In the annals of history, June 6 gets prime billing.  That’s understandable, because the successful Normandy landings on D-Day (June 6, 1944), probably saved Western Civilization.  (Or maybe that heroic endeavor simply preserved liberal democracy for another 75 years, now that we seem encircled by fanatics both home and abroad who view the Enlightenment with disdain.)  But June 7 is no slacker.  On June 7, 1776, Richard Henry Lee introduced the Lee Resolution, which later became the Declaration of Independence. 364 days before D-Day, the American Navy decisively won the Battle of Midway, which turned the tide of the Pacific War.  On June 7, 1892, Homer Ferguson refused to leave the whites-only part of a train.  He later lost his Supreme Court case, Plessy v. Ferguson.  That opinion upheld “separate but equal,” a nasty judicial stain that would not be scrubbed away until 1954.  (SCOTUS Lesson #1: Horrible Supreme Court precedents can be overturned, but it can take a terribly long time – almost as long as the interval between NBA Finals games.)  One year later, on June 7, 1893, an Indian barrister offered a very similar refusal in South Africa.  That refusal is usually counted as Gandhi’s first act of civil disobedience.  And on June 7, 1965, the Supreme Court issued its decision in Griswold v. Connecticut, holding that married couples have a constitutional right to contraception.  Maybe there are people in 2017 who regret that decision (see our overly political parenthetical above) but we’d be surprised to meet such people, just as we’d be surprised to meet people who regret Brown v. Board of Education.  Still, the High Court arrived at that sensible result via a fuzzy analysis (e.g., “penumbras” and “emanations”) that could justify just about anything.  (SCOTUS Lesson #2: Good results and good reasoning do not always operate in tandem.)

In the passage of time, whether viewed as a Hegelian movement of ideas or as merely One Damned Thing After Another, June 7 is a significant date.  Now here comes the inevitable strained segue: today’s case, In re Cook Medical, Inc. IVC Filters Marketing, Sales Practices and Product Litigation, 2017 U.S. Dist. LEXIS 82761 (S.D. Indiana May 31, 2017), is about the passage of time.  More specifically, it is about how statutes of repose apply in drug and device litigation.

We do not often get a chance to write about statutes of repose.  We get more opportunities to discuss statutes of limitations, though we infrequently seize those opportunities, because the issues are usually fact-specific and obvious.  By contrast, statutes of repose present interesting legal issues, and their force can be devastating to tardy claims.  In the In re Cook Medical case, the defendant made a motion on the pleadings to dismiss claims on the ground that they were precluded by statutes of repose.  The court wrestled with three different statutes of repose:  Georgia, Tennessee, and Texas.  The differences among those statutes resulted in different dispositions of the claims by the various IVC Filter plaintiffs’ claims.

Georgia

The Peach State bars claims for strict liability, negligence, or breach of warranty if the suit is not brought within ten years from the date of the first sale.  The Georgia plaintiffs’ claims in this case were filed more than ten years after the sale.  Buh-bye, right?  Not so fast.  Georgia’s statute of repose contains an exception if the defendant manufacturer engaged in conduct manifesting “willful, reckless, or wanton disregard for life or property.”  The plaintiffs argued that they had alleged such conduct.  How? it is not clear from the opinion.  Please excuse a slight rant.  It seems far too easy for drug and device plaintiffs to allege that any failure to warn equals reckless or wanton conduct.  Courts need to clamp down on this all-too-easy way to maintain settlement leverage or exploit jury anger.  Not adding a warning in the face of controversial or mixed studies should not be the stuff of punitive damages.  Maybe someday courts will wake up to this nonsensical hole in product liability law.  End of rant.  The In re Cook court was not such a court.  But it did limit the damage. It held that that the willful/reckless/wanton exception applied only to negligence claims, but not to strict liability and warranty claims.  Thus, the court dismissed the strict liability and warranty claims per the statute of repose.  The negligence claims remained.  So did the consumer fraud claim, which the court held was not subject to the statute of repose.

