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Michael Monheit
Michael Monheit
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Here’s The Info Zofran Lawsuit Plaintiffs Want From GlaxoSmithKline


More than 230 Zofran lawsuits, alleging that GlaxoSmithKline’s anti-nausea drug causes major birth defects, have now been consolidated in the US District Court of Massachusetts. Parents from across the country, who have filed suit on behalf of their minor children, eagerly await the beginning of “discovery,” the legal process in which crucial evidence and information is gathered.

Defendant Fact Sheet Outlines Main Lines Of Inquiry

Despite being consolidated, the lawsuits have not been made into a class action, and remain individual personal injury claims. But being part of a Multi-District Litigation has several advantages, not least of which are gains in efficiency. For one, GlaxoSmithKline won’t have to depose each individual Plaintiff initially, gathering information on a case-by-case basis. Instead, the company is in the process of negotiating a “Plaintiff Fact Sheet,” a standardized document that will be filled out by every family who has filed suit.

Plaintiffs, too, will be able to demand the most critical information from GlaxoSmithKline through a similar mechanism. For each “Plaintiff Fact Sheet” the company receives, it will have to complete a “Defendant Fact Sheet,” a draft of which was recently made public by the Boston court. The questions asked, as we suggested earlier, are a matter of negotiation, and several areas of dispute remain apparent. But the proposed document, available to view at ZofranLegal.com, outlines the broad areas of inquiry that Plaintiffs intend to pursue.

Prescribing Physicians & Sales Representatives

Many of the fact sheet’s questions center around doctors and the contact GlaxoSmithKline did or did not maintain with a family’s health care professionals. The sheet asks about “Dear Doctor” letters, mass mailings sent by drug companies to inform practicing physicians of new safety information and “Medical Information Letters,” requests made by doctors to learn more about a specific drug’s risks and benefits. Plaintiffs have also asked for information on sales representative visits, and here’s where the first dispute comes up.

Beyond asking about what, if any, contact a particular physician had with a representative of GlaxoSmithKline, Plaintiffs want to know more about those representatives than GlaxoSmithKline seems prepared to divulge, specifically whether or not they’ve earned “post-graduate degrees.” Perhaps even more pertinent, Plaintiffs want to know whether or not the representative has ever “received a written reprimand […] for his / her sales or marketing practices during the period of employment with GSK.” GlaxoSmithKline hasn’t signed off on either of those requests yet.

Financial Relationships Between Doctors & GlaxoSmithKline

Whether or not a family’s doctor ever received financial compensation from GlaxoSmithKline, for speaking or consulting services, is also a topic of interest. The company would like this question limited to Zofran-related services alone, while Plaintiffs have suggested broadening the scope to any work as a “key opinion leader” or “clinical investigator.”

In these questions, Plaintiffs have drilled down on a key aspect of the US health care industry, namely that some practicing physicians are hired or otherwise compensated by pharmaceutical companies, either directly or indirectly promoting products. Critics consider these financial relationships a “conflict of interest,” and as we wrote in our in-depth report “Pay To Promote: The Pharmaceutical Industry’s Financial Relationships With Doctors,” studies have found that payments between drug companies and doctors seem to bias prescribing decisions.

Plaintiffs also want to know how closely GlaxoSmithKline kept tabs on their physicians’ prescribing practices. Drug companies often track how many prescriptions doctors write, using the data to identify areas to increase promotional activities.

Adverse Event Reports

The Fact Sheet continues by asking whether or not GlaxoSmithKline has contacted a Plaintiff, or their medical professional, about the use of Zofran during pregnancy. A corollary question, whether or not the Plaintiff or their doctor has ever contacted GlaxoSmithKline on the topic, is also listed.

Finally, Plaintiffs have requested information on their own adverse event reports, in the event that a fetal malformation was reported to GlaxoSmithKline, along with any “underlying documentation” created by the company in relation to the report.

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