Smith v. AngioDynamics, Inc.

IN THE UNITED STATES DISTRICT COURT

FOR THE MIDDLE DISTRICT OF ALABAMA

NORTHERN DIVISION

SANDREA SMITH, )

)

Plaintiff, )

)

v.

)

ANGIODYNAMICS, INC., et al., ) CASE NO. 2:24-cv-112-RAH

) [WO]

Defendants. )

)

MEMORANDUM OPINION AND ORDER

I. INTRODUCTION

Pending before the Court is the Defendants’ Motion to Dismiss (doc. 8) which

seeks dismissal of all claims in the Complaint. With the motion having been fully

briefed and thus ripe for decision, the motion is due to be granted in part.

II. FACTS AND PROCEDURAL HISTORY

On or about April 28, 2021, Plaintiff Sandrea Smith was implanted with

Defendants’ implantable vascular access device called a Smart Port. (Doc. 1 ¶ 45.)

The device was designed, manufactured, sold, and/or distributed by the Defendants

to Smith, through her physicians and medical providers. (Id. ¶ 49.)

On February 23, 2022, Smith’s Smart Port device was found to have

fractured, which resulted in pieces of the device migrating to Smith’s heart. (Id. ¶¶

51–53.) Smith underwent surgery to remove the fractured pieces. (Id. ¶ 53.)

Smith’s experience with the Smart Port device was not unique to her because,

after the Defendants brought the Smart Port device to market but before Smith’s

device was implanted, the Defendants received large numbers of adverse event

reports from healthcare providers stating that the Smart Port, once implanted, was

fracturing and migrating throughout the body, thereby causing various injuries

including death. (Id. ¶¶ 32–33.)

In this suit, Smith brings four causes of action against the Defendants

concerning her Smart Port device: (1) a violation of the Alabama Extended

Manufacturer’s Liability Doctrine (AEMLD); (2) Negligence; (3) Breach of Implied

Warranties of Merchantability and Fitness for a Particular Purpose; and (4)

Wantonness. Defendants seek dismissal of all counts. Smith concedes dismissal of

her warranty claims.

III. STANDARD OF REVIEW

A Rule 12(b)(6) motion to dismiss tests the sufficiency of the complaint

against the legal standard set forth in Rule 8: “a short plain statement of the claim

showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). “To survive

a motion to dismiss, a complaint must contain sufficient factual matter, accepted as

true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556

U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570

(2007)).

“Determining whether a complaint states a plausible claim for relief [is] . . . a

context-specific task that requires the reviewing court to draw on its judicial

experience and common sense.” Id. at 679. The plausibility standard requires “more

than a sheer possibility that a defendant has acted unlawfully.” Id. at 678.

Conclusory allegations that are merely “conceivable” and fail to rise “above the

speculative level” are insufficient to meet the plausibility standard. Twombly, 550

U.S. at 555, 570. This pleading standard “does not require ‘detailed factual

allegations,’ but it demands more than an unadorned, the-defendant-unlawfully-

harmed-me accusation.” Iqbal, 556 U.S. at 678. Indeed, “[a] pleading that offers

‘labels and conclusions’ or ‘a formulaic recitation of the elements of a causation of

action will not do.’” Id (citation omitted).

“To decide whether a complaint survives a motion to dismiss, [district courts]

use a two-step framework.” McCullough v. Finley, 907 F.3d 1324, 1333 (11th Cir.

2018). “A district court considering a motion to dismiss shall begin by identifying

conclusory allegations that are not entitled to an assumption of the truth—legal

conclusions must be supported by factual allegations.” Randall v. Scott, 610 F.3d

701, 709–10 (11th Cir. 2010). “Second, only a complaint that states a plausible

claim for relief survives a motion to dismiss.” Iqbal, 556 U.S. at 679. Here, Smith

“bear[s] the burden of setting forth facts that entitle [her] to relief.” Worthy v. City

of Phenix City, 930 F.3d 1206, 1222 (11th Cir. 2019).

IV. DISCUSSION

A. AEMLD Claim

In Count I, Smith brings a claim under the AEMLD for defective design1 and

failure to warn. The Defendants move to dismiss this count on two grounds. First,

the Defendants argue that Alabama does not recognize defective design claims under

the AEMLD when the allegedly defective product is a medical device. Second, the

Defendants argue the failure-to-warn claim brought under the AEMLD must be

dismissed for failure to sufficiently plead such a claim.