Tennessee

Tennessee also has a ten year statute of repose, though apparently not the willful/reckless/wanton exception.  At least no such exception was raised in this case.  The Tennessee plaintiffs conceded that the strict liability claims were doomed, but they tried to keep their negligence and warranty claims alive.  Nice try, said the court, but Tennessee’s Product Liability Act defines “product liability action” to include all of the plaintiffs’ claims.  That did not quite end the debate. The plaintiffs pointed out that Tennessee extended the statute of repose to 25 years for asbestos and silicone gel implant claims.  Why should those claims get such special treatment?  Never you mind, said the court, which applied the rational basis test and concluded that the Tennessee legislature was allowed to make such distinctions.  Sure, IVC Filters might pose risks of latency, but the constitution does not compel legislators to treat all latent defects the same.  Put another way, “[i]t is no requirement of equal protection that all evils of the same genus be eradicated or none at all.”  In re Cook Medical, IVC Filters Prods. Litig., 2017 U.S. Dist. LEXIS 82761 at *14, quoting other cases.  The court dismissed all of the Tennessee claims.

Texas

“T for Texas, T for Tennessee.”  Those two states go together musically (see Guy Clark, Willie & Waylon, Lynyrd Skynyrd, etc.).  Here, they also go together legally, as the defendant prevailed on the statutes of repose from both states.  The Texas statute of repose is for 15 years.  (Of course it is bigger.  This is Texas.)  But there is an exception if the manufacturer/seller explicitly warrants that the product has a useful life longer than 15 years. The Texas plaintiff attempted to save her claims by filing an affidavit, wherein she said she was told that the device was permanent, and the Patient Guide, which stated that the IVC Filter was “safe and effective as either a permanent or temporary device.”  But this was a motion on the pleadings.  Outside materials are not allowed.  Looking just at the complaint, there was no allegation that the IVC filters were marketed as permanent devices.  That is very, very bad for the plaintiff:  “As this is a motion for judgment on the pleadings, the omission of her specific warranty allegations is fatal.”  Id. at *18.  You might think that is an extraordinarily severe result.  No matter. The court observed that even if the allegations of permanence were included in the complaint, the claims would still not fly, because the plaintiff nowhere alleged any specific person who warranted permanence, and nowhere alleged any reliance on such warranty of permanence. As for the Patient Guide, the plaintiff did not allege in either her complaint or her affidavit that “she read the Guide before her surgery, much less that she relied on the Guide rather than her own doctor’s recommendation.”  Id. at *20.  Accordingly, the exception to Texas’s statute of repose did not apply, the statute of repose did apply, the claims were timed-out, and they had to be dismissed.

Sometimes it takes a lot of words to say something.  The Iliad.  War and Peace.  SCOTUS’s Obergfell decision.  But sometimes, in just a few words, it is possible to create an image, or stir a memory, or underscore a point.  Call me Ishmael.  I have a dream.  A rose by any other name would smell as sweet.  And, apropos of sweet-smelling roses, today’s very short Georgia Supreme Court decision makes the point that expert opinions are expert opinions even when clothed as fact testimony, and must be excluded from evidence unless they meet the relevant admissibility standards. Yugueros v. Robles, 2016 WL 6407314 (Ga. Oct. 31, 2016), is not a drug or device decision.  It is a medical malpractice case, but its holding is relevant for anyone who deals with opposing experts.  Which we do, regularly and painfully.  (You can see a recent post on a similar issue here.)

In Yugueros, the appellant performed extensive cosmetic surgery on the appellee’s decedent (his wife).  Subsequently, Mrs. Robles went to the emergency room suffering from severe abdominal pain.  After an abdominal x-ray, which the E.R. doctor determined to be “unremarkable,” Mrs. Robles was discharged.  A radiologist who later saw the abdominal film could not rule out the presence of free air in the abdomen, which “could be a normal post-operative condition or could indicate a more serious issue.” Yugueros, 2016 WL 6407314 at *1.  The radiologist recommended a CT scan and posted his opinion in Mrs. Robles’s electronic medical record.

