Hon. Arlin M. Adams- A brief tribute

Upon graduating from law school, I had the great privilege of serving as a law clerk to the Hon. Arlin M. Adams, who sat on the Third Circuit for nearly two decades.  Judge Adams passed away last week at the age of 94.

The last opportunity I had to see the Judge was at a special exhibit earlier this year at the University of Pennsylvania Library, which reunited two of the few remaining copies of the Emancipation Proclamation that were autographed by Abraham Lincoln.  History buffs may recall that in 1864, a few specially printed copies of the Emancipation Proclamation, autographed by Lincoln, were put on sale at the Great Central Fair in Philadelphia’s Logan Square (visible from your humble blogger's office). And the occasion, merging history, Penn, Philadelphia, and an extraordinary legal document, was a perfect setting for an appearance by Judge Adams.

To the bench, Judge Adams brought an all too rare combination of brilliance, wisdom, civility, and insight. To his clerks, he was an invaluable mentor and teacher.  There was arguably no better way to be introduced to the legal world than mine, as I walked each morning through the courtyard of Independence Hall where the Constitution was crafted, to work in the chambers of Judge Adams in the federal court house a block away.  He was truly a scholar of substantive law and legal procedure.

His private practice and public service roles alone would mark him as a giant in the legal community. But it was his ability to be conservative and compassionate, a firm believer in the democratic process and a staunch defender of civil rights, in particular the freedom of religion, that marked his stature.

Susquehanna University has created the Arlin M. Adams Center for Law and Society at Susquehanna, and our alma mater Penn Law School established the Arlin M. Adams Chair on Constitutional Law in his honor in 2005. But his legacy may be found in more modest events. For example, appellate advocates can recount numerous examples of oral arguments in which young, new, or struggling advocates would find Judge Adams gently questioning them so their essential argument made it into the record -- not because he agreed with them necessarily, but because their clients deserved to at least be heard.

Simple, modest, honest, Judge Adams was a child of the Depression, served in the Navy in WWII, and went on to become a great judge.  While many of the articles on his passing will undoubtedly talk about the three times he was on the short list for the Supreme Court and not selected, to emphasize that would be to ignore the enormous influence he had on a generation of lawyers and the tremendous role model he should continue to be for future generations of lawyers and judges.

 

Fairness in Class Action Litigation Bill Moving Forward

Earlier this year we posted about the Fairness in Class Action Litigation Act when it was approved by the House Judiciary Committee.

Our readers know that this type of bill generally is aimed at the so-called no injury class actions in which not all of the class members are injured, sometimes even most of the class is not injured -- for example purchasers of a consumer product with an alleged design defect that has not manifested itself in most of the units. Such classes create issues for defendants, plaintiffs, and the courts. The bill's sponsors argue that when classes are certified that include members who do not have the same type and scope of injury as the class representatives, those members siphon off limited compensatory resources. Classes including uninjured parties can also artificially inflate the size of the class to command a larger settlement value.

Now comes word the bill is tentatively scheduled for consideration by the full House of Representatives early in 2016.

If enacted, the law would require the moving party to affirmatively demonstrates that each proposed class member suffered the same type and scope of injury as the named class representative or representatives. And any certification decision in a class action regarding personal injury or economic loss must include a determination, based on a rigorous analysis of the evidence presented, that the requirement was satisfied.

SHB A Finalist for Product Liability Department of the Year

The American Lawyer recently recognized Shook, Hardy & Bacon as a finalist in its Product Liability Litigation Department of the Year competition. Shook won the competition in 2008 and 2012 and was a finalist in 2010. (The American Lawyer did not include a product liability category in its 2014 competition.)


The American Lawyer evaluated firms on their product liability results achieved in a two-year period from July 1, 2013, to June 30, 2015.  AmLaw notes that our team has defended 110 active class actions and 135 product liability claims in 25 countries in the last two years.  The article cites notable defense verdicts for Boston Scientific in device litigation, for Altria in toxic tort cases, and quotes clients touting the firm's  "expertise in a number of different areas" and work in the forefront of offering alternative fee arrangements.

