State Va. Ex Rel. Darrell v. Mcgraw

• Citation: 226 W.Va. 677,704 S.E.2d 677
• Decision Date: 18 November 2010
• Docket Number: No. 35500.,35500.
• Court: Supreme Court of West Virginia
• Parties: STATE of West Virginia ex rel. Darrell V. McGRAW, Jr., Attorney General, Plaintiff Below, Appelleev.JOHNSON & JOHNSON and Janssen Pharmaceutica Products, L.P., Defendants Below, Appellants.

226 W.Va. 677

704 S.E.2d 677

STATE of West Virginia ex rel. Darrell

v. McGRAW, Jr., Attorney General, Plaintiff Below, Appellee

v.JOHNSON & JOHNSON and Janssen Pharmaceutica Products, L.P., Defendants Below, Appellants.

No. 35500.

Supreme Court of Appeals of West Virginia.

Submitted Sept. 15, 2010.Decided Nov. 18, 2010.

[704 S.E.2d 679 , 226 W.Va. 679]

Syllabus by the Court

1. “Appellate review of a partial summary judgment order is the same as that of a summary judgment order, which is de novo.” Syl. Pt. 1, West Virginia Department of Transportation, Division of Highways v. Robertson, 217 W.Va. 497, 618 S.E.2d 506 (2005).

2. “ ‘A motion for summary judgment should be granted only when it is clear that there is no genuine issue of fact to be tried and inquiry concerning the facts is not desirable to clarify the application of the law.’ Syllabus Point 3, Aetna Casualty & Surety Co. v. Federal Insurance Co. of New York, 148 W.Va. 160, 133 S.E.2d 770 (1963).” Syl. Pt. 2, Ramey v. Contractor Enterprises, Inc., 225 W.Va. 424, 693 S.E.2d 789 (2010).

3. “Collateral estoppel will bar a claim if four conditions are met: (1) The issue previously decided is identical to the one presented in the action in question; (2) there is a final adjudication on the merits of the prior action; (3) the party against whom the

[226 W.Va. 680 , 704 S.E.2d 680]

doctrine is invoked was a party or in privity with a party to a prior action; and (4) the party against whom the doctrine is raised had a full and fair opportunity to litigate the issue in the prior action.” Syl. Pt. 1, State v. Miller, 194 W.Va. 3, 459 S.E.2d 114 (1995).

4. “For issue or claim preclusion to attach to quasi-judicial determinations of administrative agencies, at least where there is no statutory authority directing otherwise, the prior decision must be rendered pursuant to the agency's adjudicatory authority and the procedures employed by the agency must be substantially similar to those used in a court. In addition, the identicality of the issues litigated is a key component to the application of administrative res judicata or collateral estoppel.” Syl. Pt. 2, Vest v. Board of Education, 193 W.Va. 222, 455 S.E.2d 781 (1995).

Rebecca A. Betts, Esq., Debra C. Price, Esq., Allen, Guthrie & Thomas, PLLC, Charleston, WV, Darrell V. McGraw, Jr., Esq., Attorney General, Frances H. Hughes, Esq., Chief Deputy Attorney General, Robert A. Goldberg, Esq., Special Assistant Attorney General, Charleston, WV, and Barry Hill, Esq., Special Assistant Attorney General, Wheeling, WV, Attorneys for Appellee.Stephanie D. Taylor, Esq., Jones Day, Pittsburgh, PA, Attorney for Amicus Curiae Product Liability Council, Inc.Johnny Knisely, Esq., Goodwin & Goodwin, LLP, Charleston, WV, Attorney for Amicus Curiae Pharmaceutical Research and Manufacturers of America.Forrest Roles, Esq., Mark A. Carter, Esq., Dinsmore & Shohl LLP, Charleston, WV, Attorneys for Amicus Curiae Washington Legal Foundation.

PER CURIAM:

The State of West Virginia, by its Attorney General, Darrell V. McGraw, Jr., (“the State”), sued Appellants Johnson & Johnson and Janssen Pharmaceutica Products, L.P. (jointly “the Appellants”) under the West Virginia Consumer Credit and Protection Act, W. Va.Code §§ 46A–1–101 to –139 (2006) ( “Consumer Protection Act”). The State asserts that the Appellants communicated false and misleading information to healthcare providers in West Virginia regarding two pharmaceutical drugs manufactured and distributed by the Appellants. The Circuit Court of Brooke County, West Virginia, entered partial summary judgment in favor of the State on the primary issue of whether certain statements and omissions contained in the Appellants' communications were false and misleading. Following a bench trial on the remaining issues, the circuit court entered final judgment in favor of the State and assessed a civil penalty of $4,475,000 against the Appellants.

