Life Science Matters

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CBD, THC, and the Hazy Boundaries of Product Labeling in the Cannabis Industry

Cannabis is a dynamic plant with tens of thousands of known applications, from clothing and paper to food and medicine. While cannabis has been cultivated for many purposes over thousands of years, much of the recent attention has been on the chemical compounds that are predominant within certain species of the genus, most notably Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Of course, THC is known for producing the high that users experience when they smoke cannabis. CBD, on the other hand, does not produce a high…  

Big Cannabis, Priority Applicants, and Social Equity in the Budding Marijuana Industry

The city of Cambridge, Massachusetts recently passed an ordinance prohibiting existing medical marijuana dispensaries from engaging in the sale of recreational marijuana for two years.[1] Specifically, the ordinance gives priority to economic empowerment applicants, defined under the state’s Cannabis Control Commission as businesses that are owned by, serve, or reside in areas disproportionately impacted by high amounts of drug-related arrests, including businesses owned by individuals of Black, African American, Hispanic, and Latino descent.[2] For the first two years after the Cambridge ordinance’s enactment,…  

Kenney v. Helix TCS, Inc.: Leveling the Playing Field in the Marijuana Industry and Beyond

Are employers in the marijuana industry excused from complying with federal law because their business practices are federally prohibited? In the recent case of Robert Kenney v. Helix TCS, Inc.[i], the U.S. Court of Appeals for the Tenth Circuit answered that question with an unequivocal “no.” The plaintiff in that case, Robert Kenney, was a former security guard for the defendant, Helix TCS, Inc., a private company that provides security services to businesses in Colorado’s state-sanctioned marijuana industry. Kenney alleged that he…  

Ketamine: Another Pandora’s Box or Viable Treatment for Pain?

In the wake of the opioid crisis, some physicians are seeking to utilize ketamine, a highly addictive drug, to treat chronic pain and depression. Ketamine is a generic name for Ketalar (ketamine hydrochloride) and belongs to a class of drugs known as dissociate anesthetics. Ketamine’s FDA label warns of the potential emergence of psychological issues with potentially dangerous drug interactions with barbiturates and narcotics. Ketamine has already proven its high potential for abuse and is well-known as a “recreational drug,” “club drug,,” and “date rape…  

Edible Cannabis: Coming to a Dispensary Near You in Florida

Medical marijuana continues its eventful 2019 in the Sunshine State. Mere weeks after Governor Ron DeSantis signed a bill ending Florida’s ban on smokable medical marijuana, the Florida Legislature pushed back on the industry. A February house bill that sought to legalize recreational cannabis died without a hearing or a vote, the House Appropriations Committee rejected an amendment that would have allowed medical marijuana to treat opioid addiction, and, despite the lack of public support, the Legislature proposed a bill that would place caps on…  

A Potential Rise in Toxic Tort Litigation: Pesticide Use on Cannabis

As more states enact medicinal and adult recreational cannabis laws each year, we are likely to see growing litigation in the toxic torts arena. Health officials have warned about the potential hazards to consumers’ health from cannabis that has been treated with chemical pesticides. The risks may vary depending on how the product is consumed, whether eaten, smoked, vaped, or dermally applied. So far, given the federal ban on marijuana, there are no pesticide products that have been approved on the federal level specific to…  

Florida Seeks to End Ban on Smoking Medical Marijuana

On Tuesday, February 12, 2019, the Florida House’s Health and Human Services Committee considered a new bill that would allow medical marijuana patients to receive their prescription in smokable form.  The Committee voted in favor of the bill, with only two votes in opposition, and it will now head to the appropriations committee as it moves closer to a vote. After Florida voted to legalize medical marijuana in 2016, then Governor Rick Scott signed the bill into law while putting into place a ban on…  

Litigation is the Pits – Claim Dismissed for Injuries Caused by Natural Food Substance

“A lady bit down on a pit in an olive …” may sound like the opening line to a bad joke, but the defendant she sued for her injuries with the help of an injury lawyer from https://www.braininjurylawyersorangecounty.com/ appears to have had the last laugh. The plaintiff filed a personal injury claim with the help of a personal injury attorney from www.kwdllp.com/workplace-accidents/ against the defendant in California state court for products liability and pursued theories of strict liability, negligence and breach of an express written…  

Michael Hamilton to Speak at Perrin Conferences on Opioid Litigation

Join Goldberg Segalla’s Michael A. Hamilton at Perrin Conferences Opioid Litigation Conference in Dallas, TX on Thursday June 28, 2018. This one-day conference covers medical perspectives on opioid prescription practices, opioid-related litigation across state courts, and more. Register here. 

