Original Drug Makers Liable for Injuries from Generics?

Drug makers may now have to provide safety warnings not just for their own products but also for those of companies that make generic drugs derived from the original manufacturer. A California appellate court ruled on Friday that name-brand drug makers can be held liable for harm caused by competing companies' generic versions.

Wyeth, a New Jersey based pharmaceutical company, is being sued by a woman named Elizabeth Conte. She claimed she developed a serious and irreversible neurological condition after long-term use of generic versions of Wyeth's Reglan to treat gastroesophageal reflux disease.  Conte argued that Wyeth should have had the duty to warn doctors that Reglan and its generic versions shouldn't be used for more than 12 weeks at a time. Conte took the drug for nearly four years

I was surprised when I read the court sided with Conte with this decision.  It seems that only manufacturer’s of a product that injured someone should be liable.  Essentially, generic drug makers get a free pass:  they profit from piggybacking off of the original drug-maker yet suffer no product liability if they harm consumers.  Original drug manufacturers will have even less incentive to invest in R&D and innovation, thereby hurting the innovation pipeline in the pharmaceutical industry.  I do agree, however, that original manufacturer’s should share any harmful information they have about the drug with generics.  But creating indirect product liability for original drug makers creates a dangerous free-rider problem.      

Conte v. Wyeth Inc.:

http://www.courtinfo.ca.gov/opinions/documents/A116707.PDF

http://www.law.com/jsp/article.jsp?id=1202425895939&rss=newswire

Comments

[Julie Cho]

This seems like a similar case to that of Phenergan, where the drug was inappropriately administered by the doctor to the patient, and the pharmaceutical company was sued for not high-lighting the side effect although it is clearly stated in the drug information. I just looked up drug information on Reglan, and it says clearly that it is for a short-term use and should not be taken more than 12 weeks at a time. I just do not see the logic in the pharmaceutical company being liable for 1. the misuse or inappropriate administration of the drug by the physicians 2. generic drugs that other pharmaceutical companies developed. I totally agree and share your concern that this is going to dramatically decrease the incentive to develop new drugs for pharmaceutical companies, which would only hurt the public.

[Nina Kini]

Also, generic drug makers are not held to the same standards as the original medication in terms of "aesthetic qualities" of the pills and some side effects. For example, if the original tablet was coated to prevent gastric distress while swallowing, there is nothing to hold the generic manufacturer from deciding not to coat and save a step in the process. They can only do this if it doesn't change the original "formula" of active ingredients. I agree that generic makers need to be held accountable for product safety as they are manufacturing these medications, particularly now that so many insurance companies refuse to cover branded products and push us toward generics.

[Joseph Logue]

Generic drug companies are allowed their low prices by not having the expensive cost of R&D and also do not have the big brand name. While they might not come up with the design of their drugs they should be held responsible for what happens with their drugs. They take on the responsibility once they sell the drug to the consumer. They need to fully understand what they are selling and be held responsible for warnings and instructions. I do agree this can cause a negative effect on the big companies that spend a lot on R&D and feel this should be addressed.

[Kristina Paschall]

I agree that a generics company should be liable for negative effects of their own drugs. I worked for Sandoz Pharmaceuticals several years ago. I want to comment though about the unbelievable commitment to quality I saw when I was there. We're not talking generic paper towels here, obviously. Sometimes it seemed so crazy beareaucratic, but you can understand why it has to be that way. I don't have any doubt at all that they fully understand what they are selling and expect to be held responsible. Of course, noone is going to admit blame in a lawsuit.
Also, often the generics companies are owned by non-generics companies (Sandoz is the generics arm of Novartis, for instance).
I actually think that, in addition to the generics companies, doctors are liable for understanding the generics versions as well as the non-generics.

After reading this on the Sandoz site: 'Even if we know the quantitative ingredients or can determine the technology, there is often a lot about the reference product that we simply don’t know. We must develop our own way around the patents using accessible equipment and ingredients in order to prove the efficacy, safety and reproducible quality of our own generic product.', it makes me think that doctors should't simply be able to say 'Generics okay' on the prescription. They should talk to the patient and decide specifically what to prescribe.

[P. Khetarpal]

I think it depends if the liability is related to manufacturing, product side effects not related to manufacturing, or proper disclosure. While I don't know much about the Conte case, from what you posted it seems like the side effects would be for LT usage of the branded or generic drug. That makes me think it has to do with the actual drug, and not specific to the manufacturing process. If this is true, I think both firms should be held liable.

[Chris Johnson]

I don't believe that the original drug developer should be held liable in any circumstance. Assuming a few things, the original developer did not sell the formula to the generic manufacturer, did not make any offer or accept any consideration. It is not in the original drug developer's interest to allow the generic manufacturer to produce and sell the drug. If this ruling is not ridiculous, it is an outrage.

I bought your crane; tore it apart; built my own and sell it for 1/2 the price yours. It failed and killed all 20 people on the jobsite, and now their families are suing your crane company? Are you kidding me?! Sign me up. I bet I can make arterial stents and motorcycle helmets in my basement in my spare time.

[Meredith Royer]

I am somewhat alarmed by what I read at the end of Kristina's comment. I falsely believed that generics were manufactured under the exact same specs as the original drug. I think that if a problem stems equally from a brand name drug and a generic drug, both manufacturers should be responsible. But if a problem comes only from the generic, then obviously the manufacturer of the generic alone should be investigated.

With the push from insurance companies towards generics and thus consumer demand for generics, I see why doctors easily prescribe "substitutions." Perhaps doctors, pharmacists, and patients should question the use of generics more often.

Chris, touché!

[Joshua Steffan]

A profound decision - here's a link to an interesting blog post that examines the implications of this case in detail:

http://druganddevicelaw.blogspot.com/2008/11/more-thoughts-on-conte-v-wyeth.html

[David Pearce]

I am very surprised by the decision - what a profound effect it will have going forward. I found this link to be especially interesting in considering the Conte vs. Wyeth decision.
http://seekingalpha.com/article/106545-wyeth-vs-conte-are-big-pharmas-now-liable-for-generics