H. Lockwood Miller III

All articles by H. Lockwood Miller III

 

First Circuit Agrees Pharmacists Provide Services, Not Sell Goods

When a plaintiff sues a pharmacist for dispensing and selling a prescribed medication that allegedly causes an injury, is the claim based on the negligent provision of services or on the sale of a defective product? Most courts agree that it is the former, and recently the U.S. Court of Appeals for the First Circuit, while recognizing that this specific issue had not yet been addressed by the appellate courts in Massachusetts, joined the majority of courts in holding that view. The case arose out…  

Update on Recent Decisions from New Jersey’s Pelvic Mesh and Ovarian Cancer/Talc Litigation

We wanted to update our readers on two decisions from the New Jersey Appellate Division that were the subject of recent posts. In March, we reported on an opinion from the Appellate Division that came out of the centralized pelvic mesh litigation pending in Bergen County, New Jersey reversing the verdicts in favor of plaintiffs in two cases because the trial courts had precluded the defendants from introducing key evidence relating to FDA clearance of the products at issue under Section 510(k). Following the issuance…  

Animal Testing Bans and Product Liability Lawsuits

On March 16, 2021, Virginia became the fourth state—following California, Nevada, and Illinois—to enact legislation banning the testing of cosmetics on animals and the sale of cosmetics that have been tested on animals. Similar legislation may follow in other states, and Representative Don Beyer of Virginia has indicated he intends to reintroduce federal legislation to establish this ban nationwide. From a defense perspective, whenever a cosmetic product company is sued in a product liability lawsuit, it is helpful to have a strong record of safety…  

Two New Jersey Pelvic Mesh Verdicts Overturned

While Covid-19 continues to be a dominant national topic, including with the recent approval of the Johnson & Johnson vaccine, there are other developments of note for the life sciences industry. One of those came on March 2, 2021, when the New Jersey Appellate Division—New Jersey’s intermediate appellate court—I issued a lengthy opinion reversing two multi-million dollar verdicts in favor of plaintiffs in pelvic mesh product liability cases. (Actually, the court issued two lengthy opinions, a long published opinion and an even longer unpublished opinion 

Do Plaintiffs’ Counsel Perceive New Jersey MCL Judge Harz as a More Favorable Jurist?

Earlier this month, we wrote about some changes to New Jersey’s MultiCounty Litigation Program–specifically the retirement of Middlesex County MCL Judge James Hyland and the appointment of Judge Bruce Kaplan to succeed him. As we noted, Judge Kaplan has now taken over management of those MCL litigations that have been assigned to Middlesex County (with the exception of the asbestos litigation assigned to Judge Viscomi). After we wrote about those changes, the New Jersey Supreme Court has posted the most recent application submitted for designation…  

New Judge for New Jersey’s Multicounty Litigation Program

This week saw a major snowstorm for parts of New Jersey, bringing more than two feet of snow in some areas of the state (including my driveway). This week also saw the assignment of a new judicial face to New Jersey’s Multicounty Litigation cases. Many of you are likely aware of the federal Judicial Panel on Multidistrict Litigation, or JPML, which can decide to consolidate and transfer cases pending in the federal district courts for consolidated pre-trial management by a single District Judge. There have…  

New Year, New Administration, New Issues?

Much of the nation is watching the transfer of power from the outgoing Trump administration to the incoming Biden administration. Each new administration brings many things, but one constant is change. Obviously, COVID-19 has been the dominant issue for nearly all of 2020, impacting everything, from the drug and medical device industries to our legal system. We expect that while the new Biden administration will continue some of the policies and programs from the Trump administration relating to COVID-19, others will change or be modified,…  

New Jersey Appellate Panel Reverses Trial Court’s Detailed Exclusion of Unreliable Expert Testimony

Although COVID-19 remains a dominant topic in America, there are still some non-related COVID-19 developments worthy of note over the past few months. Don’t worry, this is not a comment on the recent presidential election or the post-election legal battles to overturn the results. We’re providing a brief discussion of something near-and-dear to most, if not all, of those who litigate in the life sciences arena―especially in the product liability realm: expert admissibility. In 2016, Judge Nelson Johnson, the New Jersey Superior Court judge then…  

