A Life Sciences Expert Consulting Case Involving Very Expensive Pharmaceutical Drugs
A temperature controlled truck was transporting expensive human Albumin and human Immunoglobin pharmaceuticals when it got into an accident. Human Albumin has numerous clinical uses. For instance, it is used in the emergency treatment of shock, where the restoration of blood volume is urgent. It is also used to prevent hemoconcentration (increased concentration of cellular elements in the blood resulting from loss of fluid to the tissues) and to maintain appropriate electrolyte balance in burned patients. Furthermore, it is used to treat hypoproteinemia (low concentration of plasma protein and a resulting decreased circulating blood volume) due to protein malnutrition, protein catabolism (breakdown of proteins into amino acids) postoperatively or in sepsis, defective gastrointestinal absorption, faulty albumin synthesis in chronic hepatic failure, and abnormal renal losses due to chronic kidney dieses. Human Albumin is purified from large pools of adult human venous plasma via a highly complex and expensive process. The human albumin solution is sterilized for usage in the aforementioned clinical purposes.
Human immunoglobulins are proteins (also called antibodies) produced by B-lymphocytes to help prevent and treat bacterial, fungal and viral infections. Human immunoglobulin solution is used as replacement therapy for primary humoral immunodeficiency (disorders that affect the cells, tissues, and proteins of the immune system) in cases such as the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Human immunoglobulin is manufactured from human source or recovered plasma and sterilized for clinical purposes.
Human Albumin and human Immunoglobin are packaged in glass bottles/vials and stored between 20-25ºC (68-77ºF) with short excursions permitted between 15-30ºC (59-86ºF). They should not be subject to drastic temperature changes or subfreezing temperatures, which might compromise their functionality. The vials should not be shaken vigorously and should be kept in their original carton to protect them from light.
When the trailer transporting 32 pallets of these plasma pharmaceuticals got involved in a collision it was heavily damaged and the refrigeration unit became inoperable. At the time of the accident, the outside temperature was well below 0ºC. As such the products were subject to both physical damage and long term temperature abuse. The plaintiff (pharmaceutical company) claimed that these products were rendered useless for pharmaceutical purposes and disposed all of the vials. The pharmaceutical company set the value of the products at $3.4 million and filed a claim against the freight company for this amount.
I was hired by the defendant (the law firm hired by the carrier’s insurance company) to first analyze all the data/facts and determine whether the pharmaceutical company’s claim of unusability of the product for clinical purpose was valid and also to determine whether the products could have been salvaged for other applications purposes rather than being destroyed by the pharmaceutical company.
After thorough examination of all the reports I determined that the products indeed could not have been used for clinical purposes. Most of the glass bottles/vials used for the storage of the products had visible cracks. These cracks exposed the solution to air and rendered the solution unsterile with a high chance of bacterial and viral contamination. Since these pharmaceutical products are used in human subject they can only be used sterile to prevent infections. Furthermore, drastic temperature variations, exposure to subfreezing temperature, light exposure (due to the breakage of the outer packaging), and vigorous shaking of the vials during the accident subjected the products to potential denaturation (a process by which the proteins became inactive) and product degradation.
However, while the products in question could no longer have been used for clinical purposes the pharmaceutical company should not have discarded the products since they could have been used in nonclinical applications. I provided a thorough list of molecular biology procedures by which the products in question could have been tested in order to determine their concentration, activity and possible contamination levels. I also provided a long list of life sciences research applications and cosmetic applications they could have been utilized in. Furthermore, I provided a molecular biology research price structure for the products in question and compared that to the clinical value of these products. For example, human Immunoglobin could have been sold for molecular biology research applications for a price seven times higher than if it was sold for clinical purposes. In conclusion, if the pharmaceutical company had not disposed the products in question they could have been analyzed by molecular biology assays to determine their activity level and sold into life sciences and cosmetic industry at a much higher price point. As a result of my contributions to this case the law firm was able to settle the case with the pharmaceutical company and reduce the claim by more than 1.5 million dollars (or by over 50%).
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