Voss v. Johnson & Johnson

752 F. Supp. 2d 1071, 2010 U.S. Dist. LEXIS 143389
CourtDistrict Court, D. Minnesota
DecidedNovember 8, 2010
DocketCivil Nos. 06-3728 (JRT), 07-1862(JRT), 07-3960(JRT), 08-5743(JRT), 08-5745(JRT)
StatusPublished
Cited by1 cases

This text of 752 F. Supp. 2d 1071 (Voss v. Johnson & Johnson) is published on Counsel Stack Legal Research, covering District Court, D. Minnesota primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Voss v. Johnson & Johnson, 752 F. Supp. 2d 1071, 2010 U.S. Dist. LEXIS 143389 (mnd 2010).

Opinion

JOHN R. TUNHEIM, District Judge.

The instant motions concern the cases of five plaintiffs (“Phase 1 Minnesota plaintiffs” or “plaintiffs”) whose actions have been consolidated with hundreds of other cases in this multidistrict litigation. Plaintiffs assert injuries resulting from the use of Levaquin, an antibiotic medication.

Defendants have filed substantively identical joint motions for partial judgment on the pleadings in the following cases: Schedin v. Johnson & Johnson, et al., Civil No. 08-5743 (D. Minn, filed Oct. 15, 2008) (Schedin Docket No. 19)1; Christensen v. Johnson & Johnson, et al., Civil No. 07-3960 (D. Minn. filed Sept. 12, 2007) (only as to plaintiffs Calvin Christensen and Edward Karkoska) (Christensen Docket No. 79); Voss, et al. v. Johnson & Johnson, et al., Civil No. 06-3728 (D. Minn. filed Sept. 15, 2006) (only as to plaintiff Sharon Johnson) (Voss Docket No. 116); Kirkes, et al. v. Johnson & Johnson, et al., Civil No. 07-1862, 2007 WL 4588990 (D.Minn. filed Apr. 11, 2007) (only as to plaintiff Richard Kirkes) (Kirkes Docket No. 106); and Martinka v. Johnson & Johnson, et al., Civil No. 08-5745 (D. Minn. filed Oct. 15, 2008) (Martinka Docket No. 19). For the reasons stated below, the Court grants in part and denies in part defendants’ motions.

BACKGROUND2

“When evaluating a motion for judgment on the pleadings, a court must accept as true all factual allegations set out in the complaint, and must construe the complaint in the light most favorable to the plaintiff, drawing all inferences in his favor.” Wishnatsky v. Rovner, 433 F.3d 608, 610 (8th Cir.2006) (citation omitted). With that standard in mind, the Court summarizes plaintiffs’ allegations as follows.

Levaquin, defendants’ brand name for the antibiotic levofloxacin, is a broad spectrum synthetic antibacterial agent. (Compl. ¶ 15, Schedin Docket No. 1.) It is approved for use in the treatment of a variety of upper respiratory infections, urinary tract infections, prostatitis, and other bacterial infections. (Id.) Levofloxacin is part of a class of antibiotics, including ciprofloxacin (Cipro) and ofloxacin (Floxin), known as fluoroquinolones. (Id. ¶ 16.) Although considered highly effective at killing certain bacteria, fluoroquinolones are also associated with serious side effects including tendon injuries. (Id. ¶¶ 17, 4-5.) Medical research suggests that the risk of tendon injury is increased in patients over age sixty and those concurrently using corticosteroids. (Id. ¶¶ 27, 37.)

Levofloxacin is a successor drug to ofloxacin and is pharmacologically similar. (Id. ¶¶ 19, 23-25.) Floxin was highlighted in medical literature as one of the most tendon toxic fluoroquinolones. (Id. ¶¶ 29-30, 35, 37.) In 2001, several European regulatory authorities began to consider a heightened warning for levofloxacin’s label in response to medical research and post-market experiences with the drug. (Id. ¶ 71.) Specifically, plaintiffs allege that the European Agency for the Evaluation of Medicinal Products considered levofloxacin the most tendon toxic of the fluoroquinolones and proposed a label warning that would warn of its comparatively greater [1074]*1074toxicity. (Id. ¶ 72.) According to plaintiffs, despite knowledge of Levaquin’s heightened risks, defendants failed to adequately alert the medical community. (Id. ¶ 64.)

