disclose to or warn patients that there is no drug or means to reverse the
anticoagulation effects of Pradaxa, and that such irreversibility could have permanently
disabling, life-threatening and fatal consequences” such as increased risk of bleeding.16 The
Complaint further alleges that Defendants’ actions directly and proximately caused Mr.
Machala’s injuries.17
III. PARTIES’ CONTENTIONS
A. THE BOEHRINGER DEFENDANTS
The Boehringer Defendants’ main argument is that Mr. Machala’s tort claims are barred
by Delaware’s two-year statute of limitations. The Boehringer Defendants contend that the
language of Delaware’s Borrowing Statute mandates that Delaware’s—not the District of
12
Id.
13
Id. ¶¶ 16, 20.
14
Id. ¶ 56.
15
Id. ¶¶ 56–57.
16
Id. ¶ 14.
17
Id. ¶¶ 50, 57–58.
4
Columbia’s—limitations period applies to and bars this case. Alternatively, the Boehringer
Defendants argue that the Complaint fails to state a claim upon which relief can be granted
because there is no causal connection between the claimed injury and the negligent acts of
Defendants alleged in the Complaint.
B. MR. MACHALA
Mr. Machala contests the applicability of Delaware’s Borrowing Statute, arguing that it
does not apply because there is no evidence that Mr. Machala engaged in forum shopping.
However, even if the Borrowing Statute did apply, Mr. Machala argues that the limitations
period was tolled by reason of Defendants’ fraudulent concealment. As to the alternative
argument, Mr. Machala contends that the Complaint is properly pleaded because Defendants’
failure to warn of specific dangers, including but not limited to when Pradaxa fails to act as
intended, establishes a causal connection between the negligent acts of Defendants and the
claimed injury.
IV. STANDARD OF REVIEW
Upon a motion to dismiss under Civil Rule 12(b)(6), the Court (i) accepts all well-
pleaded factual allegations as true, (ii) accepts even vague allegations as well-pleaded if they
give the opposing party notice of the claim, (iii) draws all reasonable inferences in favor of the
non-moving party, and (iv) only dismisses a case where the plaintiff would not be entitled to
recover under any reasonably conceivable set of circumstances.18 However, the Court must
“ignore conclusory allegations that lack specific supporting factual allegations.”19
18
See Cent. Mortg. Co. v. Morgan Stanley Mortg. Cap. Holdings LLC, 227 A.3d 531, 536 (Del. 2011); Doe v.
Cedars Academy, No. 09C-09-136, 2010 WL 5825343, at *3 (Del. Super. Oct. 27, 2010).
19
Ramunno v. Crawley, 705 A.2d 1029, 1034 (Del. 1998).
5
V. DISCUSSION
A. WHETHER DELAWARE’S BORROWING STATUTE MANDATES APPLICATION OF
DELAWARE’S STATUTE OF LIMITATIONS
The Boehringer Defendants argue that Mr. Machala’s tort claims are controlled and
barred by Delaware’s statute of limitations. As between Delaware and the District of Columbia
(“D.C.”), the Boehringer Defendants maintain that under Delaware’s Borrowing Statute,
Delaware’s statute of limitations applies because it is the shorter of the two limitations periods.
The Court agrees that Delaware’s statute of limitations applies based on the express language of
Delaware’s Borrowing Statute.
As a general rule, the law of the forum governs in matters relating to the statute of
limitations.20 However, Delaware’s Borrowing Statute (the “Borrowing Statute”) modifies this
general rule in certain circumstances:
Where a cause of action arises outside of this state, an action cannot be brought in
a court of this State to enforce such cause of action after the expiration of
whichever is shorter, the time limited by the law of this State, or the time limited
by the law of the state or country where the cause of action arose for bringing an
action upon such cause of action.21
Under the Borrowing Statute, Delaware courts must apply the Delaware limitations period if it is
shorter than the limitations period that might apply from another jurisdiction.22
Applying the plain language of the Borrowing Statute, the Court finds that the Borrowing
Statute governs the limitations period in this case. Here, the facts are that the cause of action
arose in D.C. and not Delaware. Mr. Machala was proscribed Pradaxa and ingested Pradaxa in
D.C., and subsequently suffered a stroke in D.C. As between the Delaware limitations period
and the D.C. limitations period, the Borrowing Statute mandates that the Court apply the shorter
20
See e.g., Furnari v. Wallpang, C.A. No. 13C-04-287, 2014 WL 1678419, at *4 (Del. Super. Apr. 16, 2014).
