Boulder Business Law Advisor

The Supreme Court has agreed to take up the First Circuit's decision in Bartlett v. Mutual Pharmaceutical, Inc. which we have previously written about here and here and here.  

Despite the Supreme Court's decision in Pliva v. Mensing whereby the Court held that federal regulations preventing generic drug manufacturers from independently changing their drug's labeling pre-empted state law failure-to-warn claims for injuries caused by the generic drugs, the First Circuit in Bartlett held that the generic drug manufacturer could still be liable under state law design defect claims because they could have refused to manufacture the drug in the first place:

But although Mutual cannot legally make sulindac in another composition (nor is it apparent how it could alter a one-molecule drug anyway), it certainly can choose not to make the drug at all; and the FDCA might permit states to tell Mutual it ought not be doing so if risk-benefit analysis weights against the drug, despite what the Supreme Court made of similar arguments in the labeling context….

 And, not only has the Supreme Court not yet said it would extend [Mensing's] exception to design defect claims, but—while the generic maker has no choice as to label—the decision to make the drug and market it in New Hampshire is wholly its own. Thus, Bartlett having lost her warning claim by the mere chance of her drug store's selection of a generic, the Supreme Court might be less ready to deprive Bartlett of her remaining avenue of relief.

True, such arguments can be turned on their head. To refuse preemption here is…in tension not with the holding but with part of [Mensing’s] rationale; [however,] a generic maker can avoid defective warning lawsuits as well as design defect lawsuits by not making the drug...

As the First Circuit partially admitted in its opinion--its decision was at least opposed to the rationale of Mensing--but not the holding. Our previous posts covered the seemingly logical inconsistencies in the First Circuit's reasoning.  Moreover, other courts have since disagreed with that very same reasoning employed by the First Circuit. However, despite the First Circuit's characterization, there wasn't much of a split in the circuits on this issue anyway. For this reason, Mutual appealed, specifically presenting the following question to the Supreme Court on appeal:

Whether the First Circuit erred when it created a circuit split and held—in clear conflict with this Court’s decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)—that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products.

The apposite statement in the petition question is that the First Circuit created the circuit split with its very own decision--despite the First Circuit's views to the contrary. However, as the First Circuit stated: “[g]iven the widespread use of generic drugs and the developing split in the lower courts, …this issue needs a decisive answer from the only court that can supply it.” The First Circuit's wish has been now been granted.

The Boulder Business Lawyers at Laszlo & Associates, LLC provide legal counsel for businesses on a variety of business needs, including products liability, risk management, corporate protection, and legal compliance.

We have discussed in previous posts the Supreme Court’s decision in Pliva v. Mensing which had the effect of making generic drug manufacturer “immune” from state failure-to-warn claims.  In summary, Mensing held that because federal regulations prevented a generic drug manufacturer from effectuating a change to the labeling for a particular drug, the generic drug manufacturers could not be liable for failure-to-warn claims.  The rationale runs along these lines: If a generic drug manufacturer cannot change the warning label because of federal law, how can a generic manufacturer be liable under state law for the generic drug’s label failing to adequately warn the user when it was “powerless” to change that warning?

While a clear win for the generic drug manufacturers, Mensing caused some initial concerns for brand name drug manufacturers that worried the decision might be used to make them liable for injuries caused by generic drugs.  The logic here being that because the brand name drug manufacturer controls the warning label based federal law, the brand name manufacturer can effectuate a change to the labeling of a drug--which the generic drug manufacturer must then mirror according to federal regulations.  So a failure to warn of say a possible undisclosed side effect by the generic manufacturer’s drug can equate to brand name manufacturer liability for the brand name drug manufacturer’s failure to change the warning label.  This has been coined by some “innovator liability.”

This issue was recently visited by the Judge Higbee in the Superior Court of New Jersey in Coundouris v. Wyeth, et al., No. ATL-L-1940-10 (June 26, 2012) through a motion to dismiss filed by the brand name manufacturers.  The drug at issue there was metoclopramide (the brand name, Reglan, made by Wyeth then Schwarz then Alaven) which is used to treat gastroesophageal reflux disease and diabetic gastroparesis.  Some of the plaintiffs in Coundouris never took Reglan but the generic metoclopramide. The plaintiffs brought claims of conscious misrepresentation, negligent representation, negligence, claims under New Jersey’s Product Liability Act (“PLA”) for design defect and manufacturing defect, and warranty claims.

In their motion to dismiss, the brand name defendants argued that the plaintiffs' claims were governed by the PLA, “and that pursuant to the PLA and New Jersey case law, manufacturers of a brand-name drug may not be held liable for injuries caused by a plaintiff's use of a generic drug manufactured by another company.” In opposition:

Plaintiffs argue that their claims against Brand Defendants are not products liability claims governed by the PLA, but are instead negligence claims governed by New Jersey common law. Plaintiffs contend that the Brand Defendants owed a duty to those ingesting generic metocloprarnide to exercise reasonable care in either disseminating accurate, nonmisleading information about metocloprarnide or adequately warning doctors and patients as to the risk of the drug.