Third Circuit Affirms Summary Judgment for Pfizer in Zoloft MDL

A Third Circuit Court of Appeals panel recently upheld a lower court’s decision to dismiss plaintiffs’ claims at summary judgment in a multi-district litigation involving Zoloft, an anti-depressant manufactured by Pfizer. The MDL involved 315 plaintiffs alleging that Zoloft causes cardiac birth defects when taken during early pregnancy. The decision, which upheld an earlier ruling by the U.S. District Court for the Eastern District of Pennsylvania, has both good and bad aspects for defendants facing pharmaceutical product liability claims. The plaintiffs introduced several expert witnesses…  

Plaintiffs’ Product Case Trumped by the Learned Intermediary Doctrine

A large pharmaceutical manufacturer recently won a fundamentally important victory both within the mass tort it is facing and for all life science companies needing to rely upon the learned intermediary doctrine. In the consolidated litigation proceeding in New Jersey state court, the plaintiffs’ claim the manufacturer failed to properly warn its users of known gastro-intestinal complications associated with the drug. Relying on the learned intermediary doctrine, the judge granted the manufacturer summary judgment in some cases because the treating physicians testified they prescribed the…  

Illinois Federal Court Considers Whether Plaintiff Expert’s Methodologies Were Sufficiently Reliable under Daubert in a Pharmaceutical Case

GlaxoSmithKline has attempted to knock out the plaintiff’s experts in Dolin v. GlaxoSmithKline, in its latest round of Daubert motions. Wendy Dolin is suing GSK after the suicide death of her prominent lawyer husband, who had been taking the generic form of Paxil, paroxetine, an antidepressant.  This case made national news just a year ago when Judge Zagel of the Northern District of Illinois held that GSK could be liable for Dolin’s death under a negligence theory, not a product liability theory, even though…  

Drug Promotion on Social Media By Consumers: Can It Be Regulated?

Kim Kardashian recently used social media to promote the use of a prescription drug. In her Instagram post, Ms. Kardashian told her followers that a physician recommended use of the drug Diclegis to alleviate her symptoms of morning sickness. Ms. Kardashian is not the only public figure to recently deal with morning sickness as the Duchess of Cambridge also dealt with this issue, reported here. Having experienced positive results following the use of this drug, Ms. Kardashian posted her intent to pair with the  

Recent Philadelphia Verdict Highlights Need to Combat Punitive Damages

In the Philadelphia Court of Common Pleas, a jury recently awarded the plaintiff $2.3 million in compensatory damages for injuries he alleged arose from his use of a diabetes treatment drug.  The plaintiff claimed that the drug company failed to properly warn that its use was linked to a higher incidence of bladder cancer, a condition he subsequently developed.  In addition to awarding a compensatory sum, the jury awarded $1.3 million in punitive damages, apparently based upon evidence that the company’s pharmaceutical reps were instructed…  

Pennsylvania Supreme Court Overrules Azzarello But Declines Opportunity To Adopt Restatement Third of Torts

On November 19, 2014, the Pennsylvania Supreme Court issued its much-anticipated decision in  Tincher v. Omega Flex, Inc.Having originally granted allowance of appeal to decide whether to replace the strict liability analysis of Section 402A of the Restatement Second, Pennsylvania’s highest court declined the opportunity and instead overruled  its 1978 ruling in Azzarello vs. Black Brothers, 391 A.2d 1020 (Pa. 1978). The four justice majority opinion (available here), written by Chief Justice Ronald D. Castille, held that Pennsylvania will continue to apply…  

Alabama Supreme Court Decision Lends Support to Plaintiffs’ Innovator Liability Theory

