FDA Settles Amarin First Amendment Challenge

Amarin Pharma and the FDA recently announced a widely expected settlement of First Amendment litigation over restrictions on the company's promotion of its Vascepa product.

Readers may recall that this was one of several recent challenges to the FDA's attempt to restrict off-label promotion of prescription products, even if that speech is truthful and not misleading. Several trends have combined to undercut this overreach by FDA. A pharmaceutical representative's promotion of an FDA-approved drug's off-label use is speech. And “speech in aid of pharmaceutical marketing ... is a form of expression protected by the Free Speech Clause of the First Amendment.”  Sorrell v. IMS Health, Inc., 131 S.Ct. 2653, 2659 (2011).  Then, in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), the court vacated a conviction for conspiracy to sell a misbranded drug, recognizing that to criminalize the simple promotion of a drug's off-label use by pharmaceutical manufacturers would run afoul of the First Amendment.  Off-label drug usage is not unlawful, and the FDA's drug approval process generally contemplates that approved drugs will be used in off-label ways.  So, it does not follow that prohibiting the truthful promotion of off-label drug usage would directly further the government's stated goals of preserving the efficacy of FDA's drug approval process and reducing patient exposure to unsafe and ineffective drugs. This ruling was not limited to a subset of truthful promotional speech, such as statements responding to doctors’ queries or statements by non-sales personnel.
 

In Amarin Pharma, Inc. v. FDA, No. 1:15-cv-03588 (S.D.N.Y. Aug. 7, 2015), the issues surrounded proposed statements by the company concerning its Vascepa®, an omega-3 fatty acid, approved in 2012 as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia. The FDA had entered into an SPA (Special Protocol Assessment) with the company for an expanded use. Amarin believed it had satisfied all of FDA’s requirements to obtain approval of Vascepa® for persistently high triglycerides pursuant to the SPA.  But FDA warned that any effort by Amarin to market Vascepa® for the proposed supplemental use could constitute misbranding under FDCA.

The company sued, arguing that the threat of prosecution for misbranding has a chilling effect on commercial speech protected by the First Amendment. It sought an injunction prohibiting the FDA from bringing a misbranding action for Amarin’s truthful and non-misleading statements regarding Vascepa® directly to healthcare professionals—not in direct-to-consumer advertising.  Specifically the company wanted to affirm its right to disseminate study results; report supportive but not conclusive research shows that their product may reduce the risk of coronary heart disease; and distribute reprints of peer-reviewed scientific publications relevant to the reduction of the risk of coronary heart disease.  The company was willing to do this along with “contemporaneous disclosures” to ensure that the messages Amarin communicated to doctors concerning the use of Vascepa® in patients with persistently high triglycerides was not misleading.  The FDA did not agree, and attempted to distinguish Caronia as fact-bound, turning on the particular jury instructions given in that trial.

Judge Paul A. Engelmayer rejected FDA’s interpretation of Caronia: the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment.  Misbranding is not analogous to speech crimes of jury tampering, blackmail, or insider trading. “Where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech, under Caronia, cannot be the act upon which an action for misbranding is based.”  

The court then evaluated and ruled on each of Amarin’s proposed off-label statements concerning Vascepa® along with FDA’s responses.  The “agreed-upon statements and disclosures” (e.g., statements concerning the results of the key study; statements, along with the proposed contemporaneous disclosures) were “based on current information, truthful and non-misleading.”
The “contested disclosures” such as “not-approved for” language were handled through a court-crafted, revised disclosure. The proposed cardiovascular disease claim, as revised during litigation, given its qualified phrasing and its acceptance elsewhere by the FDA, was found by the court to be presently truthful and non-misleading.

The court did mention some caveats: A manufacturer that leaves its sales force at liberty to communicate unscripted with doctors about off-label use of an approved drug invites a misbranding action if false or misleading (e.g., one-sided or incomplete) representations result. Caronia leaves the FDA free to act against such lapses. The dynamic nature of science and medicine is that knowledge is ever-advancing. A statement that is fair and balanced today may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired. So, said the court, Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa® remain truthful and non-misleading.

