Cross et al v. Forest Laboratories
Filing
287
MEMORANDUM OPINION denying 81 MOTION for Summary Judgment based on Federal Preemption; granting 83 MOTION for Summary Judgment. Signed by District Judge Michael P. Mills on 4/6/15. (jlm)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF MISSISSIPPI
EASTERN DIVISION
ELLA MAY CROSS, et al.
PLAINTIFFS
VS.
CASE NO. 1:05-cv-00170-MPM-SAA
FOREST LABORATORIES
DEFENDANT
MEMORANDUM OPINION
BACKGROUND
This cause comes before the court on the defendant’s motions for summary judgment
based on federal preemption [81] and on state law grounds [83]. The court has reviewed the
briefs, exhibits, and relevant law and is prepared to rule.
This is a failure to warn products liability case. The plaintiffs are the family of Leon
Cross. The defendant is Forest Laboratories.
Leon Cross was an 81 year-old resident of Kosciusko, Mississippi. Mr. Cross had a
history of medical problems including prostate cancer, Type II diabetes, hypertension, chronic
anemia, arthritis, and degenerative joint disease of the lumbar spine. Mr. Cross also suffered
from chronic abdominal pain with diverticulitis and chronic constipation. In November 2003,
Mr. Cross had a colonoscopy, which revealed gastritis and diverticula coli, a possible sign of
colon cancer. Between November 2003 and May 2004, after repeated complaints of constipation
and abdominal pain, several doctors recommended that Mr. Cross undergo colectomy surgery,
but Mr. Cross declined.
In addition to his medical problems, Mr. Cross was also the primary care giver for his late
wife Ella Mae, who recently passed away after suffering from Alzheimer’s for several years. By
2004, Mrs. Cross was in an advanced stage of Alzheimer’s, which rendered her unable to care
for or assess Mr. Cross’s medical problems. Mrs. Cross was dependent on Mr. Cross for her
basic care including administering medications, preparing her food, and other basic needs. Mr.
Cross also took care of all the household chores.
Ultimately, on May 20, 2004, Mr. Cross scheduled a colectomy to deal with abdominal
pain he had been suffering. The surgery was scheduled for June 4, 2004. In the weeks preceding
the surgery, Mr. Cross experienced pre-surgery anxiety and extreme abdominal pain. On May
22, 2004, Mr. Cross’s son, Theodore, took Mr. Cross to the emergency room. Mr. Cross saw Dr.
Ked Eccles-James, an emergency room physician. Dr. Eccles-James examined and diagnosed
him with “anxiety/depression, mood disorder.” Dr. Eccles James prescribed him Lexapro, a
selective serotonin re-uptake inhibitor (SSRI) manufactured by Forest, to help manage the
anxiety. Dr. Ked Eccles-James discharged Mr. Cross with instructions to follow up with his
primary care physician the next clinic day and to return to the emergency room should Mr.
Cross’s symptoms worsen.
On the morning of May 24, Mr. Cross told his wife that he intended to kill himself. Mr.
Cross left his home and fatally shot himself in the stomach. A toxicology report revealed the
presence of an SSRI in Mr. Cross’s blood sample.
In the years before Mr. Cross’s suicide, there was discussion in the medical and scientific
community about whether SSRIs might be linked to increased violence in patients, and
especially an increased risk of suicidality. On March 19, 2004, the Food and Drug
Administration advised Forest Laboratories that labeling changes for Forest’s SSRIs were
warranted, and asked them to submit these changes as changes-being-effected (CBE). On March
22, 2004, the FDA issued a Public Health Advisory asking SSRI manufacturers to include
warnings and instructions for “close observation of adult and pediatric patients treated with those
drugs for worsening depression or the emergence of suicidality,” especially when beginning drug
therapy. On April 19, 2004, Dr. David Paul of the FDA sent an email to Forest approving
updated labeling and encouraging Forest to update the labeling “immediately,” and authorized it
to use the CBE regulation to do so. On April 30, 2004, Forest submitted its proposed label
changes but stated it only intended to include the new warning on packages distributed from their
facilities around May 31, 2004. These changes were approved on May 20, 2004, two days before
Mr. Cross was prescribed Lexapro. The changes were not actually implemented until after Mr.
