Case: 20-50462 Document: 00515734671 Page: 1 Date Filed: 02/05/2021
United States Court of Appeals
for the Fifth Circuit United States Court of Appeals
Fifth Circuit
FILED
February 5, 2021
No. 20-50462
Lyle W. Cayce
Clerk
Ramon D. Johnson, II,
Plaintiff—Appellant,
versus
Novartis Pharmaceuticals Corporation; Taro
Pharmaceuticals USA, Incorporated; Bausch Health
US, L.L.C.; Sun Pharmaceutical Industries,
Incorporated; Torrent Pharma, Incorporated,
Defendants—Appellees.
Appeal from the United States District Court
for the Western District of Texas
USDC No. 5:19-CV-1087
Before Davis, Southwick, and Costa, Circuit Judges.
W. Eugene Davis, Circuit Judge:*
Pro se Plaintiff, Ramon Johnson, appeals the district court’s grant of
Novartis Pharmaceuticals Corporation (“Novartis”), Taro Pharmaceuticals
USA, Inc. (“Taro”), Bausch Health US, L.L.C. (“Bausch”), Sun
*
Pursuant to 5th Circuit Rule 47.5, the court has determined that this
opinion should not be published and is not precedent except under the limited
circumstances set forth in 5th Circuit Rule 47.5.4.
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No. 20-50462
Pharmaceutical Industries, Inc. (“Sun”), and Torrent Pharma, Inc.’s
(“Torrent”) motions to dismiss. For the reasons that follow, we AFFIRM
the district court’s judgment.
I. Background
Mr. Johnson was prescribed Minocycline (“Generic Minocin”), a
generic form of the brand-name drug Minocin, by his physician in April of
2013 for certain dermatology issues. Roughly a year later, Mr. Johnson
developed symptoms of Peyronie’s Disease (“PD”), a painful condition
caused by a development of plaques and scar tissue in the penis. He sought
the advice of three physicians, including PD specialists, who continued to
recommend the Generic Minocin treatment. In October of 2014, Mr.
Johnson decided to stop taking Generic Minocin, and his PD symptoms
began to fade away. Later that October, Mr. Johnson saw his PD specialist
and explained what happened when he stopped taking Generic Minocin. Mr.
Johnson expressed concern that the drug may be causing PD, but the
specialist told Mr. Johnson that Minocycline does not cause PD. In
November of 2014, Mr. Johnson returned to his dermatologist and expressed
the same concerns. Like the PD specialist, the dermatologist, who regularly
prescribes Generic Minocin, also told Mr. Johnson that the drug does not
cause PD.
In June of 2017, Mr. Johnson was prescribed Carbamazepine
(“Generic Tegretol”), a generic form of the brand-name drug Tegretol, at
the recommendation of his pain management physician. After roughly three
months of taking Generic Tegretol, Mr. Johnson noticed a worsening of his
PD symptoms. During this time, Mr. Johnson began independent research
on his issues. Mr. Johnson’s research uncovered two findings: (1) that
Minocycline and Carbamazepine could cause drug-induced lupus which, like
PD, is a connective tissue disease; and (2) that there is a correlation between
2
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high TGF-beta levels and PD. Based on his research, Mr. Johnson asked his
rheumatologist to order a TGF-beta blood test for him on September 12,
2017. Around the same time, Plaintiff returned to his PD specialist to report
his research and the worsening of his PD, but the PD specialist once again
told Mr. Johnson that drugs do not cause PD. On September 13, 2017, Mr.
Johnson decided to stop taking Generic Tegretol. On the next day, Mr.
Johnson’s TGF-beta test came back reporting that his TGF-beta levels were
high.
On December 8, 2017, now three months off of Generic Tegretol and
Generic Minocin, Mr. Johnson had another TGF-beta test which came back
normal. Mr. Johnson continued his independent research into his health
condition, and in August of 2019, Mr. Johnson found an article from 1989
that linked Carbamazepine to PD. He also found articles showing that
Minocycline and Carbamazepine can increase TGF-beta levels, and he found
websites saying that medications can cause PD.
On September 10, 2019, Mr. Johnson filed suit against all Defendants
under theories of strict liability, products liability, breach of warranty, and
loss of consortium under Texas state law. Plaintiff later clarified the
relationship between Defendants. Generic Minocin was manufactured by
Ranbaxy, which was acquired by Sun and subsequently “spun off” to
Torrent. Sun and Torrent used the label information from brand-name drug
Minocin which is manufactured by Bausch. Similarly, Generic Tegretol was
manufactured by Taro who used label information from Novartis’s brand-
name drug, Tegretol. It is undisputed that Sun, Torrent, and Taro (together
“Generic Defendants”) are manufacturers of the generic version of the two
drugs Mr. Johnson actually took which he alleges caused his PD. Similarly,
Novartis and Bausch (together “Brand Defendants”) are the manufacturers
of the brand-name versions of the drugs Mr. Johnson alleges caused his PD.
