Diabetes Drug Avandia to be Severely Restricted in U.S., Unavailable in Europe

In a highly anticipated decision, the widely used diabetes medication Avandia will be pulled from the market entirely in Europe and will now only be available in the United States under tough new restrictions, according to a recent article in The Washington Post. As we previously reported here, the Avandia debate has been a longstanding, contentious issue regarding the pharmaceutical industry and the U.S. Food and Drug Administration’s ability to police its safety. The issue, for years, has been the drug’s potential to increase users’ risks for cardiovascular problems, as there were conflicting reports and studies on the issue.

In our previous post on this issue, we reported that the FDA had said in a February 2010 safety announcement that it would continue to examine studies and data on Avandia health issues before it would take any action with regard to the drug. Since February, according to The Washington Post, both the FDA and European Medicines Agency have concluded that the risk that Avandia could cause heart attacks and strokes outweighs the drug’s benefits for most patients. This decision will have a significant impact–approximately 600,000 diabetics in the United States currently take Avandia.

Starting within the next few months, the drug will be unavailable in Europe. The European agency did, however, stop short of taking the most drastic measure of completely revoking the drug’s approval. Rather, European officials have recommended only suspending the approval, leaving open the option of reinstating the drug if further data on the issue emerge. In the United States, patients will be allowed to take Avandia only if they are not able to control their blood sugar with other medications. As such, doctors who prescribe Avandia will have to justify their decisions to do so. Additionally, patients who want to continue their use of the drug will be required to sign statements indicating that the understand the associated risks. Use of the drug in the U.S. is expected to decline significantly.

According to The Washington Post, the “unusual” coordinated announcement by the U.S. and European drug agencies is representative of the more collaborative relationship between the agencies that has been in place since the 2003 globalization of the pharmaceutical industry. The two coordinated their announcements to attempt to avoid confusion among patients.

Although this announcement stopped short of a total withdrawal of the drug from the U.S. market, it certainly is not good news for its manufacturer, GlaxoSmithKline. The company reportedly already faced approximately 13,000 lawsuits from plaintiffs who alleged that the maker failed to warn patients of heart attack risks. Although GlaxoSmithKline announced this summer that it had reached settlements in approximately 10,000 of those suits, more are sure to follow on the heels of this announcement.

Relation-Back Doctrine Applied, Reversing Jury Verdict against Manufacturer

Recently, the First Circuit affirmed the decision of the District of Massachusetts in granting manufacturer’s post-verdict motion to alter or amend judgment, reversing judgment entered upon a jury verdict, by applying the relation-back doctrine. Coons v. Industrial Knife Co., No. 09-1791, 2010 WL 3516849 (1st Cir. Sept. 10, 2010) [PDF]. Three years after William Coons (“Coons”) was injured by an industrial paper-cutting knife while on the job, he filed suit against A.F. Chapman Corporation who he alleged manufactured and distributed the the knife that caused his injuries. A year later, after pre-trial discovery, A.F. Chapman sought, and was granted, leave to file a third-party complaint against Industrial Knife, alleging that Industrial Knife was the manufacturer and distributor of the knife. Almost two years after filing his original complaint, Coons sought, and was granted, leave to amend his complaint to assert claims against Industrial Knife.

Industrial Knife answered, asserting the statute of limitations as a defense. Two years later, Industrial Knife filed a motion to dismiss based upon the statute of limitations. The District Court denied its motion as untimely and the case went before a jury. The jury found in favor of Coons, awarding him $350,000 in compensatory damages. At the close of Coons’ case, Industrial Knife moved for judgment as a matter of law based upon the statute of limitations; this motion was also renewed before the jury deliberated. The District Court denied these motions without prejudice.
Following the return of the jury verdict, Industrial Knife filed a motion to alter or amend the judgment, arguing that Coons’ claims against it were time-barred. The District Court agreed and entered judgment for Industrial Knife. Coons appealed. The First Circuit first found that since Coons’ claims against Industrial Knife were filed well after three years from the date of the accident — when the cause of action accrued, Coons could only prevail if his amended complaint against Industrial Knife “related back” to his original complaint that was filed within three years of the date of the accident. There are three requirements that must be met for an amended complaint to “relate back” to the original complaint when a new party is added — the claim must arise out of the same conduct, the new party must have had some notice, and new party either must have known or should have known that the action could have been brought against it.
The First Circuit agreed with Industrial Knife that it had no notice of the action within the applicable time frame. Success in making this argument was attained only after defense counsel persisted in making the argument throughout the life of the case. A teaching point for all defense counsel.