Best Wishes for a Happy Thanksgiving

It would be an understatement to say that 2020 has been a difficult year for most, if not all, of us in the United States. Since March, most of our posts have tried to relate to at least one of the myriad issues raised by the ongoing COVID-19 pandemic. We are by no means alone in that effort, but we hope that we have been able to provide some helpful information and/or promote some useful thinking for many of you. (If we did, feel free…  

Potential Supreme Court Review of Another Punitive Damages Case

Much of the nation is understandably focused on the presidential election results, as well as the troubling rise in COVID-19 cases across the country. While questions of punitive damages are likely far from the minds of most everyone at the present, the Missouri Supreme Court rejected a bid from Johnson & Johnson (J&J) to review the $2.1 billion damages award rendered against it in favor of a group of women suing over alleged ovarian cancer risks. As readers may recall, the initial verdict against J&J…  

Take-home Exposure Claims May Lead to COVID-19 Litigation

Anyone familiar with asbestos litigation over the past several decades is well-aware of the so-called “take-home exposure” claim, in which the injured plaintiff claims to have been exposed to and injured by asbestos that another household member brought home on their person or clothing. This type of claim often arises out of an alleged workplace exposure to asbestos. In that scenario, the injured plaintiff does not claim to have been personally exposed to asbestos at the workplace, but instead asserts that a family member was…  

Are You Going to Eat That?

We have written before about issues related to hand sanitizers and household cleaners, which have expectedly taken on increased importance as people look for ways to protect themselves and others from the spread of COVID-19. Recently, the FDA addressed another potential concern that it believed consumers and manufacturers should be aware of―the risk of misuse of hand sanitizers manufactured or packaged in a way that may mimic foods or beverages. As reported by the FDA, some manufacturers have packaged hand sanitizers in containers resembling beer…  

COVID-19 and Expert Believability

Recently, I was speaking with a plaintiff’s lawyer whom I like and respect about the potential impacts of COVID-19 on the concept of a reasonably prudent person—something we have written about before. He suggested to me that an even bigger impact—not necessarily tied solely to COVID but certainly exacerbated by it—could be with respect to jurors’ willingness to listen to and believe scientific testimony. In many life sciences lawsuits, science and scientific evidence play important roles. Many defendants in life sciences cases—particularly product…  

FDA Announces Laboratory Testing Method for Hand Sanitizers

We have written before on some of the issues relating to hand sanitizers, including troubling information about how some people misuse hand sanitizers in dangerous ways and the FDA’s efforts to publicize information about various hand sanitizers identified by the FDA as being hazardous to users. The FDA has warned consumers not to use those hand sanitizers and has warned importers, consignees, distributors, retailers, and others not to distribute or sell those hand sanitizers, even if the corresponding manufacturers have not recalled them. Earlier this…  

Hands Off for More Sanitizers

Recently we posted about the FDA’s warnings regarding various potential dangers and harmful effects from hand sanitizers. Notwithstanding FDA’s efforts, reports continue of consumers using – or misusing – hand sanitizers and being injured. For example, on August 5, CNN reported about multiple significant injuries caused by people drinking hand sanitizers. But on the same day that we posted, the FDA released a further update and warned consumers and users of hand sanitizers about a different potential problem: the use of hand sanitizers that contain…  

As Temperatures Heat Up, Remember Litigation Will, Too

For many litigators, including those of us who handle pharmaceutical and medical device litigation, the past several months have seen various departures from how we might otherwise have pursued our pending cases. While effects varied in different parts of the country, and courts in different jurisdictions have adopted different plans for reopening and allowing cases to continue, everyone has likely seen at least some changes. Some attorneys have embraced virtual/remote depositions, while others have opted to wait to schedule and depose witnesses in the hopes…  

Remember to Explore a Plaintiff’s Pandemic Actions

Recently, we offered some thoughts about the heeding presumption in light of recent news reports of Americans acting in ways that are contrary to public health recommendations. Since then, the CDC published a report of a survey conducted of approximately 500 U.S. adults regarding their understanding and use of some chemical cleaning products and practices. Some of the reported results are shocking – even to those who profess to no longer be surprised by any unwise behaviors that people might engage in. For example, the…  

