BAKER v. APP PHARMACEUTICALS, LLC et al
Filing
87
MEMORANDUM OPINION filed. Signed by Judge Joel A. Pisano on 8/21/2012. (mmh)
NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
__________________________________________
)
EVANGELINE BAKER et al.,
)
)
Plaintiffs,
)
)
v.
)
Civil Action No. 09-05725 (JAP)
)
APP PHARMACEUTICALS LLP et al.,
)
MEMORANDUM OPINION
)
)
Defendants.
)
_________________________________________ )
PISANO, Judge
This matter comes before the Court upon a Motion for Summary Judgment by defendant1
Baxter Healthcare Corporation (“Baxter” or “Defendant”) to dismiss Counts I, II, and VIII of
plaintiffs Evangeline Baker (“Mrs. Baker”) and Bruce Baker’s (collectively “Plaintiffs”) First
Amended Complaint. (DE 74.) Plaintiffs oppose the Motion. (DE 82.) The Court has
considered the parties’ submissions and decided the matter without oral argument pursuant to
Federal Rule of Civil Procedure 78. For the reasons set forth below, the Court will grant the
Motion for Summary Judgment.
I.
BACKGROUND
Mrs. Baker visited her primary care doctor complaining of chest pain on September 4,
2007. (Defendant’s Statement of Undisputed Material Fact (“Def. SUMF”) ¶ 27; DE 74-2.)
Mrs. Baker was taken by ambulance to the Hunterdon Medical Center Emergency Room where a
cardiac catheterization procedure revealed she had severe coronary artery disease. (Id. ¶ 28.)
1
Defendants App Pharmaceuticals, LLC and Hospira World Wide Inc., doing business as
Hospira Inc., are no longer parties to this action. (See DE 20, 64.)
Mrs. Baker was thereafter transferred to Morristown Memorial Hospital, and Dr. James Slater, a
cardiac surgeon, performed a triple coronary bypass on Mrs. Baker on September 5, 2007. (Id. ¶
4.)
During her hospital stay, Mrs. Baker was administered the commonly prescribed drug
heparin. (Id. ¶ 31.) Heparin is an anticoagulant that prevents blood clots. (Id. ¶ 4.) But the drug
is known to cause heparin induced thrombocytopenia (“HIT”), or low blood platelet count. (Id. ¶
6.) HIT is an allergic reaction, which begins when antibodies attack heparin molecules bound to
platelet factor 4 protein. (Plaintiffs’ Counter Statement of Material Facts (“Pls. SUMF”) ¶ 8; DE
81.) HIT may progress to a more serious adverse reaction called heparin induced
thrombocytopenia and thrombosis (“HITT”). (Id.) HITT occurs when heparin antibodies
activate blood platelets, which in turn cause blood clots. (Id.) HITT can lead to, among other
things, deep vein thrombosis, stroke, heart attack, gangrene of the extremities, and possibly
death. (Def. SUMF ¶ 22.)
Mrs. Baker received heparin during and after her surgery.2 Dr. Slater administered a
heparin drip during Mrs. Baker’s coronary artery bypass surgery on September 5, 2007, (Pls.
SUMF ¶ 13), and intravenous heparin flushes during the two days after surgery, (Def. SUMF ¶
32). Mrs. Baker developed atrial fibrillation (a cardiac arrhythmia) on September 7th, and so
heparin was reinitiated by Dr. Slater on September 11th and continued through September 14th.3
(Id. ¶¶ 33, 34.) On September 11th, Mrs. Baker’s platelet count was measured to be
2
Mrs. Baker also received heparin during her cardiac catheterization at Hunterdon Medical
Center, but that heparin was not manufactured by Baxter. (Def. SUMF ¶ 29.)
3
In their opposition to Defendant’s Statement of Undisputed Material Facts, Plaintiffs dispute
that there is any evidence that heparin was reinitiated because of Mrs. Baker’s atrial fibrillation.
(Plaintiffs’ Response to Defendant’s Statement of Undisputed Material Facts (“Pls. RSUMF”) ¶
34; DE 81.) But Plaintiffs’ expert, Dr. Stephen B. Shohet, inferred that heparin was reinstated
due to the atrial arrhythmia. (Expert Report of Stephen Shohet, M.D. at 5, Pls. Ex. H to Poondi
Decl.; DE 82-9.)