The ABA Journal’s Top 100 Legal Blogs Nominations

You may have seen some of the more shameless plugs on other legal blogs requesting your vote for the annual best legal blog contest. If you’re drawing a blank, allow me to educate you on this matter. Very recently, The ABA Journal requested input from the law blog, or blawg, reading public to generate its annual list of top legal blogs. (As one who nominates a blog to the 100 best legal blogs list, you are referred to by the ABA as “blawg amici.”). You can find the nomination form and related information here. Obviously, we here at Abnormal Use take our blogging quite seriously, and we would never condescend to overtly request that you tell the fair editors at The ABA Journal how awesome we are. In fact, we specifically request that, if you were so moved as to submit Abnormal Use to The ABA Journal, that you not say that we are simply a “great blog.”

That’s just our way here at this site, and for better or ill, we can be nothing but ourselves.

Nevertheless, as we all fight tirelessly for justice in this world, we would simply note that justice comes in many forms, and certainly, it would be an injustice for a blog that is inferior to Abnormal Use to receive some notoriety void of any true substance, when Abnormal Use brings you almost-award winning content involving subjects as wide-ranging as injury by chicken sandwich, body odor, frozen mice, jet packs, tuna fish, or Superman.

Furthermore, we must remind you that we here at Abnormal Use care for your children, informing you of objects with lead toxicity, and providing evidence that television will rot your brain. Were any of you physically located here in Greenville, South Carolina, I’m sure you could hit us up for some free babysitting, too. Because we care about you and your children, Abnormal Use is also working to make the world a better place by engaging in the Israeli-Palestinian peace talks and working with multiple teams of economists to come up with a second stimulus plan that will provide full employment while simultaneously lowering taxes and the federal deficit. We have also been endorsed by Nick Saban as the most awesome blog created since the Big Bang (provided, of course, that you believe in the Big Bang). Speaking of the creation of the universe, we here at Abnormal Use are soon to issue a unified theory of the history of the universe (through our research at the Large Hadron Collider) that will explain the existence of humanity to the complete satisfaction of people of all religions, humanists, evolutionists, and atheists.

In sum, self-promotion does not come easy to us, but we need to set the record straight about the place of Abnormal Use in the legal blogosphere, and we encourage you to do the same. In contravention of what we said earlier, please click here and tell the fine editors at The ABA Journal how truly resplendent and awesome we are, how our content is innovative and fresh, and that you look forward to seeing what we post when you wake up in the morning. Thanks.

Oh, and you’d best hurry. The nomination period ends this Friday, October 1.

A Lawyer Reviews "The Defenders," The New CBS Legal Drama

The new legal drama “The Defenders,” not to be confused with the superhero team of the same name, premiered last Thursday night on CBS. The premise: Nick Morelli (Jim Belushi) Peter Kaczmarek (Jerry O’Connell) are rough and tumble criminal defense attorneys practicing in Las Vegas. The two name partners are not alone. Joining them is brand new associate Jess Merriweather (Jurnee Smollett, formerly of the excellent “Friday Night Lights”), who is mercilessly mocked by a menacing assistant district attorney for having paid for law school through exotic dancing. Although the program maintains a silly charm, it harbors the same sorts of lawyer cliches and conventions that we’ve seen on network television for decades. Alas.

Belushi, in this clip , describes the two leads as “working class guys who passed the bar and have a great street sense how to figure out the angles.” They go out into the field the day before trial and find new evidence or formulate new theories which ultimately save the day for their previously doomed clients. They’re brash, they’re smug, and they delight in their refusal to play by the book. TV critic Alan Sepinwall curiously referred to them as “ambulance-chasing Vegas defense lawyers,” although there is no reference to them practicing personal injury law.

