Substantive law:

3D Printing (2/5/15)

Administrative Law –Exclusion of administrative standards that are more lax than legal standards (4/8/10)

Administrative law – No private FDCA right of action (2/18/10)

Artificial Intelligence (7/24/17)

Biomaterials Access Act (8/19/16)

Bulk Suppliers – Liability (11/29/12)

Causation – Duty to Report (9/19/16)

Causation – Increased risk/lost chance (11/30/15)

Causation – Individualized reliance (9/19/13)

Causation – Plaintiff conduct (9/18/17)

Causation – “Regulatory causation” (1/19/17)

Causation – Risks plaintiff never suffered (4/24/17)

Comment k/Unavoidably Unsafe Product – Application to medical devices (1/12/12)

Comment k/Unavoidably Unsafe Product – PMA devices (11/30/17)

Consumer Fraud – Lack of damages (2/5/09)

Consumer Fraud – Prescription medical products not “consumer” goods (2/10/12), and again (6/25/15)

Consumer Fraud – Regulatory compliance as defense (5/24/07) and (3/6/14)

Co-Promoters – Cases rejecting liability (12/7/11)

Damages – Phantom damages (discounted medical bills) (10/9/14)

Decisions in MDL – State law decisions in out-of-state MDLs (4/25/13)

Design Defect – Alternative design requirement in medical device cases (8/8/13), and again (12/12/17)

Design Defect – Manufacturing defect comparison (6/30/16)

Design Defect – Pre-approval design defect (5/8/17)

Distributors – Limits to liability (2/10/15)

Duty to Report − Causation (9/19/16)

Duty to Train or Advise Physicians – Decisions rejecting (9/15/11) and (5/30/13)

Duty to Update Claims (9/12/16)

Emotional Distress – Defeating emotional distress claims in drug/device litigation (2/3/11)

Experimental/Investigational Drugs – No duty to supply (3/15/12)

FDA – Warning letters lack force of law (9/3/15)

First Amendment – Defense to tort liability (12/14/12)

First Amendment – Off-label promotion (1/13/16), and again (1/15/16)

Fraud – Promotion of off-label use not fraudulent (7/27/12)

Fraud On The Market – Causation (2/17/12)

Heeding Presumption – New York law (10/8/15)

Heeding Presumption – Precedent rejecting presumption (7/2/09)

Homeopathic Products (8/11/15)

Informed Consent – Off-label use need not be disclosed (6/21/07), again (1/14/10), and yet again (10/20/11)

Junk Faxes (7/29/15)

Learned Intermediary Rule – Adoption (3/3/16)

Learned Intermediary Rule – Burden of proof where prescriber testimony nonexistent (3/10/14)

Learned Intermediary Rule – Direct to consumer (non)exception (1/20/11)

Learned Intermediary Rule – Non-physicians as intermediaries (2/20/17)

Learned Intermediary Rule – Physician as “consumer” in consumer expectation test (5/7/12)

Learned Intermediary Rule – Policy reasons for rule (7/6/07)

Learned Intermediary Rule – Warning causation cannot be proved by “reasonable doctor” expert (4/19/07)

Medicare Secondary Payer – Recovery from attorneys (1/16/17)

Medical Malpractice – Off-label use and the standard of care (11/2/12), and again (2/13/17)

Medical Malpractice – Standard of care (12/12/17)

Medication Guides – Claims about (2/21/14)

Negligence – Duty (9/17/09)

Negligence Per Se – State-law defenses to FDCA-based negligence per se actions (2/7/08), and again (2/12/09)

Negligent Design – Alternative design requirement (2/27/17)

Off-Label Use – State authority to regulate (1/27/17)

Pharmacogenomics (5/26/15)

Preemption – 510(k) preemption post-Lohr (9/24/15), and again (4/22/16), and yet again (8/22/16), and once again (10/30/17)

