The Pennsylvania Supreme Court’s recent decision in Sullivan v. WernerCo., 206 A.3d 846 (Pa. Super 2023) dealt a blow to defense interests by reaffirming that compliance with governmental standards is not admissible in strict liability cases.
The holding in Sullivan confirmed that evidence of industry and governmental standards remains inadmissible following the Pennsylvania Supreme Court’s holding in Tincher v. Omega Flex, 104 A.3d 328 (2014). Tincher confirmed the adoption of Section 402A of the Restatement (Second), which imposes strict liability on sellers of an unreasonably dangerous product. Notably, Tincher overruled Azzarello v. Black Brothers Co., Inc., 391 A.2d 1020 (1978), which previously held, in part, that the “unreasonably dangerous” standard poses a legal question. Under Tincher, the “unreasonably dangerous” inquiry is a question of fact requiring a jury to determine if a product is defective.
Following Tincher, uncertainty lingered as to whether the overruling of Azzarello also overruled the “Lewis Rule,” under which evidence of industry and governmental standards is inadmissible in strict product liability cases. Lewis v. Coffing Hoist Div., Duff-Norton Co., Inc., 528 A.2d 590 (1987), However, the Lewis Rule was developed before Tincher, while Azzarello was still controlling precedent, thus creating confusion and requiring the Pennsylvania Supreme Court to resolve an issue that has plagued litigants in strict liability litigation for a decade.
The Sullivan court closely examined two tests created by Tincher to determine whether a product is unreasonably dangerous: (1) whether the product danger exceeds the expectations of an ordinary consumer (the “consumer expectation test”) and (2) whether the risk of danger outweighs the utility of a product (the “risk-utility test”). It is important to note that Tincher rejected any application of traditional negligence concepts in strict liability litigation, meaning that a product seller can still be strictly liable even if it exercised due care or acted reasonably in a manner that would usually preclude negligence liability under Pennsylvania law.
The Sullivan court confirmed that the Lewis Rule still applies post-Tincher, even though Lewis rested on the negligence-based concepts of Azzarello. The Supreme Court reasoned that Tincher is not compatible with a rule permitting trial evidence of industry-standard compliance, bootstrapping the Lewis Rule into a more modern post-Tincher standard. Compliance is “irrelevant if a product is designed with all possible care….because the manufacturer is still liable if the product is unsafe.”
The Sullivan decision is yet another example of Pennsylvania common law reinforcing the wall between strict liability and negligence theories. Defendants may be liable for selling a dangerous product, even if the defendants designed the product reasonably and with the utmost due care and compliance with governmental standards. What Sullivan did not address, however, is the role that certain federal preemption rules—such as those found in the Federal Hazardous Substances Act or Food and Drug Administration regulations—may have on defective product cases. It may be another ten years before the Supreme Court has an opportunity to address these types of issues, and, until then, uncertainty created by Tincher will continue to affect strict product liability litigation in the Commonwealth.
If you have any questions about this legal update or any other legal developments, please contact the authors or Gordon Rees Scully Mansukhani’s Environment/Toxic Tort practice group for more information.
The anticipated period of survival for a patient after a diagnosis of mesothelioma is of great significance in any mesothelioma lawsuit. Beyond the significance to the patients themselves, a predicted short life expectancy can dramatically impact the pace of litigation. For example, cases in California and Illinois may receive a “preference” or “expedited” trial date to accelerate litigation when the plaintiff can produce evidence raising substantial medical doubt that the plaintiff is unlikely to live more than six months. It has long been assumed that the prognosis for all mesothelioma patients is dire, even more so for pleural mesothelioma than peritoneal mesothelioma, but there is evidence that a significant percentage of mesothelioma patients live longer than 12 to 21 months from diagnosis.
Trends of Increased Survival for Mesothelioma Patients
The prognosis for mesothelioma patients varies by the location of the cancer, the cell type of the cancer, and the “stage” assigned to the cancer. The general statement is that life expectancy is between 12 and 21 months. Patients with peritoneal mesotheliomas tend to do better, and with surgery, they often have life expectancies greater than five to seven years.
The American Cancer Society approaches the issue differently by discussing the likelihood of achieving a five-year relative survival rate. Relying on surveillance, epidemiology, and end results (“SEER”) data, which tracks mesothelioma cases around the world, the American Cancer Society says only 12 percent of all cases have five-year relative survival rates. [1] However, the same data showed that for mesotheliomas that were considered “localized, ” the prognosis was the best with 24 percent of those cases having a five-year relative survival rate.[2]
A 2022 epidemiological analysis revealed a stable overall incidence of malignant peritoneal mesothelioma (“MPM”) but improved recognition of epithelioid histology. [3] Survival improved over time and was associated with cancer-directed surgery, suggesting that accurate diagnosis of epithelioid histology, or tissue and skin cancer, may lead to more patients being considered for appropriate multimodal treatment and contribute to improved overall survival. Although the overall age-adjusted incidence of MPM remained stable from 2000 to 2018, there has been an increase in cancer-directed surgery and a concurrent improvement in MPM survival over time. This contemporary analysis of MPM survival reflects trends after the increased adoption of effective therapies for MPM, including cytoreductive surgery (“CRS”) and hypothermic intraperitoneal chemotherapy (“HIPEC”).
