GUIDRY, Justice.
The Attorney General for the State of Louisiana brought an action against the defendant pharmaceutical companies alleging inter alia certain violations of the Louisiana Medical Assistance Programs Integrity Law ("MAPIL"). Following trial in September 2010, the district court entered a judgment upon the jury's verdict in favor of the Attorney General finding the defendants' alleged misconduct in marketing certain drugs had violated provisions of MAPIL as it read in November 2003, and awarding civil penalties of $257,679,500.00, attorney fees of $70,000,000.00, and costs in the amount of $3,000,200.00. The court of appeal affirmed the district court's judgment. We granted the writ applications of both the Attorney General and the defendants to determine the correctness of the lower courts' rulings. For the reasons set forth below, we find the Attorney General failed to establish sufficient facts to prove a cause of action against the defendants under MAPIL because no evidence was presented that any defendant made or attempted to make a fraudulent claim for payment against any Louisiana medical assistance program within the scope of MAPIL. Accordingly, we reverse the district court's judgment in favor of the Attorney General.
The Attorney General filed the instant suit in September 2004 against Janssen Pharmaceutica, Inc., and Johnson & Johnson (hereinafter, "defendants"), asserting various legal theories of recovery stemming
In its suit, the Attorney General alleged the defendants "knowingly misrepresent[ed]" that Risperdal was "safer and/or more effective" than other antipsychotics. Further, the Attorney General alleged: that the defendants' marketing misrepresentations affected the decisions of prescribing physicians, who relied upon the misleading information disseminated by the defendants; that the defendants knew that many of the prescriptions written for Risperdal would be paid for by Louisiana's Medicaid program; that the State would not have purchased, or reimbursed for, Risperdal had it known of the defendants' misrepresentations; and that the State had suffered actual damages "in excess of one thousand dollars" related to misrepresentations made by the defendants in the marketing of Risperdal.
Risperdal was introduced in 1994 as a second-generation or atypical anti-psychotic, and is considered to be highly beneficial in permitting schizophrenia patients consigned to institutional care to return to living more productive lives. The defendants do not dispute that Risperdal, like other atypical antipsychotics, has the potential for serious side effects, but such side effects, including new onset diabetes, are generally fewer and milder, and more treatable, than first generation antipsychotics. In May 2000, the Federal Food and Drug Administration ("FDA") asked all manufacturers of atypical antipsychotics to conduct a comprehensive data review for a possible association between such drugs and new onset diabetes. The defendants responded in August 2000 with fifteen volumes of data arising out of 66 clinical trials involving more than 11,000 Risperdal patients. The defendants maintained that the clinical trials, supported by epidemiologic review and patient monitoring, showed a low incidence of diabetes and related conditions in patients taking Risperdal. The FDA took no action on the defendants' submission until September 2003, some three years later.
The Attorney General's case begins with the FDA's action in September of 2003, when the FDA notified all manufacturers of atypical antipsychotics, not only the defendants, that new class warnings would be required to be included on the drug labeling to advise health care providers and the public of the increased risk of hyperglycemia and diabetes-related adverse events associated with this class of drugs. The defendants, believing a uniform class warning to be unjustified, thereafter corresponded with the FDA to attempt a negotiation of certain aspects of the warning to be required for Risperdal, succeeding only in part.
Additionally, the FDA required all atypical antipsychotic drug manufacturers to send out a letter to all health care providers nationwide (a type of correspondence referred to in the drug manufacturing industry as a "Dear Health Care Provider" letter (hereinafter, "DHCP letter")) to advise of the label change.
On November 10, 2003, the defendants sent out a DHCP letter stating the FDA had requested all manufacturers of atypical antipsychotics, including Risperdal, to include a class warning label regarding hyperglycemia and diabetes mellitus in their product labeling and to enclose updated prescribing information for Risperdal (generically known as "risperidone"). The November 10, 2003 DHCP letter included the diabetes class warning label within the attached prescribing information,
These additional statements arguably constituted off-label statements, and they are the subject of the Attorney General's contention that the defendants engaged in misrepresentation in an attempt to defraud Medicaid by failing to truthfully and fully disclose information required under MAPIL.