The New Jersey court makes short work of the plaintiffs argument.  First the court holds the plaintiffs’ claims are product liability claims.  Since the plaintiffs’ claims fall under the PLA, Plaintiffs' action must fail because they did not ingest a product made or sold by the brand name defendants. In New Jersey, "it is well-settled that in products-liability litigation, [a plaintiff] must demonstrate that his or her injuries were caused by ... defendant's ... product."

Where Plaintiffs never ingested metoclopramide manufactured or sold by the Brand Defendants, they are unable to establish an essential element of their prima facie case under New Jersey law, and their claims against the Brand Defendants must be dismissed.

In its decision, the New Jersey court quotes a prior New Jersey decision, Rossi v. Hoffman-LaRoche, No. ATL-L-690-05 (January 3, 2007), which dealt with a similar issue of brand name drug manufacturer liability for injuries caused by a generic drug: there is “no evidence” that “the New Jersey legislature intended for prescription drug liability to extend to the name-brand manufacturer when the alleged victim ingested a generic equivalent manufactured and sold by another company."  Thus, in Rossi, as in Coundouris, the court declined to create a duty on the part of the brand name manufacturer to the consumers of a generic drug.

The Boulder Business Lawyers at Laszlo & Associates, LLC provide legal counsel for businesses on a variety of business needs, including products liability, risk management, corporate protection, and legal compliance.  

The Pennsylvania Supreme Court issued an opinion that, according to one asbestos plaintiffs' blog, "could have far-reaching implications." Betz v. Pneumo Abex LLC was an automotive friction products asbestos case.  The focus of the court’s decision was on the admissibility of plaintiff’s expert opinion that “that each and every exposure to asbestos—no matter how small—contributes substantially to the development of asbestos-related diseases.”  This opinion is often referred to as the "‘any-exposure,’ ‘any-breath,’ or ‘any-fiber’ theory of legal (or substantial-factor) causation.”  This particular case was selected from others below using a similar “any-exposure” theory of causation.  

When determining the admissibility of expert testimony, Pennsylvania still uses the Frye test of “general acceptance in the relevant scientific community applicable to novel scientific evidence” and does not use the Daubert standard.  

First, the Pennsylvania Supreme Court agreed with the court below that the any-exposure theory was novel and thus a Frye hearing was warranted.  In turning to the any-exposure theory of substantial causation, the court noted that the expert’s opinion created an “irreconcilable conflict with itself” because "[s]imply put, one cannot simultaneously maintain that a single fiber among millions is substantially causative, while also conceding that a disease is dose responsive."

In fact, the court quoted the plaintiff’s experts’ own testimony to demonstrate this contradiction:

Now, individual exposures differ in the potency of the fiber to which an individual is exposed, to the concentration or intensity of the fibers to which one is exposed, and to the duration of the exposure to that particular material. So those are the three factors that need to be considered in trying to estimate the relative effects of different exposures. But all exposures have some effect.

To elucidate his opinion that even a single asbestos fiber can be a substantial contributing factor in developing an asbestos-related disease, plaintiff’s expert offered an analogy of a glass of water with marbles being placed into the glass.  In other words, each marble is a substantial factor in the water overflowing.  However, the court found this analogy discomforting, particularly in light of the plaintiff’s expert's previous testimony as to size and potency of asbestos fibers:

In this regard, the analogies offered by [plaintiff’s expert] in support of his position convey that it is fundamentally inconsistent with both science and the governing standard for legal causation. The force of his marbles-in-a-glass illustration changes materially upon the recognition that, to visualize this scenario in terms of even a rough analogy, one must accept that the marbles must be non-uniform in size (as asbestos fibers are in size and potency), microscopic, and million-fold. From this frame of reference, it is very difficult to say that a single one of the smallest of microscopic marbles is a substantial factor in causing a glass of water to overflow.

While this was one of many analogies used by the plaintiff’s expert (also employed: a “soldier in the field” analogy, an “Ellis Island” analogy, a “boxer’s glancing blow” analogy, and a “single cigarette among many” analogy), no analogy offered to the court was found convincing:

We appreciate the difficulties facing plaintiffs in this and similar settings, where they have unquestionably suffered harm on account of a disease having a long latency period and must bear a burden of proving specific causation under prevailing Pennsylvania law which may be insurmountable. Other jurisdictions have considered alternate theories of liability to alleviate the burden. Such theories are not at issue in this case, however, and we do not believe that it is a viable solution to indulge in a fiction that each and every exposure to asbestos, no matter how minimal in relation to other exposures, implicates a fact issue concerning substantial-factor causation in every “direct-evidence” case. The result, in our view, is to subject defendants to full joint-and-several liability for injuries and fatalities in the absence of any reasonably developed scientific reasoning that would support the conclusion that the product sold by the defendant was a substantial factor in causing the harm. 

