Court Opinion

ID: 62837
Source: CourtListenerOpinion
Date Created: 2010-04-26 04:48:13+00
Date Added: 2024-06-11T14:58:23.770096
License: Public Domain

UNPUBLISHED OPINION - APPENDIX

                                                                         [DO NOT PUBLISH]

                  IN THE UNITED STATES COURT OF APPEALS
                                                                FILED
                             FOR THE ELEVENTH CIRCUIT U.S. COURT OF APPEALS
                              ________________________  ELEVENTH CIRCUIT
                                                            JULY 29, 2008
                                                         THOMAS K. KAHN
                                     No. 07-12258
                                                               CLERK
                              ________________________
                           D. C. Docket No. 06-80702-CV-KLR

LORI JO BAILEY,
as the Personal Representative of the
Estate of Chad Beal,
                                                                             Plaintiff-Appellant,

                                              versus

JANSSEN PHARMACEUTICA, INC.,
JANSSEN, L.P., et al.,

                                                                         Defendants-Appellees.
                                ________________________

                       Appeal from the United States District Court
                           for the Southern District of Florida
                             _________________________

                                         (July 29, 2008)

Before ANDERSON and SILER,* Circuit Judges.**
______________
* Honorable Eugene Siler, Jr., United States Circuit Judge for the Sixth Circuit, sitting by
designation.

** Judge Frank M. Hull was a member of the panel which heard oral argument but recused herself
following oral argument and did not participate in this decision. The case is decided by a quorum.
See 28 U.S.C. §46(d) (2006); 11th Cir. R. 34-2.
PER CURIAM:

      This opinion is provided as an appendix to our simultaneously issued

published opinion in the above-styled case. Finding the district court erred in part

in granting appellee’s motion to dismiss, we reverse in part and affirm in part the

dismissal of appellant’s First Amended Complaint.

                                 I. BACKGROUND

      The decedent, Chad Edgar Beal (“Beal”), died on March 5, 2004, after

having received a lethal dose of a pain narcotic, fentanyl, via a transdermal skin

patch prescribed to him by his doctor. The prescription patch, Duragesic, was

manufactured by defendant Alza Corporation (“Alza”) and distributed by defendant

Janssen Pharmaceutica, Inc. (“Janssen”), both of which are subsidiaries of the

holding company, defendant Johnson & Johnson, Inc. (“Johnson & Johnson”). The

patch was sold to Beal at a South Florida store of defendant Walgreen Company

(“Walgreen”).

      Beal underwent spinal surgery two days before his death and was prescribed

the Duragesic patch by his doctor to help him manage his post-surgical pain. The

patch is designed to release a controlled dose of fentanyl, a powerful opiate, to its

wearer over a seventy-two-hour period. Despite the box’s warning that the

Duragesic patch was “not for acute or postoperative use,” Beal’s doctor prescribed

                                           2
him the medication.1 Appellant alleges that the patch malfunctioned and delivered

to Beal the entire dose of fentanyl at one time, as opposed to slowly over the

seventy-two-hour period. Appellant originally brought this action in state court on

behalf of Beal, seeking relief under various tort and contract theories for Beal’s

wrongful death.

       At the time the district court ruled on appellant’s motion to remand, which is

the subject of our published opinion, the court also dismissed appellant’s original

(state court) complaint on procedural and substantive grounds. This complaint was

a typical “shotgun complaint,” and alleged numerous “sub-counts” within each of

eight separate counts. For example, Count I of the original complaint, which was,

generally, a “strict liability” claim, raised sub-claims A through F: strict liability

product defect, strict liability failure to warn, breach of warranty of fitness for a

particular purpose, breach of warranty of merchantability, fraudulent

misrepresentation, and reckless disregard of unreasonable risk of harm. The

district court, in dismissing the complaint without prejudice to permit repleader,

held: “The Defendants are entitled to a Complaint containing specific allegations of

       1
              Plaintiff did not plead facts with regard to what the warning on the box actually
said; Defendants described the content of the warning label in their motion to dismiss, Docket
No. 9.

                                                3
their alleged wrongdoing separated into individual counts.” District Court Order,

Docket No. 30, at 5.

       The district court, at the time it dismissed appellant’s complaint for

repleader, also addressed a number of substantive deficiencies in the complaint.