2
279,000/mm3, which is normal. (Pls. SUMF ¶ 14.) However, by September 15th, her platelet
count was down to 45,000/mm3, alerting Mrs. Baker’s physicians to the possibility of HIT. (Id.
¶¶ 14, 16.) Indeed, an HIT study confirmed that Mrs. Baker was positive for heparin antibodies.
(Def. SUMF ¶ 37.) It is not known, however, at what point between September 11th and
September 15th that Mrs. Baker’s platelet count reached thrombocytopenic levels. (Id. ¶ 46; Pls.
RSUMF ¶ 46.) That is because no one measured Mrs. Baker’s platelet level during this time
period, despite the hospital’s stated protocol to monitor a patient’s platelet count every three days
in order to detect HIT. (Def. SUMF ¶¶ 41, 42, 44.)
Over the next several weeks, Mrs. Baker developed blood clots and gangrene in her left
leg, confirming a clinical diagnosis of HITT. (Pls. SUMF ¶¶ 17, 18.) She required a partial
amputation of her left foot in November 2007 and amputation of her left leg below the knee in
February 2008. (Id. ¶ 19.) Plaintiffs thereafter sued several manufacturers of heparin, including
Baxter, asserting various product liability claims.4 Plaintiffs allege that Baxter, the only heparin
manufacturer remaining in the action, was aware of but failed to adequately warn of the serious
side-effects associated with heparin use.
Defendant’s heparin was first approved by the United States Food and Drug
Administration (“FDA”) forty years ago. (Def. SUMF ¶ 5.) Before the FDA approves a drug,
the manufacturer must show that the drug is safe and effective for its intended use. See 21
U.S.C. § 355. To do so, the manufacturer submits a new drug application (“NDA”), which
includes, among other things, clinical trial data, a risk-benefit analysis, and proposed labeling.
See 21 C.F.R. 314.50. Prescription drug labeling must “contain a summary of the essential
scientific information needed for the safe and effective use of the drug.” 21 C.F.R. 210.56(a)(1).
4
Counts III, IV, V, VI, and VII of the First Amended Complaint as well as Plaintiffs’ claim for
punitive damages were dismissed on November 30, 2011. (DE 46.) Only Counts I, II, and VIII
remain.
3
The FDA has the authority to enforce its labeling requirements, and may go so far as to withdraw
approval for the drug if the drug’s labeling is false, misleading, and/or contains inadequate
warnings. See 21 U.S.C. § 352(a), (f); 21 U.S.C. § 355(e).
The parties agree that Defendant’s heparin has always contained FDA-approved labeling,
including risk disclosures and warnings. (Def. SUMF ¶ 5; Pls. RSUMF ¶ 5.) In 2001, the
heparin label disclosed the risk of HIT and HITT in the “Precautions” section. (See Def. Ex. 3 to
Miller Decl.; DE 74-7.) In 2005, Defendant submitted a supplemental NDA via the “changes
being effected” process to include additional HIT and HITT information the “Warnings” section
of its heparin labeling. See 21 C.F.R. 314.70. The FDA suggested several alterations, all of
which Defendant incorporated into the labeling, and the FDA found the updated labeling
“acceptable” in June 2007. (See Def. Ex. 7 to Miller Decl.; DE 74-12.) That labeling, the same
labeling found on the heparin administered to Mrs. Baker, stated in the “Warnings” section:
Thrombocytopenia
Thrombocytopenia has been reported to occur in patients receiving
heparin with a reported incidence of up to 30%. Platelet counts
should be obtained at baseline and periodically during heparin
administration . . . .
Heparin-induced Thrombocytopenia (HIT) and Heparin-induced
Thrombocytopenia Thrombosis (HITT)
Heparin-induced Thrombocytopenia (HIT) is a serious antibody
mediated reaction resulting from irreversible aggregation of
platelets. HIT may progress to the development of venous and
arterial thromboses, a condition referred to as Heparin-induced
Thrombocytopenia and Thrombosis (HITT). Thrombotic events
may also be the initial presentation for HITT. These serious
thromboembolic events include deep vein thrombosis, pulmonary
embolism, cerebral vein thrombosis, limb ischemia, stroke,
myocardial infarction, mesenteric thrombosis, renal arterial
thrombosis, skin necrosis, gangrene of the extremities that may
4
lead to amputation, and possibly death. Thrombocytopenia of any
degree should be monitored closely. If the platelet count falls
below 100,000/mm3 or if recurrent thrombosis develops, the
heparin product should be promptly discontinued and alternative
anticoagulants considered, if patients require continued
anticoagulation.
