Sean T. Stadelman

All articles by Sean T. Stadelman

 

Superior Court of Pennsylvania Issues Ruling Addressing Multiple Issues in Pharmaceutical Case

In an opinion filed January 8, 2018, Pennsylvania’s intermediate appellate court addressed multiple issues arising after a plaintiff’s verdict in a case from the In Re: Risperdal Litigation. The issues the court addressed are discussed below. Initially, the court, citing Frye, reiterated that in Pennsylvania, a party wishing to introduce novel scientific evidence must demonstrate that the relevant scientific community has reached general acceptance of the principles and methodology employed by the expert witness to testify regarding his conclusions. However, the conclusions themselves…  

Blacklist of “Scientific” Journals to Return

For any television fans that may have stumbled upon this post, it has nothing to do with Raymond Reddington and it will not be as clever as this author’s favorite James Spader character, Alan Shore (from Boston Legal). Nonetheless, as readers of scientific journals we were excited at the announcement this week that the “blacklist” of “scientific” journals is returning, albeit from a new publisher and with a little help from the original. For those that may not have followed Jeffrey Beall’s blog that…  

Seventh Circuit: Insurer Has Duty to Defend Drug Distributor in “Pill Mill” Lawsuit

This week, a unanimous Seventh Circuit panel found that a major insurance company has a duty to defend H.D. Smith, L.L.C. against a lawsuit brought by the State of West Virginia. The lawsuit claims that the drug distributor helped cause the state’s prescription drug abuse epidemic by knowingly oversupplying painkillers to certain pharmacies and clinics, pejoratively known as “pill mills.” The decision reversed an earlier ruling by the U.S. District Court for the Central District of Illinois. By way of background, in June 2012, the…  

“Symptom Threshold Methodology” Rejected by Court of Appeals of New York Pursuant to Frye

In an opinion decided February 11, 2016, the Court of Appeals of New York precluded two causation experts put forth by a plaintiff in a toxic tort case. The case involved allegations that a minor was born with severe mental and physical disabilities caused by in utero exposure to unleaded gasoline vapor. The vapor was allegedly emitted into the car from a defective fuel hose. The automobile manufacturer subsequently recalled the vehicle at issue due to defects in the feed fuel hoses. In support of…  

District Court Judge Denies Manufacturer of OTC Pain Reliever Summary Judgment Based on Preemption

Judge Lawrence Stengel of the United States District Court for the Eastern District of Pennsylvania denied summary judgment to the manufacturer of an over-the-counter pain reliever. The manufacturer had sought to dismiss the plaintiff’s fraud and fraudulent misrepresentation claims as preempted by federal law. The Food and Drug Administration (FDA) regulates how OTC drugs should be labeled and sold. The Federal Trade Commission regulates whether an OTC drugs advertising is misleading. In the case before Judge Stengel, the OTC manufacturer argued that the fraud claims…  

Ninth Circuit Outlines for Plaintiff How to Meet the Twombly/Iqbal Standard in a Third Amended Complaint

In this case, the plaintiff, Nicole Weber, appealed the United States District Court for the District of Arizona’s dismissal of her second amended complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). The issue on appeal before the Ninth Circuit panel was whether Weber’s allegations were sufficient to survive a 12(b)(6) motion under the Twombly/Iqbal standard requiring a complaint to set out a plausible claim. Since the Supreme Court’s rulings in Bell Atlantic v. Twombly and Ashcroft v. Iqbal, federal district courts have seen…  

U.S. Supreme Court Denies Certiorari in Generic Pharmaceutical Preemption Case

The United States Supreme Court today issued an order declining a generic pharmaceutical manufacturer’s petition for a writ of certiorari. The drug manufacturer had sought to challenge a ruling from the Iowa Supreme Court. In that state court ruling, the Iowa Supreme Court found that the U.S. Supreme Court’s preemption decision in Mensing did not necessarily prohibit failure to update claims. The U.S. Supreme Court’s decision in Mensing held that failure to warn claims brought against generic drug manufactures were preempted. The plaintiffs’ attorneys have…  

Will Supreme Court End Split Over Whether Generic Drug Companies Can Face “Failure to Timely Update” Claims?

