United States: Recent Trends In Class Action And Aggregate Litigation In The Life Sciences Industry

INTRODUCTION

For the last several years, the life sciences industry has been fertile ground for class action and aggregate litigation. Developments in this area have driven several trends, including state consumer fraud claims, securities class actions, antitrust class actions, and aggregate litigation brought by private healthcare insurers and state attorneys general. These recent trends have been driven, in part, by legislative and doctrinal developments. For example, in 2005—based on legislative findings of abuse in class action practice in state courts—Congress enacted the Class Action Fairness Act (CAFA), permitting defendants to remove to federal court putative class actions that previously may have been subject to less stringent standards in state court. In Standard Fire Insurance Co. v. Knowles,¹ the U.S. Supreme Court held that a plaintiff's stipulation that he would not accept more than $5 million in damages could not be used to avoid CAFA's amount in controversy requirement. In other words, a class representative may not agree to seek less money to try to keep a case in state court.

Recent U.S. Supreme Court decisions have also significantly shaped class action practice. The Supreme Court's decision in Wal-Mart Stores, Inc. v. Dukes² established that claims for individual money damages may be certified under Federal Rule of Civil Procedure (FRCP) 23(b)(2) in only limited circumstances, and the Court's decision also announced a more restrictive view of the meaning of a "common question" under FRCP 23(a). Most recently, in Comcast Corp. v. Behrend,³ the Court held that plaintiffs seeking class certification in antitrust cases must tie their theory of harm and damages to their liability theory, and, in appropriate circumstances, individual questions of damages can predominate over liability issues common to the class.

These developments have likely played a role in shaping the kinds of class actions that companies in the life sciences industry are seeing today. For example, personal injury class actions and other kinds of mass torts are now largely viewed as inappropriate for class treatment and often must confront motions to strike the class claims from the complaint at the outset of the case. Claims requiring plaintiffs to prove reliance on alleged conduct also face significant obstacles to class certification. After the Dukes decision, in particular, these obstacles seem to have resulted in an increase in consumer fraud actions brought by individuals, healthcare insurers, and state attorneys general. The recent developments also may explain the increase in proposed class actions in the securities and antitrust arenas. These trends as well as some considerations for minimizing risk in such litigation are discussed in further detail below.

CLASS ACTION LITIGATION TRENDS

Products Liability Claims

Individualized questions of causation and damages have driven the vast majority of courts to refuse class action treatment in products liability actions in the pharmaceutical and medical device arenas.⁴ In response to these developments, plaintiffs bringing personal injury claims have attempted to create multidistrict litigation proceedings and serial litigation to "aggregate" claims of individual plaintiffs in lieu of a class action. In short, plaintiffs are bringing mass actions instead of class actions.⁵ Still, many consumers and third-party payors pursue class actions seeking solely economic losses.

Third-Party Payor Claims

A recent wave of third-party payor litigants sued the pharmaceutical and medical device industries, seeking to recover alleged economic losses arising from their payments for pharmaceutical medicines or medical devices and, in some cases, payments to treat personal injuries. The third-party payors included private insurers and states as Medicaid payors. These third-party payors advanced claims for breach of warranty, violation of consumer protection statutes, violation of the Racketeer Influenced and Corrupt Organizations (RICO) Act,⁶ common law fraud, and unjust enrichment. The claims have proven vulnerable to attack for lack of injury and lack of a direct causal link between the supposed injury and the challenged conduct. For example, in Ironworkers Local Union 68 v. AstraZeneca Pharmaceuticals, LP,⁷ the U.S. Court of Appeals for the Eleventh Circuit affirmed the dismissal of claims by a consumer and third-party payors suing under RICO and various state laws to recover payments for off-label prescriptions of a medicine where an allegedly cheaper substitute medicine was available. The court stated the following:

Similarly, in Pennsylvania Employees Benefit Trust Fund v. AstraZeneca Pharmaceuticals LP,⁹ a third-party payor sued for breach of express warranty and unjust enrichment, claiming that "it was duped into expending millions of dollars in reimbursements for . . . prescriptions issued for medically unnecessary uses" and forced to pay for treatment of personal injuries allegedly caused by those prescriptions.¹⁰ The claims were dismissed for failure to establish causation between the alleged damages and the challenged conduct. The plaintiff's request for recovery of treatment costs required "onerous individualized inquiries into the specifics of each patient's medical history and the circumstances of each patient's alleged injury."¹¹ And, because the alleged warranties reached the third-party payor "only by way of a treating physician's prescription pad, if at all," they could not have formed the basis of a bargain between the payor and AstraZeneca, as is required under state law.¹² A payor "cannot simply rely on the prescription pads of physicians or claims for reimbursement from pharmacies as a means by which express warranties [a]re conveyed."¹³ This is, in essence, the learned intermediary doctrine: Where a claim requires "'proof of justifiable reliance and causation, . . . such requirements cannot be present when the defendant is a pharmaceutical company that did not sell its product directly to the patient.' The same reasoning extends to manufacturers of prescription medical devices."¹⁴ Other recent opinions provide a solid foundation for defending similar claims.¹⁵

Consumer Protection Act Claims

Plaintiffs bringing Consumer Protection Act (CPA) causes of action aim to focus the courts' attention on an alleged common course of action by the defendant. As a result, the heightened requirements for class certification established by Dukes may, in some cases, be more easily avoided by class claims under states' CPAs. For example, the plaintiff in Delarosa v. Boiron, Inc. made CPA claims in an apparent effort to avoid the Dukes requirements.¹⁶ In that case, the plaintiff alleged that the defendant falsely marketed a homeopathic cold remedy that allegedly had no beneficial effect on cold sufferers. The plaintiff brought CPA claims and common law fraud claims. The U.S. District Court for the Central District of California found that common issues predominated and that class certification was justified because, in its view, the claims turned primarily on one defendant-focused issue—whether the defendant's advertising included false statements. In Delarosa, the plaintiff's choice of law and venue was key to avoiding a reliance requirement that could have interfered with certification. In California, a plaintiff is presumed to have relied on a defendant's misrepresentation if the misrepresentation was material.¹⁷

Another emerging strategy among plaintiffs is to characterize the class CPA claims as involving concealment of or a failure to disclose material information to the class members to avoid the element of reliance. In White v. Wyeth, the plaintiffs structured their claims in this fashion.¹⁸ The plaintiffs alleged that a pharmaceutical manufacturer had withheld material information regarding a hormone replacement drug. They brought class action claims under the West Virginia Consumer Credit and Protection Act. Normally, reliance is a required element of this type of action, and the defendant attempted to defeat class certification on this basis. The court concluded, however, that "[w]here concealment, suppression or omission is alleged, and proving reliance is an impossibility," the putative class was not required to prove reliance.¹⁹

The foregoing cases illustrate plaintiffs' focus on framing claims as CPA causes of action. Put simply, some plaintiffs have concluded that "[a]lleging a common course of conduct or business practice that applies uniformly to class members . . . is the key to certifying a CPA class post-[Dukes]."²⁰ Plaintiffs can be expected to continue to actively seek class certification through state consumer protection statutes.²¹

Securities Fraud Claims

In recent years, despite a significant decrease in securities fraud class actions overall, these actions have been more prevalent against pharmaceutical and medical device companies. Securities class actions "'pose a special risk of vexatious litigation'" because of the cost of defending them coupled with substantial potential liability exposure.²²

Shareholders have recently filed claims under section 10(b) of the Securities Exchange Act of 1934²³ and its implementing regulation, Rule 10b-5.²⁴ Shareholders have a right of action to enforce these laws, but such laws exist "not to provide investors with broad insurance against market losses, but to protect them against those economic losses that misrepresentations actually cause."²⁵ To prevail on a claim under section 10(b) and Rule 10b–5, a plaintiff must plead and prove "(1) a material misrepresentation (or omission); (2) scienter, i.e., a wrongful state of mind; (3) a connection with the purchase or sale of a security; (4) reliance . . . ; (5) economic loss; and (6) loss causation[.]"²⁶ A plaintiff's complaint must also satisfy the heightened pleading requirements of FRCP 9(b) and the Private Securities Litigation Reform Act of 1995.²⁷

