Boulder Business Law Advisor

Democrats in the House and Senate introduced bills that would permit generic drug manufacturers the ability to revise the warning labels for generic drugs--in effect making the regulations applicable to brand name drugs applicable to generics. However, it appears that both the bills in the House and Senate bills died in committee.

The bills were introduced in response to the Supreme Court's decision in Pliva v. Mensing about which we have previously written (here and here). In Mensing, the Supreme Court held that federal law preventing generic drug manufacturers from independently changing their generic drugs' warning label pre-empted state law failure-to-warn claims. In essense, according to the Court, it was "impossible" for generic drug manufacturers to comply with both state and federal law. As we previously stated:

Thus, according to the Court, generic drug manufacturers are caught between a proverbial “rock and a hard place”: because state law failure-to-warn claims impose a duty on generic drug manufacturers to provide a “safer label” than required by federal regulations, if the manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law which requires generic drug labels be the same at all times as the corresponding brand name drug labels. “Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.”

The bills would have changed this dynamic by allowing generic drug manufacturers the ability to propose changes to the warnings for their generic drugs in response to safety concerns.

Interestingly, 41 state attorney generals signed a letter in support of the bills, stating:

Consumers whose prescriptions happen to be filled with the brand-name version of a drug are protected by state law from inadequate warnings, but consumers whose pharmacists fill their prescriptions with the generic versions are now denied this protection. Congress can readily cure this problem by amending federal law.

Despite the support of the attorney generals, the bills appear to be going nowhere. Consequently, for now, generic drug manufacturers remain largely immune from product liability lawsuits, particularly those based on state law failure-to-warn claims.

The Boulder Business Defense Lawyers at Laszlo & Associates, LLC provide legal counsel for businesses on a variety of business needs, including products liability, risk management, corporate protection, and legal compliance.

We have discussed in previous posts the Supreme Court’s decision in Pliva v. Mensing which had the effect of making generic drug manufacturer “immune” from state failure-to-warn claims.  In summary, Mensing held that because federal regulations prevented a generic drug manufacturer from effectuating a change to the labeling for a particular drug, the generic drug manufacturers could not be liable for failure-to-warn claims.  The rationale runs along these lines: If a generic drug manufacturer cannot change the warning label because of federal law, how can a generic manufacturer be liable under state law for the generic drug’s label failing to adequately warn the user when it was “powerless” to change that warning?

While a clear win for the generic drug manufacturers, Mensing caused some initial concerns for brand name drug manufacturers that worried the decision might be used to make them liable for injuries caused by generic drugs.  The logic here being that because the brand name drug manufacturer controls the warning label based federal law, the brand name manufacturer can effectuate a change to the labeling of a drug--which the generic drug manufacturer must then mirror according to federal regulations.  So a failure to warn of say a possible undisclosed side effect by the generic manufacturer’s drug can equate to brand name manufacturer liability for the brand name drug manufacturer’s failure to change the warning label.  This has been coined by some “innovator liability.”

This issue was recently visited by the Judge Higbee in the Superior Court of New Jersey in Coundouris v. Wyeth, et al., No. ATL-L-1940-10 (June 26, 2012) through a motion to dismiss filed by the brand name manufacturers.  The drug at issue there was metoclopramide (the brand name, Reglan, made by Wyeth then Schwarz then Alaven) which is used to treat gastroesophageal reflux disease and diabetic gastroparesis.  Some of the plaintiffs in Coundouris never took Reglan but the generic metoclopramide. The plaintiffs brought claims of conscious misrepresentation, negligent representation, negligence, claims under New Jersey’s Product Liability Act (“PLA”) for design defect and manufacturing defect, and warranty claims.

In their motion to dismiss, the brand name defendants argued that the plaintiffs' claims were governed by the PLA, “and that pursuant to the PLA and New Jersey case law, manufacturers of a brand-name drug may not be held liable for injuries caused by a plaintiff's use of a generic drug manufactured by another company.” In opposition:

Plaintiffs argue that their claims against Brand Defendants are not products liability claims governed by the PLA, but are instead negligence claims governed by New Jersey common law. Plaintiffs contend that the Brand Defendants owed a duty to those ingesting generic metocloprarnide to exercise reasonable care in either disseminating accurate, nonmisleading information about metocloprarnide or adequately warning doctors and patients as to the risk of the drug.