Continue Reading Expert Testimony in Sheep’s Clothing is Still Expert Testimony, Says Georgia Supreme Court

Usually, when res judicata comes up in our cases, we are trying to fend it off. Luckily, non-mutual offensive res judicata is rarely recognized, so plaintiffs usually fail when trying to preclude the drug or device manufacturer from putting up a full defense based on a prior ruling or verdict in a different case. Occasionally, in serial product liability litigation, we find a plaintiff trying to sue over the same injury twice, but that rarely requires motions, let alone motions based on res judicata. Today, however, we are discussing a Georgia state court case where a drug company’s settlement with Georgia and other governmental entities in a longstanding federal case precluded eight Georgians from suing the same company on behalf of Georgia. Were we to channel a fellow blogger, we might draw some parallel to “The Walking Dead,” which is filmed in Georgia and had been based in Georgia until season 5 (when the gang headed up to Virginia). We might say something about how related cases that pop up after an adjudication on the merits are like “walkers” and have to be disposed of accordingly. We might inject some spoilers by mentioning which main character got shot in the most recent episode and which main character is rumored to die in the next episode. We might even connect these events to an earlier failure to resolve an earlier dispute more definitively. Instead, we will just stick to the case.

Jordan v. State, No. A15A1733, 2016 Ga. App. LEXIS 176 (Ga. App. Mar. 23, 2016), does not have the drug manufacturer as a party to the appeal because it was the State of Georgia that filed and won the motion to dismiss below (although treated as a motion for summary judgment on appeal). This procedural quirk flows from the nature of qui tam litigation. In 2004, a relator named Starr filed a suit in the Eastern District of Pennsylvania against her former employer claiming that its marketing of a prescription anti-psychotic for off-label uses created liability under various statutes, including the federal False Claims Act for reimbursement by various governmental entities. (Some of this background is presented in Jordan, but some details are added from public information.) Over time, other relators filed similar cases, the United States intervened, and Starr’s complaint was amended to include claims under the later-enacted Georgia False Medicaid Claims Act (GFMCA) and various similar state statutes. In late 2013, there was a massive settlement of criminal and civil cases between the manufacturer, the United States, and a number of states—including Georgia—resulting in, among other things, payment of millions of dollars to Georgia and a dismissal with prejudice of the Starr case.

Continue Reading Some Good Georgian Res Judicata

We’re pleased to report that good things continue to happen in Atlantic County product liability proceedings following recent judicial turnover. On February 19, 2016, the Reed Smith Bard/Davol defense team scored a hat trick – going three for three on summary judgments in New Jersey hernia mesh litigation. The three decisions are: Goodson v. C.R. Bard, Inc., 2016 WL 743478 (N.J. Super. L.D. Feb. 19, 2016); Utech v. C.R. Bard, Inc., 2016 WL 743477 (N.J. Super. L.D. Feb. 19, 2016); and Yakich v. C.R. Bard, Inc., 2016 WL 743476 (N.J. Super. L.D. Feb. 19, 2016).

A bit of background. These three are not mass tort cases. They are examples of what happens when there is indiscriminate plaintiff-side advertising. People call up these 800 numbers because they had “mesh” implanted. They don’t have the targeted product but – what the hey? – it’s mesh and some of the raw materials are the same, so rather than turn away a potential plaintiff, the same attorneys file one-off cases against virtually every mesh product that exists, even if (as is true here) the particular product has been the medical standard of care for the relevant surgical procedure for decades.

As one might expect with pattern litigation, these three lawsuits, and thus these three opinions, look a lot alike. So we’ll concentrate on the Goodson opinion – if for no other reason than alphabetical order.