The court noted, chief among the substantive deficiencies, that appellant failed to

allege “how, if at all, the patch was defective,” id. at 5, and whether the defect

came from the “product’s design or manufacturing process”—or, in other words,

whether any purported defect occurred on the assembly line or in the design

process. Id. at 6. Further, the original complaint, the district court held, failed to

adequately plead strict liability for failure to warn because it did not make a factual

allegation that “the warnings were inadequate in light of the generally recognized

and prevailing scientific and medical knowledge at the time of manufacture.” Id. at

7. Nor did the complaint allege facts that might establish that the warnings to

Beal’s prescribing physician had been inadequate.2 Appellant’s claims for breach

of implied warranties failed for lack of privity between the consumer and all

Defendants other than Walgreen, the retailer who sold the product to Beal. The

claim for breach of implied warranty of merchantability against Walgreen

       2
               Florida law applies the learned intermediary doctrine whereby the duty to warn
runs to the physician and not the patient. See Buckner v. Allergan Pharm., Inc., 400 So. 2d 820,
822 (Fla. 5th DCA 1981).

                                                4
nevertheless failed because the complaint contained “no allegations that the patch

failed during its use in its reasonable and usual manner,” nor did the complaint

allege that the product was unmerchantable at the time of sale. Id. at 11.

       Following the court’s order dismissing appellant’s original complaint

without prejudice, appellant filed an improved and shorter First Amended

Complaint, which attempted to overcome the procedural and substantive

difficulties highlighted by the district court in its November order. Although the

First Amended Complaint did not expressly commingle the claims in the same

manner as the original complaint (i.e., not as express sub-claims), the district court

still found the First Amended Complaint infirm for procedural and substantive

errors not remedied following the earlier dismissal. Among the procedural errors,

the court found the allegations “wholly conclusory.” District Court Order, Docket

No. 42, at 4. As a result of a typographical error, the first sentence of each count in

the First Amended Complaint read: “Plaintiff adopts and realleges the foregoing

paragraphs of this complaint as if fully set forth herein.”3 First Amended

Complaint, Docket No. 31, at 13, 18, 20, 22, 23-24, 25, 27, 28 (emphasis added).

In effect, then, each subsequent count incorporated into it the prior counts, as well

       3
               Appellant recognized below at the hearing on the motion to dismiss and in her
brief in response thereto, that there was this typographical error in the complaint.

                                               5
as the preceding factual allegations. Putting aside this typographical error,

however, the district court also determined that the complaint commingled claims,

albeit in less obvious ways than creating strict subdivisions within a single count.

For example, according to the district court, Count I, which is the “strict liability”

count, purportedly raised at least five causes of action against all defendants: (1)

design defect, (2) manufacturing defect, (3) failure to warn, (4) alter ego/piercing

the corporate veil, and (5) conspiracy. Similarly, Count II, for negligence,

purportedly raised several individual causes of action under the rubric of

“negligence” against all defendants: (1) negligence, (2) design defect, (3)

manufacturing defect, (4) failure to warn, (5) alter ego/piercing the corporate veil,

and (6) conspiracy. The district court held that because appellant failed to adhere

to its earlier instruction that each defendant was “entitled to a Complaint containing

specific allegations of their alleged wrongdoing separated into individual counts,”

at least in so far as the complaint did not break down claims by defendant into

separate counts, that the First Amended Complaint should be dismissed with

prejudice.

      The district court also, again, found the First Amended Complaint

substantively infirm, and ordered its dismissal with prejudice under Fed. R. Civ. P.

12(b)(6). The district court believed that the First Amended Complaint failed to

                                           6
remedy the deficiencies the court had brought to appellant’s attention. Among the

substantive deficiencies noted by the district court, the amended complaint did not

properly allege that the defendants failed to adopt a reasonable alternative design,

did not distinguish between design defect and manufacturing defect, and also failed

to plead how the warnings on the product were deficient in light of “the generally

recognized and prevailing scientific and medical knowledge at the time of the

manufacture.” District Court Order, Docket No. 42, at 6, 7, 8. According to the

district court, Count II, the negligence claim, “contain[ed] no facts establishing

how Defendants breached their alleged duty to perform adequate inquiries

regarding the cause of the alleged defects, promptly recall the patch at issue, or

reduce the danger of injury associated with use of the patch.”4 Id. at 8.

       The court ordered dismissal of the First Amended Complaint with prejudice

as a result of the procedural and substantive insufficiencies. Appellant brought the

instant timely appeal and only challenges the merits of the district court’s decision

with regard to Counts I, II, and IV—respectively, her strict products liability claim,

her negligence claim, and her breach of the implied warranty of merchantability

claim against Walgreen. Moreover, with respect to Count I, appellant challenges

       4
              The court did not expressly discuss substantive deficiencies of Count IV, the
implied warranty claim, and we will therefore assume that its dismissal was on procedural
grounds.

