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Today we have a guest post from Reed Smith‘s Elizabeth Minerd discussing a PMA preemption case dealing with unusual “parallel claim” allegations involving the conduct of clinical trials.  As always our guest posters are 100% responsible for what they write and deserve 100% of the credit (and any blame) for what follows.  Take it away Liz.

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Ever since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), in cases involving premarket-approved (“PMA”) devices, plaintiffs have taken to loading their complaints with allegations of violations of federal requirements in an attempt to escape federal preemption.  Fortunately, many courts have demonstrated a willingness to sort through these allegations and throw out those that do not fit through the oft-cited “narrow gap” between express and implied preemption described in In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010).  See the blog’s PMA preemption scorecard.  In Gravitt v. Mentor Worldwide, LLC, 2018 U.S. Dist. LEXIS 4822 (N.D. Ill. Jan. 11, 2018), the Northern District of Illinois once again did just that.

In Gravitt, the plaintiffs alleged that the wife plaintiff was implanted with a premarket-approved silicone breast implant (in the wake of the Breast Implant mass tort of the 20th century, such implants were required to obtain PMA, and are now protected by preemption). Id. at *8-9.  The plaintiffs asserted the usual claims against the defendant manufacturer: negligence, strict products liability (manufacturing and marketing), strict products liability (failure to warn), and loss of consortium. Id. at *10.

Obviously anticipating a preemption motion, the plaintiffs packed their complaint with allegations of violations of federal requirements—including novel theories attacking the defendant’s conduct of certain post-approval studies and patient follow-up required by the FDA’s PMA letter. Id. at *4-*6.  According to the plaintiffs, the defendant’s conduct was deficient because:

  1. Participant follow-up in one study supporting the PMA application was 6 years, instead of 10;
  2. Participant follow-up in the same study supporting the PMA application was less than 100%;
  3. A post-approval study did not have a sufficient number of participants;
  4. Participant follow-up in that post-approval study was not high enough; and
  5. The defendant did not provide sufficient detail about why study participants required additional surgical intervention.

Id. at *4-*6.

The court methodically addressed each of these alleged deficiencies to determine whether any fit through the “narrow gap” between express and implied preemption. Unfortunately for the plaintiffs, fortunately for the defense, none did.  Thus, defendants achieved a rare preemption win in a court bound by the notoriously bad decision, Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010).

First, the court analyzed each deficiency through the lens of express preemption—i.e., asking, “did this alleged deficiency actually violate a federal requirement?”  The court found that the first three deficiencies (if true) would violate specific requirements enumerated in the PMA letter. Gravitt, 2018 U.S. Dist. LEXIS 4822, at *21-*22.  However, the court found no federal requirement addressing the last two purported deficiencies because “the [PMA] letter does not require any particular follow-up rate for that study” and the plaintiffs did not even allege “that the [PMA] letter or any other federal law required [defendant] to provide more detailed reasons for re-operation than it actually provided.” Id. at *18-*19.  Thus, items 4 and 5 were expressly preempted.

Second, the court analyzed the three remaining deficiencies through the lens of implied preemption—i.e., asking “did this alleged deficiency violate a traditional tort duty under Illinois law?”  Here, the court answered “no” for every one of the remaining purported deficiencies, rendering them impliedly preempted.  The court reasoned that there was no “well-recognized duty owed to [the plaintiffs] under state law” requiring the defendant to follow up with study participants for 6 instead of 10 years, follow-up with all study participants, or enroll a specific number of study participants. Id. at *24-*25 (quoting Bausch, 630 F.3d at 558).  More generally, there simply are no state law requirements relating in any way to the methodology of FDA-mandated post-approval studies. Gravitt, 2018 U.S. Dist. LEXIS 4822, at *25.  Further, the plaintiffs made no effort to analogize these alleged deficiencies to any traditional state law failure to warn claim. Id.  Accordingly, the court dismissed plaintiffs’ novel claims based on alleged deficiencies in post-approval studies, id., creating valuable precedent in case any other plaintiff tries this type of preemption dodge.

Apart from the alleged deficiencies in the post-approval studies, the plaintiffs also alleged that the defendant had violated manufacturing standards based on allegations that the FDA had cited the defendant for non-compliance with manufacturing standards several times. Id. at *7-*8.  While the court recognized that, under Bausch, such a claim might survive express preemption (id. at *22), the court dismissed this theory as impliedly preempted because the plaintiffs failed to tie the alleged non-compliance with manufacturing standards to any state law claim that her specific device was defectively manufactured. Id. at *26.

The court did allow one narrow Stengel-type (failure to report) claim to survive based on the plaintiffs’ allegations that the defendant was aware of a higher rate of implant ruptures than it reported to the FDA. Id. at *27-*28.  The court reasoned that, were the plaintiffs to prove that the defendant concealed the true rate of implant ruptures from the FDA in violation of federal law, then the defendant “may have breached its state law duty to warn potential customers—and their physicians—of the product’s risks.” Id. at *31.

Overall, a solid win for the defense that significantly narrowed the scope of the plaintiffs’ claims going forward.

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Strict liability is not the same as absolute liability.  We learned that truth in law school, but too many plaintiff lawyers and judges seem to have unlearned it along the way.  The key separator between strict liability and absolute liability is comment k to section 402A of the Restatement (Second) of Torts (1965), which observes that “[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.”  Think of dynamite, for example.  More pertinent to our practice area, comment k included prescription drugs and vaccines among its examples.  But it did not mention medical devices.  That is probably because comment k antedated anything approximating the degree of regulation of medical devices we enjoy today.  In any event, we are left with this question: does comment k apply to medical devices?  If so, which ones?

