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 for summary judgment. More than that we have to wait for our client’s permission to say. Suffice it to say that the decision, and the reasoning, is beyond excellent.

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:

Federal Judge In California Cabins Innovator Liability

By Steven Boranian on December 2, 2022

We wrote recently that California’s courts have never met a case they did not like. We were speaking somewhat tongue in cheek of course, but still California remains a destination for litigation tourists trying to take advantage of laws and procedures that many view as plaintiff friendly. One bulwark against blatant forum shopping is personal jurisdiction under the U.S. Supreme Court’s Bauman and Bristol-Myers Squibb cases, the latter reversing the California Supreme Court, which restored some measure of discipline to jurisdiction over out-of-state defendants.

Another potential bulwark is choice of law. That is to say, even when a plaintiff sues in California, the applicable choice-of-law rules might compel the application of another state’s law, which could doom the plaintiff’s claims.

That is what happened this week in Nelson v. F. Hoffmann-La Roche, Inc., No. 21-cv-10074, 2022 WL 17259056 (N.D. Cal. Nov. 28, 2022) (to be published in F. Supp. 3d), where a Florida resident and Army veteran used a generic prescription drug while stationed in Kentucky and overseas and allegedly suffered complications. But he chose to sue in California. Why? Because the manufacturer of the branded version of the drug (not the generic version that the plaintiff actually used) was based in California at the time he filed (having relocated from New Jersey), and California is one of a very few states that allows innovator liability—i.e., holding an innovator/branded manufacturer potentially liable for a generic product that it did not make, did not sell, and from which it did not make any profit.

Criticizing FDA Reporting Systems Should Not Be Enough To Plead A Warnings Claim

By Eric Alexander on December 1, 2022

Two weeks ago, we decried the pattern that some courts follow in allowing shifting slates of boilerplate allegations to cases to discovery. The decision in Corrigan v. Covidien LP, No. 22-cv-10220, 2022 U.S. Dist. LEXIS 210296 (D. Mass. Nov. 21, 2022), reminded us of another of our post-TwIqbal pet peeves: when courts treat sweeping legal conclusions as if they were plausible factual assertions. The basic allegations in Corrigan were that the plaintiff’s surgeon used defendant’s surgical stapler to perform an anastomosis—reattachment of two parts of the digestive tract—in connection with removing part of his sigmoid colon (for unspecified reasons, but often diverticulitis or cancer) and the anastomosis later leaked, leading to further surgical intervention. As we said two weeks ago, medical device manufacturers are not insurers. That makes sense because surgery on humans, even done by the best surgeons, in the best hospitals, and with the best devices and equipment, has less than a 100% success rate. Anastomoses leak, infections develop, hernias recur, patients report post-operative pain, and all manner of complications and less than optimal outcomes occur. A common refrain when scientists are presented with a surgical study reporting no complications or failures is that the study was too small, too short, and/or insufficiently rigorous. Thus, a common procedure with a very high success rate will still generate large numbers of reported failures, like anastomoses that leak. This is part of why rates, and particularly comparative rates, provide more useful information about devices and surgeries than do gross numbers.

Even more authoritative sources than this Blog agree with us. FDA, for instance, makes clear that data from its Manufacturer and User Facility Device Experience (“MAUDE”) database “is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.” The reasons for this are not a secret: “The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.” Directly stated, “[t]he submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event.” FDA’s description of the MAUDE database also makes clear in a number of places that the data may be outdated or incomplete for various benign reasons.

E.D. Louisiana Dismisses Antiperspirant/Benzene Claims

By Stephen McConnell on November 30, 2022

In preparation for our OTC panel next week at ACI-NY, we have kept our eyes open for any OTC cases that raise interesting issues. Today’s case, Rooney v. Procter & Gamble Co., 2022 U.S. Dist. LEXIS 210218 (E.D. La. Nov. 21, 2022), involves a claim by the plaintiffs that a woman developed triple negative breast cancer as a result of using an antiperspirant that she asserts contained benzene.

The assertion that benzene was in the antiperspirant rested on testing by Valisure, an analytical pharmacy. Some of you have heard of a Valisure before, as its testing, and results allegedly showing contamination, have been relied upon by plaintiffs in other mass torts. Valisure calls itself “the pharmacy that checks.” Perhaps we are cynical, but we think of a different sort of checks when we see a purported independent outfit that seems to cooperate closely with plaintiff lawyers. Here, Valisure ran tests on batches of the antiperspirant and came up with concentrations of benzene significantly higher than levels recommended by OSHA. Valisure filed a Citizen’s Petition with the FDA seeking a recall of antiperspirant batches containing too much benzene. (Sound familiar?) The FDA had not responded to the Citizen’s Petition. The defendant voluntarily implemented a recall of certain batches of the antiperspirant.

Before the court was the defendant’s motion to dismiss the plaintiffs’ second amended complaint. The plaintiffs alleged that the defendant violated the Louisiana Products Liability Act by selling antiperspirants without issuing adequate warnings. The plaintiffs also alleged that the defendant was liable under theories of negligence, gross negligence, strict liability, and “fault,” and that the defendant violated the FDCA. Some of those claims seem weird (some of what’s missing also seems weird, but it’s not our job to help plaintiffs author complaints – our criticisms are strictly destructive), but remember, we’re in Louisiana. Not that we’re complaining. The people are fun, the food is great, and did we mention that the Judge in this case dismissed the second amended complaint?

Sales Representative’s Presence in Operating Room Not Enough to Beat Fraudulent Joinder

By Michelle Yeary on November 29, 2022

We have had occasion over the years to opine on cases involving allegations against sales representatives who are present in the operating room—a not uncommon practice when medical devices are being used. While the practice is not uncommon, what is rare are instances where a sales representative participates in the surgery. Rare, but not non-existent. Where the line is drawn between presence and participation, and possibility liability or not, is extremely fact sensitive. And as the court in Owens v. Boston SCI Corp. concluded, in the absence of facts, conclusory allegations of participation are not enough. 2022 U.S. DIST. Lexis 212427, *7 (E.D. Mo. Nov. 23, 2022).

Plaintiff underwent surgery involving implantation of a pelvic mesh medical device. Plaintiff alleged complications following surgery and filed a lawsuit against the manufacturer alleging design defects and against one of the manufacturer’s sales representatives for failure to warn both plaintiff’s surgeon and plaintiff. The manufacturer removed the case to federal court alleging the sales representative, who was not diverse to plaintiff, was fraudulently joined. Plaintiff moved to remand.

Drug & Device Law