Top Five Drug and Device Developments of 2018

by Faegre Baker Daniels

Faegre Baker Daniels

It’s that time of year again—the end of one and beginning of another—when we pause, reflect and look forward to the year ahead. In this retrospective, we consider the past year’s legal developments in the drug and medical device sphere, with brief summaries of those we believe to have significant implications for our clients and colleagues. Here are our top five picks for 2018.

1. FDA’s Proposed 510(k) Overhaul

This past year saw a dramatic increase in mainstream media focus on the medical device industry and the U.S. Food and Drug Administration (FDA). This was exemplified in the release of The Bleeding Edge documentary on Netflix at the end of July, a self-dubbed “searing exposé of the medical device industry,” and the November publication by the International Consortium of Investigative Journalists entitled “Medical Devices Harm Patients Worldwide as Governments Fail on Safety.” Industry responded to the documentary in particular, decrying it as sensationalized fearmongering. The Advanced Medical Technology Association (AdvaMed), the industry’s lobbying group, stated: “[The] film does a disservice to the hundreds of millions of patients worldwide who have benefited from medical technology. The filmmakers could have crafted a thoughtful and balanced piece that explores the latest in medical innovation, including the risks and benefits of any medical technology and how to help patients make informed choices. Instead, they chose the easy route with an irresponsible film that might cause patients to forgo what could be life-saving procedures. Where are the voices of the millions of patients who can see, hear, walk and live normal, healthy everyday lives thanks to medical technology?”

This sharpened media focus comes seven years after the Institute of Medicine released its controversial report in July 2011, originally commissioned by FDA. The report criticized the 510(k) regulatory pathway, which is the process through which the majority of medical devices reach the U.S. market. The pathway allows certain devices that fit within a risk classification profile to seek clearance from FDA if they are deemed to be substantially equivalent to a predicate device already on the market.

On November 26, with less drama and fanfare than the journalism reports but potentially more actual impact, the FDA announced a proposal to overhaul the 510(k) pathway. The proposal engendered immediate reaction from commenters on all sides of the issue. There are questions aplenty about how the proposals will be implemented, the one-size-doesn’t-fit-all plan, and what input the industry can suggest for the new framework.

The FDA was quick to point out that the use of older predicates “doesn’t mean the products are unsafe.” Rather, FDA reiterated that it “believe[s] firmly in the merits of the 510(k) process,” noting that the proposal is “aimed at continuing to ensure that new and existing devices meet our gold standard for safety and effectiveness.” With the overhaul, the FDA’s goal is to modernize the framework that has been in place for 42 years, with advances in technology creating devices that may not fit within the regulations first implemented in 1976. The proposal aims to promote the use of more recent predicates by emphasizing a 10-year cut off period with potential public disclosure of current devices that are based on predicates that are more than 10 years old, to update the De Novo pathway for low-to-moderate risk novel devices, and to create an alternative pathway called the “Safety and Performance Based Pathway” for manufacturers of certain well-understood devices to rely on objective safety and performance criteria instead of predicate devices.

Look for public feedback on certain aspects of this proposal and finalized guidance in early 2019.

2. Differing Results as to the Admissibility of 510(k) Evidence

In the past few years, several courts have held that evidence of FDA’s 510(k) clearance of devices was inadmissible at trial under Federal Rules of Evidence 402 and 403. The general rationale was that, unlike the more stringent Premarket Approval process, the 510(k) process is not relevant to a product’s “safety and effectiveness.”1

The District of Arizona broke from this recent history, with its conclusion that the 510(k) evidence was both relevant and highly probative in Bard’s inferior vena cava litigation.2 The inferior vena cava filter at issue, designed to catch blood clots before they reach the heart or lungs, received FDA clearance through the 510(k) process.3 The plaintiff had asserted design defect, failure to warn and punitive damages claims under Georgia law.4

The court found the 510(k) evidence to be relevant for two reasons.5 First, whether a manufacturer acted reasonably affects the risk-utility analysis that is crucial to design defect claims in Georgia.6 That Bard did comply with federal regulations is one factor the jury might consider in its reasonableness assessment.7 While “[c]ompliance with the regulations may not render a manufacturer’s design choice immune from liability, []it can be a ‘piece of the evidentiary puzzle.’”8 Second, whether a manufacturer acted with conscious indifference to the dangers posed by its device can impact a claim for punitive damages in Georgia.9 Again, the court found that a jury could consider Bard’s compliance with federal regulations as one factor in its assessment of whether Bard’s actions showed the requisite willful and wanton misconduct to justify punitive damages.10 According to the court, the evidence’s probative value outweighed any risk of confusion, and exclusion of this evidence would only add to the jury’s confusion.11 “[I]f the evidence was half-baked, containing some references to the FDA but not explaining what role the FDA played with respect to the Bard filters, the jury would be left to speculate about the FDA’s involvement and conclusions.”12

