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Gentile v. Biogen Idec, Inc.

Superior Court of Massachusetts, Middlesex

July 25, 2016

Gerald Gentile [1]
Biogen Idec, Inc. et al. [2] No. 134362

         Filed July 28, 2016


          Peter B. Krupp, Justice

         Plaintiff Gerald Gentile (" plaintiff') has sued defendants Biogen Idec, Inc. (" Biogen") and Elan Pharmaceuticals, Inc. (" Elan") (collectively " defendants") to recover for injuries his wife, Diane Gentile (" Mrs. Gentile"), suffered after taking defendants' drug, Tysabri (" Tysabri"). The case is before me on defendants' motion for summary judgment and plaintiff's motion to amend his Second Amended Complaint. For the following reasons, defendants' motion for summary judgment is ALLOWED and plaintiff's motion to amend is DENIED .


         A. Record Facts

         The summary judgment record, viewed in the light most favorable to plaintiff, contains the following facts material to this motion.

         In 1981, Mrs. Gentile was diagnosed with multiple sclerosis (" MS"). MS is a chronic, progressive, disabling autoimmune disease of the central nervous system. It can lead to brain atrophy and cognitive impairment, confine an individual to a wheelchair or bed, and result in death. MS has no known cure.

         In 2004, the United States Food and Drug Administration (" FDA") first approved the prescription drug Tysabri for the treatment of relapsing forms of MS. Tysabri is intended to decrease the number of MS relapses and reduce and delay nerve damage and resulting disability.

         Defendants collaborated on aspects of research, development and commercialization of Tysabri. Biogen, a Delaware corporation with its headquarters in Massachusetts, manufactured the drug and held the FDA license and regulatory responsibilities associated with it. Elan, a Delaware corporation with a principal place of business in California, distributed the drug and also marketed it to treat Crohn's disease.

         In February 2005, defendants received reports that two patients involved in clinical trials of Tysabri, who also concurrently used Avonex, another MS medication, developed progressive multifocal leukoencephalopathy (" PML"). PML is a rare viral brain infection caused by the John Cunningham virus (" JCV"). A significant portion of the adult population has been exposed to JCV, which is typically harmless.[3]

         On February 28, 2005, following the reports of the PML cases, Biogen withdrew Tysabri from the market and suspended its clinical trials.[4] Defendants attempted to better understand and quantify the risk of PML. In March 2006, an FDA advisory panel considered Biogen's proposal to put Tysabri back on the market. On June 5, 2006, the FDA approved returning Tysabri to the market, subject to conditions and requirements to address the PML risk. One of these conditions required that Tysabri only be prescribed in accordance with a mandatory risk evaluation and management strategy program, also known as the Tysabri Outreach: Unified Commitment to Health (" TOUCH") Program. The TOUCH Program was intended " to assess the risk of [PML] associated with [Tysabri], minimize the risk of PML, minimize death and disability due to PML, and promote informed risk-benefit decisions regarding TYSABRI® use."

         The TOUCH Program required, among other things: (1) prior to prescribing Tysabri, a physician must acknowledge, in writing, that the physician understands the PML risk and must obtain a written acknowledgment of the risk from the patient; (2) prior to each Tysabri infusion, a specially trained nurse must confirm that the patient has read the Medication Guide that includes the PML warnings; and (3) the nurse must also question the patient about the patient's understanding of the PML risk and any new symptoms that could be early signs of PML.

         Another condition for the reintroduction of Tysabri to the market was the requirement of a " black box" warning to inform prescribers that Tysabri use increases a patient's risk of developing PML. The black box warning stated, in part:

[PML], an opportunistic infection caused by the JC virus that typically occurs in patients that are immunocompromised, has occurred in 3 patients who received TYSABRI® in clinical trials (see BOXED WARNING). Two cases of PML were observed in 1869 patients with multiple sclerosis treated for a median of 120 weeks. The third case occurred among 1043 patients with Crohn's disease after the patient received 8 doses. The absolute risk for PML in patients treated with TYSABRI® cannot be precisely estimated, and factors that might increase an individual patient's risk for PML have not been identified. There are no known interventions that can reliably prevent PML or adequately treat PML if it occurs. It is not known whether early detection of PML and discontinuation of TYSABRI® will mitigate the disease. There is limited experience beyond 2 years of treatment. The relationship between the risk of PML and the duration of treatment is unknown.
All three cases of PML occurred in patients who were concomitantly exposed to immunomodulators . . . or were immunocomprised due to recent treatment with immunosuppressants . . . Ordinarily, therefore, patients receiving chronic immunosuppressant or immunomodulatory therapy or who have systemic medical conditions resulting in significantly compromised immune system function should not be treated with TYSABRI® . However, the number of cases is too few and the number of patients treated too small to reliably conclude that the risk of PML is lower in patients treated with TYSABRI® alone than in patients who are receiving other drugs that decrease immune function or who are otherwise immunocompromised.