On appeal, the Appellants argue that the circuit court erred in entering partial summary judgment against them because, in so doing, the circuit court treated two informal and advisory warning letters issued by the federal Food and Drug Administration (“FDA”) as legal determinations that the parties are precluded from relitigating. Alternatively, the Appellants contend that the circuit court's reliance on those warning letters is preempted by federal law and violates their First Amendment free speech rights. The Appellants additionally raise several assignments of error relating to the evidence considered at the bench trial and the circuit court's method of assessing the civil penalty. Having considered the briefs of the parties,¹ oral argument, and the record in this case, the Court concludes that the circuit court erred in finding that the Appellants' communications to healthcare providers were false and misleading as a matter of law. The circuit court's order entering partial summary judgment is therefore reversed, and the case is remanded for further proceedings consistent with this opinion.

I. FACTS

Janssen Pharmaceutica Products L.P. (“Janssen”), a pharmaceutical company, is a

[226 W.Va. 681 , 704 S.E.2d 681]

subsidiary of Johnson & Johnson. At issue in this case are representations Janssen made to healthcare providers in West Virginia concerning two of its drugs: Risperdal, an antipsychotic drug used to treat schizophrenia, and Duragesic, a narcotic pain relief medication that is administered through a patch worn on the patient's skin. Both drugs have been approved by, and their distribution is regulated by, the FDA.

A. Risperdal

Risperdal, known generically as risperidone, is among a class of antipsychotic drugs known as “atypical antipsychotics.” Atypical antipsychotics are linked as a class because they significantly reduce the occurrence of certain side-effects, called extrapyramidal side-effects, that plagued the earlier generation of antipsychotic drugs. In 1993, the FDA approved Risperdal for use in managing various psychotic disorders, including schizophrenia.

In the late 1990s, research emerged indicating an increased risk of hyperglycemia and Type II diabetes among patients taking atypical antipsychotics. At the request of the FDA, Janssen provided it with clinical data on Risperdal that, Janssen asserts, indicated that Risperdal was not associated with “alterations in glycemic control.” In addition, Janssen undertook its own studies regarding the issue by convening a panel of twenty-five experts. That panel unanimously agreed that “convincing evidence” existed to show that risperidone's effect on glucose metabolism was lower than other atypical antipsychotic drugs.

In the summer of 2003, several new studies were released concerning the connection between atypical antipsychotics and hyperglycemia. The studies indicated that the risk of diabetes mellitus (chronic hyperglycemia) was increased among patients using atypical antipsychotics as compared to other classes of antipsychotics. However, other studies suggested differences among the drugs within the class of atypical antipsychotics. The Appellants contend that these studies indicated that the risk posed by Risperdal was less than the risk posed by certain other atypical antipsychotics, and no greater than the risk posed by typical antipsychotics.

Following the release of these various studies, the FDA directed all manufacturers of atypical antipsychotics, as a class, to add a warning to their drug package insert labels regarding the increased risk of hyperglycemia, diabetes mellitus and ketoacidosis, a serious complication of diabetes that can lead to a coma or death. In addition, the FDA determined that all patients treated with atypical antipsychotics should be monitored for hyperglycemia. After receiving this directive, Janssen responded to the FDA that it did not believe a warning was necessary for Risperdal. Nevertheless, despite its disagreement, Janssen cooperated with the FDA's request and developed a new warning label that, after some modifications, the FDA approved.

On November 10, 2003, Janssen mailed the revised warning label to prescribers of Risperdal, including healthcare providers in West Virginia, along with a cover letter. The cover letter explained that the FDA had requested that all manufacturers of atypical antipsychotic drugs include a warning with their product regarding an increased risk for hyperglycemia and diabetes mellitus. The letter then states:

Hyperglycemia-related adverse events have infrequently been reported in patients receiving RISPERDAL. Although confirmatory research is still needed, a body of evidence from published peer-reviewed epidemiology research suggests that RISPERDAL is not associated with an increased risk of diabetes when compared to untreated patients or patients treated with conventional antipsychotics. Evidence also suggests that RISPERDAL is associated with a lower risk of diabetes than some other studied atypical antipsychotics.

(Footnotes omitted). The letter omits any mention of the need to monitor patients receiving atypical antipsychotics for symptoms of hyperglycemia. Janssen addressed this letter with the salutation “Dear Healthcare Provider.”

Later that same month, the FDA contacted Janssen and requested that it send out a formal letter to healthcare providers, known

[226 W.Va. 682 , 704 S.E.2d 682]

as a “Dear Doctor” or “Dear Healthcare Provider” letter (“DHCP letter”), informing them of the revised label. DHCP letters are used in the pharmaceutical world to timely advise healthcare professionals of changes in drug labeling and risks associated with drugs. In response, Janssen sent the FDA a copy of its November 10, 2003, letter (the “Risperdal DHCP letter”), which it had already disseminated to the healthcare community, suggesting that the letter was sufficient to meet the FDA's request.

Several months later, in April 2004, the Director of the FDA's Division of Drug Marketing, Advertising and...