On April 19, 2004, after a review of the defendants' November 10, 2003 DHCP letter, the FDA's Division of Drug Marketing, Advertising and Communications ("DDMAC") sent a "warning" letter to the defendants, directing the defendants to deliver corrective information about Risperdal, relating to hyperglycemia and diabetes, to the recipients of its DHCP letter.
The July 21, 2004 correction letter further stated that hyperglycemia and diabetes warnings had been added to the product labeling in November 2003; the entire text of that FDA-required warning (set forth above) was also quoted in the correction letter. The FDA's DDMAC closed the matter in October 2004 without taking any further action.
The matter went to trial on the issue of whether the defendants had any liability, under MAPIL, arising out of their dissemination of the off-label statements contained in the November 10, 2003 DHCP letter to Louisiana health care providers. The district court, interpreting MAPIL and its application to the Attorney General's allegations, found that "if [the Attorney General and the State] prove false, misleading, misrepresentative, deceitful, intent to defraud type statements, attempts to defraud type statements, that in and of itself is the causation [] needed" for the defendants to be liable for civil penalties. Following trial held in September and October of 2010, the jury via interrogatories found the following: the defendants "knowingly presented or caused to be presented a false or fraudulent claim in violation of [MAPIL];" the defendants "knowingly engaged in misrepresentation to obtain, or attempt to obtain, payment from the Medical Assistance Program Funds in violation of [MAPIL]"; the defendants "conspired to defraud, or attempted to defraud, the Medical Assistance [Program Funds] through misrepresentation or by obtaining or attempting to obtain, payment for a false or fraudulent claim in violation of [MAPIL]." Finding the State was entitled to recover civil penalties, the jury found 35,146 violations of MAPIL (this number consisted of the 7,604 copies of the November 10, 2003 DHCP letter mailed to Louisiana health care providers, and 27,542 sales calls made by sales representatives on Louisiana doctors during the ensuing nine-month period; the Attorney General had contended that each letter and sales call was a separate violation of MAPIL). Without finding any evidence of actual damages sustained by the State, the jury assessed a civil penalty of $7,250.00 per violation. The jury apportioned 90% liability to Janssen Pharmaceutica and 10% to Johnson & Johnson.
The district court on March 9, 2011 signed a judgment in favor of the Attorney General and against the defendants in the following amounts: $257,679,500.00, with legal interest from the date of the jury's October 14, 2010 verdict; $70,000,000.00 in attorney fees; $3,000,200.00 in costs and expenses; and legal interest on the attorney fees and costs from the date of the district court's February 11, 2011 oral reasons and rendition of judgment on those issues.
Both the Attorney General and the defendants appealed the district court's judgment to the court of appeal, which affirmed the judgment in its entirety. See Caldwell ex rel. State v. Janssen Pharmaceutical, Inc., 2011-1184 (La.App. 3 Cir. 8/31/12), 100 So.3d 865. Thereafter, on the application of both the Attorney General and the defendants, this court granted writs to determine the correctness of the lower courts' rulings. See Caldwell ex rel. State v. Janssen Pharmaceutical, Inc., 2012-2447, 2012-2466 (La.1/18/13), 107 So.3d 620.
The defendants maintain the district court erred in entering judgment against them because the trial record is insufficient to establish a violation of MAPIL. Their argument, raised in a motion for summary judgment and at trial, centers on their position that Subsections A, B, and C of La.Rev.Stat. 46:438.3 do not apply to the improper marketing or labeling conduct challenged by the Attorney General, because there is no evidence the defendants presented or caused to be presented any false claim or misrepresentation for payment out of medical assistance program funds. The Attorney General contends this interpretation ignores the broad purpose of MAPIL, which is to protect the fiscal and programmatic integrity of the medical assistance programs from health care providers and other persons who engage in fraud, misrepresentation, abuse or other ill practices to obtain payments to which these health care providers and other persons are not entitled. The Attorney General contends the defendants, based on their misrepresentations, fraudulently received payments, or attempted to seek payment for a claim.
