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Larson v. Abbott Laboratories

United States District Court, Fourth Circuit

November 5, 2013

KAREN LARSON, Plaintiff,
ABBOTT LABORATORIES, et al., Defendants.


ELLEN L. HOLLANDER, District Judge.

Karen Larson, as guardian for her brother, Kraig Larson, sued several defendants in the Circuit Court for Baltimore City, alleging that Mr. Larson suffered severe and permanent brain damage proximately caused by his use of the prescription drug Adalimumab, commonly known as HUMIRA. See Complaint, ECF 2. According to Ms. Larson, HUMIRA increases the risk of severe injury or death from infection when taken by individuals with immunodeficiency, such as human immunodeficiency virus ("HIV"). Id. ¶ 14. Mr. Larson, a former space engineer, is HIV positive ("HIV"), and the drug was prescribed to him for the treatment of his psoriasis.[1] Id. ¶¶ 4, 38.

In particular, Ms. Larson sued Abbott Laboratories ("Abbott"), the manufacturer of HUMIRA, and Harrison & Star ("H&S"), a healthcare marketing agency that marketed HUMIRA from 2005 through 2009 (collectively, the "Pharmaceutical Defendants"). Id. ¶ 5-7. She also sued Monte S. Meltzer, M.D., who prescribed HUMIRA in 2010 to Mr. Larson, and Monte S. Meltzer, M.D., LLC; the Union Memorial Hospital in Baltimore, at which Dr. Meltzer worked; Dr. Ellen Yang, M.D., an infectious disease physician who monitored Mr. Larson's "HIV" condition; and Annapolis Infectious Disease Associates, L.L.P., for whom Dr. Yang worked (collectively, the "Medical Defendants"). Id. ¶ 92.

As to Abbott, plaintiff alleges strict liability failure to warn, negligent failure to warn, and breach of implied warranties. Id. ¶¶ 62-76. She also seeks to recover punitive damages. Id. ¶¶ 77-78. As to both Abbott and H&S, plaintiff alleges common law misrepresentation and violations of Maryland's Consumer Protection Act, Md. Code (2012), § 13-301 et seq. of the Commercial Law Article. Id. ¶¶ 79-90. With respect to the Medical Defendants, Ms. Larson alleges medical malpractice, negligence, and lack of informed consent. Id. ¶¶ 91-115.

As discussed, infra, Ms. Larson had previously sued the Medical Defendants, but she subsequently dismissed that suit.[2] In a subsequent suit, filed on January 2, 2013, she added the Pharmaceutical Defendants. On February 20, 2013, Abbott filed a Notice of Removal, asserting that this Court has federal question jurisdiction under 28 U.S.C. § 1331 and diversity jurisdiction under 28 U.S.C. § 1332. ECF 1. Because I was unable to determine from the Notice of Removal whether this Court has subject matter jurisdiction, I directed the parties to brief the matter. ECF 24. The Pharmaceutical Defendants argue in their Memorandum of Law ("Memo, " ECF 30) that this Court has both diversity jurisdiction and federal question jurisdiction. In their Response ("Med. Resp., " ECF 32), the Medical Defendants assert that this Court has federal question jurisdiction, but not diversity jurisdiction. Plaintiff filed a Motion to Remand ("Larson Mot., " ECF 27), accompanied by a Memorandum (ECF 27-1), and a Response in Support of Remand ("Larson Resp., " ECF 33), arguing that this Court lacks subject matter jurisdiction. No hearing is necessary to resolve the matter. See Local Rule 105.6. For the reasons that follow, I conclude that this Court lacks subject matter jurisdiction. Therefore, I will remand the case to the Circuit Court for Baltimore City.

Factual Summary[3]

Testing and Marketing of HUMIRA

HUMIRA is an immunosuppressant and tumor necrosis factor inhibitor ("TNF Inhibitor")[4] manufactured by Abbott. Complaint ¶ 11. Following a series of clinical trials, which did not include HIV individuals, the Food & Drug Administration ("FDA") approved HUMIRA in December 2002 for treatment of rheumatoid arthritis. Id. ¶ 12, 13. Abbott launched HUMIRA in 2003. Id. ¶ 15. From 2005 until early 2009, HUMIRA was marketed by H&S. Id. ¶ 7.

Abbott ran additional clinical trials in 2003 and 2004 to establish the efficacy of HUMIRA to treat some forms of psoriatic arthritis. Id. ¶ 16. However, these trials did not include any known HIV patients. Id. According to Ms. Larson, the prescribing information distributed by Abbott emphasized HUMIRA's effectiveness while understating its risks. Id. In particular, the prescribing information did not warn that HUMIRA had not been proven safe for use by HIV patients. Id.

In 2005, HUMIRA sales exceeded one billion dollars; in 2006 they exceeded two billion dollars; and in 2007 they exceeded three billion dollars. Id. ¶ 19. Ms. Larson alleges that throughout this time period, "Abbott over-promoted HUMIRA through misleading and deceptive communications that were intended to stimulate demand for HUMIRA notwithstanding the drug's dangerous propensities, including to Kraig Larson and other members of the HIV community." Id. ¶ 20.

On January 18, 2008, the FDA approved the use of HUMIRA for "adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.'" Id. ¶ 23. In approving HUMIRA, the FDA noted that HUMIRA "poses a serious and significant public health concern relating to increased risk for serious infections, '" and it required Abbott to conduct continued testing to "assess the incidence of serious adverse events....'" Id. ¶ 24.

