JURGEN VOLLRATH v. DePUY SYNTHES BUSINESS ENTITIES, JOHNSON & JOHNSON, DOES I through X, and ROE Business Entities I through X
Case No. 3:19-cv-1577-SI
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF OREGON
February 03, 2022
Michael H. Simon, District Judge
Jurgen Vollrath, Plaintiff, pro se.
Anne M. Talcott, SCHWABE, WILLIAMSON & WYATT PC, 1211 SW Fifth Avenue, Suite 1900, Portland, OR 97204; David L. Ferrera, NUTTER MCCLENNEN & FISH LLP, 155 Seaport Boulevard, Boston, MA 02210; David R. Schmahmann, LAW OFFICE OF DAVID SCHMAHMANN, 1577 Beacon Street, Brookline, MA 02446. Of Attorneys for Defendants DePuy Synthes Business Entities and Johnson & Johnson.
Michael H. Simon, District Judge.
Plaintiff Jurgen Vollrath (Vollrath), pro se, brings this lawsuit against Defendants DePuy Synthes Business Entities (DePuy) (whom Defendants explain is properly known as “Medical Device Business Services, Inc.“) and Johnson & Johnson (collectively, Defendants). In his Complaint, Vollrath alleges that DePuy, a wholly owned subsidiary of Johnson & Johnson, manufactured and sold S-ROM modular hip implants with a separate titanium stem, sleeve, and
STANDARDS
A. Daubert Motion to Strike Expert Reports
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:
(a) 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;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
(d) the expert has reliably applied the principles and methods to the facts of the case.
Further, the court must assess an expert‘s reasoning or methodology, using, when appropriate, criteria such as testability, publication in peer-reviewed literature, known or potential error rate, and general acceptance. See Estate of Barabin v. AstenJohnson, Inc., 740 F.3d 457, 463-64 (9th Cir. 2014) (en banc). But these factors are “meant to be helpful, not
The test “is not the correctness of the expert‘s conclusions but the soundness of his methodology.” Primiano, 598 F.3d at 564 (quotation marks omitted). “The objective of [Daubert‘s gatekeeping requirement] is to ensure the reliability and relevancy of expert testimony. It is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” Kumho Tire, 526 U.S. at 149. When an expert meets the threshold established by
B. Motion for Summary Judgment
A party is entitled to summary judgment if the “movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.”
BACKGROUND
Vollrath was born in 1962. ECF 46-5, at 53:16-22. He had his first hip replacement in 2003. Id. at 138:5-10. In 2010, Vollrath presented to Dr. William Griffin at OrthoCarolina Hip and Knee in Charlotte, North Carolina, complaining of pain in both hips that severely limited his physical activity. Id. at 155:19-156:17. After some discussions regarding the risks of the surgery, Vollrath elected to move forward with left total hip replacement surgery with Dr. Griffin. Id. at 156:18-161:21. On December 2, 2010, Vollrath underwent the surgery, during which Dr. Griffith implanted the S-ROM modular hip system. Id. at 161:12-21; id. at 169:19-24.
Following the surgery, Vollrath remained physically active, engaging in interval training as well as using an elliptical machine and, on one occasion, cycling from Seattle to Portland over a five-day period. Id. at 27:21-30:14. He exercised, on average, five days a week. Id. at 29:13-14. Vollrath no longer ran as a form of exercise following his surgery. Id. at 30:1-5.
