Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-alnd-2_18-cv-01460/USCOURTS-alnd-2_18-cv-01460-0/pdf.json

Nature of Suit Code: 367
Nature of Suit: TORTS - Personal Injury - Health Care/Pharmaceutical Personal Injury/Product Liability
Cause of Action: 28:1441 Petition for Removal- Wrongful Death

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IN THE UNITED STATES DISTRICT COURT 

FOR THE NORTHERN DISTRICT OF ALABAMA 

SOUTHERN DIVISION 

ROBIN J. COMPSTON, as Personal )

Representative and Administrator of )

the Estate of John Jacob Compston, )

III, )

)

Plaintiff, )

)

v. ) Case No. 2:18-cv-1460-MHH 

)

MYLAN TECHNOLOGIES, INC., )

et al., )

) 

Defendants. ) 

 MEMORANDUM OPINION AND ORDER

Pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure, defendants 

Mylan Pharmaceuticals, Inc. and Mylan Technologies, Inc. have asked the Court to 

dismiss the claims brought against them in this wrongful death action. (Doc. 17). 

According to Ms. Comspton’s allegations in her amended complaint, the Mylan 

defendants design, manufacture, and market the Mylan Fentanyl Transdermal 

System, a patch that doctors prescribe to deliver therapeutic levels of fentanyl to 

treat chronic pain. (Doc. 16, p. 3). Ms. Compston alleges that her husband applied 

a prescribed fentanyl patch on September 14, 2016 and died one day later. (Doc. 16, 

p. 3). A senior state medical examiner reported that the cause of death was “Multiple 

FILED

 2020 Jan-27 PM 04:29

U.S. DISTRICT COURT

N.D. OF ALABAMA

Case 2:18-cv-01460-MHH Document 23 Filed 01/27/20 Page 1 of 4
drug toxicity (Fentanyl, Alprazolam, and Zolpidem).” (Doc. 1-1, p. 8; see also Doc. 

16, p. 3, ¶ 9).

To recover damages from Mylan for her husband’s death, in her amended 

complaint, Ms. Compston alleges claims for negligent design, manufacturing, 

marketing, and distribution of the fentanyl patch and failure to provide adequate 

warning of the risks associated with use of the fentanyl patch. She also asserts a 

claim under the Alabama Extended Manufacturer’s Liability Doctrine – or AEMLD, 

alleging that the fentanyl patch distributed to her husband was defective or 

unreasonably dangerous in its design, manufacture, sale, and product warnings. 

(Doc. 16, pp. 4–8). In response to Mylan’s motion to dismiss, Ms. Compston 

concedes that her “claims for design defect and failure to warn are preempted by 

federal law.” (Doc. 19, p. 2). Therefore, the Court must resolve Mylan’s motion to 

dismiss with respect to Ms. Compston’s manufacturing defect claim.

Ms. Compston alleges that the fentanyl patch that Mr. Compston used was 

defective in that it lacked “safe matrix technology or sealing integrity to assure 

timely and safe distribution” of the patch’s “ingredients/medication,” and that as a 

consequence, Mr. Compston had in his system at the time of his death “a fentanyl 

level of 14 ng/ml, which is greater than the published therapeutic level and is within 

the level reported to be toxic or fatal.” (Doc. 16, p. 7, ¶¶ 9, 16, 22). Mylan 

persuasively argues that Ms. Compston’s allegation concerning “safe matrix 

Case 2:18-cv-01460-MHH Document 23 Filed 01/27/20 Page 2 of 4
technology” is a criticism of the patch’s design and therefore fails along with Ms. 

Compston’s other design defect theories. (Doc. 20, pp. 4–5). Mylan does not 

specifically address Ms. Compston’s allegation that the sealing integrity of the patch 

that Mr. Compston used did not assure “timely and safe distribution” of fentanyl, 

causing Mr. Compston to receive a fatal amount of the drug.

To evaluate this manufacturing defect theory, the Court must view the 

allegations in the amended complaint in the light most favorable to Ms. Compston 

and draw inferences from the factual allegations in the light most favorable to her. 

Sun Life Assurance Co. v. Imperial Premium Fin., LLC, 904 F.3d 1197, 1207 (11th 

Cir. 2018). Under Alabama law, to assert an AEMLD claim for a manufacturing 

defect, a plaintiff must allege that she (or her decedent) suffered an injury “by one 

who sells a product in a defective condition unreasonably dangerous” to the plaintiff 

(or her decedent) “as the ultimate user or consumer” of the product, that the 

defendant is “engaged in the business of selling such a product,” and that the product 

has reached the end-user “without a substantial change in the condition in which it 

was sold.” Casrell v. Altec Indus., Inc., 335 So. 2d 128, 132–33 (Ala.1976), quoted 

with approval in Tanksley v. ProSoft Automation, Inc., 982 So. 2d 1046, 1049–50 

(Ala. 2007). Contrary to Mylan’s assertion, Alabama law does not require a plaintiff 

asserting a manufacturing defect claim to allege a specific flaw in the manufacturing 

process. (Doc. 17, p. 26). See McDaniel v. Mylan, Inc., No. 7:19-cv-209 (N.D. Ala. 

Case 2:18-cv-01460-MHH Document 23 Filed 01/27/20 Page 3 of 4
Dec. 16, 2019) (Doc. 21, p. 16) (“Because proof of the specific manufacturing error 

is not a required element of the claim, pleading facts pertinent to the specific 

manufacturing error is not necessary to state a plausible claim to relief.”). Ms. 

Compston has sufficiently alleged that the fentanyl patch that Mr. Compston used 

had a defective seal, and that that manufacturing defect caused an unsafe level of 

fentanyl to be released into his system.1 

Within 14 days of the entry of this order, the parties shall please confer and 

submit a Rule 26 report consistent with the initial order in this matter, (Doc. 22). 

DONE and ORDERED this January 27, 2020.

 _________________________________

 MADELINE HUGHES HAIKALA

 UNITED STATES DISTRICT JUDGE

 

1 Ms. Compston has alleged that the fentanyl patch that her husband used reached her husband 

“without change in the condition in which it was produced, manufactured, sold, distributed, and 

marketed” by Mylan. (Doc. 16, p. 6, ¶ 19).

Case 2:18-cv-01460-MHH Document 23 Filed 01/27/20 Page 4 of 4