Straka v. Johnson & Johnson et al
Filing
185
MEMORANDUM OPINION AND ORDER denying defendants' 44 Motion for Summary Judgment (Written Opinion). Signed by Judge John R. Tunheim on December 28, 2011. (DML)
UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
MDL No. 08-1943 (JRT)
IN RE LEVAQUIN PRODUCTS
LIABILITY LITIGATION
___________________________________ ___________________________________
CLIFFORD STRAKA,
Plaintiff,
Civil No. 08-5742 (JRT)
v.
JOHNSON & JOHNSON; ORTHOMCNEIL-JANSSEN
PHARMACEUTICALS, INC.; ORTHOMCNEIL PHARMACEUTICAL; and
JOHNSON & JOHNSON
PHARMACEUTICAL RESEARCH AND
DEVELOPMENT
MEMORANDUM OPINION AND
ORDER DENYING DEFENDANTS’
MOTION FOR SUMMARY
JUDGMENT
Defendants.
Ronald S. Goldser and David M. Cialkowski, ZIMMERMAN REED,
PLLP, 1100 IDS Center, 80 South Eighth Street, Minneapolis, MN 55402;
and Lewis J. Saul, LEWIS SAUL & ASSOCIATES, 183 Middle Street,
Suite 200, Portland, ME 04101, lead counsel for plaintiff Straka.
James B. Irwin, IRWIN FRITCHIE URQUHART & MOORE, LLC,
400 Poydras Street, Suite 2700, New Orleans, LA 70130; Dana M. Lenahan
and Tracy J. Van Steenburgh, NILAN JOHNSON LEWIS, PA, 120 South
Sixth Street, Suite 400 Minneapolis, MN 55402, William V. Essig,
DRINKER BIDDLE & REATH LLP, 191 North Wacker Drive, Suite
3700, Chicago, IL 60606, lead counsel for Defendants.
Plaintiff Clifford Straka brought this action against Johnson & Johnson; Johnson
& Johnson Pharmaceutical Research and Development, LLC; Ortho-McNeil-Janssen
Pharmaceuticals,
24
Inc.;
and
Ortho-McNeil
Pharmaceutical,
Inc.
(collectively
“Defendants”). Straka asserts both failure to warn and fraud claims, seeking damages for
injuries he claims resulted from the Defendants’ failure to adequately warn about the
risks of taking the drug Levaquin. Straka’s action has been selected by the Court as the
third bellwether case to be tried from many plaintiffs whose claims have been
consolidated for coordinated trial proceedings into multi-district litigation (“MDL”).
Defendants move for summary judgment on all of Straka’s claims. Because the Court
finds that material issues of fact exist regarding the adequacy of Defendants’ warnings
and whether the prescribing doctor read the drug’s package insert, the Court will not
grant summary judgment.
BACKGROUND
I.
STRAKA’S LEVAQUIN DOSE AND TENDON INJURY
In 2006, Straka began experiencing symptoms of an upper respiratory infection or
inflammation. (Dana M. Lenahan Aff., Ex. K, Clifford Straka Dep. at 27:5-10, Aug. 18,
2009, Docket No. 46; Ronald S. Goldser Decl., Ex. A, Katayoun Baniriah Disc. Dep. at
57:7-15, Aug. 23, 2011, Docket No. 55.) Dr. Katayoun Baniriah diagnosed Straka with
pneumonia and prescribed a ten-day course of Levaquin. (Baniriah Disc. Dep. at 61:1318.) After taking Levaquin for nine days, Straka suffered bilateral Achilles tendon
ruptures. (Compl. ¶ 108, Docket No. 1.)
Dr. Baniriah does not remember if she had read the package insert for Levaquin
before prescribing it to Straka. (Goldser Decl., Ex. 2, Baniriah Trial Dep. at 97:15-23,
Aug. 23, 2011, Docket No. 55.) She testified that she was not aware of the risk of tendon
-2-
injury associated with Levaquin or other fluoroquinolones at the time of the prescription
– nor did she become aware of the risk or the warning on the label until a couple of years
ago. (Id. 98:18-99:9.)