The New Jersey court makes short work of the plaintiffs argument.  First the court holds the plaintiffs’ claims are product liability claims.  Since the plaintiffs’ claims fall under the PLA, Plaintiffs' action must fail because they did not ingest a product made or sold by the brand name defendants. In New Jersey, "it is well-settled that in products-liability litigation, [a plaintiff] must demonstrate that his or her injuries were caused by ... defendant's ... product."

Where Plaintiffs never ingested metoclopramide manufactured or sold by the Brand Defendants, they are unable to establish an essential element of their prima facie case under New Jersey law, and their claims against the Brand Defendants must be dismissed.

In its decision, the New Jersey court quotes a prior New Jersey decision, Rossi v. Hoffman-LaRoche, No. ATL-L-690-05 (January 3, 2007), which dealt with a similar issue of brand name drug manufacturer liability for injuries caused by a generic drug: there is “no evidence” that “the New Jersey legislature intended for prescription drug liability to extend to the name-brand manufacturer when the alleged victim ingested a generic equivalent manufactured and sold by another company."  Thus, in Rossi, as in Coundouris, the court declined to create a duty on the part of the brand name manufacturer to the consumers of a generic drug.

The Boulder Business Lawyers at Laszlo & Associates, LLC provide legal counsel for businesses on a variety of business needs, including products liability, risk management, corporate protection, and legal compliance.  

The title of this post might seem like an obvious statement but it is something worth reviewing from time to time...forest-for-the-trees and all.

Rodriguez v. Stryker Corp. was a recent pain pump decision delivered by the Sixth Circuit.  We previously wrote about another pain pump decision in Pritchett v. I-Flow Corp., involving the use of a “differential diagnosis” to establish general causation.  While also involving issues of causation, the opinion in Rodriguez also dealt with whether it was possible for Stryker to reasonably know that its pain pump could have caused the injury complained of in 2004.

In November 2004, the plaintiff, Andrew Rodriguez, had shoulder surgery in which a pain pump was implanted.  Through the pain pimp, the plaintiff received a local anesthetic, bupivacaine, to the shoulder joint.  While the plaintiff initially improved, his condition worsened until he discovered in 2008 that he longer had any cartilage in his shoulder—a condition called chondrolysis.  The plaintiff filed suit in 2008 alleging negligence, strict liability, and breach of warranty.  The district court concluded that Stryker could not have reasonably known in 2004 of the risk of pain pumps causing chondrolysis and thus Stryker had no duty to warn of what was unknowable at the time.

The Sixth Circuit began its inquiry by noting that under Tennessee law (similar to many states) a manufacturer must warn of known risks caused by its products or risks that should have been known through exercising reasonable care.  The court quickly determined, and the plaintiff did even attempt to claim to the contrary, that it was impossible for Stryker to know in 2004 that anesthetics injected by its pain pump could cause chodrolysis—“no reported case of chondrolysis linked to anesthetics appears until 2005.”  So the only way for the plaintiff to show that Stryker had a duty to warn was to establish that Stryker should have known of the chondrolysis risk.

Which brings us to the thirteen published articles submitted by plaintiff.  According to the court, 

none of the articles draws a connection between pain pumps and chondrolysis, leaving Rodriguez to argue something more inferential:  that the studies “document[ ] significant damage to articular cartilage after prolonged exposure to foreign solutions, including bupivacaine”….Even that is a stretch, however, given what the articles say.

After reviewing each article, the court determined: “[w]hen all is said and done, not one of Rodriguez’s thirteen articles shows that medical experts understood in 2004 that infusing a joint with bupivicaine for two days could cause irreversible cartilage damage.”  For this reason, “Stryker had no duty to understand what the relevant medical literature did not.”