Other research has also analyzed how the number of mesotheliomas among men and women has changed in the decades since asbestos regulations came into effect in the 1970s. These analyses have all shown much more significant declines in cases among males, while incidences among females have remained relatively stable. [4]
Physicians continue to develop their understanding and differential diagnoses of mesotheliomas and have found that some peritoneal mesothelioma patients have life expectancies more than five years after treatment, depending on the particular cell type and origin of disease. In one study of 164 female patients with peritoneal mesothelioma, 85.3 percent lived more than five years after treatment![5] Other studies have made preliminary showings that patients with a BAP1-related mesothelioma can have a much longer survival rate of five to seven years for the median, with 26 percent of patients living more than 10 years. This is much longer than the average of 11 months reported in the international SEER database.[6]
Much of the research and scientific study on mesothelioma patients is affected by the monetary value of a case in which the plaintiff is alleged to have a terminal, incurable illness. This monetary influence is even affecting the decisions of treating doctors not directly involved in the litigation. Even though genetic testing is “standard practice,” some patients are being advised by their oncologists to seek information about the genetic component of their mesotheliomas through research studies or decline testing altogether to keep this information out of their litigation.[7]
Long-term Survival of Mesothelioma Plaintiffs in Recent California Cases
The case of “Decedent A” is particularly notable. In 2010, Decedent A filed a personal injury–asbestos action after being diagnosed with peritoneal mesothelioma in 2009. Decedent A moved for a preference trial date asserting that their survival beyond six months was unlikely. The court granted a preference trial date within three months after Decedent’s motion was heard, and litigation pursued.
However, Decedent A survived for 12 years and passed away in 2021. Decedent A’s 2009 diagnosis was made without the benefit of more recent diagnostic and therapeutic tools. Decedent’s death certificate asserted the immediate causes of death were coronary artery disease, atrial flutter, congestive heart failure, and peripheral artery disease. Mesothelioma and Type 2 Diabetes were additionally named as other significant conditions in Decedent’s death. Decedent’s heir has now filed a wrongful death action.
“Plaintiff L” is also a long-term mesothelioma survivor. Plaintiff L was diagnosed with pleural mesothelioma in January 2021. Since their diagnosis, Plaintiff L has filed two separate asbestos personal injury actions. The first lawsuit was filed in May 2021. Similar to Decedent A, Plaintiff L also moved for a preference trial date due to their medical condition. The court granted Plaintiff’s motion, and ultimately this lawsuit resolved at trial.
It has been two years since Plaintiff L’s mesothelioma diagnosis. In fact, Plaintiff L has recently filed a second separate personal injury lawsuit for the same disease but has now named different defendants. Unlike their first lawsuit, there is no preference trial motion pending. The court has taken notice that the “expert” declarations submitted in Plaintiff L’s first lawsuit moving for preference have been shown to be unduly pessimistic in regard to Plaintiff L’s survival.
As survival rates for peritoneal mesothelioma patients continue to increase, it is clear that the landscape of asbestos litigation will also develop. As seen with Decedent A, although medical evidence was presented to support the court’s finding for an expeditious trial date, they lived far beyond the assumed six months. With Plaintiff L, their increased survival allowed them the opportunity to bring a second separate lawsuit against different defendants but may have also barred them from seeking a second potential preference trial date. In many of our cases, the defense bar is continuing to resist requests for preference trial dates with some success. As more instances are reported of cases involving survival well beyond the oft-quoted rates, perhaps there will be more such successes in the future.
[3] Calthorpe, et al. 2022, Contemporary Trends in Malignant Peritoneal Mesothelioma: Incidence and Survival in the United States, Cancers 2023, 15, 229.
[4] Price 2022, Projection of future numbers of mesothelioma cases in the US and the increasing prevalence of background cases: an update based on SEER data for 1975 through 2018, Critical Reviews in Toxicology, 52:4, 317-32
[5] Malpica 2022, Peritoneal Mesothelioma – An Update, Adv. Anatomic Pathology 2022; Malipca et al. 2021, Malignant mesothelioma of the peritoneum in women: a clinicopathologic study of 164 cases Am. J. Surg. Pathol. 2021: 45-48.
[6] Pastorino S, Yoshikawa Y, Pass HI, et al: A subset of mesotheliomas with improved survival occurring in carriers of BAP1 and other germline mutations. J Clin. Oncol 36:3485-3494, 2018. See also Carbone M, Pass HI, Ak G, et al: Medical and surgical care of patients with mesothelioma and their relatives carrying germline BAP1 mutations. J Thorac Oncol 17:873-889, 2022.
[7] Hathaway 2023, Family Matters: Germline Testing in Thoracic Cancers, American Society of Clinical Oncology Educational Book.
The Texas Supreme Court recently handed down an opinion that may help rein in the rash of “nuclear verdicts” juries have been awarding in the last few years. Until now, Texas juries have generally been allowed to pick any number when determining the damage amount. In Gregory v. Chohan, the Supreme Court of Texas addressed the evidence needed to support non-economic damage awards in wrongful death claims.
Gregory was a wrongful death lawsuit arising from a tragic multi-vehicle pileup. The jury delivered a verdict of $38.8 million, with one family receiving an award of just over $15 million in non-economic damages. The defendants appealed the lower court’s ruling on several grounds, including the size of the non-economic damages award. The court of appeals, sitting en banc, affirmed the lower court’s ruling on all grounds. The Supreme Court of Texas then overturned the verdict, in large part because of a lack of actual evidence supporting the amount of non-economic damages awarded.