Cross’s death.
The Cross family filed suit alleging that Forest had failed to include an adequate warning
about the increase of suicidality at the beginning of treatment and the need to monitor the patient
during the first few months of drug therapy. Forest has filed a motion for summary judgment
based on federal preemption [81] and several state law grounds [83].
STANDARD OF REVIEW
Summary judgment is appropriate when there is “no genuine issue of material fact and
the movant is entitled to a judgment as a matter of law.” Fed. R. Civ. P. 56(a). The facts and
evidence are taken in a light most favorable to the non-moving party. LeMaire v. La. Dep't of
Transp. & Dev., 480 F.3d 383, 386 (5th Cir.2007).
A dispute regarding a material fact is “genuine” if the evidence is such that a reasonable
jury could return a verdict in favor of the nonmoving party. Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 248, 106 S. Ct. 2505, 2510, 91 L. Ed. 2d 202 (1986). Summary judgment is
appropriate if “critical evidence is so weak or tenuous on an essential fact that it could not
support a judgment in favor of the non-movant.” Armstrong v. City of Dallas, 997 F.2d 62 (5th
Cir.1993). A party opposing a properly supported motion for summary judgment “may not rest
upon the mere allegations or denials of his pleading, but … must set forth specific facts showing
that there is a genuine issue for trial.” Anderson, at 248. If the nonmoving party fails to meet this
burden, the motion for summary judgment must be granted.
I.
FEDERAL PREEMPTION
A state law may be federally preempted under the Supremacy Clause, U.S. Const., Art.
VI, cl. 2, in three ways. English v. Gen. Elec. Co., 496 U.S. 72, 78, 110 S. Ct. 2270, 2275, 110 L.
Ed. 2d 65 (U.S. 1990). The first is express preemption, where Congress explicitly defines to what
extent the federal law preempts state law. Id. The second is field preemption, where the state law
is preempted because it attempts to regulate “conduct in a field that Congress intended the
Federal Government to occupy exclusively.” Id. at 79, 110 S. Ct. at 2275. Last is conflict
preemption, where the state law actually conflicts with the federal law. Id. This includes cases
where it is impossible for a party to comply with both state and federal requirements. See, e.g.,
Flordia Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143, 83 S.Ct. 1210, 12171218, 10 L.Ed.2d 248 (1963).
The FDA approves a new drug application (NDA) only when it meets certain standards
for safety and effectiveness, including proper labeling. 21 C.F.R. § 314.105(c). Generally any
changes to the label require the manufacturer to submit a supplemental submission and obtain
approval. 21 C.F.R. § 314.70(b). However, manufacturers may make some changes without prior
FDA approval under the changes-being-effected (CBE) provision. In 2004 the CBE provision
read:
(iii) Changes in the labeling, except for changes to the information
required in § 201.57(a) of this chapter (which must be made pursuant to
paragraph (b)(2)(v)(C) of this section), to accomplish any of the
following:
(A) To add or strengthen a contraindication, warning,
precaution, or adverse reaction;
(B) To add or strengthen a statement about drug abuse,
dependence, psychological effect, or overdosage;
(C) To add or strengthen an instruction about dosage and
administration that is intended to increase the safe use of
the drug product;
(D) To delete false, misleading, or unsupported indications
for use or claims for effectiveness; or
(E) Any labeling change normally requiring a supplement
submission and approval prior to distribution of the drug
product that FDA specifically requests be submitted under
this provision.
21 C.F.R § 314.70(c)(6)(iii)(2004).
In Wyeth v. Levine, the Supreme Court directly addressed “whether the FDA's drug
labeling judgments preempt state law product liability claims premised on the theory that
different labeling judgments were necessary to make drugs reasonably safe for use.” 555 U.S.