Turning to the expert report, the court was similarly unconvinced that it provided evidence that Stryker had a duty to warn about chondrolysis in 2004.  According to the court, the plaintiff's expert report claimed that “general medical knowledge about articular cartilage, combined with the then-extant scientific literature, should have put Stryker on notice that this pain pump would harm cartilage.”  After stating the proposition that a court has a duty to inspect the reasoning of an expert, “including whether an expert’s sources support his conclusions,” the Sixth Circuit found the latter requirement lacking in the plaintiff’s expert report:

[The expert] relies on several articles published after Rodriguez’s surgery, which do not speak to what Stryker should have known months or years earlier based on expert knowledge at the time.  He also relies on articles published before Rodriguez’s surgery, but they are the same thirteen articles discussed above, and none of them supports the conclusion that Stryker reasonably should have known about the risk that its pumps could cause chondrolysis.  The thirteen articles, indeed, undermine the expert report because they show that medical experts did not understand the risks posed to cartilage by pain pumps in 2004, when Rodriguez had his surgery.

Neither the thirteen articles nor the expert report submitted by the plaintiff demonstrated that Stryker had a duty in 2004 to warn of the risk of chondrolysis.  Stacking inference upon inference does not establish a duty-to-warn.  Moreover, the district court need not have submitted this case to a jury “containing only a spark or glimmer of evidence that requires the finder-of-fact to make a leap of faith to find the defendant liable for the plaintiff’s injury.” Thus, the court held that the plaintiff failed to establish that Stryker had a duty to warn of the risk of chondrolysis caused by its pain pumps in 2004:

That is just the problem here.  Rodriguez asks a jury to find that because there were isolated instances over seventy years when evidence showed that a few foreign solutions caused temporary harm to joint cartilage, Stryker should have known (and warned) that using its pain pump in a joint with bupivicaine would cause permanent damage.  On this record, the theory requires two speculative leaps.  It requires the inference that evidence of harm resulting from other solutions meant that anesthetics would cause the same harm.  And it requires the inference that evidence of transient harm to joints meant that irreversible cartilage damage was likely.  Both are far too conjectural and too many steps removed from the problem that developed.  Just because ingesting one type of liquid over a period of time may cause a problem does not mean that ingesting another liquid will cause the same problem.  And just because cleaning a wound with rubbing alcohol causes temporary discomfort does not permit the inference that cleaning a wound more than once will produce permanent discomfort.  To conclude otherwise would establish a claim for hindsight negligence, not common law negligence.

The Boulder business lawyers at Laszlo & Associates, LLC provide legal counsel to businesses on a variety of business needs including products liability, risk management, corporate protection and legal compliance.

We previously wrote about the First Circuit's decision in Bartlett v. Mutual Phamaceutical Co., Inc. which refused preemption for a design defect product liability claim against a generic drug manufacturer.  In our previous post on Bartlett, we discussed the apparent frustration on the part of the First Circuit with the Supreme Court's decision in Pliva v. Mensing.  For this reason, the First Circuit was unwilling to leave the injured plaintiff in Bartlett with no avenue of remedy for her injuries from a generic drug and decided against preemption for her design defect claims.

Taking a look at the Bartlett opinion again, the First Circuit did not even attempt to distinguish the difference between the impossibility of a generic drug manufacturer changing the drug's label under federal law with the impossiblity of the generic drug manufacturer changing the chemical composition of the drug under federal law.  Moreover, as the First Circuit recognizes: it is unclear "how [a manufacturer] could alter a one-molecule drug anyway."  The First Circuit acknowledged that Mutual's argument--that a generic drug manufacturer cannot alter the label of the drug or the composition of the drug under federal law--had "some force" but quickly rejected it. 

As we discussed previously (here and here), the Supreme Court's decision in Mensing found federal preemption for state law failure-to-warn claims against a generic drug manufacturer based largely on the "impossibility" of generic drug manufacturers' ability to comply with both state law and federal law. For the most part, a generic drug manufacturer cannot change the label on its drug; all label changes must proceed through the brand name manufacturer.  When a generic drug manufacturer is sued under state law for failing to adequately warn of certain harmful side effects on its drug's label, state law is in effect creating additional labeling standards above what is required by federal law.  On its face, this might not seem to be of much issue as it occurs in numerous areas where federal and state law overlap, but when you add the "impossibility" of complying with both state and federal law in the mix, here is where preemption comes in.  

