NEW PUBLICATION
"A Separate Piece in Seeking Justice", American Association for Justice Winter Journal
Preemption
IN RE MEDTRONIC SPRINT FIDELIS LEADS: Juge Kyle in the Medtronic MDL issued a broad ruling on preemption that effectively dismissed all of Plaintiffs claims, including manufacturing defects, consumer deception, fraud, and alleged parallel claims. This ruling surprised many attorneys and consumer advocates in that the court limited the application of "parallel claims" and manufacturing claims. The court specifically noted that the claims have no remedy in any court but are congessional issues.
RIEGEL v. MEDTRONIC: What Claims are available post Riegel?
In the first of three significant cases that could have profound effects on the rights of patients and consumers of medical devices and pharmaceuticals, the Supreme Court has ruled to limit the types of claims that can be brought. Specifically, the court held: "The Medical Device Acts?s pre-emption clause bars common law claims challenging the safety or effectiveness of a medical device marketed in a form that received Pre-Market Approval from the FDA."
Riegel is a narrow holding and strives to balance an individual?s rights under state law with the federal health care demands.
The fundamental policy supporting pre-emption is that a company is required by federal law to take certain steps to obtain approval of a medical device. The PMA process is the strictest of all avenues for approval, and the underlying policy is that it would be unfair and inefficient for our society to allow manufactures to be subjected to liability, where they complied with all federal requirements. In Riegal the court addressed a unique case where the plaintiff?s claims were not based upon the company?s failure to comply with the federal duties. As such, the court interpreted the claims to create added and additional requirements to the manufacturer, where even though the company complied with federal law, it was also subject to additional state law issues. The court found that Congress added express language to the Act to prevent this kind of double standard to protect the industry and health care needs.
"Parallel" Common Law Claims Survived Riegel.
While the decision steered away from the policy that federal requirements are ?minimal requirements?, the decision does not mean that a common law tort claim is bared, even in the light of PMA approvement. The decision is clear that the common law claim is viable provided it is consistent with the federal requirements and does not create added duties. In other words, the federal regulations and laws can serve as a basis for the state law causes of action. The practical effect is that each claim must be pled and evaluated with both federal and state law if the product was approved under the PMA. Under federal law, the companies have duties to disclose all relevant information, update warnings, provide post market surveillance, manufacture the device according to approved specifications and conditions, and only market the product for purposes for which it was approved. The mass torts that come to fruition are always based upon a company?s failure to meet these federal duties. As such, though the defendants will certainly claim Reigel grant borad pre-emption, the language of the decision, and consensus of the judges (8-1) indicates that very few cases should fall under the narrow rational of Riegel.
KNIPE v. SMITHKLINE BEECHAM (E.D. PA):
Plaintiffs claims involving failure to warn related to Paxil use were not preempted.
FDA NEWS
INFUSION PUMPS ADULTERATED
The Food and Drug Administration (FDA) determined that Hospira infusion pumps (including the Plum Family line, LifeCare PCA3, and Symbiq) are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. 351(h)).
The inspection revealed that these devices are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820.
First Human Stem Cell Human Trial is Approved for Spinal Cord Injuries
The FDA approved a human trial aimed at treating spinal cord injuries, The FDA approval offers patients suffering with spinal cord injuries hope for recovery. Future trials may likely focus on repairing cardiac muscles, liver failure, pancreatitis, and arthritis.
Vicks Vaporub may cause respiratory injury in infants.
An animal study concluded that Vicks Vaporub may cause respiratory distress in infants.
Ketek Loses Approval Due To Safety Concerns
An FDA panel that met this December determined that the Sanofi-Avenits antibiotic Ketek should no longer be marketed to treat sinus and bronchial infections because the drug's safety risks outweigh the benefits. However, the drug will not be withdrawn from the market, and it remains indicated for more serious pneumonia, though the drug will carry a black box warning?, the strongest warning. Ketek has been linked to liver damage.
Ketek has been the center of controversy since its approval by the FDA without a major safety study. The medical community and patient advocacy groups have pointed to Ketek as yet another example of a big business influence over the FDA.
PRODUCT SAFETY: APATRIM DECEPTIVE ADVERTISING
Demand has been souring for a new weight loss product in Ohio. Apatrim has been reported to start restricting cravings and appetite within minutes of ingestion. The manufacturer, Patent Health, has reported that a primary study based soley on 26 participants (who took Apatrim as directed and were instructed not to exercise) over a four week period loss five times the amount of weight as the sugar pill arm of the study.
The active ingredient in the product come from an edible cactus known as Caralluma Fimbriata. While there may be some evidence that Caralluma is effective at suppressing hunger, there is little evidence that the dosage found in these products are sufficient to obtain the results that are marketed. The Federal Trade Commission has warned against the use of such "miracle weight loss" products. And the statements and safety of this product are not reviewed or approved by the FDA.
There are a number of reports from consumers that are unhappy with the product. Please see the Apatrim Blog.
Health News Minute provided an excellent report on the effectiveness of weight loss drugs.
If you have taken this product and experienced any adverse events or feel the advertising was deceptive, please contact our Firm for a free consultation.