Here is what I learned about the practice of law from the program, and the top medical malpractice attorneys in Chicago shall also agree with the same:

As in all other television courtrooms, a lawyer can simply object by saying “Objection!” with some level of aplomb, and the court will rule thereupon. Presumably, this preserves error, as it happens so often on television without any ill effect.

At a charge conference, a defense lawyer can condescendingly yell at the judge, “You are wrong!” when a requested jury instruction is rejected.

Criminal defense lawyers, upon leaving said charge conference, advise their partners to handle the judge’s rulings as follows: “Screw him! Instruct them yourself!”

Prosecutors, rather than objecting, simply rise and scornfully ask “Judge, is there a question here?” when opposing counsel is querying a witness.

Judges, rather than ruling upon objections from the bench, say things like “leave the editorials for the papers.” (This is strange, too, because no one reads newspapers any more, right?)

First year associates are apparently already licensed on their first day at work, as they are left to fly solo at arraignments by partners too busy to accompany them.

Young male partners at criminal defense firms negotiate pleas by sleeping with ridiculously attractive and formidably ambitious female assistant district attorneys, and vice versa.

We’ve always dug Jim Belushi (especially in 1990’s Mr. Destiny), but we can’t say we’re too familiar with his modern television career, never having seen any of the 182 episodes of his sitcom, “According to Jim,” which apparently aired for eight years. O’Connell, for his part, we remember fondly from 1985’s Stand By Me, and his brief appearance in 1996’s Jerry Maguire, in which he did his own acoustic cover of Nirvana’s “Something in the Way.”

Let’s face the facts. Television writers are not lawyers. Their only legal education, so to speak, is watching the myriad awful television shows written by other television writers ignorant of legal practice and procedure. Thus, stereotypes and inaccurate portrayals are compounded and perpetuated indefinitely.

Friday Links

In the comic book cover above, World’s Finest #186, published in 1969, we learn that Superman may not be the biggest fan of the federal sentencing guidelines. Or the Eighth Amendment, for that matter.

Last week, we posted our review of the awful new television legal drama, “Outlaw,” starring Jimmy Smits. Just a few days later, the Above The Law blog published its own review of the first episode. Are we here at Abnormal Use now trendsetters?

John A. Day at the Day on Torts blog has a post entitled “Googling Potential Jurors,” in which he analyzes one trial court’s recent prohibition of Plaintiff’s counsel using Google in the courtroom to investigate those who might become jurors. On appeal, the appellate court rebuked the trial court for shutting down the searches. (See also this post at the Internet Cases blog for more on that same case).

David A. Oliver at the DRI Blog asks if we have now reached “The End of Toxic Tort Litigation in Texas?” That’s an often asked question, but Oliver has some new thoughts.

Lawyerist has this post on “How to Run Effective Meetings.” This should, perhaps, be mandatory reading for shareholders at firms across the United States.

Seattle Weekly offers its list of the seven best covers of Paul McCartney songs, with accompanying video. We might have included Stevie Wonder’s cover of “We Can Work It Out” (but perhaps that was influenced a bit too much by John Lennon to truly constitute a “Paul McCartney song.”).

Class Action Alleging BMW BO/Crayon Odor Tossed

A recently dismissed class action lawsuit was seemingly pulled from the pages of the “Smelly Car” episode of Seinfeld. Suit was filed in federal court in New Jersey in October 2009 on behalf of owners of BMW Model E46 owners, who alleged that a noxious odor permeated the cabins of their ultimate driving machines. Alban v. BMW of North America, LLC, Civ. No. 09-5398 (D.N.J. 2010). The 20-page complaint actually includes quotes purportedly pulled from various websites dedicated to the issue. Some favorites from the complaint: “It kind of smells like a mix of BO and crayons.” “[The smell] burns your nostrils!” And finally, as if quoted from Elaine herself, “I shampoo’d, etc. Nothing helps.”

