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Jonathan Tabasky represents architects, attorneys, engineers, real estate brokers and appraisers, and independent insurance adjusters, among others, in negligence/professional malpractice cases. He also represents a broad range of companies in product liability and toxic tort cases including manufacturers of prescription drugs, protective clothing, fittings, heating devices, wire and cable, trucks, aircraft and turbines.

The overwhelming majority of courts (including all seven federal circuits that considered the issue) have rejected the so-called “innovator liability” doctrine.[1]  In 2017, however, the California Supreme Court in T.H. v. Novartis Pharm. Corp.[2] unanimously recognized the doctrine holding that brand-name prescription drug manufacturers owe a duty to warn to consumers who use generic drugs.[3]  In March of 2018, the Massachusetts Supreme Judicial Court (SJC) considered the issue, and took a middle ground.  Specifically, in Rafferty v. Merck & Co., Inc.,[4] the SJC held that plaintiffs who ingest the generic form of a drug may bring failure to warn claims against the brand-name manufacturer of the drug if the brand-name defendant acted recklessly by “intentionally fail[ing] to update the label on its drug while knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use.”[5]  In so doing, the SJC reasoned that a plaintiff is, in fact, injured by a brand-name product’s label despite never having used said product because statutes require identical labeling of the generically manufactured version.[6]

 

The Facts

 

In 2010, a physician prescribed Finasteride, the generic version of the brand name drug Proscar, to treat Rafferty’s enlarged prostate.[7]  Rafferty experienced anticipated temporary side effects from the drug, causing him to stop taking the medication.[8]  Rafferty, however, continued to experience these side effects and his physician informed him that they could actually continue “indefinitely.”[9]  The potential lifelong side effects of this drug were not disclosed within the brand-name manufacturer’s nor the mirrored generic manufacturer’s warning label.[10]  Rafferty presented evidence that the brand-name manufacturer became aware of these potential long-term side effects by 2008, when it updated Proscar’s warning label in select European markets to include this risk.[11]

 

Rafferty filed suit against the brand-name manufacturer in 2013, asserting a claim of negligence for, inter alia, failure to warn and for violation of the Commonwealth’s Consumer Protection Statute, G.L. c. 93A.[12]  The Superior Court dismissed Rafferty’s claims, “ruling that [the brand-name defendant] owed no duty of care to [him].”[13]  The SJC took over the case by its own motion from the Appeals Court.[14]

 

The SJC Weighs In

 

Traditionally, Massachusetts has not recognized liability for products manufactured by others.[15]  However, the SJC noted that The Restatement (Third) of Torts allows a modification to this general rule in exceptional cases.[16] The SJC considered innovator liability to require such a modification given the certainty that a user of a generic drug will rely on the label fashioned by the brand-name manufacturer and as state law shields failure to warn claims from generic manufacturers, leaving plaintiffs without recourse for their injuries.[17] However, the SJC also recognized that imposing innovator liability could impact the public policy of encouraging innovation in the drug market and a potential increase in drug pricing.[18]

 

Balancing these competing interests, the court held that, “a brand-name manufacturer that controls the contents of the label on a generic drug owes a duty to consumers of that generic drug not to act in reckless disregard of an unreasonable risk of death or grave bodily injury.”[19]  As an added protection to the manufacturers, it will be the trial judge’s responsibility to determine whether an injury constitutes an “unreasonable risk of death or grave bodily injuries.”[20]  The court went on to define recklessness as an act performed while knowing or having reason to know of facts which would lead a reasonable person to realize that his or her conduct creates an unreasonable risk of physical harm to another and that such risk is substantially greater than that which is necessary to make his conduct negligent.[21] In order to meet this threshold with regard to failure to act, there must be “an intentional or unreasonable disregard of a risk that presents a high degree of probability that substantial harm will result.”[22]

 

The court then vacated the dismissals and remanded the case to Superior Court where the plaintiff would be granted leave to amend his complaint should he believe his claims meet the newfound threshold.[23]

 

National Scope

 

