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Legal Ramifications of Reduced Risk Tobacco Products: Implications of FDA Regulations

Explore how FDA bill impacts tobacco litigation, potential effects of safer products on lawsuits, and the minimal impact of FDA regulations on litigation processes.

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Legal Ramifications of Reduced Risk Tobacco Products: Implications of FDA Regulations

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  1. The Future of Tobacco Litigation: Impact of Reduced Risk Products and the FDA Bill Richard A. Daynard, J.D., Ph.D. Public Health Advocacy Institute Northeastern Univ. School of Law

  2. The Future, Currently • Punitive damages live (I think) • California litigation unleashed • Thousands of Engle class action follow-on cases • Massachusetts strict product liability cases • DOJ case sanctions, and appeal • Light cigarette class actions • Canadian health care (AG-like) cases

  3. BTW, Why do we Care? • Bad documents, bad karma • Trashing their customers • Raise the price, reducing consumption • New, better settlements? • Improve political climate

  4. What difference would Reduced Risk Products make? • The current “safer” products – “light” cigarettes – have gotten them in trouble • Schwarz v. PM (OR) products liability case saw $100 million punitive damages for light cigarette fraud • Miles v. PM (IL) “lights” consumer class action case saw $8 billion compensatory damages, reversed on (non-existent) technicality • Aspinall v. PM (MA), similar to Miles, given green light by state Supreme Judicial Court • Schwab (national RICO lights class action), certified by Judge Weinstein, on appeal

  5. Whether new “safer” products produce similar litigation depends on how they’re marketed and whether they’re really safer • If FDA bill passes, FDA-approved reduced risk products/marketing will be bullet-proof • Marketing a genuinely safer product puts their other products at legal risk • Demonstrates alternative design possibility, needed for strict product liability • Raises question why they didn’t do it earlier, and to their whole product line

  6. Effect of FDA bill on litigation? • Very little (other than for approved reduced risk products)! • Manufacturers can tell juries that “we’re regulated”, suggesting (a) they no longer have free choice, and (b) no need for punitive damages since they are unable to sin anymore, but • They will still make choices • Current diseases result from pre-regulation products • General deterrence • Drug companies have been regulated for a century, but still get hit with big verdicts

  7. Questions? Catcalls?

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