In early 2008, the Pharmaceutical Defendants began promoting HUMIRA to dermatologists as a treatment for psoriasis. Id. ¶¶ 25, 28. As part of its marketing efforts, Abbott hired Dr. Meltzer to make presentations about HUMIRA to other dermatologists. Id. ¶ 36. In making the presentations, Dr. Meltzer allegedly relied on information about HUMIRA provided to him by Abbott. Id. Ms. Larson alleges, id. ¶ 37:

The information Abbott provided to Dr. Meltzer overall was inadequate and misleading, resulting in Dr. Meltzer erroneously concluding that if an HIV patient with moderate to severe psoriasis that cannot be controlled by topical medications or phototherapy reports both being under the care of an infectious disease doctor and not being on an antiretroviral medication, it is acceptable and reasonably safe to treat that patient with HUMIRA injections without consulting his infectious disease doctor and without knowing his patient's CD4[5] count of viral load.

Abbott also placed an advertisement in the Post Meeting News, which was distributed in February 2008 after the 66th annual meeting of the American Academy of Dermatology ("AAD"). Id. ¶¶ 25, 27. The advertisement stated that HUMIRA had been approved for "moderate to severe chronic plaque psoriasis, " but did not state that HUMIRA was only approved for use "when other systemic therapies are medically less appropriate." Id. ¶ 28; see id. ¶ 23. Dr. Meltzer is a member of AAD, id. ¶ 26, and, according to Ms. Larson, he received a copy of this advertisement and "trusted the truth of the message to his own detriment and the detriment of Kraig Larson." Id. ¶ 29.

The FDA sent a warning letter to Abbott on December 16, 2008, notifying Abbott that its advertisement in the Post Meeting News was misleading. Id. ¶ 27. The warning letter stated, in part, id. ¶ 28:

The AAD Post Meeting News Ad is misleading because it suggests that HUMIRA is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience.... This claim misleadingly suggests that HUMIRA is approved for any patient with moderate to severe chronic plaque psoriasis.... HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Due to the drug's high risk profile, the use of HUMIRA in plaque psoriasis needs to be very carefully considered, a message not conveyed in the ad....
The overall effect of this presentation undermines the communication of important risk information, minimizing the risks associated with HUMIRA and misleadingly suggesting that HUMIRA is safer than has been demonstrated.

Soon after the FDA issued the warning letter, Abbott fired H&S. Id. ¶ 30.

Academic Research on HUMIRA

In her Complaint, Ms. Larson refers to several academic papers published between 2004 and 2009, which highlighted the risks posed to HIV individuals by TNF inhibitors. Ms. Larson alleges that Abbott knew or should have known of such research. Id. ¶¶ 18, 22, 32, 34. Yet, Abbott never included the papers' conclusions in its communications about HUMIRA; never included information about the risks of HUMIRA to HIV patients in its communications with doctors; never indicated which patients, if any, were proper candidates for the use of HUMIRA; never provided information as to the necessary precautions for use of the medication; and never conducted clinical trials to determine whether HUMIRA was safe for HIV patients. Id.

For example, Ms. Larson identified a 2004 paper by Dee Dee Wu, M.D., of New York's Hospital for Special Surgery, in which Dr. Wu stated that "it is reasonable to conclude that anti-TNF agents can be used with great caution in HIV patients with significant morbidity from a TNF-a-mediated illness.'" Id. ¶ 17. On January 15, 2008, rheumatologist Jon Giles, M.D. published a paper for the Johns Hopkins Arthritis Center that, among other things, pointed out that clinical practice "dictated that [TNF inhibitor therapy] [should not be] initiated in patients with a CD4 count below 200 or a viral load[6] greater than 60, 000 copies.'" Id. ¶ 22 (second alternation in Complaint); see also id. ¶ 21. In April 2009, dermatologist Jason J. Emer, M.D., of the Mount Sinai School of Medicine in New York City, published a paper in which he concluded: "TNF inhibition in HIV should be reserved for highly selected patients who have failed other treatment options and are well controlled under antiretroviral therapy until the potential for long-term effects... have been more clearly determined.'" Id. ¶ 31. The Medical Board of the National Psoriasis Foundation published a paper in August 2009, titled "Psoriasis in Patients with HIV Infection, " which stated that "patients with HIV-associated psoriasis should be followed up carefully for potential adverse events with regular monitoring of the CD4 counts and HIV viral loads, and regular consultation with an infectious disease specialist.'" Id. ¶ 33.

Mr. Larson's Use of HUMIRA

Kraig Larson was diagnosed as HIV in 2004. Id. ¶ 38. He also has psoriasis. Id. ¶ 41. From 2004 through 2010, Mr. Larson's HIV status was monitored by Dr. Yang, an infectious disease physician with Annapolis Infectious Disease Associates, LLP. Id. ¶ 39. On or about October 21, 2009, Dr. Yang evaluated Mr. Larson and noted that his psoriasis had worsened since the last time she examined him. Id. ¶ 42. However, she told Mr. Larson that his HIV remained asymptomatic and stable. Id.

Dr. Yang conducted a blood draw on Mr. Larson on October 21, 2009. Id. ¶ 43. Subsequent blood tests indicated that Mr. Larson's CD4 count was 266 and his viral load was 138, 500 copies. Id. Previously, Mr. Larson's lowest reported CD4 count was 434 and his highest viral load was 53, 143 copies. Id. According to plaintiff, it was "Dr. Yang's duty to promptly review and clinically correlate the change in Mr. Larson's CD4 count and viral load in November of 2009 and place Mr. ...

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