This is not the first time that we have faced this issue.  Back in 2011, we authored a magnum opus called “Comment k, Some of the Way.”  To this day, it is one of our most widely read posts.  The question keeps cropping up, as product liability plaintiffs keep trying to minimize the scope of comment k.  One simple way of bifurcating judicial treatment of comment k is “across-the-board” versus “case-by-case,” but that misses some nuances.  In 2015, in a post charmingly entitled “How Does a Bad Idea Get Implanted?” we blasted the commonplace California plaintiff argument that comment k applied to medical devices only if they were implantable.  As we demonstrated, that argument lacked sense and support, and the real issue should be whether the medical device required a doctor’s prescription. Tongue depressors come with neither prescriptions nor comment k protection, but, say, medical lasers should come with both.  In 2017, we revisited the issue to look beyond California, finding cases in other jurisdictions applying comment k to medical devices. It is an important issue, and it keeps surfacing.  Here is another post where we scrutinized the contours of comment k. So, is it unusual for courts to apply comment k to medical devices?  Not at all.  Take a look at our favorite reference book, Beck/Vale, Drug and Medical Device Product Liability Deskbook, section 2.02[2] and footnote 14.  There are literally hundreds of cases that have applied comment k to medical devices, in the same way they apply it to prescription drugs. 

Recently, the scope of comment k surfaced in Burningham v. Wright Med. Grp., Inc., 2018 U.S. Dist. LEXIS 10726 (D. Utah Jan. 23, 2018).  In that case, the plaintiff alleged injuries from an implanted hip device.  The design defect claims were premised on a theory of strict liability.  The defendants argued that the hip implant was an “unavoidably unsafe” product and was, therefore, categorically barred from design defect claims. Utah law controlled and the Utah Supreme Court has adopted the comment k “unavoidably unsafe products” exception to strict products liability.  But while the Utah Supreme Court has explicitly applied comment k to prescription drugs (categorically, not case-by-case), it has thus far been silent on whether comment k reached medical devices.  The defendant in Burningham argued that the doctrine regarding unreasonably unsafe products should apply equally to the medical device at issue.   

The Burningham case has traveled a circuitous path through the judicial system.  It was filed in California state court, then became part of a coordinated proceeding, then was released from that proceeding, then was moved by consent to the federal court in Utah.  Meanwhile, there is a federal MDL in Georgia dealing with design defect claims against these same hip implants.  Not so long ago, we authored a screed against a decision in that litigation involving what we saw as a complete misreading of Utah law on … wait for it .. comment k.  The Georgia federal court did not apply comment k to the medical devices and, just for good measure, completely mangled Utah law on design defect.  We were disappointed. Then the Eleventh Circuit affirmed the horrible result and wretched reasoning.  We were disappointed again.

So we have some history with this topic.

You will not be surprised to hear that we agree with the defense argument that Utah law should and would include hip implant medical devices as “unavoidably unsafe” products warranting comment k protection. The Burningham court stated that the defendant pointed “to decisions from courts in Oklahoma, Washington, California, and Pennsylvania, which do apply the doctrine to implanted medical devices.”  Yikes – there’s that unnecessary/wrong restriction to implanted devices, but since the devices in Burningham definitely were implanted one can see why the defendant in that case would take the most conservative approach.  If the federal court was going to try to predict which way the Utah Supreme Court would go, the broader reading of comment k, which would include medical devices, would probably prevail. But because the “question of whether the categorical exception applies to implanted medical devices is a question of first impression for Utah courts,” the federal court sua sponte (on its own) decided to issue an order certifying the issue to the Utah Supreme Court.  Our bet is that the defense will persuade the Utah court to extend comment k to medical devices.  Just don’t dig in too hard on the question of implantation.  Leave us room later to argue that comment k should apply to all prescription medical devices, please-and-thank-you.

Meanwhile the federal court was in a perfectly fine position to dismiss the misrepresentation and breach of warranty claims for lack of reliance.  The complaint supplied conclusory allegations of generalized reliance, but never listed any factual allegations that the plaintiff or his doctors “actually read or saw Defendant’s misrepresentations” and the complaint contained “no allegation that the Defendants’ express warranties were ever communicated to Plaintiffs or Mr. Burningham‘s physicians.”  The complaint could not “withstand the Twombly/Iqbal analysis.”  So much for those claims, and now it is up to the Utah Supreme Court to read comment k correctly and pave the way for dismissal of the strict liability claims. 

 

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Aren’t we all guilty of having that drawer, that shelf, that cabinet, maybe even a whole closet where things just get dumped. And as new stuff gets dumped, the old stuff gets pushed to the back. Then one day the space simply can’t hold anymore and you reach to the back to see just what’s there. What do you find? Old empty checkbooks. Gift card to a restaurant that closed two years ago. Any variety of expired items from coupons to salad dressing to cough medicine. And of course that half-eaten bag of cookies that are so stale you can use them as coasters. But, sometimes you also find a hidden gem. Like the cord to charge your radio that you haven’t been able to use for the last 6 months. Or the great family photo from Aunt Susie’s 80th birthday. Or your favorite pair of socks. How did they get there?

Well cases, just like socks and salad dressing, can get pushed to the back of the shelf – where they too get stale. And if courts still used paper dockets, the file in Beswick v. Sun Pharmaceutical Industries, Ltd., 2018 U.S. Dist. LEXIS 15012 (W.D.N.Y. Jan. 30, 2018) would be covered in an inch of dust with discolored pages stuck together from sitting at the bottom of a pile in a basement storeroom. The decision rendered just last week is on a motion that was filed in June 2012 on the basis of the Supreme Court’s ruling in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). A 5 ½ year old motion based on a 6 ½ year old ruling. Fortunately, the decision is to dismiss the case, but it’s a decision that could have been entered a long time ago. We imagine the delay has not been without some financial consequences to the defendant. Indeed, plaintiff’s counsel withdrew back in 2015, likely recognizing the folly of pursuing what is essentially a failure to warn case against a generic drug manufacturer. But still the case sat.

The complaint, alleging plaintiff suffered from Stevens Johnson Syndrome as a result of using defendant’s generic anticonvulsant drug to treat his epilepsy, was filed in 2010. Id. at *1, *4-5. In early 2011, the court granted defendant’s motion to dismiss all claims except those alleging breach of express and implied warranty. Id. at *2. The case was then stayed pending the Supreme Court’s decision in Mensing. Id. A year after Mensing, defendant file a motion for judgement on the pleadings on the two remaining claims and the motion was fully briefed by August 2012. Defendant then filed supplemental declarations in support of its motion in November 2012 and again in August 2013. In 2015, defendant formally requested that the stay be lifted and filed yet another supplemental declaration in support of its motion. Id. at *3-4. The supplements we assume necessitated by the development of the law over the years the motion was pending. And finally, three years later the motion was ruled on.