Rather than appeal, the government worked towards a settlement.  Under its terms, the FDA agrees to be bound by the court's conclusion that Amarin may engage in truthful and nonmisleading speech promoting the off-label use of the drug.  The company committed t ensure that it stays current on evolving science and updates its promotional statements accordingly.  The settlement agreement also provides for a procedure by which the FDA will give advance review to as many as two promotional communications annually for off-label uses of Vascepa, along with a timetable and process for resolving any concerns that the FDA may have about those new communications.

 

A copy of the settlement here.

 

 

Stay in Amarin Extended

The court recently extended its stay of the proceedings in Amarin Pharma Inc.'s suit against the FDA challenging threatened agency action concerning the alleged promotion of drugs for off-label uses See Amarin Pharma, Inc. v. FDA, No. 15-cv-3588 (S.D.N.Y.,  order 10/30/15).  The stay to December 17th is reportedly to give the parties more time to engage in settlement discussions. This one remains a case to watch for those in the pharma practice area.

First Amendment doctrine, and its relationship to the FDCA, has changed dramatically since the FDCA and many of its implementing regulations were adopted.  And one may question whether the FDA has kept up with these changes.

Earlier this Summer, the district court granted a motion for preliminary injunction in favor of Amarin, reaching the merits of Amarin’s First Amendment claims.  The case concerned Vascepa , an omega-3 fatty acid obtained from fish oil. Vascepa was approved to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Amarin was seeking a new indication pursuant to a Special Protocol Assessment (“SPA”) agreement with FDA, for patients with “persistently high” triglycerides (≥ 200 and ≤ 500 mg/dL).  While Amarin believed it had satisfied all of FDA’s requirements to obtain the new approval, FDA disagreed and rescinded the SPA. FDA went further to warn Amarin that any effort by Amarin to market Vascepa for the proposed supplemental use could constitute "misbranding" under the Federal Food, Drug, and Cosmetic Act.

Amarin filed a civil complaint against FDA, claiming that this threat of prosecution for misbranding had a chilling effect on its commercial speech.  Amarin proposed to engage in truthful, non-misleading speech about Vascepa directly with healthcare professionals, such as disseminating study results and reprints of peer-reviewed scientific publications. The company also proposed to make "contemporaneous disclosures” to ensure that the messages were not at all misleading.

The court noted that in contrast to FDA’s long-standing position that off-label promotion of drug products can constitute criminal misbranding, off-label use is not illegal and may even be the standard of care in some circumstances.  The company relied on the Second Circuit's First Amendment decision in Caronia, but the FDA argued Caronia was a narrow, fact-bound decision, turning on particular jury instructions given at the sales rep's  trial. At the least, it ought to be construed in harmony with FDA regulations distingusihing between directed off-label speech and requests by the practicioner for information. The court rejected FDA’s interpretation, finding the FDA may not bring such an action based on truthful promotional speech alone. “Where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech, under Caronia, cannot be the act upon which an action for misbranding is based.”

With this rule in mind, the court evaluated and ruled on each of Amarin’s proposed off-label statements concerning Vascepa along with FDA’s responses.  This included the “agreed-upon statements and disclosures,” which were found to be “based on current information, truthful and non-misleading.”  And then the additional “contested disclosures” (such as “not-approved for” use language). The court eventually crafted a revised hybrid disclosure on that.  The court also said the proposed cardiovascular disease claim, as revised during litigation, given its qualified phrasing and its acceptance in other contexts by the FDA, was presently truthful and non-misleading.

 

The court offered a few important caveats: a manufacturer that leaves its sales force at liberty to converse unscripted with doctors about off-label use of an approved drug invites a misbranding action if false or misleading (e.g., one-sided or incomplete) representations result.

And the dynamic nature of science and medicine is such that knowledge is ever-advancing. A statement that is fair and balanced today may become incomplete in the future as new studies are done or new data is acquired.

Again, one to keep an eye on.
 

