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Mohr v. Targeted Genetics

November 18, 2009


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


This case is before the Court on the Plaintiff's motion to remand, Defendant Abbott Laboratories, Inc.'s motion to dismiss, and Defendant Western Institutional Review Board, Inc.'s motion to dismiss and, in the alternative, motion to strike.


The Plaintiff's complaint alleges claims for personal injury and wrongful death stemming from Jolee Mohr's participation in a clinical trial for an investigational gene therapy for rheumatoid arthritis. Mohr, who was 36, died on July 24, 2007. According to the complaint, Defendant Targeted Genetics, Inc. designed and manufactured the gene therapy at issue, tgAAC94, and Defendant Western Institutional Review Board, Inc. ("WIRB") supervised the clinical trial and designed its protocol. In February 2007, Mohr's treating physician, Dr. Robert Trapp, informed her that he considered her to be a good candidate for a clinical trial utilizing gene therapy sponsored by Targeted Genetics titled, "A Phase 1/2 Study of Repeat Intra-Articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fc Fusion Gene, in Inflammatory Arthritis Subjects with and without Concurrent TNF-alpha Antagonists" ("the experiment").

At some point, Mohr was prescribed Humira, a TNF inhibitor manufactured by Abbott. Abbott states that this drug is an FDA-approved prescription medication for the treatment of rheumatoid arthritis. Moreover, Abbott neither contributed to the design or manufacture of tgAAC94 nor participated in any way in the clinical trial that is the focus of the complaint. Abbott claims that its sole connection to the events recited in the complaint arises from Mohr's use of Humira.

The Plaintiff alleges that the experiment involved gene transfer in which subjects were injected with millions of particles of tgAAC94, which contained an Enbrel gene. Enbrel is also a TNF inhibitor. The Plaintiff claims that it is well-known that patients treating with TNF inhibitors, such as Humira, should not be placed on any other TNF inhibitor as such combinations can cause serious adverse reactions, including death. Targeted Genetics contracted with WIRB to serve as the federally required institutional review board. Those Defendants designated and approved Dr. Trapp to serve as Principal Investigator for the experiment conducted at his site, "The Arthritis Center." The Protocol which governed the experiment was designed and approved by WIRB and Targeted Genetics.

On February 26, 2007, Mohr received her first injection. The Plaintiff states that it was not known whether she received the virus vector or placebo. Mohr suffered no ill effects from this injection, nor did she discern any benefit. On July 2, 2007, Dr. Trapp injected the virus vector directly into Mohr's joint. Immediately thereafter, Mohr began to experience nausea and pain; by the next afternoon she started vomiting and her temperature rose to 101 degrees. By July 7, 2007, Mohr's temperature reached 104 degrees and she was admitted to the emergency room. Her condition quickly deteriorated. By July 9, physicians at St. John's hospital in Springfield noted that she had an elevated liver enzyme and white blood count. By July 18, Mohr was suffering from liver and kidney failure, loss of blood and sepsis. She was transferred to the University of Chicago Hospital as a potential liver and kidney transplant.

Mohr died on July 24, 2007. According to the Plaintiff, the cause of death was a direct and proximate result of her participation in the experiment or as a result of the experimental drug combined with intake of Humira. Specifically, Mohr suffered from histoplasmosis, a potentially deadly fungal infection and known adverse reaction to TNF blockers, such as Humira.

The Plaintiff further alleges that, 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.

Abbott contends that, in contrast to the factual allegations levied against Targeted Genetics and WIRB, the Plaintiff's "bare-bones allegations" asserted against it constitute nothing more than "[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements," which are not enough to sustain a claim under Ashcroft v. Iqbal, 129 S.Ct. 1937, 1949-50 (2009). Thus, Abbott alleges that the claims asserted against it must be dismissed for failure to state a claim under Rule 12(b)(6).

Abbott further asserts that, to the extent that the Plaintiff's conclusory claims against Abbott are premised on injuries allegedly resulting from the combined use of Humira and the investigational gene therapy, such claims are subject to dismissal under the "learned intermediary" doctrine. Specifically, "manufacturers of prescription drugs have a duty to warn prescribing physicians of the drugs' known dangerous propensities, and the physicians, in turn, using their medical judgment, have a duty to convey the warnings to their patients." Kennedy v. Medtronic, Inc., 366 Ill. App.3d 298, 305 (1st Dist. 2006). The Plaintiff contends that the learned intermediary doctrine does not apply because Abbott did not warn physicians of the precise risk.



Abbott first alleges that Plaintiff has asserted nothing more than conclusory statements against it. Specifically, the connection between Abbott and the events recited in the complaint arises from Mohr's concomitant use of Humira with the investigational gene therapy treatment during the clinical trial. Abbott further contends it is significant that the Plaintiff does not and cannot allege that Abbot approved of or participated in any way in the decision to design the clinical ...

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