The Boulder business lawyers at Laszlo & Associates, LLC provide legal counsel to businesses on a variety of business needs including products liability, risk management, corporate protection and legal compliance.

Pritchett v. I-Flow Corporation, Inc. is a recent pain pump case in front of the United States District Court of Colorado.  The plaintiff had shoulder surgery in 2005.  The surgeon used a pain pump manufactured by I-Flow to inject an anesthetic into the shoulder joint over a 48 hour period which allegedly led to the development of “chondrolysis”—a partial or complete loss of cartilage in the shoulder joint.  Plaintiff alleged that the pain pump was marketed by the defendant I-Flow “without doing a single study to determine whether pain pump anesthetics could harm cartilage.”  Additionally, the plaintiff claimed that I-Flow waited years to inform physicians after receiving notice that its pain pump could damage cartilage.

The issue in the April 17, 2012 decision surrounded the defendant’s attempts at excluding the plaintiff’s expert witness, Dr. Jon Hyman.  Among other reasons for excluding the plaintiff’s witness, the defendant argued that Dr. Hyman’s “differential diagnosis of specific causation is invalid in light of the lack of evidence of general causation and because Dr. Hyman failed to rule out other potential causes of Plaintiff's shoulder injury.”  A differential diagnosis is generally the determination of which one of several diseases may be producing the symptoms experienced by a patient.

After reviewing Fed. R. Evid. 702's analysis and application generally, the court, in a rather conclusory fashion, determined that the Dr. Hyman's opinions were admissible.  According to the court, quoting a prior pain pump case McClellan v. I-Flow Corp., “taking [I-Flow's] argument to its logical conclusion, [I-Flow] would have [Plaintiff] prove causation to a medical certainty before expert testimony could be admitted.“  The court found this “wholly inconsistent with Daubert and the fundamental premise of Rule 702.”  Moreover, again quoting from McClellan:

Daubert did not impose an exacting standard of causality beyond the preponderance of the evidence simply because scientific issues are involved…The issue is not whether the proponent of expert testimony can prove that the expert is correct; it is whether the testimony is reliably derived from scientific methodology and is relevant to the facts of the case.

According to the court, Dr. Hyman’s use of a differential diagnosis did not “doom” his opinions under Daubert since “numerous courts have approved opinions based on differential diagnosis to show general causation, despite the absence of conclusive causal evidence.” (emphasis added).

As stated above, the court’s support for its conclusion is not rigorously grappled with: “[g]enerally ‘the basis for establishing the scientific validity of a differential diagnosis will vary depending on the type of injury and whether it involves a complicated biological explanation, a long latency period or the lack of a single sharp exposure event.’” For this reason, despite the fact that Dr. Hyman used a differential diagnosis in his opinion of the plaintiff’s condition:

Case-specific factors, such as the temporal relationship between the continuous infusion and Plaintiff's development of chondrolysis, Plaintiff's lack of other toxic exposures, and Plaintiff's lack of other systemic disease or injury unrelated to the area or purpose of exposure, increase the reliability of the differential diagnosis methodology used here.  In these circumstances, Dr. Hyman's testimony on general causation should be admitted because it is based on a reliable differential diagnosis and reliably flows from the underlying facts of the case.

The court was not overly concerned that Dr. Hyman’s opinion may attribute a different cause for the plaintiff’s condition to say the least.  Moreover, the court, in what justification it did offer, seemed to be convinced that the lack of “complexity” as to the nature of the plaintiff’s injury provided an acceptable basis for summarily allowing a differential diagnosis to support general causation.

The Boulder business lawyers at Laszlo & Associates, LLC provide legal counsel to businesses on a variety of business needs including products liability, risk management, corporate protection and legal compliance.

A number of our previous blog posts (here, here, and here) discussed the Supreme Court’s decision in Pliva v. Mensing, which held that state failure-to-warn claims against generic drug manufacturers were preempted by the Federal Food, Drug, and Cosmetic Act, particularly the 1984 Hatch-Waxman Amendments.  Our most recent post on the topic was Metz v. Wyeth in which the Middle District of Florida applied Mensing and found preemption for a number of product liability claims for recovery but did not find preemption for claims of breach of implied warranties.  