                                                7
the district court’s decision only with respect to strict liability for design or

manufacturing defect and strict liability for failure to warn. Similarly with respect

to Count IV, appellant challenges the district court decision only with respect to

breach of implied warranty of merchantability.5

                               II. STANDARD OF REVIEW

       The district court’s dismissal with prejudice of the First Amended Complaint

for failing to remedy the procedural infirmities identified by the court in its

November 2006 order was tantamount to a dismissal pursuant to Rule 41(b), for

failing to adhere to a court order. We review dismissals with prejudice pursuant to

this Rule for abuse of discretion. Gratton v. Great Am. Commc’ns, 178 F.3d 1373,

1374 (11th Cir. 1999).

       The court below also ordered dismissal of the complaint on substantive

grounds under Rule 12(b)(6). This Court reviews a dismissal pursuant to Rule

12(b)(6) de novo and applies the same standard as the district court did. Hoffman-

Pugh v. Ramsey, 312 F.3d 1222, 1226 (11th Cir. 2002). This Court accepts as true

the factual allegations in the complaint and construes them in a light most favorable

to the plaintiff. Id. at 1225. However, the complaint’s “[f]actual allegations must

       5
               Any appeal with respect to other aspects of the district court decision which are
not thus challenged are deemed abandoned.

                                                 8
be enough to raise a right to relief above the speculative level.” Bell Atl. Corp. v.

Twombly, __ U.S. __, 127 S. Ct. 1955, 1965 (2007); see also Watts v. Fla. Int’l

Univ., 495 F.3d 1289, 1295 (11th Cir. 2007). “The Supreme Court’s most recent

formulation of the pleading specificity standard is that ‘stating such a claim

requires a complaint with enough factual matter (taken as true) to suggest’ the

required element.” Watts, 495 F.3d at 1295 (quoting Twombly, 127 S. Ct. at

1965). This rule does not “impose a probability requirement at the pleading stage.”

Twombly, 127 S. Ct. at 1965. Instead, the standard “simply calls for enough fact to

raise a reasonable expectation that discovery will reveal evidence” of the required

element. Id. “It is sufficient if the complaint succeeds in ‘identifying facts that are

suggestive enough to render [the element] plausible.’” Watts, 495 F.3d at 1296

(quoting Twombly, 127 S. Ct. at 1965).

                                      III. DISCUSSION

       A.      The Complaint Generally6

       We have frequently admonished litigants for “shotgun pleadings.” Although

the First Amended Complaint was improved, both complaints here nevertheless fall

       6
               We will excuse appellant’s typographical error, whereby the complaint
reincorporated all prior paragraphs into each count. This mistake did not appear in the original
complaint and was represented to the court below, in response to the motion to dismiss, as a
typographical error.

                                                 9
within the category of “shotgun complaints.” See, e.g., Strategic Income Fund,

L.L.C. v. Spear, Leeds & Kellogg Corp., 305 F.3d 1293, 1295 (11th Cir. 2002)

(“The typical shotgun complaint contains several counts, each one incorporating by

reference the allegations of its predecessors, leading to a situation where most of

the counts (i.e., all but the first) contain irrelevant factual allegations and legal

conclusions.”); Johnson Enters. of Jacksonville, Inc. v. FPL Group, Inc., 162 F.3d

1290, 1333 (11th Cir. 1998) (“These types of cases invariably begin with a long list

of general allegations, most of which are immaterial to most of the claims for relief.

The general allegations are incorporated by reference into each count of the

complaint . . . .”); Cesnik v. Edgewood Baptist Church, 88 F.3d 902, 905 (11th Cir.

1996) (“[The complaint] was framed in complete disregard of the principle that

separate, discrete causes of action should be plead [sic] in separate counts. Count

one, for example, which is labeled ‘Wrongful Placement and Adoption,’ purports to

plead at least nine discrete theories of recovery.” (internal citation omitted)).

      When faced with a shotgun complaint, we have encouraged defendants to

make motions for more definite statements or courts to demand repleader—and not,

as the case were, to dismiss a complaint with prejudice. See Anderson v. Dist. Bd.

of Trs. of Cent. Fla. Cmty. Coll., 77 F.3d 364, 367 & n.5 (11th Cir. 1996) (stating

that defendant is “expected” to move the court for a more definite statement in

                                            10
response to a shotgun pleading and, failing that, the district court should sua sponte

strike a shotgun complaint and require plaintiff to make a more definite statement);

see also Davis v. Coca-Cola Bottling Co. Consol., 516 F.3d 955, 983-984 (11th

Cir. 2008) (describing same procedure). But, that said, the Court has suggested at

least once that if a party fails to heed the court’s direction to revise a shotgun

complaint, under some circumstances a dismissal and sanctions might be

appropriate. See Byrne v. Nezhat, 261 F.3d 1075, 1133 (11th Cir. 2001) (“Implicit

in such instruction is the notion that if the plaintiff fails to comply with the court’s

order—by filing a repleader with the same deficiency—the court should strike his

pleading or, depending on the circumstances, dismiss his case and consider the

imposition of monetary sanctions.”). We are not, however, convinced that the

instant case was one with respect to which a dismissal with prejudice was

appropriate under the circumstances.

