THE STATE OF SOUTH CAROLINA In The Supreme Court

State of South Carolina ex. rel. Alan Wilson, in his capacity as Attorney General of the State of South Carolina, Respondent,

v.

Ortho-McNeil-Janssen Pharmaceuticals, Inc., f/k/a Janssen Pharmaceutical, Inc., and/or Janssen, L.P., and Johnson & Johnson, Inc., Defendants,

of whom Ortho-McNeil-Jansse n Pharmaceuticals, Inc. is the Appellant.

Appellate Case No. 2012-206987

Appeal from Spartanburg County Roger L. Couch, Ci rcuit Court Judge

Opinion No. 27502 Heard March 21, 2013 – F iled February 25, 2015

AFFIRMED IN PART, REVERSED IN PART AND

REMANDED

Steven W. Hamm and Stev en J. Pugh, both of Richardson, Plowden & Robinson, PA, of Columbia; C. Mitchell Brown, William C. Wood, Jr., A. Mattison Bogan, and Miles E. Cole man, all of Nelson Mullins Riley & Scarborough, LLP, of Columbia; Edward M. Posner and Chanda A. Miller, both of Drinker Biddle & Reath, LLP, of Philadelphia, Pennsylvania, for Appellant.John B. White, Jr., and Donald C. Coggins, Jr., both of Harrison, White, Smith & Coggi ns, PC, of Spartanburg; John S. Simmons, of Simmons Law Firm, LLC, of Columbia; Attorney General Alan M. Wilson, Deputy Attorney General Robert D. Cook, and Assistant Deputy Attorney General C. Havird Jones, Jr. all of Columbia; Fletcher V. Trammell, Robert W. Cowan, and Elizabeth

W. Dwyer, all of Bailey P eavy Bailey, of Houston, Texas, for Respondent.

Gray T. Culbreath and Laura W. Jordan, both of Gallivan White & Boyd, P.A., of Colu mbia, for Amicus Curiae,

The South Carolina Chamber of Commerce.

JUSTICE KITTREDGE: Appellant Ortho-McNeil-Janssen Pharmaceuticals (Janssen) is a pharmaceutical company th at manufactures the antipsychotic drug Risperdal. Risperdal is among a class of drugs prescribed primarily for the treatment of schizophrenia. The Attorney General of South Carolina believed that

Janssen had violated the South Carolin a Unfair Trade Practices Act (SCUTPA) 1 by engaging in unfair methods of competiti on by willfully failing to disclose known

risks and side effects asso ciated with Risperdal.

On January 24, 2007, the State and Jan ssen entered into a tolling agreement concerning the statute of limitations. SCUTPA has a three-year statute of limitations, as section 39-5-150 of the So uth Carolina Code provides that "[n]o action may be brought under th is article more than thr ee years after discovery of the unlawful conduct which is the subject of the suit." Th e State filed its Complaint on April 23, 2007, seeking stat utory civil penalties against Janssen on

two claims. The first claim arose from the content of the written material furnished by Janssen since 1994 with each Risperdal prescription, the so-called labeling

claim. The second claim centered on alleged false information contained in a November 2003 Janssen-genera ted letter sent to the S outh Carolina community of prescribing physicians, the so-called Dear Doctor Letter. Because both claims arose more than three years prior to Janu ary 24, 2007, Janssen pled the statute of limitations as a bar to the Complaint.

1 S.C. Code Ann. §§ 39-5- 10 to -180 (1985 & Supp. 2013).The matter proceeded to trial. A jury re ndered a liability verdict against Janssen on both claims. The trial court rejected Ja nssen's defenses, including the statute of limitations, finding that both claims were timely. The trial court imposed civil penalties against Janssen for both clai ms totaling $327,073,700 based on 553,055 separate violations of SC UTPA in connection with its deceptive conduct in the sales and marketing of Risperdal.

Janssen appeals. We affirm the liability judgment on the labeling claim but modify the judgment to limit the imposition of civil penalties to a period of three years from the date of the tolling agreement, which is essentially coextensive with the three-year statute of limitations, subject to an additional three months by virtue of the time period between the January 24, 2007, tolling agreement and the filing of the Complaint on April 23, 2007. We further remit the civil penalties on the labeling claim to $34,545,400. We affirm the liability judgment on the DDL claim, but remit those civil penalties to $101, 480,000. Accordingly, we affirm in part, reverse in part, and remand for en try of judgment against Janssen in the amount of $136,025,400.

I. FDA Regulatory Process and Background

A brief summary of the Food and Dr ug Administration's (FDA) regulatory authority over the pharmaceutical industry and the evolution of antipsychotic drugs provides a helpful backdrop to the facts of this case. "In the 1930's, Congress became increasingly concerned about unsa f e drugs and fraudulent marketing, and it enacted the Federal Food, Dr ug, and Cosmetic Act (FDCA)." 2 Wyeth v. Levine

, 555 U.S. 555, 566 (2009) (citation omitted). The FDCA's "most substantial innovation was its provision for prem arket approval of new drugs." Id. Following implementation of the FDCA, the FDA "r equired every manufacturer to submit a new drug application, including reports of investigations and specimens of proposed labeling" for regul atory review and approval. 3 Id. "Until its application

2 The FDCA is codified at 21 U. S.C. §§ 301–399f (2006 & Supp. V 2011).

3 Prior to submitting a new drug application to the FDA for approval, the developer of the drug must first "gain authoriza tion to conduct clinical trials (tests on humans) by submitting an investigational new drug application (IND)." Merck KGaA v. Integra Lifesciences I, Ltd. , 545 U.S. 193, 196 (2005) (citations omitted).became effective, a manuf acturer was prohibited from distributing a drug." Id. FDA regulations require a new drug applicati on to "include all clinical studies, as well as preclinical studies related to a drug's efficacy, toxicity, and pharmacological properties." Merck KGaA v. Integra Lifesciences I, Ltd. , 545 U.S. 193, 196 (2005) (citing 21 C.F.R. § 314.50(d)(2), (5) (2005)).

The FDA new drug approval process include s specific procedures through which warning labels are drafted, approved, and required to be included in the packaging of manufactured drugs. A drug label "m ust contain a summary of the essential

scientific information needed for the safe and effective use of the drug," and the

label "must be informative a nd accurate and neither prom otional in tone nor false or misleading in any particular." 21 C. F.R. § 201.56(a)(1)–(2) (2014). Indeed, federal regulations set forth detailed requirements as to the content, the formatting, and the order of required information ab out potential risks and the safe and effective use of a drug. Id . § 201.57(c) (2014). Specifically, FDA regulations require drug labels to include, inter alia : (1) "black box" warnings about serious risks that may lead to death or serious injury; (2) contraindications describing any situations in which the drug should not be used because the risk of use outweighs any possible therapeutic benefit; (3) warnings and precautions about significant

adverse reactions and other potential safety hazards; and (4) any adverse reactions

for which there is a basis to believe a causal relationship exists between the drug

and the occurrence of the adverse event. Id . As these FDA regulations make clear, the category in which a particular risk a ppears on a drug label is a critical indicator of both the degree of the risk and also th e likelihood and severity of the adverse consequences the drug may cause.

After a new drug application has been appr oved, the drug's sponsor has continuing duties to the FDA to ensure the long term efficacy and safety of the approved drug. For example, once drugs are approved by th e FDA, the drug's sponsor is required to review, and report to the F DA, all "adverse drug experience" 4 information it

4 FDA regulations define an "adverse drug experience" as:

Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring fromreceives from any source, including a dverse experiences reported during the process of post-marketing clinical trials. 21 C.F.R. § 314.80(b), (c) (2014). As new risks and side effects are discovered, a manufacturer must re vise a drug's label "to include a warning about a clinically significant hazard as soon as there is

reasonable evidence of a causal associati on with a drug; a causal relationship need not have been definitely established." 21 C.F.R. § 201.57(c)(6)(i). As the FDA does not conduct independent sc ientific testing, it is incumbent upon sponsors to

disclose all clinical data to ensure the safe and effective use of drugs.

Some have expressed a growing concern regarding the pharmaceutical industry's reticence to disclose negative clinical da ta, and the impact this has on the public

health and welfare. Indeed , it has been stated that:

[T]he failure to disclose study resu lts not only impacts clinical trial participants, but the health of the general public may be put in jeopardy as well. For drugs that have received FDA approval, postmarket clinical trials investigati ng new uses of the medication often reveal important information con cerning side effects and related adverse complications with the tr eatment. To the extent that prescribing physicians do not have this essential data, they could inadvertently be putting their patient s at serious risk by continuing to

recommend the medication.

Over the past few years, numerous scandals in the drug industry illustrate that concealing unfavorable research results is far from an isolated practice. . . . . In a quest to boost sales and increase corporate profits, the temptation to hi de or selectively disclose clinical trial data has proven to be too much.

Christine D. Galbraith, Dying to Know: A Demand for Genuine Public Access to

Clinical Trial Results Data , 78 Miss. L.J. 705, 710 (2009).

"The FDA's premarket approva l of a new drug application includes the approval of the exact text in the proposed label." Wyeth , 555 U.S. at 568 (citing 21 U.S.C.

drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action.

21 C.F.R. § 314. 80(a) (2014).§ 355 (2006); 21 C.F.R. § 314.105(b) (2008)). Subsequent to approval of the new drug application, a drug manufacturer must submit a supplemental application to

the FDA in order to effect a ny changes in the drug label. Id. (citing 21 U.S.C. § 355 (2006); 21 C.F.R. § 314.105(b) (2008 )). "There is, however, an FDA regulation that permits a manufacturer to make cert ain changes to its label before receiving the agency's approval." Id. (emphasis added).

Among other things, this "changes being effected" (CBE) regulation provides that if a manufacturer is changing a label to "add or strengthen a contraindication, wa rning, precaution, or adverse reaction" or to "add or strengthen an instruction about dosage and

administration that is intended to increase the safe use of the drug product," it may make the la beling change upon filing its supplemental application with the FDA; it need not wait for FDA approval.

Id. (quoting 21 C.F.R. §§ 314.70( c)(6)(iii)(A), (C)).

Following FDA approval of a new drug (or a new indication for an existing drug), pharmaceutical companies may begin to market the drug, subject to federal regulations. See, e.g., 21 C.F.R. § 203.2 (2014) ("The purpose of this part is . . . to protect the public health . . . ."). T ypical pharmaceutical marketing strategies include both direct sales calls (i.e., vis its to prescribing doctors to distribute literature and samples) and academic writings and speaking events led by healthcare professionals.

Risperdal (risperidone) is an antipsychotic drug primarily used to treat schizophrenia. Schizophrenia is a chronic, debilitating mental illness that affects approximately 1% of the population. Fo llowing onset, schizophrenia is a lifelong, incurable disease, an d treatment almost always involve s the use of an antipsychotic drug. Between the 1950s and 1990s, me dical practitioners prescribed typical antipsychotics such as Thorazine (chlorpr omazine), Prolixin (fl uphenazine), Haldol (haloperidol), Loxitane (loxapine), and Mellaril (thioridazine) to treat schizophrenia. Although effective, these t ypical antipsychotics posed a number of negative side effects, including invol untary muscle movements and tardive dyskinesia, a long-lasting movement disorder.

