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 accident in which the plaintiff flipped over his handlebars and landed on his head, resulting in quadriplegic injuries. His claims against the manufacturer of his helmet proceeded to trial, and his attorney sought to offer testimony from his expert about an article that, according to ...
Continue Reading...


Medical Marijuana Faces Potential Challenge by the Federal Government

During the last week of June 2017, the House Appropriations Committee released its 2018 Commerce, Justice, Science (CJS) Appropriations bill, which determines the funding levels for numerous federal agencies, including the Department of Justice. Interestingly, the bill did not include language limiting the Justice Department from taking action against state-sanctioned medical cannabis producers, retailers, or consumers. This language is known as the Rohrabacher-Blumenauer amendment. It is interesting because on or about May 1, 2017, the President signed an extension of the Rohrabacher-Farr Amendment (the bill’s previous incarnation), extending the protection of medical marijuana use through September 30, 2017. The amendment blocks federal government from spending money on medical marijuana prosecutions, assuming growers and dispensaries follow state rules. Although the amendment was reauthorized by Congress in May, US Attorney General Jeff ...
Continue Reading...

Lobbying is not Conspiracy

Plaintiffs often seek to demonize corporate defendants, and one way they try to do so is by asserting that defendants engaged in a “conspiracy.”  For a plaintiff in one of the many talc/ovarian cancer cases pending in California state court, that tactic was unsuccessful as she failed to convince the court that she could proceed with such a claim. The plaintiff, Eva Echevarria, sought to convince Los Angeles Superior Court Judge Maren E. Nelson that she had sufficient proof that defendants Johnson & Johnson and its talc supplier, Imerys Talc America, Inc., conspired to influence the FDA and to prevent stricter regulation of talc products.  Judge Nelson rejected the plaintiff’s offer of proof, concluding that the record supported the existence of advocacy by the defendants “either directly or through the ...
Continue Reading...

Notable Win for Baby Powder Manufacturer & Distributor, as New Jersey Federal District Court Judge Grants Motion Dismissing Claims for Lack of Standing

On July 14, 2017, a New Jersey Federal District Court Judge handed Johnson & Johnson a victory in a case involving talc and ovarian cancer, dismissing the plaintiff’s amended complaint for lack of standing and for failure to state a claim. Initially, the plaintiff filed her complaint in California Federal District Court, alleging that Johnson & Johnson engaged in unfair business practices by manufacturing, marketing, and distributing talc-based baby powder products without informing consumers that use of baby powder by women could lead to an increased risk of developing ovarian cancer.  Johnson & Johnson moved to dismiss the action in California for lack of standing, and the California Federal District Court Judge agreed. Plaintiff then filed an amended complaint in California Federal District Court, alleging causes of action for violations ...
Continue Reading...

Shifting Regulatory Landscape for Off-Label Promotion Continues

On Wednesday, July 12, 2017, the Health Subcommittee of the Energy and Commerce Committee held a hearing to discuss proposed legislation that would impact the regulation of off-label use and promotion for drug products. There were representatives from all facets of the industry discussing the potential impact of decreasing regulation of off-label use of drugs and how it could affect patients, the public, manufacturers, and the economy. The FDA last solicited public comment on the issue of off-label use over six years ago, and the proposed bill is meant to help clarify certain confusion that has existed between the current regulations and more recent court rulings that appear to contradict and conflict with the current regulatory scheme.  The bill, in its current form, seeks to reduce regulation in order to ...
Continue Reading...

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 party hosts failed to warn her of a dangerous condition (i.e. the sleeping dog). The plaintiff, who was carrying a glass of wine when she tripped over the dog, claimed she could not see the dog because the chairs, the guests and a wall obscured her view. ...
Continue Reading...

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 pharmaceutical and medical device claims. Those familiar with the program, which has its own webpage on the New Jersey Judiciary website, know that cases can be centralized for coordinated judicial management before one of four trial court judges: Judge Johnson in Atlantic County, Judges Viscomi ...
Continue Reading...

Federal Court Denies Qui Tam Action Against Medical Device Manufacturer Rejecting Novel Theory that Free Product Support Services Create Liability Under Anti-Kickback Statute

Medical device manufacturers operate in a competitive market. To differentiate themselves from their competitors, manufacturers may offer above-and-beyond customer service. A recent federal qui tam action alleged that too much customer service constitutes an illegal kickback under the federal Anti-Kickback Statute. The court rejected the claim, and its reasoning supplies some comfort and some questions for medical device companies going forward. The federal Anti-Kickback Statute, 42 USC sec. 1320a-7b (AKS), makes it unlawful to knowingly and willfully solicit any remuneration (e.g. bribe, kickback, rebate, etc.) for referrals of services covered by federally funded medical services. What constitutes remuneration often presents the key question in evaluating an AKS claim. A straight payment of money in return for the purchase of a medical device may be a clear violation of the AKS, ...
Continue Reading...

Will the Statute of Limitations on Medical Malpractice Actions in New York Be Extended?

For decades, section 214-a of the New York Civil Practice Law & Rules set forth the statute of limitations for medical malpractice actions. Under current law, the statute of limitations for a medical malpractice action expires two and half years after the date of the alleged malpractice. New York is one of only a handful of states without a date of discovery law regarding medical malpractice actions. A date of discovery law tolls the statute of limitations for a medical malpractice claim until the injury should have been discovered. However, this may be changing, at least for New York cancer patients. Last week, proposed legislation to adopt a discovery rule passed in the New York Senate and is on its way to Governor Cuomo. Under the legislation, the statute of ...
Continue Reading...

Introduction of CARERS Act Next Step Forward in Medical Marijuana Field

On June 15, 2017, the Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2017 was re-introduced in the U.S. Senate. It was introduced by Senators Kirsten Gillibrand (New York), Cory Booker (New Jersey), Al Franken (Minnesota), and Rand Paul (Kentucky). It was additionally supported by Republican Senators Lisa Murkowski (Alaska) and Senator Mike Lee (Utah). It was previously introduced in March 2015. The CARERS Act is intended to safeguard patients in states with medical cannabis programs and to expand research opportunities. It would allow for the possession, production, and distribution of medical marijuana in states that have made medical marijuana legal as long as the parties complied with state laws. It would also lift the ban on Veterans Affairs doctors recommending medical marijuana to patients in those states ...
Continue Reading...