21
11 Del. C. § 8121.
22
Burrell v. Astrazeneca LP, C.A. No. 07C-01-412, 2010 WL 3706584, at *4 (Del. Super. Sept. 20, 2010).
6
of the two periods. Delaware’s limitations period for tort claims is two years.23 D.C’s is three
years.24 As such, the Borrowing Statute dictates that Delaware’s two-year limitations period
applies.
Mr. Machala asks the Court to ignore the plain language of the Borrowing Statute and
read-in a forum shopping exception. Mr. Machala relies on the decisions in Saudi Basic
Industries Corporation v. Mobil Yanbu Petrochemical Company25 and Furnari v. Wallpang in
support of his argument.26 In these cases, the particular court declined to apply the Borrowing
Statute, in part, based on a lack of evidence that the plaintiffs engaged in forum shopping when
selecting Delaware to litigate their claims. The Court finds that these cases are both exceptional
and distinguishable from the rest of the Delaware’s Borrowing-Statute jurisprudence.
In Saudi Basic, the plaintiff, Saudi Basic Industries Corporation (“SABIC”), brought a
declaratory judgment action against defendants, Mobil Yanbu Petrochemical Company and
Exxon Chemical Arabia, Inc. (collectively, “ExxonMobil”) in Delaware.27 ExxonMobil then
asserted counterclaims in tort and for breach of contract.28 In response, SABIC argued that the
Borrowing Statute applied to and barred ExxonMobil’s counterclaims.29 SABIC relied on the
plain language of the Borrowing Statute and argued that because (i) the counterclaims arose in
Saudi Arabia, and (ii) Delaware’s limitations period was shorter than Saudi Arabia’s limitations
period, Delaware’s limitations period applied to and barred the counterclaims.30
In ruling, the Saudi Basic court noted that the Borrowing Statute, if applied, would bar
ExxonMobil’s counterclaims, despite the fact that ExxonMobil did not choose to litigate the
23
See 10 Del. C. § 8119.
24
See D.C. Code § 12-301(8).
25
866 A.2d 1 (Del. 2005).
26
C.A. No. 13C-04-297, 2014 WL 1678419, at *1 (Del. Super. Apr. 16, 2014).
27
Saudi Basic, 866 A.2d 1, 6 (Del. 2005).
28
Id.
29
Id.
30
Id. at 13.
7
claims in Delaware and that the counterclaims, if brought in Saudi Arabia, would not have been
barred.31 Based on these facts, the Saudi Basic court rejected the “literal construction” of the
Borrowing Statute and read-in a limited forum shopping exception in order to preserve
ExxonMobil’s counterclaims.32 The Saudi Basic court explained that the Borrowing Statute was
designed for the very specific purpose of preventing a non-resident plaintiff from forum
shopping, i.e. “circumventing the shorter limitations period mandated by the jurisdiction where
the cause of action arose.”33 The Saudi Basic court found that the “literal construction” of the
Borrowing Statute, if applied to these facts, would subvert the statute’s underlying purpose and
deprive ExxonMobil of any forum to assert its counterclaims because “the party that was
shopping for the most favorable forum was SABIC, not ExxonMobil. . . .”34 The Saudi Basic
court thus crafted an exception that rejected SABIC’s attempt to use Delaware and Delaware law
for the sole strategic purpose of insulating itself from ExxonMobil’s counterclaims.35
This Court in Furnari similarly declined to apply the plain language of the Borrowing
Statute in favor of a forum shopping exception.36 The plaintiff, a Florida resident, sued
defendant, a Delaware corporation based in Ontario, Canada, in a Florida court on two separate
occasions.37 Both lawsuits were dismissed for lack of jurisdiction.38 Consequently, plaintiff
filed a lawsuit in Delaware for the sole purpose of obtaining jurisdiction over defendant.39 This
Court found that the Borrowing Statute did not apply to or bar plaintiff’s claims because
“plaintiff was not attempting to circumvent the expiration of his claims by filing in Delaware, but
31
Id. at 16.
32
Id.
33
Id. at 16–17.
34
Id. at 17.
35
Id.
36
Furnari, 2014 WL 1678419, at *1.
37
Id.
38
Id. at 5.
39
Id.