II.
PACKAGE INSERTS
Levaquin, the brand name for the drug levofloxacin, is a member of the
fluoroquinolone class of antibiotics. (Compl. ¶¶ 15-16.) Since its release in 1997,
Levaquin’s package insert (sometimes referred to as the “label”) has contained a warning
of the risk of tendon rupture associated with the drug’s use. (Compl. ¶ 15; Lenahan Aff.,
Ex. A., 1997 Package Insert, Docket No. 46.) In 2001, Defendants changed the label to
include the following language, “Post-marketing surveillance reports indicate that this
risk may be increased in patients receiving concomitant steroid, especially in the elderly.”
(Compl. ¶ 65.) In 2004, the label was updated again to state:
Tendon Effects: Ruptures of the shoulder, hand, Achilles tendon, or other
tendons that require surgical repair or result in prolonged disability have
been reported in patients receiving quinolones, including levofloxacin.
Post-marketing surveillance reports indicate that this risk may be increased
in patients receiving concomitant corticosteroids, especially in the elderly.
Levofloxacin should be discontinued if the patient experiences pain,
inflammation or rupture of a tendon. Patients should rest and refrain from
exercise until the diagnosis of tendonitis or tendon rupture has been
confidently excluded. Tendon rupture can occur during or after therapy
with quinolones, include levofloxacin.
(Lenahan Aff., Ex. C, 2004 Package Insert at 6, Docket No. 46 (emphasis in original).)
This warning was in place at the time of Straka’s prescription.
In 2005, the FDA received a citizen petition from the Illinois Attorney General’s
office asking that the FDA require all fluoroquinolone manufacturers to include a black
-3-
box warning on their labels highlighting the risk of tendinopathies. (Lenahan Aff., Ex. E,
May 18, 2005, 2005 Citizen Petition, Docket No. 46.) In a 2005 internal memorandum,
two divisions of the FDA declined to recommend the addition of a black box warning
because they concluded that a black box warning “ may miscommunicate the full safety
profile of the drug since several other adverse events of potentially equal or more serious
(even fatal) sequelae are also included in the WARNING section.” (Second Dana M.
Lenahan Aff., Dec. 7, 2011, Ex. I, FDA Memos. at 10, Docket No. 83.)
In 2008, the FDA, in response to new data and an additional citizen petition
submitted by the Office of the Illinois Attorney General (see Lenahan Aff., Ex. F,
Aug. 29, 2006, 2006 Citizen Petition, Docket No. 46.), ordered the addition of a black
box warning emphasizing the association between fluoroquinolone use and tendon injury
to the label of all fluoroquinolones. (Lenahan Aff., Ex. G, FDA Letter, July 24, 2008,
Docket No. 46.) In 2008, Defendants also issued a “Dear Doctor” letter noting that the
label had been updated to include the black box warning. 1
III.
EVIDENCE OF COMPARATIVE TOXICITY
As part of the review that ultimately led to the black box warning, the FDA also
addressed concerns that levofloxacin had a higher number of tendon-related adverse
events than other fluoroquinolones. (See Lenahan Aff., Ex. J, Department of Health and
Human Services Memo. at 6, April 30, 2008, Docket No. 46.) The FDA reviewed the
1
Although the Defendants reference this letter in their briefs, the letter was not submitted
as an exhibit. A copy of the letter is available at
http://www.fqresearch.org/pdf_files/Levaquin_11_2008_ortho_mcneil_dear_dr_letter.pdf.
-4-
available medical literature, including three new studies, and found that the data do not
“suggest a robust difference in the risk for tendon rupture between these
[fluoroquinolone] agents.” (Id. at 8.) Neither party has offered evidence of a randomized
clinical study that has demonstrated a statistically significant increase in the risk of
tendinopathies with Levaquin compared to other fluoroquinolones. (See, e.g., Lenahan
Aff., Ex. I, Cheryl Blume Dep. at 103:23-105:12.)