Continue Reading New Jersey Mesh Summary Judgment Hat Trick

This post is from the non-Reed Smith side of the blog.

It has been over 2 months since we lasted posted about an InFuse decision.  What’s been happening (outside the DDL Blog world) since that last post.  The Cuban flag was raised at its embassy in Washington DC officially restoring full diplomatic relations between the two countries for the first time since 1961.  At almost the same time, the Confederate flag was removed from the South Carolina Capitol ending 54 years of it being on display.   The Boy Scouts of America ended its ban on gay adult leaders and the first two women graduated from the Army Ranger School.  And the last time Labor Day gas prices were this low, George W. Bush was in his first term as president (under $2 in New Jersey).

There is nothing quite so historical or monumental about the latest InFuse decision.  It doesn’t break new ground or celebrate the demise of old prejudices.  But it is a good, strong, solid opinion and another nail in the coffin for off-label promotion claims.

The case is Latimer v. Medtronic, Inc., No. 2014-CV-245871, slip op.,  (Ga. Sup. Ct. Sept. 4, 2015).  The allegations are essentially the same as we’ve seen in other InFuse cases – because my doctor chose to use the device off-label, preemption should fly out the window.  But as this court recognized, slip op. at 11-12, almost every court in the country that has considered that argument has found it significantly lacking.  Time to add Georgia to the list.  The decision includes a nice recitation of PMA preemption law, id. at 8-11, which serves as the court’s foundation for its ultimate conclusion that with the exception of affirmative fraud claims (which weren’t adequately pleaded), none of plaintiff’s other claims pass through the narrow gap between express and implied preemption.  Id. at 11.

This plaintiff started like other InFuse plaintiffs by arguing that express preemption should not apply because his surgeon used the device off-label.  Plaintiffs wield “off-label use” like vaudevillian magicians used “abracadabra.”  Instead of pulling a rabbit out of a hat, plaintiffs try to make preemption disappear.  But the courts have seen the smoke, the mirrors, and the strings – and they’re simply not buying it.  Use doesn’t matter.  PMA federal regulations are applicable to the device, not the use.  Id. at 13.  Plaintiffs’ parlor tricks don’t improve when they switch to “off-label promotion.”  “[N]othing in §360k(a) suggests that the preemption analysis somehow depends on how the device is being promoted to be used.”  Id. at 14 (citations omitted).  So, regardless of off-label use and promotion, preemption still applies.

Failing to avoid preemption all together, plaintiff’s next argument was to claim that he was asserting a parallel claim for prohibited off-label promotion.  The court by-passed the question of whether off-label promotion is in fact prohibited, ruling instead that even if it was – a claim based on it would be impliedly preempted.  Id. at 15.  There is no state law cause of action prohibiting off-label promotion. Off-label use is completely a “creature of the FDCA.”  Therefore, “any claim based on off-label promotion would be in substance a claim for violating the FDCA.”  Id. (citations omitted).  That’s a Buckman no-no.

Having put aside any notion that off-label use/promotion somehow changes the equation, the court turned to applying the preemption analysis to plaintiff’s specific claims.  First the court pooled together all of plaintiff’s failure to warn claims.  Regardless of how they are “labeled” (negligence, strict liability, statutory fraud), “to the extent each claim rests on a contention that Medtronic failed to inform Plaintiff or his surgeon about risk allegedly associated with the use of the Infuse device, each is at bottom, a failure to warn claim.”  Id. at 15.  And since each is a claim that Medtronic should have provided warnings different from or in addition to those required by the FDA, each is preempted.

The court didn’t pull any punches.  Even though the failure to warn claims were preempted, the court went on to find that they would also have failed as a matter of Georgia law.  Having looked at the labeling and other medical information available from the FDA at the time of plaintiff’s surgery, the court concluded that “Medtronic had no duty to warn Plaintiff’s surgeon, because where a product is vended to a particular group or profession, the manufacturer is not required to warn against the risks generally known to such group or profession.”  Id. at 22.