It is a bedrock principle of the American legal system that a product manufacturer is typically not held responsible for an injury to a plaintiff when that manufacturer’s product was not used.  In other words, if a plaintiff was injured while using Product A, the manufacturer of Product B cannot be responsible. This common-sense rule has been challenged over the years by various plaintiffs’ theories, and one of those efforts – the so-called “innovator liability” theory – recently gained a bit more traction in a…  

Drug Decision Discusses Learned Intermediary Doctrine and Failure to Warn Claims

On July 28, 2014, Judge Mark R. Hornak of the Western District of Pennsylvania granted Novartis partial summary judgment on product liability claims for Zometa in Rowland v. Novartis Pharmaceuticals Corp., 12-cv-1474.  These plaintiffs brought claims in strict liability, negligence and breach of warranty arising out of their use of Zometa, a prescription bisphosphonate medication for metastatic bone cancer. The plaintiffs claimed that the use of Zometa caused osteonecrosis of the jaw bone. Novartis moved for summary judgment arguing that the plaintiffs’ claims were not…  

This Week’s Life Science Headlines

        Litigation  

This Week’s Life Science Headlines

        Litigation  

This Week’s Life Science Headlines

        Litigation  

Last Week’s Important Life Science Headlines

        Litigation  

This Week’s Life Science Headlines

        Litigation  

Keep Us Posted: FDA Updates Rules On Changes To Medical Devices

The U.S. Food and Drug Administration has updated its rules regarding how manufacturers of medical devices disclose manufacturing and design changes to previously approved medical devices. The focus of the FDA’s update is on annual reports for Class III devices which are subject to premarket approval. Under the FDA’s updated guidelines, manufacturers are to disclose in their annual report all changes made to either the manufacturing or design of the device and the underlying rationale and scientific basis for the change. For more significant and…  

This Week’s Life Science Headlines

        Litigation  

Pennsylvania Supreme Court Opens Door for Negligent Design Claims Against Pharmaceutical Manufacturers

In a decision with significant potential ramifications, the Pennsylvania Supreme Court has issued a ruling that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs, regardless of claims that the drugs had been properly labeled and tested, as well as approved by the U.S. Food and Drug Administration. The ruling, announced January 22nd, upholds an intermediate appellate court decision against a Pfizer, Inc. subsidiary in a wrongful death action involving the diet drug Redux. In its 4-2 decision, the…  

This Week’s Science Headlines

        Litigation  

This Week’s Life Science Headlines

        Litigation  

Claims Regarding Post-FDA Approval Problems Not Preempted

While Medical Device Amendments of 1976, 21 U.S.C. § 360k(a) provides protection to manufacturers for medical devices approved by the FDA, certain post-FDA approval activities may still give rise to claims.  In this recent case, the defendant St. Jude Medical, Inc. moved to dismiss the complaints against it for injuries allegedly resulting from St. Jude Riata leads on implantable cardiac defibrillators where the insulation failed and caused unnecessary shocks in the body.  The product was removed from the market in 2010, a warning letter was…  

This Week’s Life Science Headlines

        Litigation Regulatory  

FDA Addresses Antibacterial Soaps and Body Washes and Opens Its Proposal to Public Comment

In December 2013, the U.S. Food and Drug Administration (“FDA”) issued a proposed rule that would require manufacturers of antibacterial hand soaps and body washes to provide substantial data to demonstrate that “their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.” Under this proposed rule, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabelled to remain on the market. The…  

This Week’s Life Science Headlines

        Litigation  

This Week’s Life Science Headlines

        Litigation Regulatory Recalls  

This Week’s Life Science Headlines

        Litigation Regulatory  

This Week’s Life Science Headlines

        Litigation  

This Week’s Life Science Headlines

        Litigation  

The US Food & Drug Administration is Looking into Whether Morning-After Emergency Contraceptive Pills Fail to Work in Women Over a Certain Weight

The FDA quickly addressed a recent report that European health regulators have ordered a label change on an emergency contraceptive product sold by French drugmaker HRA Pharma under the brand name Norlevo(levonorgestrel). The European authorities now require the drug’s labeling to address the potential that there is diminishing effectiveness of the pill depending upon the weight of the user. According to HRA, the emergency contraceptive begins to lose its effectivness for wormn who weigh more than 165 pounds and is completely ineffective for women…  

