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Cross v. Forest Laboratories

United States District Court, N.D. Mississippi, Eastern Division

April 6, 2015

ELLA MAY CROSS, et al., PLAINTIFFS
v.
FOREST LABORATORIES, DEFENDANT

For Ellis Donnell Cross, William L. Cross, Theodore Cross, Sandra McFadden, Plaintiffs: Arnold Anderson Vickery, LEAD ATTORNEY, PRO HAC VICE, VICKERY & WALDNER, LLP, Houston, TX; Charles Kiel Garella, LEAD ATTORNEY, PRO HAC VICE, THE VICKERY LAW FIRM, Houston, TX; Christopher L. Coffin, LEAD ATTORNEY, PRO HAC VICE, PENDLEY BAUDIN & COFFIN, LLP, New Orleans, LA; Nicholas R Rockforte, LEAD ATTORNEY, PRO HAC VICE, PENDLEY, BAUDIN & COFFIN, LLP, Plaquemine, LA; W. Howard Gunn, LEAD ATTORNEY, W. HOWARD GUNN & ASSOCIATES, Aberdeen, MS.

For Forest Laboratories, Defendant: Christopher P. Fisher, LEAD ATTORNEY, PRO HAC VICE, ULMER & BERNE LLP, Cleveland, OH; Christopher J. Mulvaney, Jeffrey F. Peck, John R Ipsaro, LEAD ATTORNEYS, PRO HAC VICE, ULMER & BERNE, LLP, Cincinnati, OH; Joseph P. Thomas, Mary Lynn Tate, LEAD ATTORNEYS, PRO HAC VICE, ULMER & BERNE, LLP - Cincinnati, Cincinnati, OH; Randi Peresich Mueller, Ronald G. Peresich, LEAD ATTORNEYS, PAGE, MANNINO, PERESICH & MCDERMOTT, P.L.L.C., Biloxi, MS.

JUDGMENT

MICHAEL P. MILLS, UNITED STATES DISTRICT JUDGE.

Pursuant to the memorandum opinion issued this day, it is hereby ordered and adjudged that this case is dismissed.

This the 6th day of April, 2015.

MEMORANDUM OPINION

BACKGROUND

This cause comes before the court on the defendant's motions for summary judgment based on federal preemption [81] and on state law grounds [83]. The court has reviewed the briefs, exhibits, and relevant law and is prepared to rule.

This is a failure to warn products liability case. The plaintiffs are the family of Leon Cross. The defendant is Forest Laboratories.

Leon Cross was an 81 year-old resident of Kosciusko, Mississippi. Mr. Cross had a history of medical problems including prostate cancer, Type II diabetes, hypertension, chronic anemia, arthritis, and degenerative joint disease of the lumbar spine. Mr. Cross also suffered from chronic abdominal pain with diverticulitis and chronic constipation. In November 2003, Mr. Cross had a colonoscopy, which revealed gastritis and diverticula coli, a possible sign of colon cancer. Between November 2003 and May 2004, after repeated complaints of constipation and abdominal pain, several doctors recommended that Mr. Cross undergo colectomy surgery, but Mr. Cross declined.

In addition to his medical problems, Mr. Cross was also the primary care giver for his late wife Ella Mae, who recently passed away after suffering from Alzheimer's for several years. By 2004, Mrs. Cross was in an advanced stage of Alzheimer's, which rendered her unable to care for or assess Mr. Cross's medical problems. Mrs. Cross was dependent on Mr. Cross for her basic care including administering medications, preparing her food, and other basic needs. Mr. Cross also took care of all the household chores.

Ultimately, on May 20, 2004, Mr. Cross scheduled a colectomy to deal with abdominal pain he had been suffering. The surgery was scheduled for June 4, 2004. In the weeks preceding the surgery, Mr. Cross experienced pre-surgery anxiety and extreme abdominal pain. On May 22, 2004, Mr. Cross's son, Theodore, took Mr. Cross to the emergency room. Mr. Cross saw Dr. Ked Eccles-James, an emergency room physician. Dr. Eccles-James examined and diagnosed him with " anxiety/depression, mood disorder." Dr. Eccles James prescribed him Lexapro, a selective serotonin re-uptake inhibitor (SSRI) manufactured by Forest, to help manage the anxiety. Dr. Ked Eccles-James discharged Mr. Cross with instructions to follow up with his primary care physician the next clinic day and to return to the emergency room should Mr. Cross's symptoms worsen.

