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Mohr v. Targeted Genetics

March 3, 2010

ROBBY MOHR, AS ADMINISTRATOR OF ESTATE OF JOLEE MOHR, PLAINTIFF,
v.
TARGETED GENETICS, INC., ABBOTT LABORATORIES, INC., AND WESTERN INSTITUTIONAL REVIEW BOARD, INC., DEFENDANTS.



The opinion of the court was delivered by: Richard Mills, U.S. District Judge

OPINION

In sum: motion to dismiss denied; motion to remand allowed. But first, the background.

ABBOTT'S MOTION TO DISMISS

I. INTRODUCTION

The Plaintiff's amended complaint purports to state two counts against Defendant Abbott Laboratories, Inc., strict products liability in Count III and wrongful death in Count IV.*fn1

The Plaintiff filed his initial complaint in the Circuit Court of Christian County, Illinois. Abbott, with the consent of the other Defendants, removed this case from state court on July 2, 2009. On August 13, 2009, Abbott moved to dismiss the Plaintiff's original complaint. That motion was granted. On December 14, 2009, the Plaintiff filed his first amended complaint, which Abbott now moves to dismiss.

Abbott contends that the complaint should be dismissed for three separate reasons: (1) the claims do not allege facts establishing a plausible claim for relief under the Ashcroft v. Iqbal*fn2 pleading standard; (2) the claims should be dismissed under the "learned intermediary" doctrine because the FDA-approved labels for Humira specifically warn of the risk of histoplasmosis and the risks from the concomitant use of Humira with other immunosuppressive therapies--the risks complained of in the amended complaint; and (3) the claims against Abbott should be dismissed under Illinois Supreme Court Rule 103(b) for failure to exercise reasonable diligence in effecting service of process because the Plaintiff delayed service for nearly one year after filing the complaint.

II. FACTS

The Plaintiff notes that the basic factual claims alleged against Abbott are as follows:

a. For seven years preceding her death, Jolee Mohr was treated for rheumatoid arthritis which was under control with various established treatments and drugs. (Amended Complaint at ¶ 6).

b. Ms. Mohr was treating with Humira for a period of time preceding her death as prescribed by her treating physician, Dr. Robert Trapp of Springfield, Illinois. (Amended Complaint at ¶¶ 7, 9).

c. Ms. Mohr's treating physician recommended that she enroll in the experiment involving a genetically modified virus containing a TNF inhibitor. (Amended Complaint at ¶¶ 10-11).

d. Patients on TNF inhibitors such as Humira should not be placed on other TNF inhibitors. (Amended Complaint at ¶ 12).

e. On July 2, 2007, after receiving her second course of the experimental drug, Ms. Mohr experienced acute adverse symptoms consistent with the known adverse effects of TNF blockers, which escalated at an alarming rate until her death on July 24, 2007. Ms. Mohr died as a direct result of her participation in the experiment, or as a result of the experimental drug combined with prior intake of Humira. (Amended Complaint at ¶¶ 29-39).

f. Humira's label at the time failed to warn physicians of the serious risk of histoplasmosis; rather, the warnings section of the package insert solely mentioned the risk of infection, as follows:

SERIOUS INFECTIONS, SEPSIS, TUBERCULOSIS AND RARE CASES OF OPPORTUNISTIC INFECTIONS, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH THE USE OF TNF BLOCKING AGENTS INCLUDING HUMIRA. MANY OF THE SERIOUS INFECTIONS HAVE OCCURRED IN PATIENTS ON CONCOMITANT IMMUNOSUPPRESSIVE THERAPY THAT, IN ADDITION TO THEIR RHEUMATOID ARTHRITIS, COULD PREDISPOSE THEM TO INFECTIONS. (Amended Complaint at ¶ 41).

g. On September 4, 2008, in response to a number of deaths involving histoplasmosis in patients treating with TNF blockers, the FDA ordered Abbott to incorporate stronger warnings into Humira's label, in addition to the mandated black box warning regarding infection risk already in place, advising of the risk of fungal infections and histoplasmosis in particular. (Amended Complaint at ¶ 42).

Humira's label at the time Ms. Mohr took the drug did mention histoplasmosis, which the Plaintiff alleges is a potentially deadly fungal infection and a known adverse reaction to TNF blockers, such as Humira.*fn3 The label, which is attached to the Amended Complaint,*fn4 states in relevant part:

PHYSICIANS SHOULD EXERCISE CAUTION WHEN CONSIDERING THE USE OF HUMIRA IN PATIENTS WITH A HISTORY OF RECURRENT INFECTION OR UNDERLYING CONDITIONS WHICH MAY PREDISPOSE THEM TO INFECTIONS, OR PATIENTS WHO HAVE RESIDED IN REGIONS WHERE TUBERCULOSIS AND HISTOPLASMOSIS ARE ENDEMIC. (Amended Complaint, Ex. C at 13). The label included other warnings about infections:

TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS RECEIVING HUMIRA. SOME OF THESE INFECTIONS HAVE BEEN FATAL.

Some cases of opportunistic infections and tuberculosis have been fatal (see WARNINGS). In postmarketing experience, infections have been observed with various pathogens including viral, bacterial, fungal, and protozoal organisms. Infections have been noted in all organ systems and have been reported in patients receiving HUMIRA alone or in combination with immunosuppressive agents.