(See Def. Ex. 6 to Miller Decl. at 5; DE 74-11.)
Plaintiffs claim that this labeling was inadequate and caused Mrs. Baker’s injuries. In
particular, Plaintiffs allege that Baxter’s heparin product failed to warn of the dangers of heparin
administration (Count I) and was defective in design because it did not have an adequate warning
label (Count II). (See First Am. Compl.; DE 18.) In addition, Plaintiff Bruce Baker alleges loss
of consortium resulting from his wife’s injuries (Count VIII). (Id.) Defendant moved for
summary judgment dismissing Counts I, II, and VIII on May 11, 2012. (DE 74.) Plaintiffs filed
a brief in opposition on June 19, 2012. (DE 79, 82.) On July 9, 2012, Defendant filed a reply
brief in further support of its Motion for Summary Judgment. (DE 86.)
II.
STANDARD OF REVIEW
A court shall grant summary judgment pursuant to Rule 56 of the Federal Rules of Civil
Procedure “if the movant shows that there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). The substantive law
identifies which facts are critical or “material.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
248 (1986). A material fact raises a “genuine” issue “if the evidence is such that a reasonable
jury could return a verdict” for the non-moving party. Healy v. N.Y. Life Ins. Co., 860 F.2d
1209, 1219 n.3 (3d Cir. 1988).
On a summary judgment motion, the moving party must show, first, that no genuine issue
of material fact exists. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). If the moving party
5
makes this showing, the burden shifts to the non-moving party to present evidence that a genuine
fact issue compels a trial. Id. at 324. The non-moving party must then offer admissible evidence
that establishes a genuine issue of material fact, id., not just “some metaphysical doubt as to the
material facts.” Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986).
However, “a party who does not have the trial burden of production may rely on a showing that a
party who does have the trial burden cannot produce admissible evidence to carry its burden as to
the fact.” Celotex Corp., 477 U.S. at 323.
The Court must consider all facts and their logical inferences in the light most favorable
to the non-moving party. Pollack v. American Tel. & Tel. Long Lines, 794 F.2d 860, 864 (3d
Cir. 1986). The Court shall not “weigh the evidence and determine the truth of the matter,” but
need determine only whether a genuine issue necessitates a trial. Anderson, 477 U.S. at 249. If
the non-moving party fails to demonstrate proof beyond a “mere scintilla” of evidence that a
genuine issue of material fact exists, then the Court must grant summary judgment. Big Apple
BMW v. BMW of N. Am., 974 F.2d 1358, 1363 (3d Cir. 1992).
III.
LEGAL STANDARD AND ANALYSIS
This is a diversity action, over which the Court has jurisdiction pursuant to 28 U.S.C. §
1332. (See First Am. Compl. ¶¶ 1, 2, 4.) It is well established that a federal court sitting in
diversity must apply the substantive law of the state whose law governs the action. Erie R. Co.
v. Tompkins, 304 U.S. 64, 78 (1938); Griggs v. Bic Corp., 981 F.2d 1429, 1431-32 (3d Cir.
1992). Here, the parties agree that the substantive law of New Jersey applies to all claims in this
litigation.
In New Jersey, product liability actions are governed by the New Jersey Products
Liability Act (“PLA”). N.J. Stat. Ann. §2A:58C-1, et seq. The New Jersey Legislature enacted
6
the PLA based on an “urgent need for remedial legislation to establish clear rules with respect to
certain matters relating to actions for damages for harm caused by products.” Id. § 2A:58C-1(a).
In so doing, “[t]he Legislature intended . . . to limit the liability of manufacturers so as to balance
[] the interests of the public and the individual with a view towards economic reality.” Zaza v.
Marquess & Nell, Inc., 675 A.2d 620, 627 (N.J. 1996). The New Jersey Supreme Court has
observed that “[t]he language chosen by the Legislature in enacting the PLA is both expansive
and inclusive, encompassing virtually all possible causes of action relating to harms caused by
consumer and other products.” In re Lead Paint Litigation, 924 A.2d 484, 503 (N.J. 2007).
A.