Bartlett v. Mutual Pharmaceutical Co., Inc. is another recent application of Mensing--this time from the First Circuit Court of Appeals. In Bartlett, the First Circuit held that a state design defect claim against a generic drug manufacturer was not preempted under Mensing.  In Bartlett, the First Circuit refused to extend Mensing preemption to design defect claims declaring “that it is up to the Supreme Court to decide whether [Mensing’s] exception is to be enlarged to include design defect claims.”  While the court's conclusion in itself is interesting in the context of pharmaceutical products liability, the court's reasoning is really what gives pause--namely, that the generic drug manufacturer did not have to manufacture and sell the drug in the first place.

Bartlett involved the generic drug sulindac, a Non-Steroidal Anti-Inflammatory Drug (“NSAID”).  Karen Bartlett was prescribed the brand name drug “Clinoril” for shoulder pain, but was given the generic sulindac by her pharmacist.  As a result of ingesting sulindac, manufactured by Mutual Pharmaceutical, Ms. Bartlett developed Stevens-Johnson Syndrome and toxic epidermal necrolysis.  This resulted in the deterioration of the 65% of the outer layer of her skin and near blindness.  Based on the extent and permanency of Ms. Bartlett’s injuries, the First Circuit concluded: “Bartlett's injuries were truly horrific.”  Bartlett brought a number of claims against the generic drug manufacturer, Mutual.  She received a substantial jury verdict which was appealed on a number of grounds.  In this post, we review the First Circuit’s handling on appeal of the design defect claim only. 

The court begins by noting that courts “traditionally have refused to review the reasonableness of the designs of prescription drugs.”  However, the court found that New Hampshire law permits such review—namely, liability can be found  for selling “any product in a defective condition unreasonably dangerous to the user or consumer when the product causes injury to the user or consumer.”  Mutual countered with Buckingham v. R.J. Reynolds Tobacco Co. which required not merely unreasonable dangerousness but proof that an alternative, safer design exists.  However, Mutual argued that the plaintiff's claim failed because there could not possibly be an alternative, safer design because sulindac could not be made in a different and safer form—“sulindac is a one-molecule drug; and the variations in suldinac as sold consist of inactive ingredients that ordinarily do not have significant pharmacological effects.”  

The court first dismissed Mutual's interpretation of Buckingham in that an allegation of a safer alternative design was necessary for a design defect claim.  In turning to the issue of preemption, the First Circuit noted that Mensing only preempted failure-to-warn claims because generic manufacturers, unlike brand name manufacturers, cannot unilaterally change their label.  Under similar logic, Mutual argued “with some force” that a generic manufacturer cannot alter the chemical composition of its drug either and thus Mensing should preempt state design defect claims also.  The First Circuit remained unconvinced since Mutual could have refrained from selling the drug to begin with:

But although Mutual cannot legally make sulindac in another composition (nor is it apparent how it could alter a one-molecule drug anyway), it certainly can choose not to make the drug at all; and the FDCA might permit states to tell Mutual it ought not be doing so if risk-benefit analysis weights against the drug, despite what the Supreme Court made of similar arguments in the labeling context….

And, not only has the Supreme Court not yet said it would extend [Mensing's] exception to design defect claims, but—while the generic maker has no choice as to label—the decision to make the drug and market it in New Hampshire is wholly its own. Thus, Bartlett having lost her warning claim by the mere chance of her drug store's selection of a generic, the Supreme Court might be less ready to deprive Bartlett of her remaining avenue of relief.

True, such arguments can be turned on their head.  To refuse preemption here is…in tension not with the holding but with part of [Mensing’s] rationale; [however,] a generic maker can avoid defective warning lawsuits as well as design defect lawsuits by not making the drug...

Thus, the First Circuit refused to extend Mensing preemption to design defect claims, leaving it “to the Supreme Court to decide whether [Mensing’s] exception is to be enlarged to include design defect claims.”  Moreover, “[g]iven the widespread use of generic drugs and the developing split in the lower courts, …this issue needs a decisive answer from the only court that can supply it,” obviously implying the Supreme Court.

The First Circuit's reasoning in Bartlett is rife with frustration at the Supreme Court’s decision in Mensing.  The court cannot bring itself to the conclusion that Mensing might have implied total immunity from products liability claims for generic drug manufacturers.  For this reason, Bartlett seems to be an ends-based decision--a way to provide an avenue of relief for the unfortunate injuries suffered by Karen Bartlett.  A decision leaving her with no remedy under the law was an unfair and unjust option that the court was not willing to take.  Moreover, in more than one instance throughout its opinion, the First Circuit wanted to make apparent its refusal to participate in eliminating the last avenue of remedy for Karen Bartlett, almost daring the Supreme Court to decide otherwise.  It remains to be seen if Mutual will take up the First Circuit’s "challenge."

The Boulder business lawyers  at Laszlo & Associates, LLC provide legal counsel to businesses on a variety of business needs including products liability, risk management, corporate protection and legal compliance.