Thus, the issue presented is twofold: the interpretation and applicability of MAPIL and La.Rev.Stat. 46:438.3. Accordingly, the interpretative aspect of this case presents us with a question of law, which is reviewed by this court under a de novo standard of review. First Nat. Bank, USA v. DDS Const., LLC, 11-1418, p. 11 (La.1/24/12), 91 So.3d 944, 952; Broussard v. Hilcorp Energy Co., 09-0449, p. 3 (La.10/20/09), 24 So.3d 813, 815-816; Louisiana Municipal Ass'n v. State, 04-0227, p. 35 (La.1/19/05), 893 So.2d 809, 836. We need not give deference to the legal conclusions made by the courts below, because this court is the ultimate arbiter of the meaning of the laws of this state. Id.; Broussard, 09-0449, p. 3, 24 So.3d at 816; Cleco Evangeline, LLC v. Louisiana Tax Com'n, 01-2162, p. 3 (La.4/3/02), 813 So.2d 351, 353.
It is a fundamental principle of statutory interpretation that "[w]hen a law is clear and unambiguous and its application does not lead to absurd consequences, the law shall be applied as written, and no further interpretation may be made in search of the intent of the legislature." La. Civ.Code art. 9 (2004); McLane Southern, Inc., pp. 5-6, 84 So.3d at 483; Conerly v. State, 97-0871, p. 3-4 (La.7/8/98), 714 So.2d 709, 710-11. When the language of the law is susceptible of different meanings, it must be interpreted as having the meaning that best conforms to the purpose of the law, and the words of law must be given their generally prevailing meaning. La. Civ.Code arts. 10 and 11 (2004); Lockett, 03-1767 at p. 4, 869 So.2d at 91; Ruiz v. State, 97-2412, p. 4 (La.5/19/98), 713 So.2d 442, 444. When the words of a law are ambiguous, their meaning must be sought by examining the context in which they occur and the text of the law as a whole, and laws on the same subject matter must be interpreted in reference to each other. La.Rev.Stat. § 1:3 (2004); La. Civ.Code. arts. 12 and 13; Lockett, 03-1767 at p. 4, 869 So.2d at 91.
The meaning and intent of a law is determined by considering the law in its entirety and all other laws on the same subject matter and placing a construction on the provision in question that is consistent with the express terms of the law and with the obvious intent of the legislature in enacting it. Boyter, 99-0761 at p. 9, 756 So.2d at 1129; Stogner, 98-3044 at p. 5, 739 So.2d at 766. The statute must, therefore, be applied and interpreted in a manner that is consistent with logic and the presumed fair purpose and intention of the legislature in passing it. McLane Southern, Inc., pp. 5-6, 84 So.3d at 483; Boyter, 99-0761 at p. 9, 756 So.2d at 1129. This is because the rules of statutory construction require that the general intent and purpose of the legislature in enacting the law must, if possible, be given effect. McLane Southern, Inc., pp. 5-6, 84 So.3d at 483; Backhus v. Transit Cas. Co., 549 So.2d 283, 289 (La.1989). Courts should give effect to all parts of a statute and should not give a statute an interpretation that makes any part superfluous or meaningless, if that result can be avoided. McLane Southern, Inc., pp. 5-6, 84 So.3d at 483; Boyter, 99-0761 at p. 9, 756 So.2d at 1129. It is likewise presumed that the
In Pumphrey, we explained that "[i]t is a fundamental principle in the construction of statutes that the meaning of a word or phrase may be ascertained by the meaning of other words or phrases with which it is associated." 05-0979, p. 14, 925 So.2d at 1211. "[G]eneral words are not to be construed in their widest extent, but are to be held as applying only to such classes of things of the same general kind as those specifically mentioned." Id. (citing Continental Group, Inc. v. Allison, 404 So.2d 428, 431 n. 4 (La.1981)).
We necessarily start with the language of the statutes under review. M.J. Farms, Ltd. v. Exxon Mobil Corp., 07-2371 (La.7/1/08), 998 So.2d 16, 27. At all pertinent times, La.Rev.Stat. 46:438.3 provided as follows:
The purpose of these provisions and MAPIL, enacted in 1997 by Act No. 1373, § 1. could not be more clearly stated by the legislature in La.Rev.Stat. 46:437.2(A): "to combat and prevent fraud and abuse committed by some health care providers participating in the medical assistance programs and by other persons and to negate ;the adverse effects such activities have on fiscal and programmatic integrity." The legislature further stated its intention to designate the Department of Health and Hospitals, the attorney general, and private citizens as agents of the state "to pursue civil monetary penalties, liquidated damages, or other remedies to protect the fiscal and programmatic integrity of the medical assistance programs from health care providers and other persons who engage in fraud, misrepresentation, abuse, or other ill practices, as set forth in this Part, to obtain payments to which these health care providers or persons are not entitled." The Attorney General does not argue that the defendants are health care providers within the meaning of the statutes, but instead focuses on the inclusion of "other persons" who engage in fraud or misrepresentations against the medical assistance programs.