Plaintiff tried to save his failure to warn claims by alleging failure to report adverse events to the FDA.  The argument is that since that is a federal requirement, a failure to warn claim based on it is a non-preempted parallel claim.  First, plaintiff didn’t plead that claim in his complaint.  But even if he had, “there is not duty under Georgia law to report adverse events to the FDA.”  Id. at 17.  For a state law claim to parallel a federal requirement, the state law claim must exist.  This one does not.  But the court didn’t stop there.  It held that a failure to report claim would also be impliedly preempted as nothing more than a prohibited private right of action to enforce FDA reporting requirements.  Id. at 18.  Another Buckman no-no.  And, the court found that the failure to report claim would fail because plaintiff did not allege a causal connection between the purported failure to report and his injuries.  Id. at 18n.5.  Express preemption, implied preemption, and no causation – a trifecta.

Moving next to design defect, it’s hard to argue that a claim that a product should have been designed in a manner different than that approved by the FDA is not expressly preempted.  It is.  Id. at 18-19.  More importantly, applying Bartlett the court also found the claim impliedly preempted.

To the extent Plaintiff contends that Georgia law required Medtronic to change Infuse’s design or labeling without FDA approval, his claims are impliedly preempted, because federal law affirmatively prohibits manufacturers from changing the design or labeling of PMA-approved devices without obtaining prior or ultimate FDA approval. Any claim predicated on the contention that Medtronic was as a matter of state law required to adopt a different design or label fails, because under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted.

 

Id. at 19 (quotation marks and citations omitted).

The court also ruled that plaintiff’s breach of express and implied warranty claims were preempted.  Plaintiff’s claim was based on allegations that Medtronic had breached warranties that the device was safe.  “To prevail on this claim, a jury would need to find that Infuse was not safe and effective as labeled” which would conflict with the FDA’s PMA determination that the device was safe and effective.  Id. at 20.  That conflict means that the state would be imposing different or additional requirements (express preemption) and that the claims “interfere with FDA’s regulation of Class III medical devices” (implied preemption).  Id. at 20-21.

Finally, the court dismissed plaintiff’s claims under the Georgia Fair Business Practices Act and Uniform Deceptive Trade Practices Act.  The claims survived preemption only to the extent they were predicated on “alleged affirmative misrepresentations rather than purported omissions.”  Id. at 16.  Fraud by omission requires a state law “disclosure requirement” that would be different from or additional to the requirements of federal law.  Id.  But these claims failed to clear several other obstacles — such as the fact that both statutes have safe harbors that exempt actions or conduct authorized or in compliance with federal law.  Id. at 22.  Since the FDA granted premarket approval and authorized the sale of the device – plaintiff is outside the scope of either act.  Moreover, the Fair Business Practices Act applies only to consumer products, which a prescription medical device is not and the Uniform Deceptive Trade Practices Act only provides injunctive relief not damages.  Id. at 22-23.  To top it all off, these fraud claims were not pleaded with the requisite specificity. The complaint is missing the who, what and when for any alleged misrepresentation.  And it might even be missing the misrepresentation.  Plaintiff alleged that doctors were paid to promote off-label use.  But “off-label marketing . . . is itself not inherently fraudulent.”  Id. at 24.  Off-label does not mean false.  

This case might not be as newsworthy as say today’s trending news such as the NFL switching from Roman to Arabic numerals for Super Bowl 50, or that 5 NYPD police officers tackled and cuffed former tennis star James Blake after he was misidentified, or that Donald Trump has soared to 32% in the polls.  Then again, if those are the headlines – we’ll stick with off-label use.

Holism is a concept modernly used most commonly in medicine –treating both the body and the mind.  We don’t see it too often in legal parlance as it’s come to be associated with a somewhat touchy-feely approach.  Not something litigators are often accused of being.  At its core, holism is a philosophy based on treating something as more than the sum of its parts.  So when we read in Schmidt v. C.R. Bard, 2014 U.S. Dist. LEXIS 146459 (S.D. Ga. Oct. 14, 2014) that on a motion to dismiss, the judge was “[r]eading Plaintiff’s Complaint holistically,” we were fairly sure we weren’t going to be happy with the results.  And we were right.

