Monday, July 23, 2018

Pinnacle Hip Replacement Litigation Documents Online

The UCSF Drug Industry Documents Archive (DIDA) is please to announce the Pinnacle Litigation Documents, a new collection of documents from the MDL lawsuit DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation.

From 2002 to 2012, DePuy Orthopaedics, a subsidiary of Johnson & Johnson (J&J), manufactured metal-on-metal (MoM) hip implants sold under the brand name Pinnacle. The lawsuit charged the hip implant was defectively designed and fraudulently marketed and that DePuy failed to warn patients and doctors about the risks of the devices. Prosecutors claimed that DePuy, in an effort to gain and keep a large share of the hip replacement market, rushed the Pinnacle metal-on-metal hip implant to market without ever testing it in humans. Instead, the company used a loophole known as the FDA's 510(k) regulatory pathway. The 510(k) allowed manufacturers to skip clinical trials and test the implants only on mechanical simulators if they could show the implants were 'substantially equivalent' to other devices already in use.

The plaintiffs in the Pinnacle lawsuits experienced high levels of cobalt and metal ion in their systems, a condition called metallosis, due to the wear from the surface of the implant’s femoral head. Ultimately, many of these hip implants failed and had to be replaced. In addition to defective design and health risks, the suit charged DePuy fraudulently marketed the Pinnacle hip replacement system by using a team of 'design surgeons' as a sales force. Called KOLs (key opinion leaders), these surgeons signed off on ghostwritten articles, hosted speaking engagements and large regional sales meetings, and taught other surgeons how to use the Pinnacle system. In return, documents show these design surgeons received millions of dollars in royalties from the sales of the Pinnacle hip replacement system.

• See Volume 2 of the court transcript for opening statements that give context and specific complaints.
• Lists of royalty payments to physicians (note there are some greater than $20 million): https://www.industrydocumentslibrary.ucsf.edu/drug/docs/zjxn0226
• Presentation by 'design surgeon' Thomas Schmalzried on how to sell the "Second Billion": https://www.industrydocumentslibrary.ucsf.edu/drug/docs/sghn0226

Thursday, June 21, 2018

New Tobacco and Drug Industry Documents Posted

345 new documents were added to the Truth Tobacco Industry Documents library today.

• 183 Philip Morris records
• 162 DATTA documents - opening and closing statement transcripts from Engle Progeny Cases

New Collection of Cymbalta Litigation Documents posted:
This set of documents comes from the MSJ: Hagan-Brown & Ali v. Eli Lilly and Company; Case No. 1:14-cv-01614-AJT-JFA
The case alleges Lilly omitted important information about the drug’s withdrawal risks in the company’s labeling and marketing materials and therefore consumers were unable to make an informed choice about whether to take Cymbalta.

Thursday, November 16, 2017

22,000+ Confidential Philip Morris Records Released and New Drug Industry Collections

23,240 new documents posted to the UCSF Industry Documents Library today!
This includes:

• 22,909 Philip Morris Records - most of these were confidential and have been released as public.
• 2 Brown & Williamson Records
• 11 RJ Reynolds Records

2 New Drug Industry Documents collections:

• Actos Litigation Documents - This collection contains 228 selected documents and court transcripts from Allen v Takeda Pharmaceuticals which show Takeda mislead the FDA and the healthcare community regarding the efficacy and safety of Actos and hid the harmful side-effects that surfaced in their clinical trials.


• Risperdal Litigation Documents - This collection contains an initial set of 90 documents from a variety of lawsuits concerning Johnson & Johnson/Janssen's concealment of Risperdal's harmful side effects such as the development of gynecomastia in young men.

Tuesday, October 03, 2017

Industry Documents Library Bibliography reaches 1000!

The UCSF Industry Documents Library Bibliography reached its 1000th citation this September 2017. The IDL Bibliography is a running list of papers, publications and posts that utilize our Tobacco Industry, Drug Industry and Chemical Industry Documents as primary source materials. See what others have already written; consult the Bibliography first before delving into any new research project.

Thursday, September 21, 2017

New Celexa and Paxil Documents Posted

179 new Drug Industry Documents were posted today.

• 78 new Celexa documents


• 101 Paxil Litigation, Adult Suicide documents - This new collection of documents comes from Paxil litigation regarding adult suicide. Lawsuits alleged Glaxo SmithKline (GSK) was aware of the high rate of suicidal behavior in adults during clinical trials of Paxil. GSK argued that because the FDA did not mandate GSK warn about the suicidality risk, it could not have warned or disclosed these risks any sooner. GSK argued that Paxil’s FDA-approved label shielded the pharmaceutical company from liability for failing to warn doctors and patients of that elevated suicidal behavior risk, a legal defense called 'preemption.' Read more on our Paxil Litigation Adult Suicide collection page

Friday, September 30, 2016

New Documents Posted

238 new documents have been posted to the Industry Documents Library.

This includes:

• 221 Neurontin Litigation documents.
  These additions come from the 2009 Neurontin Marketing and Sales Practices Litigation suit where consumers and third-party payers, including insurance companies and trade unions, sought repayment of billions of dollars paid for Neurontin prescriptions alleging Pfizer fraudulently misrepresented the drug's benefits.


• 15 Philip Morris documents


• 1 American Tobacco document


• 1 Lorillard document

Friday, May 13, 2016

Announcing our New and Improved Industry Documents Bibliography

The UCSF Industry Documents Library has been hard at work for this month's release of documents and features.

1) 825 new tobacco documents were posted to the Truth Tobacco Industry Documents yesterday.

• This includes 30 previously confidential videos from PM that have been made public and can be streamed

2) The improved Industry Documents Bibliography!

Our Bibliography is a running list of papers and publications created using our industry documents. It has long been a helpful tool for research and education and we are excited to unveil the new interface today.

The Bibliography now lives on the Industry Documents Library site and can be found by clicking on "Bibliography" in the menu bar.



Depending upon which industry you start from (IDL, tobacco or drug), you will see citations for publications and papers based upon that specific industry archive's documents. For instance, if you access the Bibliography from the main IDL home page you will interact with citations from both Tobacco and Drug documents but if you access the Bibliography from the Tobacco area, you will only interact with tobacco document citations.

Key features for the new Bibliography:

• Searchable!
  Our new Bibliography interface allows you to search in the citations for keywords, authors and titles and also allows you to facet results by Category and Reference Type. Click on the title link or the URL in the Link field to access the publication directly.


• "Newly Added" citations will be tagged with the "newly added" status so that these recent citations can be found quickly by users.
  At this time we have 11 newly added citations to the Industry Documents Bibliography.
  
  
• Direct links to the documents cited
  You will note in each citation record, there is a "Document Cited" field which holds the IDs of industry documents used as primary sources. If you click on one of the IDs in the "Documents Cited" field, you will be taken to the document record.
  
  
  
  Conversely, if you are searching in the documents, you will notice links to a Bibliography citation from the search results and the document view if the document has been cited in one or more papers.
  
  

The new and improved Industry Documents Bibliography reflects all industries and will grow as we grow our document collections. As you browse the citations and take a look around, please let us know how it's working for you and if you have any suggestions.

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