Reasonably Prudent and COVID-19

Hyperbole aside, the impacts from COVID-19 have been pervasive, touching all aspects of our society. Commentators continue to identify just how far and wide these impacts have been, and it will likely take a number of years for us all to truly understand the breadth of the changes being wrought, including in the legal industry generally, and in litigation specifically. As life science companies and their counsel know full-well, a critical component of tort law in many jurisdictions is the concept of the “reasonable person”…  

COVID-19 and the Heeding Presumption

Much has been written about the so-called “heeding presumption,” which allows a fact-finder to presume, in a failure-to-warn case, that a plaintiff would have heeded an adequate warning if one had been provided. When applied, the heeding presumption obviates the need for the plaintiff to introduce evidence to prove that she or he would have followed the warning that the defendant is alleged to have failed to give. Life science companies and the attorneys who defend them in failure-to-warn cases are well-acquainted with this doctrine…  

COVID-19, Duty to Warn, and Potential Product Misuse

Under the law of most, if not all, U.S. jurisdictions, product manufacturers are required to provide product-related warnings associated with foreseeable uses of their products. The law in most of these jurisdictions also extends the duty to warn to reasonably foreseeable misuses of a company’s products. But, generally speaking, misuses that are not reasonably foreseeable do not require a warning – product manufacturers are not required to dream up and warn against every theoretical possible misuse of their products. While the duty to warn with…  

Which Gate Do I Enter? Expert Admissibility Standards Far From Uniform

  In August, the New Jersey Supreme Court released its opinion in In Re: Accutane Litigation, which as fans of expert-admissibility standards will know essentially moved New Jersey into the column of states that apply a Daubert-based test, rather an a Frye-based test, in evaluating the admissibility of scientific and expert testimony. For anyone who has not yet seen the opinion, a copy can be found here. (Note – it is lengthy, so get a full cup of coffee before you sit…  

Florida’s Second Circuit Invalidates State Legislature’s Attempt to Ban Use of Smokable Marijuana in Private

Medical marijuana has become more and more widespread and accepted throughout the country and state legislatures have drafted legislation that regulates its use.  However, when a state’s legislature oversteps its limits, the courts must be willing to respond and invalidate such measures.  That’s exactly what happened on Friday, May 25th, 2018, in People United for Medical Marijuana v. Florida Dept. of Health, Index No.: 2017-CA-1394 (2nd Judicial Circuit, Leon County). In November 2016, Floridians voted to amend their state constitution and allow…  

Lone Pine Orders: Not Just for Multi-Plaintiff Litigation?

So-called “Lone Pine” orders derive from Lone Pine v. Lore, 1986 WL 637507 (N.J. Sup. Ct. Law Div. Nov. 18, 1986), and have often been used by state and federal courts to promote efficiency in discovery by requiring plaintiffs to provide some medical or scientific proof that their exposure to a product caused their injuries before requiring the parties to engage in the usual full-blown and expensive discovery process. In most instances, Lone Pine orders are employed in cases involving large numbers…  

Failure to Identify Author Supports Rejection of Publication as Learned Treatise

The use of a learned treatise at trial, either with one’s own expert or on cross-examination of an opposing expert, arises frequently in life sciences cases. When doing so with your own expert, is it helpful for your expert to have actually relied on the publication and to be able to identify who wrote it and why it is reputable? Not surprisingly, the answer, according to a New Jersey court, is yes. Lawson v. K2 Sports USA, et al. arose out of a mountain biking…  

Word to the Wise: Let Sleeping Dogs Lie … or at Least Lawsuits Based on Them

Since it is a holiday week surrounding Fourth of July we are keeping the content light and irrelevant to our blog topic. But, when a court determines that a dog sleeping in a hallway does not create an unreasonable risk, we can’t resist. In Parella v. Compeau, a panel of the New Jersey Appellate Division tackled the question of whether a “hidden” sleeping dog created a dangerous condition at a Christmas dinner (wine) party hosted at the defendants’ house. The plaintiff alleged the homeowner…  

New Jersey, (Mass Actions) & You — Still Perfect Together?