A holistic approach to pleadings is precisely what TwIqbal aims to prevent.  Either the complaint contains sufficient and specific factual allegations that go beyond speculation and legal conclusions or it doesn’t.  Using the TwIqbal standard, a complaint is only as good as its parts; its allegations. You can’t fix bad pleadings by reading into them more than what is there.  But we think that is exactly what the court did in this case.

The suit involves the implantation of a mesh device to repair a hernia.  Plaintiff ultimately had to have the device removed and alleges permanent injury as a result.  Id. at *1-2.  Assessing whether plaintiff sufficiently pleaded a design defect claim, the court starts off with a general statement we support:  “a bald assertion that the [device] was defective in design . . ., was unreasonably dangerous, and the foreseeable risks outweighed the [] benefits would be insufficient to survive a motion to dismiss.”  Id. at *8.  But then the court goes on to conclude, and repeatedly state, that plaintiff listed 9 possible design defects and therefore survives a motion to dismiss.  The court never identified what those 9 “defects” were, so we looked at the complaint ourselves.

Continue Reading Georgia Court Takes a Holistic Approach to Pleading

Not quite a year ago we praised a decision out of the Northern District of Georgia for dispatching a plaintiff’s expert after applying Daubert and dispatching an entire case after applying logic.  The case was called Brown v. Roche Laboratories, Inc., 2013 U.S. Dist. LEXIS (N.D. Ga. June 6, 2013), and it was another of those sad SJS/TEN cases.  The plaintiff expert’s causation opinion was based on a temporal association and not much else.  Moreover, as we reported with a surfeit of accuracy and eloquence, “the learned intermediary rule precluded the claim, inasmuch as the doctor knew of the risk and made a considered decision to prescribe the drug in spite of the risk.  No expert in the world could solve that problem for the plaintiff.”

It’s seldom a good idea to reread something you wrote a while ago.  You plop down in the chair, don the Kmart reading glasses, and take another look at your precious prose.  Within seconds, disappointment and embarrassment plop down beside you.  Our review of the Brown blogpost was mixed.  We think we were right, but we also think we were unduly prolix.  We took eight paragraphs to summarize an uncomplicated opinion.

And now the Eleventh Circuit has issued an opinion affirming the lower court’s ruling, affirming our own take on the case, and affirming our hunch that our verbosity was unnecessary.  In an unpublished opinion that barely makes it onto the fourth page, the court affirmed summary judgment without even reaching the Daubert issue.  Brown v. Roche Laboratories, Inc., 2014 U.S. App. LEXIS 9946 (11th Cir. May 20, 2014).  The plaintiff could not prove that the failure to warn physicians to test and substitute an alternative antibiotic for penicillin-sensitive patients was the proximate cause of the plaintiff’s skin condition.  Under Georgia law, “if a manufacturer of a prescription drug warns a patient’s physician of any risk or hazards of the drug and, despite the known risk of harm, the physician administers the drug, the manufacturer is insulated from liability for injuries by the patient.”  The doctor who prescribed the medicine testified that he knew the plaintiff was sensitive to penicillin and that there was a possible cross-reactivity, yet he went ahead with the prescription.  That “reasoned decision … severed any causal link between the alleged ineffectiveness of the warning label” and the alleged injury.

Perhaps we have already been too loquacious in rendering this sound, straightforward result.   Sometimes it is hard to resist the impulse to be a singer of tales.  And we will let that stand as the first clue about where this writer will be on vacation by the time you read this – just in case anybody wants to play the game of Where in the World is Stevie Mac.  Further hint: think of a country a long ways away and with a pretty long coastline.  Further further hint:  think of a country that wasn’t a country when Bush 41 was in office.

