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Practices + Industries

Drug and Medical Device

Overview

South Carolina has identified the biosciences industry as a target area of future growth and development. Between an advantageous corporate tax structure, qualified work force and collaborative business environment, companies in the biosciences have found the Palmetto State a supportive and cost effective location. But state and federal laws governing drug and medical device companies are just as rigorous in South Carolina as elsewhere in the country. From patents to regulatory compliance to products liability, the legal issues that companies in the biosciences face can mean tough consequences or great reward.

Drug and medical device manufacturers have an interest in maximizing their investment in researching and developing new products. They need quality legal counsel who can pursue intellectual property protections at the state and federal levels, including securing and protecting patents. They also need to address potential regulatory barriers and minimize exposure to enforcement actions. And in the unfortunate case of product failure or complication, drug and medical device companies need counsel who can help them develop a quick and effective response.

The Drug and Medical Device team at Turner Padget has extensive experience addressing the panoply of legal matters that our clients face. Our attorneys are well-versed in the technical aspects of pharmaceuticals and medical devices. Drawing on our firm’s rich litigation tradition, we have successfully presented highly technical issues to judges and juries alike and have handled complex lawsuits involving multiple parties and multiple jurisdictions. Our patent attorneys advise clients on ownership of patents and inventions, portfolio management and provide patent protection. We frequently represent drug and medical device manufacturers in fraud litigation and governmental investigations. As our attorneys stay current with cutting-edge legal developments impacting the biosciences industry, we stand ready to represent our clients no matter how complex or technical their legal issue may be.

Experience

  • Product liability
    • Phenylpropanolamine (PPA)
    • Rezulin
    • Abilify
    • Ephedra
    • Hormone replacement therapy (HRT)
  • Class actions
  • Patents
    • Licensing
    • Prosecutions
    • Portfolio management
  • Fraud investigations
  • Regulatory actions
  • FDA pre-market approval
  • Product testing

Representative Engagements

Litigation

  • Currently defending the manufacturer of a device prescribed for post surgical pain control and management in cases in which the patients developed post-arthroscopic glenohumeral chondrolyis (PAGCL).
  • Represented medical device manufacturer in nationwide litigation with health insurers over the insurers’ refusal to pay for products used by attending physicians.
  • Defended one of the largest manufacturers of surgically implanted spinal devices in litigation arising from adverse surgical events.
  • Represented the manufacturer of an electro-surgical pencil unit for cauterization involving injuries to a patient discovered during surgical recovery. We obtained a dismissal of this complex product defect claim against the manufacturer.
  • Represented the manufacturer of a clot-buster drug in a wrongful death case in which both plaintiffs withdrew their claims.
  • Defended a radiology facility regarding its allegedly undersized MRI unit. The case was settled under product misuse claims. 

  • Obtained dismissal of a product defect suit against a French manufacturer of basket catheters for claims related to defective products, resulting in infections.

 

Intellectual Property

  • Obtained patents for diagnostic devices for detecting analytes.
  • Secured patents for devices and methods of high-speed pharmaceutical processing.
  • Obtained patents for medical devices such as catheters and stents.
  • Negotiated and managed IP option agreements and development licenses, for example between a research physician and a university development office for commercialization of new medical technologies.