A claim is defined as including "any request or demand ... made against medical assistance programs for payment." La.Rev.Stat. 46:437.3(6). A payment is defined as "the payment to a health care provider from medical assistance funds pursuant to a claim, or the attempt to seek payment for a claim." La.Rev.Stat. 46:437.3(18). "Medical assistance programs" refers to Medicaid, Title XIX of the Social Security Act, "and other programs operated by and funded in the department which provide payment to health
La.Rev.Stat. 46:438.3(A) provides: "No person shall present or cause to be presented a false or fraudulent claim." As noted above, there is no evidence the defendants ever presented a claim for payment from medical assistance funds. Accordingly, the Attorney General focuses on the language "or cause[s] to be presented a false or fraudulent claim." The Attorney General contends the defendants' conduct, in which they misrepresented the potential for known side effects from the use of Risperdal, caused a false or fraudulent claim to be presented for payment. The legislature has defined a "false or fraudulent claim" as follows: "A `false or fraudulent claim' means a claim which
The flawed interpretation of this provision advanced by the Attorney General is evidenced by examining the improper conduct that would have had to have been proven at trial. To be liable under this provision, the Attorney General would have had to show that a Louisiana doctor who prescribed Risperdal for his patient, or a health care provider who dispensed the drug to the patient, knew that the defendants had made misleading statements about their product, but nonetheless prescribed or dispensed the drug to the patient knowing that there may be drugs that are equally safe, and less expensive, or safer than Risperdal, and notwithstanding that knowledge, prescribed or dispensed Risperdal. Of course, the doctor or health care provider could have still medically determined that Risperdal is the more appropriate drug for a particular patient, despite the misleading statements of the defendants, in which case there could be no legitimate basis for alleging the doctor knowingly presented a false claim for payment. The doctor or health care provider would have had to have knowingly committed malpractice, prescribing or dispensing Risperdal despite knowing there were better, cheaper, or safer, more efficacious drugs available, for the defendants to be liable under this provision. Certainly the record contains no evidence that any doctor or health care provider knowingly committed malpractice based on the defendants' improper marketing statements, and then submitted a
The Attorney General places much emphasis on the second sentence in the definition of "false or fraudulent claim," in which the legislature adds that a "[f]alse or fraudulent claim shall include a claim which is part of a pattern of incorrect submissions in regard to material information or which is otherwise part of a pattern in violation of applicable federal or state law or rule." The Attorney General argues the defendants' marketing statements constituted a pattern in violation of FDA rules. Again, even if this were so, and we assume for the sake of argument that the defendants' conduct did initially run afoul of FDA DDMAC instructions, the clear wording of the statute is that the "claim," i.e., the "request or demand ... made against medical assistance program funds for payment," La.Rev.Stat. 437.3(6), must be shown to be part of a pattern of incorrect submissions in regard to material information or is part of a pattern of such claims in violation of federal law or rule. The Attorney General suggests the defendants' labeling misstatements were "a pattern in violation of federal or state law or rule," and that the claims for payment were "part" of that pattern. But such an interpretation is overly expansive, and loses sight of the original provision that requires that, to be liable under MAPIL, the person must have knowingly caused a health care provider or its billing agent to present a claim for payment the health care provider or its billing agent knew to be false or misleading. See La. Rev. Stats. 46:438.3(A) and 46:437.3(8). There is no evidence in this record that the defendants' improper marketing statements caused any health care provider or his billing agent to submit a claim for payment the provider or his agent knew was false or misleading or that violated a federal or state law or rule. Accordingly, we find that La.Rev.Stat. 46:438.3(A) does not apply to the defendants' improper marketing statements.
