Watt v. Johnson & Johnson, 2015 ONSC 1032

COURT FILE NO.: 08-CV-43085

DATE: February 13th, 2015

SUPERIOR COURT OF JUSTICE - ONTARIO

RE: ELTA WATT, et. al, Plaintiffs

AND:

JOHNSON & JOHNSON (a New Jersey Corporation), et. al., Defendants

BEFORE: MASTER MACLEOD

COUNSEL: Donna Crabtree, for the Plaintiffs

Robin Linley, for the corporate defendants

Karen Hamway for the defendant physician

HEARD: January 29th, 2015

ENDORSEMENT

[1] This is a motion for refusals and undertakings arising from the discovery of the corporate defendants. Prior to hearing the motion, at the request of the parties, I conducted a case conference to adjust the timetable for the proceeding. The results of the case conference are contained in a separate endorsement. Ms. Hamway represents the defendant physician. She participated in the case conference but not in the argument of the motion.

Background & Nature of the Litigation

[2] The corporate defendants are the developers, manufacturers and distributors of an artificial hip, their Canadian subsidiary and their parent company, Johnson & Johnson. For purposes of the motion I need not distinguish amongst these defendants and will collectively refer to them as “DuPuy”. As against these defendants the action is a products liability case.

[3] Briefly the facts are these. The plaintiff underwent a right hip replacement in November of 2001. The operation was performed by the defendant physician utilizing an “AML® hip stem” designed and manufactured by DuPuy. In August of 2007 it was discovered that the metal hip stem had fractured and “revision arthoplasty” – a second hip replacement – was required the following year. The plaintiff suffered considerable discomfort and has been left with significant physical limitations. She asserts that the failure of the prosthetic device was due to the negligence of one or more of the defendants. She commenced this action for damages in 2008.

[4] Fractures of metal stem implants are apparently a risk known to DuPuy and to physicians using the hip components. In this case the plaintiff asserts there was a manufacturing defect which gave rise to the failure. There is evidence of a small chip in the metal component though it is not conceded that this was a manufacturing defect nor that it was significant. Even if this was not a defect, however, the plaintiff also asserts liability for negligent design and for failure to properly identify and warn of the risk of post-operative fracture. The defendant concedes on the basis of the pleadings there is relevance to design, to manufacturing processes and to the duty to warn. Where the parties disagree is on the breadth and scope of the necessary production and discovery and in particular whether DuPuy need only produce records specific to the precise device implanted in the plaintiff.

[5] The AML hip stem was developed by DuPuy in the United States as part of a total hip system. It was submitted for pre-market approval by the FDA in the 1980s. It was approved by the FDA for use in the United States and subsequently by Health Canada for use in this country. The particular device installed in the plaintiff’s femur was an “AML 10.5 MMA 6.3 5/8 STD 12/14” cementless femoral stem with Porocoat®. Porocoat is a porous coating of sintered metal spheres which allows for bone tissue to grow into and bond with the implant. From the lot number the defendants have been able to identify the date and location of manufacture in early 2001. The manufacturing records for the hip stem in question are available and have been produced. As I will come to shortly, the most significant dispute concerns the relevance and proportionality of other records and the extent to which DuPuy can be required to mine its data to satisfy the plaintiff’s requests.

[6] DuPuy operates in many countries and as a manufacturer of medical devices is subject to rigorous approval and reporting requirements particularly in the United States. There is therefore considerable documentation available concerning the product design, product approval and the manufacturing process. To complicate matters, DuPuy has manufactured a range of products including many models and sizes of prosthetic hip joint using different designs and materials at different times.

The discovery process

[7] At the outset I would observe that there have been changes to the discovery regime since this action was launched in 2008. Firstly counsel are now expected to engage in a collaborative discovery planning exercise pursuant to Rule 29.1 and the parties and the court are to be guided by principles set out in that rule and in Rule 29.2. To do so meaningfully, each party must be prepared to disclose its information architecture. By that I mean the existence, format and location of documents and other discoverable information.[^1] If the parties encounter difficulty in their discovery planning they may seek early assistance from the court by requesting a case conference.[^2] At least in Ottawa such conferences are readily made available. Mutual agreement on the parameters of production and discovery appears to have been largely absent in this case.

