A hospital? What is it? It’s a big building with patients, but that’s not important right now. Airplane, 1980. It’s also a big building filled with doctors and that is important right now. Those doctors are learned intermediaries between prescription drug and device manufacturers and the patients. A manufacturer’s duty to warn runs to the doctor and it then becomes the doctor’s responsibility to use his/her medical expertise to counsel his/her patient and advise the patient of the risks of the recommended treatment, therapy, drug, device, etc. This is drug and device products liability law 101.

Well, now in Washington, device manufacturers (not sure how this will impact prescription drugs) have another duty to warn – the duty to warn the hospital that purchased the device. See Taylor v. Intuitive Surgical, Inc., 2017 Wash. LEXIS 200 (Wash. S.Ct. Feb. 9, 2017). In a bizarre decision, the Washington Supreme Court creates what we believe is a unique, separate duty by device manufacturers to provide warnings to a hospital. Nowhere in the opinion does the court cite any precedent for this alternative warning claim, because there isn’t any. They also hold that the learned intermediary doctrine does not apply to this unprecedented duty. And then the court also refused to apply a negligence standard to plaintiff’s traditional failure to warn claim under comment k. Surely you can’t be serious. I am serious . . . and don’t call me Shirley.

The device at issue in Taylor was a robotic surgical device used for laparoscopic surgeries, including prostatectomies such as the one performed on plaintiff. Id. at *3. It is a complex medical device for which the manufacturer requires surgeons undergo training, including performing at least two proctored surgeries before being credentialed to use the system and recommends surgeons choose “simple cases” for their initial unproctored procedures. Id. at *4-5. The manufacturer also specifically warned surgeons not to use the device for prostatectomies on obese patients or on patients who had undergone prior lower abdominal surgeries and advised that the patient should be in a steep head down position during the procedure. Plaintiff Taylor was the first unproctored procedure for his surgeon and his surgeon opted to use the device despite plaintiff being obese and having had prior abdominal surgery. The surgeon also did not place plaintiff in the downward position due to his weight. Id. at *5-6. Plaintiff’s surgeon conceded plaintiff was not an optimal candidate for using the device. Id. at *6.

Plaintiff brought suit against the surgeon, the hospital, and the manufacturer, then settled with the surgeon and hospital before trial. At trial against the manufacturer, the jury found the manufacturer was not negligent in providing warnings to the surgeon. Id. at *7-8. As noted above, the warnings seem detailed and clear. On appeal, plaintiff argued that the trial court erred in not instructing the jury that the manufacturer had a duty to warn the purchasing hospital and erred in applying a negligence standard to the failure to warn claim.

Continue Reading Washington State Creates Device Manufacturer Duty to Warn Hospitals

A lot of companies rely on retired and otherwise former employees for information in litigation – including product liability litigation. Particularly where a product (such as a drug that’s now gone generic) has a long history, they are often the best source of knowledge about what happened years ago.  In dealing with ex-employees, however, defendants must keep in mind that, for purposes of the attorney/client privilege, discussions with ex-employees are subject to being treated much differently (and less protectively) than corporate communications with current employees.

The recent case, Newman v. Highland School District No. 203, 381 P.3d 1188 (Wash. 2016), although not involving prescription medical products, or even product liability, is a cautionary tale.  The defendant in Newman was a governmental entity, a school district.  The plaintiff alleged that he suffered a brain injury playing high school football, and that the injury occurred because the plaintiff was allegedly allowed to play in a game the day after suffering a concussion in practice.

The plaintiff in Newman didn’t sue until some three years after the injury. Id. at 1189-90.  By then, most of the coaching staff had turned over, and the individuals with the best knowledge of what had happened were employed elsewhere.  The school district’s litigation counsel contacted the ex-coaches and when they were deposed, claimed to represent them.  Id. at 1190.  Plaintiff challenged that representation as a conflict of interest and “sought discovery concerning communications between [the defendant] and the former coaches.”  Id.  The defendant resisted discovery with a claim of attorney/client privilege, and plaintiff opposed.  The defendant lost, and appealed denial of its motion for a protective order.  Id.