In August of 2017, the United States District Court – District of Massachusetts held in In re Zofran[24] that a brand-name manufacturer is not liable for a generic version’s failure to warn claim spawning from an injury caused by the use of the generic.[25]  Judge Dennis F. Saylor IV articulated this point by emphasizing the consistency of the Circuit Courts’ decisions and citing to a Sixth Circuit multi-district litigation holding “affirming the dismissal of claims against brand-name manufacturers under the laws of 22 states.”[26]  Notwithstanding this majority view, in December of 2017, the Supreme Court of California held that a brand-manufacturer is liable for a failure to warn claim arising from “risks about which it knew of reasonably should have known, regardless of whether the consumer is prescribed the brand-name drug or its generic ‘bioequivalent.’”[27]  Here, the SJC has offered a compromise to the majority and minority viewpoints by adopting a recklessness standard, which is a higher threshold than the minority view, while still maintaining failure to warn liability against the brand-name manufacturer, in contrast with the majority.

 

The court’s concern that redress be available to those who ingest generic drugs by establishing liability to the controlling brand-name manufacturer carried the day.  Our hope is that innovators will continue to advance modern pharmaceutical products despite their increased potential for liability. We will be watching this space for further developments.

 

 

[1] In re Zofran (Ondansetron) Products Liability Litigation, 261 F.Supp.3d 62 (D. Mass. 2017) (citing In re Darvocet, Darvon, and Propoxyphene Products Liability Litigation, 756 F.3d 917, 938-939 (6th Cir. 2014)).

[2] 407 P.3d 18, 29 (Cal. 2017).

[3] Id. at 47.

[4] Rafferty v. Merck & Co., Inc. & Sidney Rubenstein, No. SJC–12347 (Mass. Mar. 16, 2018).

[5] Id. at 2-3.

[6]Rafferty v. Merck & Co., Inc., No. SJC–12347 at 3-4. The statutory and regulatory constructs pertaining to drug labeling are quite complicated.  Relevant to the matter considered by the SJC, the Drug Price Competition and Patent Term Restoration Act, informally known as the “Hatch-Waxman Act” requires the “manufacturer of a generic drug [to] provide its users with a warning label that is identical to the label of the brand-name counterpart.”  Id. at 4.  In accordance with the “federal duty of ‘sameness’” the two opportunities to alter a generic manufacturers preexisting warning are to: (1) update their label in response to their brand-name counterpart’s update; and (2) per specific FDA instruction. Id. at 6-7 (citing PLIVA, Inc. v. Mensing, 564 U.S. 604, 613-616 (2011)).  These federal laws makes it almost impossible for generic manufacturers to follow Massachusetts labeling laws because they do not have the unilateral power to act. See id.

[7] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 8.

[8] Id.

[9] Id.

[10] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 8-9.

[11] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 9.

[12] Id. Plaintiff also asserted a G.L. c.93A § 9 Consumer Protection Act claim and a negligent failure to obtain informed consent action against his physician.

[13] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 10; Rafferty v. Merck & Co., Inc. & Sidney Rubenstein, No. 2013–04459, 4 (Mass. Super. May 23, 2013) (emphasizing that because “Rafferty did not ingest the drug that Merck manufactured, Merck owes Rafferty no duty of care”).

[14] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 11.

[15] See e.g. Mathers v. Midland-Ross Corp., 403 Mass. 688, 691 (Mass. 1989); Mitchell v. Sky Climber, Inc., 396 Mass. 629, 631 (Mass. 1986).

[16] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 16.

[17] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 17. This was especially so given generic products command approximately ninety percent of the market. Id.

[18] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 20-22.

[19] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 29.

[20] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 30.

[21] See Rafferty v. Merck & Co., Inc., No. SJC–12347 at 29 (citing Boyd v. National R.R. Passenger Corp, 446 Mass. 540, 546 (Mass. 2006); Restatement (Second) of Torts, § 500, 587 (1965)).

[22] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 30.

