1 See Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 850 F.3d 52 (1st Cir. 2017).

2 See e.g., Carrier, Michael A. & Wander, Daryl, Citizen Petitions: An Empirical Study, 34 Cardozo L. Rev. 249, 263 (2012)Google Scholar (describing brand-name pharmaceutical companies’ deployment of citizen petitions, which are generally subject to Noerr-Pennington immunity, as an anticompetitive delaying tactic to impede generic drug competition); Steinhauer, Esther H., Is Noerr-Pennington Immunity Still a Viable Defense Against Antitrust Claims Arising from Hatch-Waxman Litigation?, 61 Food Drug L.J. 679 (2006)Google Scholar (describing pharmaceutical firms’ efforts to use the Noerr-Pennington doctrine to escape liability for “sham” litigation in the context of the Hatch-Waxman litigation).

3 Noerr-Pennington immunity shields a party’s good-faith efforts to elicit favorable government action even if the purpose or consequence of those efforts brings about anticompetitive effects. The doctrine stems from two US Supreme Court Cases, Eastern Railroad Presidents Conference v. Noerr Motor Freight, Inc., and United Mine Workers v. Pennington. In Noerr, the Supreme Court held that “the Sherman Act does not prohibit two or more persons from associating together in an attempt to persuade the legislature or the executive to take particular action with respect to a law that would produce a restraint in trade or a monopoly.” Eastern Railroad Presidents Conference v. Noerr Motor Freight, Inc., 365 U.S. 127, 136 (1961). In Pennington, the Court held “joint efforts to influence public officials do not violate the antitrust laws even though intended to eliminate competition.” United Mine Workers v. Pennington, 381 U.S. 657, 670 (1965).

4 The pharmaceutical industry has coined the term “product life-cycle management” to describe efforts to maintain market exclusivity after regulatory and patent exclusivity periods end. See e.g., Michael Enzo Furrow, Analyzing the Laws, Regulations, and Policies Affecting FDA-Regulated Products: Pharmaceutical Patent Life-Cycle Management After KSR v. Teleflex, 63 Food Drug L.J. 275, 276 (2008)

5 See e.g., Michael A. Carrier & Carl Minniti, Citizen Petitions: Long, Late-Filed, and At-Last Denied, 66 Am. U.L. Rev. 305 (an empirical study of citizen petitions asking the FDA to act against a pending generic drug application under the cover of Noerr-Pennington immunity); Shadowen, Steve D., Leffler, Keith B. & Lukens, Joseph T., Anticompetitive Product Changes in the Pharmaceutical Industry, 41 Rutgers L.J. 1 (2009)Google Scholar (discussing the process by which a branded firm reformulates its drug to prevent pharmacy-level substitution of subsequently released generics); Steinhuaer, supra note 1.

6 See Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 850 F.3d 52 (1st Cir. 2017).

7 The United States Pharmacopeial Convention (USP) is a scientific non-profit organization that helps design and recommend standards for the FDA to adopt and enforce. See generally U.S. Pharmacopeial Convention, http://www.usp.org/ (last visited Apr. 11, 2017). To determine the appropriate testing standard for enoxaparin, the USP assembled a panel of experts, which included employees of enoxaparin manufacturers. A Momenta employee, Dr. Zachary Shriver, represented Momenta on the USP panel responsible for developing the enoxaparin testing standard. Under USP policy, all participants to the standard-setting process are required to disclose potential conflicts of interests. Dr. Shriver failed to disclose any conflicts, despite the fact that he was later named as an inventor on Momenta’s patent covering the testing method that was later advanced by the USP and ultimately adopted by the FDA. See Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 850 F.3d 52, 55 (1st Cir. 2017). See also Complaint at 10-11, Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 2016 WL 4033107 (D. Mass. 2016) (No. 16-10112).

8 See Momenta Pharms., Inc. v. Amphastar Pharms., Inc., 882 F. Supp. 2d 184 (D. Mass. 2011).

9 See id. (enjoining Amphastar from marketing its infringing product).

10 Complaint at 15-16, Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 2016 WL 4033107 (D. Mass. 2016) (No. 16-10112) (seeking damages for Amphastar’s lost profits during a three-month temporary restraining order).

11 Amphastar Pharms., Inc., v. Momenta Pharms., Inc. v. No. 16-10112, 2016 LEXIS 98066 (D. Mass. July 27, 2011).

12 Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 850 F.3d 52, 54-55 (1st Cir. 2017).