It should come as little surprise that the warranty claims, premised on a failure to warn, were found to be preempted.  Plaintiff alleged that defendant breached its express warranty that the drug was safe and effective by failing to disclose known risks of side effects including SJS. Id. at *6-7. Plaintiff similarly alleged that defendant breached the implied warranties of merchantability and fitness for the drug’s intended use by failing to warn about the drug’s side effects and risks. Id. at *7-8.

The court then analyzed both claims in light of Mensing and Bartlett (5 years old itself) which we know held that because generic drug manufacturers are prohibited from making any unilateral change to the drug’s label, federal law “preempts any duty the generic drug manufacturer otherwise would have under state law to provide additional warnings.” Id. at *18. Therefore, because plaintiff’s warranty claims are essentially “state law tort claims attacking a drug label warning as insufficient” they are preempted. Regardless of the theory, if the claim is premised on a failure to warn, it is preempted. See id. at *22.

Plaintiff attempted to advance two arguments to avoid preemption. First, plaintiff argued that defendant didn’t have to change its label but rather could have sent out Dear Doctor letters containing additional warnings. The Supreme Court deferred to the FDA that such letters would be misleading because they would imply a “therapeutic difference” between the brand and generic drugs. Id. Second, plaintiff argued that defendant should have pulled the drug off the market. This too has been rejected by the Supreme Court. When faced with a conflict between federal and state law, the manufacturer is not obligated to stop selling. If that were the case, “impossibility preemption would be all but meaningless.” Id. at *23 (citing Mensing).

There is nothing new or novel about the court’s decision other than the amount of time it took to be entered. The case simply hung around for way too long and could have been disposed of five years ago. Like the receipt for the gloves you bought your mom for Christmas 2014.

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On January 30, 2018, Judge Goodwin entered four case management orders in the Ethicon, Boston Scientific, Bard, and American Medical Systems mesh MDLS.  These CMOs establish discovery and briefing deadlines for 13200, 6174, 2876, and 952, cases respectively – a total of 23202 cases.

The discovery and briefing schedules are identical in all four orders. The deadlines are:

Plaintiff Fact Sheets.                                                              03/19/2018

Defendant Fact Sheets.                                                          04/19/2018

Deadline for written discovery requests.                                05/18/2018

Expert disclosure by plaintiffs.                                               06/04/2018

Expert disclosure by defendants.                                           07/05/2018

Expert disclosure for rebuttal purposes.                                 07/23/2018

Deposition deadline and close of discovery.                          09/04/2018

Deadline to file list of general causation experts.                   09/11/2018

Filing of Dispositive Motions.                                                09/21/2018

Response to Dispositive Motions.                                          10/05/2018

Reply to response to dispositive motions.                              10/12/2018

Filing of Daubert motions.                                                      10/05/2018

Responses to Daubert motions.                                              10/19/2018

Reply to response to Daubert motions.                                   10/26/2018

In addition to the plaintiff’s deposition, the parties may take up to 4 treating physician depositions. See Paragraph two of the orders.  Depositions of friends and family are not subject to these deadlines. Id. Depositions are limited to three hours (both sides), absent other agreement of the parties. Id.

Assuming that each plaintiff timely files a fact sheet by the March 19 deadline, that means that the defendants have 167 days thereafter in which to schedule depositions. Assuming an average of three treating physician depositions (at least one implanting surgeon, at least one post-injury treater, and an additional from either of those categories) per case, that means about four depositions in each of 23202 cases, for a total of some 92,808 depositions.  Spread equally across the 167 days after defendants learn the nature of each plaintiff’s case, and who the plaintiffs’ physicians are – the parties are being ordered to take approximately 556 depositions each day.

This 556 deposition per day figure does not count depositions of other witnesses, such as sales representatives, friends and family, and expert witnesses. Nor does it address preparation of each side’s fact sheets, and motion practice, all of which are now scheduled in the 23202 cases that are the subject of the four mesh CMOs.

Good luck to all – you’ll need it.

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This year’s Academy Award nominations came out last week. That means that we have spent the past few days setting a schedule for seeing all of the Best Picture nominees (well, most – we don’t do war movies and tend to opt out of love stories involving semi-animate objects) and scouring recipe blogs for perfect Oscar party buffet items.  We have also reminisced, with amusement, about the climactic moments of last year’s show, during which the presenters announced the wrong Best Picture winner before an Academy official shoved them out of the way and corrected the error.  As we recall, it turned out (not surprisingly) that the mistake was caused by sloppiness.  The Academy’s accountant handed the presenters a duplicate envelope for an award that had already been presented, starting the embarrassing domino cascade.  We recall that heads rolled in the ensuing days.

Today’s case also involves the consequences of sloppiness, along with a couple of interesting legal rulings. In its unpublished decision in Small v. Amgen, Inc., et al., 2018 WL 501354 (11th Cir. Jan 22, 2018), the Eleventh Circuit considered the plaintiff’s appeal of two summary judgment orders:  a grant of partial summary judgment for the defendants, and a later grant of summary judgment on all of the remaining claims.

The plaintiff was prescribed the defendants’ drug to treat her rheumatoid arthritis. She took the drug for nearly six years then suffered a perforated bowel and a diverticulitis infection, for which she underwent multiple surgeries.  She sued the drug’s manufacturers, asserting all of the usual claims. In 2014, the district court granted summary judgment on the plaintiff’s failure-to-warn claims, holding that Florida’s learned intermediary doctrine precluded the claims.  Later, when the plaintiff’s expert disclosures revealed her sloppy omissions — although she identified five treating physicians she intended to use as non-retained experts, she had no expert to testify to general or specific causation — the defendants moved for summary judgment on the plaintiff’s remaining claims.  In 2017, the district court granted the defendants’ motion.

On appeal, the plaintiff did not dispute or even address the 2017 summary judgment order. Instead, she argued that the 2014 dismissal of her warnings claims was improper because there were factual issues “regarding the district court’s treatment of [her prescriber] as a learned intermediary.” Small, 2018 WL 501354 at *2.  She also argued that “the district court incorrectly decided that the direct ‘patient labeling requirement’ in the FDA medication guidelines did not preempt Florida’s learned intermediary doctrine.” Id.

With respect to the prescriber-as-learned-intermediary argument, the court explained that the plaintiff’s prescribing physician had 22 years of experience in rheumatology and “intentionally selected [the drug] for [the plaintiff], despite the risk of possible infections, because other forms of rheumatoid arthritis therapy had failed.” Id. What’s more, the prescriber was involved in clinical trials with the drug, and the plaintiff was a participant, giving the prescriber “more reason to know of and discuss possible side-effects or concerns” associated with the drug.” Id. The prescriber “knew that infections were possible but prescribed the drug anyway . . . because the benefits outweighed the risks.” Id. As such, because “the prescribing physician had substantially the same knowledge as an adequate warning from the manufacturer should have communicated,” the plaintiff could not prove warnings causation and her warnings claims failed as a matter of law. Id. (internal punctuation and citation omitted).   In other words, “the failure of the manufacturer to provide the physician with an adequate warning . . . is not the proximate cause of a patient’s injury if the prescribing physician had independent knowledge of the risk that the adequate warning should have communicated.” Id. (citation omitted).

Next, the plaintiff argued that Florida’s learned intermediary doctrine was preempted by the FDA’s requirement that the manufacturers provide patients with a “medication guide” for the drug. The court emphasized that “the historic police powers of the State [were] not superseded unless that was the clear and manifest purpose of Congress.” Id. at *3 (internal punctuation and citation omitted).   To discern such “clear and manifest purpose” in cases of implied preemption, the court explained that it considered “the promulgating agency’s contemporaneous explanation of its objectives as well as the agency’s current views of the regulation’s preemptive effect.” Id. (internal punctuation and citation omitted).

In the case of the medication guide regulation, the FDA had specifically addressed concerns that the regulation would alter the framework for manufacturers’ liability by abrogating the learned intermediary doctrine.  In response, the agency stated that “the written patient medication information provided did not alter the duty, or set the standard of care for, manufacturers [or] physicians . . . .” Id. (citation omitted).   Given this “contemporaneous explanation” from the FDA, coupled with the reality that “courts have not recognized an exception to the learned intermediary defense in situations where the FDA has required patient labeling . . . ,” the court held that there was no preemption.  We love this holding, and we believe this is the first time that an appellate court has so held.

No preemption, no warnings causation – summary judgment on warnings claims affirmed. And, because the plaintiff did not address her inexplicable failure to identify causation experts, the court held that she had waived any appeal of the 2017 summary judgment order.   Case (tidily) dismissed, in a no-nonsense decision we like very much.  We’ll let you know if we are similarly pleased by this year’s Oscars.

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The pushback by Plaintiffs’ lawyers against the Supreme Court’s BMS decision continues, and it continues to largely fail.

The lawsuit in Dyson v. Bayer Corp., 2018 WL 534375 (E.D. Mo. Jan. 24, 2018), began in state court in St. Louis, a favorite destination of plaintiffs’ lawyers. The complaint made product liability claims about Bayer’s implantable birth-control device, Essure, and named 95 individual plaintiffs. Only 3 of those individuals lived in Missouri. The other 92 lived in other states, including states that could destroy complete diversity and prevent removal of the case to federal court. But defendants removed the case to federal court anyway, arguing that Missouri courts could not exercise personal jurisdiction over the claims of those 92 plaintiffs, who were not only non-residents but who also did not receive their Essure implants in Missouri. Plaintiffs responded by filing a motion to remand the case to state court or, in the alternative, to conduct fact discovery on the existence of personal jurisdiction. Id. at *1-2. And, with that, the latest challenge to the breadth of the BMS decision was teed up.

The plaintiffs’ lawyers’ theory as to why Missouri courts could exercise personal jurisdiction over the claims of these 92 plaintiffs was based on an observation made by the Supreme Court in BMS: “BMS did not develop, create a marketing strategy for, manufacture, label, package, or work on the regulatory approval for Plavix in [the forum state of California.]” Id. at 4 (quoting Bristol-Myers Squibb Co. v. Super. Ct. of Cal., 137 S. Ct. 1773, 1778 (2017). So the complaint in Dyson alleged, in some detail, that the defendants conducted clinical trials for the regulatory approval of Essure in Missouri and started their marketing campaign for Essure in Missouri. As the Dyson court put it, plaintiffs claimed that these allegations, in the least, made a prima facie case for personal jurisdiction:

Plaintiffs seize upon that [BMS] language and suggest the Supreme Court offered those factors as a blueprint for establishing personal jurisdiction. Plaintiffs thus believe they have solved their personal jurisdiction problems because they allege that the defendants worked on regulatory approval for Essure in Missouri and also worked on the Essure marketing campaign in Missouri. Plaintiffs argue that they have at least made a prima facie case for personal jurisdiction and that they should be able to conduct jurisdictional discovery to prove the plaintiffs’ claims’ connections to Missouri.

Id. at 4.

The Dyson court started its analysis by first addressing personal jurisdiction. This was a significant choice. If the court had instead addressed subject matter jurisdiction, it could have (blindly) declared a lack of complete diversity and remanded the case to state court. But it, properly, started with personal jurisdiction because, as the court put it, the personal jurisdiction inquiry was straight-forward. The deficiencies of the allegations under BMS were just too significant:

This Court agrees that, despite these new allegations made by plaintiffs, personal jurisdiction remains the more straightforward inquiry. To address subject matter jurisdiction at this juncture would involve deciding whether non-Missouri plaintiffs had been fraudulently joined or misjoined, which is a notoriously complex issue. As shown below, the personal jurisdiction inquiry is a much simpler matter. Further, because plaintiffs do not make a prima facie showing for personal jurisdiction, the motion for jurisdictional discovery (#24) will be denied.

Id. at *3 (citations omitted).

Having decided that personal jurisdiction was a threshold issue, the court addressed plaintiffs’ claim that defendants started their Essure marketing campaign in Missouri. The court waded through the details of plaintiffs’ marketing allegations and found that they did not establish a sufficient connection to claims of plaintiffs who did not live in Missouri, were not prescribed and did not purchase the Essure device in Missouri, were not injured in Missouri, and did not see or rely on marketing in Missouri:

With respect to plaintiffs’ arguments that personal jurisdiction may be supported by the alleged Missouri marketing campaign genesis, those arguments are contrary to BMS. In fact, the BMS plaintiffs themselves alleged that BMS marketed, advertised, and actively sought to promote Plavix in California specifically. Id. at 1779, 1783. Plaintiffs here go a step farther, saying defendants used Missouri as “ground zero” for its national campaign — that is, St. Louis was the first city to commercially offer the Essure procedure and was one of eight “test marketing” campaign sites. (Petition ¶ 165.) Plaintiffs also state that defendants cite to data from the Missouri clinical trials on Essure’s labels and in marketing materials distributed to plaintiffs and their physicians. (Id.) Plaintiffs add that defendants’ success with Essure in St. Louis allowed defendants to achieve profitability and launch a nationwide advertising campaign. (Id.) However, the non-Missouri plaintiffs do not allege they viewed Essure advertising in Missouri. That Missouri happened to be Essure’s first marketed area has no bearing on the non-Missouri plaintiffs’ claims where those plaintiffs did not see marketing in Missouri, were not prescribed Essure in Missouri, did not purchase Essure in Missouri, and were not injured by Essure in Missouri. Thus the allegations still do not suffice to provide the necessary “connection between the forum and the specific claims at issue.” BMS, 137 S. Ct. at 1781.

Id. at *4.

The court next considered—and rejected—plaintiffs’ argument that the court had personal jurisdiction over the non-resident claims because defendants sponsored clinical trials in Missouri as part of their effort to secure regulatory approval of Essure. The court, once again, found this to be an inadequate link to establish personal jurisdiction:

As for plaintiffs’ allegations about the clinical trials having occurred in Missouri, plaintiffs argue that such activities play directly into BMS’s invitation to prove personal jurisdiction by showing the defendant “work[ed] on the regulatory approval of the product” in Missouri. Id. at 1778. But the Missouri clinical trials — the existence of which defendants readily admit — are simply too attenuated to serve as a basis for specific personal jurisdiction for defendants. Indeed, the trials would serve more properly as evidence of general personal jurisdiction. The non-Missouri plaintiffs do not allege they participated in a Missouri clinical study or that they reviewed and relied on Missouri clinical studies in deciding to use Essure. Plaintiffs also seem to suggest that specific jurisdiction exists because Essure could not have been approved without clinical trials, and some of those clinical trials occurred in Missouri. But again, this does not serve as an “adequate link” between Missouri and nonresidents’ claims that their individual device injured them in another state. See id. at 1781.

Id. at *5. With that, the court dismissed the claims of all 92 non-Missouri residents and retained jurisdiction over the claims of the remaining 3 plaintiffs.

While this was an excellent opinion, its importance may be greater than the ordinary opinion rejecting efforts to stretch personal jurisdiction under BMS. The District Court Judge was Stephen Limbaugh. He is a former Chief Justice of the Missouri Supreme Court and, as we understand it, well respected. This suggests that the current members of the Missouri Supreme Court will give his opinion a close read. Given how many product liability cases are filed in Missouri, that has to be a good thing.

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Having worked in the federal government, we are familiar with how important Department of Justice Guidance Policy memoranda can be.  They set priorities, outline criteria for acceptable guilty pleas and sentencing factors, and can make a huge difference in terms of who gets indicted or sued for what, when, and under which circumstances.  These DOJ guidances are seldom secret.  They can make quite a splash and set in motion a series of CLE conferences, complete with client glad-handing, Statements of the Obvious, and rubber chicken lunches. 

 

Now that we work on drug and device law, we are familiar with how important Food and Drug Administration Guidances can be.  They can address all sorts of things, such as off-label communications, social media, 510(k) submissions, cybersecurity, and 3D printing, just to name a few.  They, too, inevitably prompt a series of CLE circuses.  We have also become familiar with the propensity for plaintiff lawyers to hire FDA ‘experts’ who skillfully turn to the jury at just the right moment, break out in a wise and world-weary grin, and spin a tale of how the corporate malefactor broke the law.  It is, frankly, a mystery to us why some judges permit these travelling pseudoexperts to instruct the jury on the law,  and it is even worse when the experts’ legal opinions are not close to being legally sound.  For example, think of cases where an expert pretend-ruefully lays out a company’s purported violation of some FDA guidance (a violation, by the way, that the FDA itself has not decried), that is not even an actual violation of law.  What we have in such cases is a faux negligence per se theory – call it negligence per say so.

 

We’re now more than a month past Christmas, but the federal government seems to be handing out swell presents to the drug and device defense bar.  We wrote earlier this week about the Pharmaceutical Information Exchange Act, which is pending in the House of Representatives and which would introduce a rare note of sanity into the controversy over off-label communications.  A couple of weeks ago we praised the FDA’s decision to postpone implementation of its execrable “intended use” rule.  Today, we have the good fortune to report on the DOJ’s January 25, 2018 announcement that “Guidance documents cannot create binding requirements that do not already exist by statute or regulation.”  This remarkably refreshing policy flows from the Attorney General’s November 16, 2017 Guidance Policy, which stated that government guidances, which are not subject to the notice-and-comment rulemaking process, cannot bind the public.  The Attorney General in November 2017 was talking about DOJ guidances, but last week’s announcement makes clear that the same principles “should guide Department litigators in determining the legal relevance of other agencies’ guidance documents in affirmative civil enforcement.”  Thus, going forward, DOJ “litigators may not use noncompliance with guidance documents as a basis for proving violations of applicable law” in civil enforcement cases.  To the extent that guidances offer a useful paraphrase from existing statutes or regulations, they might be relevant.  To the extent that a defendant read a specific guidance, that fact could conceivably establish knowledge of a legal mandate that can be traced to a statute or regulation.  But the government cannot “treat a party’s noncompliance with an agency guidance document as presumptively or conclusively establishing that the party violated the applicable statute or regulation.”

 

At first blush, this new guidance will have immediate and profound effects on actions brought by the government against health care companies under the False Claims Act.  Too many of those actions are premised on no actual false statement and no actual violation of a statute or regulation.  Instead, these FCA cases have been permitted to go forward and exercise their in terrorem effect based on some vague violation of vague FDA guidances.  Even if not vague, an FDA guidance has no real legal effect.  The DOJ’s recognition of what guidances are and, more importantly, what they are not, should have the effect of cabining FCA actions in some reasonable and predictable fashion.  (If you think we are leaping to an unwarranted conclusion about what looks to us like the government’s concern about overreaching FCA cases, consider the fact that on January 10, 2018 – shortly before the policy guidance that inspired this post – the government published another policy memorandum, and that memorandum set out the factors that government attorneys should take into account in deciding whether the government should dismiss unmeritorious qui tam lawsuits.  QED.)  Since January 25, some defendants in qui tam cases have already filed motions based on the new DOJ policy.  If you represent a qui tam defendant, and if the complaint cites an alleged violation of an FDA policy, you might want to file a motion.  

 

What about civil cases brought by private plaintiffs?  The DOJ closed its January 25 announcement of the new policy by stating that “it is not intended to, does not, and may not be relied upon to, create any rights, substantive or procedural, enforceable at law by any party in any matter civil or criminal.”  That is all fine and good and is a typical  of careful draftsmanship.  But why wouldn’t the DOJ announcement strengthen an argument that we have already made (here, for example) that FDA guidances are only what they say they are – guidances – and are not laws or regulations?  Such guidances  have no legal effect on defendants, certainly do not establish negligence per se, and should not be in the bag of tricks of some plaintiff FDA expert who seeks to invade the province of both jury and judge.  Maybe a court will not consider the DOJ’s guidance to be binding, but wouldn’t it be fine if the court at least took the guidance as a worthy source of … guidance?    

   

 

 

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As we demonstrated in a post back in 2013, FDA compliance evidence generally − and the fact of a medical device’s clearance as “substantially equivalent” in safety and effectiveness to a predicate device under §510k of the Medical Device Amendments (now 21 U.S.C. §360c(f)(1)(A)) specifically – had for decades been admissible evidence in product liability litigation involving FDA-regulated drugs and devices.  In 2013 we found a half dozen §510k cases directly on point. Block v. Woo Young Medical Co., 937 F. Supp.2d 1028, 1047 (D. Minn. 2013); Placencia v. I-Flow Corp., 2012 WL 5877624, at *6 (D. Ariz. Nov. 20, 2012); Musgrave v. Breg, Inc., 2011 WL 4620767 (S.D. Ohio Oct. 3, 2011); Pritchett v. I-Flow Corp., 2012 WL 1340384, at *5 (D. Colo. Apr. 18, 2012); Miller v. Stryker Instruments, 2012 WL 1718825, at *9 (D. Ariz. Mar. 29, 2012); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1964337, at *7 (D. Minn. June 29, 2007); Corrigan v. Methodist Hospital, 874 F. Supp. 657, 658 (E.D. Pa. 1995); Strum v. Depuy Orthopaedics, Inc., 2013 WL 3184765, at *1 (Ill. Cir. March 8, 2013).

Then, in the Mesh litigation, rulings began to change the law on the premise that, because the United States Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), had held that §510k clearance was not preemptive – that is, not entitling a defendant to judgment as a matter of law – it was not even relevant in product liability litigation.  This argument turned on taking a phrase from Lohr out of context:  “[T]he 510(k) process is focused on equivalence, not safety” (id. at 493) and applying it in the evidence context.  As we had pointed out, so doing was contrary to the Supreme Court’s Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), decision holding that §510(k) clearance was intended “to ensure . . . that medical devices are reasonably safe and effective.” Id. at 349-50.  Our more recent blogposts have pointed out:  (1) that the FDA now considers §510k clearance to involve considerations of safety and effectiveness, and that (for a variety of reasons) the continued viability of Lohr itself is open to question.

Nonetheless, defendants in mesh litigation have largely been deprived of well-established FDA compliance evidence, and based on the capacious abuse of discretion standard applicable to evidentiary decisions at trial, such rulings have been upheld on appeal. See Eghnayem v. Boston Scientific Corp., 873 F.3d 1304, 1317-18 (11th Cir. 2017) (discussed here); In re C.R. Bard, Inc., MDL. No. 2187, Pelvic Repair Systems Products Liability Litigation, 810 F.3d 913, 921-22 (4th Cir. 2016) (discussed here) (“Cisson”); but see Winebarger v. Boston Scientific Corp., 2015 WL 5567578, at *7 (W.D.N.C. Sept. 22, 2015) (rejecting MDL rulings and admitting §510k clearance evidence in mesh case).

Yesterday, however another MDL judge considered the admissibility of §510k evidence, and held it admissible, flatly rejecting the Mesh decisions.  See In re Bard IVC Filters Products Liability Litigation, 2018 WL 582542 (D. Ariz. Jan. 29, 2018).  In IVC Filters, Judge David Campbell allowed the defendant’s “FDA defense,” ruling that the jury should be allowed to hear about §510k devices’ FDA pedigree.  Id. at *2.  Such evidence was doubly relevant under relevant state law:

  • “Georgia courts have adopted a risk-utility analysis for design defect claims. . . . One of the many factors a jury may consider in its reasonableness determination is the manufacturer’s compliance with federal regulations.” Id. at *2 (citation omitted).
  • “The evidence is also relevant to Plaintiff’s punitive damages claim. Under Georgia law, . . . [c]ompliance with federal regulations is not sufficient to preclude an award of punitive damages, but it is probative.” Id.

Coincidentally, Cisson also purported to interpret Georgia law, but reached a diametrically opposite conclusion.

IVC Filters rejected the false equivalence between preemption and relevance, and Mesh courts’ misapplication of Lohr:

Plaintiffs note, correctly, that the 510(k) process focuses on device equivalence, not device safety.  [Lohr citation omitted]  But this does not render evidence of the 510(k) process irrelevant to the reasonableness of [defendant’s] conduct.  The FDA grants 510(k) clearance only where the device “is as safe and effective as a [predicate device] and does not raise different questions of safety and efficacy than the predicate device.” Safe Medical Devices Act of 1990, Pub. L. No. 101-629, § 12(a)(1)(A)(ii).  The 510(k) process may not speak directly to the applicable standard of care . . ., but it does have probative value in the determination of this action.

Id. at *2 (citation omitted).  See also Id. at *3 n.2 (a preemption decision does “not address[] any evidentiary issue” and even as to preemption “the 510(k) process can in some circumstances preempt state law claims”) (citations omitted).

The excuses given for exclusion in Cisson, the jury giving clearance undue weight and a possible “mini-trial” regarding compliance, could “be adequately addressed without excluding relevant evidence to the detriment of Defendants.”  Id. at *3.  Reasonable “time limits” for each side’s evidence would prevent FDA issues from devolving into any “mini-trial.”  Id. at *4.  On the merits:

Both sides, through appropriate expert testimony or other admissible evidence, will be permitted to tell the jury about the role of the FDA in its oversight of medical device manufacturers, the regulatory clearance process for devices such as IVC filters, and [defendant’s] participation in the 510(k) process and its compliance (or lack thereof) with that process.

Id.  “[A]ny potential confusion” did not require exclusion, but only “a limiting instruction regarding the nature of the 510(k) process.”  Id. Indeed, IVC Filters correctly observed that the issue of jury confusion more likely cuts the other way – in favor of admission of FDA evidence:

[T]he absence of any evidence regarding the 510(k) process would run the risk of confusing the jury as well.  Many of the relevant events in this case occurred in the context of FDA 510(k) review, and much of the evidence is best understood in that context. Attempting to remove any references to the FDA from the trial would risk creating a misleading, incomplete, and confusing picture for the jury.

Id.  “[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 [IVC] filters, the jury would be left to speculate about the FDA’s involvement and conclusions.”  Id.

Until IVC Filters, we had feared that a single mass tort, under a discretionary standard of review and with the unwillingness of appellate courts to require MDL do-overs, could tilt the evidentiary playing field towards what IVC Filters cogently described as “a misleading, incomplete, and confusing picture for the jury” that excluded §510k clearance evidence that previously been admissible almost as a matter of course.  Now our side has a clearly articulated and compelling opposing view to argue.

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When Congress enacted HIPAA and its Privacy Rule in the mid-1990s, it was a big deal. Healthcare providers surely protected patient privacy in the pre-HIPAA days, but the federal statute gave them a standard set of rules with which to comply and a uniform referent against which to gauge their privacy practices.  All told, HIPAA’s impact has been both pervasive and positive.  Moreover, one of its lasting virtues is that, because the statute created no private right of action, you can’t get sued under HIPAA.

At least not directly. A plaintiff cannot file a complaint outwardly claiming damages for a “HIPAA violation,” but that has not stopped some state courts from permitting negligence claims using HIPAA to define a standard of care.  The latest is Connecticut, whose Supreme Court recently created the new tort of “unauthorized disclosure of confidential information.”

The case is Byrne v. Avery Center for Obstetrics and Gynecology, P.C., 327 Conn. 540 (2018) (to be published in A.3d), and its outcome will give healthcare providers in Connecticut even greater pause when producing medical records in litigation.  In Byrne, the plaintiff/patient instructed the defendant healthcare provider not to release her medical records to her ex-boyfriend, who later filed a paternity action against the plaintiff. Id. at 542.  The defendant healthcare provider then received a third-party subpoena in the paternity action ordering a records custodian to appear and produce the patient’s medical records, which the provider did by mailing records directly to the court a few days later. Id.

This is where Connecticut’s new tort comes in. Alleging that her ex-boyfriend viewed her records in the court file and then harassed her, the patient sued her doctor for breach of contract and negligence in multiple forms. Id. at 543-44.  The trial court ruled initially that the negligence claims were preempted because the plaintiff was using HIPAA as the basis for her claims. Id. at 544-545.  The Connecticut Supreme Court, however, reversed that order in 2014 and held that HIPAA did not preempt the claims.  Given the purpose of HIPAA—i.e., to enact uniform rules—and the transparent nature of the plaintiff’s effort to enforce HIPAA through civil litigation that the statute does not permit, we would have criticized this ruling had we written on it when it came out in 2014.

But that is not today’s story. On remand, the trial court again ruled for the defendant and granted summary judgment on the basis that Connecticut law did not recognize a common law claim for breach of physician confidentiality. Id. at 548.  On appeal, the Connecticut Supreme Court filled that gap:

We conclude that recognizing a cause of action for the breach of the duty of confidentiality in the physician-patient relationship by the disclosure of medical information is not barred by [Connecticut statutes] or HIPAA and that public policy, as viewed in a majority of other jurisdictions that have addressed the issue, supports that recognition.

Id. at 550. So Connecticut patients not only can sue their doctors now for negligently disclosing their medical information, but can do so for responding to a subpoena in a pending legal action.

The core of the opinion examines both federal law and other states’ laws to conclude that the “majority” support the new cause of action. On federal law, the Court held that HIPAA supported a common law claim because Connecticut doctors follow HIPAA anyway and that a state-law tort would support HIPAA:

We further conclude that, to the extent it has become common practice for Connecticut health care providers to follow the procedures required under HIPAA in rendering services to their patients, HIPAA and its implementing regulations may be utilized to inform the standard of care applicable to such claims arising from allegations of negligence in the disclosure of patients’ medical records pursuant to a subpoena.

. . . [N]egligence claims in state courts support at least one of HIPAA’s goals by establishing another disincentive to wrongfully disclose a patient’s health care record.

Id. at *556-57.

As for other states’ laws, the Court surveyed state cases and found eight states that recognized comparable claims (although the one case cited from New York does not really say that) and four that did not. Id. at 557-68.  In following the states that have recognized the tort, the Court cited various sources for the duty, including state licensing statutes, evidentiary rules governing privileged communications, common law “principles of trust,” and the Hippocratic Oath. Id. at 564.

We have a few questions about this new tort. First, it is highly questionable to cite federal law as “supporting” a civil action with HIPAA defining the standard of care.  As even the Connecticut Supreme Court acknowledged, “It is by now well settled that the statutory structure of HIPAA . . . precludes implication of a private right of action.” Id. at 555.  Having recognized this principle on the one hand, the Court should not have invoked HIPAA to support its new private right of action on the other.

Second, it stands out that the Court spent about nine pages discussing the state authorities that support its position, but dismissed the four states that reject the tort in a single paragraph and a single sentence of analysis: “[Connecticut statutes] created a broad physician-patient privilege, and, therefore, the rationale of these jurisdictions that decline to recognize a common-law action for breach of duty of confidentiality is not persuasive in Connecticut.” Id. at 567.  More discussion of the contra authorities would have been helpful, especially considering that Connecticut is not unique in recognizing a physician-patient privilege.

