Medical Research | The Health Law Firm Blog

Clinical Trial: When Research Goes Wrong

Three patients died in an unapproved medical trial conducted between 2003 and 2004. Now, the executives of Snythes Inc., a medical-device company, are awaiting sentencing this week after pleading guilty to a misdemeanor as “responsible corporate officers,” according to Business Week.

The Synthes officials allegedly bypassed FDA protocol to have surgeons test bone cement in people with spine fractures. The product was not approved for that use, and three people died in the operating room in 2003 and 2004. The patients who died suffered a severe drop in blood pressure following the injections. The surgeons involved could not rule out the bone cement as a factor in the deaths, but it also wasn’t definitively responsible.

Synthes pleaded guilty to corporate health care […]

By The Health Law Firm|2024-03-14T10:00:27-04:00June 1, 2018|Health Care Industry, Medical Research, The Health Law Firm Blog|

Implications of Clinical Research Misconduct and Fraud Accusations

One of the most notorious recent cases of research misconduct involved a South Korean stem cell researcher who claimed to have cloned human embryonic stem cells. However, the researcher was accused of fabricating crucial data and charged with fraud and embezzlement. The fraud charges were eventually lifted, but not before the researcher’s reputation was destroyed.

Although accusations of research misconduct and fraud have been present for decades, the number of complaints is on the rise, according to the FDA. In many cases, the researcher accused of such misconduct may actually be the victim of one or more unscrupulous individuals who make the complaint for his or her own ulterior motives. Some researchers may be targeted by an academic institution or the […]

By The Health Law Firm|2024-03-14T10:00:29-04:00June 1, 2018|Medical Research, The Health Law Firm Blog|

Consequences of Clinical Research Fraud and Misconduct

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Michael L. Smith, J.D., R.R.T., Board Certified by The Florida Bar in Health Law and Medical

Medical and clinical researchers, whether in an academic community or in a practice setting, spend years on clinical trials and investigations in hopes of contributing to their respective fields. Many of these researchers, however, find themselves defending their reputation after being accused of research fraud or research misconduct.

Why Researchers are Accused of Misconduct.
Although accusations of research fraud and misconduct have been present for decades, the number of complaints is on the rise, […]

By The Health Law Firm|2024-03-14T10:00:34-04:00June 1, 2018|In the Know, Medical Research, The Health Law Firm Blog|