Preemption – Buckman applies to fraud on agencies other than the FDA (9/25/08)

Preemption – Design defects in branded drugs (1/1/16), and again (8/18/17)

Preemption – Failure to contraindicate claims (6/26/17)

Preemption – Failure to recall claims (9/28/12)

Preemption – First Amendment (8/27/15), and again (12/9/15)

Preemption – Fraudulent concealment in PMA context (11/29/17)

Preemption – FDA prosecutorial discretion (10/5/12)

Preemption – Generic drugs, various topics (4/5/12)

Preemption – HIPAA and informal defense interviews of treating physicians (2/15/07)

Preemption – Injunction against selling FDA-approved product (2/9/16)

Preemption – OTC/monograph drugs (11/25/08), and again (12/12/16)

Preemption – Off-label warnings (12/19/13), and again (3/20/17), and yet again (9/20/17)

Preemption – Peer review material discovery (11/5/15)

Preemption – PMA devices and good manufacturing practices (9/14/14)

Preemption – PMA devices where the classification has arguably changed (10/7/10)

Preemption – PMA plaintiffs can’t establish parallel FDCA violation by res ipsa loquitur (1/26/12)

Preemption – Branded drug impossibility preemption post-Levine – non-NDA-holder, boxed warnings, major changes, failure to recall (8/22/14), and again (8/13/15)

Preemption – Post-Riegel parallel violation claims (6/26/08), and again (12/18/08), and yet again (7/30/09)

Preemption – Presumption against preemption (11/15/06), and again (10/30/17)

Preemption – Product development protocol (9/6/11)

Preemption – Question of law (3/28/17)

Preemption – Transitional devices (10/31/13)

Product Liability – Definition (2/16/17)

Publisher Liability – Is a publisher of a pharmaceutical warnings, who is not a drug manufacturer, liable for substantive errors or omissions in what it publishes? (4/7/11) and again (7/18/13)

Punitive Damages – Compliance as a defense (3/8/07), and again (11/5/09)

Punitive Damages – No constitutional right to obtain (4/30/12)

Punitive Damages – Territoriality (12/29/06)

Punitive Damages – Warnings as a defense (2/24/12)

Recalls – Duty to recall, subsequent remedial measures and other recall-related issues (9/24/09)

Res Ipsa Loquitur – Broken medical devices are not ipso facto defective (12/31/09)

Restatement (Third) §6(c) – Adoption or rejection (5/3/11)

Sales Representatives – Duties when present in operating room (9/23/11)

Sales Representatives – Fraudulent joinder (7/14/09)

Warnings – Boxed warnings as adequate as a matter of law (7/10/17)

Warnings – Causation issues (5/8/08), and again (10/2/08)

Warnings – Expert proof requirement in learned intermediary rule cases (6/11/09)

Warnings – No duty to warn about competing products (7/19/07)

Warnings – Overwarning (1/9/14)

Warnings – Plaintiffs can’t assert failure to warn of risks they never suffered (10/26/07), and again (4/1/10), and yet again (4/24/17)

Warnings – Statistics (11/13/14)

Warranty – Application of learned intermediary rule to bar claims (11/10/11)

Procedural law:

Adverse Event Reports – Rejecting their use, either as evidence or as a basis of expert testimony (6/7/07)

Attorney/Client Privilege – Ex employees (11/28/16)

Bankruptcy – Judicial estoppel of plaintiff not listing claim as asset (9/25/12)

Class Actions – Ascertainability (1/23/15)

Class Actions – Cross jurisdictional statute of limitations tolling (3/22/07)

Class Actions – Cy pres (10/15/09)

Class Actions – Personal jurisdiction (11/20/17) and (1/26/2018)

Class Actions – Punitive damages (7/17/09), and again (2/26/09)

Class Actions – Single issue certification (11/19/09)

Courts – Conflict in precedents (4/12/17)

Daubert – 2.0 relative risk standard for more likely than not (12/28/07)