1. Defective Design Claim

In 1976, Alabama adopted a modified version of the American Law Institute’s

Section 402A of the Restatement (Second) of Torts, called the AEMLD, in place of

a system of strict product liability. See Casrell v. Altex Indus., Inc., 335 So. 2d 128,

130–33 (Ala. 1976); Atkins v. Am. Motors Corp., 335 So. 2d 134, 142 (Ala. 1976);

see also Bodie v. Purdue Pharma. Co., 236 F. App’x 511, 517 n.9 (11th Cir.

2007) (“Alabama does not adhere to a system of strict product liability, but instead

1 Smith does not appear to make a manufacturing defect claim—which is to say that there was a

defect in her Smart Port device caused during the manufacturing process. Rather, her theories turn

on the intended design itself which makes the product unreasonably dangerous.

follows a modified version of strict liability known as the Alabama Extended

Manufacturer's Liability Doctrine[.]”); Batchelor v. Pfizer, Inc., No. 2:12-cv-908-

WKW, 2013 WL 3873242, at *2 (M.D. Ala. July 25, 2013) (“Alabama has not

adopted a no-fault concept of products liability and has instead retained a fault-based

system known as the [AEMLD].”). The AEMLD has been described as “a hybrid

of strict liability and traditional negligence concepts.” Pitts v. Dow Chemical Co.,

859 F. Supp. 543, 550 (M.D. Ala. 1994) (citing Casrell, 335 So. 2d at 132). Common

law defenses—e.g., contributory negligence, assumption of the risk, and,

sometimes, lack of causal relation—remain available to AEMLD defendants. Id.

Comment k to § 402A acknowledges that certain products are unavoidably

unsafe and are therefore subject to a special rule that such products will not be found

to be unreasonably dangerous when they are accompanied by proper directions and

warnings. Prescription drugs are one such category of products. As Comment k

acknowledges:

Unavoidably unsafe products. There are some products which, in the

present state of human knowledge, are quite incapable of being made

safe for their intended and ordinary use. These are especially common

in the field of drugs. An outstanding example is the vaccine for the

Pasteur treatment of rabies, which not uncommonly leads to very

serious and damaging consequences when it is injected. Since the

disease itself invariably leads to a dreadful death, both the marketing

and the use of the vaccine are fully justified, notwithstanding the

unavoidable high degree of risk which they involve. Such a product,

properly prepared, and accompanied by proper directions and warning,

is not defective, nor is it unreasonably dangerous. The same is true of

many other drugs, vaccines, and the like, many of which for this very

reason cannot legally be sold except to physicians, or under the

prescription of a physician. It is also true in particular of many new or

experimental drugs as to which, because of lack of time and opportunity

for sufficient medical experience, there can be no assurance of safety,

or perhaps even of purity of ingredients, but such experience as there is

justifies the marketing and use of the drug notwithstanding a medically

recognizable risk. 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 in original).

States that have adopted Comment k have generally interpreted the Comment

as allowing only failure-to-warn claims in personal injury cases involving

prescription drugs, and by extension, to prescription medical devices. See Gunter v.

Bos. Sci. Corp., No. CV N20C-11-032 PEL, 2021 WL 1921891, at *4 (Del. Super.

Ct. May 21, 2021) (applying Alabama law, dismissing defective medical mesh

device claim due to Comment k); McMichael v. Am. Red Cross, 532 S.W.2d 7, 11

(Ky. 1975) (blood); McKee v. Moore, 648 P.2d 21, 26 (Okla. 1982) (intrauterine

device).

In their motion to dismiss, the Defendants argue that Comment k applies to

defective product claims in Alabama, see Purvis v. PPG Indus., Inc., 502 So. 2d 714

(Ala. 1987), including product claims involving prescription drugs, see Stone v.

Smith, Kline & French Lab’ys., 447 So. 2d 1301 (Ala. 1984). They further argue

that Comment k applies to medical devices for the same reasons it applies to

prescription drugs. Smith acknowledges the applicability of Comment k in Alabama

but disputes its applicability to defective medical device claims.

The Court agrees with the Defendants that Comment k can and should apply

to certain medical devices just as it applies to prescription drugs because, like drugs,

certain medical devices are unavoidably unsafe products. As the Alabama Supreme

Court noted in Stone, “[t]here are some products which, in the present state of human

knowledge, are quite incapable of being made safe for their intended and ordinary

use” and “for this very reason cannot legally be sold except to physicians, or under

the prescription of a physician.” Stone, 447 So. 2d at 1303 n.1 (citation omitted).