In 2003, Cervelo, the maker of high end road bicycles, voluntarily, and in conjunction with the U.S. Consumer Product Safety Commission, recalled 317 Wolf all carbon road bicycle forks.  In April 2012, a Massachusetts man riding on a bike fitted with the recalled forks crashed and died.  Police stated that the rider was on a Cervelo Soloist and that it appeared a "mechanical failure" causing the forks to separate from the bike led to the crash.  An investigation is currently underway, but let us assume, for purposes of this article, that the recalled Cervelo forks caused the accident and ultimately the man’s death.

Most punitive damage awards stem from evidence that the manufacturer knew or should have known about a post-sale problem but failed to take adequate remedial measures to prevent accidents.

In the Cervelo case, the recalled Cervelo forks were sold from April 2003 until July 2003 - with a recall announced July 31, 2003.  It would appear that Cervelo worked swiftly to recall the defective forks.  But with only 300 forks sold in such a short period of time, how was it that Cervelo was unable to reach all owners of the forks?  The bottom line is no one should have been riding on those forks.  In its latest Consumer Product Safety Commission Recall Handbook, the CPSC lists dozens of ways to inform consumers of a product hazard and recall.  Of note is the social media aspect, perhaps the most efficient way to reach your consumer:

The Commission encourages companies to be creative in developing ways to reach owners of recalled products and motivate them to respond ... As new or innovative methods of notice and means of communication become available, such as social media, the staff encourages their use. ...  use of a firm’s social media presence to notify consumers of the recall, including Facebook, Google +, YouTube, Twitter, Flickr, Pinterest, company blogger networks, and blog announcements.

Just this week, bike manufacturer Specialized issued a recall due to hazardous break levers. However, the company has not yet announced the recall on Twitter - where it has more than 60,000 followers.  Others have tweeted about the recall but nothing from the Specialized company itself (as of the writing of this blog post). This is such a missed opportunity - Specialized can immediately reach 60,000+ consumers who will immediately get the information it provides (not to mention there are more likely than not some affected consumers following on Twitter.)

In the Cervelo case, a question will certainly be asked whether Cervelo did everything it reasonably could have done to ensure all forks were replaced.  How did (if at all) Cervelo try to inform the man that his bike was one that had the defective forks? Twitter was not around in 2003, and it is doubtful the company had policies and procedures in place to notify customers via social media at that point. But times have changed.  It is 2012, and there is simply no excuse not to use social media to inform consumers of hazards and recalls associated with your products.  And keep in mind that many (if not most) of your jurors will use and understand Twitter, Facebook and the latest social media - and wonder why you did not use it to let them know they could get hurt.

The Boulder lawyers at Laszlo & Associates, LLC provide legal counsel to businesses on a variety of business needs including products liability, risk management, corporate protection and legal compliance.

In Moeller v. Garlock Sealing Technologies, LLC, (6^th Cir. Sept. 28, 2011), the Circuit court decided whether evidence presented by a Plaintiff regarding exposure to asbestos was sufficient to support a determination that the manufacturer's asbestos-containing gaskets were a substantial factor in bringing about the pipefitter's injuries and death.  The court held the evidence was insufficient.   In Moeller, Mr. Moeller, a pipefitter, worked with asbestos insulation from 1962 through 1975.  During the same period, Plaintiff worked with Garlock gaskets which contained asbestos.  Mr. Moeller died from mesothelioma in 2008, his widow sued numerous defendants including Garlock.  Under Kentucky state law, to prevail on a negligence claim, a plaintiff must prove that a defendant’s conduct was a substantial factor in bringing about the harm.  At trial, with respect to causation, Plaintiff presented the testimony of a doctor of internal medicine who opined that Plaintiff’s exposure to asbestos from Garlock gaskets, along with other exposures, contributed to Robert’s mesothelioma. 

The jury returned a verdict for Plaintiff in the amount of $516,094.  Defendant Garlock moved for judgment as a matter of law and for a new trial – both motions were denied.    Here, because Plaintiff’s experts admittedly never testified that Plaintiff’s exposure to Garlock gaskets was a substantial factor in causing his mesothelioma, the Sixth Circuit held that Plaintiff was unable to establish that exposure to Garlock gaskets in and of itself was a substantial factor in causing the mesothelioma.  Therefore, under Kentucky law, Plaintiff failed to prove her case and Garlock’s motion for judgment as a matter of law should not have been denied. 

This case reaffirms the recent theme the importance of good and thorough expert testimony.  Here, Plaintiff’s experts did not, as they were likely unable, to opine that Garlock’s gaskets were a substantial factor in causing Mr. Moeller’s mesothelioma.  With such evidence being so critical to the claim however, plaintiff’s counsel should have developed additional or alternative evidence regarding causation.    