By the 1980s, clozapine was being investigated for the treatment of schizophrenia on the theory that it might be more eff ective and cause fewer movement disordersthan typical antipsychotics. Clozapine was termed an "atypical antipsychotic" because it affected a different part of the brain than the older, typical antipsychotics. The medica l community soon discovered th at clozapine, too, had negative side effects, including agranuloc ytosis—a dramatic and sometimes deadly decrease in white blood cell count. Thus, in spite of its efficacy in treating the symptoms of schizophrenia, clozapine was usually used only as a "last resort" drug, prescribed for only about 10% of the schizophrenic population.

In 1994, Janssen introduced Risperdal in the United States as the second atypical antipsychotic drug on the market. Fro m 1994 to 1996, Risperdal held a unique place in the market—it was promoted as being more effective than the older, typical antipsychotics, without the dangerous side effects associated with clozapine. In 1996, Eli Lilly (Lilly) intr oduced a third atypical antipsychotic drug to the market: Zyprexa. Zyprexa was dramatically successful when it hit the market, and Lilly and Janssen competed to capture the antipsychotic market.

Spurred by this fierce competition, Jansse n developed a marketing strategy to distinguish Risperdal and protect its market share. By 1998, Janssen was promoting Risperdal as having a lower risk of weight gain a nd a lower metabolic risk profile than Zyprexa. 5 Despite the claims made by Janssen, post-marketing studies, some as early as 1994, revealed Risperdal posed a serious risk of substantial weight gain, increased prol actin levels, and hyperprolactinemia in patients taking atypical antipsychotics. This increased the long-term risk of developing various kinds of cancer, oste oarthritis, cardiovascular disease, and stroke. Additionally, atypical antipsychotics greatly increased the risk of diabetes mellitus, which can have very serious, even life-threat ening consequences. By 1997, Janssen also had information that Ri sperdal posed a serious risk of stroke, cardiac arrest, and sudden death in the elderl y. Despite this clinical information, it was several years before Janssen updated the Risperdal la bel to accurately reflect the frequency and severity of the risk of hyperprolactinemia, weight gain and diabetes, or stroke, cardiac arrest, and sudden death in the elderly.

In 1997, Janssen commissioned a clinical trial (Trial 113) designed to establish Risperdal's superiority over Zyprexa as to metabolic side effects, including weight

5 In turn, Lilly differentiated Zyprexa as posing a lower risk for movement disorders and hyperprolactinemia, a hor monal imbalance causing serious and lasting reproductive side effects, when compared to Risperdal.gain and diabetes. In 1999, the results of Trial 113 were not what Janssen desired, as the study concluded that there was no difference between Ri sperdal and Zyprexa in terms of long-term weight gain or the onset of diabetes mellitus. Janssen did not disclose or publish the results of Trial 113 and continued to claim that Risperdal was superior to Zyprexa in terms of these negative metabo lic side effects.

By August 2000, Janssen also received resu lts from two epidemiological studies. One study was based on a review of the re cords of patients treated with atypical antipsychotics in a New England insuranc e database (ERI st udy). The ERI study showed that Risperdal patients developed diabetes mellitus at a significantly higher incident rate than patients taking Z yprexa. The second study was commissioned by Janssen (HECON study), and it concluded that Risperdal was not associated

with an increased risk of diabetes mellitus. By this time, and notwithstanding Janssen's furtive efforts, the risks and adve rse side effects associated with atypical antipsychotic drugs were fairly well known.

In May 2000, the FDA asked sponsors of at ypical antipsychotic drugs to submit a comprehensive review of all clinical data pertaining to metabolic side effects. In response, Janssen did not disclose the re sults of the Trial 113 study but disclosed only the favorable results from its own HE CON study, affirmatively indicating to the FDA that no long-term trials pertaini ng to metabolic side effects had taken place. The FDA's review was not thwart ed by Janssen's effo rts, as the FDA's investigation prompted it to request that product labeling for all atypical antipsychotic medications, including Risperdal, include a warning about hyperglycemia and diabetes.

Janssen was concerned that the FDA-mand ated label warning would result in a substantial loss of Risperdal market shar e. Notwithstanding the Trial 113 and ERI study results suggesting an association betw een Risperdal and diabetes, in October 2000, Janssen's Associate Director of Cen tral Nervous System Medical Affairs wrote an email to her colleagues urging that Janssen must a void Risperdal being "lumped in to [sic] the atypical class for diab etes. . . . [W]e need to work hard on a strategy to avoid risperdal being thought of as a diabetes-inducing medication. Instead, when worried about diabetes, we want doctors to prescr ibe Risperdal."

Janssen then determined it would take control of how the message surrounding the new diabetes warning would be communicated. Janssen officials' strategy was to "soften the blow" through what is known in the industry as a D ear Doctor Letter (DDL). The inspiration came from a DDL that Lilly sent to prescribers, informingthem that the entire class of atypical antipsychotics was now subject to a new

"class label" for diabetes and hyperglycemia. A senior vice president for Janssen's parent company wrote in an internal email that "Lilly's DDL is pretty clever. How much commercial liability would we incu r if we sent a similar letter about Risperdal, assuming the FDA is unw illing to communicate the issue?"

On November 10, 2003, Janssen dissemina ted a DDL, which did not include the text of the new diabetes/hyperglycemia warning, but stated:

Hyperglycemia-related adverse events have infrequently been reported in patients receiving R ISPERDAL. Although confirmatoryresearch is still needed, a body of evidence from published peerreviewed epidemiology research suggests that RISPERDAL is not

associated with an increased risk of diabetes wh en compared to untreated patients or patients treated with conventional antipsychotics. Evidence also suggests that RISPER DAL is associated with a lower

risk of diabetes than some othe r studied atypical antipsychotics.

To put it mildly, the November 2003 DDL contained false information.

Additionally, in training its employ ees on the labeling update, Janssen

communicated to its field sales team that Risperdal had a "0%" increased diabetes risk compared to placebo. This was part of the message communicated to physicians in DDL follow-up visits with physicians.

Meanwhile, by January 2004, Janssen had upda ted the Risperdal label to include the new diabetes/hyperglycemia warning. Janssen determined that the negative sales impact had been minimal because of its deceptive efforts in the November 2003 DDL. In other words, the November 2003 DDL worked, as far as Janssen was concerned, in protec ting its market share.

Thereafter, in April 2004, the FDA's Division of Drug Marketing Advertising and Communications (DDMAC) 6 issued a "Warning Letter" to Janssen, characterizing

the November 2003 DDL as "f alse or misleading" in violation of the FDCA. Specifically, the letter provided:

6 This agency is now known as the Office of Prescription Drug Promotion (OPDP).DDMAC has concluded that the DHCP 7 letter is false or misleading in violation of Sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. 325(a) and 321(n)) because it fails to disclose the addition of information relating to hyperglycemia and diabetes mellitus to the approved pr oduct labeling, minimizes the risk of hyperglycemia-related adverse ev ents, which in ex treme cases is

associated with serious advers e events including ketoacidosis, hyperosmolar coma, and death, fa ils to recommend regular glucose control monitoring to identify diabetes mellitus as soon as possible, and misleadingly claims that Risper dal is safer than other atypical antipsychotics. The healthcare co mmunity relies on DHCP letters for accurate and timely information rega rding serious risks and associated changes in labeling and the dissemin ation of this letter at a time critical to educating healthcare provi ders is a serious public health

issue.

The FDA also determined that the scientif ic studies referenced in the DDL "do not represent the weight of the pertinent scientific evidence" nor did the DDL accurately describe the results of the cited studies. As a result of the FDA's warning, Janssen issued a corrective lette r in July 2004, acknowledging that the

November 2003 DDL "omitted material info rmation about Risperdal, minimized potentially fatal risks, and made misleading claims sugge sting superior safety to other atypical antipsychotics without adequa te substantiation, in violation of the [FDCA]."

As to Risperdal's label, Janssen did not update the label to include a boxed warning regarding the risk of stroke, cardiac arre st, and sudden death in the elderly until February 2005, and no warn ing about hyperprolactinemia appeared in the label until August 2008. 8

7 Dear Health Care Provider, which is a nother term for a Dear Doctor Letter.

8 To be sure, prior versions of the Risperdal label mentioned the risk of

"cerebrovascular adverse events" in elderl y patients, increased prolactin levels, and hyperprolactinemia; however, Janssen's cate gorization of those risks on the label underrepresented and minimized the frequency and severity of the risks associated with Risperdal. As noted, the category in which a particular risk appears on a drug label is a critical indicator of both the degree of the risk and also the likelihood and severity of the adverse cons equences the drug may cause. See 21 C.F.R.In April of 2007, the Attorney General of South Carolina filed a state law claim against Janssen, seeking civil penaltie s under SCUTPA. The State pursued two claims against Janssen, one in connecti on with the Risperdal label (the labeling claim) and the second concerning the November 2003 DDL (t he DDL claim). Following a twelve-day trial, the jury retu rned a verdict on liability in favor of the State, finding that Janssen's actions with respect to both the labeling and DDL

claims were willful viol ations of SCUTPA.

After dismissing the jury, the trial cour t separately consid ered evidence and arguments during a two-day hearing to determine the appropriate penalty for

Janssen's SCUTPA violations . The trial court issued an order assessing penalties against Janssen of $152,849,700 for th e labeling claim and $174,224,000 for the DDL claim, for a total pena lty of $327,073,700. This a ppeal followed. This case was transferred from the court of appeals to this Court pursuant to Rule 204(b),

SCACR.

II. Analysis Concerning Liability

SCUTPA "declares unfair or deceptive ac ts or practices in trade or commerce

unlawful." Singleton v. Stokes Motors, Inc. , 358 S.C. 369, 379, 595 S.E.2d 461, 466 (2004) (citing S.C. Code Ann. § 39-5-20(a) (2002 )). "An unfair trade practice has been defined as a practice which is offensive to public policy or which is immoral, unethical, or oppressive." deBondt v. Carlton Motorcars, Inc. , 342 S.C. 254, 269, 536 S.E.2d 399, 407 (Ct. App. 2000) (citing Young v. Century LincolnMercury, Inc. , 302 S.C. 320, 326, 396 S.E.2d 105, 108 (Ct. App. 1989), aff'd in part, rev'd in part on other grounds , 309 S.C. 263, 422 S.E.2d 103 (1992)).

SCUTPA provi des for both civil acti ons brought by private citizens and enforcement actions brought by the Attorney General on behalf of the State. S.C. Code Ann. §§ 39-5-50(a), -110(a), -140(a) (1985). While the only section of

SCUTPA at issue in this case is an en forcement action brought by the Attorney General, we note the distin ction between the two types of actions. In an action brought by a citizen under section 39-5-140( a) of the South Carolina Code, there is

§§ 201.56, 201.57 (setting forth detailed requirements on the content and format of information on drug labels to ensure labels are not inaccurate, false, or misleading and convey all pertinent inform ation regarding the safe a nd effective use of drugs).a requirement that the person suffer an "a scertainable loss of money or property, real or personal, as a result of the use or employment by another person of an unfair or deceptive method, act or practice . . . ." Thus, SCUTPA requires that a private claimant suffer an actual loss, injury, or damage , and requires a causal connection between the injury-in-fact a nd the complained of unfair or deceptive acts or practices. S.C. Code Ann. § 39-5-140(a). 9

Conversely, an enforcement action brought by the Attorney General has no such actual impact requirement. See S.C. Code Ann. § 39-5-50(a). The Attorney General "may recover on behalf of the St ate a civil penalty of not exceeding five thousand dollars per violation. " S.C. Code Ann. § 39-5- 110(a). "The legislature intended . . . [SCUTPA] to control and e liminate the large scale use of unfair and deceptive trade practices within the state of South Carolina." Noack Enters. v. Country Corner Interiors of Hilton Head Island, Inc. , 290 S.C. 475, 477, 351 S.E.2d 347, 349 (Ct. App. 1986) (quota tions and citations omitted).