Earlier this month, we wrote about a choice-of-law decision from the New Jersey Supreme Court that we believe will invite more out-of-state plaintiffs to forum-shop and file suit in New Jersey. This prospect of increased “litigation tourism” brought to mind the old New Jersey tourism slogan “New Jersey and You – Perfect Together.” It also brought to mind that New Jersey’s state-law version of an MDL — the New Jersey Multicounty Litigation program — remains a favorite vehicle for plaintiffs and their lawyers to pursue…  

Judicial Call for More Guidance on Punitive Damages Awards

Earlier this year, in a bellwether trial in the Actos multidistrict litigation, a Louisiana federal court jury awarded $9 billion  in punitive damages to plaintiffs who claimed that the use of the diabetes drug Actos caused bladder cancer. Not surprisingly, post-trial challenges followed. In particular, while the defendants did not challenge the amount of compensatory damages ($1,475,000), they argued that the award of punitive damages had to be reduced in order to comply with previous United States Supreme Court rulings that established limits on punitive…  

Judge Higbee to the Appellate Division?

It is being reported today that Judge Carol Higbee, who is one of several judges assigned to handle multi-county litigation pending in New Jersey, is being temporarily assigned to the Appellate Division.  Currently, Judge Higbee presides over several multi-county litigations pending in Atlantic County, New Jersey, many of which involve product liability claims against pharmaceutical products or medical devices.  The Appellate Division assignment is reported to run from mid-April to mid-June, with the possibility that it could become a permanent assignment. It remains to be…  

New Alternative Causation for Pharma Defendants in Surgeon General’s Smoking Report?

Last week, the Office of the Surgeon General of the U.S. Department of Health and Human Services released a new report on the health consequences of smoking on the 50th anniversary of the first Surgeon General’s report on smoking and health.  The report is available, click here. The 2014 report – entitled “The Health Consequences of Smoking—50 Years of Progress” – adds colorectal and liver cancer to the list of cancers causally linked to smoking. The report also adds several non-cancers to the list of…  

New Alternative Causation for Pharma Defendants in Surgeon General’s Smoking Report?

Last month, the Office of the Surgeon General of the U.S. Department of Health and Human Services released a new report on the health consequences of smoking on the 50th anniversary of the first Surgeon General’s report on smoking and health. The 2014 report – entitled “The Health Consequences of Smoking—50 Years of Progress” – adds colorectal and liver cancer to the list of cancers causally linked to smoking.  The report also adds several non-cancers to the list of chronic diseases causally linked to smoking,…  

Roche Recusal Victory Short-Lived

Last week, we commented on what appeared to be some success for Hoffman-La Roche in its efforts to force the recusal of Judge Carol Higbee from her role presiding over the centralized multicounty litigation involving Accutane.  However, the order issued by New Jersey Supreme Court Justice Jaynee LaVecchia — which imposed a stay on the trial court proceedings and appeared to us to suggest that Roche’s application would receive further review on the merits before the Appellate Division — was superceded by two further orders 

Roche Wins Battle in Recusal Fight

We continue to follow with great interest the on-going efforts by Hoffman-La Roche to force the recusal of Judge Carol Higbee, who has been overseeing the thousands of claims pending against Roche involving Accutane in the Superior Court of New Jersey.  Up until now, Roche’s efforts have been unsuccessful, beginning with Judge Higbee’s initial denial of the recusal application, followed by the New Jersey Appellate Division’s rejection of Roche’s application for leave to appeal that denial. However, Roche’s fortunes may be changing — at least…  

Generic Defendants’ PA Preemption Battle Gets Potential Boost from NJ Judge

The issue of generic-drug preemption continues to be one of the key battlegrounds in pharmaceutical product liability litigation. Recently – as we discussed here – the FDA released a proposed rule that, if adopted, would eliminate the broad preemption of failure-to-warn claims against generic pharmaceutical manufacturers established two years ago by the U.S. Supreme Court in PLIVA v. Mensing. In the wake of Mensing, multiple courts across the country have taken up efforts by generic pharmaceutical defendants to dismiss failure-to-warn claims, as well…  

New Jersey Supreme Court Denies Another MultiCounty Litigation Application Without Explanation

In a notice posted earlier this week, the New Jersey Supreme Court has denied another application seeking centralization of cases under New Jersey’s established multicounty litigation procedures.  Unfortunately, this denial — rendered with respect to cases involving DuraPro brand toilet supply lines — offers no analysis or explanation for why the Court rejected the application.  The denial by the Court — similar to prior denials — again references comments received with respect to the application for centralization without providing any discussion of those comments, or…  