Discovery – Cost sharing (5/15/17)

Daubert – Differential diagnosis as faulty methodology (5/7/09)

Discovery – Counsel’s ability to speak with his/her own during an ongoing deposition (2/10/11)

Discovery – Deposing current FDA employees (5/22/13)

Discovery – Litigation holds (4/3/14)

Discovery – Lone Pine orders (8/11/08)

Discovery – Predictive coding/technology assisted review of documents (3/24/16)

Discovery – Protection of customer lists from discovery (4/2/09)

Discovery – Scope after 2015 rules amendments (4/25/16)

Discovery – Translation of non-English documents not required (7/9/08)

Erie Doctrine – Obligation to be conservative in making state-law predictions (11/28/06), and again (5/13/11)

Evidence – Exclusion of animal studies (7/19/07)

Evidence – Exclusion of corporate ethics expert (7/19/07)

Evidence – Exclusion of foreign regulatory standards (8/7/07), and again (6/30/11)

Evidence – Exclusion of fraud on the FDA evidence (7/19/07)

Evidence – Exclusion of warning letters (4/21/10)

Evidence – FDA §510k clearance (7/5/12)

Evidence – Sham affidavits (9/25/17)

Evidence – Warning changes as subsequent remedial measures (2/2/10)

Expert Witnesses – Legal conclusions are inadmissible (2/9/08), and again (3/14/08)

Expert Witnesses – Postmortem redistribution (4/18/12)

Expert Witnesses – Suzanne Parisian (8/9/12) and again (8/14/13), and yet again (3/30/17)

Expert Witnesses – Testimony on corporate intent, ethics, and similar subjects is inadmissible (5/19/2011)

Expert Witnesses – Videotaping expert product examinations (4/2/15)

Joinder – Misjoinder (1/7/10)

Judicial Notice – FDA-related materials (9/20/07), and again (4/17/08), and yet again (7/2/09)

Multidistrict Litigation – Direct filing (10/16/17)

Personal Jurisdiction – Arising out of/Relating to test (1/22/2018)

Personal Jurisdiction – Claim-by-claim analysis (1/11/2018)

Personal Jurisdiction − Class actions – (11/20/17) and (1/26/2018)

Personal Jurisdiction – Consent by registering to do business (3/5/15)

Personal Jurisdiction – Dormant commerce clause (7/5/16) and (2/22/2018)

Personal Jurisdiction – Fifth Amendment (2/19/2018)

Personal Jurisdiction – Jurisdiction by consent (7/23/2018)

Personal Jurisdiction – Litigation tourism (10/20/17)

Personal Jurisdiction – Stream of Commerce (3/12/2018)

Personal Jurisdiction – Third-party subpoenae (6/23/16)

Pleading – Moving to dismiss MDL master complaints (8/20/09)

Pleading – TwIqbal − “And/or” pleading (7/23/09)

Pleading – TwIqbal − Fraudulent joinder (6/15/12), and again (7/9/12), and yet again (4/19/13)

Pleading –TwIqbal − Generally (12/2/11)

Pleading – TwIqbal − “Otherwise negligent” pleading (11/23/12)

Pleading – TwIqbal − PMA preemption cases (12/9/10)

Pleading – TwIqbal − Product liability cases generally (8/6/09)

Pleading – TwIqbal − Removal to federal court (11/18/10)

Pleading – TwIqbal − State court (10/29/09)

Pleading –TwIqbal – Various dismissal grounds (5/16/12)

Removal – Bad faith and fraudulent joinder (7/18/16)

Removal – “Order or other paper” (3/22/13)

Removal – Various removal issues (misjoinder, TwIqbal, consent) (10/1/09)

Standing – No private FDCA cause of action (6/7/12)

Trial – Consolidated multi-plaintiff trials (12/16/11)

Trial – Gag orders (6/28/16)

Wikipedia (1/23/17)