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Over the years, we have worked with several major pharmaceutical firms over a range of different topics. We have helped them design clean rooms for the manufacture of specialized medical devices, utilizing novel ventilation techniques. We were also involved in writing the original guidelines for identifying acceptable levels of contamination of these products by metals or trace chemicals. We have served as advisors and expert witnesses in litigation involving the presence of trace quantities of metals in certain medical devices, hip implants, stents, and other devices. We assisted a trade association in the European Union (EU) in helping characterize the alleged hazard due to the use of cobalt in various medical devices.
We have examined medical devices to identify plausible long-term health hazards due to the chemicals or metals present within them. For instance, we were able to identify a design flaw in a device meant to produce inhalable drugs, which would be administered several times a day for a lifetime. By assisting with the redesign, we helped minimize the risk to patients and the possibility of product liability litigation.
Our team has extensive experience in providing litigation support to their clients in nearly every industry impacted by human health and environmental health challenges. We have close to four decades of experience specializing in litigation support for over 15 chemicals, including asbestos and talc matters, benzene, chromium, beryllium, dioxins, furans, PCBs, chlorinated solvents, e-cigarettes, sunscreen compounds, and PFOS/PFAS compounds.
We have served as expert witnesses in nearly 1000 cases involving contaminated groundwater, air emissions to the community, consumer product safety matters, occupational exposures, landfills, community exposures, run-off, fugitive chemical emissions, and emissions associated with fires/explosions. We are currently also providing support to clients affected by SARS-CoV-2 (COVID-19/coronavirus) pandemic.
We provide consulting support to producers, suppliers, manufacturers, distributors, retailers, food service, trade associations, insurers, and attorneys on issues involved concerns about chemical contamination in food and beverages. We have worked on many contaminated food issues where there was a question about whether a recall was necessary. We routinely conduct health risk assessments when there is a question about hazards posed by bacterial contamination or contamination by trace concentrations of various chemical agents in processed foods, fresh produce, or food containers.
Our specialists have significant experience in issues ranging from EPA/FDA/USDA regulatory support for raw agricultural commodities, new foods, ingredients, seeds, or pesticides to manufacturing operations or wastewater issues at facilities. We perform root cause analyses and advise on the reformulation of products and re-validation of processes, product recall issues, Proposition (Prop) 65 60-day notices and other regulatory actions.