 

PhRMA Responds to FDA Letter in First Amendment Dispute

The Pharmaceutical Research and Manufacturers of America last week submitted an amicus brief relating to the FDA's response to a drug company's suit challenging limits on truthful communications about off-label uses of a drug. See Amarin Pharma, Inc. v. FDA,  No. 15-cv-03588 (S.D.N.Y)(amicus brief filed 6/11/15).

Readers will recall that the case involves FDA interpretations that potentially make a drug manufacturer criminally and civilly liable for providing truthful and non-misleading scientific and medical information to well-trained health care professionals regarding unapproved uses of FDA-approved drugs or data that are not contained in the FDA approved labeling for such medicines. (Our friends over at the Drug and Device Law Blog have covered this issue extensively.)

PhRMA said in the amicus brief filed June 11th in the U.S. District Court for the Southern District of New York that FDA's recent maneuver -- a regulatory letter to the plaintiff, Amarin Pharma  --did not “cure the constitutional defects in FDA's content-based restrictions on protected speech.” In the letter, the FDA said it now all of a sudden doesn't object to many of the "off-label statements" the company might consider making about its cholesterol treatment drug.  So, the agency wouldn't necessarily consider the dissemination of some of that information to be false or misleading.

Because doctors routinely lawfully prescribe FDA-approved drugs for unapproved uses, informed patient care relies upon doctors having access to accurate, comprehensive, and current information about such uses. Biopharmaceutical manufacturers are an important source of this knowledge, said the brief. Amarin has a First Amendment right to provide such truthful and non-misleading  information. Doctors have a First Amendment right to receive it. And patients have a strong health-related interest in an affirmation of those rights. 

FDA’s recent made-for-litigation “regulatory letter” to Amarin does not cure the constitutional defects in FDA’s content-based restrictions on protected speech. The brief argued that instead FDA exacerbates and reinforces them in a footnote which reiterates in broad strokes the Agency’s 
longstanding position that the FDCA and FDA’s implementing regulations prohibit manufacturers from speaking to healthcare professionals about unapproved uses. Beyond that, the letter purports to be an exercise of enforcement discretion, relies on “draft” guidance documents that FDA itself contends do not bind the Agency, and contains significant caveats that preserve the Government’s option to pursue criminal and civil enforcement based on manufacturers’ protected speech.

For example, “under these circumstances,” FDA stated in the letter, it does not intend to object to the proposed communications “if made in the manner and to the extent described below.” FDA thus seeks to create a one-off discretionary exception, applicable to this case and nowhere else -- precisely the type of case-by-case determination regarding the legality of speech that the First Amendment forbids. Moreover, the letter relies exclusively on guidance documents that FDA itself contends are non-binding. Even if they would be deemed binding, many of the guidance documents cited in FDA’s letter remain in “draft” form.  PhRMA and others have submitted comments to FDA objecting to many aspects of these draft guidance documents, because, among other things, they continue to censor and burden protected speech based on both its content and the identity of the speaker.

The brief points out that FDA’s letter is not the first instance of a discretionary modification of ostensibly nonbinding guidance infringing on First Amendment rights. When manufacturers have
challenged FDA’s approach to speech about unapproved uses in Court, FDA has previously made ad hoc statements backing off of certain of those policies as a matter of enforcement discretion and with carefully vague caveats. FDA should not be permitted, argued the amicus, to avoid judicial scrutiny of its published regulations restricting protected speech on the basis of such non-final and potentially nonbinding “guidance” and such revocable assertions of enforcement discretion. 

Certainly one to watch.

PhRMA Submits Amicus Brief on First Amendment Issues

The Pharmaceutical Research and Manufacturers of America recently submitted an amicus brief urging a federal court to dismiss a whistleblower's False Claims Act suit because the off-label claims in the case violate the defendants' free speech rights. See U.S. ex rel. Solis v. Millennium Pharmaceuticals Inc. et al., No. 2:09-cv-03010 (E.D. Cal. Brief August 15, 2014). The Pharmaceutical Research and Manufacturers of America (“PhRMA”) is a voluntary, nonprofit association representing the nation’s leading research-based pharmaceutical and biotechnology companies.