[8] My second observation is that it has been necessary to make rulings that are somewhat more general and holistic than is usual with these kinds of motions. Ordinarily a discovery motion is brought after discovery has taken place and before the witness is brought back for further discovery. In this case there have actually been three rounds of discovery of these defendants. Jason Foley was examined on behalf of the defendants on July 19th, 2012, July 31, 2013 and subsequently by written question and answer in August of 2013. Despite that the plaintiff is now moving on questions from the 2012 discovery.

[9] As a consequence though it is still necessary to look at the specific question and to determine if it was a relevant and proper question at the time, it must now also be viewed in context of subsequently obtained information. The initial round of discovery was made at a time when there were no expert reports and when most of the subsequent production was unknown. Since then the parties have exchanged expert reports containing specific opinions on the cause of the fracture. Furthermore a great deal of additional information and documentation has been provided in answers to undertakings, to satisfy their production obligations and in an attempt to satisfy the plaintiff that this motion was not required.

[10] For this reason it would have served little purpose to simply decide whether the question as framed in 2012 should or should not be answered. It is apparent from the evidence that the question as asked may now be moot or was misdirected or has now been answered. It is also evident what the follow up question or request for information would be. A great deal of argument was directed to this issue and to determining whether or not the requests for more production were proportionate or disproportionate.

[11] The practice on discovery motions (as required by Rule 37.10 (10)) is for the moving party to prepare a chart with a list of all disputed questions or unanswered undertakings. The chart is to include the location of the question in the transcript and the justification for the question in relation to the pleadings. The responding party is then to prepare a responding chart showing the answer provided or the basis for the refusal or failure to satisfy the undertaking. In this way the parties are encouraged to narrow the issues. The chart also facilitates the grouping of related questions so that it is not necessary to argue each disputed question.

[12] Charts had been exchanged and the issues narrowed. Ultimately it was only necessary to argue a small group of questions but the complexity and volume of the material required some considerable time in argument.

[13] I should note that one set of discoveries was conducted in the United States and the other in Canada. In accordance with American practice the questions in the American transcript are not numbered and are identified by page and line numbers. The discovery conducted in Canada follows the Canadian practice with each question assigned a number. The numbers used in these reasons are the numbers appearing in column one on the motion charts and are not transcript pages or question numbers.

[14] As is usual on such motions, I called upon each counsel to fully argue each disputed question or group of questions before moving on to the next issue. This is preferable to hearing global submissions on all of the issues and frequently allows the court to provide immediate rulings on each issue. In this instance, though I indicated to counsel orally how I intended to rule, I also advised that I would give more precise and detailed written reasons. I do so now.

Rulings

Discovery of July 19th, 2012

Adverse event report

[15] Question 1 is illustrative of the problem discussed above. The argument metamorphosed from the question itself to an argument about the scope of DuPuy’s obligation to extract data from an electronic data base and it is the latter with which my ruling is ultimately concerned.

[16] The question itself was simply a demand to know how many claims arising from fractured femoral stems were outstanding with DuPuy in 1998. Claims against the company in 1998 (3 years prior to the manufacture of the femoral stem in question) would be relevant because claims for compensation are evidence that the matter of femoral stem fractures had previously been brought to the attention of the company. The question may have been motivated by the belief that 1998 was the year when Johnson & Johnson acquired DuPuy and hence the question of claims would have formed part of due diligence. So this was a proper and relevant question but the objective of the question was to determine what knowledge DuPuy had about the propensity of its femoral stems to fracture.

[17] Although DuPuy did not answer the question about claims as such, it has instead produced information about fracture incidents reported to DuPuy (which is a broader response than simply claims) but has limited the information to the specific size and model AML femoral stem used in the plaintiff (which is a narrower response than the question).

[18] From the subsequent answers it is now known that because it is a regulated manufacturer of medical devices DuPuy is required to keep track of all “adverse incidents.” DuPuy maintains a computerized data base of such incidents. What DuPuy has now produced is a “Worldwide Complaints (Custom Query)” print out showing records of four fractured implants including that of the plaintiff. The dates when the data was entered into the system range from 2001 to 2009.