The U.S. Supreme Court (SCOTUS) has (again) been asked to determine the question of whether claims can be made against generic drug manufacturers for failing to timely update and/or disseminate their labels following U.S. Food and Drug Administration (FDA) approvals. Essentially, the issue is whether the time taken by a generic company to effect a labeling change can be tortious and subject to a private cause of action.  A Law360 article with the Petition for Writ of Certiorari in Pliva Inc., v. Huck can be…  

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…  

Direct Mailers for Aranesp Targeted by FDA

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) recently criticized the makers of Aranesp for a direct mailer that was allegedly in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, the mailer was found to be false or misleading because it omitted important risk information, suggested use beyond that which was substantiated, made unsubstantiated efficacy claims, and omitted material facts. OPDP also found that the mailer evidenced that Aranesp was intended for a new…  

FDA Using Authority Under Food Safety Modernization Act To Control Dietary Supplements

On Wednesday, November 20, 2013, the Food and Drug Administration (FDA) issued a notice advising consumers that the product Slim Max should not be purchased or used. Slim Max, a weight loss product, was found to contain Sibutramine and Phenolphthalein, according to FDA laboratory analysis. Due to safety concerns, Sibutramine was removed from the market in October 2010. Sibutramine can substantially increase blood pressure and/or pulse rate in some users which may present a significant risk for patients with some medical conditions. Phenolphthalein is classified…  

Tolling Agreements Cause Coverage Concern

An insurance coverage dispute has arisen in connection with litigation involving a robotic surgery medical device maker. A declaratory judgment action seeking rescission of product liability insurance policies issued to the manufacturer was filed in the U.S. District Court for the Northern District of California. If successful, the insurer may avoid obligations under its primary and excess insurance policies providing $15 million per occurrence and $50 million aggregate. To read the rest of this article, visit Life Science Matters – An inside look at the  

Tolling Agreements Cause Coverage Concern

An insurance coverage dispute has arisen in connection with litigation involving a robotic surgery medical device maker. A declaratory judgment action seeking rescission of product liability insurance policies issued to the manufacturer was filed in the U.S. District Court for the Northern District of California. If successful, the insurer may avoid obligations under its primary and excess insurance policies providing $15 million per occurrence and $50 million aggregate. The declaratory judgment action stems from allegations that the manufacturer entered into tolling agreements with several potential…  

MMA: No Longer Just An Acronym for Mixed Martial Arts, Mobile Medical Apps May Own That Sooner Rather Than Later

Mobile device software (apps) that give nursing home doctors access to drug reference databases help prevent serious and potentially life-threatening medication errors. That was one of the findings of a recent study published in the Journal of the American Medical Director’s Association (JAMDA), which also found that use of the drug reference apps was fairly routine for the physicians with access to them. The researchers found that nursing home physicians who used drug reference apps were more aware and less likely to give medications…  

Laser Therapy Lawsuits Increase

recent study published in the medical journal,JAMA Dermatology, brings to light a   growing number of lawsuits related to cosmetic laser surgery complications. A recurring theme in those lawsuits is that the procedure was performed by a non-physician. To read this rest of this article, please visit Risky Business: Avoiding Product Liability, Commercial, and Other Litigation 

Laser Therapy Lawsuits Increase

A recent study published in the medical journal, JAMA Dermatology, brings to light a growing number of lawsuits related to cosmetic laser surgery complications. A recurring theme in those lawsuits is that the procedure was performed by a non-physician. The study from researchers at the University of California-Los Angeles (UCLA) used an online national database of public legal documents to determine those that involved laser surgery and non-doctors. They found 175 claims filed between 1999 and 2012. In 43 percent, the error…  

Are (Legally) Imported Prescription Drugs a Thing of the Future: Maine Thinks So

Maine has passed a law that takes effect today which permits the direct purchase of prescription drugs from certain foreign pharmacies. More specifically, the law exempts foreign pharmaceutical vendors from state pharmaceutical licensing laws. The law, which is noted to be the first of its kind, has come under attack from the pharmaceutical industry. Drug makers argue that consumer safety will be lost if the purchase of drugs from foreign pharmacies is allowed and that FDA oversight is impinged upon by the new law. The…  

Dietary Supplement Company Slammed By FDA For Failure To Comply With CGMP

Brower Enterprises was recently hit with a warning letter from the U.S. Food and Drug Administration (FDA) that excoriates them for violating Current Good Manufacturing Practices (CGMPs). The violation of CGMPs caused a number of Brower’s products to be adulterated within the meaning of the Federal Food, Drug and Cosmetic Act (the Act). Examples of violations of CGMPs included keeping written procedures for quality control operations, holding and distributing operations, returned dietary supplements, and product complaints. Additionally, Brower failed to comply with CGMPs because it…  