At the outset of our analysis, our review of the extensive reco rd compels us to acknowledge that Risperdal has been an effective drug. Th e State did not file this case because of concern with Risperdal' s efficacy as an atypical antipsychotic. 10
Risperdal, like virtually all pharmaceutical drugs, has risks and side effects. The

State filed this case because of its be lief that Janssen e ngaged in unfair and deceptive conduct in South Carolina by faili ng to properly disclose Risperdal's

9 "Under section 39-5-140, a plaintiff can r ecover treble damages where 'the use or employment of the unfair or deceptive . . . act or practice was a willful or knowing violation of § 39-5-20.'" Wright v. Craft , 372 S.C. 1, 23–24, 640 S.E.2d 486, 498 (Ct. App. 2006) (quoting Noack Enters., Inc. v. Country Corner Interiors of Hilton Head Island, Inc. , 290 S.C. 475, 477, 351 S.E.2d 347, 348–49 (Ct. App. 1986)).

10 Similar Risperdal litigation against Ja nssen and its parent company, Johnson & Johnson, has been ongoing throughout th e United States. In November 2013, Johnson & Johnson agreed to pay more th an $2.2 billion in civil and criminal settlements with the United States Department of Justice to resolve claims that it improperly marketed Risperdal.

Following oral argument, we received s upplemental citations filed by Janssen regarding similar litigation in Louisiana and Arkansas. After closely examining the reported decisions in those states, we have determined that the cases involve statutory claims which do not mirror the SCUTPA.risks and side effects in an attempt to mislead prescribing physicians and the public. An objective review of the ev idence and law bears out the State's allegations that Janssen engaged in a syst ematic pattern of de ceptive conduct.

Janssen raises a number of issues in thei r appeal. While we reach the merits of a number of these issues, many of the issu es are not preserved for this Court's review, and we address them only briefly.

A. Opening and Closing Arguments

Janssen claims that various portions of the State's opening and closing arguments were inflammatory and unduly prejudici al and thus warrant a new trial. Specifically, Janssen claims th at the State invited the jury to impose liability on the

basis of Janssen's size a nd commercial success by repeat edly referring to Janssen's profits from selling Risperdal and claiming th at Janssen put "profits over safety."

We find that Janssen's arguments on app eal are procedurally barred. Although Janssen noted a generalized "continuing objec tion" at the outset of trial, apparently believing it could make a more specific after-the-fact objection to any alleged improper argument or evidence, such an appr oach is wholly inconsistent with our law requiring a contem poraneous objection. See Young v. Warr , 252 S.C. 179, 200, 165 S.E.2d 797, 807 (1969) ("[T]he proper course to be pursued when counsel makes an improper argument is for opposi ng counsel to immediately object and to

have a record made of the statements or language complained of and to ask the court for a distinct ruling thereon." (citing Crocker v. Weathers , 240 S.C. 412, 424, 126 S.E.2d 335, 340 (1962))). This rule is designed to enable the trial court to timely address and reme dy a founded objection. See Herron v. Century BMW , 395

S.C. 461, 465, 719 S.E.2d 640, 642 (2011) ("'Issue preservation rules are designed to give the trial court a fair opportunity to rule on the issues, and thus provide us with a platform for meaningful appellate review.'" (quoting Queen's Grant II Horizontal Prop. Regime v. Greenwood Dev. Corp., 368 S.C. 342, 373, 628 S.E.2d 902, 919 (Ct. App. 2006))). Here, absent a contemporan eous objection identifying the particular comments complained of and the basis for the objection, Janssen has waived its right to complain about this issue on appeal. Webb v. CSX Transp., Inc.

, 364 S.C. 639, 655, 615 S.E.2d 440, 449 ( 2005) (holding that the failure to contemporaneously object precluded the defe ndant from raising an issue on appeal(citing Taylor v. Medenica , 324 S.C. 200, 212, 479 S.E.2d 35, 41 ( 1996))). 11

Moreover, Janssen's "continui ng objection" at trial concerning the propriety of counsel's statements to the jury was limi ted to relevance, which is an entirely different basis than the inflammatory/u nduly prejudicial argument that Janssen now advances on appeal. Thus, even ge nerously construing Janssen's pre-trial objection as sufficient to preserve the objection, Janssen's claim is nonetheless procedurally barred from appe llate review because Jansse n argues a different basis on appeal than was argued at trial. State v. Dunbar , 356 S.C. 138, 142, 587 S.E.2d 691, 694 (2003) ("A party may not argue one ground at trial and an alternate ground on appeal." (citing State v. Prioleau , 345 S.C. 404, 411, 548 S.E.2d 213, 216 (2001); State v. Benton , 338 S.C. 151, 157, 526 S.E.2d 228, 231 (2000))).

Janssen's claims of error are without merit in any event. Janssen relies on our holding in Branham v. Ford Motor Co. , 390 S.C. 203, 701 S.E.2d 5 (2010), in urging this Court to order a new trial. In Branham , the plaintiff's attorney strayed beyond the parameters of permissible jury argument and sought punitive damages for the damage caused to non-parties. Id. at 235, 701 S.E.2d at 22. We ordered a new trial, holding that "[t]he closing argument invited the ju ry to base its verdict on passion rather than reason. . . . [and] denied [defendant] a fair trial." Id . We find

that Branham is readily distinguishable from this case. Here, counsel for the State directly linked the elements of SCUTPA to Janssen's misleading and deceptive practices and its motivations to retain (and increase) Risperdal ma rket share. Such arguments were within proper bounds as th e State sought to establish that Janssen acted willfully and contrary to the public interest. In addition, the nature of counsel's comments is more closely associ ated with what Janssen believes was a grossly excessive award of civil penalties, and the jury's role was limited to

11 We acknowledge the rule in South Carolin a that counsel is not required to harass the trial judge by making continued objections after an issue has been ruled upon.

See Dunn v. Charleston Coca-Cola Bottling Co. , 311 S.C. 43, 45–46, 426 S.E.2d 756, 758 (1993) (noting that where a trial judge has fair opportunity to consider and rule upon an issue, it is not incumb ent upon counsel "to harass the judge by parading the issue before [the trial judge ] again"). However, that is not the situation before us, for Janssen failed to br ing to the trial court's attention any of the comments of which it now complains or specify the basis for its objection, much less obtain a ruling from the trial cour t. Thus, because the trial court did not have a fair opportunity to consider a nd rule upon Janssen's specific objections, it was incumbent upon Janssen's counsel to object contemporaneously.determining liability. The jury had no role in determining the amount of the civil penalties.

B. Admission of 1994, 1999, and 2004 DDMAC Letters

Janssen argues that the admission of seve ral DDMAC letters was reversible error

because the letters constitute inadmissibl e hearsay and should also have been excluded under Rule 403, SCRE . Once again, we find that Janssen has not preserved these assignments of error for appellate review. 12 Even if we were to

reach the merits of these cl aims, however, we would affirm the admission of these letters pursuant to Rule 220(b)(1), SCACR. This evidence was relevant to the issue of liability and concomitantly the statute of limitations concerning the labeling claim, which, as discussed be low, inures to Janssen's benefit.

12 Janssen's contemporaneous objection at trial to admission of the 1994 DDMAC

letter was on the basis of rele vance, not on the basis of hearsay or Rule 403, SCRE. See Talley v. S.C. Higher Educ. Tuition Grants Comm. , 289 S.C. 483, 487, 347 S.E.2d 99, 101 (1986) ("It is an axiomatic ru le of law that issues may not be raised for the first time on appeal." (citing Am. Hardware Supply Co. v. Whitmire , 278

S.C. 607, 609, 300 S.E.2d 289, 290 (1983))). While it a ppears that Janssen was more specific in objecting to the admissi on of the 1999 DDMAC letter—objecting on relevancy, hearsay, a nd Rule 403, SCRE grounds—the trial judge did not specifically rule on the hearsay or Rule 403, SCRE, issues. Thus, Janssen's assignment of error is not pres erved for appellate review. Kleckley v. Nw. Nat.

Cas. Co. , 338 S.C. 131, 138, 526 S. E.2d 218, 221 (2000) ("An issue not raised to or addressed by the trial court or the Court of Appeals is not properly preserved for review by the Supreme Court . . . ." (citing Anonymous (M-156-90) v. State Bd. of

Med. Exam'rs , 329 S.C. 371, 375, 496 S.E.2d 17, 18–19 (1998); Camp v. Springs Mortg. Corp. , 310 S.C. 514, 516, 426 S.E.2d 304, 305 (1993))). Regarding the 2004 DDMAC letter, no challenge is preserve d for our review. Janssen's pre-trial objection to admission of the letter was only with regard to use or mention of the letter during opening statements, and Jan ssen's counsel did not state the specific grounds for the objection. Wilder Corp. v. Wilke , 330 S.C. 71, 76, 497 S.E.2d 731, 733 (1998) ("[A]n objection must be sufficie ntly specific to inform the trial court of the point being urged by the objector." (citation omitted)).C. Adverse Impact

Janssen argues that the Stat e's SCUTP A claims fail as a matter of law because the

State failed to show that Janssen's unf air and deceptive conduct had an adverse impact within South Carolina. We disagree. We reject Janssen's attempt to ascribe an injury-in-fact element in an individua l claim to an Attorney General directed claim, for to do so would be judicial e ngrafting of an element beyond that imposed by the legislature. In the context of th is case, Janssen's attempt to judicially impose an injury-in-fact el ement to an Attorney Gene ral initiated SCUTPA claim is nothing more than an "if we lied, nobody fe ll for it" defense. In this regard, we observe that Janssen seeks to impose an ab surd adverse impact element in a claim concerning alleged unfair and deceptive mark eting of prescription medicines. In many instances, as here, the manifesta tions of adverse consequences from prescription medicines are not immediate, but occur over time. Such is generally the case with Risperdal. In any event, Janssen's de ceptive conduct had an adverse impact on the citizens of South Carolina, for Janssen maintained its superior market share, which, after all, was what Janssen sought to achieve by its dishonesty.

The provisions of SCUTPA allow three types of enforcement actions: (1) lawsuits initiated by the Attorney General seeking injunctive relief; (2) lawsuits by the Attorney General seeking civil penalties; or (3) lawsuits by private parties who

have suffered ascertainable losses. S. C. Code Ann. §§ 39-5-50, -110, -140; see also Michael R. Smith, Note, Recent Developments Under the South Carolina Unfair Trade Practices Act , 44 S.C. L. Rev. 543, 54 3–44 (1993) (discussing generally various provisions of SCUTPA). Although this case is an appeal from a lawsuit by the Attorney General seeking civil penalties, we note some important distinctions between actions brought by the Attorney General a nd those brought by private parties.