Readers know that physicians may lawfully prescribe FDA-approved drugs to treat any condition or disease, including unapproved uses, based on their independent medical judgment. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001). Indeed, many unapproved uses are integral to the practice of medicine, and reflect the standard of patient care. E.g., Joseph W. Cranston et al., Report of the Council on Scientific Affairs: Unlabeled Indications of Food and Drug Administration-Approved Drugs, 32 Drug Info. J. 1049, 1050 (1998). The case here involved a qui tam False Claims Act (FCA) suit against defendants. This case raises serious First Amendment concerns, said amicus, because relator’s and the United States’ construction of the FCA would impose liability on manufacturers for engaging in truthful speech about “off-label” uses of their drugs, i.e., particular uses of an FDA-approved medication that the FDA has not yet approved. The First Amendment unquestionably protects such truthful and non-misleading speech. E.g., Sorrell v. IMS Health Inc., 131 S. Ct. 2653, 2659 (2011).  The prevalence of unapproved—but fully legal—uses of many FDA-approved prescription medicines to treat patients makes it critical that healthcare professionals have access to accurate, comprehensive, and current information about such uses. 

Notably, pointed out amicus, neither relator nor the government alleged that the speech at issue here—relaying reprinted articles about unapproved uses of the drug Integrilin from peer-reviewed journals, and summarizing the results of clinical trials—was false or misleading. Relator and the United States did not even agree on why the FCA proscribes this speech, or how this speech somehow causes others to submit false claims. But their interpretations of the FCA shared a critical flaw according to the Brief: both threaten core First Amendment rights and should be rejected under principles of constitutional avoidance. See Edward J. DeBartolo Corp. v. Fla. Gulf Coast Bldg. & Const. Trades Council, 485 U.S. 568, 575 (1988).

These constitutional concerns seem well-founded: “Speech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.” Sorrell, 131 S. Ct. at 2659. Interpreting the FDCA to punish manufacturers for truthfully speaking about unapproved uses impermissibly restricts speech based on its content and the identity of the speaker, and thus triggers heightened scrutiny. These First Amendment concerns apply with particular force to the speech that relator targeted here. The Complaint alleged that the manufacturer merely distributed reprints of medical studies published in reputable independent journals like Cardiology, the American Heart Journal, and the American Journal of Cardiology, and sent letters accurately relaying summaries of clinical trials.  There was no question that the authors of the reprints, the studies’ investigators, physicians, or anyone other than manufacturers can speak about the reprints and trial results as much as they wish. Indeed, everyone but manufacturers apparently can talk to physicians about prescribing Integrilin for unapproved uses without penalty. Relator even conceded that the manufacturer can distribute reprints promoting unapproved uses so long as physicians request such information.

Physicians who received the reprints or other information from the manufacturer in this case received precisely the type of educational information that a trained physician would wish to receive about his patients. Physicians were not only free to disregard these reprints; their Hippocratic Oath obligated them to use their own, independent medical judgment as to whether a given prescription was warranted. And after those physicians prescribed the FDA-approved drug for an unapproved use, hospitals then made additional, independent determinations whether the prescriptions were reimbursable. Only after that did hospitals submit claims to the government.

A good summary of the issues from defense perspective.

 

Class Complaint Dismissed WITH Prejudice

The Second Circuit recently affirmed a trial court decision dismissing a proposed class action challenging the marketing of certain cosmetic products.  See DiMuro v. Clinique Labs, LLC, No. 13-4551 (2d Cir. 7/10/14) (unpublished).

Plaintiffs filed a putative class action complaint asserting claims under the Connecticut, New Jersey, and Illinois consumer fraud statutes, along with claims for breach of express warranty, breach of implied warranty, and unjust enrichment, arising from defendants’ marketing of seven different cosmetic products sold under the “Repairwear” product line. But while plaintiffs’ consolidated class action complaint asserted claims arising out of the marketing of seven different products, the named plaintiffs only alleged to have purchased and used three of the seven products.

