March 2013

I knew there was a reason I got licensed to practice law in consumer-friendly Washington:

A Washington state court yesterday denied Intuitive’s bid to throw out a lawsuit over the death of a patient operated on using the company’s da Vinci surgical system, according to court filings. The judge found the state’s product-liability laws require medical-device makers to properly train physicians who buy their products.

Source: Intuitive Surgical Loses Bid to Throw Out Robot Lawsuit – Bloomberg

So, the Supreme Court will decide two interesting cases.  The one below will decide whether or not a brand name manufacturer can simply pay generic companies not to bring generic drugs to market:

WASHINGTON (AP) — Federal regulators are pressing the Supreme Court to stop big pharmaceutical corporations from paying generic drug competitors to delay releasing their cheaper versions of brand-name drugs. They argue these deals deny American consumers, usually for years, steep price declines that can top 90 percent

Source: The Associated Press: Court: Can drug companies pay to delay generics?

The second is whether or not generic manufacturers can be held liable if their drugs injure consumers.  One of the arguments against letting generic manufacturers be sued is that they may take their products off the market due to the cost of litigation.  This is an entirely false argument if for no other reason than generic manufacturers can buy insurance that covers any payouts.

But, if you accept the premise that it’s too important to make sure generic drugs are on the market to allow generic manufacturers to be sued, then you should also accept the premise that brand name companies shouldn’t be allowed to pay to keep generics off the market.  It will be interesting to see which justices rule which way on both cases.

Here’s a little more in-depth analysis of the generic drug argument before SCOTUS:

Andre Mura, litigation counsel at the Center for Constitutional Litigation in Washington, D.C., said the government’s argument was troubling. “There were suggestions that the FDA shouldn’t be second-guessed, but as the Court said in Wyeth v. Levine, the FDA approval process does not mean, and should not be taken to mean, that a drug is absolutely safe even for approved uses,” said Mura, who wrote an amicus brief for AAJ in Bartlett. “Congress didn’t intend the FDA to provide the sole level of consumer protection, and a broad preemption ruling here would ignore that clear congressional intent.”

Source:

Supreme Court grapples with generic drugs and design defects

A recent article published by DailyRx.com, a prominent pharmaceutical commentary website, has commented on FDA warnings that Zithromax Z-Pak can cause fatal heart rhythms, and suggests that potential users of the drug be very cautious.

The author of the article, Dr. Sarah Samaan, writes:

“Patients at particular risk for developing a potentially deadly irregular heart rhythm from azithromycin include those with known risk factors such as low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias.”

Read the whole article about the danger of Zithromax Z-Pak here.

Recently, the United States Food and Drug Administration has required that the warning label for the popular antibiotic drug Zithromax be updated to include information regarding the drug’s likelihood to cause cardiovascular death.  Some studies have shown that the drug raises the risk for cardiovascular death by a factor of 2.5, compared with other antibiotic drugs, such as amoxicillin.  Read the full report concerning Zithromax and heart failure by following the link above.

Just imagine the sleazy sales manager who wrote the e-mail below”

Company e-mails introduced in a lawsuit filed against Intuitive in Kitsap County, Washington, suggest salesmen lobbied hospitals to scale back doctor training. One manager’s e-mail lauded a salesman for persuading a hospital that five supervised operations were too many. In another, a manager told a sales team not to “let proctoring or credentialing get in the way” of meeting goals on the number of robot surgeries.

Source: Intuitive Robosurgery Training Seen Lacking in Lawsuits – Bloomberg

There’s also a BS line in here about how the company can’t require the doctors to do anything.  Wrong.  As part of a licensing agreement with the hospital the company could require the doctors to do as many supervised surgeries as it wanted. 

On the one hand it’s disappointing to see them give up the fight.  On the other, at least this won’t lead to a SCOTUS ruling that strips the FDA of more power.  The fear of such a ruling is why I suspect the FDA gave up.

(Reuters) – The government has dropped its push for cigarette labels to carry images of diseased lungs and other graphic health warnings, and will craft new anti-smoking ads that do not run afoul of free speech rights.

In a letter to Republican House Speaker John Boehner last Friday, Attorney General Eric Holder said that the Food and Drug Administration would go back to the drawing board to develop the ads, as required by legislation passed by Congress in 2009.

Source: Government changes course on graphic cigarette warnings | Reuters

More on generic liability:

 

During a one-hour oral argument justices questioned whether federal law, in this case the requirement that generics have same design as the name-brand version, prevents plaintiffs from making such claims under state law.

 

Some justices signaled concern about juries making sweeping judgments about the effectiveness of drugs while others questioned how to differentiate the case from another case involving generics decided in 2011.

‘U.S. high court weighs generic drugmaker liability | Reuters