[19] The print out was obtained by querying the data base and at least some of the filters applied to that query are apparent on the face of the document. In particular it is a query only designed to find records of “code 64 – fractured device” and “101 – other – implant fracture” in the specific product used in the plaintiff’s hip – that is the model with product code “155702000” (which is the“AML 10.5 MMA 6.3 5/8 STD 12/14” ) and no other model or size.

[20] The same model of femoral stem is produced in other sizes bearing different product codes. For example the next larger size, 12.0 is product code 155703000. In fact the AML stem is manufactured in 7 different thicknesses designed for patients with different skeletal sizes. Moreover there are “standard” products in the same size that are not produced with Porocoat. DuPuy acknowledges that one of the effects of Porocoat is that it may reduce the strength of the metal stem. Accordingly the plaintiff is seeking information not only about this specific product but similar products as well.

[21] This is quite reasonable although it is impossible to say, without knowing what the data would show, how many models and sizes would be relevant. For example if the data shows that fractures were frequently reported in the 10.5 Prorocoat model and in no other model, that would be relevant. But it would also be relevant if fractures were also reported in larger (and presumably stronger) sizes without the coating or in the same or similar models with a different kind of coating.

[22] A database or a computer storage device falls within the definition of “document” in the Rules of Civil Procedure.[^3] This means that any relevant data is discoverable. That said I agree with counsel for the defendants that Rule 29.2 and common sense requires a reasonable balance be struck. The database query that has been produced is overly precise. But it would be disproportionate to permit the plaintiff to go on what is fondly referred to as a “fishing expedition” by requiring the defendants to troll through their data just in case it might uncover some random information of assistance to the plaintiff.

[23] While the data in a database is itself captured by the definition of document, it is only the relevant data that must be produced. The anomalous point about a data base is that the only way to extract useful information from it is to run a “query” which is another way to say that the data must be filtered. This is unlike other documents because unless the resulting report is a regularly produced report or business record, it is necessary to run a custom query to produce a report displaying the filtered data.

[24] In a sense ordering a party to produce such a report is ordering it to create a document that does not yet exist. In reality however it is being ordered to extract relevant electronically stored information from its data base which is itself a “document” under the rules. I have previously held that the court has the authority to make such an order as it is the only practical way to extract the relevant information.[^4] This is clearly preferable to ordering production of the entire data base and is in principle no different from permitting a party to produce a redacted document. It has been held that while there is no obligation on a party to include reports it could theoretically run (but has not) in the affidavit of documents, a request to run a report may be a proper discovery demand.[^5]

[25] In this case DuPuy has now run and produced a filtered report. The question now is whether it should be ordered to run a broader query. Since the capacity of the defendant to run such a report is now apparent, this is a more efficient way to obtain the information the original question was intended to uncover. It is necessary to determine the appropriate scope of the query both in terms of date range and in terms of applicable data codes or key words.

[26] The objective in the context of this action is twofold. Firstly the defendant must disclose what knowledge the defendant had in 2001 and the years immediately following about the propensity of this product or class of products to fracture. As the device was implanted in 2001 and manufactured as part of lot VF5E71 between February and April of that year, DuPuy must disclose the state of its knowledge at that time. This is relevant to the duty to warn and to duty of care arising from foreseeability. A reasonable date range for that inquiry would be all adverse fracture incidents known to DuPuy by 2001 when the femoral stem was implanted or reported before 2008 when the revision was performed and the action was commenced.

[27] There is also relevance to adverse fractures reported after 2008 because while it is acknowledged that fractures occasionally occur in metal femoral stems there is the question about how significant a risk this actually is. For that purpose, the defendant must disclose evidence it has concerning the degree of risk. While the duty to warn only engages DuPuy’s knowledge at the particular point in time, evidence of the actual degree of risk would also include information learned subsequently. So there is relevance to quite a broad span of time and no difficulty in obtaining the data.

[28] Consequently DuPuy should be ordered to disclose all known instances of femoral stem fractures between 1998 (the date of the question which happens to be 3 years prior to the manufacture and sale of the device in issue) and 2008 and from 2008 to the present.

[29] In terms of scope, the printout produced by the defendants is limited to the “155702000” model but this is too narrow. The defendant must also disclose adverse fracture events in similar models. Fracture of the artificial femoral stem due to metal fatigue or other causes is a known risk and is identified as such under “adverse effects” in the DuPuy AML literature. The question of course is whether the risk is so acute that it requires a more specific warning or whether the risk attached to this particular model is higher than other similar products.