Dietary Supplement Company Slammed By FDA For Failure To Comply With CGMP

Brower Enterprises was recently hit with a warning letter from the U.S. Food and Drug Administration (FDA) that excoriates them for violating Current Good Manufacturing Practices (CGMPs). The violation of CGMPs caused a number of Brower’s products to be adulterated within the meaning of the Federal Food, Drug and Cosmetic Act (the Act). Examples of violations of CGMPs included keeping written procedures for quality control operations, holding and distributing operations, returned dietary supplements, and product complaints. Additionally, Brower failed to comply with CGMPs because it…  

Study May Be Concern For da Vinci Robot

A new study from researchers at the University of Texas Southwestern Medical Center reports that the use of a surgical robot to perform a hysterectomy is no safer than laparoscopic surgery, and may actually increase the risk of certain complications, including pneumonia.   The study published in the medical journal Obstetrics & Gynecology, found complications in approximately 9% of robotic hysterectomies. Additionally, the study indicates that using the da Vinci system to perform a hysterectomy provides no safety benefits to justify the increased cost. The…  

FDA to Consider Permitting Dosage Information on OTC Children’s Fever/Pain Remedy Products

The Consumer Healthcare Products Association (“CHPA”) has petitioned the FDA to allow dosing information to be provided on fever/pain relief drug labels. The CHPA is a trade group representing OTC manufacturers of acetaminophen products. Any parent with young children knows that OTC fever/pain relief products currently do not contain dosing information for children under two years of age. Although parents may have obtained the proper dosing instructions from their child’s pediatrician, recalling and/or finding that information (especially in the middle of the night) can be…  

$2M Vaginal Mesh Verdict in West Virginia

C.R. Bard, Inc. was hit with a jury verdict of $2 million on August 15, 2013 in a vaginal mesh case. The case was tried in the United States District Court for the Southern District of West Virginia. Unanimous jury findings included that plaintiff had proven her design defect and failure to warn claims and that Bard did not prove its assumption of the risk defense. The jury awarded the injured plaintiff $250,000 in compensatory damages. Perhaps most notably the jury found that punitive damages…  

Class Action Over Walgreens Supplement Survives

Walgreens Co. won a partial victory recently in New York Federal Court when the Judge dismissed warranty claims regarding its glucosamine supplements. However, the remainder of the claims in the putative class action alleging false marketing of the cartilage rebuilding powers of the product survived. To read the rest of this post, please visit Risky Business: Avoiding Product Liability, Commercial, and Other Litigation. 

New Lawsuit Over Alleged DMAA Death

A dietary supplement containing DMAA allegedly caused the death of 34-year old man according to a complaint filed in the United States District Court for the Eastern District of Pennsylvania. USPlabs, LLC and Bodybuilding.com, LLC were sued on July 15, 2013 by the widow of Todd Battuello alleging the DMAA in OxyELITE Pro (product of USPlabs) caused her husband’s cardiac arrest. A toxicology report revealed the presence of DMAA. Over the last couple years manufacturers of products containing DMAA have been under increased scrutiny from…  

FDA Gets Aggressive With Companies Over Marketing of Alleged Diabetes Treatments

The U.S. Food and Drug Administration (FDA) has started its campaign to stop sales of multiple products advertised and labeled as diabetes treatments. According to data from 2011, over 25 million people in the U.S. have diabetes and perhaps more alarming is that 79 million people have prediabetes. Clearly there is a market for diabetes remedies. To read the rest of this blog post, please visit Risky Business: Avoiding Product Liability, Commercial, and Other Litigation 

Weight Loss Products Recalled Due to Undeclared Ingredient

On July 19, 2013, dietary supplement company, Herbal Give Care LLC, issued a voluntary total recall of its products: Esbelin siloutte te and Esbelin siloutte Herbal Blend with L-Carnitine (30 Capsules). According to the manufacturer, Esbelin siloutte te is a fat burner that removes stored fat, achieving elimination through the urine and preventing fat accumulation. Additionally, the product is intended to promote healthy digestive functioning. The Esbelin siloutte Herbal Blend with L-Carnitine (30 capsules) product is used to help normalize nervous appetite, preventing fat accumulation…  