In Stone, the Alabama Supreme Court held that prescription drugs reside in this

category of products and therefore “in the case of an ‘unavoidably unsafe’ yet

properly prepared prescription drug, the adequacy of the accompanying warning

determines whether the drug, as marketed, is defective, or unreasonably

dangerous.” Id. at 1304. See also Barcal v. EMD Serono, Inc., No. 5:14-cv-1709-

MHH, 2016 WL 1086028, at *3 (N.D. Ala. Mar. 21, 2016).

It requires no leap to conclude that some, and perhaps most, medical devices

carry risks that make them unavoidably unsafe and that they, therefore, must be

accompanied by warnings. See Emody v. Medtronic, Inc., 238 F. Supp. 2d 1291,

1296 (N.D. Ala. 2003) (finding at summary judgment that “an implantable,

prescription-only medical device” is an unavoidably unsafe product). But the Court

is unwilling to apply a blanket rule of application across all medical devices as the

Defendants seem to argue. Instead, the applicability of Comment k to a medical

device must be determined on a case-by-case basis. See e.g, Bryant v. Hoffmann-La

Roche Inc., 585 S.E. 2d 723, 726–27 (Ga. Ct. App. 2003); Adams v. G.D. Searle &

Co., 576 So. 2d 728, 733 (Fla. Dist. Ct. App. 1991); Weiss v. Fujisawa Pharm. Co.,

No. 5:05-527-JMH, 2006 WL 3533072, at *3 (E.D. Ky. Dec. 7, 2006); Freeman v.

Hoffman-La Roche, Inc., 618 N.W. 2d 827, 837 (Neb. 2000); Tansy v. Dacomed

Corp., 890 P.2d 881, 886 n. 2 (Okla. 1994). And at present, the Court cannot discern

at this early stage of the proceedings whether Comment k should apply. Most likely

Comment k does apply, but that is a determination for another day when additional

facts are presented about the Smart Port device. As a result, the Defendants’ motion

seeking dismissal of Smith’s AEMLD defective design claim on the basis of

Comment k will be denied.

2. Failure-to-Warn Claim

Aside from a defective design, Smith also makes a failure-to-warn claim

under the AEMLD. (Doc. 1 ¶ 86.) The Defendants argue this claim should be

dismissed because Smith does not satisfactorily identify the contents of the alleged

warnings or how they were inadequate.

In AEMLD cases involving unsafe prescription drugs, “the adequacy of the

[manufacturer's] accompanying warning determines whether the drug, as marketed,

is defective, or unreasonably dangerous.” Stone, 447 So. 2d at 1304. Alabama

courts follow the learned-intermediary doctrine, in which a “manufacturer's duty to

warn” a consumer about a drug “is limited to an obligation to advise the prescribing

physician of any potential dangers that may result from the drug's use.” Id. (quoting

Reyes v. Wyeth Lab’ys., 498 F.2d 1264, 1276 (5th Cir. 1974)). This also includes a

duty to provide instructions to physicians about how to mitigate warned-of risks.

Blackburn v. Shire U.S., Inc., No. 1210140, 2022 WL 4588887, at *8 (Ala. Sept. 30,

2022) (“The adoption of Comment k in Stone provided a strong indication that a

prescription drug manufacturer’s duty to warn is not necessarily limited to listing a

drug’s known side effects but may also include directions for mitigating those side

effects.”). “The principle behind the learned-intermediary doctrine is that

prescribing physicians act as learned intermediaries between a manufacturer of a

drug and the consumer/patient and that, therefore, the physician stands in the best

position to evaluate a patient’s needs and to assess the risks and benefits of a

particular course of treatment for the patient.” Id. at *5 (quoting Wyeth, Inc. v.

Weeks, 159 So. 3d 649, 672–73 (Ala. 2014)).

However, if the warning to the learned intermediary is inadequate or

misrepresents the risk, the manufacturer remains liable for any injuries to the patient.

See Fields v. Eli Lilly & Co., 116 F. Supp. 3d 1295, 1304 (M.D. Ala. 2015). The

patient must show that the manufacturer failed to warn the physician of a risk not

otherwise known to the physician and that the failure to warn “was the actual and

proximate cause of the patient's injury.” Id.