555, 563, 129 S. Ct. 1187, 1193, 173 L. Ed. 2d 51 (2009) (quotations omitted). The plaintiff in
Levine had her right forearm amputated as a result of an IV-push injection of Phenergan. Id. at
559, S. Ct. at 1191. Wyeth, the drug’s manufacture, argued that it was impossible to comply with
both a state-law warning cautioning against IV-push injections of the drug and FDA labeling
requirements. Id. at 568, S. Ct. at 1196.
The Supreme Court, however, held that “when the risk of gangrene from IV-push
injection of Phenergan became apparent, Wyeth had a duty to provide a warning that adequately
described that risk, and the CBE regulation permitted it to provide such a warning before
receiving the FDA's approval.” Id. at 571, S. Ct. at 1198. The CBE regulation shows that it is
“the manufacturer's ultimate responsibility for its label and provides a mechanism for adding
safety information to the label prior to FDA approval.” Id. Preemption would apply only if the
defendant showed “clear evidence that the FDA would not have approved a change.” Id. What
constitutes clear evidence is not defined, and “lower courts are left to determine what satisfies
this . . . standard in each case.” Dobbs v. Wyeth Pharm., 797 F.Supp.2d 1264, 1270 (W.D. Okla.
2011) (quoting Schilf v. Eli Lilly & Co., No. CIV 07–4015, 2010 WL 3909909, at *4 (D.S.D.
Sept. 30, 2010)).
Forest argues that FDA regulations prevented it from implementing a “black box
warning” or distributing a Medical Guide. It is correct in that regard. See 21 C.F.R. § 201.80(e)
(only FDA may require addition of boxed warning to labeling); 21 C.F.R. §208.24 (manufacturer
must “obtain FDA approval of the Medication Guide before [it] may be distributed”). Forest also
argues that the FDA would have rejected a proposed warning about the link between SSRIs and
suicidality in adults because the FDA has not found a clear causal link between the two. But the
Crosses do not ask for such a warning. Instead, the Crosses argue that a warning was required to
caution physicians and patients about the need for close observation and certain symptoms that
were a precursor to suicidality.
Actions by both Forest and the FDA cast serious doubt that the FDA would have denied a
change. Indeed, prior to Mr. Cross’s suicide, the FDA asked that such a change be made.1 On
March 19, 2004, the FDA requested that Lexapro’s label be updated to include the following:
Nevertheless, patients being treated with antidepressants should be
observed closely for clinical worsening and sociality, especially at the
beginning of a course of drug therapy . . . . Families and caregivers of
patients being treated with antidepressants for major depressive disorder
or other indications should be alerted about the need to monitor patients
for emergence of agitation, irritability, and other symptoms described
above, as well as the emergence of suicidality, and to report such
symptoms immediately to health care providers.
Dkt. 90, Ex. Y, Correspondence from FDA, at 2. This language was substantially similar to the
suggested warning given by the plaintiff’s expert. Dkt. 87, Ex. 1, Hamrell Report, at 17. Forest
agreed to implement these changes only on packages distributed from the company’s facilities on
1
Prior to 2007, the FDA lacked authority to order drug manufacturers to revise their labels based on safety
information made available after the drug’s initial approval. See 121 Stat. 924-926.
or before May 31. Dkt. 90, Ex. AA., Correspondence from Forest to FDA, at 2. Forest forwarded
the proposed changes to the FDA, which were approved on May 20, 2004, the same day Mr.
Cross was prescribed Lexapro. Dkt. 90, Ex. BB, Correspondence from FDA.