[23] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 36. Additionally, Rafferty’s G.L. c. 93A § 9 claim was vacated because it did not satisfy the “any trade or commerce” provision, which requires that the unfair or deceptive practice is directly related to the advertising, selling, or trade of a Merck product.  Id. at 38.  Thus, because Rafferty used Finasteride, as opposed to Proscar, the claim is beyond the scope of G.L. c. 93A § 9.  Id. at 38-39

[24] 261 F.Supp.3d 62 (D. Mass. 2017). A multi-district litigation matter regarding side effects not purported within the label of Zofran and in-turn not purported on the label of the generic version, Ondansetron.

[25] In re Zofran, 261 F.Supp.3d at 64-65.

[26] In re Zofran, 261 F.Supp.3d at 71-72 (citing In re Darvocet, Darvon, and Propoxyphene Products Liability Litigation, 756 F.3d at 938-939.

[27] T.H. Novartis Pharm. Corp., 407 P.3d at 29 (citing Dolin v. SmithKline Beecham Corp., 62 F.Supp.3d 705 (N.D. Ill. 2014); Chatman v. Pfizer, Inc., 960 F.Supp.2d 641, 654 (S.D. Miss. 2013); Kellogg v. Wyeth, Inc., 762 F.Supp.2d 694, 704 (D. Vt. 2010); Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014)). See also Conte v. Wyeth, Inc., 168 Cal.App.4th 89 (Cal. Ct. App. 2008).

For the first time since 1989[1], Connecticut’s Supreme Court addressed the plaintiff’s burden of proof in the asbestos context, in Wayne Bagley v. Adel Wiggins Group et al, SC 19835 (11/7/17).  In a win for defendants facing such claims, the court found that plaintiffs bringing claims pursuant to the Connecticut Product Liability Act (under both strict liability and negligence theories) require expert testimony to prove exposure at levels sufficient to cause their asbestos-related disease, and not merely general testimony that an asbestos-containing product generated an indefinite amount of dust in the plaintiff’s vicinity.

 

The decedent, Wayne Bagley (“Bagley”) worked at Sikorsky Aircraft Corporation (“Sikorsky”), and alleged exposure to an adhesive product used to bind interior components of helicopter blades. The material, an epoxy, came in the form of a sheet with strippable release paper, it contained 8.6 percent asbestos, and was manufactured by Wyeth Holdings’ predecessor. Employees removed any excess epoxy with chisels or by sanding. The Bagley estate called a former co-worker to testify that Bagley’s work area overlooked the blade shop, that Bagley’s daily responsibilities required him to enter the sanding room frequently, and that the sanding process created visible dust to which Bagley and he would have been exposed to.

 

At trial, the plaintiff presented causation expert testimony from Dr. Arnold Brody and Dr. Jerrold Abraham. Dr. Brody testified in detail regarding the process by which asbestos causes mesothelioma. However, he acknowledged on cross-examination that his testimony was based upon the assumption that a person has already been exposed to respirable asbestos fibers.

 

Dr. Abraham, a pulmonary pathologist testified that a proximate cause of the decedent’s mesothelioma was the exposure to asbestos fibers from the epoxy while the decedent passed through the sanding room of the blade shop. While discussing causation, Abraham was given a hypothetical scenario that reflected Bagley’s alleged exposure during his ten-month tenure as the manufacturing engineer. In response, Abraham testified that the scenario was a clear description of an exposure to asbestos fibers emitted from working with epoxy, and that the mere presence of dust indicated inadequate control of the product. On cross-examination, Abraham acknowledged that he never inspected the epoxy, that he did not speak with anyone at Sikorsky about the ventilation in the sanding room, and that he did not know of any studies concerning fiber release of the product when manipulated.

 

Once the plaintiff rested, Wyeth moved for a directed verdict, arguing that the estate failed to present any evidence of either a design defect or that asbestos dust from the epoxy caused the decedent’s death. Moreover, the defendant argued that expert testimony is required to prove the dangerousness of the epoxy, as it was a complex product for which an ordinary consumer could not form a safety expectation. The trial court denied the motion for directed verdict reasoning that the plaintiff presented sufficient evidence from which the jury could conclude that the epoxy was unreasonably dangerous and that the defendants were negligent in failing to test the fiber release from the epoxy. The jury returned a verdict for the plaintiff in the amount of $804,777. Wyeth Holdings then filed a motion to set aside the verdict and for judgment notwithstanding the verdict, both of which were denied at trial.