In September 2017, Vollrath experienced a stab of pain and the inability to put weight on his left leg. Id. at 175:7-23. He presented to the Emergency Room at Legacy Meridian Park, where X-rays revealed a fracture of his S-ROM femoral stem. Id. at 177:9-14. Dr. Jacob Adams attended to Vollrath, and, following a “long, lengthy discussion” regarding Vollrath‘s condition and revision surgery, Dr. Adams conducted the revision surgery. Id. at 179:13-182:9. Vollrath now brings suit against Defendants, the manufacturer and seller of the S-ROM modular hip, asserting claims of negligence, failure to warn, breach of warranty, willful concealment and fraud, and intentional infliction of emotional distress, stemming from the failure of the S-ROM
DISCUSSION
In their motion for summary judgment, Defendants first argue that Vollrath‘s only two expert witnesses do not meet the admissibility requirements of
A. Expert Testimony Admissibility
Defendants purport to challenge the admissibility of Vollrath‘s proposed experts’ testimony based on each of the four requirements of
Dr. Danks is a metallurgist and tribologist,3 with expertise in, among other things, casting foundations, railroads, and oil and gas. ECF 48-14, at 58:23-59:14. Dr. Danks testified that he examined the implant in question to determine the nature of the fracture. Id. at 37:22-38:2. Specifically, Dr. Danks testified that there are two major categories of fractures: a sudden fracture as a result of a single event, and a fatigue failure that occurs over a longer period of time, and that the failure in this case was a fatigue failure. Id. at 38:8-39:9. Dr. Danks’ testimony was cabined similarly to that of Professor Higgins:
Q. I guess, Dr. Danks, in fairness to you and to your long history in metallurgy, I just want to make sure that you‘re not painting outside the lines, to be blunt. I want to make sure that your opinion is confined to your expertise here.
Your expertise basically is, I examined the surface. I said this was a fatigue failure. I gave some other details about the nature of the fatigue failure.
And that is the sum and substance of your opinions in this case; am I right?
A. Yes, I think that is a fair characterization.
Q. So you can‘t give any information as to whether or not this is an excellent device in terms of its performance, an average device, or a below-average device?
A. That is correct. I cannot.
Q. And you‘re not offering any opinions in this case about this device and its design and material at all; correct?
A. Just on the failure analysis of the -- of the part itself.
Id. at 57:12-21. Neither Professor Higgins nor Dr. Danks have a medical background, and neither have education, training, or experience in orthopedics, biomaterials, anatomy, or physiology.
Defendants, however, advance no argument that these two experts are unqualified in their respective fields, that their reports lack the rigor or methodology that those fields require, or that their proposed testimony is irrelevant or unhelpful. In fact, Defendants clarified at oral argument that they do not disagree that the two experts are qualified to give expert testimony in their respective areas of expertise and do not challenge their conclusions regarding the impact of larger offsets on fatigue and that the failure here was the result of fatigue. ECF 45, at 14; id. at 16. Defendants’ sole argument in support of excluding this proposed testimony is that because the experts are not medical experts—or medical device experts—that their testimony does not present a genuine issue of material fact.
The Court finds the Ninth Circuit‘s analysis in Stilwell v. Smith & Nephew, Inc. instructive. 482 F.3d 1187 (9th Cir. 2007). In Stilwell, the plaintiff had two metal reconstruction nails implanted to stabilize a fracture of her right femur. Id. at 1188. The two nails failed, causing the plaintiff pain, suffering, and disability. The plaintiff sued the manufacturer of the devices, asserting claims based strict liability, negligence, and breach of warranty. Id. The
The Ninth Circuit on review held that the trial court wrongly excluded the testimony but, upon reviewing the record, affirmed the grant of summary judgment for defendant because the record did not demonstrate that any alleged defects were the cause of the plaintiff‘s injuries. Id. at 1189. The Ninth Circuit described the “twin concerns” of reliability and helpfulness embodied by
B. Summary Judgment
Having concluded that Vollrath‘s proposed expert testimony is admissible, the Court considers whether there is a genuine issue of material fact sufficient to survive summary judgment. Following the voluntary dismissal of two of his claims at oral argument, Vollrath‘s remaining claims—negligence, failure to warn, and breach of warranty—sound in products liability.4 At oral argument, Vollrath clarified that, in addition to negligence, he alleges strict products liability and, further, that with respect to his strict liability claims, he alleges design defect, manufacturing defect, and failure to warn. The Court first considers Vollrath‘s negligence claim, then his three theories of strict products liability, and finally his breach of warranty claim.
In his response to a prior motion, Vollrath raised a variety of factual assertions suggesting that the regulatory submission of the S-ROM to the FDA was insufficient, that Defendants’ design and manufacturing records are insufficient by FDA standards, and that Defendants’ reporting to the FDA was insufficient. ECF 41 (Vollrath‘s Response to Defendants’ Motion to Stay Expert Discovery). Defendants respond to these arguments in their Motion for Summary Judgment, anticipating that Vollrath would again raise them in his response to that motion. ECF 45, at 25. Defendants were correct, as Vollrath‘s response outlines DePuy‘s alleged failure to comply with applicable FDA regulations. ECF 47, at 10-11. Vollrath clarified at oral argument that his theory of negligence is that Defendants acted negligently insofar as they did not seek FDA approval when they made certain modifications to the S-ROM.
