Photo of Bexis

Seems to be Texas law.

The Third Restatement of Torts – controversially – includes an extremely limited form of “design defect” claim that it would allow against manufacturers of drugs and medical devices.  That doesn’t really make sense in the drug context because, with some minor exceptions (such as quantity of active ingredient per dose, or multi-ingredient drugs) you can’t change the “design” of a chemical molecule without creating a different drug.

But Restatement §6(c) does make somewhat more sense in the medical device context because it’s possible to rejigger things here or there (move the position of a screw or change the composition of a protective coating, for instance) and still have essentially the same product.  Restatement §6(c) would allow a design defect claim where, compared to the plaintiff’s proffered alternative design, the current design wouldn’t be appropriate for any patients at all:

A . . . or medical device is not reasonably safe due to defective design if the foreseeable risks of harm [it] pose[s] . . . are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe . . . medical device for any class of patients.

Restatement (Third) of Torts, Products Liability §6(c) (1998).  See also Id. §2(b) (articulating “reasonable alternative design” requirement for all design defect claims).

Restatement §6(c) hasn’t been widely adopted – certainly not in drug cases.  E.g., Freeman v. Hoffman La Roche, Inc., 618 N.W.2d 827, 840 (Neb. 2000); Lance v. Wyeth, 4 A.3d 160, 169 (Pa. Super. 2010), appeal pending; Bryant v. Hoffman-La Roche, Inc., 585 S.E.2d 723, 727 (Ga. App. 2003); In re Fosamax Products Liability Litigation, 742 F.Supp.2d 460, 471-72 (S.D.N.Y. 2010) (applying Florida law) (all refusing to apply §6(c) in cases involving prescription drugs).

It’s had somewhat more acceptance in device and vaccine cases where an alternative design requirement at least isn’t physically impossible.  E.g., Transue v. Aesthetech Corp., 341 F.3d 911, 919 (9th Cir. 2003) (applying Washington law); Gebhardt v. Mentor Corp., 191 F.R.D. 180, 185 (D. Ariz. 1999), aff’d mem., 15 Fed. Appx. 540 (9th Cir. 2001); Sita v. Danek Medical, Inc., 43 F. Supp.2d 245, 258-59 & n.9 (E.D.N.Y. 1999); Taylor v. Danek Medical, Inc., 1998 WL 962062, at *7 (E.D. Pa. Dec. 29, 1998), Militrano v. Lederle Laboratories, 769 N.Y.S.2d 839, 851-52 (N.Y. Sup. 2003), aff’d, 810 N.Y.S.2d 506 (N.Y.A.D. 2006), but even with redesignable products the reception has been mixed.  See Mele v. Howmedica, Inc., 808 N.E.2d 1026, 1038-39 (Ill. App. 2004) (refusing to follow §6(c) in device case).

Most states haven’t said anything, which in and of itself is part of the resistance §6(c) has encountered.  As discussed most thoroughly in Freeman, supra, this is a section of the Restatement that doesn’t seem to be restating much law, since design defect claims of any sort have traditionally been disfavored where prescription medical products are concerned.

This is why Ethicon Endo-Surgery v. Gillies, ___ S.W.3d ___, 2011 WL 1549555 (Tex. App. April 26, 2011), is interesting.  Gillies involved a medical device, a stomach stapler, that the plaintiff claimed was defective because it could be used, improperly plaintiff claimed, to staple stomach tissue that was “too thick.”  The plaintiff ostensibly dropped her design claims and claimed to be proceeding on a “negligent marketing” theory, id. at *3-4, but in fact it was the same claim about the stapler not being appropriate, due to its design, for stapling unusually thick stomach tissue.  Id. at *5-6.

However, the product was a multi-use device.  It came with different size (all color coded) staples for use with different size tissue.  Id. at *1.  That the plaintiff claimed it was defective because it could be used on stomach tissue that was more than two millimeters in thickness, id. at *6, could not, as a matter of law, establish a defect because the stapler was perfectly appropriate for a patient population with lesser tissue thickness:

In [plaintiff’s expert’s] opinion, because the [device] was not appropriate for use on gastric tissue more than two millimeters thick, it should not have been marketed for use in bariatric surgery.  Simply stating that a product was defectively designed for use in certain situations and, therefore, should not have been marketed at all, does not establish a standard of ordinary care applicable to the marketing of the product for use in other situations. . . .  We conclude [plaintiff] failed to provide expert testimony establishing either the appropriate standard of care for her negligent marketing claim or that appellant failed to comply with that standard.

Gillies, 2011 WL 1549555, at *6.

Although couched in terms of “negligent marketing” due to plaintiff’s attempt to play fast and loose with her causes of action (to avoid admission of certain adverse evidence), the court’s reasoning in Gillies is for all intents and purposes that of Restatement §6(c) – that because it was appropriate to use the device for other patient populations (with stomach tissue < 2 mm), it could not be defective simply because it would not be appropriate to use the device in this plaintiff’s group (stomach tissue > 2 mm).

Because risk as to one does not equal defect as to all, the device manufacturer received judgment n.o.v. (which in Texas we guess they call reversing and rendering judgment).  The law received a relatively rare example of a common-law case following the rationale of Restatement §6(c) without relying on the Restatement (presumably due to the claim being styled as “defective marketing”).