3
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However, it is uncontested that Mr. Johnson did not ingest the brand-name
drugs.
The Generic Defendants and Brand Defendants filed Rule 12(b)(6)
motions to dismiss arguing that all of Mr. Johnson’s claims are precluded as
a matter of law by federal preemption and this Court’s precedent. The
district court granted the motion. Mr. Johnson timely appealed.
II. Discussion
We review Rule 12(b)(6) dismissals de novo. 1 “To survive a Rule
12(b)(6) motion, a plaintiff must plead enough facts to state a claim for relief
that is plausible on its face.” 2
A. Claims against the Generic Defendants and Preemption
In PLIVA v. Mensing, the Supreme Court held that state law claims
against generic drug manufacturers that turn on the adequacy of the drug’s
label are preempted by federal law. 3 The Mensing Court found that under the
1984 Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic
Act 4 and accompanying FDA regulations, a generic drug manufacturer “is
responsible for ensuring that its warning label is the same as the brand name’s
[label].” 5 In addition, generic drug manufacturers are not allowed to
unilaterally strengthen or change their drug labels through the FDA’s
process for changing labels. 6 Instead, “[g]eneric drug manufacturers that
1
Eckhardt v. Qualitest Pharm., Inc., 751 F.3d 674, 677 (5th Cir. 2014).
2
Id. (citing Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007).
3
564 U.S. 604, 618 (2011).
4
21 U.S.C. § 301 et seq.
5
Mensing, 564 U.S. at 613.
6
Id. at 614.
4
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become aware of safety problems must ask the agency to work toward
strengthening the label that applies to both the generic and brand-name
equivalent drug.” 7 Because a generic drug manufacturer has no ability, on its
own, to change its label, the Mensing Court held that it was impossible for
generic drug manufacturers to comply both with federal law regulations and
state law duties to change warning labels. 8 Two years after Mensing, the
Supreme Court held in Mutual Pharmaceutical Co., Inc. v. Bartlett that state
law strict liability design-defect claims against generic drug manufacturers
are also preempted when the adequacy of a drug’s label is at issue. 9
In light of these two Supreme Court decisions, this Court has twice
held that strict liability, breach of warranty, negligence, and products liability
claims under Texas law against generic drug manufacturers are preempted
under Mensing and Bartlett. 10 We have emphasized that when analyzing
whether a plaintiff’s various state law claims against a generic drug
manufacturer are preempted, we look at whether the substance of the claims
“turn on adequacy of labeling and related information.” 11
Mr. Johnson argues that at least one of his claims somehow escapes
preemption because it is a “strict liability marketing defect claim.” Under
Texas law, “[a] marketing defect occurs when a defendant knows or should
know of a potential risk of harm presented by the product but markets it
7
Id. at 616. Notably, the Supreme Court rejected the plaintiffs’ argument that the
ability of the generic defendants to ask the FDA for assistance in changing the label allows
generic pharmaceutical manufacturers to comply with their state law duties. Id. at 620–21.
8
Id. at 618.
9
570 U.S. 472, 484–87 (2013).
10
Lashley v. Pfizer, Inc., 750 F.3d 470, 474 (5th Cir. 2014); Eckhardt v. Qualitest
Pharm., Inc., 751 F.3d 674, 678 (5th Cir. 2014).
11
Lashley, 750 F.3d at 474; see also Eckhardt, 751 F.3d at 678.
5
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without adequately warning of the danger or providing instructions for safe
use.” 12 In order to comply with this law, the Generic Defendants would need
to update their label when they acquired actual or constructive knowledge of
a risk of PD from their drug. This is the same scenario that the Mensing Court
reasoned was impossible under federal law. 13 Thus, Mr. Johnson’s
characterization of his claim as a marketing defect claim turns on the
adequacy of the Generic Defendants’ labels, and his claim is preempted
under Mensing. The same is true of all claims in Mr. Johnson’s complaint
which can be accurately characterized as products liability claims for a failure
to warn of the side effects of Minocycline and Carbamazepine. 14
B. Claims against the Brand Defendants and their duties under Texas law
Two prior panels of this Court have held that brand-name
pharmaceutical companies cannot be held liable under Texas products
liability law when a plaintiff ingests a generic manufacturer’s drug rather than
the brand-name manufacturer’s drug. 15 Products liability law in Texas is
governed by statute and defines the actions as “any action against a
manufacturer or seller for recovery of damages arising out of personal injury
. . . allegedly caused by a defective product . . . .” 16 We found that under this
12
Daimlerchrysler Corp. v. Hillhouse, 161 S.W.3d 541, 546 (Tex. App. 2004) aff’d on
other grounds, 161 S.W.3d 541 (Tex. 2004).
13
Mensing, 564 U.S. at 618.