As noted by the court, the jury’s duty is to find an amount that “would fairly and reasonably compensate for the loss.” Importantly, the court held that it is insufficient for plaintiffs to show the existence of mental anguish or other consortium-type loss: plaintiffs must also present evidence justifying the amount of non-economic damages sought. Put simply, the amount of damages must have a rational basis for the amount that is grounded in evidence.
In Gregory, the court also expressly rejected two common techniques plaintiffs utilize to support requests for large amounts of non-economic damages: unsubstantiated anchors and unexamined ratios.
Technique 1: Unsubstantiated Anchor
Unsubstantiated anchoring is a tactic whereby attorneys suggest damage amounts by referencing objects or values with no rational connection to the facts of the case. In Gregory, the plaintiff’s counsel drew analogies to a $71 million Boeing F-18 fighter jet and a $186 million painting by Mark Rothko. Attorneys across the country use anchors like these to place monetary values on injuries and force jurors to consider damage amounts similar to the numbers offered, despite the lack of a rational connection between reasonable compensation and the suggested anchor. According to the court, unsubstantiated anchors are not evidence of the plaintiff’s loss and do not assist jurors in finding reasonable damage amounts.
Technique 2: Unexamined Ratio
The court also rejected the use of unexamined ratios, where a numerical ratio—that is not related to any evidence in the case—is used to calculate damages. In Gregory, the plaintiff’s counsel argued that the plaintiffs tried to give their “two cents worth” to the defendants throughout the course of the lawsuit. Then, counsel urged the jury to give their “two cents worth” for every one of the 650 million miles a defendant’s truck drove during the year of the accident. The court explained the plaintiff’s “two cent” argument lacked any rational basis to support the sought compensation. In fact, the Texas Rules of Civil Procedure address techniques like the ones used by the plaintiff and require counselors to confine their arguments “strictly to the evidence and to the arguments of opposing counsel.” Tex. R. Civ. P. 269(e). Furthermore, courts are obligated to prevent improper jury arguments and are not “required to wait for objections to be made when the rules as to arguments are violated.” Tex. R. Civ. P. 269(g).
In overturning the award in Gregory, the Texas Supreme Court is reinforcing the principle that all damages, even non-economic damages, must be rationally tied to the evidence in the case. Where there is no direct evidence illustrating a non-economic damage, such as emotional injury, plaintiffs must establish a rational basis for the damages awarded, such as potential financial consequences of severe emotional trauma. The nature, duration, and severity of the alleged mental anguish also remain relevant considerations when justifying the damage amount. It remains to be seen how effectively trial courts will implement this decision, but it may help limit or prevent irrational nuclear verdicts.
A recent Texas Supreme Court opinion—Gregory v. Chohan, No. 21-0017, 2023 WL 4035886 *1 (Tex. June 16, 2023)—has made it easier for defendants to present evidence of liability for parties not in the lawsuit and for juries to actually assign those parties a percentage of fault on the verdict form. Gregory clarified that the evidentiary standard for designating a responsible third party (“RTP”) for apportionment at trial is a “no evidence” standard. A defendant must only present evidence raising a genuine issue of fact to add a non-party to the verdict form. This is the same standard applied to summary judgment, which has historically been a low bar for plaintiffs in Texas courts. The Gregory ruling should enable defendants to designate RTPs more easily.
Texas has long allowed juries to consider the fault of parties not present at trial and assign them a percentage of fault on the verdict form. See TEX. CIV. PRAC. & REM. CODE §§ 33.003, 33.004. RTPs can include any person who is alleged to have caused or contributed in any way to the harm, including bankruptcy trusts, unknown parties, and even immune parties (such as employers). See TEX. CIV. PRAC. & REM. CODE § 33.011(6); see PEMEX Exploracion y Produccion v. Murphy Energy Corp., 923 F. Supp. 2d 961, 980 (S.D. Tex. 2013); see Galbraith Eng’g Consultants, Inc. v. Pochucha, 290 S.W.3d 863, 868 n. 6 (Tex. 2009).
Procedurally, a defendant must file a motion for leave to designate a responsible third party. See TEX. CIV. PRAC. & REM. CODE § 33.004(a). After an adequate time for discovery, a plaintiff may move to strike the RTP on the ground that there is no evidence the RTP contributed to the harm. Id. at § 33.004(l). Then, the burden shifts back to the defendant to “produce sufficient evidence to raise a genuine issue of material fact regarding the designated person’s responsibility for the claimant’s injury or damage.” See id.
In Gregory, a New Prime eighteen-wheeler driven by Sarah Gregory jackknifed across multiple lanes of traffic on an icy highway near Amarillo, blocking a large portion of the road. A tragic multi-vehicle pileup ensued. In addition to the New Prime truck, the accident involved two passenger vehicles and six other eighteen-wheelers. The accident claimed four lives, including Bhupinder Deol, a truck driver involved in the accident who was killed while attempting to assist others involved in the wreck. Deol’s estate sued Gregory and New Prime, among others, seeking damages for his death.
Before trial, Gregory and New Prime sought to designate several responsible third parties, including another semi-truck company involved in the accident—ATG Transportation. Gregory and New Prime argued that it was not until the ATG truck arrived on the scene, tipped over, and blocked the remaining unobstructed portion of the road that the accident became unavoidable for approaching vehicles. The defendants reasoned that if Gregory was responsible for Deol’s death because of her negligence in obstructing the road, then the ATG driver must likewise be partially responsible because their negligence contributed to the dangerous road obstruction.
The trial court, upon request of Deol’s estate, struck the defendant’s RTP designations and later reaffirmed its ruling after presentation of the evidence. On appeal, the defendants chose only to appeal the exclusion of ATG. The court of appeals affirmed the trial court’s decision to exclude ATG, reasoning that the facts that lead to Deol’s death were solely attributable to Gregory’s negligence.
The Gregory court underscored the “obvious” similarity between the RTP standard and the no-evidence summary judgment standard. 2023 WL 4035886 *14. Reviewing de novo, the court found that the evidence would have permitted a reasonable jury to assign partial reasonability to ATG for Deol’s death. The court pointed to plaintiff’s own expert who testified that the ATG driver steered aggressively beyond the normal steering input and failed to control their speed. Further, a fact witness testified that when the ATG truck crashed it “went straight up in the air like it was [a] catapult.” “Prohibiting the jury from considering ATG’s partial responsibility for Deol’s death was harmful error because litigants have a ‘significant and substantive right to allow the fact finder to determine the proportionate responsibility of all responsible parties.’” Id. at *16. Due to the harmful error, the Texas Supreme Court ordered a new trial.
The Texas Supreme Court’s ruling in Gregory makes clear that all Texas courts should review RTP motions in the same manner as they review no evidence motions for summary judgment—has the defendant presented sufficient evidence to raise a genuine issue of material fact. This is relatively low bar in which defendants only need to come forward with some evidence. A trial court that does not apply this standard commits a harmful error requiring a new trial. Going forward, Texas courts should be more willing to allow defendants their right to have the jury hear argument and assign fault to RTPs. This ruling emphasizes that the jury is the sole adjudicator of proportioning fault and defendants have the right to present evidence of all contributing parties, regardless of how much or little an RTP may have contributed to a plaintiff’s injury.
U.S. Supreme Court Rejects Challenge to Pennsylvania’s Corporate Consent-by-Registration Statute, Allowing Suits Against Foreign Companies Whether Arising from Acts in Pennsylvania or Elsewhere
The U.S. Supreme Court on June 27 in Mallory v. Norfolk Southern Railway Co., Case No. 21-1168 (2023) affirmed a statute that grants state courts general personal jurisdiction over out-of-state companies registered to do business in the state, even when an alleged injury occurred elsewhere, by virtue of registration alone. The Court rejected an out-of-state railway company’s Fourteenth Amendment Due Process challenge to Pennsylvania’s consent-by-registration statute. For a company registered as a foreign corporation in Pennsylvania, this is now the equivalent of being headquartered there, and that company may be hauled into court in Pennsylvania for any suit, whether the suit arises from acts in Pennsylvania or anywhere else in the country.
Expected Impact on Corporate Clients
We expect there to be an immediate impact on corporate clients with presences in consent-by-registration states, with filings based solely on the fact that the corporation is registered to do business in the state. Presently, Pennsylvania and Georgia have consent-by-registration laws for out-of-state corporations that have been upheld. We will be watching to see whether other state legislatures amend their corporate registration statutes to impose consent to jurisdiction by way of registration.
1917 Precedent Upheld as Basis for Opinion
The Court in Mallory held that its century-old decision in Pennsylvania Fire Insurance v. Gold Issue Mining, 243 U.S. 93 (1917) – which allowed a Pennsylvania insurer to be sued in Missouri by an out-of-state plaintiff on an out-of-state contract – remains controlling precedent. The Court reasoned that Pennsylvania’s law, like the Missouri law upheld in Pennsylvania Fire, explicitly provides that registration to conduct business as an out-of-state corporation allows state courts to exercise general personal jurisdiction over an out-of-state corporation as if it were a domestic corporation.
Factual Background and Statutory Scheme
Virginia resident Robert Mallory sued his former employer, Norfolk Southern, after being diagnosed with cancer that he attributed to his work as a freight-car mechanic in Ohio and Virginia. Norfolk Southern, incorporated and headquartered in Virginia, claimed that a Pennsylvania court’s exercise of personal jurisdiction over it would violate the Due Process Clause of the Fourteenth Amendment. Mr. Mallory pointed to Norfolk Southern’s corporate registration and presence in Pennsylvania, including that the company manages over 2,000 miles of track, operates 11 rail yards, and runs 3 locomotive repair shops in the Commonwealth.
Pennsylvania law provides that a foreign corporation may not conduct business in the Commonwealth until it registers with the Pennsylvania Department of Business. 15 Pa. Cons. Stat. §411(a). Pennsylvania’s long-arm statute allows Pennsylvania courts to exercise general personal jurisdiction over foreign corporations that are registered in Pennsylvania on “any cause” in the Commonwealth’s courts. 42 Pa. Cons. Stat. §5301(b).
Jurisdiction Held to be Appropriate Based on Corporate Registration
The Pennsylvania Supreme Court held that this statutory scheme violates the Due Process Clause because it grants general personal jurisdiction over foreign corporations without an affiliation that is so continuous and systematic as to render the foreign corporation essentially at home in Pennsylvania, and because compliance with Pennsylvania’s mandatory registration requirement does not constitute voluntary consent.
In vacating the Pennsylvania Supreme Court’s judgment and remanding the case, the Court held that Pennsylvania Fire remains the law and that jurisdiction was appropriate over Norfolk Southern. The Court leaned heavily on its 1917 precedent for the proposition that statutes requiring corporate “consent” to jurisdiction do not violate the Due Process Clause of the Fourteenth Amendment. The Court reasoned that a Certificate of Authority to do business within the Commonwealth confers benefits and burdens shared by domestic corporations, including amenability to suit in state court on any claim regardless of how much business a company actually conducts in Pennsylvania.
Intervening Jurisdictional Decisions
The Supreme Court found that the Pennsylvania Supreme Court improperly concluded that intervening decisions implicitly had overruled Pennsylvania Fire. Specifically, Norfolk Southern had argued that International Shoe, 326 U.S. 310 (1945), and others undermined Pennsylvania Fire. The Court disagreed, stating:
All International Shoe did was stake out an additional road to jurisdiction over out-of-state corporations . . . . Pennsylvania Fire held that an out-of-state corporation that has consented to in-state suits in order to do business in the forum is susceptible to suit there. International Shoe held that an out-of-state corporation that has not consented to in-state suits may also be susceptible to claims in the forum state based on “the quality and nature if its activity” in the forum.
The Court also rejected Norfolk Southern’s argument that requiring companies to face suits in Pennsylvania would violate the “fair play and substantial justice” principle in International Shoe, pointing to Norfolk Southern’s tracks crisscrossing Pennsylvania, the freight tonnage it moved, and its many facilities in the Commonwealth. The plurality specifically held that Pennsylvania Fire (holding that an out-of-state corporation that has consented to in-state suits to do business in a forum is susceptible to suit there) and International Shoe (holding that an out-of-state corporation that has not consented to in-state suits may be susceptible to claims in the forum State based on the quality and nature of its activity in the forum) “sit comfortably side by side.”
Auto-Jurisdiction Based on Corporate Registration
Until Mallory, general personal jurisdiction over a corporation could be found in two very distinct places: (1) the state of a company’s headquarters, and (2) the state of a company’s incorporation. Mallory now also will allow a corporation to be hauled into court in any state in which it has consented to jurisdiction. It is very clear now that state statutes explicitly requiring a company to submit to state court jurisdiction are viable and constitutional, thus creating auto-jurisdiction for any and all lawsuits where such statutes exist, regardless of where the actual basis for a suit arises or the residency of the plaintiff.
Immediate and Potential Practical Impacts of Decision
What do we make of states that simply require a company to have a registered agent of service? Is that enough to create automatic general personal jurisdiction? The Court did not answer that question directly, but based on its heavy reliance on Pennsylvania Fire, it appears the Court may venture there in the future. The practical and immediate impact of this opinion is all but certain – plaintiffs will view it as a license to forum-shop in favorable jurisdictions with little actual connection to a venue, likely resulting in a near-term increase in forum shopping and challenges to general personal jurisdiction.
Of additional concern is the Court’s repeated citation to facts regarding Norfolk Southern’s continuous and expansive business presence in Pennsylvania as justification for the fairness of making it open to suit in the Commonwealth. Is this a glimpse at the majority’s future plans to extend general personal jurisdiction over all corporations in any state in which those companies choose to do business? The Court made the point several times that Norfolk Southern has taken full advantage of the business opportunities that Pennsylvania has to offer as if it were a domestic corporation and thus must also suffer the burdens of a domestic corporation. In the modern world of extensive e-commerce, one must wonder whether a future court may hold simply that by selling products online a company has consented to jurisdiction in any place where someone may access the internet.
The future of corporate personal jurisdiction is now unclear. This will undoubtedly lead to rampant forum shopping by plaintiffs, with plaintiffs bringing suits in states with jurisdictional consent statutes where the state’s laws are favorable to plaintiffs. Product liability and toxic tort defendants will be at significant risk of being sued in courts with plaintiff-friendly rules on issues like apportionment of liability, expert witness qualifications, and causation burdens of proof, regardless of that forum’s actual relationship to the underlying facts of a case. This decision will increase the unpredictability of doing business across state borders. Companies may start to think long and hard about registering an agent for service in a state with a jurisdictional consent statute or even do business there at all, with impacts on the economic health of the state.
Moreover, Mallory may leave the door open for state courts to determine that registration is a significant – perhaps even dispositive – part of any “purposeful availment” determination for specific personal jurisdiction, even if not general jurisdiction as in this case.
A California appellate court has affirmed the exclusion of an expert witness who “(1) unreliably found causation based on [a single] study alone while disregarding other human data …; (2) analyzed animal data even though he was unqualified to do so; and (3) misapplied [several] of the nine factors of the Bradford Hill analysis.” Onglyza Product Cases involved claimed negative cardiovascular effects from a diabetes medication. The rulings are, however, broadly applicable to expert witnesses generally and to the recurring minefield that is Bradford Hill.
“A trial court does not abuse its discretion in excluding expert testimony on general causation when the expert’s opinion is based on a single study that provides no reasonable basis for the opinion offered.” Here, the studies’ authors said more study was needed to address causation.
“We do not hold that one randomized controlled trial is never sufficient to establish general causation, but on this record, the trial court did not abuse its discretion in finding that Dr. Goyal’s reliance on SAVOR alone to establish general causation was logically unsound, especially given Dr. Goyal’s own agreement that SAVOR’s finding needed to be replicated in order to determine causation.”
