Life Sciences (Pharmaceuticals, Chemicals, Biologics, Animal Feed)
Our Practice for companies in the life sciences offers an unusual combination of depth in industry knowledge and scientific expertise. Our firm includes lawyers with advanced doctoral and medical degrees, direct experience with designing, implementing and reporting on clinical and laboratory research in areas of medicine, psychiatry and psychology, and advanced training in clinical trials. Members of the Practice are well recognized for their legal work in areas of medicine, psychology, toxicology and epidemiology.
Our lawyers bring the experience and understanding gained in hundreds of major client representations, successfully presenting legal and factual issues to juries and judges in ways that are both understandable and persuasive. Our lawyers have represented companies in product, toxic tort, mass tort and class action defense, disputes over divestiture and acquisition agreements, distribution and supply agreements, insurance agreements, successor liability, employment, collaboration agreements, laboratory agreements, research agreements, trademark, licensing, and advertising.
In product liability and toxic tort litigation, we have represented companies facing claims across dozens of different medications, types of chemical exposure and types of injury. We have been retained in cases involving death, severe birth defects, neurologic and CNS injury, rheumatologic diseases, liver, blood and kidney injury, cancers and more. We have developed expert defenses based on a wide range of specialties in medicine, psychiatry, epidemiology, toxicology and chemistry.
We team well with other firms and have played specialty roles in large-scale litigation (such as Science Counsel). Our work often involves the use of sophisticated demonstrative aids, mock juries, and the interpretation for lay people of complicated expert scientific testimony.
Representative Matters by Lawyers in the Firm: Litigation
- Lead counsel in toxic tort actions alleging that chemical emissions caused cancer, wrongful death and other serious personal injuries to children in the community. Extensive work on epidemiology and toxicology defenses, leading to successful pre-trial settlement.
- Lead Counsel in corporate contract dispute over successor liability for thousands of underlying personal injury tort claims in jurisdictions across the U.S., arising out of product made by a predecessor company, obtaining summary judgment of no liability for our client.
- Lead Counsel in multi-forum corporate dispute over supply of contaminated chemical and international sales of bulk pharmaceuticals to customers in U.S., Great Britain, Japan and other countries, with successful recovery of damages, partial attorneys' fees and preserving customer relationships for the client.
- Counsel for multinational chemical company defending breast implant litigation (personal injury class action and individual cases), with development of generic, case-specific and expert defenses.
- Lead counsel in substantial insurance disputes for defense and indemnity costs, including litigation over thousands of underlying personal injuries arising from use of a prescription product in pregnancy, over hurricane damage to company facilities, and over a personal injury verdict of $124 million in punitive damage, each resulting in coverage for our clients after pre-trial or trial rulings.
- Counsel for manufacturer in multi-million dollar "toxic mold" case brought by a Texas school district. Suit was settled for less than 10% of the amount claimed million one day after Robinson/Daubert argument.
- Served as outside counsel for a major university-based medical school in complex litigation involving a wide variety of specialties of its faculty members.
- Counsel for multinational chemical company defending breast implant litigation (personal injury class action and individual cases), developed generic, case-specific and expert defenses.
- Represented pharmaceutical company in a third party product liability action filed by certain hospital and nursing defendants involving failure-to-warn allegations against anti-stroke medication. After deposition discovery, obtained pre-trial dismissal with prejudice of all claims.
- Lead Trial Counsel and appellate counsel in obtaining defense and indemnity coverage for pharmaceutical client facing hundreds of underlying personal injury claims made on account of alleged improper marketing of a prescription medicine and use in pregnancy.
- Lead defense counsel in over 100 pharmaceutical or device actions, involving serious illnesses and/or death, with expert defenses from multiple fields of medicine, psychiatry, epidemiology and toxicology. Cases filed in state and federal courts throughout Illinois.
- Lead Science Counsel for development of medical defenses in a set of personal injury claims arising from purported ground water contamination of volatile organic chemicals.
- Lead Science Counsel in multiple product liability and toxic tort engagements in different state jurisdictions. Some matters involved developing a package of science-based defenses in advance of anticipated litigation. Other matters involved developing scientific expert defenses for ongoing litigation and in coordination with firms playing different litigation roles in defending a mass tort or consumer fraud claims.
- Regional counsel/trial counsel in defense of multiple personal injury cases involving first-in-class treatment for diabetes. Focus on developing scientific defenses to under Frye/Daubert criteria, depending on jurisdiction. Cases filed in state and federal courts throughout Illinois.
- National coordinating counsel for manufacturer of vaccines administered to children. Developed and implemented successful strategy for early disposition of dozens of cases in jurisdictions across the country. Case filed nationally over 60 state and federal courts.
Representative Matters by Lawyers in the Firm: Counseling
- Risk assessment and risk management. Counseling for products in development and marketed products, to determine risks of litigation by consumers, patients, commercial partners and other parties, and to counsel on methods of minimizing or disposing of litigation risks.
- Advertising and Labeling. Counseling on compliance with advertising and labeling laws; assisting in development of accepted standards for environmental claims on products; ensuring compliance with children’s advertising rules; counseling on funding for cooperative advertising programs.
- Distribution and Sales. Drafting distribution or brokerage agreements; advising on compliance with state franchise and broker laws; advising on termination of distributors or brokers; dealing with bootlegging and counterfeiting of products; establishing exclusive dealing and distribution arrangements; negotiating import and export quotas.
- Marketing, Merchandising, and Promotion. Helping to develop campaigns to provide sampling of products; counseling on rules for establishing trade promotion programs; establishing coupon redemption programs; ensuring compliance with rules governing sweepstakes and other games of chance; counseling on public relations.
- Regulation and Food Safety. Advising on good manufacturing practices; assisting with product recalls; establishment of crisis management teams to ensure recall readiness; drafting and negotiating regulations and statutory language; developing training programs for employees; drafting food safety policies.
- Compliance, Risk Prevention and Safety Standards Review. Conducting risk management analyses and providing practical advice for limiting or eliminating safety risks across a range of products, taking account of federal, international and other applicable safety standards; working with different products regulated by the FDA, EPA, Department of Agriculture and Consumer Product Safety Commission to minimize or eliminate product safety issues; working with clients to address obstacles encountered in meeting standards or compliance with new safety regulations and laws.
- Quality Programs. Counseling on standards and regulations that frame quality assurance and quality control programs, typically in the context of an emerging product safety or liability issue; working with clients and consultants on an as-needed basis to address the existing issues and develop potential solutions.
- Product Liability Defense. Developing pre-litigation defense strategies and tactics for potential product litigation, including personal injury, consumer fraud, class action defense, warranty, and other related cases.
- Drafted HIPAA policies, procedures, and authorizations, as well as business associate and data use agreements
- Counseled client on Japanese medical device laws and regulations before and after major revisions
- Negotiated business associate agreements for use with national outcomes database having hundreds of healthcare facility participants
- Prepared infringement and validity opinions relating to, among other things, patents for various technologies, including methods of medical treatment and drug delivery, blood glucose monitors, drugs, chemical enantiomers, beverages, nutritional supplements, methanol to olefin conversion
- Counseled pharmaceutical and medical device company clients on creation and dissolution of joint ventures for product development and marketing