[30] It is difficult to predict how broad the production obligation will be until further searches are completed. Broadening the search parameters may uncover information that justifies additional searches. On the other hand it may be a dead end. The primary duty to identify relevant documents and data lies upon the defendants themselves so ordinarily the defendants’ obligation to search for relevant electronically stored information is far broader than their obligation to produce. A defendant cannot certify that it has produced all relevant documents if it has not actually looked to see what is available.

[31] DuPuy should be producing a list of fracture complaints reported to it from anywhere in the world between 1998 and 2015 in relation to this or similar devices. The data should disclose if such complaints were limited to the model in question or if this model was more or less prone to fractures than similar devices. On the other hand I agree with counsel for DuPuy that this does not justify an unlimited or open ended demand for information.

[32] It would be preferable for counsel to agree on the objectives of disclosure and if necessary to agree to an iterative process. In the absence of agreement as a starting point DuPuy is specifically ordered to generate and disclose a report showing whether or not there were any such reported fracture incidents from anywhere in the world for the MMA or standard model in the 10.5, 12.0 and 13.5 sizes during the period 1998 to 2015.

[33] This does not necessarily define the outer limits of DuPuy’s duty to disclose for the reasons discussed above. I do not therefore discount the possibility that there will be proper follow up questions or data requests. That is a question for another day but it would be prudent for DuPuy to determine if it has other relevant data and whether it is prepared to disclose it.

[34] Questions 4 & 5 were completely appropriate discovery questions concerning whether or not DuPuy obtained reports from anywhere in the world and whether it retained records of those complaints. It is entirely reasonable on discovery to ask questions about the scope of records and data in the possession, power and control of the other party.

[35] It appears these questions have subsequently been answered and in any event I have now ordered disclosure of reports made from anywhere in the world. It is important however to be clear about the scope of the document that has been produced. DuPuy is to clarify whether the document entitled “worldwide” is actually inclusive of all known reports originating from anywhere in the world or has been filtered. Similarly since the earliest incident in the report is 2001, DuPuy is to clarify whether or not the data base includes earlier incidents and if so whether the report was run to include or exclude earlier dates.

[36] Any time a party produces a report resulting from a query of a data base it may be called upon to disclose what filters were used. In the instant case this will include at least the date range, incident type, geographical limitations and models and types of devices.

Testing and testing procedures

[37] A series of questions was directed to testing performed by DuPuy in the context of original approvals and to ongoing quality assurance testing carried out by or on behalf of DuPuy. Some of these tests described in the pre-marketing submissions to the FDA are now more than 30 years old and were carried out by independent laboratories. Other testing was carried out by DuPuy or on behalf of DuPuy and is slightly more recent.

[38] Questions 9 – 15 are all questions directed to the testing methodologies. For example the plaintiff asks if “cantilever testing” was carried out, how many cycles were assumed in a typical year when duty testing”, what “protocol” was used for cantilever testing and other very specific questions. The defendants have produced the entire “PMA submission” to the FDA and the test results that accompanied it. They have also produced a list of all tests conducted internally by DuPuy itself.

[39] It is unreasonable and disproportionate to require the defendants to track down investigators who carried out tests many years ago and to pose questions to them about testing protocols. There are no allegations in the pleading about the conduct of the tests conducted during the approval process. All of those test reports have been or will be produced and the methodology and results will be reasonably apparent from the test reports themselves.

[40] The defendants are to produce the test reports if they have not already done so but these questions about testing methodologies need not be answered.

Internet article

[41] Question 16 arises because counsel for the plaintiff was able to locate an article on the internet written by a scientist at DuPuy. One of the paragraphs of that article suggests that the Porocoat process or the “sintering” involved in that process “reduces the fatigue strength from 65 ksi to 45 ksi which can lead to early fatigue failure (rotating fatigue tests)”, it then goes on to detail the solution to this problem by which a new process results in a fatigue strength of “60 ksi”.

[42] Google and other search engines are valuable tools for locating information on the internet but postings on the internet may or may not be authentic documents and their provenance is not always apparent. The article in question purports to be a technical presentation to the Indianapolis chapter of the American Society of Metals (ASM International) by Bernice Aboud who works or worked in DuPuy R & D. It appears to be the text of a talk given by her. It is of course neither an official Dupuy document nor by itself is it admissible evidence of the truth of its contents.