To recover actual damages under SCUTPA, a private clai mant must suffer an actual loss, injury, or da mages, and the claimant must demonstrate a causal connection between the injury-in-fact a nd the complained of unfair or deceptive acts or practices. S.C. Code Ann. § 39-5- 140(a). Additionally, a private party may recover treble damages if the unlawful acts at issue are determined to be willful or knowing. Id . On the other hand, where the Attorn ey General files suit on behalf ofthe State, he is not required to show any injury-in-fact to recover a civil penalty. 13

See S.C. Code Ann. §§ 39-5-1 10, -140. Rather, SCUTPA allows the Attorney General to recover statutory damages of up to $5,000 per violation upon a showing

that the unlawful acts at issue are willful. 14 S.C. Code Ann. § 39-5-110(a). If the

13 Other states have similar provisions. See

, e.g ., Mulligan v. QVC, Inc., 888 N.E.2d 1190, 1196 (Ill. App. Ct. 2008) (" Although the Attorney General may prosecute a violation of the [Consumer Fraud and Deceptive Business Practices] Act without showing that any person has in fact been damaged, it is well settled that in order to maintain a private caus e of action under the Consumer Fraud Act, a plaintiff must prove that she suffered actual damage as a result of a violation of the Act." (citation omitted)); Edmonds v. Hough , 344 S.W.3d 219, 223 (Mo. Ct. App. 2011) ("The [Merchandising Pr actices] Act eliminates th e need for the Attorney General to prove intent to defraud or reliance in order for the court to find that a defendant has engaged in unlawful practices . Intent and reliance are not necessary elements of the cause of action." (quotations and citations omitted)). We recognize, however, there are ju risdictions that require the state to show an injury

in-fact as an element of unfair trade prac tice type claim. Following oral argument in this case, Janssen has submitted s upplemental authority consisting of court decisions from other states reversing trial court verdicts against Janssen. We have carefully reviewed those decisions and c onclude they are not persuasive, for the cases submitted by Janssen involve differe nt claims with elements that do not

mirror the South Carolina UFTPA.

14 "[A] willful violation occurs when the party committing the violation knew or

should have known that his conduct" was unlawful. S.C. Code Ann. § 39-5

- 110(c). In addition to the civil penalty, the Attorney General is authorized to seek injunctive relief when he "has reasonable cau se to believe that any person is using, has used or is about to use any method, act or practice declar ed by § 39-5-20 to be

unlawful . . . ." S.C. Code Ann. § 39-5-50(a). To be sure, the legislature has granted the Attorney General broad investigative powers. See S.C. Code Ann. § 39-5-70(a) ("When it appears to the Attorn ey General that a pe rson has engaged in, is engaging in, or is about to engage in any act or practice declared to be unlawful by this article[,] . . . [he may serve] an investigative demand . . . ."). While an individual statutory claim necessarily in cludes an injury-in-fact element, an Attorney General initiated claim does not. It is the protection of the people of

South Carolina that lies at the center of an Attorney General directed claim.Attorney General determines that an en forcement action "would be in the public interest," he is statutorily authorized to proceed without making any such showing of injury-in-fact or reliance. 15 S.C. Code Ann. § 39- 5-50(a). Thus, Janssen misconstrues the legislature's manifest purpose in providing for an Attorney General directed claim, for a SCUTPA acti on brought by the State is to protect the

citizens of South Carolina from unfair or deceptive acts in the conduct of any trade

or commerce. Janssen's contention to th e contrary is not only fundamentally at odds with unambiguous legislative intent in authorizing an Attorney General SCUTPA claim, but is also inconsistent with well-established South Carolina law.

On the issue of liability, our case law interpreting and appl ying SCUTPA is clear—while a private party SCUTPA acti on requires the traditional showing of an injury, an action brought by the Attorney General on behalf of the State contains no actual injury element. For the foregoing reasons, we hold that, although the State had the burden of proving Janssen's representations had a tendency to

deceive , the State was not required to show actual deception or that those representations caused any appreciable inju ry-in-fact or adversely impacted the marketplace. We find ample support in the record that the Stat e met its burden of proving that Janssen's actions had the tend ency to deceive. Janssen's unfettered

desire for sales and market share led it to engage in a systematic pattern of intentional nondisclosure, false representa tions, and deceptive conduct in violation of SCUTPA. Most assuredly, Janssen intended to deceive the public and the medical community. Although we reject Janssen's effort to impose an injury-in

fact element in an Attorney General in itiated claim, we believe the argument carries persuasive weight in the assessment of an appropriate penalty, which we address in the penalty section.

15 "'It is in the public interest generally to prevent the use of false and misleading

statements in the conduct of business . . . [and] actual deception need not be shown; a finding of a tendency [and capacity ] to deceive and mislead will suffice.'"

State ex rel. McLeod v. Brown , 278 S.C. 281, 285, 2 94 S.E.2d 781, 783 (1982) (quoting U.S. Retail Credit Assoc., Inc. v. F.T.C. , 300 F.2d 212, 221 (4th Cir. 1962)) (ellipsis in original). Additionally, "[ t]he health, welfare, and safety of the lives and property of the people of this St ate . . . are matters of public concern."

S.C. Const. art. XII, § 1.D. Exclusion of Dr. Wecker's Expert Testimony

s that the trial court erre d in excluding the testimony of Dr. pert statistician whose test imony, according to Ja nssen, wou nssen's representations in the Risperdal label and the Novem mpact on any prescribing phys icians. The import of Dr. We Janssen claim William Wecker, an ex ld have

shown that Ja ber 2003

DDL had no i cker's testimony would have been that, notwithst anding Janssen's false representations, the community of prescribing physicians was well aware of the risks and side effects of Risperdal.

We are again presented with an issue that was not prope rly preserved for appellate

review. When the trial court filed its order on February 25, 2011, excluding the testimony of Dr. Wecker on relevancy grounds, Janssen wa ited until March 21, 2011, to make an offer of proof of his tes timony. The offer of proof came too late. TNS Mills, Inc. v. S.C. Dep't of Rev. , 331 S.C. 611, 628, 503 S.E.2d 471, 480 (1998) (noting that a failure to make a proffer of what an excluded witness's testimony would have been pr ecludes appellate review); see also Greenville Mem'l

Auditorium v. Martin , 301 S.C. 242, 244, 391 S.E.2d 546, 547 (1990) ("An alleged

erroneous exclusion of evidence is not a basis for establishing prejudice on appeal in absence of an adequate proffer of evidence in the court below." (citations omitted)). 16

On the merits, for the reasons discussed in the previous section, we would not find reversible error in any ev ent. We do acknowledge th ere was evidence presented,

which otherwise tended to su pport Janssen's thesis that its deceptive conduct had no effect on the community of prescribing physicians, for they knew the truth concerning the risks and side effects asso ciated with Risperdal. Excluding Dr. Wecker's testimony, therefore, resulted in no prejudice to Janssen. Yet, as discussed above, Janssen's relevancy argument is based on the false premise that actual harm resulting from the deceptive conduct is a necessary element of an Attorney General directed claim.

16 It is for the same reason we reject Ja nssen's claim that the trial court erred by excluding the testimony of the twenty surv eyed physicians and evidence of the 2007 Zyprexa product insert and 201 0 Latuda product insert.E.

First Amendment

bility verdic t and the penalty awar ech. We disagree.

eserved this issue for review. Alth

ent jury instruction and raised the Janssen argues that the lia d impermissibly restrict its right to fr ee spe

Again, Janssen has not pr ough Janssen requested a First Amendm issue in its motion for JNOV, Janssen failed to raise any First Amendment issues in its motion for a

directed verdict. Janssen's failure to ra ise this issue in its motion for a directed verdict precludes any appellate review. In re McCracken , 346 S.C. 87, 93, 551 S.E.2d 235, 238 (2001) ("[S]ince only ground s raised in the directed verdict motion may properly be reasserted in th e jnov motion, and since no grounds were raised in the directed verdict motion, no jnov claim is preserved for our review." (citing Duncan v. Hampton Cnty. Sch. Dist. #2 , 335 S.C. 535, 545, 517 S.E.2d 449, 454 (Ct. App. 1999))).

There is no error in any event, for th e First Amendment does not bar imposition of liability on Janssen for violating SCUTPA. Janssen relies on the false premise that its conduct was not unfair and deceptive. While commercial speech is entitled to First Amendment protections, the Constitu tion does not erect a blanket shield insulating commercial speech from liability in all circumstances. In this regard, we

find Janssen's reliance on Sorrell v. IMS Health Inc. , 131 S. Ct. 2653 (2011), is misplaced. The Supreme Court of the United States held in Sorrell that "[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment." Id . at 2659. Sorrell , however, does not deal with deceptive comme rcial speech. Instead, the Sorrell Court invalidated a Vermont law that regulated the t ype of pharmacy records that a drug manufacturer could obtain and use in marketing prescription drugs. Id. at 2659. The State of Vermont never argued "that the provision challenged . . . will prevent false or misleading speech," nor did it argue that the detailing 17 at issue was "false

17 Pharmaceutical companies such as Janssen "promote their drugs to doctors through a process called 'detailing.' This often involves a scheduled visit to a doctor's office to persuade the doctor to prescribe a particular pharmaceutical. Detailers bring drug samples as well as medical studies that explain the 'details' and potential advantages of various prescription drugs." Sorrell , 131 S. Ct. at

2659.or misleading within the meaning of [t he Supreme] Court's First Amendment precedents." Id. at 2672. We do not construe Sorrell as foreclosing a state from prohibiting unfair and deceptive prescription drug marketing.

Indeed, it is a well-settled proposition that "[t]he government may ban forms of communication more likely to deceive the pub lic than to inform it, or commercial speech related to illegal activity." Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n of N.Y. , 447 U.S. 557, 563–64 (1980) (inter nal citations omitted). The State correctly notes that commercial speech is not protected by the First

Amendment unless it concerns lawful activity and is not misleading. Johnson v.

Collins Entm't Co. , 349 S.C. 613, 624, 56 4 S.E.2d 653, 659 (2002).

Here, the j ury found that Jan ssen's acts were unfair or deceptive, and thus unlawful

under SCUTPA. In an action at law tried to a jury, the jury's factual findings will

not be disturbed unless a review of the re cord discloses that there is no evidence that reasonably supports the jury's findings. City of North Myr tle Beach v. E. Cherry Grove Realty Co. , 397 S.C. 497, 502, 725 S.E. 2d 676, 678 (2012). The record is replete with evid ence that reasonably suppo rts a finding that Janssen's conduct was unfair and deceptive. Thus, we conclude Janssen may not avail itself of the protections of the First Amendm ent to shield itsel f from its deceptive conduct and false representations.

F. Jury Instructions

Janssen argues that the trial court erred by failing to charge the jury on federal law regarding "unfairness" and instead looking to South Carolina law to define the term. We disagree.

Modeled after the language of th e Federal Trade Commission Act (FTCA), 18
SCUTPA declares unlawful any unfair or de ceptive acts or practices in trade or

commerce. Compare 15 U.S.C. § 45(a)(1) (2012) (" Unfair methods of competition in or affecting commerce, and unfair or d eceptive acts or practices in or affecting commerce, are hereby declared unlawful."), with S.C. Code Ann. § 39-5-20(a) ("Unfair methods of competition and unfai r or deceptive acts or practices in the conduct of any trade or commerce are here by declared unlawful."). SCUTPA does not define the terms "unfair" and "decep tive"; rather, the legislature intended the

18 15 U.S.C. §§ 41–77 (2012).courts to be guided by federa l interpretations of those te rms. S.C. C ode Ann. § 39

- 5-20(b) (1985) (instructing South Carolin a courts to take guidance from "the interpretations given by the Federal Trad e Commission and the Federal Courts to § 5(a)(1)" of the FTCA); see also Wright v. Craft , 372 S.C. 1, 26, 640 S.E.2d 486, 500 (Ct. App. 2006) ("Whether an act or practice is unfai r or deceptive within the meaning of the [SC]UTPA depends on the surrounding facts and the impact of the transaction on the marketplace." (citing deBondt , 342 S.C. at 269, 536 S.E.2d at 407)).