Serious infections, including tuberculosis, have occurred in patients receiving HUMIRA. Some patients have died as a result of these infections. . . . HUMIRA can block the damage that too much TNF-alpha can cause, and it can also lower your body's ability to fight infections. Taking HUMIRA can make you more prone to getting infections or make any infection you have worse.

Tell your doctor if you have or have had any of the following: Any kind of infection including an infection that is in only one place in your body (such as an open cut or sore), or an infection that is in your whole body (such as the flu). Having an infection could put you at risk for serious side effects from HUMIRA. If you are unsure, please ask your doctor.

There have been rare cases where patients taking HUMIRA or other TNF-blocking agents have developed serious infections, including tuberculosis (TB) and infections caused by bacteria or fungi. Some patients have died when the bacteria that cause infections have spread throughout their body (sepsis). (Amended Complaint Ex. C at 1, 18, 25, 26).

The Plaintiff alleges that dismissal is inappropriate, even under the heightened pleading standard. Sufficient facts have been alleged to establish plausible claims of negligence and wrongful death. The Plaintiff further contends that Abbott has failed to provide support for the other reasons it has advanced for dismissal.

III. ANALYSIS

A. Legal Standard

In reviewing a motion to dismiss under Rule 12(b)(6), courts must accept as true the facts alleged in the complaint, drawing all reasonable inferences in the plaintiff's favor. See Rodriguez v. Plymouth Ambulance Service, 577 F.3d 816, 820 (7th Cir. 2009). "The Supreme Court has stated that to survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face." Id. at 821 (internal quotations omitted). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. The plausibility requirement does not equate to a "probability requirement," but it requires "more than a sheer possibility that a defendant has acted unlawfully." See Ashcroft v. Iqbal, U.S. , 129 S.Ct. 1937, 1949 (2009). "Where a complaint pleads facts that are merely consistent with a defendant's liability, it stops short of the line between possibility and plausibility of entitlement to relief." Id. (internal quotation marks and citations omitted).

"A formulaic recitation" of the claim's elements is not enough to withstand a motion to dismiss. Reger Development, LLC v. National City Bank, 592 F.3d 759, 764 (7th Cir. 2010) (internal quotations omitted). "[A]s the Court said in Iqbal, determining whether a complaint states a plausible claim for relief will . . . be a context-specific task that requires the reviewing court to draw on its judicial experience and common sense." Cooney v. Rossiter, 583 F.3d 967, 971 (7th Cir. 2009) (internal quotation marks and citations omitted).

B. Sufficiency of allegations

Abbott alleges that, as in the original complaint, the Plaintiff simply recites the "magic words" of a strict liability claim:

a. selling a product it knew or should have known was in a defective condition by failing to adequately warn of the risk of histoplasmosis or the risks associated with taking Humira in conjunction with other TNF blockers;

b. selling a product which it knew or should have known was unreasonably dangerous to the user by failing to adequately warn of the risk of histoplasmosis or the risks associated with taking Humira in conjunction with other TNF blockers;

c. selling a product which it knew or should have known was not safe because of the known risk of histoplasmosis and/or the risks associated with taking Humira in conjunction with other TNF blockers;

d. supplying warnings with the product that it knew or should have known were inadequate by failing to adequately warn of the risk of histoplasmosis or the risks associated with taking Humira in conjunction with other TNF blockers;

e. providing instructions to be followed with regard to the prescribing of this product that it knew or should have known were not accurate and truthful;

f. failing to warn users of the dangers inherent in using this product by failing to adequately warn of the risk of histoplasmosis or the risks associated with taking Humira in connection with other TNF blockers;

g. selling a product wherein it was foreseeable that someone would be injured upon ingesting the medication in question because of the known risk of histoplasmosis and/or the risks associated with taking Humira in conjunction with other TNF blockers;

h. selling a product which it knew or should have known was not safe for its intended use because of the known risk of histoplasmosis and/or the risks associated with taking Humira in conjunction with other TNF blockers;

i. selling a product which it knew or should have known was lacking of one or more elements necessary to make it safe for its intended use because of the known risk of histoplasmosis and/or the risks associated with taking Humira in conjunction with other TNF blockers;

j. manufacturing a product which it knew or should have known was defective and which could cause injury to the user because of the known risk of histoplasmosis and/or the risks of taking Humira in conjunction with other TNF blockers;

k. designing a product which it knew or should have known was defective and which could cause injury to the user because of the known risk of histoplasmosis and/or the risks associated with taking Humira in conjunction with other TNF blockers;

l. distributing a product which it knew or should have known was defective and which could cause injury to the user because of the known risk of histoplasmosis and/or the risks associated with taking Humira in conjunction with other TNF blockers;

m. failing to see that ultimate users were advised of the dangers of said product by failing to warn of the known risk of histoplasmosis and/or the risks associated with taking Humira in conjunction with other TNF blockers;

n. failing to exercise reasonable care in the design of this product by failing to warn of the known risk of histoplasmosis and/or the risks associated with taking Humira in conjunction with other TNF blockers;

o. failing to exercise reasonable care in the marketing of this product by failing to warn of the known risk of histoplasmosis and/or the risks associated with taking ...


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