FDA Gets Aggressive With Companies Over Marketing of Alleged Diabetes Treatments

The U.S. Food and Drug Administration (FDA) has started its campaign to stop sales of multiple products advertised and labeled as diabetes treatments. According to data from 2011, over 25 million people in the U.S. have diabetes and perhaps more alarming is that 79 million people have prediabetes. Clearly there is a market for diabetes remedies. According to the FDA, companies are taking advantage of consumers seeking diabetes treatments by marketing products that claim to prevent, treat, or relieve symptoms of diabetes, but the FDA…  

Foreign Manufacturer of Surgical Masks Hit With FDA Warning Letter

The U.S. Food and Drug Administration (FDA) recently issued a warning letter to a manufacturer of surgical masks.  The manufacturer, located in Taiwan, was subject to inspection by the FDA that revealed numerous violations of the Federal Food, Drug, and Cosmetic Act (the act).  The FDA determined that the masks (medical devices) were adulterated and misbranded under the act. Violations included failure to conform with current good manufacturing practice requirements of the Quality System found at Title 21, Code of Federal Regulations (CFR), Part 820;…  

The “Pill” Does Not Work?

A recent lawsuit filed against Endo Pharmaceuticals and others claims that faulty packaging of birth control medication, commonly called the “pill,” caused an unexpected pregnancy where the baby died and the pregnant woman was seriously injured.  Generally, the complaint in Liro v. Endo Pharmaceuticals, Inc., et al claims the defendants are liable due to the defective design, manufacture, packaging, sale, and distribution of birth control pills taken by plaintiff. The plaintiff allegedly used the birth control pill Tri-Previfem as instructed but subsequently became pregnant.  She…  

House Republicans Question Supplement Companies about Ingredient Declared Illegal and Potentially Unsafe by FDA

Three members of the House of Representatives recently questioned multiple supplement companies about the continued sale of products containing DMAA (dimethylamylamine), a synthetic drug linked to several deaths. The Food and Drug Administration (FDA) has previously urged consumers to avoid products containing DMAA.  DMAA is an ingredient in some weight loss or muscle development supplements.  It is alleged that the drug could trigger heart problems.  The FDA has reportedly received over 80 reports linking supplements containing DMAA to injury, illness and death.  However,…  

Report Links Some Dietary Supplements to Potentially High Arsenic Levels

In a recent article published in Analytical & Bioanalytical Chemistry, author Rikke Hedegaard and colleagues state that “consumption of certain dietary supplements could contribute significantly to the dietary exposure to inorganic arsenic at levels close to the toxicological limits established by [the] European Food Safety Authority (EFSA).”  The article, entitled Total and inorganic arsenic in dietary supplements based on herbs, other botanicals and algae – a possible contributor to inorganic arsenic exposure, is an example of scientific developments that dietary supplement companies need…  

GAO: FDA Needs to Get to Work Tracking Adverse Events Related to Dietary Supplements

Senator Durbin (D-Illinois) and Representative Waxman (D-California) requested late last year that the Government Accountability Office (GAO) examine steps taken by the Food and Drug Administration (FDA) to enhance the regulatory oversight of the multibillion dollar dietary supplements market.  The GAO undertook the review and recently issues its findings.  The full report can be found here.  Specifically, the GAO was asked to examine the FDA Adverse Event Reporting System (FAERS) in overseeing dietary supplements.  The GAO found that from 2008-2011, the FDA received 6,307 …  

Pain Pump Marketing Pains Stryker (and others)

A False Claims Act complaint against Stryker Corp., and others, alleges the firms’ marketed pain pumps for off label use that the U.S. Food and Drug Administration had specifically denied.  The False Claims Act dates back to the Civil War and imposes liability on companies (or persons) that defraud government programs.  Stryker and the others are accused of submitting payment claims to federal programs, including Medicare, for unapproved uses of their pain pumps. The orthopedic surgeon that brought the case, as the “relator”…  

Not So OraSure: First Over-the-Counter HIV Test Requires Enhanced Labeling

OraSure Technologies Inc. took a step forward in its bid to bring to market its OraQuick In-Home HIV Test.  If approved, OraQuick would be the first over-the-counter HIV test that lets people get results without using a doctor or laboratory.  The FDA Blood Products Advisory Committee unanimously determined that the benefits of the saliva test outweigh the risks.  The primary risk being false negative results.  Final-phase trials of the OraQuick home test are reported to have found 5,384 of 5,385 negative users resulting in one…