Continue Reading A Reminder To Be Careful With Ex-Employees And Confidential Information

As drug and device lawyers we live in a comment k dominated world.  When we say comment k on this blog, everyone knows what we mean.  We aren’t talking about a scientific discovery regarding potassium.  We aren’t reviewing a new flavor of k-cup for the Keurig.  We aren’t posting about breakfast cereals.  And we definitely are not passing comment on the Kardashians, Kobe, Keanu, or K-Fed.

But just in case you need a refresher, here is the comment k that concerns us:

Unavoidably unsafe products. There 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. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, 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. . . .  The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Restatement (Second) of Torts §402A, comment k (1965)  (emphasis added).  As you can see from the highlighted language, comment k recognizes that some products – drugs and medical devices in particular – are “unavoidably unsafe” and therefore not defective if properly prepared and accompanied by an adequate warning.  Most courts to have considered the issue have interpreted comment k to mean that manufacturers do not face strict liability for properly manufactured prescription drugs that are accompanied by adequate warnings.  That is true in Washington.  Young v. Key Pharmaceuticals, Inc., 922 P.2d 59, 63 (Wash. 1996) (under comment k, a prescription drug manufacturer is liable “only if it failed to warn of a defect of which it either knew or should have known . . . it is liable in negligence and not in strict liability”).

Continue Reading No Error With Comment k Jury Instruction

This just in, courtesy of Bruce Hamlin of Martin Bischoff, an intermediate appellate court in Washington State has rejected an attempt by plaintiffs to expand the duty to warn under the learned intermediary rule from the current “adequately warn a prescribing physician” standard to “warn every health care provider.”  Falsberg v. Glaxosmithkline, PLC, No. 68264-4-1, slip op. (Wash. App. Sept. 9, 2013) (unpublished).  Why such a ruling is “unpublished,” we can’t speculate.

The court rejected the proposition that “if a warning to the prescribing physician is good, then a warning to all health care providers everywhere is better.”  Falsbergslip op. at 10.  Here’s the relevant holding:

[S]trong policy considerations support Washington’s focus upon the prescribing physician in applying the learned intermediary doctrine.  Our Supreme Court has emphasized that in examining the nature of the relationship between a drug manufacturer, a prescribing physician and a patient, the prescribing physician plays a unique and important role.
*          *          *          *
Here, [the prescriber] was both the prescribing physician and the treating physician when symptoms first appeared.  [He] was aware of the manufacturer’s warnings and, when he prescribed the drug, he advised [plaintiff] to discontinue use if he developed [those symptoms].  As to the emergency room physicians
. . ., the record before us is minimal, and it appears to be
speculative whether a more simplified . . . warning would have been of any significance.
Id. slip op. at 9-10 (quotations from Terhune v. A.H. Robins Co., 577 P.2d 975 (Wash. 1978), and Restatement §402A, comment k omitted).

As this discussion suggests, the warning in question (quoted in full at slip op. at 6-7) was rock solid and detailed – so much so that the plaintiff actually argued that it should have been “simplified.”  Falsberg is thus also of note because of the holding that the warning was adequate as a matter of law.  Id. at 8.  Finally, Falsberg is the latest addition to our collection of cases, see here and here, for the proposition that there’s no duty to tell a trained physician how to
practice medicine:

[Plaintiff] contends that the label should offer diagnostic advice because of the known risk of misdiagnosis.  But [plaintiff] does not present a compelling argument. . . .  Neither the Restatement nor [Washington precedent] support the proposition that a label must go beyond the warnings given to include diagnostic tips, or otherwise instruct a physician on how to practice medicine.
Falsberg, slip op. at 8.
We’ve been blogging since 2006.  This is our first post ever about a legal
development from Washington State.  We’re thankful that it’s a victory for our side.

