Calif. Court of Appeals overturns decision in Conte v. Wyeth; branded drug makers may be liable for generic side effects, injuries
NEW YORK If a generic drug causes adverse side effects or injuries, the manufacturer of the branded drug can be held liable, a California appeals court ruled in November 2008 in the case of Conte v. Wyeth.
The First District Court of Appeals of California overturned a lower court’s decision in favor of Wyeth, while upholding its ruling in favor of three generics companies that made versions of Wyeth’s gastro-esophageal reflux disease drug Reglan (metoclopramide). It upheld the argument by plaintiff Elizabeth Conte that because the generics companies relied on product safety information that Wyeth originally formulated, Wyeth was responsible for ensuring the information’s reliability, whether in branded Reglan or its generic equivalents.
Wyeth disputed the court’s decision and submitted a petition for review with the California Supreme Court on Dec. 17, 2008.
“Wyeth disagrees with the reasoning of the California Court, which rejected a long line of cases in which courts have uniformly found that a drug manufacturer of a brand drug cannot be held liable for injuries caused by a generic version of the brand drug that is sold by another manufacturer,” Wyeth spokesman Doug Petkus said. “Wyeth intends to appeal this California Court decision.”
Plaintiff Elizabeth Conte said she used generic versions of Reglan made by Teva Pharmaceutical Industries and others for four years to treat her GERD, and eventually developed the neurological disorder tardive dyskinesia, allegedly due to the prolonged use of the drug. Tardive dyskinesia, often associated with long-term use of certain psychiatric drugs, causes involuntary movements throughout the body, but has no cure.
The Food and Drug Administration approves metoclopramide for 12 weeks of use, though physicians often prescribe it for 12 months or longer, allegedly because the drug’s labeling understates possible serious side effects from extended use. Conte said the drug companies should have known this, and she accused Wyeth of fraud, fraud by concealment and negligent misrepresentation; she also accused the generics companies of negligence, strict products liability, negligence per se and breach of express and implied warranties. She further accused her doctor, Robert Elsen, of medical negligence.
In a Jan. 5 friend-of-the-court brief, the Pharmaceutical Research and Manufacturers of America said the court’s decision “effectively makes pioneer drug companies the indemnitors of competing generic drug companies for injuries caused by competing generic drugs.”
Teva declined to comment, and a spokesman for the Generic Pharmaceutical Association only reiterated that the labeling of a generic product must be the same as that of the branded product.
To see the full text of the court’s decision, visit <a title="http://www.courtinfo.ca.gov/opinions/documents/A116707.PDF” href=”http://www.courtinfo.ca.gov/opinions/documents/A116707.PDF” />http://www.courtinfo.ca.gov/opinions/documents/A116707.PDF
MTI launches Rite Aid Radio
MIAMI BEACH, Fla. Music Technologies International on Tuesday announced that it’s “Rite Aid Radio,” a music and messaging program designed exclusively for Rite Aid, is now available chainwide.
“We relished the opportunity to start from scratch with Rite Aid in creating a music environment that is much more ‘tune’ with their customers,” said Bradley Golden, president of MTI. “We feel that we have helped to create an even more inviting audio ambiance in the stores.”
MTI built the music library song by song to appeal to Rite Aid’s customers, the company stated, and also allows Rite Aid to broadcast messages to speak directly to its customers.
This partnership is actually the resumption of a relationship from the 1990’s when MTI provided a similar program to Rite Aid.
“Our number one priority is keeping our customers happy,” said Jerry Cardinale, Rite Aid senior vice president of indirect procurement. “We feel that MTI’s music and messaging program helps us achieve this goal. MTI shares our philosophy of absolute dedication to customer service.”
Duane Reade announces $3.5 million settlement for Q4 2008
NEW YORK Duane Reade, without admitting liability, has announced a $3.5 million litigation settlement that will result in a $3.5 million one-time, pre-tax charge for the fourth quarter.
The two class action cases concern the retailer’s alleged past payment practices for certain overtime and employee non-exempt classifications.
The settlement is subject to the approval of the U.S. District Court for the Southern District of New York. The company stated that while it believes it can “strongly defend against the matters involved in this litigation” it has decided to settle to avoid additional defense costs and uncertainty surrounding the litigation.
The retailer, which operates 251 stores, is expected to announce its fourth quarter and fiscal year 2008 results in March.