Smith’s Complaint discusses warnings to “consumers,” “healthcare

providers,” “the public,” “Plaintiff,” and “Plaintiff’s physician.” (Doc. 1 at ¶¶ 86–

93.) To the extent that the Complaint’s failure-to-warn claim implicates warnings

to Smith herself or consumers in general, the claim is due to be dismissed under the

learned intermediary doctrine. See Batchelor, 2013 WL 3873242, at *2 (“Defendant

had no duty to warn Plaintiff, only to warn her physicians adequately and

honestly[.]”).

As it concerns Smith’s physicians, the Defendants argue the Complaint fails

to state a claim because its allegations are generalized, vague and conclusory and do

not provide enough information about which warnings are alleged to be inadequate,

nor does it sufficiently allege causation. See, e.g., Bailey v. Janssen Pharmaceutica,

Inc., 288 F. App’x 597, 608-09 (11th Cir. 2008) (finding failure to warn claim

inadequate under Florida's learned intermediary doctrine where “[n]owhere does the

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

[the] 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 [prescription drug], without explaining

either the information available to [the] physician at the time of the administration

of the drug or how the contents of the label were inadequate.”).

In response, Smith points to allegations in her Complaint that she claims state

a plausible failure-to-warn claim. The Complaint alleges that the catheter

component of the Smart Port device uses barium sulfate, which is known to degrade

the mechanical integrity of silicone, and therefore the material from which the Smart

Port device is made, and this causes microfractures and other failures in the catheter

that can migrate and perforate the inside of the heart, causing injuries such as

hemorrhages, cardiac/pericardial tamponade, cardiac arryhthmia, and severe and

persistent pain. The Complaint further alleges that the Defendants have been aware

of these issues because the Defendants have received large numbers of adverse event

reports from healthcare providers and that the Defendants “intentionally concealed

the severity of complications caused by the Smart Port and the likelihood of these

events occurring” (doc. 1 at ¶ 38), and “intentionally underreported the number and

nature of the adverse events associated with fracture and migration of the Smart Port

to Plaintiff’s health care providers,” (id. ¶ 91). The Complaint later alleges that the

Defendants advertised the Smart Port device as a safe device when they knew that it

was not safe and Defendants knew of the defective nature of the Smart Port device

and its propensity to cause serious injuries. The Complaint further alleges that the

Defendants’ messaging and communications suggested that fractures of the catheter

part of the device could only occur because of incorrect physician placement rather

than “due to defects in the design, manufacturing and lack of adequate warnings,”

and that “Defendants provided incomplete, insufficient and misleading information

to physicians” causing “the dissemination of inadequate and misleading information

to patients, including the Plaintiff.” (Id. ¶¶ 40–41).

And specific to Smith, the Complaint alleges that her physician implanted her

Smart Port device on April 28, 2021, that on February 23, 2022 her medical

providers discovered that the Smart Port catheter had fractured thereby causing

immediate sharp pain, and that she underwent two surgeries on or about that date to

remove catheter fragments. (Id. ¶¶ 50–53.) It also alleges that “[i]n reliance on

Defendants’ representations, Plaintiff’s doctor was induced to and did use the Smart

Port,” and that “Plaintiff consented to undergo implantation of the Smart Port.” (Id.

¶¶ 60–61.) Smith further alleges that “[n]either [she] nor her physicians were aware,

by warning or otherwise, of the defects of Defendants’ Smart Port, and would not

have used and/or consented to undergo implantation of the Smart Port had they been

aware of the defective nature of the device,” (id. ¶ 65), that “[n]o reasonable health

care provider, including Plaintiff’s, and no reasonable patient would have used the

Smart Port in the manner as directed, had those facts been made known to the

prescribing healthcare providers or patients,” (id. ¶ 86), and that the “Smart Port was

not accompanied by proper warnings and instructions to physicians and the public

regarding potential adverse side effects associated with the Smart Port and the

comparative severity and duration of such adverse side effects.” (Id. ¶ 86.) And as

“a direct and proximate result of Defendants’ lack of sufficient warnings and/or

instructions, Plaintiff suffered serious physical and mental injury, harm, damages

and economic loss.” (Id. at 95.)

At this stage of the proceedings, the above allegations and others contained in

the Complaint are sufficient to set out a plausible failure-to-warn claim. The claim

clearly indicates that the Defendants were aware of the fracturing and migration

risks, that they misled the medical community and Smith’s physician, and that the

injuries described in the Complaint would not have occurred but for the Defendants’

wrongful conduct. While the Complaint could have been better drafted, the

Complaint has articulated a reasonable set of facts (and the inferences flowing from

those facts) that could make the Defendants liable for failure to warn.

