Life Science Matters

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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 appears to have had the last laugh. The plaintiff filed a personal injury claim against the defendant in California state court for products liability and pursued theories of strict liability, negligence and breach of an express written warranty.  This claims arises from plaintiff’s purchase of several cans of “Lindsay’s Large Pitted Olives” that she planned to…  

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. 

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…  

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…  

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  

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. …  

FDA Largely Shutdown

With the Federal Government on shutdown, the FDA is largely shutdown as well. The FDA’s official announcement regarding the shutdown states that in the absence of either a 2014 fiscal year appropriation or an FDA specific Continuing Resolution, the FDA’s activities going forward will be limited to the following;
  • emergency work involving the safety of human life or protection of property;
  • criminal law enforcement work; and
  • activities funded by carryover user fees under certain acts such as the Prescription Drug User Fee Act.
Until an…  

European Union’s Proposed Regulations Governing Medical Devices Raise Multiple Concerns for US Manufacturers

On September 25, 2013, the European Parliament Committee on the Environment, Public Health and Food Safety (“ENVI”) voted on draft Regulations including a proposal concerning high risk medical devices, raising concerns among US manufacturers. Expectations that a more restricted process in Europe could undermine the development of domestic medical devices appear increasingly well-founded, but the entire story has yet to be played out overseas. At issue is an attempt by the European Union (“EU”) to close loopholes that allowed breast implants made with industrial-grade silicone…  

FDA Issues Guidance for Wireless Technology in Medical Devices

The Federal Drug Administration issued a guidance for Radio Frequency Wireless Technology in Medical Devices.  The guidance does not establish legally enforceable responsibilities but describes the FDA’s current thinking on this topic. The guidance document addresses a myriad of considerations that may affect the safe and effective use of medical devices that incorporate wireless technology, including the selection of wireless technology, quality of wireless service, coexistence with other wireless technologies, security and electromagnetic compatibility.  Citing 21 CFR 820.30, which regulates design controls, the FDA…  

Florida Federal Court Allows Claim that Novartis Should Have Issued “Black Box” Warning on Zometa

A United States District Court Judge, sitting in the Middle District of Florida, has rejected arguments by Novartis Pharmaceutical Corporation (“Novartis”) that federal law would prohibit claims that the company should have added “Black Box” warnings regarding potential side effects of Zometa, including potential bone loss.  As a result, plaintiffs will be allowed to proceed with their claims notwithstanding the company’s arguments (1) that all of the failure-to-warn claims were controlled by the Supreme Court’s 2009 decision in Wyeth vs. Levine; and (2) that…  

New Jersey Supreme Court Rejects Federal Approach, Refuses to Consolidate Tylenol Liver Cases in New Jersey

On August 16, 2013 the New Jersey Supreme Court denied a request to consolidate all pending Tylenol liver injury lawsuits in the state court system before a single judge, finding that the cases were inappropriate for centralized management as “Multicounty Litigation”.  Earlier this year, the U.S. Judicial Panel on Multidistrict Litigation established coordinated proceedings for Tylenol litigation, assigning Judge Lawrence Stengel of the United States District Court, Eastern District of Pennsylvania, to supervise all pretrial proceedings. Approximately 14 lawsuits have been filed in New Jersey…  

5 Billion in R&D for Each New Drug?

Forbes recently estimated that it costs $5 billion for big pharma to bring each new drug to market.  That number is reduced drastically to $350 million per drug if the company is focused solely on bringing one drug to market and not engaging in multiple research projects at a time.  These numbers were calculated based on the SEC filings of 98 companies and how much they spent on R&D compared to the number of FDA approved drugs they brought to market.  These R&D costs encompass…  

There are Currently Not Enough Lipitor Diabetes Lawsuits in Different U.S. District Courts to Justify Centralized Proceedings

Lipitor (atorvastatin) is one of the most widely used brand-name medications in the United States, with millions of Americans taking the medication to help improve their health by lowering cholesterol.  Before it became available as a generic in 2011, Pfizer generated more than $125 billion in Lipitor sales. A number of lawsuits have been filed alleging that women developed diabetes from Lipitor and  that Pfizer failed to adequately research the potential side effects of the medication or warn users or the medical community of the…  

Additional Battery Testing for Medical Devices Recommended By FDA

On July 30 and 31, the Food and Drug Administration conducted a Battery-Powered Medical Devices Workshop to create awareness and address challenges associated with use of battery-powered medical devices. At the workshop, the FDA addressed the increasing number of adverse events linked to batteries in medical devices. While the FDA is confident that medical devices currently being marketed will continue to function appropriately, according to the agency, there are opportunities to further improve their design, overall performance and safety. Batteries play a significant role in…  

European Medicines Agency Issues New Restrictions on Reglan

On July 26, the European Medicines Agency (EMA) announced new restrictions on medications containing metoclopramide, known generally by the brand name Reglan, in the most recent development based upon potential neurological side effects related to use of this medication. Use of metoclopramide increased significantly in the 1990s after its predecessor, Cisapride, was found to cause serious side effects. By 2004, however, research began to suggest that use of metoclopramide was potentially related to a movement disorder known as tardive dyskinesia. Symptoms of tardive dyskinesia may…  

GlaxoSmithKline Announces $229 Million Settlement of Avandia Lawsuits

British drugmaker GlaxoSmithKline (GSK) announced on July 25th that it would pay $229 million to resolve lawsuits brought by eight U.S. states related to improper marketing of its diabetes drug Avandia (rosiglitazone).  In a regulatory filing, GSK said the settlement was within provisions it had previously set aside for litigation, and also resolved claims brought by the Attorney General of Louisiana involving other GSK products. The announcement by GSK explained that the settlements had been undertaken in order to avoid lengthy trials, and did…  

FDA Encouraging Hackers to Submit Medical Device Cybersecurity Flaws

On June 13, 2013, the Food and Drug Administration issued a safety communication to medical device manufacturers, hospitals, medical device user facilities, health care IT and biomedical engineers advising them to take steps to secure cybersecurity for medical devices and hospital networks.  The FDA warned that as medical devices are increasingly interconnected, via the internet or wireless devices, there is an increased risk of  cybersecurity breaches, which could affect how a medical device operates. The FDA advised that it has become aware of cybersecurity vulnerabilities…  

California Court of Appeals – No Breach of Duty for Medical Device Representative in the Operating Room

The California Court of Appeals upheld a lower court’s finding that the presence of a medical device manufacturer’s sale representative in an operating suite does not alone give rise to a duty of care to the patient.  Smith v. St. Jude Med., Inc., 217 Cal. App. 4th 313 (Cal. Ct. App. 2013).  The court also upheld the finding that the manufacturer’s sales representative was not a proximate cause of the injury. In Smith, a woman died following cardiac pacemaker surgery from a…  

Google Glass v. HIPAA

It is too soon to tell how fast and how far the Google Glass trend will spread.  We have all signed the HIPAA disclosure forms and seen the cover page over the sign-in sheet that “keeps us from seeking the other patients’ name” at the doctor’s office. Will we soon be asked to check our Google Glass at the door?  Reportedly, the Google Glass only needs a line of sight to record images.  If that is true, then wearing the newest, coolest tech gadget could…