Plaintiffs argued that they nevertheless had class standing to bring claims for Repairwear products that they did not buy-- a commonly attempted but seldom successful tactic.  Here, each of the seven different products have different ingredients, and defendant allegedly made different advertising claims for each product. Unique evidence would therefore be required to prove that the 35-some advertising statements for each of the seven different products were false and misleading. As a result, the court could not conclude that claims brought by a purchaser of one product would raise a set of concerns nearly identical to that of a purchaser of another Repairwear product. Accordingly, plaintiffs lacked standing to bring claims for the four products that they did not purchase.

The court also affirmed the dismissal of plaintiffs’ consumer fraud claims because plaintiffs failed to plead them with the requisite particularity under Fed. R. Civ. P. 9(b).  Rule 9(b) requires that a complaint specify the statements that the plaintiff contends were fraudulent, identify the speaker, state where and when the statements were made, and explain why the statements were fraudulent.  E.g., Mills v. Polar Molecular Corp., 12 F.3d 1170, 1175 (2d Cir. 1993). One of the cardinal purposes of Rule 9(b) is to “provid[e] a defendant fair notice of plaintiff’s claim, to enable preparation of [a] defense.” See DiVittorio v. Equidyne Extractive Indus., Inc., 822 F.2d 1242, 1247 (2d Cir. 1987). Plaintiffs’ consolidated complaint was wholly conclusory and lacked the particularity required to ensure that defendant received fair notice of the claims.

Specifically, plaintiffs’ "group-pleading" as to the products and the advertisements at issue was
inconsistent with Rule 9(b)’s particularity requirement in that the complaint failed to specify which
of the alleged statements were fraudulent and with regard to what product.  It simply alleged that the products, collectively, cannot work. Given that the seven different products have different ingredients, different intended uses, and that defendant made different advertising claims for each one, this was wholly insufficient to satisfy Rule 9(b). Plaintiffs failed to address the different product ingredients, different intended uses, and different claims.

The complaint also failed to allege that any of the named plaintiffs even used the product, let alone used the product as directed. Similarly, the named plaintiffs did not allege what results they received from their use of the product. They only alleged that they received “no value,” “did not receive what they bargained for,” or “did not get what they paid for.” Since they did not allege which particular advertising claims each of the named plaintiffs relied on when purchasing the product, the conclusion that they did not receive what they bargained for had no ascertainable meaning. 

Plaintiffs’ claims for breach of express warranty and breach of implied warranty also relied on
allegations that the products did not perform as advertised. These allegations were wholly conclusory, and did not provide a sufficient factual basis to establish a plausible breach of any specifically identified express or implied warranty.

Pretty standard stuff, really, but let's turn to the most useful aspect of the analysis.  The complaint was dismissed with prejudice.  Leave to amend is given when justice so requires.  But what too often happens is that plaintiffs file a conclusory, fishing expedition of a complaint; the defendant expends considerable cost to point out the many deficiencies of the pleading; the court dismisses appropriately dismisses the complaint, and plaintiffs use the opinion as their model to draft an amended pleading-- often repeating the process several times, until they finally get a minimally acceptable pleading that bears little resemblance to their original complaint.  Here, the court recognized that plaintiffs are “not entitled to an advisory opinion from the Court informing them of the deficiencies in the complaint and then an opportunity to cure those deficiencies.” Bellikoff v. Eaton Vance Corp., 481 F.3d 110, 118 (2d Cir. 2007). Moreover, a plaintiff need not be given leave to amend if the plaintiff fails to specify either to the district court or to the court of appeals how amendment would cure the pleading deficiencies in its complaint. The district court’s decision to deny plaintiffs leave to amend their complaint was not an abuse of discretion. First, the plaintiffs failed to provide any detail as to what facts they would or could) plead to cure their pleading deficiencies. Second -- and this is very commonly the case --  much if not all of the information necessary for a properly pled complaint was and had always been in the possession of the plaintiffs. For example, which particular representations they relied upon, if and how they had used the products, what the results were.   Useful discussion of why leave should NOT be granted in these consumer fraud cases.