Looking back at the transcript of the oral arguments for Pliva v. Mensing and my previous post (here), even if the Court was willing to accept that the preamble to the Hatch-Waxman amendments provided a duty for generics to “take steps” to revise the label, there was no formal process for which “steps” to take and neither the Plaintiff-Respondent nor the Government offered a legitimate one under questioning (most likely for good and obvious reason, given that it is not defined).  Neither seemingly wanted to admit that a generic manufacturer may have to “lobby” for revised labeling, however the Plaintiff-Respondent and the Government’s position seemed to imply that this was possible.  Both Justices Scalia and Alito seemed to highlight this in their questioning—even if there was a duty to “take steps,” neither the FDA nor the Plaintiff-Respondent had defined how that duty would be satisfied short of convincing the FDA, an independent government agency, that a revised label was in order. 

Thus, taking this line of reasoning to its end would largely destroy the concept of “conflict preemption” for Supremacy clause analysis.  This reductio ad absurdum seemed to be a sticking point for Justices Scalia and Alito in their questioning and, more importantly, Justice Thomas in his opinion: 

The question for “impossibility” is whether the private party could independently do under federal law what state law requires of it.  Accepting [Plaintiff-Respondent]’s argument would render conflict pre-emption largely meaningless because it would make most conflicts between state and federal law illusory.  We can often imagine that a third party or the Federal Government might do something that makes it lawful for a private party to accomplish under federal law what state law requires of it.  In these cases, it is certainly possible that, had the Manufacturers asked the FDA for help, they might have eventually been able to strengthen their warning label.  Of course, it is also possible that the Manufacturers could have convinced the FDA to reinterpret its regulations in a manner that would have opened the CBE process to them. Following [Plaintiff-Respondent]’s argument to its logical conclusion, it is also possible that, by asking, the Manufacturers could have persuaded the FDA to rewrite its generic drug regulations entirely or talked Congress into amending the Hatch-Waxman Amendments.

If these conjectures suffice to prevent federal and state law from conflicting for Supremacy Clause purposes, it is unclear when, outside of express pre-emption, the Supremacy Clause would have any force.  We do not read the Supremacy Clause to permit an approach to pre-emption that renders conflict pre-emption all but meaningless.  The Supremacy Clause, on its face, makes federal law “the supreme Law of the Land” even absent an express statement by Congress. (internal citations omitted).

Again, while some members of the Court would likely not have found a duty to “take steps” based on the preamble to the amendments, given their line of questioning and considering the preamble did not go through notice and comment, those justices seemed to quickly show where this argument was leading anyway.  Short of having the label revised, what could a generic manufacturer do to satisfy its duty to “take steps”?  At oral argument, Chief Justice Roberts even questioned why extremely minimal steps by a generic manufacturer would not satisfy the duty:

So if your theory of the case is accepted, this is what will happen: Every time a generic manufacturer gets an adverse incident report, it will send that on to the FDA, and there will be a boilerplate sentence at the end of it saying, We think you should consider revising the labels because of this, and then, under your theory, that manufacturer is completely protected from State suits?   

Taking the line of questioning from Justices Scalia, Alito and Roberts together, there is a considerably large disparity between “taking steps” to lobby an independent government agency to change or re-interpret its rules and policies and “taking steps” by merely placing boilerplate language on an adverse incident report sent to that agency.  Thus, because this disparity could not be explained or rectified, the majority had no other alternative—even if they were looking for something to hang their hat on. 

In response to Mensing, recognizing that there are no concrete “steps” available under the current FDA regulatory scheme for generic manufacturers and no legitimate answers offered by the FDA as to the necessary “steps” required by a generic manufacturer to satisfy its duty, Public Citizen, a consumer organization, filed a citizen petition asking the FDA to amend its current requirements. 

Their “proposal would authorize all ANDA [Abbreviated New Drug Application] holders to use the CBE [Changes Being Effected] and PAS [Prior Approval Supplement] procedures.”  As the group puts it, the Mensing court determined that “[g]eneric manufacturers’ immunity from state common-law suits is contingent on the Court’s finding that the manufacturers’ cannot change their products’ labeling under current FDA regulations, even if they learn about new risks.”  Thus, allowing a generic manufacturer the ability to request label changes would undermine an impossibility pre-emption argument, opening generic manufacturers back up to state tort lawsuits.  Public Citizen maintains their position would protect consumers and restore marketplace equality.

On June 23, 2011, the Supreme Court handed a stunning victory for generic drug manufacturers, effectively immunizing them from state law failure-to-warn claims.  In Pliva  v. Mensing, the Court held that federal regulations preventing generic drug manufacturers from independently changing their drug's labeling pre-empted state law failure-to-warn claims for injuries caused by the generic drugs.  According to the Court, it was “impossible” for the generic drug manufacturers to comply with both state and federal requirements.