To this end, our courts have interprete d those terms consistent with legislative

intent. "'An act is "unfair" when it is offensive to public policy or when it is immoral, unethical, or oppressive.'" Health Promotion Specialists, LLC v. South Carolina Bd. of Dentistry , 403 S.C. 623, 638, 743 S.E. 2d 808, 816 (2013) (quoting Gentry v. Yonce, 337 S.C. 1, 12, 522 S.E.2d 137, 143 (1999)). "'An act is "deceptive" when it has a tendency to deceive.'" Id. (quoting Gentry , 337 S.C. at 12, 522 S.E.2d at 143).

At trial, Janssen requested a jury instruc tion based on section 45(n) of the FTCA as it relates to determining whether an act or practice is "unfair." 19 Specifically,

Janssen asked the trial court to instruct th e jury that in order to find dissemination

of the November 2003 DDL to be an "unfair" trade practice, the jury must find "the act or practice causes or is likely to cause substantial in jury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition." 15 U.S.C. § 45(n) (2012). We find no error, and we view this assignment of error as closely aligned with Janssen's view that an Attorney General directed action will not lie in the absence of an actual loss or damage, a view which we reject. Nevertheless, while there is little evidence of actual harm, there is overwhelming evidence of Janssen's longstanding pattern of decepti on in pursuit of its goal to deceive prescribing physicians and the public, as well as maintain and increas e market share as a result

19 Section 45(n) of the FTCA prohibits the Federal Trade Commission (FTC) from declaring an act or practice to be "unfair" unless "the act or practice causes or is likely to cause substantial injury to c onsumers which is not reasonably avoidable by consumers themselves and not outwe ighed by countervailing benefits to consumers or to competition." 15 U.S.C. § 45(n) (2012). Further, in determining whether an act or practice is unfair, section 45(n) provides that the FTC may consider established public policy along w ith all other evidence, but such public policy considerations may not serve as the primary basis for a finding of

unfairness. Id

.of its deceptive practices.

Janssen also requested that the jury be inst ructed that a violation of public policy is not, in and of itself, a basis for finding Janssen's conduct to be an unfair trade practice and that a violation of public pol icy may not even be the primary basis upon which the jury based a finding of liability. According to Janssen, its requested jury instructions reflect the definition of "unfair" set forth in the FTCA, by which South Carolina courts are to be guided. We find no re versible error.

Although SCUTPA refers to the FTCA for guidance, we find that the language of section 39-5-20(b) of the South Carolina Code reveals that federal interpretations are persuasive but not binding authority. Our appellate courts have amassed a strong and consistent body of case law de fining "unfair" under SCUTPA. In the absence of a legislative res ponse, it would be inappropriate for this Court to depart from settled South Carolina precedent. Moreover, we do not discern the wide

chasm between the federal and state definitions of "unfair" that Janssen urges. We find that the jury instructions as give n correctly stated South Carolina law and afforded the proper test for determini ng whether Janssen's conduct was "unfair" under SCUTPA. Thus, we hold that the tr ial court did not abuse its discretion by declining to adopt Janssen's proposed jury instructions. See Pittman v. Stevens

, 364 S.C. 337, 340, 613 S.E. 2d 378, 379 (2005) ("The tria l judge is required to charge only the current and correct law of South Carolina." (citing McCourt v. Abernathy , 318 S.C. 301, 305, 457 S. E.2d 603, 606 (1995))).

G. Regulated Activity Exception to SCUTPA

Janssen claims that the State's labeli ng claim was barred by SCUTPA's regulated activity exemption. We hold that Jansse n has failed to preserve this issue for appellate review. Ho wever, even if we were to reach the merits, we would find

that Janssen is not entitled to avail itsel f of the regulated activity exemption.

SCUTPA expressly provides that it is inapplicable to "[ a]ctions or transactions permitted under laws administered by a ny regulatory body or officer acting under
statutory a uthority of this State or the United States." S.C. Code § 39-5-40(a) (1985). "This exception exempts an en tity from liability where its actions are lawful or where it does something require d by law, or does something that would otherwise be a violation of the Act, but which is allowed under other statutes or regulations." Dema v. Tenet Physician Servs. Hilton Head, Inc. , 383 S.C. 115,123, 678 S.E.2d 430, 434 (2009) (quotations omitted). Janssen argues that, after approval of a proposed label, the FDA both authorized and required the use of that approved label. Thus, Jan ssen argues that FDA approva l of the label triggers SCUTPA's regulated activity exemption and prohibits any claim in connection with the sufficiency of the label.

Initially, Janssen fails to identify any sp ecific trial court rulings claimed to constitute error. Because of this, Jan ssen's argument does not sufficiently identify with particularity the allege d error, and Janssen has aba ndoned its claim on appeal.

See Rule 208(b)(4), SCACR ("The brief shall contain references to the transcript, pleadings, orders, exhibits, or other mate rials which may be properly included in the Record on Appeal . . . to support the salie nt facts alleged. References shall also be made to where relevant objections a nd rulings occurred in the transcript."); see also First Sav. Bank v. McLean , 314 S.C. 361, 363, 444 S.E.2d 513, 514 (1994) ("Mere allegations of error are not sufficient to demonstrate an abuse of discretion. On appeal, the burden of showing abuse of discretion is on the party challenging the trial court's ruling." (citation omitted)).

However, even if Janssen ha d properly preserved this issue, we note that Janssen was not entitled to avail itself of this SCUTPA provision. Wyeth makes clear that "a central premise of federal drug regul ation [is] that the manufacturer bears responsibility for the content of its labe l at all times." 555 U.S. at 570–71. "[The manufacturer] is charged both with crafti ng an adequate labe l and with ensuring that its warnings remain adequate as long as the drug is on the market." Id . at 571 (citing 21 C.F.R. § 201.80(e); 21 C.F.R. § 314.80(b); 73 Fed. Reg. 49605). Wyeth clearly rejects the notion that a manufactur er's decision not to include a stronger warning is authorized by the FDA—absent evidence that the FDA affirmatively considered and rejected the stronger wa rning after being supplied with an evaluation or analysis of the specific dangers presented. Id . at 572–73. The very purpose of the "changes being effected " corollary to the FDCA authorizes manufacturers to strengthen the warnings on a label without FDA approval, as long as the manufacturer files a supplemental new drug application. Id . at 568; 21

C.F.R. § 314.70(c)(6)(iii)(A), (C) (2013). Indeed, the United States Supreme

Court in Wyeth noted that "Congress enacted th e FDCA to bolster consumer protection against harmful products. Co ngress did not provide a federal remedy for consumers harmed by unsafe or ineffec tive drugs in the [FDCA ]. Evidently, it determined that widely available state ri ghts of action provided appropriate relief for injured consumers." Id . at 574. Accordingly, Janssen cannot shield itself from liability by claiming that the FDA's approval of its label constituted an expressauthorization of its labeling decisions. See id . at 583 (Thomas, J., concurring in the judgment) ("[F]ederal law does not give drug manufacturers an unconditional right to market their federally approved drug at all times with the precise label initially approved by the FDA.").

H.

Statute of Limitations

Janssen claims that the trial court erred by granting the State's motion for a directed

verdict on the statute of limitations on the labeling claim and the DDL claim. We disagree concerning the DDL claim and affirm, but agr ee in part with Janssen regarding the labeling claim. The statut e of limitations bars the labeling claim insofar as the trial court imposed civil pe nalties for violations that occurred more than three years prior to the parties' tolling agreement. Because of the ongoing nature of Janssen's deceptive conduct, we affirm the judgment on the labeling

claim but lim it the imposition of civil penaltie s to a three-year period, coextensive with the statute of limitations, subject onl y to the additional period of time between the tolling agreement and the filing of the Complaint.

At the close of all of the evidence, the State moved for a directed verdict as to Janssen's statute of limitations defense, arguing that Janssen failed to present any evidence that the Attorney General's o ffice had actual or constructive notice of Janssen's unlawful conduct prior to the co mmencement of the three year statute of

limitations. 20 Specifically, the State argue d there was no evidence that the Attorney General, more than three years prior to the commencement of the statute of limitations on January 24, 2004, kne w or should have known about the deceptiveness of the DDL and the Risperda l label, the concealed studies, or the unlawful promotion of Risperdal in South Carolina.

The trial court granted the State's motion for a directed verdict, finding that neither the DDL claim nor the labeling claim wa s barred by the three-year statute of limitations. Specifically, the trial court noted that although the medical community at large was aware of the risk s associated with Risperdal, some even as early as the mid-1990s, the point in time at which th e side-effects of Risperdal became known was not the gravamen of the State's clai ms. Rather, the speci fic conduct at issue

20 The Complaint was filed on April 23, 20 07, but, as noted, the State and Janssen entered into a tolling agreement concerni ng the statute of limitations on January 24, 2007.was Janssen's false and misleading statemen ts in the DDL and Janssen's failure to update its label to reflect the known degree of risks associated with Risperdal. Accordingly, the relevant inquiry was th e point at which the State should have

known that Janssen's conduct as to the DDL and the Ri sperdal label was unfair or deceptive and, thus, gave rise to a SCUTPA claim.

As to the DDL claim, the trial court found that claim was not barred by the statute of limitations because there was no evidence that the false or misleading nature of

the DDL could have been discovered befo re the DDMAC issued its warning letter to Janssen in April 2004, wh ich was within the timeframe of the tolling agreement. As to the labeling claim, the trial court found that because Janssen took affirmative steps to prevent disclosure of unfavorable clinical trial results that revealed the serious degree of risks associated with Risperdal, the statute of limitations was equitably tolled during the period of time in which Janssen knew, but failed to disclose and shielded from public knowledge, the true degree of risks associated with Risperdal. The trial court found the labeling claim likewise was not barred by the statute of limitations, and awarded a civil penalty for each of the of 509,499 Risperdal "sample boxes" distributed in South Carolina from 1998 through the date of the Complaint, April 23, 2007, each of which included the drug label in the sample packaging.

Janssen argues this was error and that both claims are barred by the statute of

limitations because the State had actual or constructive knowledge of the claims before January 24, 2004. Specifically, as to the DDL claim, Janssen contends that

the claim was discoverable from the face of the DDL itself, and therefore, the statute of limitations began to run at the time the DDL was mailed in November 2003. As to the labeling claim, Janssen c ontends that claim is barred because the risks associated with Risperdal were wi dely known by the mid-1990s and that the alleged inadequacies in the labeling were apparent from th e face of the label itself; therefore, Janssen posits that the labels themselves put the State on notice of its labeling claim as early as 1994, and that th e three-year statute of limitations thus ran long before the State's Complaint was f iled in 2007. Janssen further argues the doctrine of equitable tolling should be spar ingly applied and that there is no basis for applying it here.

