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 – Pennsylvania law (12/9/19)
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)
Constitutional Law – Mandatory vaccination (8/2/21)
Co-Promoters – Cases rejecting liability (12/7/11)
Damages – Apportionment and intentional conduct (10/14/19)
Damages – Mitigation of damages (4/8/19)
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 Conduct Additional Studies – Decisions rejecting (1/30/20)
Duty to Report − Causation (9/19/16)
Duty to Train or Advise Physicians – Decisions rejecting (9/15/11) and (5/30/13), and again (11/18/19)
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)
False Claims Act – Government dismissing meritless claims (4/13/20)
FDA – Warning letters lack force of law (9/3/15), and (6/14/19), and again (9/9/19)
First Amendment – Compelled speech (2/18/19)
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)
Fraud on the FDA – Federal causes of action (10/29/18)
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)
Internet Website Liability (7/9/18)
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 – Contraceptives (3/11/19)
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 – Physician “would have liked to know” causation testimony (10/3/19)
Learned Intermediary Rule – Policy reasons for rule (7/6/07)
Learned Intermediary Rule – Telemedicine (9/3/19)
Learned Intermediary Rule – Warning causation cannot be proved by “reasonable doctor” expert (4/19/07)
Limitation of Actions – Cross-jurisdictional class action tolling in New York (11/26/18)
Limitation of Actions – Tolling for deliberately misfiled actions in Delaware (10/22/18)
Magnuson-Moss – OTC drugs (6/15/20)
Malfunction Theory – Inferring FDCA violations from device malfunctions (9/24/18)
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), and again (11/18/19)
Negligence Per Se – State-law defenses to FDCA-based negligence per se actions (2/7/08), and again (2/12/09)
Negligence Per Se – Vague enactments (7/8/19)
Negligent Design – Alternative design requirement (2/27/17)
Off-Label Use – State authority to regulate (1/27/17)
Off-Label Use – State law duty to prevent (6/21/21)
Pharmacogenomics (5/26/15)
Policy – Tort litigation driving FDA-regulated products off the market (1/20/20)
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 – 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 – Branded drug impossibility preemption post-Albrecht (9/26/19) and (2/3/20)
Preemption – Buckman applies to fraud on agencies other than the FDA (9/25/08)
Preemption – Burden of proof post-Albrecht (8/27/19)
Preemption – Design defects in branded drugs (1/1/16), and again (8/18/17)
Preemption – Distributors (10/28/19)
Preemption – Failure to contraindicate claims (6/26/17)
Preemption – Failure to recall claims (9/28/12)
Preemption – FDA prosecutorial discretion (10/5/12)
Preemption – FDA second-guessing (5/27/19), and again (5/4/20)
Preemption – First Amendment (8/27/15), and again (12/9/15)
Preemption – Fraudulent concealment in PMA context (11/29/17)
Preemption – “Fully Informing” FDA (9/26/19)
Preemption – Generic drugs, various topics (4/5/12)
Preemption – Highlights-based claims (8/6/19)
Preemption – HIPAA and informal defense interviews of treating physicians (2/15/07)
Preemption – Injunction against selling FDA-approved product (2/9/16)
Preemption – Medication guides (3/23/20)
Preemption – Newly acquired information (5/11/20)
Preemption – Off-label promotion (3/23/20)
Preemption – OTC/monograph drugs (11/25/08), and again (12/12/16)
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), and again (10/15/19)
Preemption – Post-Riegel parallel violation claims (6/26/08), and again (12/18/08), and yet again (7/30/09)
Preemption – Preapproval warning claims (8/23/21)
Preemption – Presumption against preemption (11/15/06), and again (10/30/17), and yet again (4/30/18)
Preemption – Product development protocol (9/6/11)
Preemption – Question of law (3/28/17), and (5/23/19)
Preemption – Transitional devices (10/31/13)
Preemption – Warnings (12/19/13), and again (3/20/17), and yet again (9/20/17)
Primary Jurisdiction (5/28/20)
Product Liability – Definition (2/16/17)
Product Liability – Seller (7/25/19)
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 – Expert Witnesses (6/17/19)
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)
Vaccines – Constitutionality of mandatory vaccination (8/2/21)
Vaccines – Mass vaccination product liability (11/23/20)