         The warnings also provided in the " Indications and Usage" section that " TYSABRI® increases the risk of [PML], an opportunistic viral infection of the brain that usually leads to death or severe disability ( see BOXED WARNING AND WARNINGS, [ PML ])." (Bold in original). Defendants also included this warning in Tysabri's Medication Guide, which was provided to patients prior to enrolling in the TOUCH Program. The Medication Guide also stated that " PML usually happens in people with weakened immune systems. No one can predict who will get PML. There is no known treatment, prevention, or cure for PML."

         In early March 2006, in response to FDA's request, Biogen submitted a report on the results of antibody testing conducted on available serum samples of patients who participated in the Tysabri clinical trials. The report concluded " there is no consensus on a clinically relevant cut off for the ELISA assay or JCV antibody detection." Biogen continued to research the significance of the presence of JCV antibodies on the risk of developing PML.

         Mrs. Gentile resided in New York. In November 2006, Mrs. Gentile's doctor, Bianca Weinstock-Guttman, M.D. (" Dr. Guttman"), an MS specialist at the Jacobs Neurological Institute in Buffalo, New York, prescribed Tysabri for Mrs. Gentile. Before doing so, Dr. Guttman performed a JCV DNA test looking for JCV in Mrs. Gentile's bloodstream. Mrs. Gentile tested negative. Also, in accordance with FDA requirements, Mrs. Gentile signed the TOUCH enrolhnent forms, which warned against PML, and acknowledged that " [m]y chance of getting PML may be higher if I am treated with other medicines that can weaken my immune system, including other MS treatments" and that " [i]t is also not known if treatment for a long period of time with TYSABRI can increase my chance for PML."

         At the time she prescribed Tysabri to Mrs. Gentile, Dr. Guttman was familiar with the prescribing information that was in effect, was enrolled as a TOUCH prescriber, was aware of the PML risks provided in the Tysabri warnings, understood the significance of black box warnings, and understood that JCV could cause PML. When Dr. Guttman prescribed Tysabri to Mrs. Gentile, the Tysabri warning indicated that " the relationship between the risk of PML and the duration of treatment is unknown."

         Mrs. Gentile received her first Tysabri infusion in January 2007. The label in effect at the time included the provision: " TYSABRI® increases the risk of [PML], an opportunistic viral infection of the brain that usually leads to death or severe disability." The Tysabri infusions were effective in stabilizing Mrs. Gentile's condition before she developed PML.

         In July 2008, the first two Tysabri-associated PML cases were confirmed following Tysabri's re-introduction to the market. After these reports, in August 2008, the FDA approved Biogen's request to update the label to include the following: " There is limited experience beyond two years of treatment. The relationship between the risk of PML and the duration of treatment is unknown, but most cases of PML were in patients who received more than one year of treatment." By July 24, 2009, eleven cases of Tysabri-associated PML had been confirmed since Tysabri was reintroduced to the market three years earlier.

         In September 2009, Mrs. Gentile received her final Tysabri infusion, her thirty-third monthly infusion since January 2007. In October 2009, Mrs. Gentile was diagnosed with PML. Hers was the twenty-third confirmed case of PML after Tysabri's re-approval. Mrs. Gentile died on December 15, 2009.

         In late 2009, Biogen developed an assay that could reliably detect JCV antibodies in the blood stream, indicating prior exposure to JCV. On December 9, 2009, an advisory board of MS and regulatory experts concluded, however, that data on the JCV antibody assay " was too preliminary to be of predictive value."

         In November 2009, FDA approved Biogen's request to update Tysabri's label so that it included more details about the increased risks of PML with longer Tysabri treatment duration. In July 2010, FDA approved an update to the label that added warnings about a correlation between a patient's prior immunosuppressant treatments and PML.

         On September 8, 2010, FDA rejected Biogen's proposal to add information to the Tysabri label regarding the significance of the JCV antibody status, concluding that " the Division does not believe that there is currently sufficient information to support the clinical ...

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