 

On appeal, Wyeth Holdings argued that the trial court improperly denied its motion to set aside the verdict and judgement notwithstanding the verdict given the lack of expert testimony on actual fiber release and exposure levels experienced by the decedent.  The plaintiff responded that the epoxy was not a complex product because ordinary jurors can understand that sanding a product creates dust and that inhaling asbestos fibers is in fact inherently dangerous. Thus, the plaintiff contended, the ordinary consumer expectation test, which does not require expert testimony, applies. The plaintiff further contended that the evidence showed there is no safe level of exposure to asbestos, and that there was ample circumstantial evidence to show that Bagley was exposed to dust from the sanding of the epoxy.

 

The Connecticut Supreme Court, however, found that the plaintiff failed to prove that respirable asbestos fibers were emitted from the epoxy during the sanding, and without such proof, there was insufficient evidence to show that the epoxy was either dangerous or the legal cause of the decedent’s mesothelioma. Specifically, the court stated:

 

“… we conclude that the plaintiff’s case lacked essential expert testi­mony to prove a vital fact in support of her negligence and strict liability claims, namely, that respirable asbes­tos fibers in a quantity sufficient to cause mesothelioma were released from {the epoxy} when it was used in the manner that it was in the Sikorsky blade shop during the decedent’s tenure there. Proof of this fact was nec­essary to prove both that (1) {the epoxy} was dangerous, and (2) the epoxy’s dangerous condition caused the decedent to develop mesothelioma.”

 

The court also rejected the estate’s argument that in the event the court were to reverse based upon the recent decisions in the Bifolck[2] and Izzarelli[3]cases, she is entitled to a new trial under any newly articulated standards from those cases. The court rejected this argument, stating that the reversal was a result of plaintiff’s failure to present evidence sufficient to prove that respirable asbestos caused injury, rather than a result of newly developed case law. Further, the court stated that because Bagley filed suit before the plaintiffs in the Bifolck and Izzarelli cases, the decisions in those cases will not retroactively have an impact on Bagley’s case.

 

In sum, Connecticut plaintiffs bringing asbestos claims under the Connecticut Product Liability Act must now prove that the products at issue emitted respirable asbestos fibers in an amount sufficient to cause disease. Moreover, this evidence must come from expert testimony, as fiber release and the causation of asbestos-related disease are matters beyond the ordinary knowledge of lay jurors.

 

[1] See Champagne v. Raybestos-Manhattan, Inc., 212 Conn. 509 (1989).

[2] In Bifolck, the Connecticut Supreme Court held that consumer expectations, as set forth in comment (i) to section of Restatement (Second) of Torts, do not apply to a product liability claim premised on negligence when determining whether a product is unreasonably dangerous. Bifolck v. Philip Morris, Inc., 324 Conn. 402, 152 A.3d 1183 (2016).

[3] In Izzarelli, the Connecticut Supreme Court held that the “modified consumer expectation test” is the primary standard with regard to the “good tobacco” exception to strict liability claims in Connecticut, and that the ordinary test applies only where a product “failed to meet the consumer’s minimum safety expectations, such as res ipsa cases” saying that a jury “could not reasonably conclude that cigarettes that cause cancer fail to meet the consumer’s minimum safety expectations.” Izzarelli v. R.J. Reynolds Tobacco Co., 321 Conn. 172, 136 A.3d 1232 (2016).

On January 31, 2017, President Trump nominated Judge Neil Gorsuch to the U.S. Supreme Court. Although time will tell, this post assumes he will make it through the Senate confirmation process, and take his place at 1 First Street, Northeast. Currently, Judge Gorsuch sits on the United States Court of Appeals for the Tenth Circuit, having been appointed to same by President George W. Bush on July 20, 2006.  While at the Tenth, Judge Gorsuch issued two interesting decisions which may prove instructive as to how he views the Court’s role as the evidentiary gatekeeper[1] of expert testimony. A discussion of those two cases, and what they foretell with regard to “all exposures contribute” testimony follows.