Defendants argue this claim must fail because there is no private right of action for noncompliance with the FDA regulations. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001) (noting that the Food, Drug, and Cosmetic Act (FDCA) “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions“). Vollrath, however, does not bring a “fraud-on-the-FDA” claim, like the one at issue in Buckman. Rather, he argues that Defendants’ failure to secure FDA approval for certain modifications to the S-ROM gives rise to a state law negligence claim, showing that Defendants breached the standard of care.
Under Oregon law, negligence per se,
is a shorthand descriptor for a negligence claim in which the standard of care is expressed by a statute or rule. When a negligence claim otherwise exists, and a statute or rule defines the standard of care expected of a reasonably prudent person under the circumstances, a violation of that statute or rule establishes a presumption of negligence. Once a violation is proven, the burden shifts to the violator to prove that he or she acted reasonably under
the circumstances. A statute that sets a standard of care addresses only one element of a negligence claim; other elements remain unaffected and must be established.
Deckard v. Bunch, 358 Or. 754, 761 n.6, 370 P.3d 478, 483 (2016) (simplified).
The Oregon Court of Appeals has held that a plaintiff may allege a negligence claim based on failure to comply with FDA regulations. Axen v. Am. Home Prod. Corp. ex rel. Wyeth-Ayerst Labs., 158 Or. App. 292, 307, opinion adhered to as modified on reconsideration sub nom. Axen v. Am. Home Prod. Corp., 160 Or. App. 19 (1999). The court in Axen explained
“When a plaintiff (or a defendant seeking to prove negligence on plaintiff‘s part) invokes a governmental rule in support of that theory, the question is whether the rule, though it was not itself meant to create a civil claim, nevertheless so fixes the legal standard of conduct that there is no question of due care left for a factfinder to determine; in other words, that noncompliance with the rule is negligence as a matter of law. This court long has held that violations of statutory safety rules by themselves provide the element of negligence with respect to those risks that the rules are meant to prevent, at least unless the violator shows that his conduct in fact did not violate the rule under the circumstances.” In other words, evidence that AHP had violated the regulations would be evidence that AHP had breached a standard of care established by those regulations. If that breach could be shown to have caused Douglas Axen‘s injuries, then AHP could be liable under a common-law theory of negligence. Thus, AHP‘s arguments that the regulations do not provide a cause of action are irrelevant, as are its arguments that plaintiffs did not preserve a statutory negligence claim.
Id. (emphasis added in Axen) (quoting Shahtout v. Emco Garbage Co., 298 Or. 598, 601, 695 P.2d 897 (1985)) (citations omitted).
Although the Oregon courts have yet to opine on the effect of Buckman on the reasoning in Axen, federal courts applying Oregon law have found that Buckman does not necessarily foreclose a state law negligence claim. See Santoro v. Endologix, Inc., 2020 WL 6295077, *13 (D. Or. Oct. 6, 2020) (citing Axen for the proposition that “Oregon law recognizes a negligence claim for breach of a standard of care based on a violation of federal regulations,” and noting that
Here, the Court need not address whether Vollrath‘s claims are the type that the Supreme Court considered to be preempted in Buckman or could support a negligence per se claim under Oregon law. Even if Oregon law permits such a claim, Vollrath has not produced any evidence with respect to Defendants’ alleged failure to comply with FDA regulations. Both of Vollrath‘s expert witnesses stated specifically in their depositions that they reviewed no regulatory material and would offer no opinion on whether the S-ROM implanted in Vollrath had been approved by the FDA. The following exchange occurred during Professor Higgins’ deposition:
Q. Did you review any regulatory materials in connection with the fabrication and testing of this device?
A. I did not.
Q. So as you sit here today you have no opinions with respect to whether or not the device did or did not comply with any of the FDA standards and rules that apply to this device?
A. That is correct.
ECF 48-13, at 17:9-17. A similar exchange took place during Dr. Danks’ deposition:
Q. All right. Did you review any regulatory materials, that is, any of the information that exists that describes what is required of hip stems in terms of performance and fatigue life?