      Moreover, a complaint—so long as it is minimally sufficient to put a

defendant on notice of the claims against him—will not fail for mere surplusage.

See United States ex rel Garst v. Lockheed-Martin Corp., 328 F.3d 374, 378 (7th

Cir. 2003) (“Surplusage can and should be ignored. Instead of insisting that the

parties perfect their pleadings, a judge should bypass the dross and get on with the

case.”); Davis v. Ruby Foods, Inc., 269 F.3d 818, 820 (7th Cir. 2001) (holding that

                                           11
“it is an abuse of discretion . . . to dismiss a complaint merely because of the

presence of superfluous matter”). We have recognized that “[p]leading facts not

necessary to state a claim is not grounds for dismissal of a complaint . . . .” Athens

Newspapers v. Jefferson Standard Life Ins. Co., 729 F.2d 1412, 1417 (11th Cir.

1984). In other words, “[a] complaint is sufficient if the plaintiff is entitled to relief

under any legal theory.” Thompson v. Allstate Ins. Co., 476 F.2d 746, 749 (5th

Cir. 1973).7 We will, therefore, overlook some of the extraneous and repetitious

statements in appellant’s First Amended Complaint, so long as the complaint is

minimally sufficient to satisfy the notice pleading standards of the Federal Rules.

       Even if we are not convinced that this was an appropriate case for the district

court to dismiss the entire complaint for procedural errors alone, we are constrained

in the form of relief we can afford appellant by her own failure here to seek leave to

amend her complaint before the district court. Under our precedent, the district

court was not obligated sua sponte to provide appellant with an opportunity to

amend her complaint prior to dismissing it with prejudice. See Wagner v. Daewoo

Heavy Inds. Am. Corp., 314 F.3d 541, 542 (11th Cir. 2002) (en banc) (“A district

court is not required to grant a plaintiff leave to amend his complaint sua sponte

       7
               In Bonner v. City of Prichard, 661 F.2d 1206, 1209 (11th Cir. 1981) (en banc),
this Court adopted as binding precedent all of the decisions of the former Fifth Circuit handed
down prior to the close of business on September 30, 1981.

                                                12
when the plaintiff, who is represented by counsel, never filed a motion to amend

nor requested leave to amend before the district court.”); see also Long v. Satz,

181 F.3d 1275, 1279-80 (1999) (requiring plaintiff to make by separate motion,

setting forth the substance of proposed amendments, a request for leave to amend a

complaint); Fed. R. Civ. P. 7(b)(1)(A) (“A request for a court order must be made

by motion. The motion must: (A) be in writing unless made during a hearing or

trial”).8 Therefore, if we are to conclude that there was an abuse of discretion by

the district court in dismissing any part of First Amended Complaint, we must find

that appellant sufficiently remedied the procedural errors in the amended complaint

such that it was unreasonable for the district court to dismiss that count. Although

this is indeed a close case, we find that the district court abused its discretion when

it dismissed Count I, the strict products liability claim, and Count IV, the breach of

implied warranty of merchantability claim. With respect to Count II, we conclude

that appellant failed to take full advantage of the opportunity afforded her by the

district court when it gave appellant an opportunity to cure the original complaint’s

       8
               The closest appellant came to making such a request was a request that her breach
of express warranty claim (Count VII) be dismissed without prejudice, after conceding in her
response to the motion to dismiss that the count failed to state a claim. Response to Motion to
Dismiss, Docket No. 37, at 7.

                                               13
procedural deficiencies, with specific instructions as to how to cure the complaint’s

errors.

      B.     Count I: Strict Products Liability

      For the following reasons, we conclude that Count I, which was pled against

all defendants, articulated a viable claim and minimally satisfied the district court’s

instructions in the context of a strict liability claim.

             1.     Procedural Sufficiency of Count I

      In its November 2006 order, the district court instructed appellant to replead

her claims because each defendant was “entitled to a Complaint containing specific

allegations of their alleged wrongdoing separated into individual counts.”

Although the court and the defendants believed that instruction to mean that

appellant should break down each individual count as to each individual

defendant—i.e., “Count I, design defect against Johnson & Johnson”—it was not

necessarily clear that its instruction to appellant would have been violated by the

First Amended Complaint’s grouping of its strict products liability claim against all

companies in the chain of distribution. Samuel Friedland Family Enters. v.