The last time we blogged about an asbestos case it was to bring you the good news about O’Neil v. Crane Co., 266 P.3d 987 (Cal. 2012) from the California Supreme Court – and our hope that it spelled the beginning of the end for Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008) (see here for our clear distaste for Conte).  Unfortunately, earlier this month, the Washington Supreme Court zigged where California zagged and Macias v.  Saberhagen Holdings, Inc., 2012 Wash. LEXIS 543 (Wash. Aug. 9, 2012) is the result.

Plaintiff Macias allegedly developed mesothelioma from cleaning respirators worn by shipyard workers to filter out asbestos, welding and paint fumes, and dust.  Id. at *2-3.  Plaintiff brought suit against the respirator manufacturers alleging that although the respirators themselves contained no asbestos, it was “foreseeable” that the respirators would be used with asbestos to which he would then be exposed when he cleaned them.  The trial court denied defendants’ motion for summary judgment, but the appellate court reversed holding that the manufacturers had no duty to warn “because they did not manufacture the asbestos-containing products that were the source of the asbestos to which [plaintiff] was exposed.”  Id. at *2.

In a 5-4 decision, the Washington Supreme Court overturned that summary judgment order finding that “the duty at issue is to warn of the danger of asbestos exposure inherent in the use and maintenance of the defendant manufacturers’ own products, the respirators.”  Id. at *2.  But, the respirators don’t contain asbestos and they don’t have to be used with asbestos – it is only foreseeable that they might be.  This is precisely the argument rejected in O’Neil.

A quick refresher on O’Neil helps to set the stage.   Plaintiff O’Neil, an aircraft carrier worker, sued the manufacturer of the carrier’s propulsion system alleging that while the propulsion system contained no asbestos at all, it was manufactured to specifications that required the addition of asbestos insulation from other sources and it was “foreseeable” that asbestos would be used in conjunction with their products.  The California Supreme Court, citing the appellate court’s decision in Macias, said no:  “California law does not impose a duty to warn about dangers arising entirely from another manufacturer’s product, even if it is foreseeable that the products will be used together.”  O’Neil, 266 P.2d at 1004.   Just like Mr. Macias, Mr. O’Neil did not allege that he was exposed to asbestos from any products actually sold by the defendants.  So how are the results in these cases so different?

Well, O’Neil is a California decision and therefore not controlling in Washington.  But Simonetta v. Viad Corp., 197 P.3d 127 (Wash. 2008) and Braaten v. Saberhagen Holdings, 198 P.3d 493 (Wash. 2008) are.  And they are virtually identical to O’Neil.  Non-asbestos containing pumps/valves on Navy ships were insulated with asbestos.  When workers had to repair or perform maintenance on the pumps/valves, they were exposed to the asbestos insulation.  They sued the pump/valve manufacturers for asbestos-related injuries.  Macias, at *16.   In those cases the Washington Supreme Court held that “to find strict liability in a product liability case, the manufacturer must be in the chain of distribution”  Id. at *10.  Applying that principle to the facts of Simonetta and Braaten, the court found:

that the manufacturers were not in the chain of distribution of the asbestos insulating products and therefore had no duty to warn of the danger of exposure to asbestos during servicing, and it makes no difference whether the manufacturers knew that their products would be used in conjunction with asbestos insulation.

Id. at *17 (emphasis added).   We wholeheartedly agree with this conclusion and its premise that a manufacturer is not required to warn users of risks inherent in another’s product.  Id. at *11.  We also highlight the portion that says foreseeability doesn’t matter – because that is where the Macias court seems to have made its biggest u-turn.