Industry Comments on Draft FDA Guidance

Several leading drug manufacturers have worked to shed light on serious issues with the social media guidance issued earlier this year by the U.S. Food and Drug Administration.

Readers may recall the draft guidance was intended to describe FDA’s current thinking about how manufacturers and distributors can fulfill regulatory requirements for postmarketing submissions
of interactive promotional media for their FDA-approved products.  A number of industry members have submitted formal comments

PhRMA and its member companies highlighted two fundamental concerns with the Draft Guidance. First, the Draft Guidance assumes that a biopharmaceutical manufacturer can be held accountable for content written by third-parties on third-party web sites if the company merely somehow "influences" the third-party. This premise is overbroad and is inconsistent with the FDCA. Put simply, third-party statements not caused or controlled by a manufacturer do not fall within the statutory or regulatory scope of FDA‘s authority to regulate promotional labeling or advertising. Second, the Draft Guidance erroneously assumes that all manufacturer statements about prescription medicines on social media constitute promotional labeling or advertising. This expansive interpretation of labeling and advertising adopted in the Draft Guidance could chill truthful and non-misleading communication protected by the First Amendment. Thus, it is critical that FDA address these fundamental issues in the Final Guidance.

WLF echoed the latter concern. noting serious problems with the Draft Guidance at Section IV (entitled, "Factors Considered in Determining Postmarket Submission Requirements for Interactive Promotional Media"). The Draft Guidance's basic premise seems to be that everything a manufacturer posts on-line: (1) qualifies as "promotional" material; (2) falls within FDA's statutory purview; and (3) is not protected from FDA regulation by the First Amendment. Those premises are 
demonstrably incorrect. Accordingly, agency policy in this area ought to begin with guidance
regarding where FDA draws the line between speech that it is and is not permitted to regulate.
The Draft Guidance brushes aside such concerns and seems to indicate that FDA intends to regulate everything that a manufacturer says regarding its products on social media sites.

It will be interesting to see how the FDA reacts to these valid comments.

 

Local Product Warning Ordinance Violates First Amendment

When we touch on Constitutional issues, most often we are posting about due process concerns raised by procedural shortcuts, proposed for administrative or efficiency reasons, at the potential expense of a defendant's rights.  Today we get to actually write about a First Amendment issue, as the Ninth Circuit recently blocked San Francisco’s attempt to implement its local cellphone radiation warning ordinance because it violates the First Amendment. See CTIA – The Wireless Association v. City and County of San Francisco, Calif., No. 11-17773 (9th Cir.).  It is a wonderful reminder about this freedom, which separates our nation from much of the world. 

San Fransisco passed an ordinance imposing warning language standards on cell phone retailers, specifically requiring cell phone sellers to make certain disclosures to consumers about radio-frequency energy emissions from cell phones. S.F. Ordinance 156-11 was originally set to take effect in October 2011, but CTIA – The Wireless Association filed suit challenging the constitutionality of the law. CTIA contended the San Francisco law conflicted with the FCC's safety standards and violated rights of free speech by forcing retailers to communicate alarmist messages about cellphone radiation. 

The district court enjoined enforcement of part of the ordinance, and both sides appealed.  The Ninth Circuit panel affirmed the injunction and noted two problems with the ordinance. First, under the standard established in Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1986), any governmentally compelled disclosures to consumers must be “purely factual and uncontroversial.” Id. at 651. The law here required cellphone retailers to provide every customer with an informational "fact sheet" about the possible health risks of radio-frequency energy emissions from cellphones.  That fact sheet contained more than just facts. It also contained San Francisco’s recommendations as to what consumers should do if they want to reduce exposure to radio-frequency energy emissions. This language could be interpreted by consumers as expressing San Francisco’s opinion that using cell phones is dangerous. The FCC, however, has established limits of radio-frequency energy exposure, within which it has concluded using cell phones is safe. See, e.g., Guidelines for Evaluating the Envt’l Effects of Radio-frequency Radiation, 11 F.C.C.R. 15123, 15184 (1996).  Even the findings made by the San Francisco Board of Supervisors on which the challenged ordinance was predicated acknowledged that there "is a debate in the scientific community about the health effects of cell phones,” and the district court observed that “San Francisco concedes that there is no evidence of cancer caused by cell phones.” The court of appeals could not say on the basis of this record that the fact sheet was both “purely factual and uncontroversial.” Zauderer, 471 U.S. at 651.