This court cannot say the FDA would have clearly rejected a change they asked to be
implemented. There is no clear evidence that the FDA would have requested changes be made on
March 19, approved said changes on May 20, but ultimately rejected a CBE implementation of
the changes on the dates in between. Nor was the FDA likely to deny a change before March 19
when they were about to request the revision be made. Several other courts have also found these
expanded warnings on SSRI labels were not preempted even before the FDA asked the labels be
changed. See Mason v. SmithKline Beecham Corp., 596 F.3d 387 (7th Cir. 2010); Koho v. Forest
Laboratories, Inc., 17 F.Supp.3d 1109 (W.D. Wash. 2014); Baumgardner v. Wyeth Pharm., 2010
WL 3431671 (E.D. Pa. Aug. 31, 2010); Dorsett v. Sandoz, Inc., 699 F. Supp. 2d 1142 (C.D. Cal.
2010); Aaron v. Wyeth, 2010 WL 653984 (W.D. Pa. Feb. 19, 2010). In each of these cases,
fellow courts have held that manufacturers did not provide clear evidence the FDA would have
rejected the updated labels as early as 2000. See, e.g., Baumgardner, 2010 WL 3431671 at * 1.
“Impossibility pre-emption is a demanding defense.” Wyeth v. Levine, 555 U.S. at 573,
129 S. Ct. at 1199. The defendant has not shown “clear evidence that the FDA would not have
approved a change.” Id. at 571, S. Ct. at 1198. For the foregoing reasons, the court finds that the
Cross’s state law claims are not preempted by federal law and as such Forest Laboratories’
Motion for Summary Judgment Based on Federal Preemption [81] is DENIED.
II.
STATE LAW CLAIMS
A. Adequacy of Warning
Under Mississippi law, pharmaceutical manufacturers, like all manufacturers, have a duty
to provide products that are defect free. See Miss. Code. Ann. § 11-1-63. Because some products
have dangers inherent in their use, manufacturers must provide warnings that are adequate to
communicate those dangers and how to safely use the product. See id. Miss. Code. Ann. § 11-163(a)(1)(2) states that a seller may not be liable unless the claimant proves by preponderance of
the evidence that the product contained inadequate warnings and instructions. In prescription
drug and medical device cases, an adequate warning is one that “[takes] into account the
characteristics of, and the ordinary knowledge common to, a physician or other licensed
professional who prescribes the drug, device or other product.” Miss. Code. Ann. §11-1-63(c)(ii).
This was a codification of the “learned-intermediary” doctrine that was adopted by the
Mississippi Supreme Court in Wyeth Labs., Inc. v. Fortenberry, 530 So. 2d 688 (Miss. 1988).
Fortenberry involved a patient who became seriously ill after receiving an influenza vaccination.
Id. at 689. On appeal, the defendant pharmaceutical company alleged that the plaintiff had failed
to prove proximate causation. Id. At 690. The Supreme Court agreed. They established that the
manufacturer has duty to warn the physician, not the patient. Id. at 691. They held where a
warning was adequate, no liability would flow to the manufacturer. Id. at 692. The Supreme
Court viewed this as a break in the “proximate cause” relationship. Id. at 691.
The test was two-part: (1) was the warning adequate; and (2) if not, would an adequate
warning have changed the prescribing physician’s conduct? Id. The Supreme Court did not reach
the second question, holding that the warning at issue was adequate. Id. They noted that “the
issue of a warning's adequacy is factual and usually will be resolved by the trier of fact,” Id. at
692, and that “the adequacy of a warning addressed to the medical community may fall into the
category of issues requiring expert testimony.” Id.
Even if the warning was inadequate, though, the Supreme Court indicated there was
insufficient evidence to find the physician would not have prescribed the medicine. “The record
contains no testimony showing that Dr. Moore would not have administered the flu shot if
adequate warning had been given.” Id. at 691. Further, the physician had testified that he stayed
up to date on the relevant medical literature and did not think there was a causal connection
between the drug and the adverse reaction. Id. at 693.
The next major case to deal with Mississippi’s doctrine was Thomas v. Hoffman-LaRoche
Inc., 949 F.2d 806 (5th Cir. 1992). Thomas began the acne treatment Accutane, and thereafter
began suffering disorientation, headaches, and eventually seizures. Id. at 808. At trial, she
presented evidence that the warning given to prescribing physicians about Accutane was
inadequate. Id. at 809-10. The district court set aside a verdict in her favor, and on appeal
Thomas argued that Mississippi law did not require the plaintiff show that an adequate warning
would have changed the prescribing physician’s action. Id. at 811-13.
