Photo of Stephen McConnell

Not so long ago we discussed how Pennsylvania law clearly precludes prescription medical product strict liability, but plaintiffs keep asserting that cause of action anyway.  The plaintiff bar is nothing if not persistent.

We also confront a similar stubbornness when it comes to California law on strict liability.  Twice in the last few months, we have encountered a plaintiff argument that is so specious as to beggar belief.  But it seems to be in the California plaintiff playbook, so let’s do our best to counter it.  Here is the argument:  California’s Restatement (Second) of Torts section 402A comment k ban on strict liability design defect claims against unavoidably unsafe products applies to medical devices only if they are implants. That argument is grounded more in opportunism than logic.  Why do plaintiffs keep making this argument?  Simple – because almost all of the California cases applying comment k to medical devices have involved implanted devices.  So what?  And did you notice how we said “almost”?

Comment k outlines the legal liability for unavoidably unsafe products. It is a necessary caveat to the strict liability provision of section 402A.  Strict liability differs from negligence in that it eliminates the necessity for the injured party to prove that the manufacturer of the product erred. It focuses not on the conduct of the manufacturer but on the product itself.  A truly rational scheme of strict liability could conceivably work well and efficiently if it reduced litigation costs, if it reduced uncertainty (which would require a rational limit on noneconomic and punitive damages), and if it excluded liability for products that are necessary but also unavoidably unsafe.  Strict liability cannot be the same as absolute liability.  That is where comment k comes in.  It begins by saying that “[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.  These are especially common in the field of drugs.”  Voila!  Drugs are the easy case.  Comment k goes on to extend the principle to “vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician.”  Vaccines, technically, are different from drugs – they are biologics.  The point is that comment k did not try to catalogue the products it covered.  Rather, it announced a principle of protecting necessary but unavoidably unsafe products. Comment k did not mention medical devices [when comment k was written in 1962-65, the FDA did not yet have explicit authority over devices] nor did it exclude devices. But, as you read above, comment k did seize upon the importance of physician prescriptions. You did not miss that, did you? Oddly, plaintiff lawyers in California keep missing it.

While defendants worry about the proclivity of some California judges to welcome all sorts of wacky theories of liability, California’s take on comment k is actually quite good.  In Brown v. Super. Ct., 44 Cal.3d 1049, 1058 (1988), the California Supreme Court held that comment k precluded a strict liability design defect claim in a case involving a prescription drug – DES.  The Brown court reasoned that “public policy favors the development and marketing of beneficial new drugs, even though some risks, perhaps serious ones, might accompany their introduction, because drugs can save lives and reduce pain and suffering.”  Brown, 44 Cal.3d at 1063.  The Brown court concluded that comment k applies to all prescription drugs because “the risk of injury from [prescription] drugs is unavoidable,” not simply because the drug is ingested into the body.

Did the Brown court mean to limit comment k to prescription drugs, omitting prescription medical devices?  No, it is just that it was a prescription drug that was at issue in the Brown case.  We wonder whether some plaintiff lawyer argued immediately after Palsgraf that its foreseeability limitation applied only to cases involving firecrackers. California courts had no problem quickly deciding that the Brown comment k rationale also applied to medical devices.  See, e.g., Plenger v. Alza Corp., 11 Cal. App. 4th 349 (1992) (HUD); Hufft v. Horowitz, 4 Cal. App. 4th 8 (1992) (penile prosthesis).  Those two particular cases did, indeed, involve implanted medical devices.  But it is not as if it was the implantable nature of the medical devices that made them unavoidably unsafe.  There are many medical devices that are inserted into the body temporarily and that are just as unavoidably unsafe.  Think of medical laser devices, for example.  A much better indicator of unavoidable unsafeness is that the medical device is available only by prescription because of its inherent risks.  See 21 C.F.R. § 801.109 (certain devices require a prescription because the “potential for harmful effect” makes the device unsafe except under a physician’s supervision).  California courts have recognized that the requirement of prescription is what matters.  See, e.g., Artiglio v. Super. Ct., 22 Cal. App. 4th 1388, 1397 (1994) (1994) (“[T]he imposition of the condition of ‘prescription’ provides insulation between the manufacturer and the user such as to warrant elimination of the consumer protections afforded by strict liability.”).