8
only [sought] jurisdiction over the parties.”40 The Furnari court thus crafted an exception that
preserved plaintiff’s claims when plaintiff was forced, for jurisdictional reasons, to file in
Delaware.41
The Court does not find that any of the concerns raised by the Saudi Basic or Furnari
courts are implicated in this case. This is not a case where Mr. Machala was brought as a
defendant to Delaware to litigate this action. Moreover, Mr. Machala did not have to file this
action in Delaware in order to assert jurisdiction over the Boehringer Defendants. Mr. Machala
is a non-resident plaintiff who chose to file his claims in Delaware. In fact, Mr. Machala’s
counsel admitted at the hearing on the Motion to Dismiss that this case could been filed in D.C.,
but that counsel chose to file in Delaware because Delaware courts have experience litigating
claims involving Pradaxa.42 The Court concedes that this civil action does not present as the
standard scenario of shopping for a forum with a longer limitations period, but it is forum
shopping nonetheless. As such, even if the Court chose to read-in a forum shopping exception to
the Borrowing Statute, such an exception would not preclude application of the Borrowing
Statute.
Given the facts of this case, the Court chooses to follow the majority of decisions that
have applied the plain language of the Borrowing Statute in situations similar to the one
presently before the Court. In Huffington v. T.C. Group, LLC43, this Court applied the plain
language of the Borrowing Statute and held that plaintiff’s claim was time barred.44 In rendering
its decision, the Court rejected plaintiff’s assertion that Saudi Basic created a broad ruling
40
Id.
41
Id.
42
See Tr. of Apr. 7, 2017 Hr’g.
43
C.A. No. N11C-01-030, 2012 WL 1415930, at *1 (Del. Super. Apr. 18, 2012).
44
Huffington, 2012 WL 1415930, at * 9.
9
limiting the Borrowing Statute to only those instances where the plaintiff seeks to avoid a
jurisdiction with a shorter limitations period.45
The Delaware Court of Chancery reached a similar conclusion in TrustCo Bank v.
Mathews.46 The court found that the Borrowing Statute applied “when a plaintiff’s cause of
action arose out of state, irrespective of whether the plaintiff is forum shopping.”47 The court
further explained that the application of Saudi Basic was limited to instances where “an absurd
outcome or result that subverts the Borrowing Statute’s fundamental purpose would otherwise
occur.”48 The court left any greater alternation of the Borrowing Statute to the Delaware
Legislature.49
Finally, then-Chancellor, now-Chief Justice Strine reached the same conclusion in
Century Mortgage Co. v. Morgan Stanley Mortgage Capital Holdings, LLC.50 In that case, the
court refrained from any statutory analysis or legislative history of the Borrowing Statute and
opted to apply the statute’s plain language.51 The court succinctly held that, where the cause of
action arose in New York, Delaware’s shorter three-year limitations period for contract disputes
applied rather than New York’s six-year limitations period.52
45
See id. (“Saudi Basic did not create a broad ruling banning the use of the borrowing statute in all situations except
for the ‘typical’ scenario. Rather, it demonstrates the Delaware Supreme Court’s unwillingness to allow the
borrowing statute to be abused by a party shopping for a forum to avoid an adversary’s counterclaims . . . At most,
Saudi Basic provides a very narrow holding with respect to borrowing statute jurisprudence in that the Supreme
Court recognized that applying the borrowing statute in that scenario would ‘basically turn the borrowing statute on
its head for the purpose for which it was enacted.’”).
46
C.A. No. 8374, 2015 WL 295373, at *1 (Del. Ch. Jan. 22, 2015).
47
TrustCo Bank, 2015 WL 295373, at *8.
48
Id.
49
Id.
50
C.A. No. 5140, 2012 WL 3201139, at *1 (Del. Ch. Aug. 7, 2012).
51
Cent. Mortg., 2012 WL 3201139, at *16.
52
Id. (“Here, Delaware’s three-year limitations period governs Central Mortgage’s breach of contract claims under
the Master Agreement and transaction-specific agreements because it is shorter than the equivalent period prescribed
by New York law, which is six years.”).
10
Mr. Machala has pointed to no exceptional reason why the Court should depart from the
clear and unambiguous language of the Borrowing Statute.53 Mr. Machala chose to file his
claims in Delaware and is now subject to the terms of the Borrowing State. Accordingly, the
Court finds that Delaware’s statute of limitations governs the claims in this case.
B. WHETHER MR. MACHALA’S TORT CLAIMS ARE BARRED BY DELAWARE’S TWO-YEAR
STATUTE OF LIMITATIONS
The question before the Court now becomes, as argued by the Boehringer Defendants,
whether Mr. Machala’s tort claims are barred by Delaware’s two-year statute of limitations. Mr.