The Supreme Court's "impossibility" analysis under Mensing is of importance because the First Circuit in Bartlett larglely ignores the reasoning of the Mensing decision.  If the First Circuit actually followed the Supreme Court's reasoning in Mensing, it most likely would have concluded that if the "impossibility" of changing a drug's label under federal law allowed for preemption of state law failure-to-warn claims then the "impossibility" of changing a drug's chemical composition under federal law would lead to a finding of preemption for state law design defect claims.  For this reason, the First Circuit's opinion that "the generic drug manufacturer need not make the drug in the first place to avoid design defect claims" rings hollow because the Supreme Court could have ruled the same for a generic drug manufacturer facing the impossibility of changing its drug's label in the context of a failure-to-warn claim.  In other words, faced with the impossibility of complying with state and federal---beit the drug's label or the drug's composition--the Supreme Court could have simply stated that "the generic drug manufacturer need not make the drug in the first place to avoid the impossibility of complying with both state and federal law."  The Supreme Court of course did not come to this decision.  

In fact, the First Circuit knew that the Supreme Court rejected similar arguments that the generic drug manufacturer need not make the drug at all:

Mutual argues with some force that the generic maker also cannot alter the composition of the drug and so PLIVA's policy of encouraging generics by preempting state tort claims should extend to design defect as well as claims based on inadequate warning.  But although Mutual cannot legally make sulindac in another composition (nor is it apparent how it could alter a one-molecule drug anyway), it certainly can choose not to make the drug at all; and the FDCA might permit states to tell Mutual it ought not be doing so if risk-benefit analysis weights against the drug, despite what the Supreme Court made of similar arguments in the labeling context.

Thus, the First Circuit seemingly recognized that the Supreme Court's reasoning in Mensing would lead to preemption for design defect claims as well, but refused to accept such a conclusion.

The Boulder Business Lawyers at Laszlo & Associates, LLC provide legal counsel for businesses on a variety of business needs, including products liability, risk management, corporate protection, and legal compliance.  

Our previous posts (here and here and here) discussed the Supreme Court’s decision in Pliva v. Mensing which largely immunized generic drug manufacturers from state law failure-to-warn claims.  In Mensing, the Court held that federal regulations preventing generic drug manufacturers from independently changing their drug's labeling preempted state law failure-to-warn claims for injuries caused by the generic drug since it was “impossible” for the generic drug manufacturers to comply with both state and federal requirements.

Since Mensing, there have been a number of district court opinions finding preemption for product liability claims against generic drug manufacturers, regardless of the theory.  For this reason, courts overwhelmingly have dismissed numerous claims based upon preemption grounds.

However, the decision in Metz v. Wyeth provided a gasp of air for a plaintiff’s product liability claims against a generic drug manufacturer.  In Metz, the court, similar to numerous other courts addressing the issues, dismissed the claims of strict liability, misrepresentation, and fraud on preemption grounds but found that the plaintiff’s implied warranty claim was not preempted. 

Metz involved claims for injuries caused by the generic of Reglan, metoclopramide.  According to the court, under Mensing, the plaintiff’s implied warranty claim would be preempted “to the extent it stems from [defendant’s] failure to provide additional warnings relating to the risks associated with long-term metoclopramide use or Actavis' failure to stop manufacturing and marketing the generic version of metodopramide.”  

However, the court offered a possible interpretation for an implied warranty claim that may survive preemption under Mensing:

Unlike Plaintiffs' strict liability claim which must demonstrate that metoclopramide was unreasonably dangerous when used in a manner consistent with the FDA approved label, an implied warranty claim may survive preemption based on a showing that [defendant] knew metoclopramide was likely to be used to treat GERD for longer than twelve weeks and implicitly warranted that it was safe and effective for such use despite the warning to the contrary in the FDA approved label. That is, it is conceivable that Actavis could have taken additional steps consistent with the FDCA and the FDA approved label to impact the manner in which physicians prescribed metoclopramide (i.e., the “intended” use) and that a claim based on this failure to act may survive preemption under Mensing.

While generic drug manufacturers have been scoring preemption victories for most claims in the wake of Mensing, implied warranty claims may survive Mensing preemption. 

The Boulder business lawyers at Laszlo & Associates, LLC provide legal counsel to businesses on a variety of business needs including products liability, risk management, corporate protection and legal compliance. http://www.laszlolaw.com/product-liability

In the wake of the Supreme Court’s Pliva v. Mensing decision (previously discussed here and here), the Sixth Circuit Court of Appeals in Smith v. Wyeth followed suit, holding that state law failure-to-warn claims against generic pharmaceutical manufacturers were pre-empted by federal law.  According to the Sixth Circuit, “[t]he plain language of the Pliva decision compels the same result here”:

The Supreme Court held unequivocally…that federal law preempts state laws that impose on generic-drug manufacturers the duty to change a drug’s label, thus barring the plaintiffs’ state-law tort claims.  

