Kravitz v. Evans Med. Ltd.

Decision Date27 September 2010
Docket NumberCase No. 09–21414–CIV–JORDAN.
Citation741 F.Supp.2d 1299
PartiesSteven KRAVITZ, et al., Plaintiffsv.EVANS MEDICAL LTD., et al., Defendants.
CourtU.S. District Court — Southern District of Florida

OPINION TEXT STARTS HERE

Lewis S. Eidson, Colson Hicks Eidson, Coral Gables, FL, Paul Courtney Huck, Jr., Office of the Attorney General, Fort Lauderdale, FL, for Plaintiffs.Mercer Kaye Clarke, Rossana Navarro, Clarke Silverglate & Campbell, P.A., Hildy M. Sastre, Shook Hardy & Bacon, James Pierce Murray, Fowler White Burnett, Miami, FL, Andrew J. Calica, Henninger S. Bullock, Mayer Brown LLP, New York, NY, Brian Douglas Equi, Seipp & Flick, LLP, Lake Mary, FL, David J. Walz, Edward Walter Gerecke, John Anderson Camp, Carlton Fields, Tampa, FL, for Defendants.

Order on Pending Motions

ADALBERTO JORDAN, District Judge.

Applying the standard set forth in Bell Atlantic v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007), and for the reasons which follow, the defendants' motions to dismiss [D.E. 66, 68, 72] are denied. The motions to adopt filed by Sanofi Pasteur, Henry Schein, and Medeva Pharmaceuticals, CA [D.E. 69, 73, 74] are granted.

I. The Allegations

In their amended complaint, Steven and Wendy Kravitz allege the following facts.

Sometime in December of 1996, Dr. Joseph Singer administered an influenza vaccine to Mr. Kravitz. The vaccine, which was manufactured and sold by one or more of the defendants,1 was supposed to protect Mr. Kravitz against a specific strain of flu virus for his lifetime. Approximately three weeks after receiving the vaccine, Mr. Kravitz first began experiencing double vision and weakness and numbness in his hands. As a direct result of the vaccine, Mr. Kravitz developed (and continues to suffer from) an acute and chronic form of Guillain–Barre Syndrome (GBS), known as Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a neurological disorder characterized by progressive weakness and impaired sensory function in the legs, arms, and other parts of the body. CIDP is caused by damage to the myelin sheath of the peripheral nerves.

Mr. Kravitz has asserted negligence and strict liability claims against each of the defendants. Mrs. Kravitz has asserted a loss of spousal consortium claim against each of the defendants.

II. Discussion

The defendants have moved to dismiss the amended complaint under Rules 12(b)(1) and 12(b)(6), essentially arguing that the claims against them cannot proceed because Mr. and Mrs. Kravitz have not first filed a claim with the Vaccine Court (a special master acting under the jurisdiction of the Court of Federal Claims) under provisions of the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa–1 et seq., and because the claims are barred by the applicable statute of limitations and statute of repose under Florida law. I do not believe these arguments are persuasive at this stage of the litigation.

A. The Vaccine Act

The pre-suit /exhaustion provision of the Vaccine Injury Act provides that “no person may bring a civil action for damages in an amount greater than $1,000 or in an unspecified amount against a vaccine administrator or manufacturer in a state or federal court for damages arising out of a vaccine-related injury ... associated with the administration of a vaccine after October 1, 1988, ... unless a petition has been filed, in accordance with [§ ] 300aa–16 of this title, for compensation under the [National Vaccine] Program for such injury ... [.] See § 300aa–11(a)(2)(A). If a civil action which is barred under this provision is filed in a state or local court, the court shall dismiss the action.” See § 300aa–11(a)(2)(B).

In relevant part, § 300aa–11(b)(1)(A) provides that a person who suffered a vaccine-related injury “may, if [he] meets the requirements of subsection (c)(1) of this section, file a petition for compensation under the Program.” In turn, § 300aa–11(c)(1)(A) says, among other things, that a person can file a petition if he suffered a vaccine-related injury from a vaccine “set forth in the Vaccine Injury Table.” Thus, it is necessary to look at the Vaccine Injury Table to determine a person's eligibility to file a petition for compensation.