The trial court’s “decision was based on various methodological defects it found in Dr. Goyal’s application of six of the nine Bradford Hill factors, and that because he failed to weigh them together, it could not identify any predicate opinion on a specific factor that was not essential to his ultimate opinion. As a result, it concluded that methodological defects in any of the factors would upset the ultimate opinion on causation. This was a proper exercise of the court’s gatekeeping responsibility.”
In some instances, the court ruled that the expert was “refusing to engage with a factor of the Bradford Hill analysis on its terms” by essentially re-defining the terms to suit his opinions. Sound familiar?
For example, “consistency … is upheld when the same finding is shown in multiple studies across different populations and settings.” Yet the expert relied on only one study. He also relied on data from preclinical animal studies, though he was not qualified to interpret animal data.
Similarly, “specificity” is met “if the exposure is associated only with a single disease or type of disease.” The expert testified that specificity was nonetheless met through the single study because “the randomized controlled trial allows you to fulfill that criterion.” “[A]nother example of Dr. Goyal refusing to engage with a factor of the Bradford Hill analysis on its terms.”
“‘Biological plausibility’ refers to whether there is a plausible biological mechanism to explain a cause-and-effect relationship between exposure and disease. … The trial court noted that the strongest mechanism Dr. Goyal could identify was only ‘a proposed hypothesis.’” His opinion was therefore rejected because he did “not undertake an analysis of whether the data that exists supports or undermines his opinion that the proposed mechanisms are plausible.”
“‘Analogy’ considers whether there have been associations found between a related or similar substance to the one at issue and the disease or outcome.” The expert analogized to a different class of diabetes medication than the one at issue (DPP-4). “The trial court reasonably concluded that this opinion was not reliable because the only reason for Dr. Goyal to analogize saxagliptin to TZDs rather than to other DPP-4 inhibitors was that the former supported his ultimate conclusion on causation and the latter did not.”
Bonus for the defense: because general causation must be proven by expert evidence, and plaintiffs’ sole expert on general causation was excluded, summary judgment followed. The trial court denied plaintiffs’ request to re-open discovery and allow them to find another expert. The Court of Appeal affirmed that too.
The California law commonly referred to as “Proposition 65” prohibits businesses from knowingly and intentionally exposing any individual in the State to a listed chemical without first giving a clear and reasonable warning. Violations of Proposition 65 can lead to penalties of up to $2500 per violation per day, and can carry the possibility of paying a plaintiff attorneys’ fees. Proposition 65 provides private parties the right to enforce this law on behalf of the People of the State (if the State chooses not to), which has spawned a cottage industry of enforcement plaintiff attorneys capitalizing upon this plaintiff-friendly law.
PFAS Chemicals Added to the List
Under Proposition 65, the State maintains two lists of chemicals: one for carcinogens and another for reproductive toxicants. The List now exceeds over 900 such chemicals and the State updates the List annually with new additions.
PFAS (per- and polyfluoroalkyl substances) are a class of thousands of chemicals, and they are found in many different consumer, commercial, and industrial products. PFAS appear set to take center stage on the Proposition 65 landscape, both from a litigation and regulatory perspective. In 2017, perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) were identified by the State as reproductive toxins and added to the List. On December 31, 2021, the State added perfluorononanoic acid (PFNA) to the List. Following a one-year grace period, enforcement for PFNA can now begin on January 1, 2023. The State is also considering several other PFAS: PFHxS and PFDA. As research concerning the impacts of many PFAS is intensively proceeding, we would expect the State may identify further PFAS to add to the List in the near future.
Products of Concern
PFAS have many beneficial properties, which has led to its use in many different industries and for varied products. PFAS can impart oil, water, stain and soil repellent barriers, chemical and temperature resistance, and surfactant properties to products, some of which are considered essential to health, safety, or modern life. The following are examples of some common products:
Water resistant clothing and footwear
Upholstery and carpeting
Cosmetics and dental products
Electronics
Paints and other coatings
Firefighting foam, and equipment and protective clothing
Medical products
Paper and cardboard, including food packaging
Recent Notices
Gordon Rees Scully Mansukhani regularly monitors the Proposition 65 Notices of Violation to keep on top of any trends, so that we may promptly inform our clients who may be impacted. Significantly, we have noticed an important trend over the last 2 months: a dramatic increase in the number of Notices targeting products with PFAS. Recent Notices have targeted outerwear clothing and rain jackets, baby bibs, bath pillows, duffel bags, umbrellas, shower liners, crib mattress pads, tablecloths, paper straws, and numerous cosmetics.
Tips for Companies to Help Protect Against Proposition 65 Liability
To minimize the potential for Proposition 65 liability, companies should consider the following:
Working with Suppliers to obtain maximum protection: companies obtaining products from upstream suppliers should obtain the best information possible from those suppliers regarding the presence of PFAS in the product, and confirm Proposition 65 compliance in its contract.
Product Testing: Depending upon the circumstances, product testing can be considered. Attorney involvement should also be considered if testing, as attorney-client privileges may be important. Also, companies obtaining product from upstream suppliers should request any testing results conducted by the suppliers.
Proper Warnings: Proposition 65 provides a “safe harbor” for those products containing a compliant warning. The law allows for both long-form and short-form warnings. The long-form warnings require identification of at least one listed chemical, whereas the short-form warnings generically identify carcinogens and/or reproductive toxicants. When considering warnings, in the quest to avoid Proposition 65 liability, some companies will provide a Proposition 65 warning regardless of any specific information actually requiring the warning. We recommend extreme caution attempting to achieve Proposition 65 compliance by providing long-form warnings identifying PFAS without information confirming the presence of PFAS. The regulatory landscape for PFAS is evolving rapidly, and some states, including California, and have banned the use of PFAS in certain products; thus, a long-form Proposition 65 warning concerning PFAS (without any specific supporting data) raises the potential for triggering liability under other laws.