In Amgen Inc. v. Connecticut Retirement Plans & Trust Funds,²⁸ a retirement fund sued a biotechnology company for violations of section 10(b) and Rule 10b-5. The complaint alleged that Amgen and several of its officers allegedly concealed safety information about an anemia medicine arising from clinical trials, exaggerated the safety of its medicine, and failed to inform investors that it had allegedly promoted the medicine for off-label indications. According to the complaint, those alleged misrepresentations and omissions artificially inflated the price of Amgen's stock. The U.S. Supreme Court granted certiorari in the case to resolve a circuit court split over whether a plaintiff in a securities fraud class action must prove (as opposed to plausibly allege) the materiality of the supposedly false statements in order to invoke the fraud-on-the-market presumption of reliance at the class certification stage of the case. In a 6–3 decision, the Court held that proof of materiality "is not a prerequisite to class certification" in securities fraud cases.²⁹ The Court found that "the pivotal inquiry is whether proof of materiality is needed to ensure that questions of law or fact common to the class will 'predominate over any questions affecting only individual members' as the litigation progresses."³⁰ The Court noted further that "materiality can be proved through evidence common to the class" and that a failure to prove of materiality would not result in individual questions predominating.³¹ The decision is important because it allows plaintiffs to establish elements of FRCP 23 without proving an essential element of a fraud-on-the-market theory, thus potentially increasing defendants' exposure to substantial discovery costs and threats of large judgments.

A recent U.S. Supreme Court opinion addressing disclosure of adverse events is Matrixx Initiatives, Inc. v. Siracusano.³² There, the plaintiffs filed a putative class action claiming violations of section 10(b) and Rule 10b-5. The plaintiffs alleged that a pharmaceutical company failed to disclose reports of adverse events associated with an over-the-counter cold-remedy product and that those alleged omissions were "material," even if the reports did not represent a statistically significant number of adverse events. The Court agreed, reasoning that "[a] lack of statistically significant data does not mean that medical experts have no reliable basis for inferring a causal link between a drug and adverse events."³³ The Court made clear that pharmaceutical manufacturers need not disclose all reports of adverse events, which "are daily events in the pharmaceutical industry,"³⁴ and stated:

The Court concluded that the plaintiffs in Siracusano adequately pleaded materiality.

In In re Boston Scientific Corp. Securities Litigation, another putative class of shareholders filed suit alleging violations of section 10(b) and Rule 10b-5.³⁶ There, the U.S. Court of Appeals for the First Circuit underscored the Supreme Court's holding in Siracusano that section 10(b) "'do[es] not create an affirmative duty to disclose any and all material information.'"³⁷ In Boston Scientific, the company conducted an audit of a segment of its sales force regarding expenses incurred to provide food and entertainment to physician customers. The company also received a subpoena from the U.S. Department of Health and Human Services (HHS), requesting information about contributions it made to charities with ties to physicians or their families. The company did not immediately disclose the audit or the subpoena to the public. More than a month later, the company issued a press release and held a conference with investors and analysts discussing its sales prospects for a particular product line. Two weeks later, the company publicly disclosed the HHS subpoena, and, two weeks after that, it began to fire some of its previously audited employees. Many of the fired employees were hired by the company's direct competitor, a fact that the company later disclosed and that was followed by a drop in the company's stock price. From the First Circuit's perspective, all of these alleged omissions from the company's public statements in question were either immaterial or unaccompanied by allegations or evidence from which scienter could be inferred. The claims, therefore, were dismissed.

Other recent cases illustrate that a variety of public statements have given rise to securities fraud claims and that evaluation of such claims at the motion to dismiss stage are highly fact specific.³⁸

