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On Demand Audio

Drug and Medical Device Product Liability (And Related) Claims

(692 reviews)

Produced on December 22, 2014

Taught by
$ 89 Personal Injury and Negligence and Litigation In Stock

Course Information

Time 92 minutes
Difficulty Intermediate

Course Description

Drug and device product litigation brings together a multiplicity of causes of action, both statutory and common law, and intersects with the different regulatory regimes governing branded drugs, generic drugs, and medical devices. This course, presented by attorney Andrea Bierstein, explores the different causes of action that are commonly used in drug and device product liability litigation, highlights common variations in state laws, and dissects issues that arise in proving these cases. The course further looks at some types of related claims, such as consumer fraud and third-party payor claims, that may be brought alongside traditional product claims. Ms. Bierstein also untangles the numerous Supreme Court and circuit Court of Appeals decisions concerning the operation of federal preemption in product liability litigation involving branded drugs, generic drugs, and medical devices. Overall, the course provides an overview of the legal framework for this important and growing area of litigation.


Learning Objectives

I.     Review the causes of action used to bring claims involving injuries arising from pharmaceutical drugs and devices

II.    Grasp issues involved in proving the causal connection between a drug or device and the plaintiff’s injuries, including general and specific causation, the “learned intermediary” doctrine, and expert witnesses and Daubert challenges

III.   Know the effect of direct-to-consumer advertising on pharmaceutical drug and device claims

IV.   Understand how federal preemption affects the various types of pharmaceutical and device product claims




Andrea Bierstein

Simmons Hanly Conroy LLC

Born New York, New York. Admitted to bar: 1985, New York; 1986, U.S. District Court, Southern and Eastern Districts of New York; 1987, U.S. Court of Appeals, Second Circuit; 1993, Massachusetts; 1997, U.S. Court of Appeals, Third Circuit; 1999, U.S. Court of Appeals, Ninth Circuit; 2005 U.S. Court of Appeals, Eleventh Circuit; 2008, U.S. Court of Appeals, Seventh Circuit. Education: Princeton University (A.B., 1978); New York University (J.D., cum laude, 1984).


By almost anyone’s account, Ms. Bierstein is one of the premier appellate brief-writers and oral advocates in the nation. She is highly experienced in virtually all forms of civil litigation and is a former law professor who designed and taught a civil litigation clinic and taught courses in Evidence and Remedies. She has made the roster of New York Super Lawyers in each year from 2007 to 2011.


Representative Cases

  • In Re: Depuy Orthopaedics, Inc. Pinnacle Hip Implant Product Liability Litigation, MDL 2244 (N. D. Tex.): (representing individuals injured by defective metal-on-metal hip implants)
  • Jean-Charles v. Perlitz, 3:11cv614 (RNC) (D. Conn.) and St. Louis v. Perlitz, No.: 3:13-cv-01132 (RNC) (representing victims of pedophile)
  • ISynergetics USA, Inc. v. Alcon Laboratories, Inc. and Alcon, Inc., 2008-cv-3669 (DLC) (S.D.N.Y.) (plaintiff's contingency fee antitrust suit; settlement of $32 million and fee of $10.5 million);
  • In re Oil Spill by the Oil Rig “Deepwater Horizon” in the Gulf Of Mexico, on April 20, 2010 litigation (environmental litigation);
  • Easton Capital Management v. Rush, No. 09 Civ. 1307 (S.D.N.Y.) (representing venture capital investment funds prosecuting fraud and related claims arising from their investments in a medical device company);
  • In re Gadolinium-Based Contrast Agents Products Liability Litigation, MDL 1909 (N.D. Ohio) (representing individuals injured by contrast media used in MRIs)
  • In re Terrorist Attacks on September 11, 2001, MDL 1570 (S.D.N.Y) (argued appeal in Second Circuit)
  • In re Zyprexa Litigation, MDL 1596 (E.D.N.Y.) (third-party payer class action)
  • Reid v. Siniscalchi, No. 2874-VCN (Delaware Chancery) (representing investor in a derivative action involving claims arising from a joint venture to finance Russian communications satellites)
  • In re OxyContin, 15 Misc.3d 388, 833 N.Y.S.2d 357 (Sup. Ct. Richmond Co. N.Y.Sup. 2007)
  • Class actions and individual actions involving franchisees suing franchisor and other parties for breach of contract
  • Bartold v. Glendale Federal Bank, 81 Cal.App.4th 816, 97 Cal.Rptr.2d 226 (2000) (successful appeal)
  • Ramadan v. Chase Manhattan Corp., 156 F.3d 499 (3rd Cir. 1998) (successful appeal)
  • Class actions against automobile financing companies seeking recovery of illegal charges assessed at early termination of car leases
  • Class action seeking refund of unconstitutional tax on out-of-state companies
  • Class actions against banks and mortgages companies over failure timely to clear liens upon satisfaction of home loans 


Ms. Bierstein resides in New York City.


Anne P.

Great presentation

Gregory C.

Excellent presentation. Very comprehensive, thorough and informative.

Edward P.

This was an exceptionally comprehensive review of the law and its history. Superb course.

Dan R.

Very informative; well organized and great explanation of nuanced material

Bradley S.

Really helpful and well presented!

Sheldon M.

Good program.

Anna L.

Excellent, well-organized presentation

Michael J.

Very informative on difficult topic in short amount of time.

Jennifer B.

It is always so obvious when you are dealing with an expert when they are this relaxed in a presentation. She connected it together really nicely.

Richard A.

Great overview. Excellent job of identifying sources of law governing the issues.

Kathy M.

Very informative.

Carl L.

Excellent!! I'll keep this presentation in my library!!

Robert S.

Andrea did a fantastic job with presentation. Highly recommended.

Reginia B.

very thorough and well presented.

John B.

Great speaker

Donald G.


Michael H.

the speaker was very good

Jonathan D.

excellent speaker!

Robert R. H.

well done, Andrea B

Joshua L.

Highly recommend!

Mary F W.

I have some experience in this area, and Ms Bierstein did an exemplary job of organizing the current issues and laws.

Nathaniel F.

Excellent presentation.

Thomas Y.

excellent presentation

Daniel G.

Very well done.

Michael B.

Good overview and certainly alerted one to the various pitfalls involved in this type of litigation.

Matthew M.

Very good presentation. Ms. Bierstein starts with first principles of strict liability doctrine and then builds and expands on them. That approach allows her to effectively take the listener through the latest developments in the law and the reasoning beh

Todd R.

good presentation

Jade P.

This may be the best CLE course I've ever listened to. Thank you!

Michelle M.

Excellent presentation of complicated subject matter.

James H. G.

very good

Joan L.

Excellent, well-organzied, substantive presentation.

Wynn K.

Very good!

Jeffrey G.

this was excellent, up to date, professionally presented, focused, precise, with good context

Phillip P.

Well done - obvious that the presenter is an expert in the material and a very good speaker.

Scott C.

Solid program

andrew s.

good course.

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