Opinion
MDL No. 1477, (Docket No. 448).
July 19, 2006
MEMORANDUM OPINION AND ORDER
By virtue of the Third Amended Settlement Agreement ("Agreement") (Docket Sheet Document # 184), the parties designated the undersigned to review any appeals filed by plaintiffs regarding decisions by the Claims Administrator placing them in certain fund categories pursuant to the Agreement and the Schedule of Payments, which is attached to the Agreement as Exhibit B. The Schedule of Payments describes the objective criteria needed to qualify for recovery under Funds A, B, C and D. Funds A, B and C require a showing of a qualifying medical condition and submission of documents showing that the qualifying medical condition is temporally associated with the use of Serzone®. Funds A, B and C are subcategorized according to specific medical criteria. Fund D is the sole fund category which requires only that the plaintiff "can document that he or she purchased Serzone® or used Serzone®, or alleges that he or she was injured by Serzone® and is not making a claim for benefits or eligible under Funds A, B or C. . . ." (# 184, Exhibit B.)
On November 28, 2005, Plaintiff April M. Moyer submitted a claim form seeking placement and award within Fund C. By letter dated January 16, 2006, the Claims Administrator notified Plaintiff that the claim was incomplete. On June 6, 2006, the Claims Administrator advised Plaintiff she had been placed in Fund D. By letter dated June 12, 2006, Plaintiff, who is pro se, timely appealed the decision of the Claims Administrator. (# 448.) Bristol-Myers Squibb Company ("BMS") has filed a brief in response to the appeal. (# 549.) The court has carefully considered the submissions of both parties.
Under the Agreement, the undersigned must "review . . . all documents submitted to the Claims Administrator (including the completed Claims Form and supporting documentation as well as any documents submitted by BMS). . . ." (# 184, p. 14.) Pursuant to the Memorandum Opinion and Order Approving Settlement and Certifying the Settlement Class (# 296) entered by the presiding Multi-District Litigation ("MDL") Judge, Judge Goodwin, the undersigned must set aside the Claims Administrator's award if the factual determination was "clear error." (# 296, p. 49.)
For purposes of the instant appeal, "clear error" has not been defined by the parties or the court. Pursuant to Rule 72(a) of the Federal Rules of Civil Procedure, which governs the review of a magistrate judge's order on a nondispositive matter, a decision shall not be modified or set aside unless it is "clearly erroneous or contrary to law." In Marks v. Global Mortgage Group, Inc., 218 F.R.D. 492, 495 (S.D.W. Va. 2003), Judge Goodwin observed that "[a] district court should reverse a magistrate judge's decision in a discovery dispute as `clearly erroneous' only if the district court is left with a definite and firm conviction that a mistake has been made." (Citing Clark v. Milam, 155 F.R.D. 546, 547 (S.D.W. Va. 1994)). In the criminal realm, "plain error" as used in Rule 52(b) of the Federal Rules of Criminal Procedure is defined as affecting "substantial rights." In United States v. Olano, 507 U.S. 725, 733-34 (1993), the United States Supreme Court explained that there must be an error that is "plain," which affects "substantial rights." For an error to affect substantial rights, it must "have affected the outcome of the district court proceedings." Id. at 734. If these conditions are met, the court may exercise its discretion to notice the error, but only if the error "`seriously affect[s] the fairness, integrity or public reputation of judicial proceedings.'" Id. at 736 (quoting United States v. Atkinson, 297 U.S. 157, 160 (1936)).
To recover under Fund C, Plaintiff must submit:
(1) hospital records from an admission in which treatment for an alleged Serzone® related liver injury was provided or, if claimant was not hospitalized, medical records from contemporaneous treatment in which a licensed medical physician stated that the claimant's qualifying liver injury was temporally associated with the ingestion of Serzone®; or
(2) a report from a hepatologist, board certified gastroenterologist or board certified internist, which states that the claimant's qualifying liver injury was temporally associated with the ingestion of Serzone®.
The claimant must also complete the Fund C Non-Serious Hepatic Injury Claim Form and provide all documents required by that Form.
To qualify under Fund C, the claimant must provide documented evidence of elevated liver enzymes or total bilirubin levels in Temporal Association with the use of Serzone®.