However, these cases are different than a straight-forward Mensing-type case in that the plaintiffs also sued the brand-name manufacturers of the drug for injuries caused by the generic manufacturers’ drug under a vicarious liability, failure-to-warn theory.  In brief, the theory is based on the federal regulatory structure governing drugs where brand-name drug manufacturers are the only entity in the position to propose label changes.  The generic drug label must mirror the brand-name drug's label, leaving generic manufacturers largely with no power or avenue to request label changes.  According to plaintiffs, it is foreseeable that doctors and patients will rely on the label controlled solely by the brand-name manufacturer—whether that label is on the brand-name drug or the generic drug.  Consequently, the brand-name manufacturer thus has a duty to all of the drug’s users, both brand-name and generic, to maintain an adequate label warning of the risks associated with the drug.  

Despite plaintiffs' best efforts, the Sixth Circuit wasn't sold and quickly dismissed this theory, stating that it has been rejected by all but one of the courts that have considered it.  (The one being Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299, 313 (Cal.  Ct. App. 2008) (“[W]e have no difficulty concluding that [the name-brand defendant] should reasonably perceive that there could be injurious reliance on its product information by a patient taking generic metoclopramide.”)).  The Sixth Circuit stated that:

 …adopting [plaintiffs'] theory of liability would require the court to attribute any deficiency in a name-brand manufacturer’s labeling and marketing of its products to products manufactured by its generic competitors.  Such a theory, however, fails to satisfy the threshold requirement of a products-liability action – that the defendant’s product have injured the plaintiff.  As the district court stated, “Just because a company is in the same business as a tortfeasor, the company is not automatically liable for the harm caused by the tortfeasor’s product.”

The Court relied upon “the leading case” that considered this issue, Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994), in “reject[ing] the argument that a name-brand drug manufacturer owes a duty of care to individuals who have never taken the drug actually manufactured by that company.”

As previously discussed here, there has been speculation that plaintiffs using this vicarious liability theory would increase as a result of the Mensing decision.  The Sixth Circuit Court seems to want to nip that theory in the bud...quickly.  However, the Court does leave the door slightly open, emphasizing that its decision primarily rests upon the inability of plaintiffs to show this theory was viable under state law:  “Moreover, and most significantly, the plaintiffs have not convinced us that the state courts of Kentucky would adopt their vicarious-liability argument under the Kentucky Products Liability Act.”  (emphasis added).  This could imply that if a state’s product liability statute could be construed by a plaintiff in a manner that would hold a brand-name drug manufacturer liable under a vicarious liability theory for “controlling the warning label of a drug” then a plaintiff’s state law failure-to-warn claim may proceed against the brand name manufacturer for injuries caused by the generic drug. 

On June 23, 2011, the Supreme Court handed a stunning victory for generic drug manufacturers, effectively immunizing them from state law failure-to-warn claims.  In Pliva  v. Mensing, the Court held that federal regulations preventing generic drug manufacturers from independently changing their drug's labeling pre-empted state law failure-to-warn claims for injuries caused by the generic drugs.  According to the Court, it was “impossible” for the generic drug manufacturers to comply with both state and federal requirements.

Under the Hatch-Waxman Amendments of 1984, for a generic drug manufacturer to receive FDA approval to market its drug, the manufacturer must show that the drug is equivalent to an already FDA approved brand name drug and that the generic drug sought for marketing has the same safety and efficacy labeling as the brand name drug.  Thus, federal regulations require a generic drug's labeling mirror that of the brand name drug's.  While there are certain limited circumstances where a label can be altered by a manufacturer without prior FDA approval, such as the “changes-being-effected” (CBE) process or via “Dear Doctor” letters, the FDA denied that either option was available for the generic manufacturer in Mensing, with the Court deferring to FDA discretion.  Thus, according to the Court, generic drug manufacturers are caught between a proverbial “rock and a hard place”: because state law failure-to-warn claims impose a duty on generic drug manufacturers  to provide a “safer label” than required by federal regulation, if the manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law which requires generic drug labels be the same at all times as the corresponding brand name drug labels.  “Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.”  Section III.A.