Under the Hatch-Waxman Amendments of 1984, for a generic drug manufacturer to receive FDA approval to market its drug, the manufacturer must show that the drug is equivalent to an already FDA approved brand name drug and that the generic drug sought for marketing has the same safety and efficacy labeling as the brand name drug.  Thus, federal regulations require a generic drug's labeling mirror that of the brand name drug's.  While there are certain limited circumstances where a label can be altered by a manufacturer without prior FDA approval, such as the “changes-being-effected” (CBE) process or via “Dear Doctor” letters, the FDA denied that either option was available for the generic manufacturer in Mensing, with the Court deferring to FDA discretion.  Thus, according to the Court, generic drug manufacturers are caught between a proverbial “rock and a hard place”: because state law failure-to-warn claims impose a duty on generic drug manufacturers  to provide a “safer label” than required by federal regulation, if the manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law which requires generic drug labels be the same at all times as the corresponding brand name drug labels.  “Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.”  Section III.A.

Interestingly, while the FDA denied that the CBE process or the “Dear Doctor” letter were options available to the generic manufacturer in Mensing, the FDA nonetheless determined that generic drug manufacturers do in fact have a duty to seek FDA assistance with the warning label about known health risks or concerns based on the preamble to the 1992 amendments to the Hatch-Waxman amendments.  See 57 Fed. Reg. 17961 (“If a [generic drug manufacturer] believes new safety information should be added to a product’s labeling, it should contact FDA, and FDA will determine whether the labeling for the generic and listed drugs should be revised”).  According to the FDA,       “[g]eneric drug manufacturers that become aware of safety problems must ask the agency to work toward strengthening the label that applies to both the generic and brand name equivalent drug” or "take steps" as described in oral argument.  Section II.B.3.  However, because the Court already found pre-emption, it declined to resolve the duty issue, despite deferring to the FDA on the previous issues. 

Although it declined to resolve the duty to "take steps" issue, the Court, assuming arguendo that a generic manufacturer does in fact have a duty to request FDA assistance with a label, noted that Plaintiff-Respondents’ claims were not based on “the Manufacturers’ alleged failure to ask the FDA for assistance in changing the label” anyway.  Further, even if plaintiffs' claims were based on such duty, seeking FDA assistance possibly would satisfy a manufacturer’s federal duty but would not address its’ state law duty: “[s]tate law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.”  Section III.A.  Notably, the Court's decision does not address whether there would even be a private cause of action by an injured plaintiff for breach of a duty to seek FDA assistance or whether such a breach of duty would be enforceable only by the FDA.

In reaching its decision in Mensing, the court also distinguished Wyeth v. Levine in that Wyeth involved a brand name drug manufacturer.  In Wyeth, the Court held that a state failure-to-warn claim against a brand name drug manufacturer was not pre-empted because it was possible to comply with both federal and state statutes and regulations.  Because federal statutes and regulations for brand name drug manufacturers differ from those applicable to generic drug manufacturers, “[t]his Court will not distort the Supremacy Clause in order to create similar pre-emption across a dissimilar statutory scheme.  Congress and the FDA retain authority to change the law and regulations if they so desire.”  Section III.C.  Thus, where it was possible for a brand name drug manufacturer to comply with both state and federal law, it was impossible for a generic drug manufacturer.

While this decision may be a strong win for the generic manufacturers, its practical effects ultimately may be minimal.  The Court noted in footnote 9 that the FDA stated this particular situation with generic manufacturers arises infrequently, largely because most generic drug manufacturers arrive in the market years after the brand name drug has been marketed.  For this reason, new information about a drug’s risk generally arises before the generic manufacturer enters the market.  Further, although many consumers may be completely unaware or totally uninterested in the Mensing decision, consumer knowledge of this decision would most likely not cause them to decide against purchasing generic drugs even if they knew that its manufacturer would not be liable for failing to provide adequate safety warnings, even where the generic manufacturer had actual knowledge of certain risks.  Given the price difference between a brand name and generic drug, not to mention insurance company requirements to purchase generics if available, consumers would probably still choose generics.  (This does however put insurance companies in an interesting situation by steering their insureds toward cheaper generics and  into a position where their insureds abdicate a strong potential right of recovery for injuries though a failure-to-warn claim.) 

Finally, even if a consumer choses a generic drug, does this decision possibly open up a brand name manufacturer in any way to additional liability for failing to warn about safety risks when a person is injured by the generic, especially considering the brand name manufacturer is now more than ever the gatekeeper to that drug's label?  Seems like a bit of a reach considering the consumer was not injured directly by the brand name manufacturer's drug, but such a theory of liability is not without precedent.  (See Expanded Liability for Generic, Brand Manufacturers Ahead?).  While suits in California and Vermont have held that a brand name manufacturer could be held liable for labeling on a generic drug, it difficult to discern whether other courts will follow this line of reasoning.  However, as stated over at Pharmaexec.com: "[w]hile the California and Vermont decisions don’t necessarily constitute a consensus...“there are 50 states out there, and a lot of them have a great penchant for saying, ‘We really don’t like to leave our injured citizens without a remedy.’”

