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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.
The UCSF Industry Documents Library (IDL) is pleased to announce the addition of two new collections to our Chemical Industry Documents Archive. These documents reveal the scientific, legislative, regulatory and public relations activities of the agrichemical industry in defense of its products and profits.
The Roundup Products Liability Litigation Documents
Known as ‘The Monsanto Papers,’ this collection contains a set of 118 significant internal company documents (1063 pages) obtained during the Roundup Products Liability Litigation - lead Case No. 3:16-md-02741-VC. Manufactured by the agrichemical giant Monsanto, Roundup contains the chemical herbicide glyphosate and is widely used by farmers, agricultural workers and the public throughout the United States. Studies have shown that exposure to glyphosate in Roundup can cause cancer and other serious health problems yet Monsanto has repeatedly denied these claims and worked to influence regulations that would address these harms.
The USRTK Agrichemical Collection
This collection includes over 1450 documents (37,149 pages) acquired by U.S. Right to Know through state public records requests, FOIA requests, whistleblowers, and the Roundup litigation. US Right to Know is a nonprofit consumer and public health watchdog group working for transparency and accountability in our nation’s food system. Collected by Gary Ruskin, Co-Director of US RTK, and Carey Gillam, Research Director of US RTK and author of Whitewash-The Story of a Weed Killer, Cancer and the Corruption of Science, these materials are a mix of unsealed documents obtained from the Roundup/glyphosate cancer cases (the Monsanto Papers), communications to and from the EPA, FDA and US Department of Agriculture regarding glyphosate and herbicides, and emails between key academics and industry PR staff from Monsanto, Dow, Syngenta, Ketchum, Bayer and the Council for Biotechnology Information.
Topics include pesticides, GMOs, glyphosate, front groups, academic partnerships with industry public relations staff, and efforts to manage the "GMO Answers" website, which is funded by the Council for Biotechnology Information.
These documents have been used as the source for a number of publications including:
