Rottenstein Law Group Supports New Legislation Requiring Drug and Medical Device Manufacturers To Report Results of Human Clinical Trials

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The Rottenstein Law Group, which represents clients whose children have suffered birth defects allegedly caused by the Selective Serotonin Reuptake Inhibitor (SSRI) antidepressant Paxil, applauds four members of the House of Representatives for proposing legislation that would require drug and medical device companies to report the results of all human clinical trials to, a publicly-accessible federal database.

A group of House Democrats led by Congressman Edward Markey (D-Mass.) on Aug. 2 introduced the Trial and Experimental Studies Transparency (TEST) Act of 2012 (H.R. 6272), legislation that "updates and expands the clinical trial registry data bank——with stronger reporting requirements," according to a press release dated that same day.

The TEST Act would make a more valuable resource by requiring drug and device manufacturers to, among other things: (1) register with all interventional biomedical studies on humans; and (2) post the results from all such trials on within one year of the trial's completion, according to the Aug. 2, 2012, press release publicizing the legislation.

These requirements are necessary because drug and medical device manufacturers sometimes “hide negative study results, while emphasizing the positive ones,” thereby “putting people unnecessarily at risk,” according to Rep. Markey’s press release. ”High-profile examples included Paxil®, Avandia®, and Vioxx®, trials where safety concerns and negative results were suppressed by the drug companies,” the press release says.

As the advocate of patients who allege that they or their children suffered serious harm as a result of Paxil, a drug that Rep. Markey cites as having been the subject of suppressed clinical trials, the Rottenstein Law Group is in favor of legislation that, like TEST, would require the disclosure of the results of all clinical trials on human subjects.

The Rottenstein Law Group urges anyone who has suffered adverse side effects from Paxil or any other prescription medication to speak to a qualified personal injury lawyer as soon as possible. The firm maintains a Paxil Lawsuit Information page at The page has features that allow for easy sharing, including links for automatic posting on Facebook and Twitter, specifically to enable visitors to spread the word about the dangers of Paxil. (Attorney advertising. Prior results do not guarantee a similar outcome.)

The Rottenstein Law Group is a New York-based law firm that represents clients nationwide in mass tort actions. The firm’s founder, Rochelle Rottenstein, has more than two decades of experience as a lawyer. She compassionately represents clients in consumer product injury, mass tort, and class action lawsuits.

The Rottenstein Law Group, LLP
Rochelle Rottenstein, Esq.
321 W. 44th Street
Suite 511
New York NY 10036
(212) 933-9500 (office phone)
(212) 933-9980 (facsimile)

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Rochelle Rottenstein, Esq.
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