Third, what are healthcare providers supposed to do? The ex-boyfriend served a subpoena, a court-issued document that millions of litigants rely on every day to obtain documents—including medical records.  The Connecticut Supreme Court’s first reaction is to denigrate subpoenas.  Connecticut law allows disclosure of medical records without patient consent only pursuant to “statute or regulation of any state agency or the rules of court.” Id. at 568.  According to the Court, a “subpoena without a court order” is none of those things. Id. That leaves us scratching our heads, because subpoenas in our home state and also in federal court are authorized by statute and/or court rules.  We would be surprised if the law of Connecticut were different.

The Court also placed great weight on the fact that the healthcare provider did not appear in person to produce the records and did not alert the patient/plaintiff or move to quash. Id. at 569-72.  But even though subpoenas routinely order record custodians to “appear” with records, they almost never do.  They make the records available for copying, or they mail them, which is what the healthcare provider did here.  This strikes us as creating a new cause of action on the back of a technicality.  As for the requirement that the provider alert the plaintiff or seek a judicial remedy, the Court cited federal regulations.  So now we are back to enforcing HIPAA.

We sometimes advocate for a high regulation, low litigation approach to product liability, and that approach particularly suits the protection of private information. Healthcare providers take patient privacy seriously, and when pulled involuntarily into litigation, the rules they need to follow ought to be clear.  Connecticut’s new tort does not advance that cause.

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Like a lot of large firms, Reed Smith has a number of blogs. We don’t mention them much because, DDL has product liability pretty well covered, and the others mostly don’t overlap a lot with what we do.  But occasionally….

The other day, Reed Smith’s Health Industry Washington Watch blog described a couple of pieces of legislation that, without much fanfare, passed a subcommittee of the House of Representatives (Energy and Commerce Health Subcommittee ) while everyone was distracted, watching the Senate’s struggles to keep the government functioning.

We’re interested because both of them, were they ever to be enacted into law, could affect our sandbox.

The first bill, H.R. 2026, is the Pharmaceutical Information Exchange (“PIE”) Act (see here for more information)  This bill would be another step forward in the now decades-long struggle to legalize truthful manufacturer communications about off-label uses.  It’s not very long – one paragraph:

Health care economic information or scientific information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs for coverage, reimbursement, or other population-based health care management, shall not be considered false or misleading or any other form of misbranding . . ., if it is based on competent and reliable scientific evidence and relates to an investigational new drug or an investigational use of an approved drug. In order for information relating to an investigational use of an approved drug to be provided pursuant to this subparagraph, there must have been submitted to the Secretary a supplemental application for approval of such use, or the study or studies needed to support the submission of a supplemental application for such use must have been completed with the intention that a supplemental application will be submitted to the Secretary for approval of the use.  For purposes of this subparagraph, scientific information includes clinical and pre-clinical data and results relating to an unapproved drug therapy, or drug indication, or other condition of use being investigated or developed.

We’re not sure why, but as phrased PIE only applies to drugs, but not medical devices.  [subsequent note:  This has been fixed by this amendment, so that PIE applies to both drugs and devices.]

As passed by the House, PIE allows off-label communications basically to third-party payors (“TPPs”), about off-label uses.  Communications can begin when “the study or studies needed to support the submission of a supplemental application [to the FDA] for such use . . . have been completed.”  If the supplemental application has been submitted, great, but it doesn’t need to be.  And more than just studies can be discussed – so can “clinical and pre-clinical data and results,” as long as it qualifies as “competent and reliable scientific evidence.”

PIE still doesn’t comport with the First Amendment, since it limits both the audience and the circumstances under which manufacturers may speak about truthful scientific information, while not imposing any limits on anyone else.  Thus it still discriminates both by topic and speaker under Reed v. Town of Gilbert, 135 S. Ct. 2218, 2230 (2015).  Nonetheless PIE would be a decent step in the right direction in terms of litigation.

First, it would greatly reduce litigation by TPPs over alleged off-label promotion.  Second, it would be another exception to the FDA’s increasingly tattered prohibition of truthful off-label speech, and each exception makes the ban itself less defensible against First Amendment challenges.  See Greater New Orleans Broadcasting Ass’n, Inc. v. United States, 527 U.S. 173, 190 (1999) (holding the “regulatory regime is so pierced by exemptions and inconsistencies that the Government cannot hope to exonerate it”).  Third, it makes the other side’s rhetoric against off-label promotion less credible, particularly on occasions when the exact same information is already being transmitted to TPPs.  Indeed, one could argue that a prescribing physicians’ medical practice is a “similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs for . . . other population-based health care management.”

The second bill is called the Over-the-Counter Monograph Safety, Innovation, and Reform Act (“OM-SIRA”).  Apparently the subcommittee passed a “discussion draft” that doesn’t even have an “H.R.” number.   Without making a word-for-word comparison, this draft appears substantively the same as S.2315, which is available here.  OM-SIRA deals with nonprescription drugs that are marketed without an approved new drug application.  Yes, there are such things, and we blogged about preemption issues related to them here.  And preemption is what piques our interest about OM-SIRA.  As summarized by the Reed Smith blog, OM-SIRA:

would create a system for future changes to drug monographs through an administrative order procedure with the opportunity for development meetings or other consultations, submission of comments on proposed orders, and dispute resolution procedures.

This means that OTC drugs under OM-SIRA would be subject to the administrative proceedings created by the bill before their manufacturers could modify those products or their labels.  Interestingly, the FDA can act unilaterally to modify a label, but not OTC manufacturers.  §505G(b)(4)(B)).   Manufacturers can act unilaterally only as to “minor” changes that do not affect “safety and effectiveness”  §505G(c).

If OM-SIRA were enacted in its present form, it appears to us that the administrative approval procedures in the bill would provide a basis for implied impossibility preemption under the “independence principle” of PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).  Since implied preemption operates independently of express preemption, it would not be subject to the partial savings clause in 21 U.S.C. §379r(e), which would be very good thing for defendants in such litigation.

With respect to both bills, we’ll see what happens.  Maybe Congress won’t be PIE in the sky this time around.

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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