Klein v. O'Neal, Inc.

705 F. Supp. 2d 632, 2010 U.S. Dist. LEXIS 60607
CourtDistrict Court, N.D. Texas
DecidedJune 18, 2010
Docket3:03-cv-00102
StatusPublished
Cited by23 cases

This text of 705 F. Supp. 2d 632 (Klein v. O'Neal, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Klein v. O'Neal, Inc., 705 F. Supp. 2d 632, 2010 U.S. Dist. LEXIS 60607 (N.D. Tex. 2010).

Opinion

*639 MEMORANDUM OPINION AND ORDER

SIDNEY A. FITZWATER, Chief Judge.

The court must decide whether the proposed $110 million 1 settlement of this class action alleging personal injury and death claims arising from the manufacture, marketing, and distribution of E-Ferol Aqueous Solution (“E-Ferol”) is fair, reasonable, and adequate, as Fed.R.Civ.P. 23(e)(2) requires, and not the product of collusion between the parties. Following a two-day fairness hearing and consideration of the parties’ extensive submissions, and for the reasons that follow, 2 the court approves the settlement and the request of the class plaintiffs’ attorneys for a fee award of 30% of the settlement amount, reimbursement of reasonable and necessary expenses associated with the litigation, $300,000 from the settlement amount to pay for costs of administration and distribution of the settlement proceeds, and $75,000 each as compensation for the two class representatives.

I

A

This mass tort class action arises from defendants’ manufacture, marketing, and distribution in 1983 and 1984 of E-Ferol, a vitamin E supplement administered primarily to premature infants to aid in preventing a vision impairment known as retrolental fibroplasia, believed to be caused by a vitamin E deficiency. 3 Defendants marketed E-Ferol as a vitamin supplement rather than as a drug. The class plaintiffs allege that defendants made this marketing decision so that they could bypass testing requirements mandated by the U.S. Food and Drug Administration (“FDA”) for the sale of a “drug”; there were no similar requirements for new “supplements.” The class plaintiffs also assert that defendants specifically marketed E-Ferol as a means of reducing or preventing retrolental fibroplasia, and that physicians and hospitals began using EFerol under the mistaken impression that it had FDA approval. E-Ferol’s appeal was its suitability for intravenous administration, a delivery method that was considered superior to the previously available oral or intramuscular applications of vitamin E for premature infants. To allow for intravenous use, E-Ferol contained an emulsifying agent known as Polysorbate 80, which made the vitamin E water soluble.

Several months after the initial release of E-Ferol, medical providers, the FDA, and the Centers for Disease Control and Prevention (“CDC”) became aware of a pattern of harmful symptoms in premature infants to whom the drug had been given. These symptoms — which generally in *640 volved failure of the kidneys and liver — in many cases led to brain injury, blindness, and/or death, and came to be known as “E-Ferol syndrome.” The FDA and. CDC ordered defendants to conduct a full recall of the product and began investigating possible causes of the symptoms that neonatologists were reporting. Research determined that the ingredient Polysorbate 80 in E-Ferol caused the symptoms associated with E-Ferol syndrome. The investigation into E-Ferol eventually led to criminal convictions for the defendant corporations as well as some of their individual officers. See United States v. Hiland, 909 F.2d 1114 (8th Cir.1990).

B

This lawsuit was filed as a putative class action on behalf of all persons who were administered E-Ferol during the months that it was in use, the representatives or heirs of persons whose deaths were caused by E-Ferol, and family members, guardians, and legal representatives of persons who died from or were injured by EFerol. Plaintiffs alleged claims for negligence, strict liability, and negligent misrepresentation, and they sought actual and punitive damages for the deaths and injuries that E-Ferol allegedly caused. Judge Buchmeyer, to whom the case was initially assigned, certified the following plaintiffs class under Rule 23(b)(3):

All persons in the United States, including any estate representatives or heirs of deceased persons, who, during the period from November 1, 1983, until April 30, 1984, were administered EFerol. Included in the class are parents, spouses, children, guardians, and legal representatives of such persons with direct or derivative claims.

Klein v. O’Neal, Inc., 222 F.R.D. 564, 566 (N.D.Tex.) (Buchmeyer, J.) (‘Klein I”), pet. for leave to appeal denied, No. 04-00028 (5th Cir. June 21, 2004) (per curiam) (order). 4

Counsel for the class undertook a lengthy process of identifying and contacting potential class members. They began by obtaining a list from the FDA of all hospitals nationwide that had administered E-Ferol, and then contacting these hospitals to request the names of the individual recipients. Eventually, 89 locations nationwide were identified as having administered E-Ferol. Some hospitals were willing to share information with class counsel. Others did not produce information until they were subpoenaed and/or were unsuccessful in moving to quash efforts to obtain patient names. Once potential class members were identified, class counsel contacted them and requested that they complete a medical questionnaire and an authorization to release hospital records.

Notification to the class was given in July 2006 by direct mail (for those whose names and addresses were known) and through simultaneous publication in numerous daily newspapers throughout the United States, including USA Today, in an attempt to notify unidentified class members whose hospital records were still unknown. Class counsel also created a website at “www.eferol.com.” The website contained information about E-Ferol’s distribution and effects, an explanation of this lawsuit, links to the parties’ filings and the court’s opinions, a list of relevant deadlines, and contact information for any person who believed he should be included in the class. The court set September 11, 2006 as the opt out date for class members. 5

*641 Class counsel eventually identified 328 recipients of E-Ferol. The class is currently comprised of 369 members, including the families and representatives of deceased recipients. Of the 328 identified cases of E-Ferol administration, 34 are infants who allegedly died from the effects of E-Ferol, 22 are infants who allegedly suffered brain or neurological injuries (i.e., cerebral palsy) from E-Ferol exposure, and 239 are class members who either received E-Ferol without apparent injury, but require ongoing medical monitoring, or are the parents of children who died after being administered E-Ferol but whose deaths are not believed to have been caused by E-Ferol.

Also included are 33 claims that the court previously dismissed due to defenses based on statutes of limitations or of repose. See Klein v. O’Neal, Inc., 2008 WL 2152030, at *10 (N.D.Tex. May 22, 2008) (Fitzwater, C.J.) (“Klein II”).

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Bluebook (online)
705 F. Supp. 2d 632, 2010 U.S. Dist. LEXIS 60607, Counsel Stack Legal Research, https://law.counselstack.com/opinion/klein-v-oneal-inc-txnd-2010.