Antitrust Claims

The conventional wisdom has long been that antitrust claims, especially claims alleging horizontal price-fixing, were uniquely well suited for classwide resolution because of the view that "common issues regarding the existence and scope of the conspiracy predominate over questions affecting only individual members."³⁹ However, recent case law arising in the antitrust context has called that conventional wisdom into question. The trend toward more intense scrutiny of putative antitrust class actions began in earnest with the U.S. Court of Appeals for the Third Circuit's decision in In re Hydrogen Peroxide Antitrust Litigation,⁴⁰ in which the court held that there is no presumption of classwide impact in antitrust cases and that a trial court cannot permissibly certify a class without resolving disputes between experts who have posited conflicting economic theories on issues relevant to the essential elements of FRCP 23.⁴¹ The U.S. Supreme Court recently built upon those principles in its Comcast decision, where it held that plaintiffs seeking class certification in antitrust cases must tie their theory of harm and damages to their liability theory and that, in appropriate circumstances, individual questions of damages can predominate over liability issues common to the class.⁴² This decision represents a departure from lower court decisions holding that, in antitrust cases in particular, the failure by a plaintiff to come forward with a viable theory of classwide damages will not foreclose certification.

Despite the recent obstacles to class certification that have been created by these and other decisions, governmental antitrust enforcement is on the rise. As a result, it is reasonable to expect class action filings that allege violations of the antitrust laws and seek substantial damages amounts on behalf of large classes of direct and indirect purchasers. One of the areas that appears particularly ripe for antitrust class action activity in the immediate future is the life sciences industry and, in particular, pharmaceuticals.

As discussed in more detail below, the class action antitrust cases brought against pharmaceutical companies vary in terms of the exclusionary conduct theories that form the underpinnings for the claims, but the essential theme is the same, i.e., that a pioneer drug manufacturer (also referred to as a "branded" firm) has taken steps— either unilaterally or in concert with a rival—to wrongfully insulate itself from generic competition. By doing so, that firm enables itself to charge monopoly prices to those who buy the drug. The variations on this theme continue to evolve but presently focus on (1) so-called "reverse payment settlements"; (2) supposedly false Orange Book listings and manipulation of the Citizen Petition process; (3) so-called "product hopping"; and (4) alleged abuses of Risk Evaluation and Mitigation Strategies (REMS).

Reverse Payment Settlements

Among the high-profile targets of the class action bar are reverse payment settlements—or "pay for delay" settlements—in pharmaceutical patent lawsuits. In reverse payment settlements, which arise in the context of Hatch-Waxman Act⁴³ patent litigation brought by a pioneer drug company against its generic rival, the pioneer firm pays money or other consideration to the allegedly infringing generic firm, which then agrees not to enter the market with a competing generic drug for a period of years. The Federal Trade Commission (FTC) and the class action plaintiffs' bar repeatedly have challenged such arrangements on the grounds that they are, in essence, agreements between horizontal rivals not to compete, which they say invariably raise prices to consumers and are thus unlawful under the Sherman Antitrust Act.⁴⁴

After a split between the Third Circuit and three other circuit courts as to the appropriate standard to be applied to reverse payment settlements,⁴⁵ the prism through which such arrangements should be viewed recently was addressed by the Supreme Court in FTC v. Actavis, Inc.⁴⁶ On one end of the spectrum, the FTC and the class action plaintiffs' bar consistently have advocated for the application of the "quick look" standard for reverse payment settlements, under which such settlements are presumed unlawful without extensive analysis into the actual effect of the settlement on competition, thus placing the burden on the settling parties to demonstrate an absence of anticompetitive effects. That view had been adopted by the Third Circuit.⁴⁷ In contrast, the U.S. Courts of Appeals for the Second Circuit, the Federal Circuit, and the Eleventh Circuit espoused the application of the "scope of the patent" rule, which deems reverse payment agreements lawful so long as they do not go beyond the temporal or substantive limitations of the patent grant and the patent infringement suit is not a sham.⁴⁸ Although the "scope of the patent" test, which had been adopted by a majority of the circuits, was in line with longstanding precedent outside the pharmaceutical context,⁴⁹ critics of that approach argued that, in practice, the "scope of the patent" test resulted in a rule of per se legality for reverse payment settlements in pharmaceutical patent litigation that would be detrimental to consumers.

