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Michael Monheit
Michael Monheit
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As Zofran Lawsuit Discovery Nears, Parties Craft Protective Order


In collaboration, Plaintiffs and GlaxoSmithKline have crafted a protective order that would keep certain documents confidential. The negotiated proposal is designed to protect both internal corporate documents and patients’ personal information gathered during the course of discovery.

The document was submitted to the US District Court of Massachusetts by Robert K. Jenner, Esq., a sponsor of Zofran.Monheit.com and court-appointed Liaison Counsel in MDL 2657, on March 7, 2016. The agreement is now awaiting approval from the federal judge presiding over Zofran lawsuits, the Honorable F. Dennis Saylor IV.

Confidential & Privileged Materials

The proposed order (PDF available here) is meant, according to court documents, “to expedite the flow of discovery material; facilitate the prompt resolution of disputes over confidentiality; and adequately protect Confidential Information.”

Discovery is a complex legal process, and perhaps the most critical step as both sides of a dispute prepare for trial. Fundamentally, discovery involves an exchange of information, and it’s about learning what legal arguments and evidence the other side plans to introduce at trial. Of course, discovery can also produce sensitive material, including information protected by the intellectual property rights of a pharmaceutical manufacturer.

Protective orders of confidentiality, like the one recently submitted in the District Court of Massachusetts, are usually crafted to prevent that sensitive material from being made public, and specify the consequences of releasing confidential information.

What Information Would The Order Protect?

Under the terms of the order proposed in MDL 2657, attorneys, both those representing families and those representing GlaxoSmithKline, would be able to designate any document, material, “or other thing[…]” as “CONFIDENTIAL – Subject to Protective Order USDC MA (MDL 2657.”

“Confidential” materials, in this context, can include:

  • Patient identifying information, medical records, pharmacy records and any “information or material protected” by HIPAA, the Health Insurance Portability and Accountability Act. The proposal also stipulates that information can be classified as confidential under the authority of “non-U.S. data privacy laws,” likely because data privacy laws are not particularly stringent in the US.
  • “Trade secrets,” confidential information that secures a company competitive advantage within the market and, if released, “would unfairly competitively disadvantage the producing Party.”
  • “Proprietary, non-public business information.” While all trade secrets can be considered a company’s “proprietary information,” proprietary information is a broader category, one that comes to include information that, while not actually secret, represents a significant investment of resources. As such, this information has value, value that could be lost if it was openly disseminated. Copyrighted materials, customer databases and the information contained in patents are often considered proprietary information, but not trade secrets.
  • “Proprietary design, development, research and testing regarding products,” both those currently on the market (ie Zofran) and those still under development. This category specifically includes information contained in applications for FDA approval, and supplemental materials submitted in support of that approval.
  • “Clinical studies” that have not been made public.
  • “Personnel records and information.” Just as there is a stipulation protecting the personal and medical information of Plaintiffs, there is a stipulation to protect the identities of and information gathered from employees of GlaxoSmithKline.
  • Information “submitted to the FDA,” but protected by exemption 4 of the Freedom of Information Act, which “protects ‘trade secrets and commercial or financial information’ “, according to the US Department of Justice. Other exemptions cited in the protective order protect “personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy” and confidential information contained in drug approval applications.

Disclosure, according to court documents, means “to reveal, provide, describe, make known or allow to be made known to any person Confidential Information.” Information produced by “non-parties,” like doctors, who aren’t involved as either Plaintiffs or Defendant in the litigation, will be automatically treated as confidential for at least 30 days.

Who Decides What Is Confidential?

So long as a “Party or non-party” to the litigation “reasonably believes” that a document, physical item, recording or electronic file contains confidential information, they will have the right to mark it as such. The material becomes confidential at that point, even if its designation as confidential is disputed. That protection only disappears in two instances:

  1. the party who produced the material “agrees in writing that the material is no longer confidential” and no longer subject to the terms of the protective order, or
  2. the Court renders a decision that the material is not subject to the protective order. The producing Party is allowed to appeal that decision. Only when all appeals have been concluded can the material lose its status as confidential.

Two Disagreements: Cost & Redaction

While most of the order’s terms appear uncontroversial, there are two stipulations over which Plaintiffs and GlaxoSmithKline disagree. Both will ultimately be settled by the Court.

One is the issue of cost, specifically: who should pay for making copies of the documents produced during discovery? Plaintiffs, with their position highlighted in blue, say that the Party producing a document should bear the cost of its reproduction. GlaxoSmithKline’s position, highlighted in red, is that the Party receiving a document should cover that cost.

The other disagreement centers around redaction, what information a Party can remove from or obscure in a document considered confidential. Both Plaintiffs and GlaxoSmithKline agree that:

  • names and information identifying clinical trial subjects or patients in adverse event reports, product experience reports and consumer complaints;
  • individuals’ home addresses;
  • numbers issued by the US Drug Enforcement Agency to identify doctors and
  • “personal medical or family information, financial account numbers, or social security numbers”

can be redacted, when that information isn’t the focus of a discovery request.

But where “trade secrets or other highly confidential research, development, or commercial information” and “information about compounds and products that are not the subject of this Litigation” are concerned, Plaintiffs and GlaxoSmithKline disagree. GlaxoSmithKline believes those kinds of information are suitable for redaction. Plaintiffs, on the other hand, “believe this information should be produced in unredacted form and designated as Confidential Information.”

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