The Highs - Celebrating the Ten Best Prescription Drug/Medical Device Decisions of 2017

by Reed Smith
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Ending the year on a high note is one thing that the blog tries to do – with the top ten drug/device product liability decisions of the year. Occasionally, a court will do something that ruins the party, with an eleventh-hour awful decision (the infamous Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), was decided two days before Christmas), but barring that, we’re looking for nothing but happy news in going through our list of the best decisions of the year.  And make no mistake about it, there’s plenty to celebrate this year.

Before we do, we should explain one thing. Our list is limited to cases involving drugs and medical devices.  Every year some cases significantly impact our sandbox, even though their facts put them outside the drug/device arena.  Thus, we’ll give a shout out to the Supreme Court’s BNSF Railway Co. v. Tyrrell, 137 S.Ct. 1549 (2017), decision holding once and for all that Bauman is not limited to corporations incorporated in other countries.  A couple of other jurisdictional decisions of the same ilk are Aspen American Insurance Co. v. Interstate Warehousing, Inc., ___ N.E.3d ___, 2017 WL 4173349 (Ill. Sept. 21, 2017) (litigation over a fish warehouse), and State ex rel. Norfolk Southern Railway Co. v. Dolan, 512 S.W.3d 41 (Mo. 2017) (another railroad case), both of which took long strides in shutting down litigation tourism in key states.  Given the universal importance of jurisdiction, any one of these may well have more impact on particular clients’ cases than some of the decisions appearing on our list.

Enough preliminaries. Time to start celebrating good decisions:

  1. Bristol-Myers Squibb Co. v. Superior Court of California, 137 S. Ct. 1773 (2017). To the surprise of absolutely nobody who has been a regular reader of the blog, the “BMS” decision is our pick for the best decision of the year.  After the Court said “we really mean it” about the “at home” requirement of general personal jurisdiction in Bauman, litigation tourist plaintiffs simply shifted the same broad jurisdictional arguments to specific jurisdiction.  The California appellate courts immediately signed on, with a “sliding scale” that in practice allowed jurisdiction over all mass torts anywhere. That decision, which we tagged as the worst of 2016, is no more.  In BMS an 8-1 majority put the kibosh on what it described as a “loose and spurious form of general jurisdiction.”  Plaintiffs cannot obtain specific jurisdiction by osmosis – because some other plaintiffs who actually lived in the state in question could bring the same type of claim.  Rather, the conduct “giving rise” to the suit, such as the injury and the alleged tort, must happen in the state, so that there is “harm” in the state and to the state’s residents.  Equally significant, plaintiffs’ “last ditch” argument based on the presence of an in-state co-defendant, also failed.  Personal jurisdiction requirements “must be met as to each defendant” separately.  Merely “contracting with” an in-state entity failed miserably.  The beneficial effects of BMS in curbing litigation tourism have been immediate and widespread, if not total.  The abusive 99-plaintiff complaints, with a one or two plaintiffs in the jurisdiction and a the same in the defendant’s home state to defeat diversity, are being carved up and dismissed.  BMS jurisdictional issues caused havoc with the plaintiffs’ litigation strategies in both talc litigation and the Pinnacle Hip MDL.  BMS is forcing mass torts to change.  It’s not perfect, but a massive improvement on where our clients were before.  We celebrated BMS here, and to help our side, have written quite a few posts on how BMS can be beneficial in various situations.
  2. Trejo v. Johnson & Johnson, 220 Cal. Rptr.3d 127 (Cal. App. 2017).  Our second case also arises from California, and is a major preemption win for non-generic drug manufacturers (in this case, OTC) post-Levine (2009-1).  Typical for California at the time, plaintiffs were litigation tourists from overseas.  They won $55 million for SJS-TENS – a condition that tends to produce big verdicts and big decisions.  Most significantly, Trejo all but dooms design defect claims in the nation’s largest state.  Mensing/Bartlett preemption, using the “independence principle,” rendered such claims “impossible” because significant design changes (here, changing the active ingredient) require prior FDA approval.  Trejo was the first appellate court to apply this reasoning to OTC drugs (we’re 4-0 overall outside generics), and did so although “product liability” claims were expressly saved from express (not implied) preemption.  Trejo also came down hard on plaintiff’s “alternative design” being an active substance not approved by the FDA, holding such an alternative design to be no alternative at all, but merely an indirect argument for removing an FDA-approved drug from the market.  Also, Trejo made an important state-law ruling, that only “risk/utility,” and not “consumer expectation,” is a viable design defect theory for a complex product such as an OTC drug – a holding that should apply a fortiori to products that require a doctor’s prescription.  Finally, as to warnings, the court held that a defense verdict on strict liability and a plaintiff verdict on negligence were fatally inconsistent – providing some level of deterrence against plaintiffs seeking multiple bites at the liability apple.  Trejo is final.  Plaintiff unsuccessfully appealed to the California Supreme Court.  We toasted Trejo here.
  3. Cerveny v. Aventis, Inc., 855 F.3d 1091 (10th Cir. 2017).  Affirming last year’s ninth best decision, the Tenth Circuit’s opinion attests to the revived strength of implied preemption in prescription drug cases after Levine (2009-1).  Although summary judgment for the defendant was reversed in part on a minor point (warning causation – but only because the issue hadn’t been litigated in the district court), the big-deal preemption arguments were affirmed:  (1) “clear evidence” established that the FDA would not have entertained plaintiff’s proposed warning; (2) the FDA’s rejection of a citizen’s petition (a harassment technique favored by plaintiff-side organizations) was “clear evidence” that a manufacturer’s similar attempt would also be rejected, since the scientific standards are identical; and (3) an FDA rejection, for lack of scientific evidence, necessarily preempts tort claims from all earlier times, since even less data would exist at those earlier times.  Item two created a split with the Massachusetts high court in Reckis (2015-1), but the Cervemy plaintiffs did not seek certiorari in the Supreme Court.  Plaintiffs also tried to interpose Fosamax (2017-1), but the Tenth Circuit affirmed preemption anyway, given the “smoking gun” strength of the citizen’s petition evidence.  Cerveny created a much needed “bright line” in the murky post-Levine preemption landscape, eliminating older claims.  When we celebrated Cerveny here, we opined that the surviving warning claim was extremely weak, since it turned on risks the plaintiffs did not encounter.  We have since been proven right about that, so the only drawback in this powerful pro-preemption decision has disappeared.
  4. In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation, 858 F.3d 787 (3d Cir. 2017).  Next to preemption, Daubert is the strongest defense available to the good guys – capable (in our personal experience) of ending entire MDLs with a single motion.  That’s what happened with this MDL claiming that Zoloft (similar allegations have been made about this entire class of drugs) causes birth defects.  The science says the opposite, the district court followed the science (2015+9), and this year the Third Circuit affirmed.  Even with an uncalled-for second chance, plaintiffs could not offer scientifically valid general causation evidence.  Plaintiffs lost on several grounds.  Their claims of teratogenicity had no epidemiologic support.  What they did have – statistically insignificant results and cherry-picked “trend analysis” – couldn’t support a Bradford-Hill, or even weight-of-the-evidence (which the court did not adopt), analysis.  The expert’s meta-analysis was result-driven, with no inclusion/exclusion criteria beyond what would help plaintiffs win.  Generally, the methodology was inconsistent and unexplained.  As the most significant Daubert decision of the year, signaling the end of an entire MDL, we rate it number four, although we could do without some of the dictum.  We examined Zoloft here.
  5. United States ex rel. Nargol v. DePuy Orthopaedics, Inc., 865 F.3d 29 (1st Cir. 2017).  Fraud on the FDA was eliminated as a viable theory in Buckman, right?  Largely, but not entirely.  Applying basic preemption principles, Buckman held that state-law claims alleging that, but for “fraudulent” information, the FDA would have done something different than it actually did were inherently preempted, since only the FDA has authority to decide if it has been defrauded.  But the False Claims Act is a federal statute, and preemption does not apply between two competing federal requirements, so FCA plaintiffs have attempted to use fraud on the FDA as a basis for statutory liability.  In Nargol the First Circuit, expanding upon the rationale it first adopted in D’Agostino (2016+4), said “no” – and that is one of the most plaintiff-friendly FCA courts around.  Unless the FDA actually found fraud, causation is entirely speculative, since the FDA hasn’t changed its decision, plaintiffs are necessarily pursuing a counterfactual hypothesis.  Also, if the “fraud” had been material, the FDA would have done something, so that’s another necessary FCA element that such claims lack.  Materiality is a “demanding standard.”  Nargol had no patience with plaintiffs dissing of 510(k) clearance – that “process constitutes the government’s method of determining whether a device is safe and effective,” through which “the FDA affirmatively deemed the product safe and effective.”  Nargol also analogized to Buckman, finding the same concerns also weighed against allowing the FCA to become a vehicle for second-guessing FDA regulatory decisions.  Because Nargol stands in opposition to decisions like Cisson (2016-2) on the import of 510(k) and Fosamax (2017-1) on letting juries second-guess the FDA, it made our list even though it’s not classic product liability.  We gave Nargol our nod here.
