Court Opinion

ID: 4657907
Source: CourtListenerOpinion
Date Created: 2021-02-05 19:00:28.611251+00
Date Added: 2024-06-11T08:01:25.095399
License: Public Domain

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   opinion should not be published and is not precedent except under the limited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.
Case: 20-50462      Document: 00515734671           Page: 2   Date Filed: 02/05/2021

                                     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

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                                    No. 20-50462

   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.

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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.

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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.

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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.

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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).

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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.

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