Graves v. Mazda Motor Corp., 2010 WL 5094286.

This case arises out of Mrs. Graves’ trip to Hattiesburg, Mississippi. Upon arriving at the Hattiesburg airport, she picked up her rental car—a Mazda 6 with an automatic transmission. At the end of her stay and while en route to the airport to depart for home, Mrs. Graves got lost and pulled over to ask for directions. When exiting the car, Mrs. Graves left the engine running but thought she had placed the car’s shifter in “park.” As it turns out, the gear shifter was in “reverse” and, when she stepped out, the car rolled backwards, knocked her to the ground, and ran her over. Mrs. Graves sought damages from Mazda for the injuries she suffered, alleging that the company’s gear shifter was defectively designed. In support of her claim, she offered expert testimony from an expert human factors engineer. The district court, however, excluded the expert’s testimony as unreliable and then, given the absence of any other probative evidence of liability, granted Mazda’s summary judgment motion. On appeal, the plaintiff sought to undo the district court’s decision.

The district court noted that the expert failed to provide any data or industry standard, or to conduct any testing to confirm his view that Mazda’s gear shift design was defective. Instead, the expert’s proffered testimony that merely described how the Mazda shifter works, and from this, his leap to the conclusion that Mazda’s design fails to allow for “smooth” shifting and so is defective and unreasonably dangerous.

Judge Gorsuch, writing for the three judge panel (Kelly, J., Ebel, J.) noted that without any reference to data suggesting how “smoothly” an ordinary consumer would expect a gear shift to move, without any confirming evidence indicating how Mazda’s design might cause shifting troubles for ordinary drivers, without any reference to how engineering standards might have counseled against Mazda’s gear shift design, and without any other evidence suggesting its reliability, the district court was right to exclude the expert’s testimony. Judge Gorsuch noted that the expert did provide a list of “safety systems analysis” techniques that, he contended, Mazda should have used in assessing its design, but even here, the expert failed to offer any evidence suggesting that Mazda actually failed to use these techniques, or if it did, that these techniques would have led Mazda to conclude that it needed to pursue a different gear shift design.

BancFirst v. Ford Motor Co., 489 Fed.Appx. 264 (2012); 2012 WL 2899053.

This case arose out of a tragic accident, in which a child darted out of an intersection and was struck by a truck. The young victim’s guardian sought to establish that the driver counter-steered (something the driver denied) in order to place responsibility for the accident with Ford and their allegedly defective brakes. The district court, however, concluded that the expert did not meet the standards for admissible expert testimony set forth in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993), and because the guardian lacked any other evidence suggesting Ford’s braking system was the cause of the accident, granted summary judgment.  The guardian appealed.

Judge Gorsuch, again writing on behalf of a unanimous three judge panel (Tymkovich, J., and Baldock, J.), agreed with the district court judge who found “simply too great an analytical gap between the data and the opinion proffered.” This was especially so given the driver’s concession that when he saw the victim dart into the intersection he didn’t counter-steer to the right but instead hit the brakes and turned hard to the left, only to have the truck spin counterclockwise and causing its right rear corner to hit the child. As Judge Gorsuch noted, this was easily understandable as steering right into the skid would have required the driver to turn the wheel toward the child, making an already counter-intuitive maneuver all the more so given his desperate wish to avoid hitting her.

Attempting to bridge the gap between his opinion and the driver’s unhelpful admission, the expert pointed to police photographs showing that the wheels of the truck were turned to the right after the accident. But, as the district court noted, there was no indication when the wheels were turned to the right, before or after the accident. Moreover, the expert’s testimony that driver education courses usually teach new drivers to counter-steer out of a slide, fails to include evidence that the driver was so taught, or that drivers tend to follow this training in the heat of the moment when doing so requires them to turn, seemingly paradoxically, toward a person they are seeking to avoid. A similar problem recurs with the expert’s reference to a study which shows the driver theoretically had enough time to make the counter-steer. Judge Gorsuch found even if the study stood for such a proposition, there was still no evidence that the driver did counter-steer, or that drivers tend to do so even when it requires them to turn back in the direction of a person with whom they are about to collide. In so doing, the Court excluded the expert testimony and granted Ford’s Motion for Summary Judgment.

