A disturbing study reveals that both the fabrication of data and a failure to obtain ethical approval are two of the top reasons that articles in anesthesia journals are retracted. The study used a PubMed search that spanned 1987 to 2017.
The primary author of the study, Chetra Yean, commented, “In the past few years, there have been numerous retractions of anesthesia articles. Because there have been published papers that discuss retraction in orthopedics and neurosurgery, we wanted to do the same in anesthesiology. Our study seeks to qualify and quantify anesthesiology retractions, determine how much impact they have on the literature, and propose possible ideas to reduce the number and impact of retractions in the future.”
Yean is also a fourth-year student at Albert Einstein College of Medicine.
Yean and her colleagues studied only retracted articles. Yean explained, “In order to determine the percentage of retracted articles, one would have to determine how many articles were published throughout the 30-year time frame, which I would imagine to be in the tens of thousands, if not more. Therefore, retracted articles probably comprise a tiny percentage of total articles. However, it is difficult to accurately quantify how much impact these retracted articles have had on the literature, which is arguably more important.”
The study identified 316 articles that were published between 1989 and 2015. They were later retracted at some point between 1993 and 2017. The majority of the retractions was published between 2011 and 2013.
Jennifer Yoo, a co-author of the study, noted, “The average time between publication and retraction was 8.78 years, but the time span ranged from 0 years to 27 years.
The vast majority—almost 83 percent—if the retracted articles involved human subjects. The others were review articles, drug articles, or animal studies.
Yoo added, “The impact factor from these articles ranged from a low of 0.91 to a high of 8.465. The most cited article was cited 197 times, whereas the average number of citations for an article was 20 times.”
Nearly half of the retractions (45 percent) were because of data fabrication. Thirty-eight percent of the articles were retracted because the authors had not obtained proper ethical approval. Others were retracted for intellectual property theft, publication errors, and plagiarism.
Interestingly, three authors were linked to 83 percent of the retracted articles. The authors were from the United States, Germany, and Japan.
Although 71 percent of the retracted articles had a watermark noting the same, a fifth of the articles had no such mark.
Yean explained, “Retractions in anesthesiology are not a new phenomenon. In fact, there have been very high-profile cases identified in the last decade of individuals committing flagrant acts of fraud, which have been chronicled extensively by the Retraction Watch organization.”
Yean added that the individuals who discovered the fraudulent or unethical acts were members of journal editorial boards or were merely researchers who questioned the study’s results. Yean remarked, “This demonstrates that the peer review process is still the front line and the most critical factor in deterring research misconduct and preventing retractions. Identifying scientific fraud and misconduct are paramount because a lot of these data are used in meta-analyses, which eventually influences practice guidelines and patient care.”
Of course, retraction is only one remedy for researcher misconduct. Yoo suggested, “Creating a centralized repository of retractions for all fields of medicine would be helpful as well. Additionally, having standardized methods for retractions and focusing on education and outreach can reduce the prevalence and impact of academic impropriety.”
Drug and medical device manufacturers and the use of clinical studies
Many drug and medical device companies must obtain approval from the United States Food and Drug Administration before they will be allowed to market and sell certain products. Many of these companies perform clinical studies on their new products and submit the results of these studies to the FDA in hopes of earning approval.
However, in some cases, it has been discovered that the companies in charge of the clinical studies intentionally misled the FDA and others about the trial results. Some companies have been accused of concealing unfavorable data, for example. Others may structure their studies in such a way that ensures favorable results are obtained. By the time these practices are discovered, thousands of consumers may have already used—and been injured by—the products.
These companies may be held responsible for this inappropriate conduct. Most commonly, this occurs in a products liability lawsuit.
What is a products liability lawsuit?
In a products liability claim, a party alleges that a defective product has caused harm. To win a products liability lawsuit, the consumer must show:
- The item was being used as directed or as anticipated by the manufacturer
- The product was defective
- The consumer was injured
- The product’s defect caused the consumer’s injuries
The consumer must prove each of these elements to recover damages from the manufacturer. If the consumer cannot provide proof of just one of the elements, the claim will fail, and the manufacturer will not be obligated to provide any compensation to the consumer. However, with the assistance of an experienced products liability attorney, a consumer has a stronger chance of prevailing.
What types of financial compensation are available in a products liability claim?
The amount of compensation a consumer may be entitled to in a products liability claim depends on the facts of the claim. The purpose of monetary damages is to make the consumer “whole” again after being injured by a product. Damages may include:
- Medical bills, including the estimated cost of future medical care
- Lost wages
- Loss of consortium
- Pain and suffering
- Emotional distress
- If a death has occurred, loved ones may seek the expenses associated with the funeral and burial. They may also claim the estimated value of the deceased’s future earnings.
- For especially egregious conduct, punitive damages may be awarded.
Falsifying clinical trial data may certainly be considered egregious conduct that supports an award of punitive damages. In some legal cases, millions of dollars in punitive damages have been awarded by a jury for such conduct.
Evidence considered in a products liability claim
Products liability claims are notoriously complex and require the careful review of thousands of pages of documents. Relevant evidence may include:
- Medical bills and records
- Employment records
- Tax returns
- Internal company documents
- Video footage
- Witness statements
- Deposition transcripts
- Clinical trial results
- Phone records
- FDA reports
Other types of evidence may also be considered, depending on the facts of the case. Your attorney will know what types of evidence are best to support your allegations against the manufacturer. Without an attorney, you may not know what types of evidence are admissible and risk weakening your claim and reducing the amount of compensation you are entitled to.
Free Case Review for Anesthesia Drug Injuries or Fatalities
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