Amoroso, 630 So. 2d 1067, 1068 (Fla. 1994) (“The underlying basis for the

doctrine of strict liability is that those entities within a product’s distributive chain

who profit from the sale or distribution of [the product] to the public, rather than an

                                            14
innocent person injured by it, should bear the financial burden of even an

undetectable product defect.” (internal quotations and citations omitted; bracket in

original)); see also Restatement (Third) of Torts §1 (1998) (“One engaged in the

business of selling or otherwise distributing products who sells or distributes a

defective product is subject to liability for harm to persons or property caused by

the defect.”). Because the First Amended Complaint appropriately indicated that

each defendant could be liable, having participated in distributing, manufacturing,

and retailing this product, we believe appellant sufficiently satisfied the court’s

instruction as to Count I.

      The very nature of a products liability action—where the cause or source of

the defect is not obvious to the consumer—would make it difficult for an appellant

to pinpoint a specific source of defect against one entity along the chain of

distribution prior to discovery. Moreover, the Federal Rules permit pleading in the

alternative, even within one single count. See also Fed. R. Civ. P. 8(d)(2) (“A party

may set out 2 or more statements of a claim or defense alternatively or

hypothetically, either in a single count or defense or in separate ones. If a party

makes alternative statements, the pleading is sufficient if any one of them is

sufficient.”). And although the district court had discretion to order “each claim

founded on a separate transaction or occurrence . . . stated in a separate count,”

                                          15
Fed. R. Civ. P. 10(b), appellant was not in a position to know what entity along the

chain of distribution would have been responsible for the defect—or even to know

with specificity before discovery what was the likely source of the defect.

Moreover, under Florida law, we do not believe such precision would be required.

See Samuel Friedland Family Enters., 630 So. 2d at 1068 (describing liability

running with the chain of profit).

      Similarly, it would be difficult at such an early stage in the litigation for a

plaintiff to know whether a defect was due to a product’s design or manufacture,

despite the district court’s insistence that appellant specifically plead the source of

the defect and not commingle available theories of strict liability recovery. We are

not convinced that Florida law applies a rigid distinction among the various

theories of recovery available to plaintiffs under strict products liability such that a

plaintiff would be required to expressly plead “design defect” versus

“manufacturing defect” at the complaint stage. See, e.g., Clark v. Boeing Co., 395

So. 2d 1226, 1229 (Fla. 3d DCA 1981) (“In order to establish strict liability,

appellants must allege and prove the manufacturer’s relationship to the product in

question, the defect, the unreasonably dangerous condition of the product, and the

existence of a proximate causal connection between the condition and the user’s

injuries or damage.”); West v. Caterpillar Tractor Co., Inc. 336 So. 2d 80, 87 (Fla.

                                           16
1976) (same) (adopting §402A of the Restatement (Second) of Torts for strict

products liability in tort); Restatement (Second) of Torts §402A (1965)

(establishing elements of strict liability recovery but not differentiating between

design defect and manufacturing defect).9 It is difficult for a plaintiff at this stage

in the litigation to know the source of the defect that was responsible for the harm

caused: whether there was a surprising manufacturing problem, a systemic issue

with a product in its design, or a failure on the part of the manufacturer to warn

doctors that particular uses might pose an unreasonable risk of harm.

       Incidentally, we observe that Florida’s Third District Court of Appeals in

Bergalia v. Ownes-Corning Fiberglass Corp., 606 So. 2d 1213, 1214 (Fla. 3d DCA

1992), reversed the trial court’s dismissal of a strict liability count that similarly

relied on multiple theories of strict liability—design defect, manufacturing defect,

       9
                 Comment (k) to the Restatement (Second) of Torts §402A, adopted by the
Supreme Court of Florida in West, specifically contemplates strict liability for drug
manufacturers: “The seller of such products, again with the qualification that they are properly
prepared and marketed, and proper warning is given, where the situation calls for it, is not to be
held to strict liability for unfortunate consequences attending their use, merely because he has
undertaken to supply the public with an apparently useful and desirable product, attended with a
known but apparently reasonable risk.” Restatement (Second) of Torts §402A cmt. k (emphasis
added). We note that the Restatement does not separately define the elements for design defect,
manufacturing defect, and failure to warn therein, but at least manufacturing defect and failure to
warn are contemplated by Comment (k) and encompassed under the umbrella strict products
liability cause of action. Florida law also recognizes design defect in some circumstances –
whereas other jurisdictions and Comment (k) do not. See Adams v. G.D. Searle & Co., 576 So.
2d 728, 732-33 (Fla. 2d DCA 1991) (interpreting Comment (k) as an affirmative defense and
permitting design defect claims).