On the morning of May 24, Mr. Cross told his wife that he intended to kill himself. Mr. Cross left his home and fatally shot himself in the stomach. A toxicology report revealed the presence of an SSRI in Mr. Cross's blood sample.

In the years before Mr. Cross's suicide, there was discussion in the medical and scientific community about whether SSRIs might be linked to increased violence in patients, and especially an increased risk of suicidality. On March 19, 2004, the Food and Drug Administration advised Forest Laboratories that labeling changes for Forest's SSRIs were warranted, and asked them to submit these changes as changes-being-effected (CBE). On March 22, 2004, the FDA issued a Public Health Advisory asking SSRI manufacturers to include warnings and instructions for " close observation of adult and pediatric patients treated with those drugs for worsening depression or the emergence of suicidality," especially when beginning drug therapy. On April 19, 2004, Dr. David Paul of the FDA sent an email to Forest approving updated labeling and encouraging Forest to update the labeling " immediately," and authorized it to use the CBE regulation to do so. On April 30, 2004, Forest submitted its proposed label changes but stated it only intended to include the new warning on packages distributed from their facilities around May 31, 2004. These changes were approved on May 20, 2004, two days before Mr. Cross was prescribed Lexapro. The changes were not actually implemented until after Mr. Cross's death.

The Cross family filed suit alleging that Forest had failed to include an adequate warning about the increase of suicidality at the beginning of treatment and the need to monitor the patient during the first few months of drug therapy. Forest has filed a motion for summary judgment based on federal preemption [81] and several state law grounds [83].

STANDARD OF REVIEW

Summary judgment is appropriate when there is " no genuine issue of material fact and the movant is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(a). The facts and evidence are taken in a light most favorable to the non-moving party. LeMaire v. Louisiana, 480 F.3d 383, 386 (5th Cir. 2007).

A dispute regarding a material fact is " genuine" if the evidence is such that a reasonable jury could return a verdict in favor of the nonmoving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (1986). Summary judgment is appropriate if " critical evidence is so weak or tenuous on an essential fact that it could not support a judgment in favor of the non-movant." Armstrong v. City of Dallas, 997 F.2d 62 (5th Cir. 1993). A party opposing a properly supported motion for summary judgment " may not rest upon the mere allegations or denials of his pleading, but ... must set forth specific facts showing that there is a genuine issue for trial." Anderson, at 248. If the nonmoving party fails to meet this burden, the motion for summary judgment must be granted.

I. FEDERAL PREEMPTION

A state law may be federally preempted under the Supremacy Clause, U.S. Const., Art. VI, cl. 2, in three ways. English v. Gen. Elec. Co., 496 U.S. 72, 78, 110 S.Ct. 2270, 2275, 110 L.Ed.2d 65 (U.S. 1990). The first is express preemption, where Congress explicitly defines to what extent the federal law preempts state law. Id. The second is field preemption, where the state law is preempted because it attempts to regulate " conduct in a field that Congress intended the Federal Government to occupy exclusively." Id. at 79, 110 S.Ct. at 2275. Last is conflict preemption, where the state law actually conflicts with the federal law. Id. This includes cases where it is impossible for a party to comply with both state and federal requirements. See, e.g., Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143, 83 S.Ct. 1210, 1217-1218, 10 L.Ed.2d 248 (1963).

The FDA approves a new drug application (NDA) only when it meets certain standards for safety and effectiveness, including proper labeling. 21 C.F.R. § 314.105(c). Generally any changes to the label require the manufacturer to submit a supplemental submission and obtain approval. 21 C.F.R. § 314.70(b). However, manufacturers may make some changes without prior FDA approval under the changes-being-effected (CBE) provision. In 2004 the CBE provision read:

(iii) Changes in the labeling, except for changes to the information required in § 201.57(a) of this chapter (which must be made pursuant to paragraph (b)(2)(v)(C) of this section), to accomplish any of the following:
(A) To add or strengthen a contraindication, warning, precaution, or adverse reaction;
(B) To add or strengthen a statement about drug abuse, dependence, psychological effect, or overdosage;
(C) To add or strengthen an instruction about dosage and administration that is intended to increase the ...

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