Failure to Warn
In Counts I and II of their First Amended Complaint, Plaintiffs allege one of the causes of
action covered by the PLA—failure to warn. The PLA provides that a manufacturer is “not
liable for harm caused by a failure to warn if the product contains an adequate warning or
instruction . . . .” N.J. Stat. Ann. 2A:58C-4. An “adequate” warning is “one that a reasonably
prudent person in the same or similar circumstances would have provided with respect to the
danger and that communicates adequate information on the dangers and safe use of the product, .
. . taking into account the characteristics of, and the ordinary knowledge common to, the
prescribing physician. Id.
1.
Presumption of Adequacy for Prescription Drug Labels
In failure to warn cases involving prescription drugs, “[i]f the warning or instruction
given in connection with a drug . . . has been approved or prescribed by the federal Food and
Drug Administration under the ‘Federal Food, Drug, and Cosmetic Act,’” there is a rebuttable
presumption that the warning is adequate. Id. This is no ordinary rebuttable presumption.
“Compliance with FDA regulations” gives rise to “what can be denominated as a super-
7
presumption[.]” Kendall v. Hoffman-La Roche, Inc., 36 A.3d 541, 544 (N.J. 2012); see also
Perez v. Wyeth Labs., Inc., 734 A.2d 1245, 1259 (N.J. 1999) (“[C]ompliance with FDA
standards should be virtually dispositive of such claims.”). Indeed, the PLA’s presumption that
an FDA-approved prescription drug label is adequate “is stronger and of greater evidentiary
weight than the customary presumption referenced in [New Jersey Rule of Evidence] 301.”
Bailey v. Wyeth, Inc., 37 A.3d 549, 571 (N.J. Super. Ct. Law Div. 2008), aff’d sub nom.
Deboard v. Wyeth, 28 A.3d 1245 (N.J. Super Ct. App. Div. 2011).
In this case, there is no dispute that Defendant’s heparin labeling was approved by the
FDA. (See Def. SUMF ¶ 5; Pls. RSUMF ¶ 5.) In 2005, Baxter submitted updated labeling for
its heparin products. The FDA suggested several alterations, which Baxter incorporated, and in
June 2007, the FDA found the labeling acceptable. Therefore, Defendant is entitled to the
statutory presumption that its heparin labeling satisfied its duty to warn.
2.
Rebutting the Presumption of Adequacy
Plaintiffs can rebut the “super-presumption” with evidence of “intentional misconduct by
the manufacturer.” Bailey, 37 A.3d at 569. First, a plaintiff may introduce evidence of
“deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects” by the
pharmaceutical company, (the “Perez exception”). Perez, 734 A.2d at 1259. Second, a plaintiff
may introduce substantial evidence of “economically-driven manipulation of the post-market
regulatory process,” (the “McDarby exception”). McDarby v. Merck & Co., Inc., 949 A.2d 223,
256 (N.J. Super. Ct. App. Div. 2008).
a.
The Perez Exception
Plaintiffs argue that the Perez exception applies here to rebut the presumption of
adequacy because Defendant failed to disclose relevant information to the FDA when Defendant
8
sought to alter the label in 2005. According to Plaintiffs, had Defendant supplied such
information to the FDA, the label would have contained warnings that would have prevented
Mrs. Baker’s injuries. In particular, Plaintiffs conclude that Defendant failed to disclose the
following:
(1) most HIT cases (approximately 70%) present where heparin is
re-administered 4-10 days after initial heparin exposure;
(2) there is an increased risk of HIT between days 4 to 14 of
administration;
(3) surgical patients and those in critical care units are much more
likely to develop HIT;5
(4) platelet counts should be performed prior to initiating heparin
therapy;6
(5) platelet counts should be monitored at least every other day
between 4 and 14 days after initial exposure to heparin in postoperative patients receiving unfractionated7 heparin; and
(6) low molecular weight heparin has less propensity to cause HIT
in comparison to unfractionated heparin.
(Pls. Br. at 16; DE 82.)
The Court finds that Plaintiffs have failed to demonstrate how these six principles raise a
genuine fact issue necessitating a trial. First, Plaintiffs present no evidence that Defendant
5
It is not clear to whom Plaintiffs are comparing surgical and critically ill patients. Heparin is
used in patients with serious conditions such as deep vein thrombosis, pulmonary embolism,
disseminated intravascular coagulation and in patients undergoing abdominothoracic or cardiac
surgery. (See Def. Ex. 6 to Miller Decl. at 4 (“Indications and Usage”).) Thus, it makes sense
that the patient population in which heparin is indicated would be the patient population more
likely to develop an adverse reaction to HIT as compared to any other patient population.
