The global market for human blood products is experiencing significant growth, estimated to increase from $44 billion in 2024 to more than $76 billion in the next ten years.1 From the common blood transfusion to novel therapeutics developed from human tissue, the collection and use of human biomaterials continues to save lives.
These advancements aren’t without risk, however. Any number of complications can adversely impact the patients who depend on these treatments. As research transforms the life science space, blood shield laws give companies some protection from ensuing medical lawsuits that could take away time, funding and focus.
“Life science companies that embed regulatory compliance and rigorous risk management into their operational DNA will be best positioned to protect both patients and their business,” says Ian Davis, general liability technical manager at The Hartford.
What Are Blood Shield Laws?
While the practice of using blood, tissue or other human cells can be traced back hundreds of years, the legal implications gained attention in 1954, when the recipient of a blood transfusion contracted hepatitis and sued the hospital under product liability grounds. The courts determined the hospital provided services, not products, and thus established a precedent for the application of blood shield laws today.
- Blood shield laws classify the provision of human blood and tissue as a service rather than a sale, exempting these activities from certain liabilities typically associated with the sale of goods.
- Most blood shield laws were originally directed at hospitals and blood but now also include tissue, other bodily fluids, placenta and bone.
- These laws protect manufacturers, producers and providers of blood from unlimited liability but are open to interpretation by jurisdictions, leading to different outcomes depending on what state a claim is made in.
- Most states provide legal protection to blood banks and related entities. Some states specifically limit their protections to blood banks, storage facilities and hospitals. Others limit liability to negligence or misconduct during procurement, processing, storage or distribution.
- Protection from product liability claims is covered under the laws, however, they do not eliminate negligence claims.
As new lifesaving and life-enhancing treatments are developed, blood shield laws are expected to evolve as well.2 Understanding current legal policies is the first step to staying protected today. Companies that follow risk management strategies are better prepared for the future; helping to improve potential litigation outcomes, gain a competitive advantage and minimize costs.
Risk Management Best Practices
The overarching intent of blood shield laws is to help address cases where a patient alleges harm from blood or tissue treatment. These laws, coupled with a strong risk management framework and well-structured insurance program, are critical to ensuring patient safety. Life science companies can use the following best practices to benchmark their current strategies and to identify areas for continuous improvement.
1. Promote a Culture of Operational Responsibility
Leadership teams play a critical role in modeling a culture of quality. When managers connect across departments to align a roadmap, streamline messaging and coordinate with internal communications teams, they can continuously encourage the product safety narrative at all levels throughout the company.
2. Review Quality Management Systems
Engage external experts to periodically assess strengths and potential weakness in an existing QMS System. A gap analysis can identify exposures and opportunities within business and operational management systems, insurance coverages, contract obligations and value streams.
“At a minimum, companies should adhere to U.S. Food and Drug Administration regulations,” explains Frank Campbell, underwriting director for life science at The Hartford. “However, you really want to exceed them with comprehensive donor screening, extended quarantine, testing, safe storage and inventory management.”
3. Comply With Collection Standards
Product testing and inspection play a vital role, ensuring that products meet specified standards, comply with industry regulations, and are safe and reliable. Given the increase in lawsuits, product recalls, and oversight by governmental and non-governmental bodies, rigorous testing and inspection of donor blood and tissue for potential infectious disease is critical.
Primary prevention begins with a donor risk assessment (a detailed medical-social interview) and an exhaustive review of a donor’s medical records and sexual history. Donor materials are required to undergo testing for diseases such as human immunodeficiency virus, Hepatitis B, Hepatitis C, Clostridium perfringens and E. coli, and may follow a process of quarantine and release. Because tuberculosis (TB) is difficult to screen, risk factors - including travel to regions with high TB prevalence - and relevant clinical findings should be considered for all prospective tissue and organ donors to prevent contagion.
4. Prevent Contamination and Spoilage
Prevention starts at the retrieval phase with specific steps taken by the donor recovery operation to control contamination and cross-contamination. These protocols include:
- Adherence to appropriate donor eligibility guidelines, such as specific body cooling parameters and time limits for retrieval.
- Ensuring a suitable location for recovery site activities.
- Using clean techniques appropriate to the specific cells and tissues being recovered; cleaning, disinfecting and sterilization of equipment, supplies and instruments.
- Monitoring recovery activities for microorganism contamination, such as by culture results.
- Sharing all records related to donor eligibility determinations.
After retrieval, life science companies need to consistently update and practice safe storage techniques to minimize the damage to new materials and loss of access to research. Different blood and tissue products have their own temperature and storage needs to prevent spoilage, which can cause significant delays in the completion of contract research and projects.
5. Employ Contractual Risk Transfer
Ensure contract and consent forms are clear, comprehensive and frame the company as a service provider rather than a product seller. Consult with legal counsel to ensure language aligns with jurisdictional requirements and addresses gaps in blood shield protection.
6. Establish Adverse Event Protocol
Life sciences companies have a duty to protect public health with FDA-compliant reporting and tested recall procedures for adverse events. These processes should include traceability systems for rapid product retrieval and a strategy for root cause analysis.
7. Stay Current
From an enterprise risk perspective, leadership teams should participate in life science professional organizations, non-governmental organizations (like the American Association of Tissue Banks) and industry panels to stay current on evolving U.S. and global regulations and responsibilities
How Agents, Brokers and Insurers Can Help
Alleged claims and litigation tend to be complex, costly, hypersensitive, and have reputational and moral implications.
“Partnering with an insurance carrier, agent and broker with expertise in applicable blood shield laws can help ensure your company’s program is appropriately defined and aligned with jurisdictional liability protection,” says Rob Gaus, technical manager for life science at The Hartford. “They will understand what changes need to be made to a typical general liability and property form.”
Lack of knowledgeable support and confusion around FDA regulations could lead to issues such as:
- Incorrect assumptions about whether a product is unregulated, which could affect a company’s ability to obtain insurance or increase their cost of insurance.
- Gaps in insurance coverage from rising direct costs and risk exposure.
- A history of claims that could make it harder to get insurance at reasonable rates and with favorable terms.
“Even with the protection of blood shield laws, these lawsuits are expensive to defend,” says Gaus. “It affects your reputation and becomes a distraction for your leadership team. And it’s a huge responsibility as a company in the medical sciences space, because from a human health perspective, disease transmission is a serious consequence.”
Learn more about the risks that life science businesses face and how you can protect your company.
1 Human Blood Products Market Size and Volume Production, Towards Healthcare, viewed October 2025.
2 Map of State Based Legislation, America’s Blood Centers, viewed October 2025.
The information provided in these materials is intended to be general and advisory in nature. It shall not be considered legal advice. The Hartford does not warrant that the implementation of any view or recommendation contained herein will: (i) result in the elimination of any unsafe conditions at your business locations or with respect to your business operations; or (ii) be an appropriate legal or business practice. The Hartford assumes no responsibility for the control or correction of hazards or legal compliance with respect to your business practices, and the views and recommendations contained herein shall not constitute our undertaking, on your behalf or for the benefit of others, to determine or warrant that your business premises, locations or operations are safe or healthful, or are in compliance with any law, rule or regulation. Readers seeking to resolve specific safety, legal or business issues or concerns related to the information provided in these materials should consult their safety consultant, attorney or business advisors. All information and representations contained herein are as of November 2025.
The Hartford Insurance Group, Inc., (NYSE: HIG) operates through its subsidiaries, including the underwriting company Hartford Fire insurance Company, under the brand name, The Hartford®, and is headquartered in Hartford, CT. For additional details, please read The Hartford’s legal notice at www.thehartford.com.