We are appreciative of the clients who entrust us with some of their most challenging product matters, allowing us to show our stuff.

SHB Named a Product Liability Group of the Year

Proud to note that Law360 has named Shook, Hardy & Bacon among its 2015 Product Liability Practice Groups of the Year.

For the 2015 Practice Group of the Year awards, Law360 received a record 700 submissions for the series — now in its sixth year — and selected 184 winners across 30 practice areas for honors. Winners were chosen based on submissions covering major successes spanning from October 1, 2014 through October 1, 2015.

 

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Important Preemption Decision

Last week the Sixth Circuit issued a significant opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals Inc., No. 15-3104, 2015 WL 8538119 (6th Cir. Dec. 11, 2015), upholding impossibility preemption of design defect claims against brand-name drug manufacturers.

Yates alleged she experienced a stroke while using the ORTHO EVRA® birth control patch, and sued the manufacturers of the patch.  Yates alleged five causes of action against defendants: (1) strict liability in tort—failure to warn; (2) strict liability in tort—manufacturing defect; (3) negligence; (4) breach of implied warranty; and (5) breach of express warranty.  The district court granted summary judgment as to Yates's failure to warn claim. 2014 WL 1369466 (N.D.Ohio Apr. 7, 2014). Thereafter, the district court granted summary judgment as to Yates's remaining claims and entered final judgment dismissing the case. 76 F.Supp.3d 680 (N.D.Ohio 2015). Yates timely appealed the district court's dismissal of all five of her causes of action.  The Sixth Circuit affirmed.

Failure to warn.

To establish a claim against a drug manufacturer for failure to warn under New York law, a plaintiff must demonstrate that the warning was inadequate and that the failure to adequately warn of the dangers of the drug was a proximate cause of his or her injuries. Krasnopolsky v. Warner–Lambert Co., 799 F.Supp. 1342, 1346 (E.D.N.Y.1992) (quoting Glucksman v. Halsey Drug Co., 160 A.D.2d 305, 553 N.Y.S.2d 724, 726 (1990)). The manufacturer's duty to warn extends to the treating physician, and not directly to the patient. Glucksman, 553 N.Y.S.2d at 726. It has long been the law in New York that prescription medicine warnings are adequate when information regarding the precise malady incurred was communicated in the prescribing information. Alston v. Caraco Pharm., Inc., 670 F.Supp.2d 279, 284 (S.D.N.Y.2009) (quoting Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 423 N.Y.S.2d 95, 96–97 (1979)).  In this case, the “precise malady incurred” was a stroke, and the risk of stroke was communicated in the prescribing information. Defendants mentioned the risk of stroke several times in the package inserts. The label specifically stated there was an increased risk of several serious conditions including stroke. Thus, there was no genuine issue of material fact for a jury on the issue of whether defendants failed to adequately warn Yates, through her prescribing medical provider, of the risk of stroke associated with the product. 

Preemption

Readers know that state law claims can be preempted expressly in a federal statute or regulation, or impliedly, where congressional intent to preempt state law is inferred.  Congress may intend federal law to occupy the field,  or state law may conflict with a federal statute.  Conflict preemption exists where it is impossible for a private party to comply with both state and federal law, or when the state law is an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. A court needs to ascertain whether federal law expressly prohibits the defendant from complying with state law, or there is sufficient, sometimes termed clear evidence, that the FDA would have prohibited the defendant from taking the necessary steps under state law.

The next issue in this case was whether defendants could have complied with their alleged duty under New York law to have designed a safer drug, given FDA approvals of the design. The court reviewed Supreme Court guidance in three recent opinions on federal preemption in pharmaceutical products liability suits: LevineMensing, and  Bartlett, in which plaintiff argued that the manufacturers could comply with both federal and state law by choosing not to make the drug at all. The Supreme Court reversed, holding that impossibility preemption barred the plaintiff's claims. As for drug redesign, the Court found that was impossible for two reasons: (1) the FDCA requires generic drugs to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based; and thus the drug was “chemically incapable” of being redesigned. 

New York law provides that a product is defectively designed if  the product, as designed, was not reasonably safe because there was a substantial likelihood of harm and it was feasible to design the product in a safer manner. Doomes v. Best Transit Corp., 17 N.Y.3d 594, 608, 935 N.Y.S.2d 268, 958 N.E.2d 1183 (2011). New York follows a “risk-utility” approach to determining whether a product is not reasonably safe, which calls for consideration of several factors: (1) the utility of the product to the public as a whole and to the individual user; (2) the nature of the product—that is, the likelihood that it will cause injury; (3) the availability of a safer design; (4) the potential for designing and manufacturing the product so that it is safer but remains functional and reasonably priced; (5) the ability of the plaintiff to have avoided injury by careful use of the product; (6) the degree of awareness of the potential danger of the product which reasonably can be attributed to the plaintiff; and (7) the manufacturer's ability to spread any cost related to improving the safety of the design.

The court concluded that Yates's post-approval design defect claim was clearly preempted by federal law. FDA regulations provide that once a drug, whether generic or brand-name, is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product, including inactive ingredients, or in the specifications provided in the approved application. 21 C.F.R. § 314.70(b)(2)(i). Moderate changes must be reported to the FDA at least 30 days prior to distribution of the drug product made using the change. Id. § 314.70(c).  Based on the plain meaning of the regulation,  defendants could not have altered the dosage of estrogen without submission to the FDA and the agency's approval prior to distribution of the product made using the change. Changing the dosage level of the active ingredient of ORTHO EVRA® constituted a “major change."  Quite simply, federal law prohibited defendants from decreasing the dosage of estrogen post-approval.

Readers should note the Sixth Circuit going out of its way to state that the FDA pre-approval requirement for design changes applied to all prescription drugs, with a reference to “branded or generic” drugs.  The court also rejected plaintiff's contention that there is no federal law that would have prohibited defendants from designing a different drug in the first instance, as opposed to altering an approved design. Yates's argument regarding defendants' pre-approval duty was too attenuated. To imagine such a pre-approval duty exists, a court would have to speculate that had defendants designed ORTHO EVRA® differently, the FDA would have approved the alternate design. Next, the court would have to assume that Yates would have selected this method of birth control from all the choices, and in the face of whatever warnings were on the label. Further the court would have to suppose that this alternate design would not have caused Yates to suffer a stroke. "This is several steps too far".  The argument was contingent upon whether the FDA would approve the alternate design in the first place, and this “never start selling” claim was also preempted because it mirrored the “stop selling” claim rejected in Bartlett.   

The Sixth Circuit affirmed the district court’s grant of summary judgment on all claims ( the others on fact-specific issues we won't get into here).

 

New Clinical Robotics Blog

My colleagues at Shook Hardy & Bacon have launched the Shook Clinical Robotics Law Blog to examine legal trends and developments in clinical robotics. The blog is primarily authored by Shook Miami Partner Mihai Vrasmasu.

His team represents pharmaceutical and medical device manufacturers facing complex product liability claims involving medical devices and prescription drugs, and advises clients on potential issues with complex medical devices, the use of robots in regulated occupations, and hacks of medical devices.

If you are in the device space, worth a look.

SHB Recognized as Client Service A-Team

BTI Consulting Group has ranked Shook, Hardy & Bacon in the BTI Client Service A-Team 2016: The Survey of Law Firm Client Service Performance, now ranked in the top 50.

To compile its list, BTI conducted in-depth interviews with corporate counsel at some of the world's largest companies and noted direct, unprompted feedback about the firm. The resulting rankings evaluate more than 300 law firms on 17 activities that drive superior client service, including the four most strategic activities: providing value; understanding client business; client focus; commitment to help. The stated focus is on which law firms the legal decision makers recognize for delivering the absolute best levels of client service. The BTI Client Service A-Team list is used by law firms and corporate counsel alike to assess how law firms up in client service delivery.

Proud of our team and grateful to our clients for entrusting us with some of their most thorny litigation issues.