B. Negligence and Wantonness Claims

In Counts II and IV, Smith brings claims of negligence and wantonness

associated with her Smart Port device. The two tort claims largely mimic the

allegations made the basis of her AEMLD claim but with more detail surrounding

the Defendants’ duties to test, analyze, and surveil the Smart Port device, as well as

advertising and promoting the device in the context of issuing warnings about the

device given its risks. The Defendants move to dismiss both claims, arguing that the

claims are duplicative and subsumed by the AEMLD claim. Smith responds that

negligence and wantonness claims are not per se subsumed under the AEMLD and

that the cases relied upon by the Defendants are dated and have been undermined by

more recent cases.

First, it is clear that Smith’s negligence and wantonness theories are not

subsumed by the AEMLD. They are distinct claims, and thus the Defendants’

argument on this basis is rejected. See Spain v. Brown & Williamson Tobacco Corp.,

872 So. 2d 101, 105–06 (Ala. 2003) (explaining that the AEMLD does not abrogate

the common law, and that negligence and wantonness claims may be “viable

alternatives to [an] AEMLD claim”); Tillman v. R.J. Reynolds Tobacco Co., 871

So. 2d 28, 35 (Ala. 2003) (“We will not presume to so define the boundaries of the

judicially created AEMLD so that it subsumes the common-law tort actions of

negligence and wantonness[.]”); Weeks v. Wyeth, Inc., No. 1:10-cv-602-MEF, 2011

WL 1216501, at *4 (M.D. Ala. Mar. 31, 2011); Vesta Fire Ins. Corp. v. Milam &

Co. Const., 901 So. 2d 84, 102 (Ala. 2004) (rejecting premise that the AEMLD

subsumes common-law tort actions of negligence and wantonness).

Nevertheless, whether Comment k also applies to Smith's negligent and

wanton defective design claim is another matter. Although AEMLD claims and

common law negligence/wantonness claims “have different elements that must be

proven . . . there is nevertheless a measure of commonality between those claims.”

McMahon v. Yamaha Motor Corp. U.S.A., 95 So. 3d 769, 772 (Ala. 2012) (citations

omitted). Indeed, under both theories, Smith must show that “the product at issue is

defective”; that is, that it is unsafe when not accompanied by proper directions and

warnings. Id. Comment k, however, limits how a plaintiff can prove a

“defect.” See Restatement (Second) of Torts § 402A cmt. k (stating that an

unavoidably unsafe product, “accompanied by proper directions and warning, is not

defective[.]” (emphasis added)). The Alabama Supreme Court has found the safety

element common to both strict liability and negligence claims. See McMahon, 95

So. 3d at 772.

Indeed, in Stone, the Alabama Supreme Court specifically linked the

unavoidably unsafe exception to negligence principles. Stone, 447 So. 2d at 1303

n.2 (“The requirement that the product be unreasonably dangerous, as amplified by

comments j and k, produces essentially the same result as traditional negligence

theory[.]”) (quoting R. Merill, Compensation for Prescription Drug Injuries, 59 Va.

L. Rev. 1, 31 (1973)). Because the exception’s rationale turns on the notion that

prescription drugs (and therefore medical devices) are desirable even though they

may never be made fully safe, the Court concludes that Comment k equally applies

to design defect claims outside the AEMLD. See Barcal, 2016 WL 1086028, at *3

(dismissing a negligence claim based on a drug's defective design because

comment k's rationale is “equally applicable” to negligence claims); McDaniel v.

Mylan, Inc., No. 7:19-cv-209-LSC, 2019 WL 11638407, at *5 (N.D. Ala. Dec. 16,

2019). But because the Court punts the issue of Comment k under the AEMLD to a

later stage as it concerns the Smart Port device, the issue will also be punted as to

Smith’s defective design claims brought under theories of negligence and

wantonness. And since Comment k does not preclude a failure-to-warn claim, the

negligent and wanton failure-to-warn claim can proceed. Accordingly, the

Defendants’ motion to dismiss these claims will be denied on all theories.

V. CONCLUSION

Accordingly, it is ORDERED that Defendants’ Motion to Dismiss (Doc. 8)

is GRANTED in part and DENIED in part as follows:

1. The motion is GRANTED as to Count III (breach of warranties); and

2. The motion is DENIED as to Count I (AEMLD), Count II (Negligence)

and Count IV (Wantonness).

DONE on this the 23rd day of AL.

R. AUSTIN JR.

UNITED STATES DISTRICT JUDGE

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