13 Amphastar, 850 F.3d 52, 56 (1st Cir. Mar. 6, 2017) (“[E]ven assuming the questionable proposition that Noerr-Pennington immunity would otherwise apply, it has a well-established exception for knowing ‘[m]isrepresentations,’ at least in the administrative and adjudicatory contexts.”).

14 The appellate court pointed to Supreme Court case law Allied Tube, which would suggest that statements made to the USP would not qualify as petitioning to the government and, as a result, would not qualify for Noerr-Pennington immunity. Allied Tube v. Indian Head, Inc., 486 U.S. 492, 499-502 (1988) (finding that a standard-setting private association cannot be treated as a “quasi-legislative” body and petitioners to such associations do not enjoy immunity afforded to those who urge the government to take a specific, trade-restraining action).

15 “Courts have recognized that ‘[t]here is an important difference, for the purposes of the Noerr-Pennington doctrine, between using litigation… as a basis of antitrust liability and awarding damages for efforts to use the courts to carry out private cartel agreements.’” Amphastar, 850 F.3d at 57 (quoting Premier Elec. Constr. Co. v. Nat’l Elec. Contractors Ass’n, Inc., 814 F.2d 358, 374 (7th Cir. 1987) (Easterbook, J.)).

16 Brief for Fed. Trade Comm’n as Amicus Curiae, Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 850 F.3d 52, 54-55 (2017) (No. 16-10112).

17 Id.

18 Complaint at 14, Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 2016 WL 4033107 (D. Mass. 2016) (No. 16-10112).

19 Recent figures published in the Generic Pharmaceutical Association’s (GPhA) annual report, Generic Drug Savings in the U.S., demonstrate large system-wide savings resulting from generic drug sales. The GPhA is a leading trade organization representing manufacturers and distributors of generic prescription drugs, bulk active pharmaceutical chemicals, and related suppliers to the generic industry. Its annual report is compiled by the QuintilesIMS Institute (formerly known as the IMS Institute for Healthcare Informatics), a publicly traded company specializing in health care industry research and IT solutions for health and life sciences companies. Generic Pharm. Assoc., Seventh Annual Savings Report (2015), http://www.gphaonline.org/media/wysiwyg/PDF/GPhA_Savings_Report_2015.pdf.

20 See Elena Kamenir, 2 Noerr-Pennington Rulings Affirm Narrow Scope of Immunity, Law360 (Mar. 17, 2017 11:10 AM), https://www.law360.com/articles/902917/2-noerr-pennington-rulings-affirm-narrow-scope-of-immunity.

21 In a recent Law360 article, attorney Chul Pak, counsel for Amphastar, was quoted as saying, “[T]he decision set precedent that ‘will have wide-ranging implications for antitrust litigation going forward… it asked the question, is Noerr-Pennington, and therefore the patent lawsuit, so expansive as to shield the [prior] anticompetitive conduct…’No court has really addressed that,’” Cara Bayles, Momenta Isn’t Shielded From Antitrust Suit, 1st Cir. Says, Law360 (Mar. 6, 2017 10:40 PM), https://www.law360.com/articles/898824/momenta-isn-t-shielded-from-antitrust-suit-1st-circ-says.

22 Fed. Trade Comm’n v. Shire ViroPharma Inc., No. 17-00131 (D. Del. filed Feb. 7, 2017).

23 Id. See also Press Release, FTC Charges That Shire ViroPharma Inc. Abused Government Processes Through Serial, Sham Petitioning to Delay Generics and Maintain its Monopoly over Vancocin HCI Capsules, Fed. Trade Comm’n (Feb. 7, 2017), https://www.ftc.gov/news-events/press-releases/2017/02/ftc-charges-shire-viropharma-inc-abused-government-processes.

24 See Fed. Trade Comm’n. Shire ViroPharma Inc., No. 17-00131 (D. Del. filed Feb. 7, 2017). See also Jeff Overley, What To Watch As FTC Opens New Front on Generic Delays, Law360 (Feb. 8, 2017 9:07 PM), https://www.law360.com/articles/889725/what-to-watch-as-ftc-opens-new-front-on-generic-delays

1 Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017).

2 Wash. Rev. Code § 7.72.030 (1981).

3 Taylor, 389 P.3d at 530. A radical prostatectomy is a surgical procedure involving the removal of the prostate, performed to treat prostate cancer. Prostatectomy, Oxford Concise Medical Dictionary 601 (8th ed., 2010).