The Supreme Court's Actavis decision put to rest the debate as to the appropriate standard of scrutiny that should be applied to reverse payments, but the decision will likely give rise to more questions than it answers. Ultimately, the Court took a middle-ground approach, declining to adopt the "scope of the patent" rule espoused by the Eleventh Circuit and also rejecting the "quick look" presumption that was advocated by the FTC and the plaintiffs' bar and adopted by the Third Circuit in K-Dur. Instead, the Court opted for a flexible rule of reason analysis that requires courts to balance the pro-competitive benefits of an agreement against its anticompetitive effects. Although rule of reason analysis is well-trodden ground in antitrust doctrine, the Court in Actavis provided little guidance as to the structure or scope of the analysis in the context of a reverse payment settlement case, except to say that a large payment to the Abbreviated New Drug Application (ANDA) filer by the pioneer manufacturer could be evidence weighing in favor of a finding that a particular settlement violates the Sherman Antitrust Act. But, as Justice Stephen Breyer acknowledged in his opinion for the majority, the analysis of the consideration paid in the settlement is hardly a straightforward exercise, especially when a settlement payment, even if substantial, in part "reflect[s] compensation for other services that the generic has promised to perform—such as distributing the patented item . . . ."⁵⁰

Actavis has raised and will continue to raise many questions for firms—both pioneer and generic—that are seeking to resolve Hatch-Waxman Act patent litigation. However, one thing is virtually certain—as a consequence of the Supreme Court's ruling, and its elimination of the "scope of the patent" safe harbor, most reverse payment settlement cases will not be susceptible to early dismissal by way of an FRCP 12 motion and, instead, will need to be resolved on summary judgment or at trial. The fact that most reverse payment settlement cases now are likely to proceed beyond a motion to dismiss and into discovery makes them attractive cases to bring for class action lawyers and virtually guarantees that class action activity in this area will be on the rise for the foreseeable future.

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Footnotes

1. 133 S. Ct. 1345 (2013).

2. 131 S. Ct. 2541 (2011).

3. 133 S. Ct. 1426 (2013).

4. See, e.g., In re Am. Med. Sys., Inc., 75 F.3d 1069, 1084–85 (6th Cir. 1996) (vacating certification of national class in implant products liability litigation due to predominance of individual issues); In re Prempro Prods. Liab. Litig., 230 F.R.D. 555, 567 (E.D. Ark. 2005) ("As in many cases before them, Plaintiffs have attempted to frame the 'predominant' issues broadly to compensate for variations in the class members' claims. But they suffer the same fate. '[I]ndividual issues abound and are magnified by the necessity of applying diverse state laws,' making certification under 23(b)(3) inappropriate."); Zehel-Miller v. AstraZeneca Pharm., LP, 223 F.R.D. 659, 663 (M.D. Fla. 2004) (observing that certification of personal injury class arising from prescription medicine "would be indisputably inappropriate, since individual issues would overwhelm any common questions"); In re Phenylpropanolamine (PPA) Prods. Liab. Litig., 208 F.R.D. 625, 632 (W.D. Wash. 2002) ("An assessment of specific causation—in this case, whether PPA caused, may cause, or caused a fear of injury to these individuals—thus, necessarily dissolves into a myriad of individualized causation inquiries."); In re Rezulin Prods. Liab. Litig., 210 F.R.D. 61, 65–66 (S.D.N.Y. 2002) ("It . . . is not surprising that all relevant Court of Appeals and the bulk of relevant district court decisions have rejected class certification in products liability cases.").

5. Even if not styled as a "class action," a plaintiff's case may nonetheless be removable to federal court under CAFA's "mass action" provision. 28 U.S.C. § 1332(d)(11).

6. 18 U.S.C. § 1964(c).

7. 634 F.3d 1352 (11th Cir. 2011).

8. Id. at 1363 (internal citations omitted).

9. No. 6:09-cv-5003-Orl-22DAB, 2009 WL 2231686 (M.D. Fla. July 20, 2009).

10. Id. at *1.

11. Id. at *6.

12. Id. at *3.

13. Id. at *4.

14. Kee v. Zimmer, Inc., 871 F. Supp. 2d 405, 411 (E.D. Pa. 2012) (quoting Kester v. Zimmer Holdings, Inc., No. 2:10-cv-00523, 2010 WL 2696467, at *14 (W.D. Pa. June 16, 2010)).