Its Flu Season – Remember the National Childhood Vaccine Injury Act

It is getting to be flu season – with the annual barrage of public-service announcements about the importance of getting this year’s flu vaccine.  Vaccines were also in the news recently on reports of a polio outbreak in Syria. Vaccines also end up the subject of lawsuits, including the recent decision from the United States Court of Appeals for the Federal Circuit in Tembenis v. Sec’y Health & Human Servs., (October 28, 2013), available here, which ruled that future lost earnings cannot be awarded…  

Pennsylvania Court Rejects Bid to Reargue Mensing Denial

Last month, we reported on the attempt by several generic manufacturers of metoclopramide to seek reargument before the Pennsylvania Superior Court on the issue of whether the claims against them are preempted under the jurisprudence of the United States Supreme Court’s opinion in PLIVA, Inc. v. Mensing and its progeny. The generic manufacturers’ bid for reargument was rejected by the Pennsylvania Superior Court last week, meaning that the Superior Court’s prior divided decision that upheld the trial court’s refusal to dismiss the claims as preempted…  

Mensing-Preemption Battle Continues in Pennsylvania as Defendants Seek Reargument of Denial of Appeal

The nationwide battle over federal preemption in connection with generic drugs continues, with manufacturers of generic metoclopramide in Pennsylvania seeking to reargue the denial of their appeal challenging the court’s refusal to find the claims against them preempted. Since the 2011 Supreme Court opinion in PLIVA, Inv. v. Mensing, the issue of preemption in tort suits against manufacturers of generic pharmaceuticals has been an important issue. In short, preemption arises under the federal requirement that generic drug labeling must be the same as the…  

Accutane Recusal Fight Headed to NJ Supreme Court

We, like others, have been following the ongoing saga of Hoffman-La Roche’s efforts to secure the recusal of Judge Carol Higbee from her role presiding over the centalized multicounty litigation involving Accutane.  Last month, we noted that the Apellate Division had denied Hoffman-La Roche’s attempt to force Judge Higbee’s recusal.  Hoffman-La Roche, as reported by, among others, Law360 (registration required), continues to push this issue, and has now asked the New Jersey Supreme Court to review its request.  A copy of Hoffman-La Roche’s brief is…  

New York Federal Court Upholds “Failure to Update” Theory

For those who follow pharmaceutical litigation, the issue of preemption – as discussed primarily by the U.S. Supreme Court in PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, as well as in a host of other state and federal court opinions – continues to be an important battleground.  Although most courts have rejected the plaintiffs’ efforts to pursue failure-to-warn claims against generic drug manufacturers, based on the generic drug makers’ federal law “duty of sameness,” under which a warning label for a…  

Centralized Status Rejected for Tylenol Liver-Injury Suits

The New Jersey Supreme Court has rejected yet another application — again by a defendant — for centralization under Rule 4:38A.  As we previously noted, Johnson & Johnson earlier this year submitted an application seeking centralization of all suits alleging liver damage from the ingestion of Tylenol in Middlesex County.  J&J’s application came on the heels of the establishment of a federal MDL on the same issue. In a notice dated last month and released last week, the NJ Supreme Court rejected J&J’s request. …  

Appellate Division Rejects Bid to Recuse Accutane Judge

Law360 is reporting (registration required) that the New Jersey Appellate Division has rejected Hoffman-La Roche’s attempt to recuse Judge Carol Higbee from her role presiding over the centralized multicounty litigation involving Accutane.   We previously discussed Roche’s efforts here, here, here, and here. According to the Law360 article, Roche intends to continue down this path and challenge the Appellate Division’s refusal to review its application.  Given New Jersey’s strong and well-established centralized multicounty litigation program, it is doubtless that many practitioners in…  

Preemption Defense Not Completely Dead for Branded Drugs

As all who follow drug and device law know full-well, the 2009 decision from the United States Supreme Court in Wyeth v. Levine represented a significant setback for brand-name drug manufacturers seeking to defend failure-to-warn claims on preemption grounds.  In Levine, the court held that state law failure-to-warn claims involving brand-name drugs are not preempted, unless there is “clear evidence” that the Food and Drug Administration (FDA)  would not have approved whatever labeling change forms the basis for the failure-to-warn claim.  Such a standard…  