14
Every claim in the complaint alleges that Defendants failed to adequately warn
of the side of effects of the drugs with the exception of the Breach of Warranty and Loss of
Consortium claim. Nevertheless, liability for the warranty and tort claim will turn on
Defendants’ duty to warn.
15
Lashley, 750 F.3d at 477; Eckhardt, 751 F.3d at 680.
16
Tex. Civ. Prac. & Rem. Code Ann. § 82.001(2) (West). This statute was enacted
in 1993 which predates the case law beginning in 2011 regarding Mensing-preemption and
the duties of brand-name manufacturers.
6
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statute, the Texas Supreme Court has held that entities are
“‘manufacturers’ only with respect to their own products.” 17 Similarly, the
Texas Supreme Court has found that “a fundamental principle of traditional
products liability law is that the plaintiff must prove that the defendants
supplied the product which caused the injury.” 18 Because Mr. Johnson
alleges that he only ingested the Generic Defendants’ drugs and not the
Brand Defendants’ drugs, he has failed to state a products liability claim
against the Brand Defendants.
In addition to theories of products liability under the statute, this
Court has held that brand-name drug manufacturers owe no common-law
duty under Texas law to those who do not ingest their drugs. 19 The claims
Mr. Johnson advances in his complaint are the same claims that we have held
are precluded. 20 Accordingly, Mr. Johnson has failed to state any viable claim
against the Brand Defendants under Texas law.
C. Presumption against products liability for pharmaceutical companies
Under the Texas products liability law statute, a plaintiff who sues a
pharmaceutical manufacturer under a failure to warn theory must also rebut
a presumption that the manufacturer is not liable if the label was approved by
the FDA. 21 This statute provides five ways to rebut the presumption, and Mr.
Johnson argues that he has satisfied two of the statute’s provisions: (1) by
17
Lashley, 750 F.3d at 477 (citing Owens & Minor, Inc. v. Ansell Healthcare Prods.,
Inc., 251 S.W.3d 481, 485 (Tex. 2008)).
18
Id. (citing Gaulding v. Celotex Corp., 772 S.W.2d 66, 68 (Tex. 1989)).
19
Eckhardt, 751 F.3d at 682 (citing Lashley, 750 F.3d at 476).
20
Compare ROA.15-16 (products liability claims, strict liability claims, negligence,
and breach of warranty) with Eckhardt, 751 F.3d at 677 (negligence, strict liability, breach of
warranties, misrepresentation, and fraud).
21
Tex. Civ. Prac. & Rem. Code Ann. § 82.007(a)(1) (West).
7
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alleging that Defendants perpetrated a fraud on the FDA and (2) by alleging
that Defendants promoted their drug for an indication not approved by the
FDA. 22
But, we have held that Texas’s fraud-on-the-FDA rebuttal is
preempted by the Food Drug and Cosmetic Act unless the FDA itself finds
fraud. 23 We need not reach the issues surrounding this presumption statute
because even if Mr. Johnson could succeed on one of his rebuttal arguments,
he still would fail to state a claim against the Generic Defendants because of
Mensing-preemption and would fail to state a claim against the Brand
Defendants because they owe no duty. To be sure, this does not render the
presumption statute dead letter law. Had Mr. Johnson’s suit involved an
over-the-counter drug or a brand-name prescription drug that he actually
ingested, we would apply Texas’s presumption statute. 24 Because we do not
reach the issues surrounding the presumption statute, we do not consider
Mr. Johnson’s arguments regarding rebuttal of the statute.
22
Tex. Civ. Prac. & Rem. Code Ann. § 82.007(b)(1) (West) (stating that a claimant
may rebut the presumption by establishing that “the defendant, before or after pre-market
approval or licensing of the product, withheld from or misrepresented to the United States
Food and Drug Administration required information that was material and relevant to the
performance of the product and was causally related to the claimant's injury”); Tex. Civ.
Prac. & Rem. Code Ann. § 82.007(b)(3) (West) (stating that a claimant may rebut the
presumption by establishing that “the defendant recommended, promoted, or advertised
the pharmaceutical product for an indication not approved by the United States Food and
Drug Administration”).
23
Lofton v. McNeil Consumer & Specialty Pharm., 672 F.3d 372, 381 (5th Cir. 2012).
24
See, e.g. Id. (analyzing the statute when the drug involved was over-the-counter
ibuprofen); McKay v. Novartis Pharm. Corp., 751 F.3d 694 (5th Cir. 2014) (analyzing the
statute when two Novartis brand drugs were ingested and allegedly caused injury).
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III. Conclusion
We recognize that Plaintiff is left without a legal remedy based on the
case law interpreting products liability law for generic and brand-name drug
manufacturers. But, we are bound by the decisions of the Supreme Court and
prior panels of this Court. Based on the foregoing reasons, the judgment of
the district court granting Defendants’ motions to dismiss is AFFIRMED.
9
Johnson v. Novartis Pharmaceuticals
Combined Opinion