We first address the DDL claim. SCUTPA provides for a three-year statute of limitations. S.C. Code Ann. § 39-5-150 (1985). Under the discovery rule, the three-year clock starts ticking on the date the injured party either knows or should have known by the exercise of reasonable diligence that a cause of action arises from wrongful conduct. Dean v. Ruscon Corp. , 321 S.C. 360, 363, 468 S.E.2d645, 647 (1996) (citation omitted). We have carefully reviewed the record in light of the appropriate standard of review, an d we agree with the trial court. As a matter of law, the only reasonable conclu sion supported by the evidence at trial

was that the existence of a claim, i.e. the d eceptive and unfair nature of Janssen's conduct in disseminating the DDL, could not have reasonably been discovered prior to April 2004 when the FDA i ssued the Warning Letter to Janssen. 21 See id. at 366, 468 S.E.2d at 648 (finding that where the only reasonable conclusion supported by the evidence was that the laws uit accrued on a particular date, there was no issue for the jury to decide and a directed verdict was proper). We affirm the trial court's finding that the DDL claim was timely.

We turn to the labeling clai m. The procedural dilemma we confront is that the statute of limitations issue concerning th e labeling claim was resolved at trial through principles of equita ble tolling. A determination in equity is not proper for

a directed verdict motion insofar as dete rmining what matters should be submitted to the jury. It was therefore legal error to resolve the issue of equitable tolling pursuant to a directed verdict motion. Under our de novo review of this equitable issue, we agree with Janssen that there is an insufficient basis for application of that doctrine to preserve the timeliness of all labeling violations, reaching back to the time Risperdal was first introduced in 1994. See Hooper v. Ebenezer Sr. Servs.

& Rehab. Ctr. , 386 S.C. 108, 117, 687 S.E.2d 29, 33 (2009) (noting the doctrine of equitable tolling should be used sparingl y and only when the interests of justice demand its use). However, we do not view the error as one ma ndating reversal and a new trial, given the continuing nature of the accrual of labeling violations.

Clearly, much of the labe ling claim accrued more than three years prior to the January 24, 2007 tolling agreement. Th e risks associated with atypical antipsychotics, like Risperdal, were b ecoming well known by the late 1990s. The State's experts testified that the Risper dal label was inadequa te as early as 1994 when Janssen began marke ting the drug. By all accounts, in the early 2000s, evidence of the risks was pervasive. 22 We find that the only reasonable conclusion

21 Considerable argument is presented over whether the discovery rule should be analyzed through the person of the Attorney General or the typical approach of the reasonably prudent person. We need not decide the "relevant plaintiff" question and purported distinction between the two, for the result would be the same here.

22 This underscores Janssen's point that the community of prescribing physicians was well aware of the Risperdal risks, an d Janssen's resulting contention that thesupported by the evidence is that the A ttorney General knew, or most assuredly should have known, of potential SCUTPA vi olations regarding the Risperdal label prior to January 24, 2004. Thus, the labeli ng violations occurring prior to January 24, 2004, were therefore barred by the statute of limitations.

Nevertheless, the labeling claim presen ts ongoing violations of SCUTPA that

continued after January 24, 2004 and during the th ree-year-period prior to the tolling agreement. In requesting that the entire labeling claim be dismissed as time barred, Janssen assumes, wrongly so, that its ability to successfully invoke the statute of limitations to bar the labeling claim prior to January 24, 2004, ends the labeling claim altogether. We reject Ja nssen's position, for Ja nssen misapprehends the statute of limitations and the concept of continuous accrual of this SCUTPA cause of action. The labeling claim presen ts a series of discrete, independently actionable wrongs that are at the core of the typical unf air trade practice action. The principles of this type of continuous accrual respond to

the inequities that would arise if the expiration of the statute of limitations period following a first breach of duty or instance of

misconduct were treated as sufficien t to bar suit for any subsequent breach or misconduct; parties engage d in long-standing malfeasance would thereby obtain immunity in pe rpetuity from suit even for recent and ongoing malfeasance. In addition, where misfeasance is ongoing, a defendant's claim to repose, the principal justification underlying the limitations defense, is vitiated. . . . [Accordingly,] separate, recurring invasions of the same right can ea ch trigger their own statute of limitations. . . . Generally speak ing, continuous accrual applies

whenever there is a c ontinuing or recurring obligation: [w]hen an obligation or liability arises on a re curring basis, a cause of action accrues each time a wrongful act occu rs, triggering a new limitations period.

Aryeh v. Canon Bus. Solutions, Inc. , 292 P.3d 871, 880 (Cal. 2013) (quotations and citations omitted) (distinguishing the continuous accrual doctrine from the continuing violation doctrine, which involves a single injury that is the product of a series of small harms, any one of which is not actionable on its own). See Estate of Livingston v. Livingston , 404 S.C. 137, 147–48, 744 S. E.2d 203, 209 (Ct. App. 2013) (finding a new statute of limitations begi ns to run after each separate injury,

allegedly deceptive practices had little or no effect on the practice and frequency of prescribing Risperdal.and therefore statute of limitations barred only claims falling outside the three-year time period and did not bar claims occurring within that time), cert. granted , No. 2013-001505 (S.C. Sup. Ct . filed Oct. 24, 2014); see also Hogar Dulce Hogar v. Cmty. Dev. Comm'n of Escondido , 2 Cal. Rptr. 3d 497, 502 (Ct. App. 2003) ("When an obligation or liability arises on a recurring basis, a cause of action accrues each time a wrongful act occurs, triggering a new limitations period." (citation omitted)); cf. Anonymous Taxpayer v. S.C. Dep't of Rev. , 377 S.C. 425, 440–41, 661 S.E.2d 73, 81 (2008) (finding that, under the facts presented, the particular claim alleged by plaintiff constituted only one ca use of action, and therefore, there was no continuing injury that would trigger a new limitations period).

Indeed, the language of SCUTPA itself cont emplates that an unlawful method, act, or practice may result in multiple statutor y violations, and it is the violations themselves that cause the statute of limitations to begin to run. S.C. Code Ann. § 39-5-110(a) ("If a court finds that any pe rson is willfully using or has willfully used a method, act or pr actice declared unlawful by § 39-5-20, the Attorney General . . . may recover on be half of the State a civil penalty of not exceeding five

thousand dollars per violation ." (emphasis added)). We adopt the view that aligns with legislative intent as reflected in section 39-5-110, a common sense approach recognizing that the SCUTPA statute of lim itations begins to run anew with each violation. Thus, where a claim involves a series of ongoing violations, recovery is limited to a period coextensive with the applicable statute of limitations.

In sum, we agree with the State regarding the DDL claim, for we find that claim, in

the exercise of reasonable diligence, could have been discovered no earlier than April 2004 when the FDA issued its warning letter to Jan ssen. However, we agree with Janssen concerning the labeling claim insofar as civil penalties were awarded for violations occurring from 1998 until Ja nuary 24, 2004 (three years prior to the tolling agreement). Under these facts, it wa s error to award the State civil penalties

for violations in connection with the labeling claim outside the statute of limitations. An award for civil penalties within the statute of limitations was

proper.

I. Preemption

the labeling cl aim and the DDL claim are pree y, Janssen argue s the labeling claim is barred b Janssen argues that both mpted by federal law. Specificall y impliedconflict preemption and that the DDL cl aim is barred by the express preemption provision of the FDCA, 21 U.S.C. § 337(a) (2006). We disagree.

When "Congress has 'legislated . . . in a field which the States have traditionally occupied,' we 'start with the assumption th at the historic police powers of the States were not to be superseded by the Federal Act unless that was th e clear and manifest purpose of Congress.'" Medtronic, Inc. v. Lohr , 518 U.S. 470, 485 (1996) (quotations and citations omitted) (ellipses in original).

"In 1962, Congress amended th e FDCA and shifted the burden of proof from the

FDA to the manufacturer." Wyeth , 555 U.S. at 567. "Before 1962, the [FDA] had to prove harm to keep a drug out of the market, but the amendments required the

manufacturer to demonstrate that its dr ug was safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling before it could distribute the drug." Id. (quotations and citations omitted). "In addition, the amendments required the manufacturer to prove the drug's effectiveness by introducing substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use pres cribed, recommended, or suggested in the proposed labeling." Id. (quotations and citations omitted). "As [Congress] enlarged the FDA' s powers to protect the public health and assure the safety, effectiveness, and re liability of drugs, Congress took care to preserve state

law." Id . (quotations and citations omitted) . "The 1962 amendments [to the FDCA] added a saving clause , indicating that a provision of state law would only be invalidated upon a direct and pos itive conflict with the FDCA." Id. (quotations and citations omitted). "Consistent with that provision, state common-law suits 'continued unabated despite . . . FDA regulation.'" Id . (quoting Riegel v. Medtronic, Inc. , 552 U.S. 312, 340 (2008) (Gin sburg, J., dissenting)). 23

Based upon Wyeth , we find that the State's DDL cl aim is not expressly preempted by federal law. Additionally , we find that Janssen has not preserved their implied conflict preemption claim for appellate review. Even a ssuming Janssen's argument regarding implied preemption is not proce durally barred, however, we find it to be

without merit.

23 The FDA did not have the authority to mandate a manufacturer change its label

until amendments to the FDCA in 2007. 21 U.S.C. § 355(o)(4) (Supp. V 2011).1. Express Preemption of the DDL Claim

Janssen argues that the State's claim rega rding the DDL relies on a single piece of evidence—the April 2004 DDMAC warning le tter characterizing Janssen's DDL as "false and misleading." As such, Janssen asserts the DDL claim is based solely on a violation of the FDCA, which provides no private right of action. Janssen thus

concludes that this "federal claim" is preempted and may not be maintained. Because Janssen's argument is based on a false premise, we disagree.

It is true that the State pursued a SCUTPA claim based on the November 2003

DDL. It is also true that the St ate introduced the April 2004 DDMAC warning letter as evidence in support of its DDL claim. It is not true that the sole evidence establishing the false and misleadi ng nature of the DDL comes from the subsequent April 2004 DDMAC warning le tter. Janssen not only views the DDL claim myopically, but conflates the concepts of evidence and claims. There was substantial additional evidence relating to the deception surrounding the November 2003 DDL, much of which is noted above. For example, the State presented evidence that, scientific proof to the c ontrary, Janssen's Risperdal sales strategy specifically sought to differentiate Risperdal from competing drugs by emphasizing that Risperdal caused less we ight gain relative to other atypical antipsychotics such as Zyprexa.

Moreover, the State presented internal em ails between Janssen executives, one of

which included discussion of Janssen's desire to gain market share over competitors by avoiding being subjected to a class labeling requirement as to diabetes/hyperglycemia. Yet another ema il indicated that at least one Janssen scientist supported glucose screening and monitoring for Risperdal patients, but that such a position was "not the company line." Janssen's broad, aggressive, and deceptive marketing strategy resulted in the discrete DDL claim. In short, the record is replete with evidence beyond the 2004 DDMAC warning letter to support the State's DDL claim. Further, at the end of trial, the jury was charged with determining several factual issues, ea ch of which was based solely on the provisions of SCUTPA, and the trial judge assessed pena lties under SCUTPA framework. Accordingly, we find that the State's SCUTPA claim concerning the DDL is not preempted by the FDCA.2. Implied Conflict Preemption of the Labeling Claim

Janssen argues that the State's labeli ng claim is barred by implied conflict preemption. Janssen failed to raise the do ctrine of implied conflict preemption in its motion for summary judgment or its initial directed verdict motion at the close of the State's case-in-chief. Accordingl y, this argument was waived because it was

not asserted in Janssen's initial motion for directed verdict. 24 See Freeman v. A. & M. Mobile Home Sales, Inc. , 293 S.C. 255, 258–59, 359 S.E. 2d 532, 535 (Ct. App. 1987).