GRSM regularly counsels clients seeking to comply with Proposition 65 and is available to assist any company seeking advice to maximize its liability protection.
Recently, New York’s highest court and the intermediary appellate court (Appellate Division: First Department) that hears all appeals arising from New York City’s Asbestos Litigation (“NYCAL”) have ruled that it is a plaintiff’s burden to present evidence of (1) what base line exposure is necessary to cause disease; and (2) that the exposure experienced from each product reached, or exceeded, that level sufficient to cause the disease. Furthermore, common assertions by plaintiff experts like “no safe dose” and “all asbestos is dangerous” were ruled not sufficient to meet this burden.
These were set out in decision of New York’s highest court, the Court of Appeals, in Nemeth, which set aside a jury verdict (and in which our firm submitted an amicus brief).
Although we have recognized that in any given case it may be “difficult, if not impossible, to quantify a plaintiff’s past exposure” to a toxin (Sean R., 26 NY3d at 812), our standard itself is not “impossible” for plaintiffs to meet (dissenting op at 25). We must, as always, strike a balance between the need to exclude “unreliable or speculative information” as to causation with our obligation to ensure that we have not set “an insurmountable standard that would effectively deprive toxic tort plaintiffs of their day in court” (Parker, 7 NY3d at 447). The requirement that plaintiff establish, using expert testimony based on generally accepted methodologies, sufficient exposure to a toxin to cause the claimed illness strikes the appropriate balance (see Cornell, 22 NY3d at 784). The fault here is not in our standard, but in plaintiff’s proof.
Nemeth v. Brenntag N. Am., No. 24, 2022 WL 1217464, at *1 (N.Y. Apr. 26, 2022)
In Olsen, the First Department set aside one of the most massive NYCAL jury awards to date: after remittitur, $15 million in compensatory damages and $105 million in punitive damages. The First Department held that plaintiffs failed, as a matter of law, to carry their burden to establish sufficient exposure to defendant’s talc product to cause plaintiff’s mesothelioma.
Even if it is assumed that plaintiffs presented sufficient evidence to support their mineral expert’s estimate of the amount of asbestos to which plaintiff Donna Olson was exposed each time she used J & J’s talcum powder products, plaintiffs’ medical expert never set forth a scientific expression of the minimum lifetime exposure to asbestos that would have been sufficient to cause mesothelioma, the disease in question.
Matter of New York City Asbestos Litig.(Olsen), No. 14875, 2022 WL 2812015, at *1 (1st Dept. 2022).
Olsen was the first NYCAL verdict overturned on appeal following Nemeth. However, the First Department did not stop there. It issued three more decisions clarifying and extending Nemeth to motions for summary judgment—contrary to the plaintiffs’ argument throughout New York that Nemeth applied only to post-verdict rulings.
All three cases involved claimants diagnosed with lung cancer who alleged asbestos exposure from Amtico floor tiles. The court confronted the same argument and experts on causation in each case.
In reversing the lower court’s denial of defendant’s motions for summary judgment, the First Department held that defendant made out a prima facie case that plaintiffs were not exposed to sufficient quantities of respirable asbestos from defendant’s product to cause their disease, based on a 2007 simulation study showing that cutting, scoring and disruption of its floor tile did not produce sufficient airborne asbestos above ambient levels to cause the disease.
The court held that plaintiffs failed to raise an issue of fact by failing to provide any quantification and merely arguing “no safe” levels:
Dr. Ginsburg generally concludes that “[t]here is no safe minimum level of exposure to asbestos with respect to lung cancer” and that “manipulation of asbestos containing floor tiles can result in release of asbestos fibers into the workers’ environment that are exponentially greater than the ambient level of exposure.” He also states that the asbestos process releases “visible dust” and that such dust is “certainly in dangerous concentration.” However, Nemeth holds that such broad pronouncements and conclusions will not satisfy a plaintiff’s causation burden, which is to show the levels of asbestos that the plaintiff was exposed to and that the levels are known to cause lung cancer. Likewise, to the extent Dr. Ginsberg’s [sic] conclusions are based upon the presence of visible dust emanating from an asbestos-containing product, this theory fails to satisfy a plaintiff’s burden on causation in asbestos cases. Id.
Dyer v. Amchem Prod. Inc., No. 13739, 2022 WL 2811995, at *1 (1st Dept. 2022).
The court rejected plaintiffs’ argument that defense-funded experiments invalidates their conclusions, particularly given that “[p]laintiff offered no expert to counter ABI’s calculation of decedent’s cumulative lifetime exposure, and thus no question of fact was raised as to its validity.” Killian v. A.C. & S., Inc., (Grunert), No. 114345/02, 2022 WL 2812016, at *1 (1st Dept. 2022). Although Dr. Ginsberg pointed to simulation studies measuring an average level of airborne asbestos as high as 0.27 f/cc from floor tile work, the court held that he did not provide any correlation between the asbestos fiber levels to which plaintiff may have been exposed and the amount of inhaled asbestos that would have caused decedent’s lung cancer. Pomponi v. A.O. Smith Water Prod. Co., No. 14982, 2022 WL 2811997, at *1 (1st Dept. 2022).