Although in “Seinfeld” the culprit was a malodorous valet who was only briefly seated in Jerry’s BMW, here, it seems, the cause of the odor was BMW’s alleged use of excessive amounts of solvent on paneling in and around the trunk. The complaint alleged that BMW knew of and has even acknowledged in a Technical Service Bulletin the existence of an “unpleasant . . . solvent or wax crayon” odor, but that it refused to repair or replace the defective insulation after the four year or 50,000 mile warranty period passed. The odor, according to the complaint, often would take several years to manifest. The complaint set forth causes of action including breach of express and implied warranties.

The complaint in this case did not include cites to its supposed users’ commentary, but a quick Internet search does, in fact, reveal that there are sites dedicated to the BMW odor issue (see here and here).

In any event, the complaint, filed by Pennsylvania firm Chimicles & Tikellis and New Jersey’s Law Office of Lane M. Ferdinand, was recently tossed by U.S. District Court Judge Dickinson of New Jersey, who granted BMW’s motion to dismiss. The court held that the breach of express warranty claim failed due to the undisputed fact that the Plaintiff’s warranty had expired at the time the defect arose. Similarly, the claim for breach of implied warranty failed as the result of limits placed on any such claim within BMW’s warranty agreement. The court based this finding on the fact that the agreement provided, in conspicuous language, that the duration of any implied warranties was to be limited to the duration of the express warranties–“48 months or 50,000 miles, whichever occurs first.”

Colorado’s reasonable approach to distributor liability

One of the more interesting problems in products law is how to handle the middle man. If the retailer does not design or manufacture a product, but merely stocks its shelves, can he be liable to a plaintiff who is injured by the product? Different states handle the question differently.

In Colorado, unless the retailer is also the manufacturer of the allegedly defective product or a component of the product, it can’t be sued. In fact, a product liability suit cannot be maintained against a mere innocent seller of a defective product. Which begs at the obvious follow-up question: what makes a seller “innocent?”
The United States District Court for the District of Colorado was faced with just that question in the recently decided Zapien v. Home Depot, USA, Inc., No. 09-cv-02349-REB-BNB, 2010 WL 3522570 (D. Colo. Sept. 2, 2010). Home Depot rented a sewer snake to the plaintiff, who suffered injuries when it gave him a serious electrical shock. Home Depot filed a motion for summary judgment, claiming that it is an “innocent seller” under the terms of the Colorado products statute.
The “innocent seller” doctrine in Colorado, however, has a few exceptions. First, if the seller knows the product is defective, it is no longer an “innocent.” Second, if the seller alters the product, it is no longer insulated from liability (obviously, because it is no longer just a seller).
There was some tangential evidence in Zapien, based on some comments from a cashier at Home Depot, that the retailer knew that the sewer snake was defective, but the evidence was not allowed on appeal. As a result, Home Depot’s motion for summary judgment was granted.
If you didn’t build it, alter it, or know about it, you shouldn’t be held hostage by a plaintiff who, for whatever reason, can’t pin liability on those who may actually have been responsible for the defect. But if you, as a retailer, alter the product or know something about any problems it has, then it is reasonable that you should be at least partly responsible for any injuries stemming from the product. I acknowledge that “knowledge” is a slippery term that can be stretched, but the general theory is workable. Other states should take note and bring predictability back to retailer liability.

Manufacturer Remains On the Hook in EIFS Litigation in Texas

Since the 1990s, EIFS litigation has been a thorn in the side of the construction and insurance industries. Improper installation of EIFS (Exterior Insulation and Finishing System), sometimes called “synthetic stucco,” on homes across the United States resulted in a tremendous amount of litigation. Class action suits and individual litigation have been plentiful, with defendants often pointing the finger at each other as they ferret out responsibility for who must pay for the damages.