[43] It is not necessary for purposes of this decision to fully determine the use that may be made of articles posted on the internet. While the fact that an article states that something is known to DuPuy does not make it so, it may certainly be a clue to counsel to ask certain questions. It is reasonable to put questions to the defendants about what information they have concerning strength reduction in femoral stems caused by Porocoat, what they have done to combat that problem and what testing they carried out. The plaintiff can ask whether DuPuy recognizes the article and whether the contents are accurate but it will not be reasonable to cross examine a witness on a document whose authenticity, provenance and accuracy is not admitted. It is also not reasonable to ask questions that require the witness to presume the accuracy of a paper written by someone else unless a proper foundation is established for doing so.

[44] The defendant has agreed to determine if Ms. Aboud still works for DuPuy, to confirm if she wrote the article and to ask her if she believes anything in the article is inaccurate. The defendant is also to inquire whether there was the kind of testing described in the article and whether it was carried out by DuPuy or by a third party. If these tests were conducted and are not included in the tests already disclosed then the information is to be provided. Clearly there would be relevance to when a Prorocoat triggered weakness was discovered and remedial processes were introduced. If the article is accurate then the testing and timing would be relevant.

[45] In summary the defendant is to make the inquiry. That may or may not lead to follow up questions.

Defects in the plaintiff’s device

[46] The defendants have produced the records concerning the manufacturing and quality testing of the batch of femoral stems that included that used for the plaintiff. Amongst those tests were two sets of x-rays. One of these was carried out by an outside testing facility and another by DuPuy itself. There were a number of questions directed at that testing.

[47] The defendants have produced both the standard operating procedures and the description and definition of the tests that were conducted on each unit manufactured by DuPuy. They have disclosed who did the testing and they have produced the test results. I am not prepared to order them to answer questions about how they selected outside vendors and the terms of any RFP. There are no allegations for example that the x-ray testing done by Baker testing was not in accordance with DuPuy’s requirements and there are certainly no allegations that DuPuy was negligent in its selection of suppliers of testing services.

[48] Question 18 and similar questions need not be answered. I am not ordering DuPuy to locate and produce supplier audits. Questions 28 – 31 and 33 – 38 need not be answered. Question 32 has been answered by production of “SOP43003”. There appears no reason to believe that inadequate supervision of suppliers or vendors was implicated in any defect. I should note however that the defendant has undertaken to produce the x-rays conducted by Baker testing. The plaintiff and her expert have not yet had an opportunity to examine those x-rays. It is not impossible they will have further questions once they have done so.

[49] There were questions directed to a defect that was actually found in the plaintiff’s device during the manufacturing process. There was a “dark ring” or discoloration in the coating and as a result it was sent for recoating. Q. 19 – 21 are relevant but appear to have been answered.

Cycles & normal wear and tear

[50] The plaintiff has attempted to ask questions about the assumptions DuPuy makes about normal wear and tear and normal life span of its artificial hips. For obvious reasons the defendants cannot provide definitive iron clad estimates of how long a medical device will last before it is expected to wear out. Amongst other things variables such as the weight of the patient, the activity level, accidents and no doubt a host of other factors may impact on this question. The question of assumed life of a medical device may not be one that admits of a simplistic answer. On the other hand the defendant should not be allowed to avoid answering a pertinent question by reason of complexity.

[51] The plaintiff has been having great difficulty in having the defendant acknowledge or admit that there is any specific expectation of durability. This is unreasonable. Presumably the defendant will agree that the devices it manufactures are reasonably fit for their intended purpose. Given the reduced success rates of successive revisions, there must be some expectation of durability.

[52] It appears one measure used by the defendants is the concept of “cycle” which appears to be used in the sense of movement or use of the joint. At question 27 the defendant suggested that more than one million cycles was considered “high use” but in another answer the figure of 10 million is used. These questions of “cycle” also relate to testing because the plaintiff wants to know what testing is done and how many cycles the test devices are subject to.

[53] Question 27 is the question to which the answer was one million cycles. Obviously the plaintiff has follow up questions on this point and one of those is to reconcile this answer with the 10 million cycles described elsewhere. The defendant is to answer appropriate follow up questions concerned with durability of the femoral stems it manufactures and distributes.