                                                 17
and failure to warn—in a single strict liability count.10 The lower court in Bergalia

had dismissed the wordy count because it had appeared to state a claim for

       10
               The Bergalia complaint read in pertinent part as follows:

               COUNT II-STRICT LIABILITY

               15. The allegations contained in paragraphs 1 through 9 are realleged.

               16. Each of the Defendants’ asbestos products contained latent
       characteristics or latent functional manufacturing and design defects at the time
       they were manufactured and at the time Plaintiff was exposed to the asbestos
       fibers from those products which each of the Defendants knew or, in the exercise
       of reasonable care should have known, would cause injuries to persons such as the
       Plaintiff.

               17. At the time of Plaintiff’s exposure, the Defendants’ asbestos products
       were being used in the manner intended and without substantial change affecting
       their condition, but they contained latent characteristics or latent manufacturing
       design defects which made them unreasonably dangerous and unfit for their
       intended use, in that:

              a. the products were designed to contain asbestos, a substance hazardous
       and highly harmful to the Plaintiff's body;

             b. the Defendants failed to adequately test their products to determine the
       harmful effects caused by inhalation of asbestos fibers;

               c. the products did not contain a sufficient warning to advise Plaintiff that
       the asbestos and asbestos-containing products were extremely harmful to his
       health and the health of his family members.

               18. Plaintiff’s illness was a direct and proximate result of the products’
       defects and Plaintiff has suffered the damages described.

             WHEREFORE, Plaintiff demands compensatory damages, punitive
       damages, and trial by jury of all issues so triable in this cause.

Bergalia, 606 So. 2d at 1214 (quoting plaintiff’s complaint).

                                                 18
negligence, and not strict liability. Id. The district court of appeals reversed and

found that the “negligence-type allegation” was “mere surplusage,” without even

addressing itself to the fact that multiple theories of strict liability were pled within

a single count.

      For the foregoing reasons, we conclude that the First Amended Complaint

satisfied the district court’s instructions with respect to Count I. We conclude that

the district court abused its discretion in dismissing the complaint with prejudice

on account of procedural deficiencies.

             2.     Substantive Sufficiency of Count I

      In the seminal West case, the Supreme Court of Florida adopted strict

liability for manufacturers and sellers whose products reach a consumer in an

unreasonably dangerous condition and thereafter cause injury. West, 336 So. 2d at

86-87. “In order to hold a manufacturer liable on the theory of strict liability in

tort, the suer must establish the manufacturer’s relationship to the product in

question, the defect and unreasonably dangerous condition of the product, and the

existence of the proximate causal connection between such condition and the user’s

injuries or damages.” Id. at 87; see also Clark, 395 So. 2d at 1229; see also Cintron

v. Osmose Wood Preserving, Inc., 681 So.2d 859, 861 (Fla. 5th DCA 1996)

(holding that “a cause of action on the theory of strict liability may be properly pled

                                           19
by alleging: (1) the manufacturer’s relationship to the product in question, (2) the

unreasonably dangerous condition of the product, and (3) the existence of a

proximate causal connection between the condition of the product and the

plaintiff's injury.”). In other words, there are three elements to a strict liability

products claim under Florida law: (1) a relationship between the defendant and the

product; (2) a defect which caused the product to be unreasonably dangerous; (3)

causation between the defect and the harm suffered by the user.

      Although the doctrine of strict liability does not seek to make companies

insurers of their products, it does impose liability when a product is not

“reasonably safe for its intended use as manufactured and designed when it left the

plant of the manufacturer.” Clark, 395 So. 2d at 1229. The West court also

recognized that consumer misuse and contributory negligence beyond merely

failing to discover the defect itself could raise a valid defense to strict liability but

would not bar such an action. West, 336 So. 2d at 90. Florida courts apply the

basic elements of a strict liability claim with equal force to medical device and

prescription drug manufacturers, and in recognition of the dangerous nature of

those products, permit those defendants to raise a risk-benefit analysis as an

affirmative defense to liability. See Adams v. G.D. Searle & Co., 576 So. 2d 728,

732-33 (Fla. 2d DCA 1991) (permitting seller of product to raise affirmative

                                            20
defense of product’s risk-benefit analysis under a design defect theory of liability

for a medical product).

       Here, admittedly, appellant’s complaint weaves multiple defect theories

under the rubric of strict liability, but we do not find this fatal to having stated a

valid cause of action. Although it takes some piecing together, appellant

established minimally sufficient factual allegations to support her claim for strict

products liability under either a manufacturing or design defect avenue to liability

for these defendant manufacturers and sellers of the Duragesic patch.

       First, the complaint alleged that each defendant participated in the “business

of designing, creating, manufacturing, testing, labeling, packaging, supplying,

marketing, selling, advertising, warning and otherwise distributing and placing in

the stream of commerce” the patches, thus alleging (albeit very broadly) that each

defendant had a relationship to the product at issue and derived revenue from its

sale. First Amended Complaint ¶46, at 13. This minimally satisfied the required

relationship element of the strict liability test.