The Texas Supreme Court recently weighed in on some of these issues in Fresh Coat, Inc. v. K-2, Inc., —S.W.3d —-, No. 08-0592, 2010 WL 3277130 (Tex. August 20, 2010). The Court addressed the duty of a synthetic stucco manufacturer to indemnify a contractor that installed the stucco against claims of more than 90 homeowners who sued for structural damage, termite problems, and mold. The defendants settled the litigation with the homeowners, and the case proceeded to trial on the various claims that the defendants brought against each other. The jury awarded judgment to the contractor, Fresh Coat, for all damages requested against the manufacturer, K-2, Inc., which included indemnification for settlements that Fresh Coat made to the homeowners and to the homebuilder. The intermediate court of appeals in Beaumont affirmed the decision, with the exception of the amounts that Fresh Coat paid to the homebuilder. Both K-2, Inc. and Fresh Coat appealed.

In its appeal, K-2 urged the Supreme Court to rule that Fresh Coat, as a contractor for the installation of the synthetic stucco, did not qualify as a “seller” and that EIFS is not a “product,” such that K-2 would not have indemnity obligations arising under Chapter 82 of the Texas Civil Practices and Remedies Code. K-2 claimed that products placed into the stream of commerce and integrated into a house are transformed into real property and no longer retain their status as “products.” The Court disagreed, holding that a product is something distributed or otherwise placed, for any commercial purpose, into the stream of commerce for use or consumption. Here, EIFS was a synthetic stucco system made of component parts manufactured by K-2, that it was placed into the stream of commerce, and it was used in construction of homes.

K-2 further argued that Fresh Coat, as a contractor that obtained and installed EIFS, was not a seller. If Fresh Coat could be characterized as a service provider only, K-2 would not have a statutory requirement to indemnify. The Supreme Court held that Chapter 82’s definition of “seller” neither excludes a seller who is also a service provider nor requires the seller to sell only the product. The Court commented that its approach was consistent with the Third Restatement of Torts, which recognizes that a product seller may also provide services. As Fresh Coat provided the EIFS system and the services to install it, Fresh Coat qualified as a seller.

The Texas Supreme Court also ruled that the manufacturer’s statutory obligation to indemnify covers a settlement payment made by the contractor to the homebuilder, even where the contractor was independently obligated by contract to indemnify the homebuilder. The only exception under Civil Practices and Remedies Code Section 82.002(a)) to a manufacturer’s duty to indemnify sellers for losses arising out of a products liability action is for losses caused by the seller’s negligence, intentional conduct or other act or omission for which the seller would be independently liable. Because Fresh Coat made itself independently liable by contract, K-2 contended that it should not have to indemnify it. The Court held none of the statutory exceptions applied, leaving the manufacturer to bear the full loss.

"Made in China" References May Have Been Prejudicial to Jury

An important reminder: When Plaintiff’s counsel attempts to inject prejudicial statements into litigation, object. A failure to do so can be perilous indeed. In Wicklund v. Pacific Cycle, L.L.C., No. 08-CV-486-GKF-FHM, 2010 WL 3368924 (N.D. Okla. August 23, 2010), Judge Frizzell of the Northern District of Oklahoma considered whether repeated references by the plaintiffs’ attorney to the Chinese origin of the alleged defective product, a bicycle, was grounds for a new trial or relief from judgment. Counsel for the defendant, Pacific Cycle, argued that the plaintiffs’ attorney “repeatedly, deliberately and impermissibly played to the perceived anti-Chinese prejudice of the jurors, thereby irrevocably tainting the verdict.”

For instance, the plaintiffs’ attorney said, “Pacific Cycle has elected to buy cheap Chinese products rather than buying products made in the U.S.” In his closing, the attorney said that “‘Made in China’ are the three words that unfortunately have become somewhat of a concern in this country. Finally, he said:

You know, businesses that have chosen to export jobs to China for cheap labor, for cheap goods, I mean from a business side it’s understandable, but when you choose to do that, if you get quality control issues you have to pay when people get harmed from those. And that’s all that this case is basically about.