When Levaquin first entered the U.S. market in 1997, its label included the warning that the FDA required for all fluoroquinolones as a class:

Ruptures of the shoulder, hand and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported with [fluoroquinolones]. [Levaquin] should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon.... Tendon rupture can occur at any time during or after therapy with [Levaquin].

(Compl. ¶¶ 44-45, Schedin Docket No. 1.) Plaintiffs allege that this warning was inadequate; it was, among other insufficiencies, buried in a long list of potential adverse reactions and lacking any indication of an increased risk of tendon injury in the elderly or corticosteroid users. (Id. ¶ 45.)

According to plaintiffs, in 2001 defendants began crafting an epidemiology study (“the Ingenix Study”) regarding tendon rupture and fluoroquinolones that diverged from other published studies on the issue in an ultimately successful attempt to forestall and even prevent European regulatory action that would have negatively affected levofloxacin sales in both Europe and the United States. (Id. ¶¶ 74-76.) Plaintiffs allege that this study — co-authored and funded by defendant Johnson & Johnson Pharmaceutical Research & Development — was deeply flawed and manipulated to produce favorable result. (Id. ¶¶ 82-88.)

In 2002, defendants embedded an additional warning in Levaquin’s label: “Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly.” (Id. ¶ 65.) Plaintiffs assert that this warning change inadequately informed their target patient population — the elderly — that they were at an increased risk of tendon injury by “flipping the confounders.” (Id. ¶ 68.) Pursuant to the 2002 warning, plaintiffs allege, “any elderly person not on corticosteroids ... had no additional risk of a tendon injury, and the fact that the warning was so equivocal regarding corticosteroids diffused any possible effect of warning physicians of the effect of age on the frequency and severity of this debilitating injury.” (Id.)

Levaquin became the most prescribed fluoroquinolone in the United States in 2003, and the most prescribed antibiotic in the world in 2006. (Id. ¶ 95.) Levaquin’s increased popularity, plaintiffs allege, corresponded with an increase in reported tendon related injuries. (Id. ¶ 96.) Reports of tendon injuries associated with Levaquin to the Food and Drug Administration (“FDA”) in the six year period of 1997 through 2005 exceeded reports of tendon injuries associated with all pre-Levaquin fluoroquinolones in the ten year period of 1985 through 1995. (Id. ¶ 94.)

In February 2005, John Schedin, then seventy-seven years old, consumed Levaquin prescribed for an upper respiratory infection. (Id. ¶ 108.) After using Levaquin for approximately eight days, Schedin suffered partial, bilateral Achilles tendon tears. (Id.) Schedin alleges that these injuries were Levaquin-induced, and that as a result of the tears, his ability to perform normal daily tasks has been compromised and his quality of life has been severely diminished.” (Id.)

In April 2007, at the FDA’s request, defendants again changed the label for Levaquin. (Id. ¶ 101.) Plaintiffs concede that the 2007 label clearly stated the elderly are at an increased risk of tendon injury, and unequivocally stated that the risk [1075]*1075of tendon injuries is increased with concomitant use of corticosteroids, contrary to the results of defendants’ Ingenix study. (Id.) According to plaintiffs, defendants “negotiated with the FDA and insisted on a class warning [for all fluoroquinolones] to thereby minimize the heightened risk of tendon injury with Levaquin” as compared to other fluoroquinolones. (Id. ¶ 102.)

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Related

In Re Levaquin Products Liability Litigation
752 F. Supp. 2d 1071 (D. Minnesota, 2010)

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Bluebook (online)
752 F. Supp. 2d 1071, 2010 U.S. Dist. LEXIS 143389, Counsel Stack Legal Research, https://law.counselstack.com/opinion/voss-v-johnson-johnson-mnd-2010.