Wyeth and #8216: "GERD" disclaimer leads to lawsuit — (Law Review)

To view original article click here

Law Review

By Jim Porter

October 14, 2009

The drug manufacturer Wyeth produces the name-brand drug Reglan used to treat gastroesophageal reflux disease, also known as GERD, a condition I myself suffer. I also suffer high cholesterol and for that I take … oh forget it. Other less known manufacturers make generic versions of Reglan, which is actually metoclopramide. This “case of first impression” arose concerning generic metoclopramide.

Wyeth makes reglan

For four years, Plaintiff Elizabeth Conte took a generic prescription drug equivalent to Reglan. Conte developed a debilitating and incurable neurological disorder, which she attributed to taking the generic version of Reglan.

Drug manufacturer sued

Conte sued Wyeth claiming the company knew of a widespread tendency among physicians to mis-prescribe Reglan and generic metoclopramide for long periods of time even though the medication is only approved for 12 months of use ­ because the drug’s labeling substantially understates the risks of serious side effects from extended use. (i.e. Conte claimed Wyeth disseminated misleading and/or incomplete warnings about Reglan’s side effects.)

Wyeth defended Conte’s suit alleging that her prescribing physician did not rely upon the Reglan warnings and product labeling, and a name-brand pharmaceutical manufacturer owes no duty to individuals who take only generic versions of its product.

The trial court ruled in favor of Wyeth. Conte appealed.

Conte alleged a name-brand manufacturer that disseminates information about its product owes a duty of care to ensure the information’s accuracy to any doctor who prescribes the drug and relies on the information even if the patient ends up taking the name-brand product’s generic equivalent. Amazingly, no court had ever looked at this issue in California before Conte’s suit.

Just as interesting, under California law Wyeth’s duty to warn of risks associated with its products runs to the physician, not the patient, so if someone is injured by a drug and claims lack of adequate disclosure of the potential dangers, it’s not what they read about the drug that matters, it’s what their prescribing physician reads. Wow. So it is immaterial if I buy a prescribed drug relying on misleading labeling by the manufacturer. That does not seem right.

Sad digression

One of the leading cases in this area is Motus v. Phizer. Phizer makes the antidepressant Zoloft. Motus, like my younger brother, committed suicide a week or so after his physician prescribed an antidepressant ­ in his case Zoloft.  My brother was given Effexor, also manufactured by Wyeth ­ prescribed to him by a general practitioner without any warning of the drug’s known and well documented tendency to lead to an increased risk of suicidal behavior.

Victor Modus’s widow sued Phizer but lost because Victor’s prescribing physician had not read the package insert or the Physician’s Desk Reference information on Zoloft until after Victor died. Again, that makes no sense.

Generic drugs

Under the Hatch-Waxman Amendments, a generic manufacturer is not required to submit evidence of the drug’s safety, but instead need only certify that the generic product is the equivalent of the name-brand drug and that the labeling and the warning for the generic drug is the same as the name brand.

Court ruling

The Court of Appeal concluded that Conte’s physician was familiar with the Reglan warnings, and just because Wyeth did not manufacture or sell the generic version of its Reglan did not relieve the company from its obligation to disseminate accurate product warning labels.

The Court wrote: “Wyeth owes a duty of due care to those people it should reasonably foresee are likely to ingest metoclopramide in either the name-brand or the generic version when it is prescribed by their physicians in reliance on Wyeth’s representations (for the name-brand product).”

Wyeth’s product representations regarding Reglan may be relied upon by consumers of its generic equivalent as long as the prescribing physician is familiar with the product labeling and relied upon the representations before the drug was prescribed.

I would not be surprised if this case is appealed to the California Supreme Court.

Jim Porter is an attorney with Porter Simon, with offices in Truckee, South Lake Tahoe, Incline Village and Reno. He is a mediator and was the Governor’s appointee to the Fair Political Practices Commission and McPherson Commission, both involving election law and the Political Reform Act. He may be reached at porter@portersimon.com or at the firm’s web site , www.portersimon.com.


To view original article click here

Tahoe Daily Tribune

September 29, 2006

Five months ago, my youngest brother Rob shocked his family and all of us by killing himself in an apparent bout of depression.  He had just begun taking the controversial anti-depressant Effexor, which I believe is a culpable factor. Rob left behind a wide circle of family and friends, most of whom celebrated his life in an upbeat event in June.