"Temporal Association," as used in Fund C, requires the qualifying liver injury to occur within two (2) weeks after last documented use of Serzone®.
(# 184, Exhibit B.) To recover under Level C-I, claimants with normal baseline liver enzyme test results must show "AST or ALT levels greater than or equal to three (3) times the upper limit of normal" or "total bilirubin levels greater than or equal to two milligrams per deciliter (2.0 mg/dl)." (# 184, Exhibit B.) Claimants with abnormal baseline liver enzyme results must show "AST or ALT levels greater than or equal to three (3) times the claimant's average liver enzyme levels prior to his/her initial use of Serzone®" or "total bilirubin levels greater than or equal [to] two (2) times the claimant's average total bilirubin level prior to his/her initial use of Serzone® or two milligrams per deciliter (2.0 mg/dl), whichever is greater." (# 184, Exhibit B.)
To recover under Level C-II, claimants with normal baseline liver enzyme test results must show "AST or ALT or total bilirubin levels fifty percent (50%) greater than the claimant's average liver enzyme or total bilirubin levels prior to his/her initial use of Serzone®." (# 184, Exhibit B.) For those with abnormal baseline liver enzyme results, claimants must show "AST or ALT or total bilirubin levels fifty percent (50%) greater than the claimant's average liver enzyme or total bilirubin levels prior to his/her initial use of Serzone®." (# 184, Exhibit B.)
To recover under Fund D, claimant must "document that he or she purchased Serzone® or used Serzone®, or [allege] that he or she was injured by Serzone® and is not making a claim for benefits or eligible for benefits under Funds A, B or C." (# 184, Exhibit B.)
In her appeal, Plaintiff asserts that she is entitled to more than $100.00, the award for Fund D claims, because of the injuries she alleges she sustained from use of Serzone®. (# 448, pp. 1-3.)
In response, BMS argues that the Claims Administrator did not commit clear error in placing Plaintiff in Fund D. (# 549.)
The relevant medical evidence of record reveals that Plaintiff used Serzone® from May 29, 1997, through January 12, 1998. Plaintiff reported to the emergency room on May 27, 2005, complaining of abdominal pain. A discharge report indicates normal total bilirubin, ALT and AST levels and no evidence of hepatitis. Actual results of the testing on May 27, 2005, reveal an ALT level of 12 IU/L (normal range is 10-60 IU/L), an AST level of 15 IU/L (normal range is 10-42 IU/L) and total bilirubin of 0.4 mg/dl (normal range is 0.3-1.3 mg/dl). Finally, by letters dated February 6, 2006, and March 1, 2006, to the Claims Administrator, Plaintiff recounted her difficulties in obtaining evidence from her pharmacy and physician regarding her use of Serzone®.
Plaintiff has not provided documented evidence of elevated liver enzymes or total bilirubin levels in temporal association with the use of Serzone®, i.e., within two weeks after the last documented use of Serzone®, as is required for placement in Fund C. The only liver function tests submitted by Plaintiff are dated several years after she last used Serzone®, and are within normal limits. The evidence submitted by Plaintiff and considered by the Claims Administrator does not otherwise meet the requirements for placement in Fund C. Instead, Plaintiff has established that she purchased Serzone® and alleges she was injured by it. As such, Plaintiff's placement by the Claims Administrator in Fund D was appropriate.
Finally, Plaintiff believes she should be paid $30,000.00 to $40,000.00, rather than $100.00 provided for in Fund D. Plaintiff could have opted out of the Agreement (Exhibit B identified the amounts available for the various funds), or objected to the Agreement within a certain time period, but she did not. (# 184, p. 12.) As such, she cannot now object to the terms of the settlement.
Based on the above, the court finds the decision of the Claims Administrator to place Plaintiff in Fund D was not clear error as that term has been defined above.
Accordingly, it is hereby ORDERED that Plaintiff's appeal is DENIED because the decision of the Claims Administrator placing Plaintiff in Fund D was not clear error.
The Clerk is directed to transmit a copy of this Memorandum Opinion and Order to Plaintiff, counsel of record and the Claims Administrator.