Public health is reliant on companies that research and manufacture medical devices, diagnostics, therapeutics and pharmaceuticals. Yours and other companies that serve the industry are responsible for the wellbeing of the people, animals, plants and environment they provide for, and that is met with hefty legal and regulatory challenges. Just one infraction can prevent your products from ever getting to market.
Higginbotham’s Life Sciences Practice understands the business of research, product development, clinical trials, commercialization and the FDA and other governmental agencies that regulate these processes. We have served life sciences companies in every stage of development—from start-ups to global operations, including:
- Biotechnology research and development
- Medical device manufacturers and distributors
- Contract research organizations
- Contract sales and marketing organizations
- Contract manufacturing organizations
- Clinical trial companies and facilitators
- Pharmaceutical manufacturers and distributors
Higginbotham’s specialty expertise is recognized by the major life sciences insurance carriers, including:
- Allied Medical
- Berkley Life Sciences
- Chubb Life Sciences
- CNA HealthPro, Advanced Medical Technology Division
- Lloyd’s of London
- Monitor Liability
- Navigators Group
- One Beacon
Common Life Sciences Company Coverages
- Business Owners General Liability policy for emerging technology companies in leased space or incubators
- Directors and Officers Liability, including pre-revenue company coverage
- Clinical Trials for Phase I, II and III Products
- Products Liability
- Research Animals
- Clean Room Contamination
- Precision Instruments
- Loss of Grants, Endowments and Other Financing
- Bio Contamination
- Loss of Medical and Biotechnology Records
- Intellectual Capital Infringement
- Inadvertent Disclosure of Private and Confidential Information
- Inland and Ocean Transit
- International Liability
- Latent Injury Liability
- Incidental Medical Malpractice
- Product Recall
Lawsuits claiming injury from defective or dangerous medical appliances, organ transplants, prosthetic devices, surgical implants, hospital supplies, diagnostic equipment, surgical equipment and hearing and visual aids make loss control a paramount concern for life science companies. Our risk managers are familiar with the nuances of product liability, statutes of limitation and Food and Drug Administration (FDA) requirements, and we implement safety and loss prevention programs that help avoid lawsuits and noncompliance penalties.
Higginbotham is a preferred provider for the Texas Healthcare and Life Sciences Association as well as BioHouston and is a member of the Metroplex Technology Business Council. We are also key providers for several Texas-based technology incubators such as TECH Fort Worth, North Texas Enterprise Center (NTEC), UT Arlington Innovation Center and Austin Technology Incubator (ATI).
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