At his Celebration of Life (I still have a hard time with that term) we renewed commitments to mirror Rob by nurturing relationships, taking time for others and keeping our old friendships alive. My other brother Paul and I spoke every day since that day in April. We usually talked on the phone a few times a week anyway, keeping up with each other’s family life.

The Porter family is very close and Rob’s death was profoundly sad for all of us. We knew life would never be the same without him, but together we began to move on.-

Before Rob’s death in April, my mom, Paula, had phased into a moderate stage of Alzheimer’s disease. She’s a woman who was always loved by everyone ” a “second mom” to many of her four children’s friends. A year ago, at age 80, she was driving her senior buddies to the opera in San Francisco.

Now she has no short-term memory and can barely communicate. She responds to a conversation with short, safe answers like the weather is “fine” or she’ll “whip something up” for dinner, and she doesn’t even cook anymore. It’s an absolute heartbreaker and it’s the fastest descension into Alzheimer’s her doctor has ever seen. But in an ironic way, her lack of memory is a blessing. It cushions her from the harsh reality of having lost her youngest son.

Her other son Paul, my next youngest brother, died Sept. 12, at age 56, after suffering a brain aneurysm at work on Aug. 15. Paul immediately went into a coma and stayed alive for four weeks, giving us hope and, conversely, allowing us time to grieve.

During this time, we imagined what life would be like without him, too. The thought was too cruel to really sink in. How could a family lose two vital men in such a short period of time? But every few days we’d find ourselves wondering if our nightmare was going to be real. His aneurysm was so damaging that he should have died instantly, according to one of his doctors. Paul’s wife Nettie, my wife Marianne, and I never left his side.

Paul was my best friend; he was my “go-to” guy. We bounced ideas off each other all the time. After growing up together as kids, we separated during college and law school, then rejoined and spent a year vagabonding in Europe in a ’64 Volkswagen van. We returned to the states in 1973 and lived together at our family cabin in Crystal Bay until he married and moved to Truckee in 1982. I did the same in 1987.

Even after we both moved on in our marriages, our families stayed close, getting together for most vacations and holidays. When a job opportunity arose in 1991 to manage Poppy Hills Golf Course in Pebble Beach, Paul and his family moved to Carmel Valley, which only made us more determined to keep our families entwined.

We wore out paths between here and there, managing to get together every few months.

Paul was, and is, a remarkable man. A more genuine, positive person cannot be found. The heartfelt cards people are sending us are flowing with stories that tell of the caring little things he did for friends. They all remember his big, warm smile. Some people haven’t seen Paul since elementary school, and they remember how kind and loyal he was as a kid.

Recently, I met several of his employees at Poppy Hills and the Northern California Golf Association in Pebble Beach, where he was CEO of both organizations. They all told me “he is the reason I am here.” Remarkable. He affected so many people in life-changing ways. He had a gift for reading people and bringing them together.

Paul’s farewell event will be held Oct. 8 at 1 p.m., at Poppy Hills Golf Course. Any donations may be made to The Paul Porter Memorial Fund of the NCGA Foundation supporting junior golf leadership programs at 3200 Lopez Road, Pebble Beach, CA 93953.

I’m not sure where I am going with this, but I just needed to talk. I know I have learned many life lessons from my brothers. It’s basic stuff, really, but like anything worth doing, it takes constant effort: Make time for others, certainly for your family and friends; co-workers, too. Find the positive in people. Put in a good word. Lead by example. Make a difference. Nurture friendships. Take time for your family, of course. And remember, life can be surprisingly short. Live it accordingly.-

Thanks, I needed that. And with this column I don’t mean to sound like I am the only one with personal setbacks.

And mostly, thanks to all of our friends who have been there for us. Even when there may be nothing you can do or say, we know you are there. And we love you for that. We’ll get through this.

Jim Porter is an attorney with Porter· Simon, with offices in Truckee, South Lake Tahoe and Reno. He is a mediator and was the Governor’s appointee to the Bipartisan McPherson Commission and the California Fair Political Practices Commission. He may be reached at porter@portersimon.com or at www.portersimon.com.–