The Cambridge Laboratories Case Series
Dennis R. Shaughnessy
Executive Professor

“Of Mice and Men”
A Negligence and Liability Theory Case

While this is a fictional business case, prepared for class instruction purposes, students will be asked to treat certain of the information contained herein as not in the public domain and therefore confidential, as directed by the instructor.

Cambridge Laboratories, Inc. is widely known in the biomedical research community for its expertise in providing a range of services related to the management of genetically engineered (“transgenic”) mice. The Company provides a variety of specialized services to pharmaceutical and biotech companies that support the development, maintenance and use of proprietary transgenic mice, including breeding and colony scale-up, short and long-term housing, embryo cryopreservation, genetic testing, health profiling, dosing and biologics production. Cambridge has specialized facilities in several countries, including bio-secure facilities (BSL3 and below only).

Cambridge was recently approached by a small privately-held biotechnology company (BTC), to provide transgenic services on a new proprietary transgenic mouse model. BTC’s unique transgenic mouse produces a toxin that effectively disables a certain strain of filovirus, normally found in remote areas of Central Africa, known as “Tinochika” (in local dialect, “the one we live in fear of”). The so-called TC virus, a relative of the infamous “Ebola” virus, is equally deadly, but more stable and long-lived. No treatments for the human form of this rare tropical disease are currently available.

While BTC began this project with the idea that TC virus was a rare tropical disease with limited market potential, it has since learned from the Centers for Disease Control that isolated cases of TC infected people in the US have been detected in the Northeast corridor.

It has recently been reported in the news media that certain representatives of the US government consider the TC virus to be a potential biological weapon, for criminal and/or terrorism activities. It has also been reported that non-indigenous personnel have been observed extracting human tissues and blood samples from infected persons in remove African villages. In this densely forested region of Central Africa, the TC virus is carried in a rare primate species (without clinical signs of disease), and reports are that breeding pairs have been trapped by locals and sold into black markets in Africa and Asia.

BTC’s goal is to produce for commercial sale both a vaccine and a post-infection therapeutic agent for TC virus. BTC has requested that Cambridge provide certain of the transgenic services in their portfolio to support this R&D program, beginning with an immediate need to house, breed and scale-up a secure colony of their TC mice.

BTC’s senior management has concluded from its confidential internal, unpublished research that TC virus when present in an inoculated mouse is highly contagious, and that the virus is readily transmissible upon close contact (airborne) between mice and humans. In other words, the virus when present in mice will infect humans, in a deadly form. The scientific community to this point believes that the virus is transmissible only through direct fluid exchange between non-human primates and humans, not between mice and humans. (Diseases that can pass from animals to humans are known as zoonautic diseases.) Only BTC's research staff are aware of the zoonautic nature of the virus.

BTC’s senior management team concluded that the risks associated with handling this virus and infected mice were so great that any disclosure of its research results would likely result in immediate CDC intervention, and in turn, discontinuance of their research program until appropriate security and safeguards (such as biosecurity level or “BSL” 4 facility space) could be established. Also, BTC’s internal research to date indicates that the mice, when subjected to multiple doses of the virus, can develop and shed through fluids or contact a highly resistant and extremely virulent and zoonautic strain of the virus that is not otherwise naturally occurring. Neither the CDC nor the scientific community generally is aware of this information, nor could they be aware after public domain research, as it is the result of proprietary BTC research that has not been published or shared at scientific conferences.

With this extremely sensitive and unpublished research in hand, BTC has determined that its animal research and production activities for the TC project should not be undertaken internally, but rather be outsourced to a third party contractor, to avoid endangering the health and safety of BTC employees. Internal emails at BTC confirm that management is deeply concerned about the risk inherent in this project to the health of its research staff, as well as to others who come in contact with the genetically engineered “hot” models, but authorized proceeding with the work with Cambridge on an undisclosed basis in order to avoid regulatory and public health intervention.

Cambridge’s manager of transgenic services has managed a small colony of these transgenic mice for BTC for several days, informally at BTC’s request, on a short-term pilot project or “beta” basis. Such short term projects are common in the industry. She is experienced in managing complex research projects, though not a PhD. The pilot project did not include disclosure by BTC to Cambridge with respect to the genetic and health profile of the mice or the nature of the virus that the mice had been exposed to. The pilot study was placed at Cambridge after BTC's scientific staff evaluated Cambridge’s commercial and technical capabilities. The pilot mice included control (wild type) animals, the transgenic ones, as well as models of both types already inoculated with biologically active or “hot” TC virus in the BTC engineered form. Cambridge staff had not been advised by BTC of the three distinct types of mice in its custody (i.e., the staff was blind to the three categories of models), in fact, despite multiple verbal and written requests, Cambridge’s project manager received no documentation from BTC regarding the precise nature of the virus and its manifestation within the mouse models. Because this was a pilot project, and largely due to the repeated urging of BTC’s research manager as to the urgent and critically important nature of the work, as well as several oral assurances as to its general safety, Cambridge accepted this project on a temporary basis without entering into its standard customer contract. Cambridge agreed to defer a final form of signed contract containing the associated disclosure requirements for a few days pending the success of the short-term pilot activity.

At Cambridge’s facility, a just completed internal audit concluded that one breeding pair of the original inoculated or “hot” mice is currently unaccounted for. One shipping report indicates that a delivery by a courier service arranged by BTC had arrived at Cambridge with a badly damaged shipping crate. It also appears that a mouse escape from a temporary holding space in the receiving unit at Cambridge may have occurred during a brief power outage, which could lead to cross breeding of inoculated TC transgenic mice with other strains produced for researchers by Cambridge. In addition, one derivative strain of the original transgenic that was cryopreserved by Cambridge at BTC’s request was destroyed, when cryopreservation tanks thawed during the same power failure at the Cambridge facility resulting from an unprecedented electrical storm (even back-up systems were knocked out).

Finally, Cambridge’s GLP audit report indicates that tours of the facilities provided to third parties (educational tours with students, potential customers, local community officials, investors) included brief public contact with the biologically contained space in which a small number of TC mice had been temporarily housed until permanent space could be secured for the full project.

An employee of Cambridge who worked with the pilot TC mice has recently become severely ill. In addition, researchers at three institutions where the mice have been shipped by Cambridge at BTC’s direction—a federal government infectious disease research center, a large pharmaceutical company in the US, and a biotechnology business in Europe-- have also become severely ill in recent days. The press has reported an unusual viral illness among a student in the local community. Cambridge has also sent blood and tissue samples from the mice to third party laboratories for analysis, and small pilot lots of antibodies collected from the inoculated transgenic models to third party large-scale biological production firms for evaluation of manufacturing requirements.

With all of this in mind, Cambridge’s business manager has urgently turned to the CEO, Mr. Smith, for direction on how to proceed with BTC’s request to now provide the full range of transgenic services, including providing inoculated animals and biological derivatives (cells, blood, tissue samples) to researchers around the world who are collaborating with BTC on Tinochika virus characterization. The division GM indicated that she was stunned to learn last evening of the details of this extraordinary virus, during a brief telephone conversation initiated by a BTC scientist who refused to identify herself, especially the ease with which this engineered form of virus can be transmitted from mice to humans in its most virulent form, and was very concerned about the possible the risk to the health of her staff.