       Second, although the complaint alleges in a conclusory fashion that the patch

reached Beal in an unreasonably dangerous condition, it nevertheless proceeds to

suggest several possible defects existing at the time of Beal’s use of the Duragesic

patch. The amended complaint alleges that the product “[r]elased its narcotic

                                            21
medication into [Beal’s] skin, body, and circulatory system at a dangerous rate” or,

in other words, “at a rate faster than its advertised rate of 75 mcg/hour.” Id. ¶55(c)-

(d), at 16. More specifically, the complaint alleges that the patch suffered from a

malfunction in its “protective liner and functional layers,” which “leaked and failed

to deliver fentanyl from the drug reservoirs at the declared constant amount per unit

of time of 75 mcg/hour.” Id. ¶55(e), at 16.11 In short, appellant identified the

source of the defect: a leak in the protective lining and functional layers, which

caused the product to dispense its medication at a dangerous and lethal rate.

Whether this leak was the result of a manufacturing error along the assembly line

or because of a faulty design in the patch itself would be difficult for a consumer to

know prior to discovery. But these allegations are sufficient to allow defendants to

frame a responsive pleading directed at a defect in either the design or

manufacturing of the patch’s layers that caused a leak resulting in the delivery of a

fatal dose of fentanyl. The complaint, therefore, alleged a defect that made the

patch unreasonably dangerous, the second element of strict liability.

       11
               Elsewhere in the First Amended Complaint, appellant suggested other defects that
were known to the defendants at the time of Beal’s death, which also provide a sufficient factual
basis to suggest the unreasonably dangerous condition of the product. These defects included
“foldovers in the backing of the patch system; gel in the seal; seal breaches; corners of the patch
system cut off; holes in the drug reservoir; slits in the patch’s pouch and system; air bubbles in
the adhesive layers of the system; no gel in the system; and lack of adhesions in the patch
system.” First Amended Complaint ¶24, at 7.

                                                22
        Lastly, the complaint alleged a sufficient causal connection between use of

the patch and Beal’s death. It establishes that Beal died within one day of his use

of the patch as a result of fentanyl toxicity. Moreover, any apparent misuse of the

product by Beal or by his prescribing physician is relevant only as an affirmative

defense under Florida law, and therefore need not be affirmatively pled in the

amended complaint. We therefore conclude that the complaint, in Count I, set forth

sufficient factual allegations to support a claim for strict products liability under

either a design or manufacturing defect theory of recovery.12

        We are not convinced, however, that Appellant sufficiently pled any facts to

suggest that the defendant companies are responsible under a theory of strict

liability for failing to adequately warn of potential harms. Florida law applies the

learned intermediary doctrine, whereby the duty to warn flows from the drug

manufacturer to the physician, and not the ultimate consumer. See Felix v.

Hoffmann-LaRoche, Inc., 540 So. 2d 102, 104 (Fla. 1989) (“At the outset, it is

clear that the manufacturer’s duty to warn of [the drug’s] dangerous side effects

was directed to the physician rather than the patient.”). So long as a drug’s

        12
                The district court cited the failure to allege an alternative design and the feasibility
of this design as part of the substantive failures of the amended complaint. In supplemental
authority, appellant proffered a recent Florida District Court of Appeals decision where a divided
panel held that “there is no requirement of an alternative design in a design defect claim.”
Liggett Group, Inc. v. Davis, 973 So.2d 467, 477 (Fla. 4th DCA 2007).

                                                   23
warning to the prescribing physician is adequate, a manufacturer will not be strictly

liable for failure to warn when a doctor prescribes a particular drug or fails to

inform his patient of certain risks associated with the medication, such as, in this

case, post-operative administration of the Duragesic patch. Id. at 105 (“Insofar as

the liability of the manufacturer is concerned, it makes no difference that the

[plaintiff] testified that [her physician] did not warn her of the danger of taking

[drug] while pregnant. While this would present a factual issue in a claim against

the doctor, the drug manufacturer could not be penalized for the failure of the

doctor to impart knowledge concerning the dangers of the drug of which the doctor

had been warned and was aware.”). In only one conclusory sentence, the complaint

pleads the inadequacy of the warnings to doctors: “The defective patches were not

accompanied by adequate instructions and/or warnings to fully apprise the

prescribing physicians . . . of the full nature or extent of the risks and side effects

associated with its use.” First Amended Complaint ¶55(k), at 16. Nowhere does

the complaint recite the contents of the warning label or the information available

to Beal’s physician or otherwise describe the manner in which the warning was

inadequate. Count I only asserts that the warning was insufficient because it failed

to warn of various dangers of the use of this opiate, without explaining either the

                                           24
information available to Beal’s physician at the time of the administration of the

drug or how the contents of the label were inadequate.