While the court acknowledged its ruling in Simonetta that “foreseeability of injury, does not in and of itself, create a duty to warn,” id. at *22, it then undertook a risk-benefit analysis with foreseeability at its core.  Id. at *22-26.  And while the Washington Product Liability Act does look in part to foreseeability of the harm in order to determine whether a product is unsafe – that’s not the question before the court.  As the court itself said: “The only issue before us is whether as a matter of law the manufacturers are entitled to summary judgment on the basis that they had no duty to warn of the danger of exposure to asbestos when their respirators were cleaned and maintained for reuse because these manufacturers were not in the chain of distribution of the asbestos-containing products themselves.”  Id. at *10.  So, “whether the defendant is in the chain of distribution of the relevant product is a threshold matter that must be determined before considering whether the product is reasonably safe.”  Id. at *36 (dissent).  Clearly a case of the cart before the horse.

The Macias court also focused on the fact that there are exceptions to the general “chain of distribution” rule – such as “assembler liability” for defective component parts or where two non-defective products are combined and create a dangerous condition.  Id. at *12-14. But then the court goes onto say that neither exception applies to the current case.  Id. at *15.   So, if the exceptions don’t apply, shouldn’t the general rule stand?

In fact, plaintiff’s argument in Macias might be even more of a stretch than in O’Neil.  In O’Neil, defendant’s products were required to be used with insulation and the only insulation meeting Navy specifications was asbestos.  Id. at *22 n.4.    As the Macias dissent points out:

In contrast, these respirators were complete upon sale and did not require the addition of an asbestos-containing component. Moreover, these respirators were intended to protect against a number of different contaminants, including welding fumes, paint fumes, and various types of dust. The manufacturers should not be expected to warn of the dangers of every contaminant a user could conceivably encounter. Imposing such an obligation would render all the warnings given virtually meaningless.

Id. at *35 (dissent).  It is difficult to imagine the length and breadth of the warning that would be required by this decision?

Since all four cases involve maintenance performed on products that post-manufacture and post-sale come into contact with another manufacturer’s product that contains asbestos, we find it extremely difficult to understand how Macias could have come down any differently than O’Neil, Simonetta or Braaten.  And we think the court must have struggled with this too, because their ultimate holding is frankly ponderous.  To fit within the general rule that a manufacturer is only liable for harm caused by its own product, the court ruled that the respirators are “the very products that posed the risk to [plaintiff]” and “[i]t does not matter that the respirator manufacturers were not in the chain of distribution of products containing asbestos when manufactured.”  Id. at *18-19.  Wait a minute. That’s a direct contradiction of the very general rule the court claims to be applying.  If the respirator manufacturers’ products don’t contain asbestos, they shouldn’t be liable for plaintiff’s alleged exposure to asbestos.  Plaintiff wasn’t harmed by the respirator itself, but by asbestos that the respirators came in contact with.  If the respirators had been used somewhere where there was no asbestos – also very foreseeable – plaintiff wouldn’t have been injured.  There is no claim for injury without the asbestos and the defendants didn’t manufacture the asbestos-containing products.

We also need to point out the serious flaw in the court’s analogies.  The court likens the respirators to blenders or table saws – that while sitting dormant in their boxes pose no real risk.  Rather “[i]t is only when the product is put to use at some point in the future that the hazards inherent in swiftly turning blades exist.” Id. at *24.  That’s right – the risk is from the blades.  The blades are part of the product – they were designed by, manufactured by, and sold by the maker of the blender or table saw.  Not true of the asbestos that allegedly caused injury to Mr. Macias.  And a gas stove doesn’t work without gas – respirators work without asbestos.  That analogy doesn’t hold water either.  It is just a further example of how far the court had to stretch to find a cause of action against the non-manufacturer defendants.

It’s just this type of stretch that makes us nervous about where a court is heading.  The court could easily have decided that this case was governed by Simonetta and Braaten and held that the respirator manufacturers owed no duty to warn about asbestos because they were not in the chain of distribution of the asbestos-containing products.  Having gone out of its way to distinguish its prior rulings, we can only wonder what’s next in the Evergreen State.

Thank you to one of our faithful readers, Brendan M. Kenny of Blackwell Burke PA for brining this important, although unfortunate, decision to our attention.