Interestingly, while the FDA denied that the CBE process or the “Dear Doctor” letter were options available to the generic manufacturer in Mensing, the FDA nonetheless determined that generic drug manufacturers do in fact have a duty to seek FDA assistance with the warning label about known health risks or concerns based on the preamble to the 1992 amendments to the Hatch-Waxman amendments.  See 57 Fed. Reg. 17961 (“If a [generic drug manufacturer] believes new safety information should be added to a product’s labeling, it should contact FDA, and FDA will determine whether the labeling for the generic and listed drugs should be revised”).  According to the FDA,       “[g]eneric drug manufacturers that become aware of safety problems must ask the agency to work toward strengthening the label that applies to both the generic and brand name equivalent drug” or "take steps" as described in oral argument.  Section II.B.3.  However, because the Court already found pre-emption, it declined to resolve the duty issue, despite deferring to the FDA on the previous issues. 

Although it declined to resolve the duty to "take steps" issue, the Court, assuming arguendo that a generic manufacturer does in fact have a duty to request FDA assistance with a label, noted that Plaintiff-Respondents’ claims were not based on “the Manufacturers’ alleged failure to ask the FDA for assistance in changing the label” anyway.  Further, even if plaintiffs' claims were based on such duty, seeking FDA assistance possibly would satisfy a manufacturer’s federal duty but would not address its’ state law duty: “[s]tate law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.”  Section III.A.  Notably, the Court's decision does not address whether there would even be a private cause of action by an injured plaintiff for breach of a duty to seek FDA assistance or whether such a breach of duty would be enforceable only by the FDA.

In reaching its decision in Mensing, the court also distinguished Wyeth v. Levine in that Wyeth involved a brand name drug manufacturer.  In Wyeth, the Court held that a state failure-to-warn claim against a brand name drug manufacturer was not pre-empted because it was possible to comply with both federal and state statutes and regulations.  Because federal statutes and regulations for brand name drug manufacturers differ from those applicable to generic drug manufacturers, “[t]his Court will not distort the Supremacy Clause in order to create similar pre-emption across a dissimilar statutory scheme.  Congress and the FDA retain authority to change the law and regulations if they so desire.”  Section III.C.  Thus, where it was possible for a brand name drug manufacturer to comply with both state and federal law, it was impossible for a generic drug manufacturer.

While this decision may be a strong win for the generic manufacturers, its practical effects ultimately may be minimal.  The Court noted in footnote 9 that the FDA stated this particular situation with generic manufacturers arises infrequently, largely because most generic drug manufacturers arrive in the market years after the brand name drug has been marketed.  For this reason, new information about a drug’s risk generally arises before the generic manufacturer enters the market.  Further, although many consumers may be completely unaware or totally uninterested in the Mensing decision, consumer knowledge of this decision would most likely not cause them to decide against purchasing generic drugs even if they knew that its manufacturer would not be liable for failing to provide adequate safety warnings, even where the generic manufacturer had actual knowledge of certain risks.  Given the price difference between a brand name and generic drug, not to mention insurance company requirements to purchase generics if available, consumers would probably still choose generics.  (This does however put insurance companies in an interesting situation by steering their insureds toward cheaper generics and  into a position where their insureds abdicate a strong potential right of recovery for injuries though a failure-to-warn claim.) 

Finally, even if a consumer choses a generic drug, does this decision possibly open up a brand name manufacturer in any way to additional liability for failing to warn about safety risks when a person is injured by the generic, especially considering the brand name manufacturer is now more than ever the gatekeeper to that drug's label?  Seems like a bit of a reach considering the consumer was not injured directly by the brand name manufacturer's drug, but such a theory of liability is not without precedent.  (See Expanded Liability for Generic, Brand Manufacturers Ahead?).  While suits in California and Vermont have held that a brand name manufacturer could be held liable for labeling on a generic drug, it difficult to discern whether other courts will follow this line of reasoning.  However, as stated over at Pharmaexec.com: "[w]hile the California and Vermont decisions don’t necessarily constitute a consensus...“there are 50 states out there, and a lot of them have a great penchant for saying, ‘We really don’t like to leave our injured citizens without a remedy.’”