However, not all courts have shifted their view. For example, a district court in Indiana did not find this rationale applicable, where the key issue was the product’s safety and the reasonableness of the manufacturer’s conduct played no part.13 More starkly, in Campbell v. Boston Scientific Corp., the Fourth Circuit reaffirmed its conclusion that 510(k) evidence was inadmissible under Rule 403 to show that the product was safe, even where reasonableness of the manufacturer’s conduct was an issue.14 Although Boston Scientific attempted to distinguish precedent by outlining how some products with 510(k) clearances are based on “a predicate device that was grandfathered in when the process was created” while others are based on “a predicate device that itself received a thorough safety evaluation,” the court was not persuaded, concluding the evidence would “invite a battle of the experts regarding the exact meaning of 510(k) approval,” which would only add to the confusion and waste time for the jury.15

Stay tuned to see how other Circuits decide this issue in the months and years to come.

3. A Few More States Take Positions on Tort Remedies for Generic Consumers Against Brand Manufacturers

Back in early 2015, we reported on the 2014 Alabama Supreme Court decision that made it possible for generic-drug consumer plaintiffs in the state to recover against brand manufacturers based on theories of fraud or misrepresentation, known as “innovator liability.” While Alabama has since done away with innovator liability through state legislation, we can now add Massachusetts to the short list of states (California and Vermont) that recognize the minority view that there are certain tort remedies available for generic consumers against brand manufacturers.

In Rafferty v. Merck & Co., the plaintiff, suffering from an enlarged prostate, was prescribed the drug finasteride to treat his benign prostatic hyperplasia in August 2010.16 The brand version of finasteride, Proscar, was manufactured by Merck & Co. Id. However, the plaintiff only ever ingested the generic version of the drug.17 Shortly after he started taking the drug, the plaintiff began to experience side effects including erectile dysfunction and a decrease in libido.18 The product label for the generic drug, which was identical to Proscar’s label as required by federal law, did warn of these potential side effects but represented that they would dissipate after discontinued use.19 When the plaintiff reduced and eventually discontinued use of the drug, his side effects not only did not dissipate but continued to worsen.20 The plaintiff presented evidence that Merck knew of this possibility and even changed their label to reflect this in certain European countries as early as 2008.21 In filing suit against Merck, the plaintiff asserted claims based on negligent failure to warn and for a violation of the consumer protection statute22 In holding that a brand manufacturer can be held liable to a generic drug consumer plaintiff, the Massachusetts Supreme Court took a more nuanced approach than Alabama and California by making a distinction between claims based on ordinary negligence and those that rise to the level of recklessness.

[W]e conclude as a matter of public policy that allowing a generic drug consumer to bring a general negligence claim for failure to warn against a brand-name manufacturer poses too great a risk of chilling drug innovation, contrary to the public policy goals embodied in the Hatch-Waxman amendments. But we also conclude that public policy is not served if generic drug consumers have no remedy for the failure of a brand-name manufacturer to warn in cases where such failure exceeds ordinary negligence, and rises to the level of recklessness. In cases where, for instance, a brand-name manufacturer learns that its drug is repeatedly causing death or serious injury, or causes birth defects when used by pregnant mothers, and still fails to warn consumers of this danger, public policy does not dictate that these consumers be left with no remedy when those risks are realized, or that the manufacturer have little financial incentive to reveal these risks. We therefore hold 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. This recklessness standard strikes the most appropriate balance between competing public policy interests, limiting liability for brand-name manufacturers while also providing remedies for the most serious injuries and deterring the most dangerous forms of conduct.23

The Massachusetts Supreme Court vacated an order dismissing the plaintiff’s common-law claim and remanded to the trial court.24 The parties subsequently reached settlement, and the case was dismissed at the end of November, with no tidy resolution of the legal import of the Supreme Court’s analysis for those of us keeping the innovator liability scorecard.

The Rafferty decision is in stark contrast to two other jurisdictions that addressed the issue this year, either rejecting or declining to consider the novel theory of innovator liability. First, West Virginia considered but ultimately rejected the theory, cementing its place in the majority.25 And then the Seventh Circuit, in Dolin v. GlaxoSmithKline LLC, reversed a $3 million plaintiff verdict for the wrongful death of the plaintiff’s husband who only consumed a generic version of GSK’s anti-depressant Paxil.26 It is important to note that the reversal was based exclusively on federal preemption. Regarding innovator liability, the court commented: “The parties and amici have briefed extensively whether Illinois law would impose a duty on a brand-name drug manufacturer toward a patient like Stewart Dolin, who took a generic form of the drug manufactured by a different company. The Illinois courts have not yet considered the new theory of liability that plaintiff advances. Because the evidence of federal preemption is decisive, we do not offer for that question of duty a prediction of state law . . . .”27

The Rafferty decision continues a slow press on brand manufacturers – who hold only 10 percent of the drug market in the United States – into essentially insuring the generic products comprising a large part of the rest of the market. Hopefully the Illinois courts will answer the question the Dolin court left unanswered and put another tally in the majority in 2019.