Machala contends that his tort claims are not time barred because the two-year limitations period
was tolled due to Defendants’ fraudulent concealment. The Court agrees with the Boehringer
Defendants and finds that the claims are time barred.
Under Delaware law, the limitations period for personal injury claims is two years “from
the date upon which it is claimed that such injuries were sustained.”54 The moving party bears
the burden of proving that a limitations period has lapsed and that the claim is time-barred.55
However, “when a complaint asserts a cause of action that on its face accrued outside the statute
of limitations, the plaintiff has the burden of pleading facts leading to a reasonable inference that
one of the tolling doctrines” applies.56
To make this determination on a Civil Rule 12 motion, the court typically conducts a
three-part analysis.57 From the pleadings, a court looks to determine: (i) the cause of action’s
accrual date, (ii) whether the plaintiff has pleaded facts sufficient to create a reasonable inference
that the limitations period has been tolled, and (iii) assuming a tolling exception has been
53
See Leatherbury v. Greenspun, 939 A.2d 1284, 1288 (Del. 2007) (explaining that unambiguous statutes are not
subject to judicial interpretation).
54
10 Del. C. § 8119.
55
SPX Corp. v. Garda USA, Inc. C.A. No. N10C-10-162, 2012 WL 6841398, at * 2 (Del. Super. Dec. 6, 2012).
56
Winner Acceptance Corp. v. Return on Capital Corp., C.A. No. 3088, 2008 WL 5352063, at *14 (Del. Ch. Dec.
23, 2008).
57
SPX Corp., 2012 WL 6841398, at *2.
11
pleaded adequately, when the plaintiff was on inquiry notice of a claim based on the
allegations.58 On this third step, inquiry notice is defined as the date when the plaintiff discovers
“the facts constituting the basis of the cause of action or the existence of facts sufficient to put a
person of ordinary intelligence and prudence on inquiry which, if pursued, would lead to the
discovery of [of the injury].”59
The Court must first determine when the cause of action accrued. A cause of action in
tort accrues at the time of injury.60 Mr. Machala’s claimed injury is that he suffered a stroke
after Pradaxa failed to work as intended. Mr. Machala’s claims therefore accrued, at the very
latest, on December 18, 2013—the date Pradaxa purportedly failed to work as intended and Mr.
Machala suffered the stroke. The statute of limitations expired two years later on December 18,
2015. Mr. Machala did not file the Complaint until December 16, 2016—almost one year after
the statute of limitations expired. Absent tolling, all of Mr. Machala’s claims fall outside the
statute of limitations, and consequently, Mr. Machala has the burden of proving that one of the
tolling doctrines applies.
The Court must next determine whether a tolling doctrine applies. Delaware courts
recognize three tolling doctrines: (i) inherently unknowable injuries, (ii) fraudulent concealment,
and (iii) equitable tolling.61 The Complaint asserts that the fraudulent concealment doctrine has
tolled the statute of limitations.62 Under the fraudulent concealment doctrine, the statute of
limitations is tolled “if there was an affirmative act of concealment or some misrepresentation
that was intended ‘to put a plaintiff off the trail of inquiry’ until such time as the plaintiff is put
58
Id. (quoting Winner, 2008 WL 5352063, at *14).
59
In re Dean Witter P’ship. Litig., C.A. No. 14816, 1998 WL 442456, at *5 (Del. Ch. July 17, 1998).
60
Winner, 2008 WL 5352063, at *14.
61
Id. at *15.
62
Compl. ¶¶ 52–55.
12
on inquiry notice.”63 Mere ignorance of the facts by a plaintiff, where there has been no act of
concealment or misrepresentation, does not toll the statute of limitations.64
The Court finds that Mr. Machala has not pleaded sufficient facts to support the tolling of
the statute of limitations based on fraudulent concealment. The Complaint asserts that
Defendants failed to disclose the truth about the safety and efficacy of Pradaxa.65 The Complaint
further asserts that Defendants misrepresented Pradaxa as safe and effective for its intended use
and “actively concealed” the true risks associated with Pradaxa.66 The Complaint, however, does
not provide any specific way in which Defendants engaged in an affirmative act of
concealment.67 Moreover, the Complaint does not provide any factual allegations that
Defendants intended to put Pradaxa users like Mr. Machala “off the trail of inquiry” or otherwise
conceal Pradaxa’s efficacy.68
Instead, the Complaint simply points to Defendants’ purportedly negligent acts as
evidence that Defendants engaged in fraudulent concealment. The Court finds that this approach
is insufficient to toll the limitations period for two reasons. First, Defendants did not in fact
actively conceal or misrepresent the efficacy of Pradaxa with respect to the claimed injury.
