2022

Yes Virginia, Software Can Be A Product

By Steven Boranian on December 16, 2022

The idea that software can be a product (as in “product liability”) is not new, but gray areas remain with regard to when that should be and how courts should handle it. Take for example a case that we wrote on a couple of years ago, in which a district judge in Virginia granted summary judgment for the manufacturer of an electronic health records (“EHR”) system. A patient suffered severe complications after a doctor entered post-op instructions into the hospital’s EHR computer system, but the hospital implemented the orders at the wrong time. Whose fault was that? We don’t know, but the district court ruled that, even though the patient’s experts identified software changes that would have made the system safer, they did not identify a standard of care that the EHR system failed to meet.

Well, a couple of weeks ago, the Fourth Circuit reversed and held that the experts had very well identified a standard of care and further that there was evidence sufficient to support a failure-to-warn claim. The case is Lowe v. Cerner Corp., No. 20-2270, 2022 WL 17269066 (4th Cir. Nov. 29, 2022), and the facts are worth repeating. Following surgery, the patient’s surgeon entered orders for “continuous pulse oximetry” into the EHR software developed by the defendant and deployed by the hospital. However, although the surgeon intended for pulse oximetry—i.e., checking blood oxygen—to be continuous, she chose “once” and “daily” from the system’s dropdown menus, which defaulted to 10:00 each day. The system correctly displayed that time on the order confirmation screen, but several orders were entered that day, and the surgeon did not scroll down to review them all. She clicked through some version of “accept all.” Unfortunately, checking blood oxygen at 10:00 was too late for this poor patient, who suffered severe and permanent disability. Id. at *2-*3.

Divided Sixth Circuit Affirms “Unique” Application of Offensive Non-Mutual Collateral Estoppel

By Andrew Tauber on December 15, 2022

Twice this year we have reported on trial-court decisions addressing application of offensive non-mutual collateral estoppel—an offensive doctrine that precludes a defendant from relitigating an issue that it lost in earlier litigation against a different plaintiff. One court applied it; the other refused to. Today we report on a Sixth Circuit decision that affirmed, over a spirited dissent, application of the doctrine in a follow-on MDL case.

Our earlier posts catalog the doctrine’s unfair, pernicious results. A quick refresher:

Offensive non-mutual collateral estoppel risks perpetuating an erroneous result by preventing relitigation of issues previously decided against a defendant. If applied, the doctrine can give disproportionate—and potentially dispositive—weight to the decision of a lone judge or jury, no matter how wrong that decision.

The fact that an adverse judgment in one case can cripple a company’s defense in subsequent cases has two adverse consequences apart from the danger of perpetuating error. First, it gives plaintiffs tremendous leverage in settlement negotiations. Second, it induces defendants to spend much more litigating a case than would be warranted by the amount nominally in dispute.

Second Circuit Upholds New York Measles Vaccine Mandate

By Stephen McConnell on December 14, 2022

On Monday, Bexis blogged about a very bad vaccination decision — bad in its reasoning and bad in its maleficent effect on vaccine policy in this country. Over the past couple of years, we’ve written quite a few posts on vaccination cases. The law in this area has gotten a vigorous workout largely because of Covid-19, of course. That particular vaccine became a subject of massive political debate for reasons that seem entirely stupid to us.

Why stupid? Let us count the ways. First, the biggest vaccine haters are often supporters of the former President, whose administration did a lot to hasten development of the Covid vaccine. Second, the distrust of the Covid vaccine is largely premised on ignorance and conspiracy mongering. Third, the claims that Covid vaccine mandates undermine the Bill of Rights not only ignore logic, they ignore clear precedents involving other vaccines.

Indeed, we think that observing the treatment of other vaccines, free of the fog of political warfare, might help clarify thinking on vaccine mandates. Perhaps people can at least doff their tin foil hats temporarily.

In Goe v. Zucker, 43 F.4th 19 (2d Cir. 2022), the Second Circuit reviewed a proposed class action challenging the scope of medical exemptions to New York’s mandatory school immunization requirements. Prior to June 2019, New York allowed exemptions from the immunization requirements for both nonmedical and medical reasons. But after a big measles outbreak, New York repealed the nonmedical exemption (as we said in our vaccine post last week: yay) and clarified the medical exemption. The plaintiffs filed a lawsuit, contending that the new vaccine regulations violated their fourteenth amendment due process rights, as well as section 504 of the Rehabilitation Act, 29 USC section 794. The district court dismissed the complaint and the plaintiffs appealed to the Second Circuit.