4. Third-Party Financers and Plaintiffs’ Lawyers Pressuring Plaintiffs to File Lawsuits and Undergo Unnecessary Explant Surgeries

For some, the purpose behind certain mass tort litigation has moved from a means of obtaining a private civil remedy for loss or harm to a lucrative vehicle for investment. Third-party litigation financers have poured money into claims against drug and device manufacturers—to the point that financers are even willing to train lawyers to litigate in the mass tort space, having already exhausted the available interested plaintiffs and plaintiffs’ attorneys. Financers are now seeking to do two things: (1) recruit new plaintiffs and (2) drive up the “value” of existing plaintiffs’ damages claims.

This year, the New York Times reported on the growing phenomenon, examining “a network of doctors, lawyers, financiers and consultants lur[ing] women” into unnecessary surgeries in an effort to “improve their odds of winning large cash settlements in lawsuits against the manufacturers.”28 Much about how this network operates remains a mystery. Especially concerning is how third-party financers are identifying these women in the first instance and getting a hold of their private, medical histories, potentially in violation of the Health Insurance Portability and Accountability Act. Meanwhile, third-party litigation funders are fighting hard to keep their operations in the shadows.

Several investigations are underway that may soon uncover more about how this network, and others like it, operates—including investigations by the United States Attorney’s Office for the Eastern District of New York and the Florida Attorney General’s Office.

And some device manufacturers involved in litigation over allegedly defective devices have been assertive in pursuing discovery into how some plaintiffs were led to file lawsuits or inflate their damages claims.29 In its briefing, AMS summarized the issue as:

an illicit enterprise that targets and cold calls women who have received vaginal mesh implants, solicits those women (many of whom have limited education or health care options) to sue manufacturers regardless of whether the women have issues with their implants, pressures those women to obtain explant surgeries from out-of-state doctors at exorbitant prices regardless of medical necessity, creates high-interest loans secured by the women’s lawsuits to pay for the unnecessary procedures and associated expenses, and then waits for the cases to be settled to achieve a payoff.

Some courts are taking note of the implications of third-party funding and have permitted discovery into the arrangements. For example, in the opioid MDL, the judge ordered the attorneys to disclose to the court “any agreement under which any person, other than an attorney permitted to charge a contingent fee representing a party, has a right to receive compensation that is contingent on and sourced from any proceeds of an MDL Case, by settlement, judgment, or otherwise.”30

This phenomenon of financed lawsuits or surgeries has serious implications for medical device manufacturers in general, potentially swelling the number of lawsuits filed and the damages claimed. In fact, “surgical funding,” where the litigation funders take it one step further than financing the litigation and actually “invest” in the plaintiffs’ operations (sometimes including “VIP” travel arrangements for plaintiffs to have the surgery) is specifically recognized as a breed of third-party litigation funding, so prevalent it has a term. If these government investigations and discovery through the court system uncover unethical efforts to convince patients to sue, the previously hidden efforts may help demonstrate the bias of any explanter’s testimony who removed a device that was either working properly or did not need to be removed and may significantly drive down the “value” of plaintiffs’ claims. It may also stem the tide of such activity in the next mass tort. There is too much to review in this year-end summary, but we have covered it more in depth and will be watching closely as it continues to unfold.

5. MDL Claim Separation Can Lead to Case Fragmentation

A decision by the Judicial Panel on Multidistrict Litigation this year reminds us that while the panel’s main goal is to centralize, it can do so by fragmenting cases—separating out claims that it deems do not belong in an MDL.31 Breaking up claims can streamline the issues for MDL consideration—but also may force some parties to litigate their claims in more than one forum simultaneously.

The decision arose in the Equifax data breach litigation, where one pro se plaintiff sought to vacate the Panel’s order conditionally transferring his gross negligence claim to the MDL in Georgia while at the same time separating out and remanding to the transferor court in Louisiana several of his other claims (violation of Fair Credit Reporting Act, defamation, and negligence).32 In addition to arguing that his gross negligence claim involved “unique factual issues that are not common to the MDL,” the plaintiff also argued that the transferor court had already considered and rejected the defendant’s request to sever that very claim, “finding severance would be a burden.”33 The Panel was quick to point out “[we] are not bound by the transferor court’s ruling . . . [and] must consider not just the parties to Iraheta, but the parties in more than 400 actions pending in MDL No. 2800.” The fragmenting of cases in this way certainly poses a burden on both plaintiffs and defendants alike, but may help parties really tailor the claims they choose to plead and pursue.