The Fifth Circuit rejected the argument, holding that under Mississippi law, “the plaintiff
must establish that an adequate warning would have convinced the treating physician not to
prescribe the product for the plaintiff.” Id. at 812. The plaintiff had one of two avenues to present
this evidence:
[A] plaintiff may introduce either objective evidence of how a
reasonable physician would have responded to an adequate
warning, or subjective evidence of how the treating physician
would have responded. But, to create a jury question, the evidence
introduced must be of sufficient weight to establish, by the
preponderance of the evidence, at least some reasonable likelihood
that an adequate warning would have prevented the plaintiff from
receiving the drug.
Id. (citations omitted).
Janssen Pharmaceutical, Inc. v. Bailey, 878 So. 2d 31 (Miss. 2004), concerned multiple
plaintiffs who suffered adverse effects after taking medicine prescribed for gastroesophageal
reflux disease. Id at 35. After losing at trial, the pharmaceutical company appealed, challenging
the sufficiency of the plaintiffs’ causation evidence.
The Mississippi Supreme Court reiterated not only their holding in Fortenberry but also
the 5th Circuit’s holding in Thomas that the plaintiff bears the burden of establishing that “an
adequate warning would have convinced the treating physician not to prescribe the product for
the plaintiff” Id. at 58 (citing Thomas, 949 F.2d at 811). Additionally, the Court noted the
adequacy of the warning was an issue for the jury. Id.2
In applying these cases, courts have held that ordinarily a drug manufacturer owes a duty
to the prescribing physician and not the patient. A plaintiff can overcome this doctrine by
showing: (1) the warning was inadequate; and (2) the physician would have altered his conduct if
the warning was adequate. For purposes of summary judgment, then, there must be a dispute of
material fact as to both the adequacy of the warning and the knowledge and action of the
physician. The following analysis begins with the second prong of that test. Taking the evidence
in the light most favorable to the non-moving party, there still must be sufficient evidence to
show “at least some reasonable likelihood” the warning would have affected the doctor’s
conduct.
At this point, the court clarifies what is meant by “alter the doctor’s conduct.” In
Fortenberry, Thomas, and Jansseen, altering the doctor’s conduct meant altering the doctor’s
decision to prescribe the drug. Plaintiffs urge this court to distinguish between preventable and
unavoidable risks, and to determine that the risk in this case was preventable. In other words,
according to the plaintiffs, an adequate warning would have instructed how to safely use the
2
The plaintiffs’ downfall was sufficient evidence of causation – they had presented insufficient evidence
such that the jury could find for the plaintiffs, in light the numerous preexisting conditions that were much more
likely the cause of the plaintiffs’ injuries. Id. at 57-61. Ultimately, the Mississippi Supreme Court found that the
joinder of the plaintiffs in the action was improper because their claims each had a “unique set of facts and
circumstances,” and remanded the case to be severed. Id. at 63.
product, or avoid a preventable risk. In contrast, in the aforementioned cases, the inadequacy of
the warning dealt with unavoidable risks inherent in using the product. Plaintiffs have not
provided, and this court has been unable to find, any authority that would extend the meaning of
“altering the doctor’s conduct” beyond the decision to prescribe or not to prescribe and into the
realm of what instructions the doctor gives the patient when prescribing the drug. This court is
unable to make an Erie prediction that the Mississippi Supreme Court would extend failure-towarn jurisprudence to the instructions a doctor gives the patient. This court is bound by 5th
Circuit precedent on this issue and will follow Thomas’s explicit holding that “in a prescription
drug failure to warn case, the plaintiff must establish that an adequate warning would have
convinced the treating physician not to prescribe the product for the plaintiff.” Thomas, 949 F.2d
at 812 Therefore, plaintiffs must point to specific evidence that creates a genuine issue as to
whether an adequate warning would have changed Dr. Eccles-James’ decision to prescribe
Lexapro to Mr. Cross.