La.Rev.Stat. 46:438.3(B) provides as follows: "No person shall knowingly engage in misrepresentation to obtain, or attempt to obtain, payment from medical assistance programs." "Payment" is defined as "the payment to a health care provider from medical assistance program funds pursuant to a claim, or the attempt to seek payment for a claim." La.Rev. Stat. 46:437.3(18). "Misrepresentation" is defined in MAPIL as "the knowing failure to truthfully or fully disclose any and all information required, or the concealment of any and all information required on a claim or a provider agreement or the making of a false or misleading statement to the department relative to the medical assistance programs." La.Rev.Stat. 46:437.3(15). "Obtain" is not defined in MAPIL, but its common definition is "to gain or attain usually by planned action or effort." Merriam-Webster.com. Merriam-Webster, n.d. Web. 14 Jan. 2014. <http://www.merriam-webster.com/dictionary/obtain>. Top of Form Although the Attorney General asserts the defendants engaged in "misrepresentation" in an attempt to obtain payment, and that they eventually received Medicaid funds as a result of the purchases of their product Risperdal by pharmacies and health care providers, there was no showing that the defendants attempted to obtain payment to a health care provider directly from medical assistance program funds pursuant to a claim. As the trial court itself found, there was no showing on the record that the defendants themselves at any time made or attempted to make a request or demand for payment from medical assistance program funds.
Aside from the fact there is no showing the defendants knowingly attempted to obtain payment from the medical assistance programs pursuant to a claim, as discussed above, the Attorney General's proposed construction of the definition of "misrepresentation" is inconsistent with the purpose of MAPIL and could lead to absurd consequences. Although there is a disjunctive comma after "information required," divorcing the clause "the knowing failure to truthfully or fully disclose any and all information required" from "on a claim or a provider agreement" renders the "information required" vastly broad in scope. The Attorney General does not specify who would determine what information is required, or when that information is required, or by whom it should be disclosed, but instead suggests the "information required" in this case was the proper labeling instructions requested of the drug manufacturers by the FDA DDMAC. However, if that were the case, then nothing in the statute as construed by the Attorney General would limit the "information required" to information necessarily related to a claim for payment from the medical assistance program funds as administered by the Department of Health and Hospitals. Such a result would lead to absurd consequences, in that potentially any information required by any federal or state agency or source, which is not fully disclosed by any person who ultimately receives Medicaid funds, directly or indirectly, could, if not truthfully or fully disclosed, subject that person to civil penalties under MAPIL.
The clear intent of the legislature in enacting MAPIL is set forth in La. Rev Stat. 46:437.2(B), that is, "to protect the fiscal and programmatic integrity of the medical assistance programs from health care providers and other persons who engage in fraud, misrepresentation, abuse, or other ill practices ... to obtain payments to which these health care providers or persons are not entitled." Reading the definition of "misrepresentation" in pari materia with this stated intent, as well as other portions of MAPIL, we determine that a "misrepresentation" under La.Rev. Stat. 46:437.3(15) is (1) the knowing failure to truthfully or fully disclose any information required on a claim or provider agreement; (2) the concealment of any and all information required on a claim or provider agreement; or (3) the making of a false or misleading statement to the department relative to the medical assistance programs.
In this case, there was no showing the defendants either failed to disclose or concealed information required on a claim for payment made against the medical assistance program funds. See La. Rev. Stats. 46:437.3(15) and (6). Further, there was no showing that the off-label statements, even if misleading, were made to the Department of Health and Hospitals relative to the medical assistance programs in an attempt to obtain payment on a claim made against the medical assistance programs. See La. Rev. Stats. 46:438.3(B) and 46:437.3(15). Accordingly, we find La. Rev.Stat. 46:438.3(B) also does not apply to the defendants' improper marketing statements.
Lastly we turn to La.Rev.Stat. 46:438.3(C), which provides as follows: "No person shall conspire to defraud, or attempt to defraud, the medical assistance programs through misrepresentation or by obtaining or attempting to obtain, payment for a false or fraudulent claim." The defendants assert Paragraph (C) of La.Rev. Stat. 46:438.3 is a conspiracy statute, given that La.Rev.Stat. 46:438.3 itself was based on the federal False Claims Act, 31 U.S.C. § 3729(a)(1)(1986) ("FCA").