The jury awarded the plaintiffs $1,100,107.06 in damages, which did not include any punitive damages but represented $1 million over and above the actual damages, ostensibly for pain and suffering.
The court ruled that it could not award a new trial or relief from judgment because defense counsel had not preserved the issue by objecting at the appropriate times. Nevertheless, we find it a helpful reminder as to what is and is not permissible to state to a jury. A new trial may be granted when, as the court noted, “remarks about a case are made which the court believes may have influenced the jury to the prejudice of either party.” The test is “whether or not improper remarks made it reasonably probable that the verdict was influenced by prejudicial statements.”
The design and manufacture of products continues to become a more international endeavor; the “Japanese” car could be made in the next state, with parts from Germany, the United States, and France. When trying a products case, listen carefully for arguments and remarks which may play to perceived prejudices by members of the jury, and object at the appropriate times to call the court’s attention to the tactic and to preserve the issue on appeal.

Friday Links

Above, you’ll find the cover for Superman’s Pal, Jimmy Olsen #28, published way back in 1958, which depicts Jimmy Olsen as “The Boy Who Killed Superman.” Note that he is in a police line-up, presumably for identification purposes, though the police officer is already presenting the evidence against him. (We love that there is a label tied to a piece of Kryptonite noting that it is “Exhibit B,” even though Olsen has yet to be identified, much less indicted or brought to trial.). We’ll leave it to the criminal lawyers to opine on whether the officer’s asking “Where have you hidden [Superman’s] body?” constitutes a custodial interrogation. However, this being 1958, Jimmy would not yet have been afforded many of the protections fashioned by the Warren Court. Oh, well.

Speaking of comic books, after months and months of commenting upon silly and fun superhero/courtroom comic book covers in our Friday Links posts, we now learn that the Ivy League has taken an interest and created an exhibit on that very subject. Earlier this month, our friends at the Yale Law School Library debuted the exhibit, “Superheroes in Court! Lawyers, Law and Comic Books,”which is curated by Mark S. Zaid. If you find yourself in Connecticut, you must see this exhibition, which runs until December 16, 2010 . See here for some official information on the exhibit, including a handful of covers, some of which even we here had not previously seen. (Thanks to eagle eyed reader Ryan Steans for bringing this New York Times piece on the exhibit to our attention.).

Man, the Wall Street Journal Law Blog beat us to the punch with the Rolling Stones allusion in their piece on the Ninth Circuit’s striking down of a municipal tattoo parlor ban. South Carolina is no stranger to such issues, as it banned tattoo parlors until 2006, when the 36 year old prohibition, which had survived a constitutional challenge in the courts, was repealed by the legislature. For more on the Ninth’s Circuit’s recent ruling, see here, here, and here.

The Evidence Law Prof Blog analyzes a recent North Carolina case regarding the authentication of emails, still a hot topic, even after all of these years of email use.

Civility seems to be the issue of the week. The DRI Blog has a piece by Brett A. Ross entitled “Professionalism: It’s not Just for Kids Anymore,” in which the author notes that “as mature practitioners, we should know better how to respond to bad behavior by our opponents even though it often seems that is not the case.” Meanwhile, Lawyerist has “Are You Civil With Opposing Counsel?,” in which the author’s advice is “Stick to your guns and keep it civil. It will pay off in the long run.” And our pals at Overlawyered have this post, in which they analyze a recent scolding of uncooperative counsel by a U.S. Magistrate.

Yesterday, Kevin Couch, one of our intrepid bloggers at this site, posted his review of the new Jimmy Smits legal drama, “Outlaw.” Apparently, the show is about a U.S. Supreme Court Justice, played by Smits, whose frustration with the system causes him to resign his seat on the Court and go about righting wrongs and correcting injustices in the trenches. (It seems he was in a pretty good position to do that on the U.S. Supreme Court, but oh well, it’s television.). Our thought: It would have been much more interesting had this series been a direct sequel to “L.A. Law” and Smits was playing his old character Victor Sifuentes, who had somehow managed to make it all the way from Los Angeles to the nation’s High Court. Another potential benefit of that approach: Susan Dey cameos.

Finally, we learned this week that Bob Dylan, the immortal folk singer, the voice of his generation, will be playing a concert later this year in nearby Clemson. We’ve seen him before and walked away unimpressed, so we leave you with a piece from Seattle Weekly, entitled “Top 7 Reasons to Walk Out of a Bob Dylan Show.” (Full disclosure: we adore our CD of the 1966 “Royal Albert Hall” concert, but that show was some time ago.).