6
The heparin label provides, “Platelet counts should be obtained at baseline . . . .” (See Def. Ex.
6 to Miller Decl. at 5.) Therefore, Plaintiffs cannot seriously contend that Defendant failed to
disclose that platelet counts should be performed before initiating heparin, as this is plainly
stated on the heparin label.
7
There are two forms of heparin: unfractionated heparin and low molecular weight type heparin.
(See Francis Expert Report at 1-2; Pls. Ex. B to Poondi Decl.; DE 82-3.)
9
intentionally withheld or concealed this information. Significantly, all of the information
Plaintiffs accuse Defendant of withholding was publicly available in published scientific and
medical literature. See Bailey, 37 A.3d at 577 (noting the lack of intent to conceal risks where
those risks were included in the worldwide medical literature); see also Chambers v. G.D. Searle
& Co., 441 F. Supp. 377, 384 (D. Md. 1977) (directed verdict granted in favor of the defendant
drug manufacturer where “[t]here was no other information available to defendant indicating
greater risks or dangers than what was” reviewed by the FDA). Plaintiffs therefore cannot
demonstrate intentional concealment or nondisclosure by pointing only to information that was
widely available to the scientific and medical community.
The second problem with Plaintiffs’ argument is that Defendant did in fact disclose much
of what Plaintiffs claim was deliberately concealed or withheld. When submitting its proposed
updated label to the FDA in 2005, Baxter included several scientific articles and a number of
adverse event reports relating to HIT and HITT. Each article that Defendant submitted discusses
HIT/HITT in seriously ill patients and/or patients having undergone surgery, including cardiac
surgery.8 (See Def. Ex. 4 pt. 2 to Miller Decl. at 27-31; DE 74-9.) Three of the articles
submitted by Baxter to the FDA discuss thrombocytopenia and/or subsequent thrombosis in
patients re-exposed to heparin. (Id. at 30-31.)
In fact, in their submission to the FDA, Baxter cited and summarized one of the articles
that Plaintiffs accuse Defendant of failing to disclose. (Cf. Pls. Ex. L to Poondi Decl., with Def.
Ex. 4 pt. 2 to Miller Decl. at 27-28.) That article explains that “patients typically develop
thrombocytopenia while receiving heparin; the peak onset is 5 to 8 days.” (Pls. Ex. L to Poondi
8
The articles disclose, for example, patients who underwent coronary artery bypass surgeries,
aortic valve replacement, mitral valve repair, and an angiographic procedure for uterine artery
embolization. (See Def. Ex. 4 pt. 2 to Miller Decl. at 27-31.)
10
Decl. at 502.) The article also states that “[l]ow-molecular weight heparin causes immune
thrombocytopenia less often than unfractionated heparin . . . .” (Id. at 505.)
With respect to platelet monitoring, Plaintiffs argue that Defendant failed to disclose the
need for platelet measurement every other day. Plaintiffs, in support, point only to two scientific
journal articles, the first of which recommends a patient’s platelet count be monitored “every
other day,” and the second of which simply recommends “routine” platelet monitoring. (Pls.
Exs. U and V to Poondi Decl.; DE 82-22, 82-23.) Consequently, the available research does not
provide a clear-cut rule concerning at what intervals platelet counts should be measured, and
Defendant’s heparin label takes this into account by instructing that “Platelet counts should be
obtained . . . periodically during heparin administration” and that “[t]hrombocytopenia of any
degree should be monitored closely.” (Def. Ex. 6 to Miller Decl. at 5.)
In view of the above, Plaintiffs have failed to present sufficient evidence to prove that
Baxter engaged in intentional misconduct. No reasonable fact-finder could conclude that
Defendant deliberately concealed or failed to disclose information relating to the serious sideeffects of heparin, when, in reality, that information was publicly known in the medical and
scientific literature. Further, Plaintiffs cannot preclude summary judgment on the issue of
concealment or nondisclosure where the record evidence demonstrates that Defendant did in fact
disclose much of the information regarding the risks, diagnosis, and treatment of HIT and HITT
that Plaintiffs claim was intentionally kept hidden. The Court therefore finds that, as a matter of
law, Plaintiffs have failed to rebut the strong presumption of adequacy with the type of evidence
contemplated by the Perez exception.