15. See, e.g., In re Schering Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235, 238 (3d Cir. 2012) (affirming dismissal of RICO and state law claims for lack of standing under Article III of the U.S. Constitution because plaintiffs "did not allege a plausible nexus between the assailed marketing campaign and the physicians' decisions to prescribe certain drugs for off-label use"); Commonwealth v. Ortho- McNeil-Janssen Pharm., 52 A.3d 498, 511 (Pa. Commw. Ct. 2012) (affirming dismissal of the Commonwealth's claims of common law fraud and unjust enrichment in view of the absence of proof of reliance or causation); Se. Laborers Health & Welfare Fund v. Bayer Corp., 444 F. App'x 401, 408 (11th Cir. 2011) (rejecting third-party payor's economic loss claims for failure to establish a causal nexus between alleged fraud and payments for prescription medicine); UFCW Local 1776 v. Eli Lilly & Co., 620 F.3d 121, 133 (2d Cir. 2010) (rejecting class certification where plaintiffs claimed economic losses caused by third-party physicians' alleged reliance on the manufacturer's representations); In re Guidant Corp. Implantable Defibrillators Prods. Liab. Litig., 484 F. Supp. 2d 973, 984 (D. Minn. 2007) ("In essence, the TPP Plaintiffs allege that Guidant committed a tort on their insureds, causing injury and resulting in the injureds seeking medical treatment, which in turn caused economic harm to the TPPs because they were contractually obligated to pay for the injureds' medical care. Without a more direct connection, these claims are too speculative to establish a causal link between the alleged injury and the alleged misconduct."); Rivera v. Wyeth-Ayerst Labs., 283 F.3d 315, 320 (5th Cir. 2002) ("The plaintiffs claim that Wyeth violated the implied warranty of merchantability by selling a defective drug, but then aver that the drug was not defective as to them. Similarly, the plaintiffs claim Wyeth violated the [Texas Deceptive Trade Practices Act] by failing to issue warnings sufficient to advise injured users, but then concede they were not among the injured. Such wrongs cannot constitute an injury in fact.").

16. 275 F.R.D. 582 (C.D. Cal. 2011).

17. Id. at 586.

18. 705 S.E.2d 828 (W. Va. 2010).

19. Id. at 837.

20. Beth E. Terrell & Kimberlee L. Gunning, Recent Developments in UDAP Class Actions from the Plaintiff's Perspective, in 17th Annual Consumer Financial Services Institute Course Handbook Series 503, 518 (Practising Law Institute ed., 2012).

21. A number of CPA-style state common law causes of action also share the characteristics of CPA statutory actions that some plaintiffs believe make class certification easier post-Dukes. Common law causes of action that focus primarily on the conduct of the defendant—such as unjust enrichment, breach of the implied covenant of good faith, and even fraud (when reliance is not required)—can similarly be used by plaintiffs' counsel to characterize claims in a manner that avoids the heightened standard for predominance created by Dukes. See id. at 503 ("[I]n some circumstances, less utilized common-law claims, such as a claim for breach of the implied covenant of good faith and fair dealing, can be certified on a classwide basis even when a CPA claim is dismissed precertification.").

22. In re Boston Scientific Corp. Sec. Litig., 686 F.3d 21, 30 (1st Cir. 2012) (quoting Merrill Lynch, Pierce, Fenner & Smith Inc. v. Dabit, 547 U.S. 71, 86 (2006)).

23. 15 U.S.C. § 78j(b).

24. 17 C.F.R. § 240.10b-5.

25. Dura Pharm., Inc. v. Broudo, 544 U.S. 336, 345 (2005).

26. Id. at 341–42 (internal citations omitted).

27. Pub. L. No. 104-67, 109 Stat. 737 (codified as amended in scattered sections of 15 U.S.C.).

28. 133 S. Ct. 1184 (2013).

29. Id. at 1191.

30. Id. at 1195 (quoting Fed. Rule Civ. Proc. 23(b)(3)).

31. Id. at 1195–96.

32. 131 S. Ct. 1309 (2011).

33. Id. at 1319.

34. Id. at 1321.

35. Id. (internal quotation omitted).

36. 686 F.3d at 24.