Warnings – Adequacy is enough (2/24/20)
Warnings – Boxed warnings as adequate as a matter of law (7/10/17)
Warnings – Causation issues (5/8/08), and again (10/2/08), and yet again (10/3/19)
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 – Prescriber does not recall reading warnings (10/26/20)
Warnings – Statistics (11/13/14)
Warranty – Application of learned intermediary rule to bar claims (11/10/11)
Wrongful Acts Doctrine (7/13/20)
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), and again (8/28/19)
Choice of Law – Location of medical treatment (8/10/20)
Class Actions – Ascertainability (1/23/15)
Class Actions – Cross jurisdictional statute of limitations tolling (3/22/07), and again (4/2/18)
Class Actions – Cy pres (10/15/09)
Class Actions – Personal jurisdiction (11/20/17) and (1/26/18), and yet again (7/30/18)
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)
Daubert – Differential diagnosis as faulty methodology (5/7/09)
Discovery – Certification of completeness (1/16/19)
Discovery – Cloned discovery (1/28/19)
Discovery – Cost sharing (5/15/17)
Discovery – Jurisdictional discovery for defendants (12/14/20)
Discovery – Errata sheets for depositions (4/29/19)
Discovery – Genetic testing of plaintiffs (2/20/20)
Discovery – Counsel’s ability to speak with his/her own during an ongoing deposition (2/10/11), and here (5/6/19)
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) and again (1/4/19)
Discovery – Protection of customer lists from discovery (4/2/09)
Discovery – Scope after 2015 rules amendments (4/25/16)
Discovery – Third party discovery and spoliation (1/13/20)
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), again (5/13/11), again (7/25/19), and yet again (11/11/19)
Evidence – Absence of prior incidents (6/4/20)
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 – Ghostwriting (3/18/19)
Evidence – Sham affidavits (9/25/17), and again (6/1/20)
Evidence – Warning changes as subsequent remedial measures (2/2/10)
Evidence – Wayback machine (7/9/21)
Expert Witnesses – Differential etiology and largely unknown causes (9/13/19)
Expert Witnesses – Excessive fees (10/7/19)
Expert Witnesses – Legal conclusions are inadmissible (2/9/08), and again (3/14/08)
Expert Witnesses – Misconduct (9/30/19)
Expert Witnesses – Peer review and predatory journals (12/26/18)
Expert Witnesses – Postmortem redistribution (4/18/12)
Expert Witnesses – Punitive damages (6/17/19)
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 (5/19/11)
Expert Witnesses – Videotaping expert product examinations (4/2/15)
Joinder – Misjoinder (1/7/10)
Judges – Forcing settlement (7/17/19)
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)
Multidistrict Litigation – Lexecon waivers (8/14/18)
Multidistrict Litigation – MDL judge as visiting judge for trial (4/16/18)
Multidistrict Litigation – Post-remand appellate review of MDL decisions (9/3/20)
Party Presentation Rule (3/29/21)
Personal Jurisdiction – Arising out of/Relating to test (1/22/18)
Personal Jurisdiction – Claim-by-claim analysis (1/11/18)
Personal Jurisdiction − Class actions – (11/20/17) and (1/26/18), and again (10/21/19)
Personal Jurisdiction – Consent by registering to do business (3/5/15), and (3/13/19)
Personal Jurisdiction – Dormant commerce clause (7/5/16) and (2/22/18)
Personal Jurisdiction – Fifth Amendment (2/19/18)
Personal Jurisdiction – Jurisdiction by consent (7/23/18)
Personal Jurisdiction – Legal malpractice (8/7/20)
Personal Jurisdiction – Litigation tourism (10/20/17)
Personal Jurisdiction – Stream of commerce (3/12/18)
Personal Jurisdiction – Third-party subpoenae (6/23/16)
Personal Jurisdiction – Waiver (4/23/18) and (9/10/18)
Pleading – Moving to dismiss MDL master complaints (8/20/09)
Pleading – TwIqbal − Affirmative defenses (10/15/18)
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 − Laundry list violation allegations (8/22/18)
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 − Shotgun complaints (8/9/21)
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 – Pre-service removal (3/4/19)
Removal – Various removal issues (misjoinder, TwIqbal, consent) (10/1/09)
Standing – No private FDCA cause of action (6/7/12)
Subject Matter Jurisdiction – PREP Act immunity (2/19/21)
Trial – Consolidated multi-plaintiff trials (12/16/11)
Trial – Gag orders (6/28/16)
Trial – Racist or xenophobic appeals to jury prejudice (3/22/19)
Trial – Reptile theory tactics (12/16/19)
Wikipedia (1/23/17)