The Vaccine Injury Table contains a list of vaccines “for the purpose of receiving compensation under the [National Vaccine] Program.” See § 300aa–14(a). In December of 1996, the influenza vaccine given to Mr. Kravitz was not listed in the Vaccine Injury Table. See id. It was added to the Vaccine Injury Table by the Secretary for Health and Human Services, see § 300aa–14(c), with an effective date of July 1, 2005. See 70 Fed.Reg. 19092 (April 12, 2005). The Secretary's notice stated that individuals injured by influenza vaccine could file a petition for compensation under the National Vaccine Program “until July 1, 2007, as long as the vaccine-related injury or death occurred on or after July 1, 1997 (8 years prior to the effective date of the addition that included trivalent influenza vaccines as covered vaccines). See id. at 19093 (emphasis added). This statement was based on a provision of the Vaccine Injury Act dealing with revisions to the Vaccine Injury Table:

If at any time the Vaccine Injury Table is revised and the effect of such revision is to permit an individual who was not, before such revision, eligible to seek compensation under the [Vaccine Injury] Program ... such person may, notwithstanding [§ ] 300aa–11(b)(2) of this title, file a petition for such compensation not later than 2 years after the effective date of the revision, except that no compensation may be provided under the Program with respect to a vaccine-related injury ... covered under the revision of the Table if ... (2) the vaccine-related injury occurred more than 8 years before the date of the revision of the Table,

§ 300aa–16(b) (emphasis added).

Mr. Kravitz alleges that he began experiencing adverse symptoms (double vision and weakness and numbness in his hands) several weeks after the administration of the vaccine in December of 1996. Thus, viewing the complaint in the light most favorable to him, the injury from the vaccine occurred before July 1, 1997. It therefore appears that, pursuant to the Secretary's notice and the language of § 300aa–16(b)(2), Mr. Kravitz would not be able to obtain any compensation under the National Vaccine Program.

The question, then, is whether a person like Mr. Kravitz must—before suing in state or federal court—file a petition with the National Vaccine Program even if he is statutorily precluded from obtaining compensation in the first place because his injury took place outside of the 8–year “look-back” period. I conclude that the answer is no. Even if Mr. Kravitz were otherwise qualified to file a petition under § 300aa–11(b), any petition would have failed as a matter of law and would have been futile because his injury (as alleged in the amended complaint) took place before the 8–year “look-back” period specified in § 300aa–16(b) and the notice issued by the Secretary. See § 300aa-11(a)(9) (“This subsection applies only to a person who has sustained a vaccine-related injury and who is qualified to file a petition for compensation under the Program.”). In my view, Congress would not (and does not) require a person injured by a newly-added vaccine to seek compensation under the Vaccine Injury Act if that person was not eligible for any compensation—pursuant to the terms of the Act and the notice adding the vaccine to the Vaccine Injury Table—and therefore could never obtain any compensation. As the Fifth Circuit has explained, albeit in dicta, the “restriction on filing tort claims applies only to those who have ‘sustained a vaccine-related injury or death and who [are] qualified to file a petition for compensation under the [Vaccine Injury] Program.’ § 300aa–11(a)(9). In this way, the Vaccine Act treats ‘the tort suit procedural bar and Vaccine Court compensation as opposite sides of the same coin.’ [The Vaccine Injury Program] delays the filing of only those tort claims for which it first provides an alternate source of compensation. Moss v. Merck & Co., 381 F.3d 501, 505 (5th Cir.2004) (emphasis added and citation omitted).

Things would be different had Mr. Kravitz been theoretically eligible for compensation and his right to compensation depended on issues of fact like causation. In that scenario, the Vaccine Court would have had jurisdiction to initially determine whether Mr. Kravitz was entitled to compensation, and he would have been required to file a petition under the Vaccine Injury Program. See §§ 300aa–11(a)(2)(A)(B), 300aa–12(a).2

Similarly, if Mr. Kravitz's injuries from the vaccine occurred between July 1, 1997, and July 1, 2005—and not, as he alleges, in late December of 1996 or early January of 1997—then he would likely have been barred from suing here first. See, e.g., Corder v. Secretary, 2008 WL 2275570, *1 (Ct. Cl. Special Master 2008) (claimant who received influenza vaccine in December of 2004 and developed GBS in April of 2005 was required to file petition with the National Vaccine Program by July 1, 2007); Miller v. Secretary, 2008 WL 458727, *1–*2 (Ct. Cl. Special Master 2008) (dismissing petition of claimant—filed on July 16, 2007—where influenza vaccine was administered in October of 1999 and harm manifested in 2000). In such a case, Mr. Kravitz would have been eligible (or, to use the statutory language, qualified) to file a petition for compensation with the National Vaccine Program. Had he not filed a petition on time, or had he not filed one at all, he would not be allowed to file suit in state or federal court and bypass the Vaccine Court. That is what I take from the cases cited by the defendants. See, e.g., Gross v. Aventis Pasteur, Inc., 2004 WL 1717657, *2–*3 (D. Oregon 2004) (plaintiff could have filed petition with National Vaccine Program, but had let statute of limitations under Program lapse, and unsuccessfully...

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