Photo of Bexis

Plaintiffs love to tell juries how horrible the defendant’s product is.  They’ll tell them how the product kills people – even though the plaintiff in the case didn’t die.  They’ll try to bring up purported cancer risks although the plaintiff doesn’t have cancer.  They’ll argue that, if the defendant’s device were to fail, they’d face sudden death, although the plaintiff before the jury hasn’t experienced any such failure.

But when the defendant tries to defend itself and its product, by pointing out the lifesaving nature of the product, or that use of the product is was the medical standard of care (colloquially called a “gold standard”) – all of a sudden, well that’s irrelevant and/or prejudicial, and the motions in limine start flying.  That’s what we’re looking at today.

We’ll start with In re Bard IVC Filters Products Liability Litigation, 2018 WL 1109554 (D. Ariz. March 1, 2018), which dealt with both of these issues.  Under a risk/utility test, that the defendant’s product is intended to address potentially fatal medical problems justified the defendant’s characterization of that product as “lifesaving” or “life-extending.”  Id. at *4.

[P]reventing blood clots from reaching the heart and lungs saves lives.  Defendants cite statistics showing that some 300,000 people die each year from pulmonary embolisms.  Plaintiffs’ own expert has testified that the purpose of [device] is to prevent pulmonary embolisms, and in this sense the [devices] can be lifesaving devices.

Id.  A similar result on similar facts was reached in Keen v. C.R. Bard, Inc., ___ F. Supp.3d ___, 2020 WL 4818801 (E.D. Pa. Aug. 19, 2020) (other ruling discussed here).

Without understanding both the risks and benefits of the filter, the jury would be left without the proper context to understand why [defendant] would ever design or manufacture [the device] or why [plaintiff’s surgeon] implanted the [one] in [plaintiff].  The purpose of [defendant’s devices]  and their medical benefits are also relevant to the inquiry of whether [defendant] violated its duty of care when designing the [device].

Id. at *4.

The court in Bard IVC also “agree[d] that the defendant could introduce evidence that the device was “standard of care” medical treatment.  Id. at *5.

Plaintiffs express concern that reference to the “standard of care” will confuse the jury concerning the standard of care to be applied in this case. But the standard of care for [defendant’s] design and marketing of [its devices] is entirely distinct from the medical standard of care for when filters should be used to treat patients.  To avoid confusion, the parties should refer to the “medical standard of care.”

Id.  See Phillips v. C.R. Bard, Inc., 2015 WL 260873, at *3 (D. Nev. Jan. 21, 2015) (“gold standard” description allowed “[i]f Defendants have competent expert evidence that [the devices] are the preferred method of treatment”).

Similarly, in Huskey v. Ethicon, Inc., 2014 WL 3861778 (S.D.W. Va. Aug. 6, 2014), the defendant was permitted to introduce testimony describing its product as “the “gold standard” for the treatment of” the condition plaintiff had.

Whether the [product] is regarded as the “gold standard” is highly probative: it goes to the very essence of whether the [product] is unreasonably dangerous and whether there existed safer alternative designs.

Id. at *2.  To the extent “plaintiffs believe that ‘gold standard’ is imprecise, inaccurate, or confusing, they may vigorously cross-examine witnesses.”  Id.

Other courts rejecting restrictions on medical standard of care evidence include:  In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2020 WL 6605648, at *2 (S.D. Ohio Sept. 11, 2020) (“medical standard of care” only); Sutphin v. Ethicon, Inc., 2020 WL 5079170, at *3 (S.D.W. Va. Aug. 27, 2020) (“gold standard”), reconsideration denied, 2020 WL 5269409 (S.D.W. Va. Sept. 3, 2020); Salinero v. Johnson & Johnson, 2019 WL 7753438, at *10 (S.D. Fla. Sept. 25, 2019) (“gold standard”); Benson v. Boston Scientific Corp., 2018 WL 4594432, at *4 (D.S.C. Sept. 25, 2018) (“gold standard”); Herrera-Nevarez v. Ethicon, Inc., 2017 WL 3381718, at *2 (N.D. Ill. Aug. 6, 2017) (“gold standard”); In re Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation, 2014 WL 505234, at *3 (S.D.W. Va. Feb. 5, 2014) (“gold standard”); Lewis v. Ethicon, Inc., 2014 WL 505234, at *3 (S.D. W. Va. Feb. 5, 2014) (“gold standard”).

Thus, despite plaintiffs’ best (worst?) efforts to prevent it, defendants are allowed to defend their products – where appropriate – by pointing out to the jury that they save lives and that they are “gold standard,” standard of care treatment for the medical condition for which the plaintiff sought treatment.