Although this data breach class action decision might seem strange in a drug and device retrospective, products liability cases account for just about one-third of all pending MDL proceedings, and the decision has implications for those of us who are involved in that one-third.

Cheers to 2019—here’s to hoping another year of interesting legal developments lies ahead!

  1. See, e.g., In re C.R. Bard, Inc., MDL. No. 2187, Pelvic Repair Sys. Prods. Liab. Litig., 810 F.3d 913, 920-22 (4th Cir. 2016) (stating that because the process “operate[s] to exempt devices from rigorous safety review procedures[,] . . . [it] is of little or no evidentiary value” and would result in a mini-trial, serving only to mislead the jury and confuse the issues); Huskey v. Ethicon, Inc., 848 F.3d 151, 159-61 (4th Cir. 2017); Eghnayem v. Boston Scientific Corp., 873 F.3d 1304, 1318 (11th Cir. 2017) (“As the district court explained, ‘[i]f 510(k) does not go to a product’s safety and efficacy—the very subjects of the plaintiffs’ products liability claims—then evidence of BSC’s compliance with 510(k) has no relevance to the state law claims in this case.’”).
  2. In re Bard IVC Filters Prods. Liab. Litig. (Sherr-Una Booker), 289 F. Supp. 3d 1045 (D. Ariz. 2018).
  3. Id. at 1046.
  4. Id.
  5. Id. at 1047.
  6. Id.
  7. Id.
  8. Id. (citing Georgia caselaw).
  9. Id.
  10. Id.
  11. Id. at 1049.
  12. Id.
  13. Kaiser v. Johnson & Johnson, ___ F. Supp. 3d ___, 2018 WL 3751935, at *9-10 (N.D. Ind. Aug. 8, 2018).
  14. 882 F.3d 70, 77 (4th Cir. 2018).
  15. Id.
  16. 92 N.E.3d 1205, 1211 (Mass. 2018).
  17. Id.
  18. Id.
  19. Id.
  20. Id.
  21. Id. at 1212.
  22. Id. at 1213.
  23. Id. at 1219-20.
  24. Id. at 1223-24.
  25. McNair v. Johnson & Johnson, 818 S.E.2d 852, 855-56 (W. Va. 2018).
  26. 901 F.3d 803, 805 (7th Cir. 2018).
  27. Id. at 816.
  28. Matthew Goldstein & Jessica Silver-Greenberg, “Prosecutors Are Said to Issue Subpoenas Over Pelvic-Mesh Surgery Financing,” The New York Times (Sept. 11, 2018); see also Matthew Goldstein & Jessica Silver-Greenberg, “How Profiteers Lure Women Into Often-Unneeded Surgery,” The New York Times (Apr. 14, 2018).
  29. See, e.g., AMS’s Mem. of Law in Opp’n to Mot. to Quash Subpoenas Issued by Am. Med. Sys., Inc. and for a Protective Order at 1, In re: Am. Med. Sys., Inc., Pelvic Repair Sys. Prods. Liab. Litig., No. 2:12-md-02325 (S.D. W.Va. May 12, 2016), ECF No. 2294.
  30. Order Regarding Third-Party Contingent Litig. Fin. at 1, In re: Nat’l Prescription Opiate Litig., No. 1:17-md-02804-DAP (N.D. Ohio May 7, 2018), ECF No. 383.
  31. See In re Equifax Inc. Customer Data Security Breach Litig., MDL No. 2800 (J.P.M.L. Aug. 7, 2018).
  32. Id. at *1.
  33. Id. at *2-3.
  34. Id. at *3.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Faegre Baker Daniels | Attorney Advertising

Written by:

Faegre Baker Daniels

Faegre Baker Daniels on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide

JD Supra Privacy Policy

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Collection of Information

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

  • Email
  • First Name
  • Last Name
  • Company Name
  • Company Industry
  • Title
  • Country

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

How do we use this information?

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

  • Operate our Website and Services and publish content;
  • Distribute content to you in accordance with your preferences as well as to provide other notifications to you (for example, updates about our policies and terms);
  • Measure readership and usage of the Website and Services;
  • Communicate with you regarding your questions and requests;
  • Authenticate users and to provide for the safety and security of our Website and Services;
  • Conduct research and similar activities to improve our Website and Services; and
  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at:

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit
  • New Relic - For more information on New Relic cookies, please visit
  • Google Analytics - For more information on Google Analytics cookies, visit To opt-out of being tracked by Google Analytics across all websites visit This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at:

- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.