We talk a lot about preemption here.  Click on the preemption topic on the side of our webpage (here) and you’ll get pages and pages of posts.  That isn’t surprising.  Preemption can end a litigation, and we all want to hit the game-winning home run.

But plaintiffs know that too.  So, rather than taking preemption head on, we often find ourselves dealing instead with plaintiff’s attempts to get around it via “parallel violations” claims.  Now, we have problems with the very existence of such claims.  Among other things, they often appear to be improper attempts to bring private rights of action under the FDCA.  But, unfortunately, they exist, and courts recognize them.  Given that reality, however, we’d like courts to at least view them with a scrutinizing eye.  The court in Cline v. Advanced Neuromodulation Sys., Inc., 2014 U.S. Dist. LEXIS 56669 (N.D. Ga. Mar. 31, 2014), did just that.

In Cline, the plaintiff had an opportunity for limited discovery (which we’ll discuss later) into the PMA specifications that came with the approval of an implantable pulse generator (“IPG”) implanted into plaintiff. Plaintiff then filed her third amended complaint in an attempt to state parallel violation claims related to the failure of her IPG.  It didn’t go exceedingly well.  The court lowered the microscope to look at those claims for what they really were, and almost all them did not survive.

Continue Reading A District Court Takes an Exacting Look at Parallel Violation Claims

As always, discussion of the pelvic mesh litigation comes from the non-Reed Smith side of the blog.

This summer we blogged about many pre-trial and in limine rulings in the Pelvic Mesh MDL. Most were quite favorable.  One of those decisions that we thought was pretty good was Cisson v. C.R. Bard, Inc., see post, which threw out a duty to test claim and applied a stringent state-of-the-art standard.  Back in July, we thought that ruling was helpful to the defendant and would serve it well at trial.  Well, we’re clearly not seers.  While we sometimes like to look into our crystal ball, our predictions are usually based on nothing more than wishful thinking (we like to think it’s more than that, but usually it’s not).  The Cisson case went to trial and the jury returned a verdict against the defendant awarding both compensatory and punitive damages.  Defendant moved for judgment as a matter of law during trial and the court deferred until post-verdict.  Unfortunately, the court upheld the verdict and in so doing made some not so great rulings.

A quick background of the case.  Plaintiff underwent implantation of defendant’s pelvic mesh device and began experiencing pain.  Two years later, she had surgery to remove the device, but the “arms” of the device could not be removed.  Plaintiff alleged that she continue to experience pain and evidence was presented that she suffered extrusion, erosion, excessive scarring, and inflammation. Cisson v. C.R. Bard, Inc., 2013 U.S. Dist. LEXIS 149976 at *3-4 (Oct. 18, 2013).  Plaintiff presented two claims to the jury – design defect and failure to warn.

Continue Reading A Not So Peachy Decision Under Georgia Law

Marriage is a civil institution, so it’s natural that there are so many laws respecting it. Marriage is also an emotional, fragile relationship, so it’s also natural that many of the laws are a bit nutty.   For instance,  on Sundays in Hartford, Connecticut, it is illegal for a man to kiss his wife. A married couple in a rented room in Massachusetts may not legally sleep in the nude.  In Vermont, a wife must have written permission from her husband to wear false dentures.  And marriage-law-madness is not confined to New England.  You might have heard of proxy weddings, where the marriage ceremony takes place without the presence of either the groom or the bride — somebody else stands in for one of them.  There might be perfectly good reasons for that to happen.  But in Montana (and, as far as we can tell, only in Montana) there can be a proxy for both the groom and the bride. We do not know whether the Big Sky state also countenances proxy honeymoons.  In Kentucky, a woman is not allowed to marry the same man more than 3 times.  Hmmm.  Maybe that’s not so strange.  Maybe that’s just common sense.

