Opinion
MDL No. 1477.
July 21, 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 January 23, 2006, Plaintiff Martha J. Bobst submitted a claim form seeking placement and award within Fund C-I. By letter dated January 25, 2006, the Claims Administrator notified Plaintiff that the claim was incomplete, as Plaintiff had not submitted certain medical and other evidence. The Claims Administrator ultimately determined Plaintiff should be placed in Fund C-II. On June 7, 2006, Plaintiff, who is pro se, timely filed her appeal with the Claims Administrator, and it was later filed with the court on June 12, 2006. (# 445.) Bristol-Myers Squibb Company ("BMS") has filed a brief in response to the appeal. (# 616.) 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.)
In her appeal, Plaintiff asserts she wishes to appeal the amount of $2,000 in her claim settlement. Plaintiff recounts the stress and anxiety associated with medical treatment related to her liver condition and obtaining medical records in support of her claim. (# 445, pp. 1-2.)
In response, BMS argues that the Plaintiff fails to qualify under Fund C-I. Instead, according to BMS, the Claims Administrator did not commit clear error in placing Plaintiff in Fund C-II. (# 616, pp. 3-4.)
The relevant medical evidence of record reveals that Plaintiff filled prescriptions for Serzone® on April 6, 1999, August 31, 1999, December 27, 1999, February 15, 2000, and August 9, 2000. In addition, treatment notes from various providers indicate Serzone® was prescribed on August 31, 2000, January 29, 2001, July 15, 2001, and January 10, 2002.
On September 1, 1999, Plaintiff's AST level was 26 IU/L (normal is 0-45), her ALT level was 31 IU/L (normal is 0-50 IU/L) and total bilirubin was .9 mg/dl (normal is 0.1 to 1.2 mg/dl). On December 1, 1999, Plaintiff's AST level was 23 IU/L (normal is 0-45), her ALT level was 29 IU/L (normal is 0-50 IU/L) and total bilirubin was .6 mg/dl (normal is 0.1 to 1.2 mg/dl).
On January 16, 2002, Plaintiff's AST level was 29 IU/L (normal is 0-40), her ALT level was high at 45 IU/L (normal is 0-40 IU/L) and total bilirubin was 1.0 mg/dl (normal is 0.2 to 1.2 mg/dl). On March 15, 2002, Plaintiff's AST level was high at 44 IU/L (normal is 0-40), her ALT level was high at 90 IU/L (normal is 0-40 IU/L) and total bilirubin was 0.9 mg/dl (normal is 0.1 to 1.2 mg/dl). On May 16, 2002, Plaintiff's AST level was 22 IU/L (normal is 0-40), her ALT level was 25 IU/L (normal is 0-40 IU/L) and total bilirubin was 0.8 mg/dl (normal is 0.1 to 1.2 mg/dl). On July 22, 2002, Plaintiff's AST level was high at 45 IU/L (normal is 0-40), her ALT level was high at 70 IU/L (normal is 0-40 IU/L) and total bilirubin was .5 mg/dl (normal is 0.1 to 1.2 mg/dl).
On February 4, 2004, well after she stopped using Serzone®, Plaintiff's AST level was 17 IU/L (normal is 0-50), her ALT level was 37 IU/L (normal is 30-65 IU/L) and total bilirubin was 0.4 mg/dl (normal is 0.1 to 1.0 mg/dl).
On March 8, 2005, Plaintiff's AST level was 23 IU/L (normal is 0-40), her ALT level was 21 IU/L (normal is 0-40 IU/L) and total bilirubin was 0.7 mg/dl (normal is 0.1 to 1.2 mg/dl).
On February 13, 2006, Plaintiff's AST level was 23 IU/L (normal is 0-40), her ALT level was 21 IU/L (normal is 0-40 IU/L) and total bilirubin was 0.4 mg/dl (normal is 0.2 to 1.2 mg/dl).
Plaintiff underwent a CT scan of the abdomen and pelvis on May 6, 2002, because of abnormal liver function tests. Both were normal.
By letter dated August 29, 2002, Christopher L. Mabee, M.D. noted Plaintiff had been evaluated for abnormal liver biochemistry. There was no evidence of chronic liver disease, and her liver was not particularly enlarged, nor was there evidence of portal hypertension. Dr. Mabee opined that Plaintiff was suffering from non-alcoholic fatty liver disease. He recommended weight loss, serologic workup and liver function testing every three months.
On January 8, 2003, Dr. Mabee wrote that following extensive serologic workup, Plaintiff's
alpha-1-antitripsyn level . . . [was] low and subsequently we phenotyped her. She was a PiMZ phenotype. This is a heterozygote state for alpha-1-antitrypsin deficiency. The heterozygote patients with alpha-1-antritrypsin deficiency have not been associated with isolated liver disease on their own. However, there is some speculation that being heterozygote would increase their risk of liver disease should they have some other untoward stimulus or irritant to the liver. In her case, it is possible that she has concomitant fatty liver in addition to this heterozygote state. Her recent liver biochemistry is by and large normal with the exception of mild elevation of her alkaline phosphatase.
Dr. Mabee recommended weight control and liver function tests every three months.
A treatment note dated January 10, 2002, notes the recent black box warning on Serzone® and the decision by Plaintiff's physician, Cheri Lindberg, M.D., to evaluate Plaintiff's liver function. Dr. Lindberg noted on January 24, 2002, that Plaintiff had an elevated ALT level of 45 U/L (normal is 0-40 U/L). Dr. Lindberg noted Plaintiff had been on Serzone® for ten years. Dr. Lindberg decided to wean Plaintiff off Serzone®. On March 14, 2002, Dr. Lindberg noted Plaintiff had been off Serzone® for two weeks.
The court finds that the Claims Administrator did not commit clear error in placing Plaintiff in Fund C-II as opposed to C-I. In individuals with normal baseline liver enzyme test results, Fund C-I requires AST or ALT levels greater than or equal to three times the upper limit of normal or total bilirubin levels greater than or equal to two milligrams per deciliter. Plaintiff's highest test result was an ALT level of 90 IU/L on March 15, 2002 (normal is 0-40). This elevation is not three times the upper limit of normal or 120 IU/L, as is required for Fund C-I. However, this ALT level does qualify under Fund C-II. In individuals with normal baseline liver enzyme results, Plaintiff's AST, ALT or total bilirubin levels must be fifty percent greater than the upper limit of normal to qualify under Fund C-II. For Plaintiff's ALT level of 90 IU/L on March 15, 2002, the upper limit of normal was 40 IU/L. Fifty percent greater than the upper limit of normal would be 60 IU/L or higher. Plaintiff's ALT level of 90 IU/L is more than fifty percent greater than 40 IU/L and, as a result, Plaintiff falls squarely within the requirements of Fund C-II. In addition, Plaintiff established a temporal association with the ingestion of Serzone® and the qualifying liver injury, the elevated ALT level. On March 14, 2002, the day before Plaintiff's ALT level of 90 IU/L on March 15, 2002, Dr. Lindberg noted Plaintiff had been off Serzone® for two weeks.
Finally, Plaintiff believes she should be paid more than the $2,000.00 provided for in Fund C-II. 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 placing Plaintiff in Fund C-II 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 C-II 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.