37. Id. at 27 (quoting Siracusano, 131 S. Ct. at 1321).

38. See, e.g., Kleinman v. Elan Corp., 706 F.3d 145 (2d Cir. 2013) (affirming the dismissal of securities fraud claims alleging omission of preliminary clinical trial data from a press release); Pub. Pension Fund Grp. v. KV Pharm. Co., 679 F.3d 972, 981 (8th Cir. 2012) (rejecting company's argument that "the receipt of Form 483s can never render a company's statements about compliance with [Food and Drug Administration (FDA)] regulations or cGMP false or misleading"); Plumbers & Pipefitters Local Union 719 Pension Fund v. Zimmer Holdings, Inc., 679 F.3d 952, 956 (7th Cir. 2012) (affirming the dismissal of securities fraud claims alleging omissions from statements by the company's CEO during a conference call with analysts and observing that the CEO's statement was true and at worst "evasive, which is short of fraudulent," and that he "did not know what question was coming, had to answer off the cuff, and did not have an opportunity to review the question and edit his answer before the next question was posed"); Hill v. Gozani, 638 F.3d 40, 59 (1st Cir. 2011) (affirming the dismissal of securities fraud claims against devicemaker NeuroMetrix, Inc. and noting that "[a]lthough the company took an aggressive, and in the view of some, an unrealistically aggressive view of the appropriate resolution in the promotion of its product, its press release does state explicitly that the ultimate resolution of the issue is unknown and, by reasonable implication, out of its hands"), reh'g denied, 651 F.3d 151 (1st Cir. 2011); Detroit Gen. Ret. Sys. v. Medtronic, Inc., 621 F.3d 800, 806 (8th Cir. 2010) (affirming the dismissal of securities fraud claims alleging omissions from a Dear Doctor letter and noting that "[i]t is difficult to see how a letter disclosing a possible problem and an investigation into that problem was materially misleading").

39. In re Foundry Resins Antitrust Litig., 242 F.R.D. 393, 408 (S.D. Ohio 2007).

40. 552 F.3d 305 (3d Cir. 2008).

41. Id. at 323, 326.

42. Comcast, 133 S. Ct. at 1435.

43. Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (codified as amended at 21 U.S.C. § 355 (1994)).

44. In re Cardizem CD Antitrust Litig., 332 F.3d 896, 908 (6th Cir. 2003).

45. See, e.g., id.; Andrx Pharm., Inc. v. Biovail Corp. Int'l, 256 F.3d 799 (D.C. Cir. 2001); Valley Drug Co. v. Geneva Pharm., Inc., 344 F.3d 1294 (11th Cir. 2003); Schering-Plough Corp. v. FTC, 402 F.3d 1056 (11th Cir. 2005); In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187 (2d Cir. 2006), abrogated by FTC v. Actavis, Inc., 133 S. Ct. 2223 (2013); In re Ciprofloxacin Hydrochloride Antitrust Litig., 544 F.3d 1323 (Fed. Cir. 2008), abrogated by Actavis, 133 S. Ct. 2223.

46. 133 S. Ct. 2223 (2013).

47. In re K-Dur Antitrust Litig., 686 F.3d 197 (3d Cir. 2012), cert. granted, vacated sub nom. Upsher-Smith Labs., Inc. v. La. Wholesale Drug Co., 133 S. Ct. 2849 (2013), and cert. granted, vacated sub nom. Merck & Co., Inc. v. Louisiana Wholesale Drug Co., Inc., 133 S. Ct. 2849 (2013), reinstatement granted, Nos. 10-2077, 10-2078, 10-4571, 2013 WL 5180857 (3d Cir. Sept. 9, 2013).

48. FTC v. Watson Pharm. Inc. (Actavis I), 677 F.3d 1298 (11th Cir. 2012), rev'd and remanded sub nom. Actavis, 133 S. Ct. 2223.

49. See, e.g., Standard Oil Co. (Ind.) v. United States, 283 U.S. 163 (1931) (upholding, under the antitrust laws, cross-licensing agreements among patentees that settled actual and impending patent litigation).

50. Actavis, 133 S. Ct. at 2236.

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