A. I did not.
Q. So you have no opinion as to whether this device did or didn‘t perform consistent with its regulatory standards as set out by the FDA?
A. That‘s correct.
2. Strict Products Liability
The Oregon legislature codified portions of
a civil action brought against a manufacturer, distributor, seller or lessor of a product for damages for personal injury . . . arising out of:
(1) Any design, inspection, testing, manufacturing or other defect in a product;
(2) Any failure to warn regarding a product; or
(3) Any failure to properly instruct in the use of a product.
At oral argument, Vollrath asserted that he intended to rely on three theories of strict products liability—design defect, manufacturing defect, and failure to warn. The Court considers each of those three theories in turn. Defendants argue that none of Vollrath‘s products liability claims can survive summary judgment because, even viewing the evidence in a light most favorable to Vollrath, the evidence does not create a genuine issue of material fact. For the reasons explained below, the Court agrees with Defendants.
a. Design Defect
The required elements of a design defect case under Oregon law are as follows:
(1) the sale or leasing of a product by one engaged in the business of selling or leasing such products; (2) a product that was expected to, and did, reach the user or consumer without substantial change in condition; (3) a product that, when sold, was in a defective condition unreasonably dangerous to the user or consumer; (4) injury to the user or consumer, or damage to his or her property; (5) that was caused by the product‘s defective condition.
McCathern v. Toyota Motor Corp., 332 Or. 59, 77 n.15 (2001). In this case, it appears that only the third and firth elements are in dispute—whether the S-ROM‘s allegedly defective condition caused Vollrath‘s injuries.5
Oregon has codified the “consumer expectations” test for determining when a product is defective. Id. at 75. This test requires that a plaintiff “prove that, when the product left the defendant‘s hands, the product was defective and dangerous to an extent beyond that which the ordinary consumer would have expected.” Id. at 79. “Whether a product is dangerous to an extent beyond that which would be contemplated by the ordinary consumer is a factual question to be determined by the jury.” Id. at 77. A trial court must, however, “ensure that the evidence is sufficient for the jury to make an informed decision about what ordinary consumers expect.” Id. Because
Consumer expectations about how a product should perform under a particular set of circumstances may, in certain cases, be within the realm of jurors’ common experience. McCathern, 332 Or. at 78. In other cases, however, the products or circumstances involved may be such that the average person would not know what to expect. Id. “When a jury is unequipped, either by general background or by facts supplied in the record, to decide whether [a product] failed to perform as safely as an ordinary consumer would have expected . . . additional evidence about the ordinary consumer‘s expectation is necessary.” Id. (quotation marks omitted) (first alteration in original). This additional evidence may include advertising or other representations
Vollrath bears the burden of demonstrating that the S-ROM modular hip as designed was unreasonably dangerous, based on the consumer expectations test. Id. 332 Or. at 75. At oral argument, Vollrath conceded that neither of his experts were able to testify that the S-ROM was defectively designed. Vollrath instead reiterated that Professor Higgins testified that larger offsets can lead to larger stresses that have a detrimental impact on fatigue life, ECF 48-13, at 120:25-121:2, and Dr. Danks testified that the failure in question here was a fatigue failure that occurred over a relatively long period of time, ECF 48-14, at 38:8-39:9. Vollrath contended at oral argument that putting this testimony together paints a picture of why the S-ROM failed in this instance and could lead a trier of fact to the conclusion that it was defectively designed.
Even construing this evidence in the light most favorable to Vollrath, that evidence is not sufficient to meet the requirements of the consumer expectations test under Oregon law. Although the testimony of Dr. Danks and Professor Higgins is admissible and helpful for a trier of fact in considering a design defect claim, Vollrath‘s claims cannot stand on their limited testimony alone. Not only has Vollrath provided no evidence regarding consumer expectations other than his own subjective expectations about the longevity of the S-ROM, but evidence in the record suggests that, in physically active patients such as Vollrath, the device might fail prematurely. Vollrath has provided the Court only with general scientific information regarding the structure of the device and the nature of this device‘s failure. ECF 48-13, at 120:25-121:2
b. Manufacturing Defect
At oral argument, Vollrath stated that he alleged that the particular S-ROM implanted in him was defectively manufactured. When asked to explain his theory of manufacturing defect, Vollrath explained that the fact that the device failed after less than seven years, rather than the 20-plus years it was expected to last, is evidence that the particular device was defective. Vollrath conceded that he did not offer any additional evidence of a manufacturing defect, beyond the fact of the device‘s failure.