11
b.
The McDarby Exception
Plaintiffs next assert that Defendant is not entitled to the statutory presumption of
adequacy because Defendant engaged in “economically-driven manipulation of the post-market
regulatory process.” See McDarby, 949 A.2d at 256. The significance of the McDarby
exception is not immediately obvious until put in context. The case that created the exception,
McDarby v. Merck & Co., Inc., was part of the fallout from the widely-prescribed drug, Vioxx.
Id. at 229. The McDarby court found that Merck & Co., the manufacturer of Vioxx, was not
entitled to the PLA’s presumption of adequacy because, after the drug was approved and on the
market, the company downplayed a known cardiovascular risk associated with Vioxx,
misrepresented the results of Vioxx clinical studies, resisted a stronger warning label proposed
by the FDA, and actively sought to conceal Vioxx’s cardiovascular risks from physicians. Id. at
259.
Here, Plaintiffs argue that Defendant engaged in economically-driven manipulation of the
post-market regulation of heparin. (Pls. Br. at 17-18.) But in support, Plaintiffs do not offer any
evidence of the type considered in McDarby; in other words, Plaintiffs offer no evidence that
Baxter rejected the FDA’s proposed changes to heparin labeling, asked pharmaceutical
representatives to avoid discussing HIT and HITT when speaking to physicians, or manipulated
the conclusions of heparin clinical trials. Instead, Plaintiffs only cite to an August 22, 2008
Power Point presentation prepared by the Baxter Healthcare Pharmacy Advisory Board, which is
co-chaired by two non-Baxter employees. (See Pls. Ex. CC to Poondi Decl. at 1-2; DE 82-30.)
The purpose of the presentation was to get advice and feedback on Baxter’s drug, argatroban, an
anticoagulant indicated for the treatment of thrombosis in patients with HIT.9 (See id. at 53.) As
9
Baxter submitted an NDA to manufacture, market, and sell argatroban in 2008, but the FDA
has not yet approved that NDA. (See Def. Exs. 1 and 2 to Miller Supp. Decl.; DE 86-2, 86-3.)
12
such, the presentation contains extensive information on the causes, diagnosis, and treatment of
HIT. (See id. at 21-50.) Notwithstanding the educational purpose of providing this information,
Plaintiffs call the presentation a “marketing campaign,” and they ask the Court to infer that
Baxter “hid the truth about the dangers of heparin for purposes of profit, only opting to disclose
such information when it could profit from another drug[.]” (Pls. Br. at 6, 18.)
The Court will not consider this presentation as evidence properly supporting application
of the McDarby exception, or draw an inference of egregious intentional misconduct from it. To
begin, the presentation is dated August 22, 2008, whereas Mrs. Baker’s treatment with heparin
was almost a year earlier in September 2007. Plaintiffs, however, cannot satisfy the McDarby
exception with “documents concerning drugs other than [heparin] and instances of conduct by
[Defendant] that occurred long after” Mrs. Baker received heparin. See Bailey, 37 A.3d at 577.
Further, the Court cannot accept the conclusion that Plaintiffs have drawn from this
presentation. The HIT/HITT-related information contained in the presentation was compiled and
communicated not by a Baxter employee, but by a professor of clinical pharmacy at the
Philadelphia College of Pharmacy. (See Pls. Ex. CC to Poondi Decl. at 21.) Further, the focus
of the presentation, argatroban, had not been (and is still not) approved by the FDA such that
Baxter could profit from it. It is therefore unreasonable to make the inferential leap that Baxter
sought to profit from an unapproved drug with a strategically timed disclosure of the dangers of
heparin. See Lexington Ins. Co. v. W. Pa. Hosp., 423 F.3d 318, 333 (3d. Cir. 2005)
(“Speculation does not create a genuine issue of fact; instead, it creates a false issue, the
demolition of which is a primary goal of summary judgment.”) (quoting Hedberg v. Indiana Bell
Tel. Co., Inc., 47 F.3d 928, 932 (7th Cir. 1995). The Court thus finds that Plaintiffs have failed
13
to rebut the presumption of adequacy with substantial evidence of economically-driven
manipulation of the post-market regulatory process.
In sum, Plaintiffs have failed to meet their burden of coming forth with sufficient
evidence to rebut the “super-presumption” of adequacy afforded to Baxter’s FDA-approved
heparin labeling. Pursuant to the PLA, Baxter therefore cannot be held liable for a claim of
failure to warn, see N.J. Stat. Ann. 2C:58C-4, and summary judgment dismissing Counts I, II,
and VIII10 is appropriate.
