We write today fresh from a short cruise to celebrate a milestone birthday of the Drug and Device Law Dowager Countess. We view cruising, and the limitations of its inevitable confinement, as the perfect antidote to the often-unrelieved breakneck pace of our daily lives. And this cruise was no exception. We eschewed shore excursions in
This post is from the non-Reed Smith side of the blog.
This blogger is just returned from Ireland where we toured castles and abbeys, drove through amazing landscapes on tiny roads with hairpin turns (can’t say enough about Connemara except that everyone should go), sang about Molly Malone and the Fields of Athenry, visited a…
Our first stint in a law firm was on the transactional side. Yes, it sounds crazy even to us, but we spent our first 18 months in the profession pulling all-nighters on triple-tier financings of leveraged buyouts, doing clueless due diligence in far-flung back-offices, drafting trust indentures, ‘slugging’ at the printers, and collecting acrylic cubes …
It’s a fairly well known double standard. If you ask your child why he or she did that rotten, terrible, awful thing and he or she responds “just because” – that’s never good enough. When a parent is faced with the question “why,” however, “because I said so” is a fairly standard, albeit a bit…
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.
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.
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”).
We admit it. We (and “we,” in this instance, should be read in the singular) are fans of certain social media, particularly the one that involves “posting” on a “wall” then sitting back and basking in the “likes.” We tend to eschew any intellectually-challenging material that may be available on this medium. Instead, when we are not ourselves posting pictures of the Drug and Device Law Rescue Pets, we most enjoy reading accounts of others’ rescues of doggies and kitties. (Don’t start – we know.) These stories always begin with horrific, heart-wrenching facts but generally wend their way to satisfying endings.
Today’s case, Taylor v. Intuitive Surgical, Inc., 2015 Wash. App. LEXIS 1442 (Ct. App. Wash. July 7, 2015), follows a similar formula, although the ending is happy only for “learned intermediary” jurisprudence, not for plaintiff’s unfortunate decedent. Taylor involved the da Vinci System, manufactured by defendant Intuitive Surgical, Inc. (“ISI”). The highly complex da Vinci system allows surgeons to perform minimally-invasive prostatectomies, remotely operating small instruments inserted through very small incisions in the patient’s body. Taylor, 2015 Wash. App. LEXIS at *3.
Apparently, ISI tightly controls physician access to its system. We are not sure how, but the opinion describes a specific credentialing process under which every surgeon is required to be credentialed, before using the da Vinci system, by the hospital where the procedure will be performed. Each hospital sets its own credentialing protocol. Surgeons must initially perform proctored cases – two, or a number set by hospital protocol. Id. at *4-5. Next, ISI requires surgeons to “choose simple cases for their first four to six unproctored procedures and to slowly progress in case complexity.” Id. at *5 (internal punctuation and citation omitted). During their early surgeries, “surgeons are advised to choose patients with . . . BMI of less than 30 and no prior history of lower abdominal surgery.” Id.
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,…
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…