DISCUSSION
I.
STANDARD OF REVIEW
Summary judgment is appropriate where there are no genuine issues of material
fact and the moving party can demonstrate that it is entitled to judgment as a matter of
law. Fed R. Civ. P. 56(a). A fact is material if it might affect the outcome of the suit,
and a dispute is genuine if the evidence is such that it could lead a reasonable jury to
return a verdict for either party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48
(1986). A court considering a motion for summary judgment must view the facts in the
light most favorable to the non-moving party and give that party the benefit of all
reasonable inferences that can be drawn from those facts. Matsushita Elec. Indus. Co. v.
Zenith Radio Corp., 475 U.S. 574, 587 (1986).
II.
STRAKA’S FAILURE TO WARN CLAIMS
Straka asserts both strict liability and negligent failure to warn claims.
(See
Complaint ¶¶ 118, 124.) Straka asserts that the Defendants breached their duty to warn
by (1) failing to adequately communicate the changes that were made to the label, (2) not
-5-
disclosing that there is a greater risk of tendon injuries with Levaquin than with other
fluoroquinolones, (3) failing to request FDA approval for the addition of a black box
warning before the date of Straka’s prescription, 2 and (4) failing to further strengthen the
label without adding a black box warning. 3
Under Minnesota law, to prove a failure to warn claim, 4 Straka must establish that
(1) Defendants had a duty to warn, (2) Defendants breached that duty, and (3) the breach
caused Straka’s injuries.
See Balder v. Haley, 399 N.W.2d 77, 81 (Minn. 1987).
Whether there is a duty to warn of a danger is a question of law. Germann v. F.L. Smithe
Mach. Co., 395 N.W.2d 922, 924 (Minn. 1986). If a legal duty to warn is found, the
factual issue of the adequacy of the warning, breach of the duty, and causation are
considered by the factfinder. Balder, 399 N.W.2d at 81. Defendants assert that (1) they
had no duty to warn other than through the label and (2) regardless of the adequacy of the
label, Straka is unable to prove causation because Dr. Baniriah did not read the label
before prescribing Levaquin to Straka.
2
The Defendants also assert that Straka is trying to bring a failure to warn claim based on
Defendants’ failure to include a black box warning at the time of Straka’s prescription and that
this claim is preempted. (See Part IV, infra.) Straka contends that he “will not be asserting that
Defendants should unilaterally have instituted a black box warning sooner. However, evidence
pertaining to the FDA-mandated black box warning is admissible . . . [to show] that Defendants
could have requested FDA approval to introduce a black box warning.” (Pl.’s Mem. Opp.
Summ. J. at 19-20, Nov. 28, 2011, Docket No. 54 (emphasis added).)
3
Straka suggests that additional bold lettering could have been added or that the order of
the warnings in the label could have been altered.
4
The Minnesota Supreme Court has determined that strict liability and negligent failure
to warn claims are properly analyzed using the same standard. Bilotta v. Kelley, 346 N.W.2d
616, 622 (Minn. 1984). The following analysis therefore applies both to Straka’s strict liability
failure to warn claim and to his negligent failure to warn claim.
-6-
A.
Duty to Warn
The Court has previously held that the Defendants had a duty to warn of the
dangers of tendon injury associated with Levaquin.
See Schedin v. Ortho-McNeil-
Janssen Pharmaceuticals, Inc., -- F. Supp. 2d --, 2011 WL 3837104, at *7 (D. Minn.
Aug. 26, 2011).
Whether written communication of the dangers in the label was
sufficient or whether something more was required is a question of adequacy, not duty.
The adequacy of Defendants’ warning is a question for the jury. Balder, 399 N.W.2d at
81.
Glorvigen v. Cirrus Design Corp. does not change the analysis. 796 N.W.2d 541
(Minn. Ct. App. 2011), review granted 2011 Minn. LEXIS 389 (Minn. June 28, 2011).