We’ve all likely heard the phrase that the “law is an ass.”  It comes from the Charles Dickens novel Oliver Twist, when a character is schooled on the fine points of the doctrine of coverture.  Specifically, Mr. Bumble is informed that “the law supposes that your wife acts under your direction”.  Mr. Bumble replies “If the law supposes that … the law is a ass – a idiot.  If that’s the eye of the law, the law is a bachelor; and the worst I wish the law is that his eye may be opened by experience.”

Joe Hollingsworth recently sent us another defense win in the Aredia-Zometa litigation, and there are a number of aspects to it that will cheer and empower other defense practitioners.  But the case also reminded us of the way marriage sometimes sits rather oddly in the legal matrix.   In Wheeler v. Novartis Pharmaceuticals Corp., Case No. 1:11-cv-0021 (S.D. Ga. May 15, 2013), a husband brought suit both on behalf of the estate of his deceased wife and in his personal capacity for loss of consortium.  The claim was that his wife developed osteonecrosis of the jaw (“ONJ”) as a result of her use of Zometa. The court granted summary judgment for the defendant on the claims of both the estate and the husband, but for different reasons.

The court had no problem holding that the underlying claim on behalf of the wife’s estate was barred by Georgia’s statute of limitations for personal injury actions. Georgia law requires that “[a]ctions for injuries to the person shall be brought within two years after the right of action accrues…”O.C.G.A. §9-3-33.  The lawsuit was filed on December 28, 2011.  The court gave the plaintiff the benefit of the doubt by treating the prescription of the drug as a continuing tort (there were continual doses of Zometa), thus permitting the plaintiff to invoke the discovery rule.  But even the discovery rule could not save the underlying claims.

The wife arguably discovered her injury as early as July 14, 2009, when she underwent the extraction and grafting procedure of her jaw.  Less than a week after that extraction, her doctor told her that Zometa was a potential cause of her jaw injuries.  On October 8, 2009, another doctor told the wife that “she had evidence of osteonecrosis of the jaw and that continuing the Zometa would worsen the condition.” Consequently, the wife knew the cause of her ONJ on or before October 8, 2009 at the latest.  That was more than two years before she filed suit, so the claims based upon her personal injury were untimely and barred by the statute of limitations.  On July 10, 2010, the wife passed away due to her metastatic breast cancer.

The husband’s loss of consortium claim was a different matter.  We usually think of a loss of consortium claim as being completely derivative of the underlying claim. But the Wheeler court held that “[t]he running of limitation for a personal injury claim does not bar a derivative loss of consortium claim.”  The statute of limitations for a claim of loss of consortium is four years, and thus the husband’s loss of consortium claim was filed well within the limitation period.

Thus we are presented with a case where the injured party might be out of court but the spouse could proceed with the loss of consortium claim.  Still, the court granted summary judgment on the loss of consortium claim as well, because all of the underlying claims failed on the merits.  First, there was “no probative evidence” to establish causation.  The plaintiff failed to designate any expert witness to opine on causation.  Slip Op. at 14-15.  The learned intermediary doctrine barred the failure-to-warn claim because the wife’s prescribing oncologist testified that he was aware of the risks associated with Zometa at the time he prescribed it, that such risks were well known in the medical community, and most significantly, that he continues to prescribe Zometa in the same manner today as he did for the wife.  Slip Op. at 16-18. Finally, the warranty claim failed due to a lack of privity, as there was no evidence that the drug was purchased directly from the defendant.

Maybe there are sound reasons why loss of consortium actions should enjoy a longer limitations period than the underlying action.  Maybe the theory is that the spouse is less in a position to know when an action accrues.  Here, the wife had died, so maybe there is some sense in giving the surviving spouse more time to figure out that there is a lawsuit.  But the rule would seem to apply whether or not the primarily injured party was alive or not, and one could envision a very odd case where the injured party would be reduced to being a spectator to the
loss of consortium claim.  It would be just another case of marriage and the law making strange bedfellows.