The ordinance also required retailers to prominently display an informational poster in their stores, and to paste an informational sticker on all display literature for cellphones warning about the possible health risks of radio-frequency energy emissions from cellphones. The district court enjoined the original ordinance compelling distribution of these broader materials.  Since the ordinance sought to compel statements that are even more misleading and controversial than the  fact sheet, the original injunction must be affirmed, said the appeals court.

Rule 15 Amendments May Impact Removal Prospects

Readers of MassTortDefense know how important the choice of forum can be for significant product liability and mass tort matters.  The differences between federal and state court -- perhaps right down the street from each other -- can be huge, with differing juror pools, differing procedural rules, differing views on class actions, different methods of selecting the judiciary, etc.

Thus, it is worth making sure a subtle amendment to Rule 15 of the Federal Rules of Civil Procedure, which took effect Dec. 1, 2009, does not miss your attention, because of the potential impact it has on removal to federal court.

Prior to the amendments to Rule 15 — which governs amended and supplemental pleadings —  a plaintiff could amend the complaint once as a matter of course before any responsive pleading was filed.  Responsive pleading came to mean the defendant’s answer, and not a motion to dismiss.  E.g., Foster v. DeLuca, 545 F.3d 582 (7th Cir. 2008).  Thus, a defendant could eliminate the plaintiff’s right to amend as a matter of course by serving an answer.  That is, under the old version of Rule 15, a defendant could prevent amendments designed to eliminate the basis for removal by serving an answer just prior to or along with the filing of the notice of removal. When a plaintiff wanted to amend after the defendant had removed and answered, the plaintiff had to obtain consent or leave of court. So what about the removal, then? Any proposed amendment to the complaint affecting the court’s jurisdiction would trigger a heightened scrutiny of the amendment.  E.g., Hensgens v. Deere & Co., 833 F.2d 1179 (5th Cir. 1987). Defendants could argue that the  proposed amendment should be rejected on this basis. 

The new Rule 15 permits a plaintiff to amend “as a matter of course” even after the defendant has served “a responsive pleading.”  A party may file an amended pleading without leave of court within 21 days after service of a responsive pleading or 21 days after service of a Rule 12 motion, whichever is earlier. After that, a party may file an amended pleading only with leave of court. 

That raises the issue for your consideration whether the new ability of the plaintiff to amend “as a matter of course,” even after the defendant has served an answer, permits the plaintiff to make one of those jurisdiction-destroying amendments.  One possibility is that courts will look at "matter of course" amendments under the new rule the same way they were analyzed by many courts under the old rule.  That is, courts were guided by 28 U.S.C. § 1447(e), which states that if after removal the plaintiff seeks to join additional defendants whose joinder would destroy subject matter jurisdiction, the court may deny joinder, or permit joinder and remand the action to the state court. Schur v. L.A. Weight Loss Centers, Inc., 577 F.3d 752, 759 (7th Cir. 2009); Whitworth v. TNT Bestway Transp. Inc., 914 F.Supp. 1434 (E.D.Tex.,1996).  Courts, in the motion for leave context and sometimes in the "as of course" context as well, to decide between those two choices, would scrutinize the amendments closely, and due consideration is given to the original defendant’s interest in the choice of forum. Courts examine whether the purpose of the amendment is to defeat federal jurisdiction; how timely/prompt the plaintiff has been in seeking the amendment; whether the plaintiff will be prejudiced if amendment is not allowed; and any other equities. Bailey v. Bayer CropScience L.P., 563 F.3d 302 (8th Cir. 2009).

If this heightened scrutiny is applied to "matter of course" amendments made under the new version of Rule 15, removals may be in less jeopardy when when a plaintiff attempts to amend the complaint post-removal, post-answer  “as a matter of course.”