In Glorvigen, a products liability action brought against an airplane manufacturer, the
Minnesota Court of Appeals determined that a manufacturer did not have a duty to
provide training to proficiency when adequate written information putting the user on
notice of the dangers was provided.
Id. at 552.
Importantly, the respondents in
Glorvigen did not claim the written instructions were inadequate to put the pilot “on
notice of the dangers associated with piloting” the plane. Id. The Court interprets
Glorvigen to hold that a manufacturer’s duty to warn by providing adequate instructions
for a product’s safe use does not include a duty to provide separate training aside from
the written warnings if the written warnings were adequate. See id. Because Straka
asserts that the warnings at the time of the prescription were inadequate, the Court
declines to follow Glorvigen.
-7-
The Court concludes that determining whether the Defendants’ warning was
adequate – and what type of communication was required to make it adequate – is a
question of fact for the jury.
B.
Causation
Straka’s failure to warn claims do not fail because he is unable to prove causation.
Although causation is generally a question of fact, where an adequate warning could not
have prevented a plaintiff’s injuries, causation does not exist as a matter of law. See
Balder, 399 N.W.2d at 81. Defendants assert that Dr. Baniriah admits she did not read
the Levaquin label and, therefore the failure to warn claim should be precluded. See
J & W Enters. v. Econ. Sales, 486 N.W.2d 179, 181 (Minn. Ct. App. 1992) (finding that
failure to read a warning precludes a claim that warning was inadequate). Although
Dr. Baniriah admitted she did not remember reading the Levaquin package insert in 2006
(Banirah Video Dep. at 97:15-18), she did not state that she had never read the Levaquin
package insert prior to her prescribing decision. (Cf. Def. Mem. Supp. Summ. J. at 8,
Docket No. 45.) Rather, she merely testified that she was not aware of the language
regarding tendon disorders in the package insert. (Banirah Video Dep. at 98:18-99:1.)
Because there is a factual dispute regarding the adequacy of the warning about
Levaquin and whether Dr. Banirah read the warnings in the label insert, the Court will
deny summary judgment on Straka’s failure to warn claims.
-8-
III.
STRAKA’S FRAUD CLAIMS
Straka asserts that Defendants violated Minnesota’s Consumer Fraud Act
(“CFA”), Minn. Stat. § 325F.69, and are liable for an additional civil penalty under
Minnesota’s
Senior
Citizen
and
Handicapped
Person
Consumer
Fraud
Act
(“SCHPCFA”), Minn. Stat. § 325F.71. Because the Court concludes at this time that
Straka has demonstrated a public benefit, Defendants’ motion for summary judgment will
be denied with respect to these claims.
A.
CFA Claim
The CFA does not provide for a private cause of action.
§ 325F.70.
See Minn. Stat.
An individual plaintiff may, however, bring a CFA claim under the
Minnesota Private Attorney General Act (“Private AG Act”). Minn. Stat. § 8.31; Wehner
v. Linvatech Corp., Civ. No. 06-1709, 2008 WL 495525, at *3 (D. Minn. Feb. 20, 2008).
To bring a claim under the Private AG Act, a plaintiff must show that his cause of action
will benefit the public. Ly v. Nystrom, 615 N.W.2d 302, 313 (Minn. 2000).
The Defendants assert that Straka’s claim does not benefit the public because
(1) he seeks only individual damages and (2) the labels complained of at the time of his
prescription now contain the strongest warning warranted. 5
The Court previously
addressed and rejected Defendants’ assertions that an action does not benefit the public
5
Defendants also assert that Straka’s CFA claim must fail because there is no causal
connection between the allegedly deficient warning and Straka’s injuries. (See Part II.B, supra.)
Because the Court finds there is a factual dispute regarding when (or whether) Dr. Baniriah read
the label and thus relied on it, it will not address this argument.