All Exposures Contribute Testimony

Occupational diseases such as Acute Myeloid Leukemia, Mesothelioma, Byssinosis, Silicosis and Black Lung Disease have long latency periods, and often times follow multiple sources of exposure. Typically, the only viable defendants remaining at trial are those whose products are encapsulated in materials or used in a manner unlikely to cause a sufficient dose to lead to disease. To get around this evidence, plaintiffs’ experts often opine that “every exposure,” “every exposure above background,” or “total and cumulative exposure” substantially contributes to the development of the plaintiff’s disease. Often times experts also opine that “there is no known safe level of exposure and as such all exposures must be included in attributing causation.”  How courts handle such testimony has been discussed at length in this Blog, so will not be discussed here.  See e.g., Senter, Meghan, Another Blow to “Every Exposure” in Asbestos Litigation, January 5, 2017;  Cree, Jennifer, Causation Standard at Center of PA Supreme Court Asbestos Ruling, December 6, 2016; Moore, Elizabeth, Plaintiff’s Experts Barred from Offering “Any Exposure” Theory in Asbestos Lung Cancer Case, March 10, 2015.

The Graves and BancFirst decisions authored by Judge Gorsuch, may however, give us some insight as to how a Supreme Court Justice Gorsuch would handle the issue.  For example, Judge Gorsuch will not be swayed by the exceptional credentials held by many experts espousing such testimony. As he noted in Graves, … while … we appreciate and recognize the expert’s credentials and don’t doubt the value someone in his field can bring to defective design cases, the evidence he proffered in this case rests on no more than his say so—and that isn’t good enough to require its admission. “Nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence” based on only “the ipse dixit of the expert[,]” however well qualified he may be. ..” (citation omitted).  Similarly, as he noted in BancFirst, gaps between opinion and data, will inevitably result in the court’s exclusion of the testimony, … “an expert’s scientific testimony must be based on scientific knowledge, which ‘implies a grounding in the methods and procedures of science’ based on actual knowledge, not ‘subjective belief or unsupported speculation.’ (citations omitted).

Based upon the above a Supreme Court Justice Gorsuch will likely see the flawed methodology behind opinions that any exposure, no matter how slight, remote, or insignificant was a cause or substantial contributing factor to the development of disease. It appears he will be open to defendants’ arguments that such testimony is purely speculative, rests upon flawed methodology, and ultimately, cannot be said to be helpful to the trier of fact.  This will be especially so when presented with epidemiology discounting the no safe level standard, industrial hygiene evidence regarding specific products’ abilities to create exposures and the like.  If the Graves and BancFirst decisions are any indication, Justice Gorsuch takes his gatekeeper role very seriously, and will not be afraid to exclude junk science such as that referenced above.

[1] For a discussion of the court’s gatekeeper role, see Fed. R. Evid. 702; Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993); Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999).

 

district court
Washington, D.C. District Court of Appeals

The District of Columbia Court of Appeals recently adopted the standards found in Federal Rule of Evidence 702 (“Rule 702”), regarding the admissibility of testimony by expert witnesses, thereby replacing the Frye (“Frye”) test.  See Motorola Inc., et al. v. Michael Patrick Murray, et al., 2016 WL 6134870 (October 20, 2016)(“Motorola”). Washington D.C. is now the most recent jurisdiction to adopt Rule 702, a trend that has continued since Rule 702 was amended in 2000 to reflect United States Supreme Court decisions pertaining to expert witness testimony, such as Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993); Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999); and General Electric v. Joiner, 522 U.S. 136 (1997).

Rule 702 provides:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:

  1. the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;
  2. the testimony is based on sufficient facts or data;
  3. the testimony is the product of reliable principles and methods; and
  4. the expert has reliably applied the principles and methods to the facts of the case.