Additional ly, Janssen's argum ent on appeal is substantively different than the argument below. Before the trial court, Janssen moved for a directed verdict, arguing that the Wyeth "exception to preemption" did not apply since the State

failed to establish that Ja nssen could have, and should have, updated the Risperdal label without prior FDA appr oval. Given this purporte d failure of proof, Janssen argued that the State's labeling claim was preempted. The trial court rejected Janssen's argument and found that Wyeth was controlling. In contrast, Janssen now argues that the State's SCUTPA claims sought to impose labeling requirements different from those required by the FD A, and thus, according to Janssen, the doctrine of implied conflict preemption bars the State's claims. This argument, however, is not preserved for appellate review. See Dunbar , 356 S.C. at 142, 587 S.E.2d at 694 ("A party may not argue one ground at trial and an alternate ground on appeal." (citing Prioleau , 345 S.C. at 411, 548 S.E.2d at 216; Benton , 338 S.C. at 157, 526 S.E.2d at 231)).

Nonetheless, even were we to find Jan ssen's argument not to be procedurally barred, we would find it is without merit. Janssen suggests that the State sought to impose labeling requirements different th an those imposed by the FDA. The State's claim, however, did not seek to penalize Janssen for distributing its FDA

24 Notably, Janssen did ra ise express preemption as to the DDL in its initial directed verdict motion. However, c ounsel for Janssen candidly acknowledged in

its renewed directed verdict motion at th e close of the evidence, "[W]e have an argument that hasn't been made by us befo re, and that is that the package insert claim, the claim dealing with the label, is preempted by federa l law." Further, counsel for Janssen stated, "We're argui ng something quite different that we haven't argued before. We haven't [previously] argued about Wyeth against

Levine."approved label. Rather, the State sought civil penalties based on Janssen's actions in failing to discharge its ongoing, affirm ative duty to keep its label updated and ensure "that its warnings remain adequate as long as the drug is on the market." Wyeth , 555 U.S. at 571 (citing 21 C.F.R. § 201.80(e); 21 C.F.R. § 314.80(b); 73 Fed. Reg. 49605).

Further, we reject Janssen's argument that Wyeth is inapposite because this case involves an enforcement action by the Attorn ey General on behalf of the State. Regardless of whether a state-law enfo rcement action is brought by a private individual or an attorney general on behalf of a state, Wyeth makes clear that federal labeling standards are "a floor u pon which States could build" and noted the FDA's agency position that, "in establis hing minimal standards for drug labels, it did not intend to preclude the stat es from imposing additional labeling requirements." Id . at 577–78 (quotations omitted). Rather, "[f]ailure-to-warn actions, in particular, lend force to the FD CA's premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times." Id . at 579. Indeed, "federal law does not give dr ug manufacturers an unconditional right to market their federally approved drug at a ll times with the precise label initially approved by the FDA." Id . at 583 (Thomas, J. concu rring in the judgment).

Janssen's claim is without merit.

Having affirmed the trial court concerni ng Janssen's liability in connection with both the labeling claim and the DDL claim, we turn now to the penalty award. 25

25 Janssen raises a number of other issu es, each of which we have carefully

reviewed and find to be without merit or unpreserved. We a ffirm based upon Rule 220(b)(1), SCACR, and the following authorities : Fields v. J. Haynes Waters Builders, Inc. , 376 S.C. 545, 557, 658 S.E.2d 80, 86 (2008) (holding that in order to warrant reversal, the appe aling party must show both the error of the ruling and resulting prejudice) (citing Fields v. Reg. Med. Ctr. Orangeburg, 363 S.C. 19, 26, 609 S.E.2d 506, 509 (2005)); Webb v. CSX Transp., Inc. , 364 S.C. 639, 655, 615 S.E.2d 440, 449 (2005) (finding the failure to raise a contemporaneous objection at trial waives the right to complain about an issue on appeal) (citing Taylor v. Medenica, 324 S.C. 200, 214 n.9, 479 S. E.2d 35, 42 n.9 (1996)); Futch v. McAllister Towing of Georgetown, Inc. , 335 S.C. 598, 613, 518 S.E.2d 591, 598 (1999) (noting that an appellate court need not address remaining issues when disposition of prior issues is dispositive) (citing Whiteside v. Cherokee Cnty. Sch.
Dist. No. One, 311 S.C. 335, 340, 428 S.E.2d 886, 889 (1993)); Wilder Corp. v.

Wilke , 330 S.C. 71, 76, 497 S.E.2d 731, 733 (1998) ("[A]n objection must beIII. Penalty Award

SCUTPA allows the Attorney General to recover on be half of the State a civil penalty of up to $5,000 per violation. S.C. Code Ann. § 39-5-110(a). Undoubtedly, Janssen's deceptive conduct re lating to Risperdal warrants a civil penalty, and because the civil penalty aw ard under section 39-5-110(a) is within the discretion of the trial court, we revi ew the trial court's penalty award under an

abuse of discretion standard. State ex rel. McLeod v. C & L Corp., Inc. , 280 S.C. 519, 528, 313 S.E.2d 334, 340 (Ct. App. 1984) ("Th e party challenging a discretionary ruling of the trial court ha s the burden of showing a clear abuse of discretion."); accord Vanderbilt Mortg. & Fin., Inc. v. Cole , 740 S.E.2d 562, 566 (W.Va. 2013) (holding a trial court's award of civil penalties pursuant to state statute will not be disturbed on appeal unless it clearly appears the trial court abused its discretion).

The Stat e argued, and the trial court agr eed, that the distribution of each sample box containing the deceptive labeling, each DDL, and each follow-up sales call to the DDL by a Janssen representative cons tituted a separate SCUTPA violation. The trial court adopted a multi-factor te st used by the United States Court of Appeals for the Third Circuit in determini ng an appropriate civil penalty: "(1) the good or bad faith of the defendants; (2) the injury to the public; (3) the defendant's ability to pay; (4) the desire to eliminate th e benefits derived by a violation; and (5) the necessity of vindicating the author ity of [the regula tory agency]." United States v. Reader's Digest Ass'n, Inc. , 662 F.2d 955, 967 (3d Cir. 1981). 26

sufficiently specific to inform the trial court of the point being urged by the objector." (citation omitted)); Talley v. South Carolina Higher Educ. Tuition

Grants Comm. , 289 S.C. 483, 487, 347 S.E.2d 99, 101 (1986) ("It is an axiomatic rule of law that issues may not be rais ed for the first time on appeal." (citing Am. Hardware Supply Co. v. Whitmire , 278 S.C. 607, 609, 300 S.E.2d 289, 290 (1983))); Eaddy v. Smurfit-Stone Container Corp. , 355 S.C. 154, 164, 584 S.E.2d 390, 396 (Ct. App. 2003) ("[S]hort, c onclusory statements made without supporting authority are deemed abandoned on appeal and therefore not preserved for our review." (citing Glasscock, Inc. v. U.S. Fid. & Guar. Co. , 348 S.C. 76, 81, 557 S.E.2d 689, 691 (C t. App. 2001))).

26 Application of the Reader's Digest factors was proper here. Given that this is our first opportunity to address the appropr iate factors for assessing a civil penaltyJanssen challenges the penalty award on numerous grounds, including the argument that the total penalty, in excess of $327,000,000, is ex cessive. We agree with Janssen in part. There are certain factors common to the labeling and DDL claims. First, Janssen's deceit was substant ial. In order to maintain its market share, Janssen's furtive efforts to mislead prescribing physicians about the risks and side effects associated with Risperdal we re reprehensible and in callous disregard for the health and welfare of the public. Janssen's desire for market share and

increased sales 27 knew no bounds, leading to its egregious violation of South Carolina law, particularly in connecti on with the DDL. Janssen's conduct is irrefutably linked to its longstanding e fforts to conceal the truth regarding Risperdal. This corrupt corporate culture through th e years was a factor, and understandably so, in the trial court's im position of such a substantial penalty.

We agree in part with Janssen that its conduct had little impact on the community of prescribing physicians. The truth a bout the risks associated with atypical antipsychotics was well known, particular ly in the pharmaceutical and medical professions. This begs the question of why Janssen would go to such lengths to perpetuate and defend a lie. Whatever the answer, the point remains that Janssen did go to such lengths. Yet, the absence of significant actual harm resulting from Janssen's deceptive conduct leads us to concl ude the trial court erred in part in its penalty assessment.

in an Attorney General directed claim under SCUTPA, we direct that, prospectively, the following list of non-excl usive factors be used in assessing civil penalties under SCUTPA: (1) the degree of culpability and good or bad faith of the defendant; (2) the duration of the de fendant's unlawful conduct; (3) active concealment of information by the defenda nt; (4) defendant's awareness of the unfair or deceptive nature of their conduct; (5) prior similar conduct by the defendant; (6) the defendant's ability to pay; (7) the deterrence value of the assessed penalties; and (8) the actual impact or injury to the public resulting from

defendant's unlawful conduct. We further authorize our able trial judges to consider any other factors they deem a ppropriate under the circumstances. In issuing a ruling, the trial court should ma ke sufficient findings of fact concerning

all relevant factors to en able appellate review.

27 Since 1994, Risperdal sales approximated $30 billion.A. Violations and Reduced Civil Penalty

1. Labeling Claim

The trial court assessed a $300 civil penalty against Janssen for each Risperdal "sample box" distributed to South Caro lina prescribers from 1998 through the date of the Complaint, April 23, 2007, for a total of 509,499 violations. As discussed, we reverse the civil penaltie s awarded for conduct that occurred prior to January 24, 2004, for that part of the State's la beling claim is barred by the statute of limitations. Based on the record, durin g the period of time from February 2004 until the filing of the Complaint in Apr il of 2007, Janssen made 20,575 visits to prescribing physicians in South Carolina and distributed 345,454 sample boxes containing deceptive labeling. 28

Janssen challenges the penalty award of $300 pe r sample box on numerous grounds, including the argument that the pe nalty is excessive. We agree and find the $300 penalty per sample box excessi ve. Based on the totality of the

circumstances and consideration of the Reader's Digest factors, we remit the penalty to $100 per sample box, fo r a civil penalty of $34,545,400.

2.

DDL Claim

Janssen mailed 7,184 DDLs to South Caro lina physicians in November 2003. The trial court considered each letter a sepa rate violation and imposed a penalty of $4,000 per letter, for a penalty of $28,736,000. In additi on, the trial court counted each follow-up sales call to the DDL by a Janssen representative as a separate violation. There were 36,372 follow-up sa les calls. The trial court again assessed a penalty of $4,000 for each sales call, for a penalty of $145,488,000.

Janssen challenges the penalty award on numerous grounds, including

excessiveness. While the question presented is close, we cannot say that the trial

28 We arrive at this number based on documents submitted by Janssen showing the total samples distributed and the total numbe r of visits to prescribing physicians. (20,575 visits times 16.79 sample boxes per visit equals a total of 345,454.25 sample boxes, rounded to 345,454).court abused its discretion in assessing th e $28,736,000 penalty associated with the 7,184 DDLs. A $4,000 penalty pe r each DDL is indeed subs tantial. But Janssen's deceit, as described above, was also substantial. The DDL was especially egregious, for it represented not mere nondi sclosure but a corporately sanctioned decision to affirmatively lie and an atte mpt to mislead the medical community. We affirm the civil penalty of $28,736, 000 penalty associated with the 7,184

DDLs.