       In sum, then, we find that the First Amended Complaint’s procedural

deficiencies did not warrant dismissal of Count I with prejudice in light of the

nature of strict liability recovery and the particular instructions of the district court.

With respect to substantive deficiencies, we conclude that Count I minimally sets

forth the requisite factual basis to establish a design or manufacturing defect that

would give rise to strict liability against these defendants and permits appellant to

survive defendants’ motion to dismiss, as to Count I.13

       C.      Count II: Negligence

       Whereas the nature of strict products liability actions saved Count I of

appellant’s amended complaint in this instance, it does not preserve appellant’s

negligence claim in the face of the district court’s instructions to plead individual

claims against individual defendants. In other words, because a negligence action

requires the plaintiff to establish the duty, breach, and causation elements as to

each defendant, appellant’s complaint, which pleads negligence in Count II against

three defendants collectively, failed to follow the district court’s instruction. Per

       13
                  However, we affirm the district court to the extent that it dismissed with prejudice
a strict liability claim for failure to warn.

                                                  25
the district court’s instruction, appellant should have explained each defendant’s

individual duty and breach based on its role in the creation of the patch. Without

deciding, therefore, whether Count II fails substantively as well, we are unable to

say that the district court abused its discretion when it dismissed Count II on

procedural grounds alone, especially in light of appellant’s failure even to move for

leave to amend.

        D.    Count IV: Breach of Warranty of Merchantability

        It does not appear that the district court found substantive error in appellant’s

claim against defendant Walgreen, the seller, for breach of the implied warranty of

merchantability, but only dismissed this claim for procedural errors because it was

commingled with the claim for breach of fitness for a particular purpose under

Count IV. Appellant’s argument on appeal appears to concede that the First

Amended Complaint commingled a claim for breach of the implied warranty of

merchantability and breach of the implied warranty of fitness for a particular

purpose in Count IV, the “Breach of Implied Warranty Walgreen” claim.

Appellant’s brief seeks reinstatement of the “warranty of merchantability theory”

under Count IV, as opposed to suggesting that the entire Count was sufficiently

pled.

                                            26
       However, we do not find that Count IV violated the district court’s

instruction on commingling.14 It was pled only against one defendant and only

alleges a factual basis sufficient to make out a claim for breach of the implied

warranty of merchantability, and not for an implied warranty of fitness for a

particular purpose. Under Florida law, a seller must have “reason to know any

particular purpose for which the goods are required and that the buyer is relying on

the seller’s skill or judgment to select or furnish suitable goods” in order to create

an implied warranty for a particular purpose. Fla. Stat. Ann. § 672.315 (West

2006). Nowhere in Count IV did appellant allege facts to suggest that the seller,

Walgreen, was made aware of Beal’s particular use for the product, nor that Beal

relied upon the buyer’s expertise to purchase the Duragesic patch. Although

language in Count IV refers to the product as not being “fit for a particular

purpose,” having failed to plead other elements of that warranty claim, we will

ignore this language as surplusage. See United States ex rel Garst, 328 F.3d at 378;

Athens Newspapers, 729 F.2d at 1417. It was, therefore, an abuse of discretion for

the district court to dismiss the count for being commingled with another claim

when the count fails to set forth any elements of that purported additional

       14
             We are excusing the typographical error that otherwise would cause express
commingling of all the counts. See supra note 6.

                                             27
commingled claim. Because the district court did not identify any substantive

deficiencies as to the breach of the implied warranty of merchantability claim as to

defendant Walgreen, we conclude that Count IV was properly pled.

                                     IV. CONCLUSION

       In short, we conclude that the district court was within its discretion to

dismiss Count II of the First Amended Complaint but that Counts I and IV were

minimally sufficient, both in form and substance. However, the only remaining

counts on which discovery may be had and which will go to summary judgment or

trial will be whether these defendants should be held strictly liable under either a

design defect or manufacturing defect theory for Beal’s death and whether

Walgreen breached an implied warranty of merchantability when it sold the

Duragesic patch to Beal. We expect that after discovery appellant will have an

opportunity to better identify whether the purported defect at issue was a result of

design or manufacturing error or both.

       We affirm15 in part, reverse in part, and remand this action to the district

court for proceedings consistent with this opinion.

       AFFIRMED IN PART, REVERSED IN PART, and REMANDED.

       15
              As noted above, this opinion is an appendix to our simultaneously issued
published opinion affirming the district court’s denial of appellant’s motion to remand to state
court.

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