In Motorola Plaintiffs in thirteen cases sued numerous cell phone manufacturers, service providers, and trade associations, alleging that long-term exposure to cell-phone radiation caused their brain tumors. The trial Judge Frederick H. Weisberg, held four weeks of evidentiary hearings on the admissibility of the expert testimony offered by the plaintiffs. He concluded that, based on the record before him, some, but not all, of Plaintiffs’ proffered expert testimony on general causation was admissible under the Frye evidentiary standard, but “most, if not all, of Plaintiffs’ experts would probably be excluded under the Rule 702/Daubert standard.” Judge Weisberg then certified the following question of law to the Circuit Court: “whether the District of Columbia should adopt Federal Rule of Evidence 702 (or a revised Frye standard) for the admissibility of expert evidence.”

In certifying the question, Judge Weisberg noted,

[A]t the risk of over-simplification[,] if a reliable, but not yet generally accepted, methodology produces ‘good science,’ Daubert will let it in, and if an accepted methodology produces ‘bad science,’ Daubert will keep it out; conversely, under Frye, as applied in this jurisdiction, even if a new methodology produces ‘good science,’ it will usually be excluded, but if an accepted methodology produces ‘bad science,’ it is likely to be admitted.

The District of Columbia Court of Appeals, en banc., heard the question, Plaintiffs’ appeal, and adopted the Rule 702 standards unanimously, with Judge Easterly providing a concurring opinion.

Associate Judge Fisher, writing for the Court, stated, “the ability to focus on the reliability of principles and methods, and their application, is a decided advantage that will lead to better decision-making by juries and trial judges alike.” Associate Judge Fisher highlighted the language in State v. Coon, deeming the Frye test, “as both unduly restrictive and unduly permissive” because the crux of the test is general acceptance as opposed to reliability. 974 2d. 386, 394 (Alaska 1999). The standards deriving from Rule 702, however, require trial court judges to act as “gatekeepers” in the determination of whether or not expert testimony is relevant and reliable. Associate Judge Fisher cited to the Daubert decision to emphasize, “the objective of the gatekeeping requirement is to make certain that an expert…employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.”  Despite this, the Court explicitly stated that differing scientific opinions can be equally reliable. In so doing, the Court established that minority opinions within expert communities will not be per se unreliable.

The Court considered revising the Frye test, as some jurisdictions have done. It rejected doing so given their belief that Rule 702/Daubert analysis better ensures evidentiary reliability based upon scientific validity. It also found substantial benefits to be gained from adopting a test that is widely used.

The Court directed future litigants and judges to review closely the Advisory Committee Notes to Rule 702, and the cases cited therein when making Rule 702/Daubert challenges. See Fed. R. Evid. 702 advisory committee’s note (2000 Amendment); Kannankeril v. Terminix Int’l, Inc., 128 F.3d 802 (3d Cir. 1997)(regarding newly founded expert theorems); Sheehan v. Daily Racing Form, Inc., 104 F.3d 940 (7th Cir. 1997)(demanding consistency between the expert’s professional and testimonial opinion); Claar v. Burlington N.R.R., 29 F.3d 499 (9th Cir. 1994)(regarding expert’s consideration of “obvious alternative explanations”). It will apply Rule 702 to all civil and criminal cases in which the trial begins after the date of this opinion. The Court also indicated that it will consider at a later time whether the standard applies to cases that have already been tried but are not yet final on direct appeal.

The District of Columbia now joins twenty-seven states in adopting the factors of the Daubert standard and rejecting the Frye test. See Andrew Flake, Eric Harlan & James King, 50 State Survey of Applicability of Daubert, available here (last visited Oct. 28, 2016).

The full decision can be read here.