Under Oregon law, a plaintiff can demonstrate that a product was “mismanufactured“—or, in other words, was defectively manufactured—“relatively simpl[y],” by comparing the product in question “with similar articles made by the same manufacturer.” Phillips v. Kimwood Mach. Co., 269 Or. 485, 491 (1974). In some cases, however, in which no direct or circumstantial evidence of a manufacturing defect is available, a plaintiff “may nonetheless be able to establish his right to recover, by proving that the product did not perform in keeping with the reasonable expectations of the user.” Heaton v. Ford Motor Co., 248 Or. 467, 472 (1967) (“When it is shown that a product failed to meet the reasonable expectations of the user the inference is that there was some sort of defect, a precise definition of which is unnecessary. If the product failed under conditions concerning which an average consumer of that product could have fairly definite expectations, then the jury would have a basis for making an informed judgment upon the existence of a defect.“).
c. Failure to Warn
Oregon law considers a warning adequate when it is “in such a form that it could reasonably be expected to catch the attention of the reasonably prudent [person] in the circumstances of its use” and its content is “of such a nature as to be comprehensible to the average user and to convey a fair indication of the nature and extent of the danger to the mind of a reasonably prudent person.” Anderson v. Klix Chem. Co., 256 Or. 199, 207 (1970), rev‘d on other grounds, Phillips v. Kimwood Mach. Co., 269 Or. 485 (1974). More specifically,
[A user] shall have a fair and adequate notice of the possible consequences of use or even misuse. * * * The rule is that when a manufacturer undertakes by printed instructions to advise of the proper method of using [the] chattel, [the manufacturer] assumes the responsibility of giving accurate and adequate information with respect thereto, including instructions as to the dangers involved in improper use . . . .
Schmeiser v. Trus Joist Corp., 273 Or. 120, 132 (1975) (simplified).
When a warning is given, “the seller may reasonably assume that it will be read and heeded; and a product bearing such a warning, which is safe for use if [the warning] is followed, is not in defective condition, nor is it unreasonably dangerous.” Benjamin v. Wal-Mart Stores, Inc., 185 Or. App. 444, 454 (2002) (quoting
At oral argument, Vollrath argued that Defendants failed, in all of their literature on the S-ROM, to warn either patients or physicians of the proneness of the device to fail due to fretting and corrosion and the lack of FDA approval for the extended neck. Based on the above findings that Vollrath has not presented sufficient evidence to create a genuine issue of material fact as to whether the S-ROM was defective and whether Defendants obtained the necessary FDA approval, he likewise cannot meet the additional bar of demonstrating a genuine question of material fact as to whether additional warnings would have rendered the product “safe.” Absent particularized evidence that the S-ROM was defective without additional warnings, and that those additional warnings would have cured that defect, Vollrath‘s failure to warn claim cannot survive summary judgment.
3. Breach of Warranty
Although the Complaint raises a claim for breach of warranty, neither party addressed this claim in their briefing on the Motion for Summary Judgment, and that claim was not discussed at oral argument. Vollrath alleges that “[t]here is an implied warranty that the S-ROM devices designed, manufactured and sold by Defendants are suitable for the purposes for which they are intended,” and that Vollrath “used the Modular Hip as intended after it was implanted.” Compl. ¶¶ 46-47. Although Vollrath did not cite to a particular statute for this claim, the Court
Where the seller at the time of contracting has reason to know any particular purpose for which the goods are required and that the buyer is relying on the seller‘s skill or judgment to select or furnish suitable goods, there is unless excluded or modified under
ORS 72.3160 an implied warranty that the goods shall be fit for such purpose.
CONCLUSION
The Court DENIES Defendants’ request to exclude the testimony of Plaintiff‘s two expert witnesses but GRANTS Defendants’ Motion for Summary Judgment (ECF 45).
IT IS SO ORDERED.
DATED this 3rd day of February, 2022.
/s/ Michael H. Simon
Michael H. Simon
United States District Judge