In each of these four cases, the First Department made clear that a plaintiff cannot establish his or her burden at trial or summary judgment (after defendant meets its initial prima facie burden), by relying on the generalized expert opinions that exposure to a toxin is “excessive” or “far more” than others and, therefore, sufficient to cause a disease. The court needs to be presented with actual quantification of the level of asbestos exposure need to cause the disease at issue and that plaintiff’s inhalation of asbestos from defendant’s product met or surpassed that level.
A specter of the deceased’s pain and suffering will soon haunt California defendants.
California law has long been that damages for pain and suffering “die with the plaintiff,” on the rationale that such damages are personal to the individual. Recent legislation signed into law by Governor Newsom on October 5 and effective January 1 changes this, and places California’s treatment of pain and suffering damages more in line with a majority of the nation. This bill, originally introduced by Senator Laird in February 2021, has been amended slightly: pain and suffering damages will be granted a life beyond the deceased for those cases that were granted preference before January 1, 2022, or are filed between January 1, 2022 before January 1, 2026.
One could reasonably anticipate that before this sunset date, the plaintiffs’ bar will introduce further legislation to make the change permanent.
The new law will not only increase available damages in many cases, but will correspondingly make litigation more difficult to settle, and therefore costlier even where there are meritorious defenses.
The bill was required to go through the Assembly Appropriations Committee before making its way to the governor’s desk. This route is usually reserved for bills that will have a fiscal impact on California’s budget. An Assembly report highlighted that some State entities, such as the University of California, CalTrans and Cal Fire, have faced million dollar lawsuits for personal injury, so pain and suffering’s extended life will have a fiscal impact that needed to be considered before passing the bill out of the legislature.
Through the General Fund for tax payers, and more generally through increased defense costs, this may amount to California citizens paying more as these costs are passed on to consumers.
It just got tougher to pin a California plaintiff’s expert down at deposition.
Generally, a witness cannot give a declaration opposing summary judgment that is inconsistent with prior discovery responses (D’Amico v. Board of Medical Examiners (1974) 11 Cal.3d 1), and an expert witness cannot testify beyond the opinions offered at deposition (Jones v. Moore (2000) 80 Cal.App.4th 557, 565 [“When an expert deponent testifies as to specific opinions and affirmatively states those are the only opinions he intends to offer at trial, it would be grossly unfair and prejudicial to permit the expert to offer additional opinions at trial.”]).
A recent California decision throws both those principles into question. Harris v. Tomas Dee Engineering Co. ruled that an expert’s declaration advancing a new theory was not only admissible, but created a factual issue that required reversing summary judgment to the defendant.
The new theory was on a key issue in the case: whether the decedent was ever exposed to asbestos from the defendant’s activities. At deposition, industrial hygienist William Ewing testified, “If he wasn’t present when the work was done, then I don’t think there’d be any issue regarding any exposure.” When plaintiffs were confronted with a potentially fatal motion for summary judgment based on this testimony, however, the expert backtracked. He provided a declaration opining that Mr. Harris “did not need to be present at the exact time that the insulation block was being removed, swept up, and/or installed by Thomas [Dee] workers to be exposed.” Why? Because of the theory of re-entrainment. “This cycle of re-suspension is well-documented and is generally accepted in the industrial hygiene field.”
The trial court rejected the new opinion as contradictory, and granted summary judgment. The Court of Appeal reversed. It ruled that the Jones v. Moore bar applied to an expert’s trial testimony, but not to testimony on summary judgment. This is contrary to Perry v. Bakewell Hawthorne, LLC (2017) 2 Cal.5th 536, 541-543, where the Supreme Court held that the same evidentiary standards apply on summary judgment and trial. Harris does not mention Perry.
Harris also ruled that D’Amico was more limited than many defense counsel suppose, and did not bar the changed testimony. The Court of Appeal distinguished D’Amico as involving factual assertions by a party. “In contrast, in the present case, Mr. Ewing’s declaration relates a scientific theory that he apparently did not discuss in his deposition, and his statements in the declaration do not contradict any prior testimony regarding facts he observed.” Further, he explained the difference “by referencing the re-entrainment theory, which he stated is widely accepted in the scientific community.” The court distinguished cases where no explanation was offered.
Harris provides several important takeaways for defense counsel.
First, the case underscores the importance of asking the right questions of expert witnesses at deposition, ensuring that the opinions are clearly stated, and clearly stated to be the only opinions the expert has to offer.
Second, noticeably absent from the discussion in Harris was the adequacy of plaintiff’s expert witness declaration under California Code of Civil Procedure section 2034.210. Had the defense focused on the adequacy of the expert witness declaration – e.g., whether it actually advanced the re-entrainment opinion – instead of “contradictory testimony,” the result may have been different.
Third, rather than focus on excluding contradictory opinions at summary judgment, the prudent defense lawyer should focus examination at deposition on foundation for an expert’s opinions, and then assert evidentiary objections to those opinions at the summary judgment phase.
Fourth, Harris calls into question whether any strategy to lock down an expert witness can be 100% effective, or whether a plaintiff expert can always advance a new theory if it is “out there” in the literature. There are still concrete steps that counsel can take.
A specter of the deceased’s pain and suffering will soon haunt California defendants.
It just got tougher to pin a California plaintiff’s expert down at deposition.
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