MAPIL was enacted with the express purpose of combatting fraud and abuse of the medical assistance programs through the use of punitive measures against any person or health care provider who seeks to obtain payment to which that person or
For the reasons set forth above, we find the Attorney General failed to prove the defendant drug manufacturers, by misrepresenting through off-label statements the potential for the risk of side effects from the use of Risperdal, violated provisions of the Louisiana Medical Assistance Programs Integrity Law, La.Rev.Stat. 46:438.3. Having determined the legislature's intended scope of MAPIL, we find the Attorney General failed to establish sufficient facts to prove a cause of action against the defendants under MAPIL. There was insufficient evidence adduced that any defendant engaged in fraud, misrepresentation, abuse or other ill practices seeking to obtain, pursuant to a claim made against the medical assistance program funds, payments to health care providers or other persons to which the health care providers or other persons were not entitled. Because we find the Attorney General failed to prove a violation of MAPIL, we pretermit discussion of the remaining evidentiary and penalty issues. We hereby reverse the district court's judgment in favor of the Attorney General, and render judgment in favor of the defendants.
JOHNSON, Chief Justice, dissents for reasons assigned by Justice HUGHES.
KNOLL, Justice, dissents for the reasons assigned by Justice HUGHES.
HUGHES, Justice, dissents with reasons.
HUGHES, J., dissenting.
With respect, the majority opinion conflates the subparts of the definition of "misrepresentation" to include the requirement of a "claim" not provided by the statute.
While acknowledging that LSA-R.S. 46:438.3(C) proscribes an attempt to defraud
However, the definition of misrepresentation actually provides:
Thus the majority erroneously writes in the requirement of "a claim or provider agreement" to the "failure to truthfully or fully disclose" subpart of the definition. But the disjunctive "or" cannot be ignored;
The three subparts of the definition of misrepresentation separated by the conjunctive "or" each stand alone in accordance with the accepted legislative interpretation. To conflate the provisions of one subpart to reach a desired result with another subpart is unsupportable.
The majority further attempts to insert a non-existent "claim" requirement into LSA-R.S. 46:438.3(C) by reference to the "purpose" of the law. The majority writes: "The purpose of MAPIL is to prevent false or fraudulent claims from being presented to and paid by the medical assistance programs. Thus, there must be a causal link between the misleading marketing statement and a false or fraudulent claim for payment to a health care provider or other person to establish liability under MAPIL." Opinion at page 21 (emphasis added).
This desired result of the majority is likewise unsupported by the actual words of the law.
Louisiana Revised Statute 46:437.2 provides:
This broad statement of intent and purpose is much more consistent with the findings of the jury and the court of appeal that by violating federal labeling laws the defendants violated LSA-R.S. 46:438.3
In any event, "When a law is clear and unambiguous and its application does not lead to absurd consequences, the law shall be applied as written and no further interpretation may be made in search of the intent of the legislature." LSA-C.C. art. 9.
One cannot seriously argue that an anti fraud and abuse statute that penalizes one who violates federal drug labeling laws to the detriment of the citizens of Louisiana presents an absurd consequence.
It is the duty of the legislature, not judges, to make the law. Judges may not like the law, they may even consider it unwise, but they have a duty to apply the law as written. Judicial re-writing of the law to achieve a desired result and overturn a jury verdict is inimical to our system of separated powers.
The issue was raised again prior to trial. The district court believed the Attorney General's theory of the case "is to attempt to show that none of those prescriptions, or many of them, should not or may not have been written because the doctors weren't given full information. That's their theory. I don't know whether it's right or not." The district court, after reviewing the language of the statutes and its prior ruling on the motion for summary judgment, found that "if [the Attorney General and the State] prove false, misleading, misrepresentative, deceitful, intent to defraud type statements, attempts to defraud type statements, that in and of itself is the causation they need to get to their penalty statute." On appeal, rather than properly reviewing the question of law de novo, see Red Stick Studio v. State ex rel. Dept. of Econ. Dev., 10-0193 (La. 1/19/11), 56 So.3d 181, 187, the court of appeal found the district court's interpretation reasonable and not an abuse of the district court's discretion.