About the Author

Jonathan F. Tabasky is a partner with the firm. He has primary responsibility for the management, handling and defense of litigation brought against many different types of professionals. His clients include architects, attorneys, engineers, real estate brokers, real estate appraisers and independent insurance adjusters, among others. Since joining the firm, Jon has also been extensively involved in the defense of product liability and toxic tort claims. In this capacity, Jon represents a broad range of companies, including those that manufacture prescription drugs, protective clothing, fittings, heating devices, wire and cable, trucks, aircraft and turbines. As a result, Jon regularly works with renowned epidemiologists, pathologists, industrial hygienists, pulmonologists, radiologists, economists and others. Jon also defends product and premises liability cases brought against major retailers.

Alexander Zodikoff is a law clerk with Manion Gaynor & Manning LLP, and in his final year of law school at Suffolk University. Alexander received his B.A. from Virginia Tech.

File Cabinet_iStock_000022952167Small(Purchased 8-4-14)Last summer the Massachusetts Supreme Judicial Court (SJC) made several significant changes to the Massachusetts Rules of Professional Conduct (Mass. R. Prof. C.). Previous posts highlighted some of these changes, including to the Rules pertaining to jury contact following trial and the duty to remain current on technologies which impact the practice of law. The Rule discussed herein relates to a trend often seen in the service sector, and which has over the past years become more prevalent in the legal sector – outsourcing.

 

According to the American Bar Association, “globalization, technology-driven efficiencies developed and utilized by many providers of outsourced services, and the demand by clients for cost-effective services” are some of the factors that have contributed to the significant growth of outsourcing. Many firms have taken advantage of (or been directed by their clients to take advantage of) lower rates charged by companies which conduct document reviews, provide legal transcriptions, conduct research and process patents. These companies are often located outside of the United States in countries such as India and Malaysia. Several authors have noted that these efficiencies can be attractive to firms by enabling them to better compete for large matters without fear that they lack adequate resources to perform legal work and to clients by bolstering the affordability of legal services.

When lawyers outsource activities traditionally performed by them or their staff, several ethical considerations are implicated, including the protection of privileged and otherwise confidential information, and of course, quality control. See e.g., Mass. R. Prof. C. Rules 1.1 (competence); 1.2 (allocation of authority); 1.4 (communication with client); 1.6 (confidentiality); 5.4(a) (professional independence of the lawyer), and 5.5(a)(unauthorized practice of law).

To protect clients from inadequate representation the American Bar Association provides detailed guidance on the retention of lawyers and non-lawyers from outside the firm setting. See Model Comments 6 and 7 to ABA Model Rule 1.1 and Model Comments 1-4 to Model Rule 5.3. The SJC, clearly concerned about the evolution of lawyering and the growing practice of outsourcing client work followed suit, and adopted the following comments to Mass. R. Prof. C. 5.3:

3. A lawyer may use nonlawyers outside the firm to assist the lawyer in rendering legal services to the client. Examples include retaining an investigative or paraprofessional service, hiring a document management company to create and maintain a database for complex litigation, sending client documents to a third party for printing or scanning, and using an Internet-based service to store client information. When using such services outside the firm, a lawyer must make reasonable efforts to ensure that the services are provided in a manner that is compatible with the lawyer’s professional obligations. The extent of this obligation will depend upon the circumstances, including the education, experience and reputation of the nonlawyer; the nature of the services involved; the terms of any arrangements concerning the protection of client information; and the legal and ethical environments of the jurisdictions in which the services will be performed, particularly with regard to confidentiality. . . .; and

4. Where the client directs the selection of a particular nonlawyer service provider outside the firm, the lawyer ordinarily should agree with the client concerning the allocation of responsibility for monitoring as between the client and the lawyer. See Rule 1.2. When making such an allocation in a matter pending before a tribunal, lawyers and parties may have additional obligations that are a matter of law beyond the scope of these Rules.

To satisfy the Rules of Professional Conduct, Massachusetts attorneys must properly vet the recipients of outsourced work to ensure they have adequate security measures in place to guard against the release of confidential information. They must also maintain close oversight of the work being performed to ensure that it is carried out in a manner consistent with the high standards set out by the Rules.

For more information, please contact us. To read the revised rules visit:

http://www.mass.gov/courts/docs/sjc/docs/rules/a-sjc-order-rules-of-professional-conduct-adopted-march-2015.pdf