Plaintiffs argue that several pieces of testimony from Dr. Eccles-James, the prescribing
physician, create a genuine dispute as to whether an adequate warning would have altered his
conduct. First, plaintiffs point out that Dr. Eccles-James testified he generally heeds warnings
given by manufacturers. Dkt. 102, Ex. G, Deposition of Dr. Ked Eccles-James, at 70. By itself,
this does not prove or disprove that Dr. Eccles-James would have altered his conduct at the time
he prescribed Lexapro to Mr. Cross. In fact, Dr. Eccles-James was aware of the debate within the
medical community about SSRI-induced suicidality and the need to monitor patients. Id. at 2325, 34-37. Second, Cross notes that Dr. Eccles-James testified if he had been shown data
concerning the suicide risk of Lexapro, he would have done further research. Id. at 116. The
testimony is as follows (questions by plaintiffs’ counsel):
Q: Read that –
A: “A third case-control study (Juurlink and others) looked at
suicides in elderly depressed patients and the comparison was with
SSRI use was over…” – “versus use of other antidepressants. They
found nearly five-fold greater risk of suicide in SSRI-treated
patients compared to patients receiving other antidepressants but
only in the first month of treatment.”
Q: Okay. And then you see the odds ratio given to you as 4.8?
A: Mm-hmm.
Q: And then the confidence interval?
A: 1.9 to 12.2
…
Q: Is that information that you would have liked to have known
prior to treating Mr. Cross?
A: If available, yes.
Q: Well, you told me that if you had known about this, you would
have done further research.
A: What I’m saying, yes, if available. If I research – I would – it
look on to it (sic).
Id. at 116. It is important to note that Dr. Eccles-James testified that he would have done further
research if the data were available, which seems to suggest that these data were not available to
Dr. Eccles-James at the time he prescribed Mr. Cross Lexapro. The study that presumably served
as the basis for plaintiffs’ questions was published in the American Journal of Psychiatry in May
2006, authored by David N. Juurlink and others.3 This study claimed an odds ratio of 4.8 and a
confidence interval of 1.9-12.2. This data was published in 2006 and was not available to Dr.
Eccles-James at the time he made the prescription, so the court fails to see how data published in
3
Am. J. Psychiatry, 2006 May; 163(5):813-21; Juurlink DN, Mamdani MM, Kopp A, and Redelmeier DA.; See Dkt.
#87, Ex. 62.
2006 could have affected Dr. Eccles-James in 2004. Further, even if, in 2004, Dr. Eccles-James
had had the data and had done further research, he might have still prescribed Lexapro. There is
no affirmative and specific evidence provided by plaintiffs that suggest an adequate warning
would have changed Dr. Eccles-James’ conduct in a way to prevent Mr. Cross’s suicide.
Also of concern to the court, plaintiffs, in their response memorandum, state that Dr.
Eccles-James “has, in fact, ‘altered’ his prescribing practices by heeding the warnings of SSRIinduced suicidality and following the instructions in the FDA-mandated labeling to avoid these
risks.” Dkt. 101, Plaintiffs’ Memo, at 15. Plaintiffs state this without citing the record and this
court cannot find where that statement is substantiated. A similar statement is made at page 6 of
the response memorandum, but plaintiffs only cite to page 88 of the Dr. Eccles-James deposition
transcript. Dkt. 101, Plaintiffs’ Memo, at 6. A reading of the transcript at that page provides no
support for plaintiffs’ interpretation. Because the plaintiffs have failed to support the statement,
by affidavit or testimony, that Dr. Eccles-James has in fact altered his prescribing practices, the
court will disregard this statement and not consider it as evidence bearing on the summary
judgment motion.