Training

[54] Questions 39 – 42 relate to training. I agree with counsel for the defendant that it is inappropriate to ask generally and broadly about any and all training received by DuPuy employees involved in manufacturing the AML femoral stems. The defendant agrees that if expert reports or other evidence suggest that a defect in the device may have resulted from human error at a specific point in the manufacturing or inspection process, failure to train or supervise the responsible employees may be relevant.

[55] Currently, other than the question relating to the discoloration of the coating – which of course was caught by the quality assurance checks – the only other evidence suggestive of a possible manufacturing defect (as opposed to a design defect) is a chip or scratch that is found to be present on the post.

[56] The defendant is prepared to answer more specific questions relating to training or supervision if they can be related to specific evidence of lack of care. I agree with this. I decline to order wholesale production of DuPuy training protocols or manuals.

Undertaking

[57] There was an undertaking regarding x-rays. Two sets of x-rays were conducted during the manufacturing process. DuPuy has identified x-rays completed by Baker testing and has produced the test results. The defendants have also agreed to produce the original x-rays as those are available.

[58] A second set of x-rays were completed by DuPuy after the Porocoating and records have been located showing that the device passed inspection. Those x-rays have not been preserved and the x-rays themselves have not been produced.

[59] The plaintiff asks if x-rays go through the Porocoat and whether it is possible to see defects in the metal stem by way of x-ray after the Porocoat is applied? I am not persuaded this was an undertaking but the question is a reasonable question and is to be answered. This is relevant because the x-rays themselves are no longer available and cannot speak for themselves.

Discovery and written interrogatories of 2013

[60] Almost all of the outstanding issues relating to the 2013 discoveries have been resolved.

[61] Question 9 inquired if DuPuy had knowledge of unpublished studies by outside labs into the cause of fractures. In Q. 19, the defendants were asked to comment on a study attached to the original submission to the FDA. There was a study by a Dr. Engh commenting on x-rays and sclerotic lines. This question asked about a relationship between radiopaque lines and percentage of stem filling.

[62] These questions have been answered although they may give rise to follow up questions for clarification. I encourage the parties to deal with this in writing and I encourage the defendants to provide clarification in that manner if they understand what the plaintiff is seeking.

[63] Question 10 was an undertaking. An answer has now been provided but once again the plaintiff is seeking clarification. As in the previous paragraph this should be the subject of discussion and if it cannot be resolved it may attract follow up questions.

Next steps

[64] Discovery is now subject to a presumptive cap of 7 hours per party subject to agreement or court order. The parties have already exceeded this amount and so I am reluctant to simply order another round of discovery without a demonstrated need and in the absence of an agreed upon discovery plan.

[65] There are a number of questions to be answered as a result of this motion and the agreements or orders flowing from it. There may well be follow up questions.

[66] I encourage the parties to agree on a time period to provide all of the required information and on the form and need for additional follow up. In the absence of agreement the parties are to schedule a case conference. In any event Rule 77 will continue to apply to this proceeding and a timetable is to be established for the remaining steps in the proceeding.

[67] I believe certain of the documents provided to me for review are subject to a confidentiality agreement. Mr. Linley may arrange to retrieve those documents from my office.

Costs

[68] I have the costs outlines which reveal a considerable disparity in the amounts sought by each of the parties. It is evident that there will have to be submissions on costs unless counsel can resolve that issue between them.

[69] The parties may arrange to speak to costs within the next 30 days or if they prefer to make submissions in writing they are to exchange written submissions and then file them with my office in the same time period.

[70] If I do not hear from counsel within the 30 day period, there will be no order as to costs.

Master MacLeod

[^1]: See for example Sedona Canada Principle no. 4 & commentary

[^2]: Pursuant to Rule 77 or as of January 1, 2015 under Rule 50.13.

[^3]: See Rule 1.03 “document” includes “data and information in electronic form” and Rule 30.01 (1) “document” includes a “sound recording, videotape, film, …. and data and information in electronic form.”

[^4]: See for example Sourian v. Sporting Exchange Ltd. [2005] O.J. No. 753 (Master)

[^5]: LaCalamita v. McCarthy Tetrault LLP 2010 ONSC 3724 (Master)