4 Taylor, 389 P.3d at 522.

5 Id. at 523.

6 Id. at 525.

7 See The da Vinci® Surgical System, da Vinci Surgery (Oct. 2015), http://www.davincisurgery.com/da-vinci-surgery/da-vinci-surgical-system [https://perma.cc/C4VV-6BZD]; The Da Vinci Surgical System, Intuitive Surgical, https://www.intuitivesurgical.com/products/davinci_surgical_system [https://perma.cc/G8FT-QLQ5]; see also Taylor v. Intuitive Surgical, Inc., 355 P.3d 309, 310-11 (Wash. Ct. App. 2015).

8 See The da Vinci® Surgical System, supra note 7; see also Defendant Intuitive Surgical, Inc.’s Motion for Partial Summary Judgment on Plaintiffs’ Claim for Punitive Damages at 2, Taylor v. Intuitive Surgical, Inc., No. 09-2-03136-5, 2013 WL 10399736 (Wash. Super. June 7, 2013) [hereinafter Defendant’s Motion for Partial Summary Judgment].

9 Defendant’s Motion for Partial Summary Judgment, supra note 8, at 2, 2 n.4 (“There are three generations of da Vinci systems currently in use. The system used in Mr. Taylor’s surgery was a da Vinci S Surgical System …”); see generally 510(k) Premarket Notification, FDA, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm (search applicant name field for “Intuitive Surgical”).

10 FDA Clearance Letter from Celia M. Witten, Ph.D., M.D., Dir., Div. of Gen., Restorative, and Neurological Devices, to David Casal, Ph.D., Vice President of Clinical, Regulatory, and Quality Affairs, Intuitive Surgical, Inc. (July 11, 2000), https://www.accessdata.fda.gov/cdrh_docs/pdf/K990144.pdf [https://perma.cc/V6E7-VFBW].

11 FDA Clearance Letter from Celia M. Witten, Ph.D., M.D., Dir., Div. of Gen., Restorative, and Neurological Devices, to David Casal, Ph.D., Vice President of Clinical, Regulatory, and Quality Affairs, Intuitive Surgical, Inc. (May 30, 2001) (on file with author).

12 Plaintiffs’ Third Amended Complaint for Damages at 4, Taylor v. Intuitive Surgical, Inc., No. 09-2-03136-5, 2013 WL 10399736 (Wash. Super. June 7, 2013).

13 Id. at 5.

14 Id. at 7.

15 Id. at 4, 8.

16 Id. at 5-6.

17 Taylor v. Intuitive Surgical, Inc., 389 P.3d 517, 521 (Wash. 2017).

18 Id.

19 The Trendelenburg position is an operating-table position for patients whereby the patient is laid on his/her back with the pelvis inclined at a 45° angle so that the pelvis is higher than the head in order to reduce blood loss. Trendelenburg Position, Oxford Concise Medical Dictionary 748 (8th ed., 2010).

20 Taylor, 389 P.3d at 521.

21 1981 Wash. Sess. Laws 112.

22 Restatement (Second) of Torts § 402A (Am. Law. Inst. 1965) (establishing the framework to permit manufacturers to discharge their duty to market a non-defective product by warning of the product’s risks when the product is “unavoidably unsafe” or “unreasonably dangerous”).

23 See Ulmer v. Ford Motor, Co., 452 P.2d 729, 733-35 (Wash. 1969) (adopting the language of strict liability contained in the Restatement (Second) of Torts § 402A with regards to manufacturers’ liability); see also Ayers v. Johnson & Johnson Baby Prods. Co., 818 P.2d 1337, 1345 (Wash. 1991) (holding that WPLA warning claims apply a strict liability standard).

24 § 7.72.030(1) provides:

A product manufacturer is subject to liability to a claimant if the claimant’s harm was proximately caused by the negligence of the manufacturer in that the product was not reasonably safe as designed or not reasonably safe because adequate warnings or instructions were not provided…. (b) A product is not reasonably safe because adequate warnings or instructions were not provided with the product, if, at the time of manufacture, the likelihood that the product would cause the claimant’s harm or similar harms, and the seriousness of those harms, rendered the warnings or instructions of the manufacturer inadequate and the manufacturer could have provided the warnings or instructions which the claimant alleges would have been adequate.

25 Taylor v. Intuitive Surgical, Inc., No. 09-2-03136-5, 2013 WL 10372326, at 2-3 (Wash. Super. Mar. 25, 2013)

26 Verdict Form, No. 09-2-03136-5 (May 23, 2013).

27 Id.

28 Brief of Appellant at 39-60, Taylor v. Intuitive Surgical, Inc., 355 P.3d 309, 310-11 (Wash. Ct. App. 2015) (No. 45052-6-II).