In any event, the next time plaintiffs in California assert that comment k applies to medical devices only if they are implants, ask them to explain Armstrong v. Optical Radiation Corp., 50 Cal. App. 4th 580 (1996).  In Armstrong, the court held that the manufacturer of an intraocular fluid used during cataract surgery was not strictly liable for design defect under comment k.  Armstrong, 50 Cal. App. 4th 583, 595.  In so holding, the court recognized the fluid as a “surgical aid” and a medical device.  Id.  The issue is not whether the device is implanted, it is whether the device unavoidably poses risks even as it must be used by physicians to “save lives or reduce pain and suffering.”

Sadly, there is a Northern District of California case with loose language about how maybe comment k would not apply to non-implants, but (happily) the court ultimately did not reach that conclusion:

California courts have not expressly decided the issue before this Court.  Defendant asks this Court to find that manufacturers of externally-operated medical devices, such as the Shaper, are not strictly liable for design defects in their medical products.  Such a holding does not appear warranted by existing California case law.  Brown, Hufft, and Artiglio explicitly distinguished prescription drugs and implants from other medical products on the ground that drugs and implants involve unavoidable harms.  It is not clear that externally-operated medical products such as wheelchairs, surgical scalpels, or corneal shapers implicate the same policy concerns as prescription drugs, implants, or intraocular fluids whose effects depend upon the specific physical characteristics of a given patient. However, the Court need not decide defendants’ motion on this basis. Assuming strict liability to apply, plaintiffs have not established a prima facie case of causation on their design defect claim.

Chandler v. Chiron Corp.  1997 WL 464827, 3-4 (N.D. Cal., 1997).  That is dicta, and not very good dicta at that.  Did you spot the necessary addition of “intraocular fluids” to prescription drugs and implants?  Thank you, Armstrong.  Maybe the next week the Chandler court would have added cryoablation.  And then lasers.  And so on.  Meanwhile, the point of distinction or limitation in the Chandler dicta turns on a straw man, or at least a straw man riding in a wheelchair.  Wheelchairs, of course, are not prescription medical devices.  You can buy them online.  You can get them from Amazon, Walmart,, etc.  You can get them off of Craigslist.  (We are not talking about motorized wheelchairs, and neither were those courts that cited wheelchairs as nondangerous counterexamples.)  Wheelchairs are not inherently dangerous – unless Richard Widmark is pushing one in Kiss of Death.  (Click on this link for what is perhaps the noir-est film noir moment ever.)

To sum up:  all that plaintiffs have to support their argument that comment k applies to medical devices only if they are implanted is: (1) most, but not all, California cases applying comment k to medical devices involved implants; and (2) dopey dicta. But whenever comment k issues arise in California, it is wise to return to the font of all wisdom:  Brown. What can Brown do for you?  Quite a lot.   In Brown, the California Supreme Court had to decide whether comment k should apply to prescription drugs at all and, after answering Yes to that question, whether comment k should apply to all prescription drugs or should apply only on a case-by-case basis.  In a closely-reasoned analysis, the California Supreme Court decided that a categorical, across-the-board approach made much more sense.

The Brown court drew an important distinction between prescription drugs, which are necessary “to alleviate pain or to sustain life,” and other products that merely make life “easier or to provide pleasure.”  Which category do prescription medical devices more closely resemble?  Clearly, prescription drugs.  The Brown court drew a distinction between prescription drugs and non-prescription medical devices: “unlike other important medical products (wheelchairs, for example), harm to save users from prescription drugs is unavoidable.”  There are those wheelchairs again!  But the point is that harm is unavoidable from prescription medical devices too, and not just implants.  Again, think of a medical laser.  Isn’t such a product necessary to alleviate pain and suffering?  And isn’t such a product unavoidably necessary?

There is no intelligible basis for excluding non-implanted prescription medical devices from comment k.  But let’s play devil’s advocate.  Theoretically, couldn’t such risky-but-necessary non-implant medical devices be brought into the comment k fold on a case-by-case basis?  But Brown, again, tells us why an across-the-board approach makes more sense. Brown rejected a case-by-case analysis for each prescription drug because such an analysis would gobble up litigation costs, could lead to inconsistent results, would provide manufacturers with inadequate assurances, and would thereby adversely affect the public’s interest in the development availability, and affordability of such products.  See Brown, 44 Cal.3d at 1268.

The logic of Brown, coupled with the realities of risky-but-necessary prescription medical devices, coupled with the Armstrong case, should inter once and for all the plaintiff argument that comment k is limited to medical devices that are implants.  We look forward to the day when making that argument will be unavoidably unsafe from judicial derision.