B.
Causation
Even if a plaintiff is able to demonstrate that a prescription drug’s warning is inadequate,
that plaintiff still must prove that the inadequate warning proximately caused her injury. See
Campos v. Firestone Tire & Rubber Co., 485 A.2d 305, 311 (N.J. 1984). “To satisfy this burden,
[a] plaintiff must show that adequate warnings would have altered her doctors’ decision to
prescribe [the drug].” Strumph v. Schering Corp., 606 A.2d 1140 (N.J. Super. Ct. App. Div.
1992) (Skillman, J., dissenting), rev’d 626 A.2d 1090 (1993) (adopting Judge Skillman’s
dissent).
Under many circumstances, “a heeding presumption may be applicable to claims of
failure to warn of the dangers of pharmaceuticals . . . .” McDarby, 949 A.2d at 267. A heeding
presumption allows one to presume that the plaintiff’s physician would not have prescribed the
drug to the plaintiff if there had been an adequate warning; in other words, the plaintiff’s
physician would have heeded the adequate warning. Id. The heeding presumption is rebutted,
however, if the plaintiff’s physician “was aware of the risks of the drug that [he] prescribed, and
10
Count VIII, Plaintiff Bruce Baker’s loss of consortium claim, is derivative of and dependent
on the survival of Counts I and II. Therefore, since the Court will grant summary judgment
dismissing Counts I and II, it will also grant summary judgment dismissing Count VIII.
14
having conducted a risk-benefit analysis, nonetheless determined its use to be warranted[.]” Id.
at 268 (citing Strumph, 606 A.2d 1140).
Moreover, “a manufacturer who fails to warn the medical community of a particular risk
may nonetheless be relieved of liability under the learned intermediary doctrine11 if the
prescribing physician either did not read the warning at all, . . . or if the physician was aware of
the risk from other sources and considered the risk in prescribing the product.” Perez, 734 A.2d
at 1261 (citation omitted). In that case, the physician’s conduct is the “superseding or
intervening cause that breaks the chain of liability between the manufacturer and the [plaintiff].”
Id.
Here, Plaintiffs suggest that there is a genuine issue of material fact as to whether Mrs.
Baker’s treating physician, Dr. Slater, would have prescribed heparin had there been a different
warning label. (Pls. Br. at 19.) Dr. Slater testified that, hypothetically, he likely would not use a
prescription drug beyond the time period indicated on the label. (Slater Dep. 92:12-93:8; Pls.
Ex. E to Poondi Decl.; DE 82-6.) Plaintiffs infer that Dr. Slater therefore would have followed a
heparin label containing the warnings Plaintiffs argue should have been included. Plaintiffs
further suggest that Dr. Slater would have heeded warnings and instructions contained in a black
box warning, a “Dear Doctor” letter,12 or the Physician’s Desk Reference.
The Court disagrees that Plaintiffs’ evidence raises a genuine issue of material fact as to
the element of proximate cause. Dr. Slater stated that he regularly used heparin in his cardiac
11
The “learned intermediary” doctrine holds that “a pharmaceutical manufacturer generally
discharges its duty to warn the ultimate user of prescription drugs by supplying physicians with
information about the drug’s dangerous propensities.” Niemiera v. Schneider, 555 A.2d 1112,
1117 (N.J. 1989). The New Jersey Supreme Court recognized that when a drug manufacturer
markets their prescription drug directly to the consumer, there is a corresponding duty to warn
the consumer, Perez, 734 A.2d at 1263. But that corresponding duty is not at issue in this case.
12
“Dear Doctor” letters may be sent by drug manufacturers to physicians to inform them of
important new information about a drug. See 21 C.F.R. 200.5.