Janssen's misconduct in the more than 36, 000 follow-up visits may be similarly viewed, for the follow-up visits were designe d to continue the fa lse DDL narrative. Nevertheless, a penalty of $4,000 per follo w-up visit is excessive as a matter of

law under the circumstances. We find in most instances, these were follow-up calls to the same prescribing physicians w ho received the DDL in the mail. In fact, in many instances there we re multiple calls to the same physicians. We remit the penalty to $2,000 per follow-up sales call, for a penalty of $72,744,000. When combined with the penalty for the DDL ma iling, the total penalty assessed against Janssen for the DDL claim is $101,480,000.

The combined civil penalty for the labeling and DDL claims is $136,025,400.

B. Constitutionality of the Penalty Award

Janssen also raises a number of constitutional challenges to the trial court's penalty order. First, Janssen claims that th e $327 million penalty violates the Excessive Fines Clause of the Eighth Amendment to the U.S. Constitution and Article 1,

Section 15 of the South Carolina Constituti on. Second, Janssen claims that the penalty award violates due process becaus e it is grossly excessive. We analyze this argument on the basis of the rem itted penalty of approximately $136 million.

We find no constitutional violation.

"The touchstone of the constitutional inquiry under the Excessive Fines Clause [of the U.S. Constitution] is the principle of proportionality: The amount of the forfeiture must bear some relationship to the gravity of the offense that it is designed to punish." United States v. Bajakajian , 524 U.S. 321, 334 (1998); see also Medlock v. One 1985 Jeep Cherokee VIN 1JCWB7828FT129001 , 322 S.C. 127, 132, 470 S.E.2d 373, 377 (1996) (adopting the federal "instrumentality" standard in the context of civil forfeitures for purposes of South Carolina's "excessive fines" analysis). The Court will only find a violation of the ExcessiveFines Clause if the penalty is " grossly disproportional to the gravity of a

defendant's offense." Bajakajian , 524 U.S. at 334 (emphasis added). "The Ninth

Circuit and other federal cour ts have consisten tly found that civil penalty awards in

which the amount of the award is less than the statutory maximum do not run afoul

of the Excessive Fines Clause." United States v. Mackby , 221 F. Supp. 2d 1106, 1110 (N.D. Cal. 2002) (citing cases from the Firs t Circuit, Ninth Circuit, and D.C. Circuit). This is so because legislativ e pronouncements regarding the proper range of fines "represent the collective opinion of the American people as to what is and

is not excessive. Given that excessive ness is a highly subjective judgment, the courts should be hesitant to substitute their opinion for that of the people." United States v. 817 N.E. 29th Drive, Wilton Manors, Fla. , 175 F.3d 1304, 1309 (11th Cir. 1999) (citing Bajakajian , 524 U.S. at 336).

We find that the penalty in this case, now reduced, bears a rational relationship to the gravity of Janssen's conduct in perp etuating a marketing scheme in South Carolina designed to be unfair and decep tive under our law. Furthermore, the penalty awards per violation are within th e range set by the legislature in enacting SCUTPA. Accordingly, th e penalty award is not grossly disproportionate to Janssen's pattern of unfair and deceptive behavior, and, thus, we hold that the

award does not violate the Excessive Fine s Clause of the South Carolina or the

United States Constitution. We turn now to Janssen's due process argument.

The Due Process Clause of the U.S. Constitution "places a limitation upon the power of the states to prescribe penalties for violations of their laws . . . ." St.
Louis, Iron Mt. & S. Ry. Co. v. Williams , 251 U.S. 63, 66 (1919). States, however, "still possess a wide latitude of discretion in the matter, and . . . their enactments transcend the limitation only where the pe nalty prescribed is so severe and oppressive as to be wholly dispr oportioned to the offense and obviously

unreasonable." Id. at 66–67 (citations omitted); see also Shipman v. Du Pre , 222

S.C. 475, 480, 73 S.E.2d 716, 718 (1952) (embracing the Williams standard).

Given the evidence that demonstrates Ja nssen's pattern of unfair and deceptive behavior, we find that the penalties in this case are not violativ e of the Due Process Clause. We decline to set forth a bright-lin e rule or ratio to delineate what level of penalties are appropriate, instead undertak ing a case-by-case determination based on the severity of the underlying conduct. While the penalty award against Janssen is quite large, the penalty must be anal yzed in context in view of the clear legislative intent of SCUTPA to deter unfair and deceptive behavior in the conductof trade and commerce in South Carolina. When all factors are considered, we find that the penalty award does not violate the Due Process Clause.

And finally, we comment on the amicus curiae brief filed by the South Carolina

Chamber of Commerce. The Chamber seek s clarity from this Court to provide a predictable and favorable business climate in this state. The Ch amber is especially distressed by the $327 million penalty, which it views as excessive and as "overt hostility toward business." While we agre e the penalty awarded by the trial court was excessive, the Chamber's additional concerns are based on a series of false premises. The Chamber posits that Janssen's conduct is being "judged according to subjective, intangible standards." More to the point, the implication is that South Carolina stands alone in arbitrarily singling-out Janssen for what amounts to nothing more than an aggressi ve marketing strategy. That is simply not the case. Because of its deceptive condu ct in the marketing of Ri sperdal, Janssen has been the subject of litigation throughout the country. Indeed, the deceptive marketing that gave rise to this action also formed the basis of federal civil and criminal claims against Janssen and its parent co mpany; the federal litigation has thus far resulted in agreed upon penalties in ex cess of $2 billion. When viewed objectively, Janssen over the course of ma ny years consciously engaged in lies and deception in the marketing of Risperdal. Thus, the suggestion that the Attorney

General of South Carolina stands alone in pursuing amorphous and subjective claims against Janssen is without merit. Surely the Chamber de sires a legal system

that honors the rule of law and one wh ich does not insula te businesses from liability for unfair and deceptive practices . Our decision today is faithful to objective legal principles, legislative inte nt in SCUTPA and the rule of law. Moreover, we have set forth clear guida nce for the business community, the Bench and the Bar for determining what conduc t is actionable under SCUTPA and what

factors bear on the determination of an a ppropriate penalty—precisely the type of clarity the Chamber seeks.IV.

Conclusion

Based on the statute of limitations, we re verse the judgment on labeling claim to

the extent the trial court awarded civil penalties for conduct prior to January 24,

2004. We otherwise affirm as modified the judgment on the labeling claim and remit the civil penalty to $34,545,400. We affirm the liability judgment on the DDL claim, but remit those civil penalties to $101,480,000. We remand to the trial court for entry of judgment in the amount of $136,025,400.

AFFIRMED IN PART, REVERS ED IN PART AND REMANDED

.

TOAL, C.J., BEATTY, and HEARN, JJ., co ncur. PLEICONES, J., dissenting in a separate opinion.JUSTICE PLEICONES : With great respect for the majority's thorough treatment of these complex issues, I dissent from thos e portions of its opinion addressing: (1) the timeliness of the labeling claim; a nd (2) the reduction of the DDL penalty

award.

I. Statute of Limitations

I agree the Attorney General knew or s hould have known prior to January 24, 2004 that he may have had a SCUT PA claim against Janssen ba sed, in part, on research indicating Janssen's Risperdal label misl ed consumers insofar as it failed to disclose the drug's side effects. See Kreutner v. David , 320 S.C. 283, 285–86, 465 S.E.2d 88, 90 (1995) (discussing the discove ry rule for purposes of triggering the limitations period and finding that wh ere the evidence is overwhelming a reasonable person should have known she mi ght have a claim at a time beyond the statute of limitations, then such claim is time-barred). I therefore agree with the majority's conclusion that the Attorn ey General's SCUTPA claim for labeling violations occurring before January 24, 2004 was time-barred, and that the trial judge erred in holding equita ble tolling removed the bar.

My disagreement is with the majority 's application of the continuous accrual doctrine. I would not apply the doctrine in this appeal because doing so does not affirm the statute of limitations ruling to the extent the trial judge found the preJanuary 24, 2004 labeling claim timely and pe rmitted that claim to go to the jury. In my opinion, we may invoke our authority to affirm on any ground appearing in the record only when the result is to affirm the trial judge's ruling in toto. See Rule 220(c), SCACR. Here, the effect of a pplying the continuous accrual doctrine is only a partial affirmance. Further, we have no way of knowing whether the jury's liability determination was ba sed on conduct outside the limitations period since we cannot know whether this jury woul d have found a SCUTPA violation had it considered only Janssen's labeling conduct after January 24, 2004. I do not agree that reducing the amount of the penalty fo r the labeling claim cures the prejudice to Janssen given the unreliability of the ju ry's liability determination. Thus, I respectfully submit we should not apply the continuous accrual doctrine 29 in this appeal as doing so prejudices Janssen.

Accordingly, I would reverse the jury's finding of liability because the labeling

29 I leave for another day whether we should adopt this doctrine in the context of SCUTPA or other statutory claims.claim is barred by the statute of limitations. I would also reverse the trial judge's labeling claim penalty because the claim is untimely.

DDL Penalty Award

As for the reduction of the DDL penalty aw ard, I would find the trial judge did not abuse his discretion in awarding $174, 224,000 based on Janssen mailing 7,184 deceptive DDLs and following up with 36, 372 sales calls to sanction the deception already perpetrated. See State ex rel. McLeod v. C & L Corp. , 280 S.C. 519, 528, 313 S.E.2d 334, 340 (Ct. App. 1984) (reviewing the awar d of civil penalties under an abuse of discretion standard). As for Janssen's contention that the follow-up sales calls were made to the same pres cribing physicians who had already received the DDL, I would find the trial judge properly considered this argument and

exercised his discretion in fi nding Janssen's culpability ( Reader's Digest 30 Factor 2) outweighed the actual impact or injury resulting from Jansse n's unlawful conduct ( Reader's Digest Factor 8).

Ultimately, the trial judge was in the be st position to evaluate Janssen's conduct, the degree of culpability, the duration of Janssen's conduct, Janssen's active concealment of Risperdal's side effects to South Carolina health care providers, Janssen's awareness of its deceptive cond uct, Janssen's ability to pay, and the actual impact, if any, resulting fr om Janssen's deceptive conduct. See Reader's Digest Ass'n , 662 F.2d at 967. Based on the tr ial judge's articulation of the Reader's Digest factors and his proper consideration of those factors, I would find

Janssen has not shown the court abused its discretion in awarding a $174,224,000 civil penalty for the DDL claim, an amount within the limits set forth in SCUTPA.

See Wallace v. Timmons , 237 S.C. 411, 421, 117 S.E.2d 567, 572 (1960) (stating that in reviewing a trial judge's decision under an abuse of discretion standard, this Court may not substitute its judgment si mply because it might have reached a

different conclusion had it been in the trial judge's place). Therefore, I would affirm the trial judge's penalty awar d of $174,224,000 as to the DDL claim.

30 United States v. Reader's Digest Ass'n , 662 F.2d 955, 967 (3d Cir. 1981) (outlining the multi-factor analysis to determine the propriety of a statutory penalty, which the trial judge applied, th e majority has adopted, and with which I concur).