July 2015

[By Staff Writer Jay Belle Isle]

In a letter dated July 13, the FDA issued serious warning to C. R. Bard Inc. due to multiple violations. The company has been given fifteen business days to respond to the letter or else it may face “seizure, injunction and civil money penalties.” The warning is based on inspections of Bard’s Queensbury, NY and Tempe, AZ manufacturing facilities and is focused on Bard’s Recovery Cone Removal System, Models RC-15 and FBRC.

The FDA has several concerns with these devices, including that they are:

…adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).

… misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

market[ed] … without marketing clearance or approval. Percutaneous retrieval systems, such as the Recovery Cone Removal System, Model RC-15, are regulated as manual surgical instruments intended for specialized use within a specific medical specialty, and thus require marketing authorization in order to be legally marketed in the United States.

Further, the inspection revealed issues with Quality Control of Bard’s IVC filters:

Specifically, IVC filter cleaning, to include removal of chemical processing contaminants, has not been validated for IVC Filters to include Simon Nitinol Filters, Eclipse Filters and Denali Filters. For example, production of Denali Filters requires the use of several processing agents, including, but not limited to the following: nitric acid, methanol, sulfamic acid solution, thermo quench salt, glycolic acid, citric acid, and/or hydrofluric acid. The cleaning processes for IVC filters are not validated or otherwise verified to demonstrate that the above substances are reduced to acceptable levels during routine processing under worst case conditions. Therefore, your manufacturing process was not validated with a high degree of assurance and approved according to established procedures, nor were the process results fully verified by subsequent inspection and test, as 21 CFR 820.75(a) requires.  

As if that wasn’t enough, Bard’s system for reporting and investigating product complaints was found to by woefully inadequate.

The company also incorrectly filed or failed to file adverse event reports. One of these reportable instances involved a death potentially due to a Bard device malfunction. Misreporting of 10 cases as Medical Device Reports (MDR) instead of serious injury events was also noted.

The FDA found Bard’s previous answers to the results of the inspections to be insufficient. The company has until August 3 to report satisfactory resolution of the issues or plans to do so.

U.S. District Judge Cynthia Rufe or the Eastern District of Pennsylvania made the only call she could on Tuesday: the postponement of Daubert hearing in Zoloft birth defects case until September. The multidistrict litigation (MDL) against Pfizer, claiming its popular antidepressant, Zoloft causes birth defects, came to a halt as the plaintiffs’ expert was disqualified due to errors in the article upon which he was basing his argument in the plaintiffs’ favor.

The postponement came during the Daubert hearing – one that allows parties to challenge each other’s expert testimony pre-trial to save time later – when defendant Pfizer revealed a report from its own medical expert, Dr. Stephen E. Kimmel. After reviewing Dr. Nicholas Jewell’s article in the New England Journal of Medicine, Dr. Kimmel noted some data errors. Dr. Jewell’s article provided plaintiffs’ needed support in their argument that Zoloft causes congenital heart defects when used by pregnant women.

Dr. Kimmel’s report states that he contacted Dr. Jewell and told him of the errors, at which point Dr. Jewell confirmed the mistakes. Dr. Jewell then contacted the Journal to request corrections. Based on this finding, Dr. Kimmel gave the opinion that Dr. Jewell’s article could no longer be used.

Judge Rufe had no other course of action but to agree with Dr. Kimmel and decided that the rest of the Daubert hearing would have to wait until the fall so the plaintiffs could conduct further discovery and depositions. Jared: Do we want to link to the CDC piece here as a suggestion?

According to Judge Rufe, plaintiffs’ legal team has “a lot of people to talk to, we have to give them some time. I do see an advocate’s responsibility to try to determine how this change occurred.”

This isn’t the first blow plaintiffs have received in terms of experts. Anick Bérard, the first expert, was removed following a weeklong Daubert hearing in 2014. Contrary to common practice, the judge allowed a second expert. It’s unclear if the plaintiffs will get a third. That isn’t the extent of the expert epic, though.

Judge Rufe ruled in favor of Pfizer in a motion to produce a report by plaintiffs’ expert Dr. Jewell from similar litigation involving Prozac. She ordered plaintiffs to turn over both the report and the testimony from Dr. Jewell.

According to Pfizer, “Dr. Jewell and plaintiffs’ counsel, who are also counsel in the Prozac litigation, insist that the entirety of Dr. Jewell’s expert report and deposition are confidential and thus subject to a protective order. That blanket assertion is highly suspect and implausible. Dr. Jewell is a general causation expert who presents a statistical analysis of data. He typically does not review or discuss plaintiff-specific information or medical records and has not done so in this matter. His opinions in the Prozac litigation, as they are in this litigation, are presumably based primarily upon publicly available, peer-reviewed literature.”

As stated, the plaintiffs were ordered to release the report. Despite Pfizer’s assertions, there were parts that Eli Lilly had identified as confidential redacted. There were also parts that contained personal health information normally protected by HIPAA.

Pfizer’s motion further stated, “In making a blanket assertion of confidentiality over the entire deposition and report, plaintiffs’ and Dr. Jewell’s motives are transparent: They do not want the defendants or the court to ascertain and explore whether there are any inconsistencies in his methodologies in the different SSRI litigations.”

To date, Pfizer has won two of the Zoloft birth defects cases out of the approximately 550 total cases.

 

Source:

Pa. Federal Judge Postpones ‘Daubert’ Hearing in Zoloft MDL