Lone Pine Stands Tall in Zostavax MDL — Part 2

By Michelle Yeary on December 13, 2022

Earlier this year we blogged about the Lone Pine order entered in the Zostavax MDL that required those plaintiffs alleging that the anti-shingles vaccine caused them to get shingles (1,189 of them) to produce evidence of specific causation by means of a PCR test. The goal of the Lone Pine order was to winnow out non-meritorious claims. That was Part 1. Defendant’s motion to dismiss all 1,189 plaintiffs because not a single one produced the required test result or even asked for an extension – that was Part 2. Without evidence of specific causation, the court dismissed about half the cases in the MDL.

Shingles are caused by the same virus that also causes chicken pox, although the adult disease shingles is much more dangerous. The virus remains in the body for life and can either lie dormant or reactivate and cause shingles. Almost everyone over the age of 30 in the United States has had chicken pox and therefore carries the “wild-type virus” in their systems. In re Zostavax Products Liability Litigation, 2022 WL 17477553, *2 (E.D. Pa. Dec. 6, 2022). The vaccine consists of the Oka strain of the virus, a live-attenuated virus that is a weakened form of the wild-type. Defendant presented “uncontradicted medical authority” that the only way to know whether a person’s shingles was caused by the wild-type virus or the Oka strain is through a PCR test. In fact, plaintiffs’ own expert testified that specific causation could only be determined with a PCR test. Id. That is the same expert who failed to perform a differential diagnosis ruling out the wild-type virus in 5 bellwether cases that were therefore dismissed on summary judgment. That is what led to the entry of the Lone Pine order. If none of the bellwether plaintiffs had sufficient causation evidence, the court wanted to know which plaintiffs did.

Terrible Decision Contravenes the Vaccine Act’s Purpose and Would Gut Its Protections

By Bexis on December 12, 2022

Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. §§300aa-10, et seq. That litigation, involving DTP and certain other childhood vaccines, nearly destroyed this country’s ability to vaccinate its children against often deadly diseases – much to the delight of antivaxxers everywhere. After Congress acted in 1986, much to the delight of everyone else, the Act’s alternative compensation system, combined with its strong preemption provisions restricting post-compensation system litigation have largely restored the nation’s childhood vaccine supply to a sound footing. The Supreme Court did its part in Bruesewitz v. Wyeth LLC, 562 U.S. 223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead.

Lovely Warnings Causation (and More) Mesh Decision from the Central District of California

By Rachel B. Weil on December 9, 2022

We are just back from a lovely long weekend in Mexico. We were delighted to find, on our DVR, a show we’d forgotten we set to record: a special interviewing the cast and director of Love, Actually on the 20^th anniversary of that film’s release. This is our all-time favorite holiday film, and pretty close to our favorite film of any genre. We love how it has crept into popular culture (the SNL parody of the flip cards scene, featuring Kate McKinnon as Hillary Clinton is nothing short of brilliant), and we find the film endlessly charming and restorative, no matter how many times we watch it. Take a look at the special, if you missed it

Speaking of all-time favorites, today’s case deals with warnings causation, our all-time favorite doctrine. (Along with our co-blogger, Mr. McConnell, we just presented a CLE on this topic.) This is the doctrine: to prevail on a failure-to-warn claim in a prescription drug or medical device case, a plaintiff must prove both that the products warnings were inadequate and that the inadequate warning proximately caused the plaintiff’s injuries. Subject to variations of local law, the general rule is that, to prove the warnings causation piece, a plaintiff must adduce evidence that a different or stronger warning would have altered her physician’s decision to prescribe the drug or device.

In Brennan v. Johnson & Johnson, et al., 2022 WL 17219513 (C.D. Cal. Nov. 18, 2022), the plaintiff alleged that the warnings provided with her pelvic mesh devices were inadequate. She asserted failure-to-warn claims sounding in negligence and strict liability, and the defendant moved to dismiss both, arguing that the plaintiff could not prove that any inadequacy of the warnings proximately caused her injuries because her prescribing physician had not testified that she would have acted differently in the face of a different warning.