  6. Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644 (S.D.N.Y. 2017).  Did we mention already that preemption is powerful enough to shut down an entire MDL with a single ruling?  That’s exactly what happened in Utts, the only trial-level decision to make our top-ten list this year.  Not only that, Utts stomped all over litigation against new-generation bloodthinners, which we think is particularly meritless, since bleeding is about as well-known and inherent risk of these products as anything imaginable.  Utts engaged in the most extensive discussion we’ve yet seen of implied preemption of warning claims for lack of “newly acquired evidence” (the prerequisite to allowing unilateral warning “strengthening” under the FDA’s CBE regulations).  MDLs, in particular, are likely to spawn “newly acquired evidence” preemption arguments, because they have many plaintiffs spread out over the product’s entire timeline.  Supposed “deficiencies” in the earliest information are thus the only warning-related claims that can benefit all plaintiffs in an MDL.  In Utts none of the nine different types of risk information that plaintiffs alleged should have been beefed up differed materially from the information the FDA considered in approving the drug; hence no information was “newly acquired”; hence preemption.  Nor could Fosamax (2017-1) apply, since “clear evidence” only becomes an issue after a plaintiff demonstrates “newly acquired evidence.”  Aside from preemption, Utts also features defense-friendly discussions of:  (1) the FDA’s reporting system; (2) the drawbacks of overwarning; (3) comparative claims; (4) California’s state-of-the-art defense; and (5) warnings being adequate as a matter of law. Utts is a long opinion, and every word is worth reading.  We went nuts over Utts here.
  7. Johnson & Johnson v. Fortenberry, ___ So.3d ___, 2017 WL 4699593 (Miss. Oct. 19, 2017).  The Mississippi Supreme Court reversed a multi-million dollar plaintiff verdict for two important reasons.  First, the label’s warnings about the risk in question were adequate as a matter of law.  That’s a significant victory in and of itself – before we point out that the drug was an atypical antipsychotic, the risk was tardive dyskinesia, and the warning was classwide labeling.  The high court declared a lot of labels adequate in a lot of cases.  As we pointed out, that means that the defense wins without even having to consider physician-specific causation arguments.  Second, a state high court declaring that the purported tort of “negligent marketing” does not exist is also a big deal.  Plaintiffs use this claim as a vehicle for admitting “marketing” evidence, that is, irrelevant promotional evidence to which the prescriber was not exposed, and for seeking punitive damages.  In Mississippi, at least, that cause of action has failed.  Oh, yes, the court also affirmed the trial court’s determination that, as a matter of law, plaintiff failed to make a case for punitive damages.  We let out a rebel yell over this result, here.
  8. Eike v. Allergan, Inc., 850 F.3d 315 (7th Cir. 2017).  Say you bought a product.  It had exactly the characteristics it was represented to have, worked in the manner it was supposed to, and didn’t hurt you in the slightest.  Could you then sue because the product wasn’t designed in some other way that might somehow have made it more efficient or “better”?  Can you then generalize your complaint across an entire class action?  If you say yes, then you agree with the Third Circuit in Cottrell (2017-4).  If you say no, then keep reading.  In one of Judge Posner’s final opinions, he reversed class certification in a case alleging that eye-drops (yes, the drops themselves) were too large, and thus were a suboptimal use of the fluid.  The drops were exactly as represented and not injurious.  Eike found the claim bogus in several ways.  It attacked an FDA-approved design.  It purported to invoke a duty not just to make a safe and effective product, but to make the “best” product possible – with “best” being unobtainable because it is only defined by plaintiffs’ experts.  There was no standing because there had been no injury.  “[T]hat a seller does not sell the product that you want, or at the price you’d like to pay, is not an actionable injury; it is just a regret.”  We eulogized Eike (and Posner) here.
  9. State ex rel. Bayer Corp. v. Moriarty, ___ S.W.3d ___, 2017 WL 6460354 (Mo. Dec. 19, 2017).  Very late in the year, the Missouri Supreme Court recognized that Bauman and BMS have changed the parameters of personal jurisdiction, and unanimously granted mandamus  – a much tougher standard than ordinary appeal – holding that a multi-plaintiff, misjoined complaint (92 plaintiffs, 85 from out of state) against a device manufacturer could not create jurisdiction over the claims of non-resident plaintiffs against a non-resident defendant.  The court ordered the existing complaint dismissed.  “At home” means a lot more than just doing business, so no general jurisdiction.  As the court had ruled previously, registering to do business does not constitute consent to general jurisdiction, because it would “result in universal personal jurisdiction for corporations complying with registration statutes in many states.”  Nor was there specific jurisdiction, since the contacts of “other plaintiffs” was not enough to create the necessary “affiliation between the forum and the underlying controversy.”   Plaintiffs would have to show some specific facts about their claims and Missouri that would not “simply be another way of gaining general jurisdiction over [defendant] in the many states,” and could try on remand.  Because Moriarity was so recently decided, we haven’t blogged about it yet, but we expect to.
  10. In re Depuy Orthopaedics, Inc., 870 F.3d 345 (5th Cir. 2017).  Wait a cotton-picking minute here.  The defendant lost; mandamus denied.  What is this case doing in a pro-defense top-ten list?  Why?  Because the defendant didn’t really lose, although the relief sought was denied.  Mandamus is very hard to get.  The writ requires three elements, and one of them is that an eventual ordinary appeal is not an adequate remedy.  Waste of time and money between here and there doesn’t count, and the Depuy defendant didn’t clear that hurdle.  But the defense won the other two, more substantive, elements.  A majority held that the MDL-wide order concerning waiver of jurisdictional defenses was not only wrong, but “patently erroneous” and a “clear” abuse of discretion.  Waivers must be explicit; this one wasn’t; resulting in “grave error.”  Second, mandamus was “particularly appropriate” because the error had ramifications “beyond the immediate case” because the MDL ruling purported to extend to almost 10,000 MDL cases.  Reminds us of the original Batman.  These rulings – embodied in a precedential decision – were a huge loss for the MDL plaintiffs, which they recognized, since they moved for rehearing en banc, even though not technically “aggrieved.”  Although not an order (because mandamus was denied), the panel “requested” the MDL judge to vacate the offending order and halt further “bellwether” trials pending resolution of other, pending appeals.  That request was refused, and what in all likelihood was a pointless trial thereafter ensued.  All in all, this result was a rare appellate intervention into the workings of an MDL, and given what happened afterwards, it appears that one such intervention will not be enough.  We covered the oral argument, and then delighted in Depuy, here.

So there you have it, the drug/medical device decisions that we consider to be the ten best of 2017.  But we like good decisions, and 2017 featured a lot more than ten blogworthy outcomes favorable to the right side of the “v.”   As usual, we’re listing another ten good decisions for 2017 that fell just short of cracking our top ten.

These are our Honorable Mentions:  (11) Sidney Hillman Health Center v. Abbott Laboratories, 873 F.3d 574 (7th Cir. 2017).  Rejecting proof of causation of causation/damages in RICO off-label promotion suit as inadequate as a matter of law.  We applauded adherence to traditional causation standards here.   (12) In re Mirena IUD Products Liability Litigation, ___ F. Appx. ___, 2017 WL 4785947 (2d. Cir. Oct. 24, 2017).  Another affirmance of an MDL-ending Daubert order (2016+6) that, if precedential, would almost surely have made the top ten.  We cheered exclusion of plaintiffs’ ipse dixit, ginned up for litigation opinions here.  (13) M.M. v. Pfizer, Inc., 806 S.E.2d 800 (W. Va. 2017).  A state high court deciding that Michigan plaintiffs couldn’t escape adverse applicable statutes.  Plaintiffs brought that on themselves, as we explained here.  (14) United States ex rel. Ibanez v. Bristol-Myers Squibb Co., 874 F.3d 905 (6th Cir. 2017).  The FCA is an “awkward vehicle . . . for punishing off-label promotion schemes.”  The relators’ lack of personal knowledge meant they couldn’t overcome TwIqbal, as we discussed here.  (15) Inge v. McClelland, 257 F. Supp.3d 1158 (D.N.M. 2017).  A detailed and articulate reaffirmation of the principle that plaintiffs can’t recover for injuries caused by their own criminal acts, which the rise of opioid litigation makes all the more timely.  See our post here.  (16) Wolicki-Gables v. Doctors Same Day Surgery Center, Ltd., 216 So. 3d 665 (Fla. App. 2017).  This Florida appellate court has forgotten more Florida law than the Eleventh Circuit (2017-8) ever knew, particularly on negligence per se issues, as we explained here.  (17) In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 226 F. Supp.3d 557 (D.S.C. 2017) & In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 227 F. Supp.3d 452 (D.S.C. 2017).  Another MDL-ending Daubert decision, holding that, while a viable claim could exist for a particular dosage at certain times, not one of the scattershot solicited plaintiffs in the entire MDL met those criteria.  We loved Lipitor here.  (18) Barraza v. C.R. Bard Inc., ___ F.R.D. ___, 2017 WL 3976720 (D. Ariz. Sept. 11, 2017).  In over twenty years, not a single product liability/personal injury class action has survived a contested appeal.  That losing streak was not broken by medical monitoring allegations involving a medical device, as we reported here.  (19) In re Zofran (Ondansetron) Products Liability Litigation, ___ F. Supp.3d ___, 2017 WL 3448548 (D. Mass. Aug. 4, 2017).  As we explained here, innovator liability poses an existential threat to branded drug manufacturers.  Thus, a decision rejecting such liability in six states is worthy of attention, which we gave here.  (20) Aston v. Johnson & Johnson, 248 F. Supp.3d 43 (D.D.C. 2017).  Judicial Watch specializes in vast conspiracy theories, but the conspiracy alleged in its first foray into product liability was only half-vast.  Here, we tallied up the resulting favorable preemption, TwIqbal, and other substantive law rulings as the entire complaint was dismissed with prejudice.

Perusing our best and worst from 2016, the worst of 2016 became the best of 2017 with the BMS loss at the California Supreme Court turning into a win in the United States Supreme Court.  Of our ten “worst of the year” cases between 2007 and 2016, fully half of them are no longer good law (BMS and Bartlett (2012-1) outright reversed; Weeks (2014-1) and Karl (2007-1) overturned by statute; and Wimbush (2010-1) limited to its facts after Bartlett (2013+1).  Given what it takes to get to number one (either the best or the worst) that’s not a bad track record at all for the good guys.  Also, as we’ve mentioned, 2017’s worst stinker remains pending in the United States Supreme Court, with decent prospects.  By contrast, every single one of our top ten best over the past decade is still standing tall.

Going down last year’s list, we already mentioned (2017-3) the Missouri affirmance of Barron (2016-3).  An appeal in T.H. v. Novartis (2016-5) is pending, and that California Supreme Court decision – good or bad − will certainly make next year’s lists (unless decided before the end of this year).  The Pinnacle Hip entry from last year (2106-6) is on appeal, representing another decision likely to make one of next year’s lists. Certiorari was denied in another adverse jurisdictional decision (2016-8), and as far as we can tell none of the other baddies are going anywhere.  On our good list, we already mentioned the Mirena (2016+6) and Cerveny (2016+9) affirmances, an appeal in Lipitor (2016+7) is pending (4th Cir. #17-1140) and will be argued early in 2018.  Further appellate review was denied in Niedner (2016+3).  Everything else appears final.

Looking over earlier top/bottom ten lists, we lost Incretin (2015+10) to a non-substantive, unpublished reversal just a couple of weeks ago.  Jeez, the Ninth Circuit is slow.  We lost Fosamax (2013+7) to the Third Circuit’s horrible decision (2017-1) that leads this year’s bottom 10 list.  MDLs move even more slowly.  None of the other top/bottom ten cases had their status changed in 2017.

Going forward, as we’ve already discussed, 2018 could go down as the “year of innovator liability” – good or bad – with two more state high courts poised to decide the same issue that California went south on the other day.  On that same subject, there’s also that Case That Must Not Be Named in the Seventh Circuit.  The Fifth Circuit will finally have its say on the Pinnacle Hip (2016-6) rulings, and other appeals arising from that MDL.  The New Jersey Supreme Court will be reviewing several aspects of the long-running Accutane litigation.

Finally, on the administrative front, the FDA’s proposal (discussed here and here) to amend the “intended use” regulations has been in limbo for some time, with the Agency – under new management – having to formulate a First Amendment position on truthful off-label promotion that is reflective of current jurisprudential realities.  Congress has before it a bill, passed by the House of Representatives, that (as we discussed here) would alleviate some of the worst mass tort abuses that we unfortunately have to live with every day.  Maybe the Senate will pass something similar in 2018, but we’re not counting any chickens just yet.

Now it’s time to ring down the curtain on 2017 – barring something big happening in the next couple of days.  We wish all our readers good health and good cheer in 2018.  To our readers on the right side of the “v.,” we also wish a productive and successful New Year.

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.

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