Other testimony by Dr. Eccles-James in response to Forest’s questions tends to support
Forest’s position that Dr. Eccles-James would not have changed his conduct had the warning
been adequate. At pages 108-109 of the deposition transcript (questions by defense counsel):
Q: Now, Doctor, my question is: If you had that information in
your hands in 2004 when you saw Mr. Cross, that placebo studies
– clinical studies demonstrated an increased risk for children and
adolescents, would that in any way have affected your decision to
prescribe Lexapro for Mr. Cross?
A: I wouldn’t think so.
Id. at 108-09 (emphasis added). Additionally, near the end of the deposition at page 113
(questions by defense counsel):
Q: Have you seen any information, any documentation, today – do
you have any knowledge about this medicine today as we sit here
that would have changed your decision to prescribe Lexapro to Mr.
Cross when you saw him on May 22nd, 2004?
A: I don’t think so.
Q: You do still prescribe Lexapro, correct?
A: Yes. Yes, I do.
Id. at 113 (emphasis added).
Finally, as mentioned earlier, Plaintiffs also argue that an adequate warning, including the
need to closely monitor patients, would have changed the instructions Dr. Eccles-James gave Mr.
Cross. Even assuming this court adopted plaintiffs’ theory of failure to warn, Plaintiffs have
failed to point to specific facts that would support their assertion. Plaintiffs have failed to show
an adequate warning would have altered Dr. Eccles-James’ conduct in any way. Plaintiffs point
out that Dr. Eccles-James generally heeds warnings. That he would do so in this case, and that
heeding the warning would have changed his behavior, is mere speculation. In fact, the record
seems to contradict this assertion.
Dr. Eccles-James testified that he was aware and understood that patients being treated
with antidepressants should be observed closely. Id. at 34-37. Reading from the updated Lexapro
label, Forrest’s counsel asked:
Q: … “Nevertheless, patients being treated with antidepressants should be
observed closely for clinical worsening and suicidality, especially when they first
begin treatment with a medicine.” Was that your understanding or is that your
practice in 2004 as well?
A: Yes.
Id. at 34. Because Dr. Eccles-James saw Mr. Cross in the emergency department at Monfort
Jones Hospital and was not his primary care physician, Dr. Eccles-James did not have an
ongoing relationship with Mr. Cross. So, Dr. Eccles-James instructed Mr. Cross to follow up
with his primary care physician the next clinic day, especially if his symptoms got worse. Dr.
Eccles-James also gave Mr. Cross an instruction to follow up with his surgeon for pre-surgery
counseling. And finally, Mr. Cross signed discharge instructions from the emergency department
that stated: “Discharge instructions have been provided and I understand these as explained. If
my condition becomes worse, I will come to the emergency room. If my symptoms continue, I
will see my family doctor within two days.” It is unclear to this court what more Dr. EcclesJames could have done or how his behavior would have changed with an adequate warning.
In sum, plaintiffs have not borne their burden of pointing to specific facts, beyond mere
speculation, to support a genuine issue of material fact as to whether an adequate warning would
have altered Dr. Eccles-James’ decision to prescribe Lexapro, as required by the learned
intermediary doctrine. Viewing the facts in the light most favorable to the plaintiff, this court
finds a reasonable jury could not find an essential element of plaintiffs’ case, that an adequate
warning would have altered Dr. Eccles-James’ conduct. Therefore, Forest’s motion for summary
judgment will be GRANTED.
CONCLUSION
ACCORDINGLY, while the court denies Forest’s motion for summary judgment based
on federal preemption [81], the court also finds that the plaintiffs have not given sufficient
evidence to defeat summary judgment on state law grounds. Therefore, Forest Laboratories’
Motion for Summary Judgment Based on State Law Grounds [83] is GRANTED.
A separate judgment will be entered this date, pursuant to Fed. R. Civ. P. 58.
So ordered this the 6th day of April, 2015.
/s/ MICHAEL P. MILLS
UNITED STATES DISTRICT JUDGE
NORTHERN DISTRICT OF MISSISSIPPI
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