Trio of Favorable Preemption Decisions for New Jersey Pharmaceutical Companies

A trio of recent preemption decisions – from the United States Supreme Court, the United States District Court for the District of New Jersey, and the Superior Court of New Jersey – are good news for pharmaceutical companies facing product liability suits in New Jersey. First, in Mutual Pharmaceutical Co. v. Barlett, the United States Supreme Court issued an important ruling (copy available here) on several critical issues affecting product liability suits against generic pharmaceutical manufacturers.  Bartlett involved claims by a woman that…  

Trio of Favorable Preemption Decisions for New Jersey Pharmaceutical Companies

A trio of recent preemption decisions – from the United States Supreme Court, the United States District Court for the District of New Jersey, and the Superior Court of New Jersey – are good news for pharmaceutical companies facing product liability suits in New Jersey. First, in Mutual Pharmaceutical Co. v. Barlett, the United States Supreme Court issued an important ruling (copy available here) on several critical issues affecting product liability suits against generic pharmaceutical manufacturers.  Bartlett involved claims by a woman that…  

Statute of Limitations Substantive not Procedural for Foreign Plaintiff Suing in New Jersey

In an opinion released on June 14, 2013, a panel of New Jersey’s Appellate Division reaffirmed that the question of which state’s statute of limitations should be applied is a substantive, not a procedural, question. The issue arose in one of the many Zometa cases pending in Middlesex County.  In this particular case, the plaintiff, a resident of Virginia, received Zometa in 2002, was diagnosed with osteonecrosis of the jaw in December 2003, and filed suit against Novartis Pharmaceuticals Corporation, the manufacturer of Zometa, in…  

Second Time’s the Charm for Centralization of NJ Mirena Lawsuits

In a notice published yesterday, the New Jersey Supreme Court has reversed its prior refusal to centralize New Jersey state court lawsuits involving Bayer HealthCare Pharmaceuticals’ Mirena contraceptive device, and has decided to centralize all such pending suits before Judge Brian Martinotti in Bergen County. As we noted previously, Bayer submitted an application last year seeking centralization of its Mirena litigation in Middlesex County, but its request was denied several months ago.  In March, Bayer resubmitted its application, and comments supporting the application were…  

Tylenol Subject of Latest New Jersey Centralized Management Request

Suits alleging liver damage from acetaminophen are the latest subject of a request for centralized management in New Jersey.  Late last month, McNeil-PPC and Johnson & Johnson submitted an application seeking centralized management of all pending New Jersey lawsuits involving alleged liver damage from Tylenol products. The application, which comes on the heels of the establishment of a federal Multi-District Litigation for similar suits pending in the federal courts, seeks centralization of all New Jersey Tylenol cases in Middlesex County before Judge Mayer, rather than…  

Reconsideration Sought for Multi-County Litigation Denial

Previously, we noted that the New Jersey Supreme Court denied an application by Bayer HealthCare Pharmaceuticals, Inc. for centralized management of all New Jersey claims involving the Mirena contraceptive device.  Currently, there is an application for reconsideration pending before the New Jersey Supreme Court, again seeking designation of this growing litigation as a Multi-County Litigation.  However, while both Bayer and plaintiffs have sought reconsideration — and thus appear to agree that centralization is appropriate — the sides may differ on where they want that…  

Recusal Fight in Accutane Litigation Heading to Appellate Court?

As we have discussed previously, defendants Hoffman-La Roche Inc. and Roche Laboratories Inc. recently filed a motion to recuse Judge Higbee from further handling of the centralized Accutane litigation pending before her.  Last month, Judge Higbee denied that motion.  Yesterday, as reported in Law360 (registration required), the defendants filed an application for leave to appeal Judge Higbee’s decision to the New Jersey Appellate Division, asserting that, among other things, Judge Higbee’s opinion denying their motion is further evidence of an appearance of, if not actual,…  

Punitives Verdict in Pelvic Mesh Trial

Earlier this week, we noted that the first pelvic mesh trial in New Jersey against Johnson & Johnson resulted in a plaintiff’s verdict.  Yesterday, the same jury rendered a punitive damages award against J&J.  Not surprisingly, this result has drawn immediate attention from both legal and general commentators and news outlets (e.g., Law360 (registration required), New Jersey Law Journal (registration required), Bloomberg,  Given the number of other similar claims pending against J&J in New Jersey and elsewhere, it is likely that this case will…