Breaking News – Plaintiffs’ Zantac MDL “Experts” Dismissed Under Rule 702; Summary Judgment Granted

By Bexis on December 8, 2022

In a 341-page opinion, In re Zantac (Ranitidine) Products Liability Litigation, 9:20-md-02924-RLR, slip op. (S.D. Fla. Dec. 6, 2022), the MDL court held that all of the Zantac plaintiffs’ general causation experts (concerning five cancer types) failed to meet the admissibility standards of Fed. R. Evid. 702. Consequently the court granted the defendants’ motions…

No Unemployment Comp Benefits for Worker Discharged for Vaccine Refusal

By Stephen McConnell on December 7, 2022

When we let it be known we were going to ACI in New York City this week, several friends expressed concern that we might finally lose the virus lottery and contract Covid-19. There does, indeed, seem to be a recent uptick in Covid cases. But we are vaccinated and boostered, plus no one gets that close to us anyway. We are big on what Nietzsche called the pathos of distance. We are even bigger on following the medical consensus and submitting to the latest jabs.

We don’t understand the skepticism or even outright antipathy toward vaccinations, no matter which ones. They are a blessing, not an incursion on our rights. If you want to see an actual incursion on civil rights, look halfway around the world and watch what a truly authoritarian country does to its population in the face of a pandemic. Severe Covid lockdowns happen in such a place because the country lacks an effective vaccine. Put another way, vaccines are liberating.

Still, on the home front, there is plenty of bellyaching about vaccine mandates. Our Twitter feed lately has been besieged with complaints about how soldiers have left the military as a result of vaccine mandates. But those numbers are quite small, soldiers are supposed to take orders, they are forced to endure a whole host of other vaccinations, and there is ample precedent for military vaccination requirements. Or have you never heard of George Washington and his efforts to prevent smallpox among his troops?

How Many Judges Does it Take to Toss Out a Tootsie Roll Case?

By Michelle Yeary on December 6, 2022

The world may never know how many licks it takes to get to the center of a Tootsie Roll Pop, but we do know it only took three judges on the California Court of Appeals to affirm a demurrer in Tootsie Roll’s favor.

Did you know Tootsie Rolls first came on the market in 1896 and were originally delivered by horse and buggy? Or that they were said to be Frank Sinatra’s favorite candy? And long before the wise old owl bit into the Tootsie Roll pop, the candy was advertising on television dating back to the 1950s. Tootsie Roll has had its home base in New York, New Jersey, and Chicago – where they are still manufacturing 64 million rolls every day. So, what could possibly be wrong with a Tootsie Roll? According to the FDA, nothing, and that’s why the court dismissed the putative class action in Beasley v. Tootsie Roll Indus., 2022 Cal. App. LEXIS 982 (Cal. Ct. App. Nov. 30, 2022).

Plaintiff alleged that she consumed Tootsie Rolls from 2010 to 2016 apparently without knowing that they contained artificial trans fats in the form of partially hydrogenated oils (PHOs). Note: PHOs were on the label. Having consumed the Tootsie Rolls, Plaintiff alleged she was at an increased risk for conditions like cardiovascular disease and type 2 diabetes. PHOs aside, Tootsie Rolls are essentially chocolate flavored sugar. So, sure they play their role in all those nasty obesity-related health conditions. But that cannot serve as the basis for an Unfair Competition Law (“UCL”) claim or an implied warranty claim. As it turns out, thanks to very specific language from both the FDA and Congress, neither could the presence of PHOs before 2018.

Interesting Pelvic Mesh Due Process Certiorari Petition

By Bexis on December 5, 2022

Readers may recall our dissection of the ridiculous application of offensive, non-mutual collateral estoppel in Freeman v. Ethicon, Inc., 2022 WL 3147194 (C.D. Cal. 2022). Ultimately, the thumb that Freeman put on the scale didn’t matter, because the defendant won at trial despite that handicap.

We described the prior adverse decision that formed the ground for the collateral estoppel claim as “factual findings entered by a state-court judge after a bench trial in earlier false-advertising and unfair-competition litigation.” That description doesn’t really do the prior decision (in)justice. That decision, People v. Johnson & Johnson, 2020 WL 603964 (Cal. Super. Jan. 30, 2020), decided an action filed by the California attorney general that had essentially converted the allegations that product liability plaintiffs had been making against the defendants’ pelvic mesh into the basis for a statewide civil action under certain California consumer protection statutes. Here is the result of that decision, in a nutshell:

Drug & Device Law