15
surgery practice, was familiar with the risks and benefits of heparin, and was aware of HIT. (See
Slater Dep. 71:8-72:24; Def. Ex. 10 to Miller Decl.; DE 74-15.) In addition, Dr. Slater stood by
his decision to administer heparin to Mrs. Baker. (See id. 53:13-54:13.) “Evangeline Baker
required heparin by standard medical procedure, and well documented clinical knowledge at
several different time points during her operation and for several different reasons . . . She
appropriately received heparin during the course of her cardiac surgery. She appropriately
received heparin when she developed atrial fibrillation after her cardiac surgery.” (Id. 53:1354:7.) Where, as here, a plaintiff’s physician testifies that he was “aware of the risks of the drug
that [he] prescribed and, having conducted a risk-benefit analysis, nonetheless determined its use
to be warranted . . . the [heeding] presumption [is] rebutted as a matter of law.” See McDarby,
949 A.2d at 268 (internal citation omitted).
Further, Dr. Slater testified in his deposition that he does not read the label of drugs he
prescribes often, which includes heparin. (Slater Dep. 70:23-71:7, Def. Ex. 10 to Miller Decl.)
Moreover, Plaintiffs concede that Dr. Slater never testified that he would have consulted a black
box warning or “Dear Doctor” letter, or that he ever reviewed the Physician’s Desk Reference
when prescribing heparin. Therefore, a different warning would not have made a difference in
Mrs. Baker’s treatment or outcome because Dr. Slater would not have reviewed it. See Perez,
734 A.2d at 1261 (explaining that a manufacturer is not liable under the learned intermediary
doctrine where the plaintiff’s physician did not rely on any information from the manufacturer in
prescribing the drug) (citation omitted).
Finally, it is undisputed that, despite Dr. Slater’s order, the staff at Morristown Memorial
Hospital failed to follow its own heparin treatment protocol. (Pls. RSUMF ¶ 44; Def. SUMF ¶
44.) Had the hospital staff followed the treatment protocol, Mrs. Baker’s blood platelet levels
16
would have been monitored every three days during heparin administration. And, had that
monitoring occurred, Mrs. Baker’s physicians would have discovered the onset of HIT sooner.
(See Shohet Expert Report at 9; Pls. Ex. H to Poondi Decl.; DE 82-9.)
Plaintiffs’ expert, Dr. Stephen B. Shohet, attributed Mrs. Baker’s injuries to “defects in
medical management,” including the failure to monitor Mrs. Baker’s platelet count between
September 11th and September 14th. (Id. at 8.) While finding the lack of detail in the heparin
label regarding HIT in cardiac surgery patients “relevant” to the defects in medical management,
Dr. Shohet nevertheless concluded that had the hospital staff measured Mrs. Baker’s platelet
level consistent with its protocol, “Mrs. Baker’s subsequent HIT would probably have been
detected substantially earlier[.] Heparin would have been discontinued; HIT progression to
HITT would have been averted, and much of the long series of progressive morbidity, including
sequential amputations would not have occurred.” (Id. at 8, 9.) Dr. Shohet affirmed this opinion
during his deposition, testifying that had the hospital staff monitored on the third day of heparin
administration, according to hospital protocol, Mrs. Baker’s injuries “would have been
substantially mitigated” with a “good chance of avoiding the amputation.” (Shohet Dep. 223:21224:25; Def. Ex. 11 to Miller Decl.; DE 74-16.) Therefore, Plaintiffs have failed to raise a
genuine issue of material fact that it was the heparin labeling, as opposed to the failure of the
hospital to follow its treatment protocol, that was a “substantial factor in causing or
exacerbating” Mrs. Baker’s injuries. James v. Bessemer Processing Co., 714 A.2d 898, 909
(N.J. 1998).
Ultimately, Plaintiffs cannot demonstrate that the alleged inadequacy of Defendant’s
heparin labeling resulted in Mrs. Baker’s injuries. Because Dr. Slater was aware of and
understood the risks of heparin, and did not choose to read heparin’s warning label or any
17
additional information from Defendant, no reasonable jury could conclude that a different label
would have altered Dr. Slater’s decision to administer heparin. Lastly, Mrs. Baker cannot
demonstrate that it was the heparin label, rather than the hospital’s failure to monitor her platelet
levels, that was the substantial factor in causing her blood clots, gangrene, and eventual
amputations. As such, summary judgment dismissing Counts I, II, and VIII is also appropriate
because Plaintiffs have failed to demonstrate sufficient evidence to raise a genuine issue of
material fact as to the element of proximate cause.
IV.
CONCLUSION
For the reasons above, the Court grants Defendant’s Motion for Summary Judgment and
dismisses Counts I, II, and VIII of Plaintiffs’ First Amended Complaint. An appropriate order is
filed herewith.
Dated: August 21, 2012
/s/ JOEL A. PISANO
United States District Judge
18
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?