Legal Briefing: Generic Pharmas Are Responsible for Drug Safety Too

A daily look at legal news and the business of law...

Generic Drugmakers Can Be Sued for Not Warning About Risks

For many drugs, generic versions prove equally effective and safe for much less cost -- but not in all cases. Legal Intelligencer reports that a time-release generic version of antidepressant Wellbutrin caused patients problems because unlike the original, which released the drug slowly so that the patient got the highest dose in about five hours, versions made by Teva Pharmaceuticals (TEVA) and Impax Laboratories (IPXL) created peak concentrations in two hours. (Generic versions produced by Watson Pharmaceuticals (WPI) and Anchen Pharmaceuticals produced peak concentrations at five hours.)

Patients who suffered serious side effects because of the accelerated release sued, charging that Teva and Impax knew about the different release speed and the problems it caused but didn't warn anybody about it.

Teva and Impax defended themselves by pointing to the Food and Drug Administration's certification that their versions were "bioequivalent" to the original Wellbutrin and were equally safe and effective. That certification absolved them of any need to tell doctors or patients about the different release speed and related problems, even though the companies knew about them. As a result, the companies asked Judge Berle M. Schiller to dismiss the case.

Citing the recent U.S. Supreme Court decision Wyeth v. Levine, Judge Schiller rejected the companies' argument and allowed the suit to go forward, noting that "Levine teaches that the ultimate responsibility rests with the drugmaker, not the FDA, to either adequately inform the public or remove the drug from the market."

Google/YouTube and Viacom Gain Allies in Their War

Google and Viacom are at war over YouTube's hosting of unlicensed copyrighted Viacom (VIA) material. The case, with lots of nasty details, became public last March, and now four Internet giants have joined Google's (GOOG) side. Yahoo!, eBay, Facebook and IAC filed a friend-of-the-court brief on Google/YouTube's side, urging the judge to rule as a matter of law that YouTube is not liable for hosting the unlicensed material.

The Internet giants are interested because the defense Google asserts -- the safe harbor of the Digital Millennium Copyright Act -- is a defense the companies want to ensure is as robust as possible. If Google loses, they worry their own protection will be limited.

Nonsense, replies Viacom, claiming the suit focuses on activities so extreme that the safe harbor doesn't apply, so a Viacom win won't affect its scope. Viacom is not without allies of its own -- a friend-of-the-court brief was filed on its behalf by NBC Universal, Warner Bros., Disney, the Screen Actors Guild, and Directors Guild of America.

In addition to the friend-of-the-court filings, another recent development was the revelation that Google offered Viacom several times more than any other company to license its works -- at least $592 million -- but the two companies never reached agreement. The high offer reflects Google's awareness of how valuable the Viacom content was to YouTube's success.

On the other side, an early e-mail from a Viacom attorney suggests YouTube is doing nothing wrong, not pirating content as Viacom now claims. That statement should be read in context -- Viacom was bidding on YouTube at the time.

And in the Business of Law...

The Wall Street Journal reports on the changing of the guard at Cravath, as partners in their 30s and 40s make their mark. The conservative law firm's culture is changing, becoming more aggressive: "This is not your grandfather's Cravath." Over the next decade or so, it'll be interesting to see if the reputation the youngsters are now building for the firm maintains its near-mythic status for power and quality built by those grandfathers.

Above the Law takes UCLA to task for not only posting grades late, but its syrupy sweet, pat-you-on-the-head communication style in telling students about it. As ATL rightly notes: "This e-mail is going to give me diabetes."