This Week’s Life Science Headlines

        Litigation  

This Week’s Life Science Headlines

        Litigation  

Newly Released Study Links Glaucoma to Long-Term Use of Oral Contraceptives

Building upon data secured from the Centers for Disease Control and Prevention, an international team of researchers has concluded that women who have used birth control pills on a long-term basis are twice as likely to have glaucoma, a leading cause of blindness in the United States. Glaucoma is caused by increased fluid pressure on the eye, resulting in irreversible damage to the optic nerve. Glaucoma usually affects patients who are middle-aged and older, and has no known cure. Scientists from the University of California,…  

This Week’s Life Science Headlines

        Litigation  

Despite Reported Risks, Side Effects and Threatened Litigation, Crestor Top Selling Drug

According to a report by the research firm IMS Health, (free membership login required) new prescriptions and refills for Crestor, a drug used to lower cholesterol, exceeded all other prescribed drugs in the United States between October 2012 and September 2013. Crestor (rosuvastatin), like Lipitor (atorvastatin) is widely-used to lower cholesterol and belongs  to a family of drugs called “statins.” Among the best-selling drugs in the United States, statins use the liver to block the body’s creation of cholesterol, which is a key contributor…  

This Week’s Life Science Headlines

        Litigation  

First New York Court Rejects Controversial Drug Developer Liability Rule

In a controversial 2008 decision in Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (Cal. Ct. App. 2008), a California Court of Appeals held defendant drug developer, Wyeth, Inc., liable for inadequate warnings in connection with the plaintiff’s use of a competitor’s generic version of the gastrointestinal reflux drug Reglan. The court in Conte held “the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends not only to consumers of its own product,…  

This Week’s Life Science Headlines

        Litigation  

Philadelphia Jury Returns $4 Million Verdict in Topamax Lawsuit, But Will it Stand?

A Philadelphia County jury returned a verdict in excess of $4 Million on behalf of plaintiffs who alleged that their child suffered birth defects related to his mother’s use of Topamax during pregnancy, but the complex procedural battle which occurred before the October 30th verdict suggests that the final chapter has yet to be written in this case. Plaintiffs, April and Blake Czimmer, filed suit in 2011 alleging that April took the anti-seizure medication Topamax (Topiramate) for six months during her pregnancy, and their child…  

McIntyre Prevails Again – Contacts with the U.S. Are Insufficient to Establish Jurisdiction in Arkansas

In keeping with McIntyre, the Eastern District of Arkansas has ruled that the foreign manufacturer of the pharmaceutical metronidazole is not subject to jurisdiction.  In the Woods and Brinker matters the plaintiffs alleged that they were injured by contaminated metronidazole and they made claim under the Arkansas Product Liability Act.  The decision is available, click here.  The metronidazole was manufactured in India by Claris Lifesciences Limited (Claris India) pursuant to a supply agreement with Pfizer. Pfizer then sold the drug as its own with a…  

This Week’s Life Science Headlines

        Litigation  

Last Week’s Important Headlines

Here are some other notable decisions and developments from last week in the Life Science area: Litigation Regulatory  

Indiana Appellate Court Holds Negligence Action Involving Medtronic Defibrillator Not Preempted by Federal Law

An Indiana appellate court decided that oral representations by a medical device manufacturer during a surgery about the function of device are not preempted by federal law.  Could this be a significant exception to the U.S. Supreme Court’s seminal decision in Riegel vs. Medtronic? In 1997, David Malander received an implanted Medtronic defibrillator and right ventricular lead (“Lead”), which remained in place until he began experiencing problems several years later.  The Lead was a Class III medical device subject to premarket approval by the…  

Consumer Fraud Case Moves Forward Against Non-Purchased Product

The federal district court of the Southern District of California recently added to the growing body of case law on class action claims based on false advertising, breach of warranty and consumer protection statutes.  In Dorfman v. Nutramax, the plaintiff sought to be the putative class member and alleged that Nutramax’s statement that its’ Cosamin DS and Cosamin ASU (glucosamine hydrochloride with chondroitin sulfate) was: “the ONLY brand proven effective in controlled, published U.S. clinical studies to reduce joint pain,” was false and misleading. …