Pradaxa’s label has contained, since its original approval in 2010, language addressing efficacy
for stroke prevention.69 Mr. Machala knew he was using Pradaxa and he was aware that he had a
63
Winner, 2008 WL 5352063, at *14.
64
Id.
65
Compl. ¶ 52.
66
Id.
67
Contra Council of Unit Owners of Sea Colony East, Phase III Condo. v. Carl M. Freeman, Assoc. Inc., 1988 WL
90569, at *5 (Del. Super. Aug. 16, 1988) (finding that there existed a genuine issue of material fact as to whether
defendants engaged in fraudulent concealment in a negligent design case where plaintiffs produced letters, reports,
and confidential memoranda proving that defendants knew of the negligent design and did nothing).
68
Id.
69
The “Indications and Usage” section states that “Pradaxa is a direct thrombin inhibitor indicated to reduce the risk
of stroke and systemic embolism in patients with non-valvular atrial fibrillation.” The Court, pursuant to Rule 201
of the Delaware Uniform Rules of Evidence, has taken discretionary judicial notice of Pradaxa’s 2010 label, which
is publicly available on the FDA’s website. See In re Gen. Motors Shareholders Litig., 897 A.2d 162, 171 (“[I]t was
13
stroke. At that point, Mr. Machala could have engaged in due diligence on whether Pradaxa was
the proximate cause of his injuries. Any failure by Mr. Machala to engage in due diligence about
Pradaxa’s efficacy is not a basis for tolling the limitations period in this case.70 Moreover, in
negligence actions, a plaintiff must assert more than the negligence itself in order to support the
occurrence of fraudulent concealment.71 Therefore, absent specific information above and
beyond the claims of negligence, the Complaint does not assert facts to support tolling the statute
of limitations based on fraudulent concealment.
Even if the Complaint asserted such facts, the Court still finds that the claims are time
barred. Under the third factor, the Court must determine when Mr. Machala was placed on
inquiry notice of the claims. As just discussed, Mr. Machala received inquiry notice of the
claims on December 18, 2013— the date he suffered a stroke and the injury occurred. Once
Pradaxa failed to work as intended by causing a stroke, Mr. Machala knew or reasonably should
have known that Defendants engaged in concealment or misrepresentations regarding the
efficacy of Pradaxa.72 December 18, 2013 is the same date Mr. Machala’s claims accrued in the
first instance. This means that the limitations period still would have expired two years later on
December 18, 2015, making the Complaint filed on December 16, 2016 time barred. Therefore,
proper for the Court of Chancery to take judicial notice of the publicly available fact, reported by GM in a Form 10-
Q filed with the SEC, that a majority of both classes of GM stockholders voted to approve the Hughes transaction.”).
70
See Shockley v. Dyer, 456 A.2d 798, 800 (Del. 1983) (explaining that if a plaintiff could have discovered her
rights by exercising due diligence, the statute of limitations was not tolled).
71
See id. (rejecting plaintiff’s argument that her physician engaged in fraudulent concealment when he failed to
disclose all the facts surrounding the operation because “this argument has no relevance” to whether or not the
statute of limitations was tolled).
72
See In re Dean Witter, 1998 WL 442456, at *7 (“Inquiry notice does not require actual discovery of the reason for
the injury. Nor does it require plaintiffs’ awareness of all the aspects of the alleged wrongful conduct. Rather, the
statute of limitations begins to run when plaintiffs should have discovered the general fraudulent scheme.”)
(emphasis in original).
14
regardless of whether the statute of limitations was or was not tolled, the claims in this case are
barred by the statute of limitations.73
VI. CONCLUSION
For the reasons set forth above, the Court GRANTS Defendants Boehringer Ingelheim
Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corp.’s Motion to Dismiss Plaintiff’s
Complaint. Accordingly, the Court will dismiss the Complaint with prejudice.
IT IS SO ORDERED.
Dated: June 29, 2017
Wilmington, Delaware
/s/ Eric M. Davis
Eric M. Davis, Judge
73
Because the Court is granting the Motion to Dismiss on this basis, it need not address the Boehringer Defendants’
alternative argument that the Complaint fails to state a claim for relief under Civil Rule 12(b)(6).
15