-9-
unless the plaintiff seeks more than money damages. In re Levaquin Prods. Liability,
752 F. Supp. 2d 1071, 1078 (D. Minn. 2010). Ruling on a motion for judgment on the
pleadings and thus construing all the plaintiffs’ allegations as true, the Court allowed a
CFA claim to move forward because it found the lawsuit might indirectly lead to the
strengthening of Levaquin’s label. Id. Straka argues, as have previous plaintiffs, that the
earlier Levaquin warnings were inadequate because they did not sufficiently warn that
Levaquin was comparatively more tendon toxic than other fluoroquinolones. See id.
That inadequacy, he alleges, is continuing. Thus, consistent with its previous rulings, the
Court finds that this lawsuit may indirectly cause Defendants to redress a public safety
hazard, a result that would benefit the public, as required by the Private AG Act. The
Court also rejects Defendants’ argument that the Levaquin label now contains the
strongest warning warranted; it is at least theoretically possible that comparative labeling
or stronger language could be added to the label, and additional enumeration of the
drug’s risks could potentially provide a public benefit.
The Court admits to lingering doubts concerning whether there is standing to bring
the CFA claim and specifically, about the sufficiency of Straka’s (and other plaintiff’s)
claim of a public benefit necessary to provide standing. The Court will evaluate this
claim further during the trial and may consider the claim again on a Rule 50 motion if
evidence that bears on whether there is a public benefit conferred by this case is deemed
lacking.
- 10 -
B.
SCHPCFA Claim
The SCHPCFA provides for an additional civil penalty in certain circumstances if
the conduct prohibited by the CFA is perpetrated upon senior citizens. See Minn. Stat.
§ 325F.71 subds. 1(a), 2(a). Straka’s SCHPCFA claim stands or falls with his claim
under the CFA. In re Levaquin, 752 F. Supp. 2d at 1079. Since the Court declines to
grant summary judgment on Straka’s CFA claim at this time, the Court will also deny
Defendants’ summary judgment motion on the SCHPCFA claim.
IV.
PREEMPTION
Defendants assert that all of Straka’s label-based claims are preempted by the
Supreme Court’s ruling in Pliva v. Mensing, 131 S. Ct. 2567 (2011) (holding that a
generic drug manufacturer meets the burden of impossibility preemption for state failure
to warn claims by showing that it could not independently satisfy state duties due to its
position in the FDA’s regulatory scheme).
The Court has previously addressed
Defendants’ argument that the standard from Mensing should apply to the cases in the
MDL, and concluded:
Taken together, Wyeth [v. Levine, 555 U.S. 555 (2009)] and Mensing stand
for the proposition that to trigger pre-emption, a brand-name manufacturer
must show that the FDA would not have approved a proposed label change
that is the basis for a state law failure to warn claim; indeed, the brand
name manufacturer likely must proffer evidence of the FDA’s rejection of
an actual label change. Such a rejection was not in evidence in Wyeth, nor
in the instant case.
Schedin, 2011 WL 3837104, at *3-4. (internal citations omitted) (emphasis in original).
The Court found the “independent action” standard of Mensing inapplicable to a brand
- 11 -
name manufacturer Id. at *2. The Court rejects Defendants’ assertion that Straka’s labelbased claims are preempted by Mensing for the same reasons set forth in its previous
orders.
In the alternative, Defendants assert that the FDA’s 2005 Internal Memorandum is
conclusive evidence that the FDA would have rejected a label change proposed by
Defendants. At the time of the memorandum, the FDA was considering only a citizens’
petition, not a request from a brand name manufacturer.
Because a brand name
manufacturer has the responsibility to update a label with new safety information, see
Wyeth at 571, the FDA could have responded differently to a petition from the
Defendants than it did to the citizens’ petition. Therefore, the Court finds that the
Defendants have not proffered evidence that the FDA would have denied defendants’
request for a label change. The label-based claims are thus not preempted under Wyeth.
ORDER
Based on the foregoing, and all the files, records, and proceedings herein, IT IS
HEREBY ORDERED that Defendants’ Motion for Summary Judgment [Docket
No. 44] is DENIED.
DATED: December 28, 2011
at Minneapolis, Minnesota.
____s/
____
JOHN R. TUNHEIM
United States District Judge
- 12 -
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?