29 Taylor, 355 P.3d at 316.

30 Id. at 314.

31 Petition for Review, Taylor v. Intuitive Surgical, Inc., 389 P.3d 517, 523 (Wash. 2017).

32 Taylor, 389 P.3d at 530.

33 Id. at 523.

34 Id.

35 Id.

36 Id. at 525.

37 Id.

38 Id.

39 Id.

40 Id. at 524.

41 Id. at 526.

42 Restatement (Second) of Torts § 402A cmt. k (Am. Law. Inst. 1965); see Bruesewitz v. Wyeth LLC, 562 U.S. 223, 234 (2011) (“Comment k [of the Restatement (Second) of Torts § 402A] exempts from this strict-liability rule ‘unavoidably unsafe products.’”).

43 Id. at 526-28; see Restatement (Second) of Torts § 402A cmt. k.

44 Taylor, 389 P.3d at 528.

45 Compare id. at 523 (rejecting the application of the comment k exemption to medical device manufacturers), with Hurley v. Heart Physicians, P.C., 898 A.2d 777, 783 (Conn. 2006) (applying comment k to all prescription medical products), and Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996) (holding that comment k applies to all prescription products), and Stone v Smith, Kline & French Labs., 447 So. 2d 1301, 1304 (Ala. 1984) (holding that the comment k exception applies to all prescription products).

46 The customary view of the learned intermediary doctrine is that a manufacturer only has a duty to warn the learned intermediary, the prescribing physician. See, e.g., In re Norplant Contraceptive Prods. Liab. Litig., 165 F.3d 374, 376-77 (5th Cir. 1999) (holding that when a drug manufacturer adequately warns a prescribing physician of the its product’s risks, the manufacturer need not warn each patient who receives the drug, as the doctor stands as a learned intermediary between the manufacturer and the patient); McEwen v. Ortho Pharm. Corp., 528 P.2d 522, 529 (Or. 1974) (holding that as the prescribing physician acts as a learned intermediary between the manufacturer and the patient, the manufacturer’s duty is to warn the doctor, rather than the patient). Generally, the manufacturer’s duty to provide a product that is not unreasonably dangerous is satisfied by adequately warning the prescribing physician. The manufacturer’s liability to the patient is eliminated by adequately warning the physician. See e.g., id. And, in some cases, the manufacturer is not liable to the patient, despite an inadequate warning, if the physician was aware of the risks of the product and still used or prescribed the product. See, e.g., Dyer v. Danek Med., Inc., 115 F. Supp. 2d 732, 741 (2000); Hansen v. Baxter Healthcare Corp., 723 N.E.2d 302, 312 (Ill. App. Ct. 2000) manufacturer did not have a duty to warn doctors about of which the doctors and the medical community were already aware); Willett v. Baxter Int’l, Inc., 929 F.2d 1094, 1098-99 (5th Cir. 1991). In holding that a manufacturer is liable to the patient, even though the manufacturer adequately warned the physician, the Taylor court seemingly destroyed the learned intermediary doctrine.

47 Some courts have held that a hospital is an intermediary. See, e.g., Seifried v. Hygenic Corp., 410 S.W.3d 427, 433 (Tex. Ct. App. 2013) (holding that the manufacturer had a duty to warn the hospital as the hospital was an intermediary); Brown v. Drake-Willock Int’l, Ltd., 530 N.W.2d 510, 516 (Mich. Ct. App. 1995) (holding that, under learned intermediary rule, the hospital was a proper recipient of the warnings). However, the Washington Supreme Court is the first court to impose an independent duty on manufacturers to warn the hospital.

48 See Shirkey v. Eli Lilly & Co., 852 F.2d 227, 232 (7th Cir. 1988) (“Most” jurisdictions … rely on comment k [of § 402A] as authority for applying … a negligence standard when they assess the adequacy of warnings.”); see, e.g., Green v. Smith & Nephew AHP, Inc., 629 N.W.2d 727, (Wis. 2001) (explaining that Wisconsin follows the strict liability test set forth in the Restatement (Second) of Torts § 402A); Brown v. Superior Court, 751 P.2d 470, 475-77 (Cal. 1988); Feldman v. Lederle Laboratories, 479 A.2d 374, 385-87 (N.J. 1984); Werner v. Upjohn Co., 628 F.2d 848, 858 (4th Cir.1980).