One of the most important issues in any product liability action is product identification.  In many instances, it is not a major hurdle – the plaintiff has a receipt, a doctor’s prescription or has the product in his or her possession. 

Where product identification becomes a larger issue however, is in cases where the injured party came into contact with the product at their place of work, often decades ago, and potentially over many years.  This scenario of product identification is the hallmark of recent asbestos litigation. 

Whether a plaintiff can sufficiently identify a product they used that caused their exposure to asbestos can make or break a case.  Many asbestos lawsuits take the “shotgun” approach of suing countless manufacturers whose products the plaintiff may have used or come in contact with.  Such approach also greatly increases the likelihood that the plaintiff will be able to identify some product and survive dispositive motions on the issue.

Recently, in Cowley v. Acands, Inc., MDL 875, 2010 WL 5376338 (E.D. Pa. Dec. 23, 2010) Robreno, Dist. J., the MDL Court addressed a situation where the plaintiff sought to use previous deposition testimony on the issue of product identification. 

The MDL Court, applying Maryland law, held that the previous deposition testimony of the Plaintiff was inadmissible as to product identification as the deposition was given in a different lawsuit where the Plaintiff was a witness.  In the previous lawsuit there was a different defendant and while the Court noted the interests of PPG and Pittsburgh-Corning were aligned as to general factual issues they were not aligned as to issues of product identification.  Therefore, the testimony was inadmissible hearsay.  Without the testimony, Plaintiff was unable to present sufficient evidence and the summary judgment motion was granted.    

 An often repeated scenario in personal injury asbestos litigation involves the admissibility of deposition testimony taken in an earlier action against a defendant who was not a party to the earlier litigation. This is understandable given the long latency period of various diseases caused by exposure to asbestos fibers. Under the circumstances, the plaintiff may be deceased and the testimony of a co-worker in an earlier action may constitute the sole product identification evidence. The answer to the question admittedly is not clear cut and ultimately, the admissibility of such deposition testimony depends largely upon whether, at the time the deposition was taken, the interests of the defendant in the earlier litigation could be considered aligned with the interests of the defendant in the present case against whom the deposition is being offered.

By contrast, only two weeks prior, the MDL Court, applying Utah law, denied motions for summary judgment by Georgia-Pacific and Union Carbide that sought judgment on grounds of product identification.

 “In the present dispositive motions, two defendants challenge Plaintiff's product identification. Both argue that Plaintiff cannot show that she was exposed to a defective asbestos-containing product attributable to them.”  In re Asbestos Products Liab. Litig. (No. IV) Dianna K. Larson, et al. v. Bondex International, et al., MDL 875, 2010 WL 5093223 (E.D. Pa. Dec. 10, 2010) Angell, Magistrate J.

In Larson, the Plaintiff used drywall joint compound or “mud” during the construction of two homes in the mid to late 1970s.  The plaintiff identified Georgia-Pacific joint compound as the cause of her injury.  She testified that she specifically remembered using five gallon plastic buckets of Georgia-Pacific brand joint compound because she moved from the South to the West and associated “Georgia” with the South and “Pacific” with the West. 

She further testified that the buckets in which the compound came were plastic with metal handles.  However, Georgia-Pacific presented affidavit evidence that at the time plaintiff claimed to use the joint compound Georgia-Pacific did not offer an asbestos containing product in plastic buckets and therefore could not have caused her injuries.  Plaintiff argued that there were inconsistencies with the affidavits relied on by Georgia-Pacific - and while the conclusions regarding Georgia-Pacific’s manufacture of joint compound in plastic buckets appeared consistent, the Court held 

There is evidence of record which suggests that plastic containers were used by Georgia-Pacific during the relevant time. It is up to the jury to decide whether Ms. Larson was mistaken about the material which the five gallon bucket was made of, and what weight, if any, this has on her testimony, as well as to weight to assign the testimony of various corporate representatives in light of internal inconsistencies in their statements.

Union Carbide joined in the arguments of Georgia-Pacific and further argued that there was evidence that Georgia-Pacific used additional asbestos suppliers in manufacturing its joint compound, and therefore, “Plaintiffs cannot establish that it is more likely than not that Ms. Larson was exposed to Union Carbide asbestos rather than some other suppliers' asbestos.”  This argument too was rejected by the Court that held that there was sufficient question of fact that Georgia-Pacific used Union Carbide asbestos in its joint compound.

The take away from these recent decisions is that assessment of the strengths and weaknesses in issues of product identification are critical to each case.  While that seems rudimentary, these decisions show that a well prepared defendant or plaintiff can triumph by focusing on specific issues to close the door or keep open issues of fact for a jury.