From the Drug & Device Defense Law Blog
and a post by Reed Smith’s Rachel B. Weil …
In In re Bard IVC Filters Prods. Liab. Litig., 2018 WL 1109554 (D. Ariz. Mar. 1, 2018), the court ruled on a number of motions in limine in advance of a mid-March trial. The plaintiff alleged that she was injured when defendant’s filter, inserted in her inferior vena cava (“IVC”) to capture blood clots, migrated and fractured. The filter that was implanted in the plaintiff, a Class II device, was granted 510(k) clearance by the FDA because of its “substantial equivalence” to an earlier filter model the defendant had marketed. And that is the source of the most interesting rulings.
The ruling presents a quandary. We have spent many years defending manufacturers of Class 2 medical devices and advocating for admission of evidence of 510(k) clearance. We can appreciate the tension and the difficulty of drawing appropriate evidentiary lines. But evidentiary lines and regulatory requirements are different. This is a variant of the same fallacy underlying the 510(k) admissibility point discussed above. FDA regulatory requirements and admission of evidence in civil litigation are two different things, created for different purposes, and often don’t mix well.
That is true here. For one thing, there is more to 510(k) than just substantial equivalence (“SE”). The entire relevant part of the FDCA allows for an SE finding where the device being considered ….
READ MORE of Rachel’s post at the excellent, if not vibrantly green, Drug & Device Law Blog.
Relevant HB Programs
Mass Torts Judicial Forum with Hon. Marina Corodemus
Mass Tort Med School for Plaintiff Attorneys
Drug & Device Defense Forum for Defense Attorneys
Questions about the content? Write to me, the comparable Tom Hagy, at Tom.Hagy@LitigationConferences.com.